CFR 2023 Title21 Vol6

Title 21
Food and Drugs

Parts 500 to 599
Revised as of April 1, 2023
Containing a codification of documents

of general applicability and future effect
As of April 1, 2023
Published by the Office of the Federal Register

National Archives and Records Administration
as a Special Edition of the Federal Register
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VerDate Sep<11>2014 16:35 May 05, 2023 Jkt 259076 PO 00000 Frm 00001 Fmt 8091 Sfmt 8091 Q:\21\21V6.TXT PC31
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Table of Contents
Page
Explanation ................................................................................................ v
Title 21:
Chapter I—Food and Drug Administration, Department of Health

and Human Services (Continued) ................................................. 3
Finding Aids:
Table of CFR Titles and Chapters ....................................................... 643
Alphabetical List of Agencies Appearing in the CFR ......................... 663
List of CFR Sections Affected ............................................................. 673

iii
Cite this Code: CFR
To cite the regulations in

this volume use title,
part and section num-
ber. Thus, 21 CFR
500.23 refers to title 21,
part 500, section 23.
iv
Explanation
The Code of Federal Regulations is a codification of the general and permanent
rules published in the Federal Register by the Executive departments and agen-
cies of the Federal Government. The Code is divided into 50 titles which represent
broad areas subject to Federal regulation. Each title is divided into chapters
which usually bear the name of the issuing agency. Each chapter is further sub-
divided into parts covering specific regulatory areas.
Each volume of the Code is revised at least once each calendar year and issued
on a quarterly basis approximately as follows:
Title 1 through Title 16..............................................................as of January 1
Title 17 through Title 27 .................................................................as of April 1
Title 28 through Title 41 ..................................................................as of July 1
Title 42 through Title 50 .............................................................as of October 1
The appropriate revision date is printed on the cover of each volume.
LEGAL STATUS
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For changes to the Code prior to the LSA listings at the end of the volume,
consult previous annual editions of the LSA. For changes to the Code prior to
2001, consult the List of CFR Sections Affected compilations, published for 1949-
1963, 1964-1972, 1973-1985, and 1986-2000.
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vi
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OLIVER A. POTTS,
Director,
Office of the Federal Register
April 1, 2023
vii
THIS TITLE
Title 21—FOOD AND DRUGS is composed of nine volumes. The parts in these
volumes are arranged in the following order: Parts 1–99, 100–169, 170–199, 200–299,
300–499, 500–599, 600–799, 800–1299 and 1300 to end. The first eight volumes, con-
taining parts 1–1299, comprise Chapter I—Food and Drug Administration, Depart-
ment of Health and Human Services. The ninth volume, containing part 1300 to
end, includes Chapter II—Drug Enforcement Administration, Department of Jus-
tice, and Chapter III—Office of National Drug Control Policy. The contents of
these volumes represent all current regulations codified under this title of the
CFR as of April 1, 2023.
For this volume, Ann Worley was Chief Editor. The Code of Federal Regula-
tions publication program is under the direction of John Hyrum Martinez, as-
sisted by Stephen J. Frattini.
ix
Title 21—Food and
Drugs
(This book contains parts 500 to 599)
Part
CHAPTER I—Food and Drug Administration, Department of

Health and Human Services (Continued) ........................... 500
CHAPTER I—FOOD AND DRUG
ADMINISTRATION, DEPARTMENT OF HEALTH
AND HUMAN SERVICES (CONTINUED)
EDITORIAL NOTE: Nomenclature changes to chapter I appear at 69 FR 13717, Mar. 24, 2004,
and 69 FR 18803, Apr. 9, 2004.
SUBCHAPTER E—ANIMAL DRUGS, FEEDS, AND RELATED PRODUCTS
Part Page
500 General .................................................................... 5
501 Animal food labeling ............................................... 15
502 Common or usual names for nonstandardized ani-
mal foods .............................................................. 32
507 Current good manufacturing practice, hazard anal-
ysis, and risk-based preventive controls for food
for animals ........................................................... 34
509 Unavoidable contaminants in animal food and
food-packaging material ...................................... 68
510 New animal drugs .................................................... 72
511 New animal drugs for investigational use ............... 85
514 New animal drug applications ................................. 90
515 Medicated feed mill license ..................................... 127
516 New animal drugs for minor use and minor species 132
520 Oral dosage form new animal drugs ........................ 158
522 Implantation or injectable dosage form new ani-
mal drugs ............................................................. 272
524 Ophthalmic and topical dosage form new animal
drugs .................................................................... 357
526 Intramammary dosage form new animal drugs ....... 384
528 Intentional genomic alterations in animals ........... 390
529 Certain other dosage form new animal drugs .......... 391
530 Extralabel drug use in animals ............................... 398
556 Tolerances for residues of new animal drugs in food 404
558 New animal drugs for use in animal feeds ............... 420
564 [Reserved]
570 Food additives ......................................................... 564

571 Food additive petitions ........................................... 576
21 CFR Ch. I (4–1–23 Edition)
Part Page
573 Food additives permitted in feed and drinking
water of animals ................................................... 581
579 Irradiation in the production, processing, and han-
dling of animal feed and pet food ......................... 608
582 Substances generally recognized as safe ................. 609
584 Food substances affirmed as generally recognized
as safe in feed and drinking water of animals ...... 633
589 Substances prohibited from use in animal food or
feed ....................................................................... 634
590–599 [Reserved]
SUBCHAPTER E—ANIMAL DRUGS, FEEDS, AND RELATED
PRODUCTS
PART 500—GENERAL 500.92 Implementation.
Subpart F—Methods for Detection of Resi-

Subpart A [Reserved] dues of Carcinogenic Compounds
Subpart B—Specific Administrative Rulings Used in Food-Producing Animals
and Decisions 500.1410 N-methyl-2-pyrrolidone.
Sec. AUTHORITY: 21 U.S.C. 321, 331, 342, 343, 348,
500.23 Thermally processed low-acid foods 351, 352, 353, 360b, 371, 379e.
packaged in hermetically sealed con-
SOURCE: 40 FR 13802, Mar. 27, 1975, unless
tainers. otherwise noted.
500.24 Emergency permit control.
500.25 Anthelmintic drugs for use in ani-
mals. Subpart A [Reserved]
500.26 Timed-release dosage form drugs.
500.27 Methylene blue-containing drugs for Subpart B—Specific Administrative
use in animals. Rulings and Decisions
500.29 Gentian violet for use in animal feed.
500.30 Gentian violet for animal drug use. § 500.23 Thermally processed low-acid
500.45 Use of polychlorinated biphenyls foods packaged in hermetically
(PCB’s) in the production, handling, and sealed containers.
storage of animal feed.
500.46 Hexachlorophene in animal drugs.
Except as provided in § 507.5(b) of this
500.50 Propylene glycol in or on cat food. chapter, the provisions of parts 507 and
113 of this chapter apply to the manu-
Subpart C—Animal Drug Labeling facturing, processing, or packing of
Requirements low-acid foods in hermetically sealed
containers, and intended for use as food
500.51 Labeling of animal drugs; mis- for animals.
branding.
500.52 Use of terms such as ‘‘tonic’’, ‘‘tone’’, [80 FR 56337, Sept. 17, 2015]
‘‘toner’’, or ‘‘conditioner’’ in the labeling
of preparations intended for use in or on § 500.24 Emergency permit control.
animals. The provisions of part 108 of this
500.55 Exemption from certain drug-labeling chapter shall apply to the issuance of
requirements. emergency control permits for the
manufacturer or packer of thermally
Subpart D—Requirements for Specific processed low-acid foods packaged in
Animal Drugs hermetically sealed containers, and in-
500.65 Epinephrine injection 1:1,000 in 10- tended for use as food for animals.
milliliter containers for emergency
[61 FR 37681, July 19, 1996]
treatment of anaphylactoid shock in cat-
tle, horses, sheep, and swine.
§ 500.25 Anthelmintic drugs for use in
animals.
Subpart E—Regulation of Carcinogenic
Compounds Used in Food-Producing (a) The Commissioner of Food and
Animals Drugs has determined that, in order to
assure that anthelmintic drugs, includ-
500.80 Scope of this subpart. ing animal feeds bearing or containing
500.82 Definitions. such drugs, which do not carry the pre-
500.84 Conditions for approval of the spon- scription statement are labeled to pro-
sored compound. vide adequate directions for their effec-
500.86 Marker residue and target tissue. tive use, labeling of these anthelmintic
500.88 Regulatory method. drugs shall bear, in addition to other
500.90 Waiver of requirements. required information, a statement that

a veterinarian should be consulted for
§ 500.26 21 CFR Ch. I (4–1–23 Edition)
assistance in the diagnosis, treatment, mal drug application, or listed in the

and control of parasitism. index, as required by paragraph (a) of
(b) The label and any labeling fur- this section.
nishing or purporting to furnish direc- (c) The fact that the labeling of this
tions for use, shall bear conspicuously kind of drug may claim delayed, pro-
the following statement: ‘‘Consult your longed, controlled, or sustained-release
veterinarian for assistance in the diag- of all or only some of the active ingre-
nosis, treatment, and control of para- dients does not affect the new animal
sitism.’’ drug status of such articles. A new ani-
(c) For drugs covered by approved mal drug application or index listing is
new animal drug applications, the la- required in any such case.
beling revisions required for compli- (d) New animal drug applications for
ance with this section may be placed timed-release dosage form animal
into effect without prior approval, as drugs must contain, among other
provided for in § 514.8(c)(3) of this chap- things, data to demonstrate safety and
ter. For drugs listed in the index, the effectiveness by establishing that the
labeling revisions required for compli- article is manufactured using proce-
ance with this section may be placed dures and controls to ensure release of
into effect without prior granting of a the total dosage at a safe and effective
request for a modification, as provided rate. Data submitted in the new animal
for in § 516.161(b)(1) of this chapter. drug application must demonstrate
(d) Labeling revisions required for
that the formulation of the drug and
compliance with this section shall be
the procedures used in its manufacture
placed into effect by February 25, 1975,
will ensure release of the active ingre-
following which, any such drugs that
dient(s) of the drug at a safe and effec-
are introduced into interstate com-
tive rate and that these release charac-
merce and not in compliance with this
teristics will be maintained until the
section will be subject to regulatory
expiration date of the drug. When the
proceedings.
drug is intended for use in food-pro-
[40 FR 13802, Mar. 27, 1975, as amended at 71 ducing animals, data submitted must
FR 74782, Dec. 13, 2006; 72 FR 69120, Dec. 6, also demonstrate that, with respect to
2007] possible residues of the drug, food de-
rived from treated animals is safe for
§ 500.26 Timed-release dosage form
drugs. consumption.
(a) Drugs are being offered in dosage [42 FR 8635, Feb. 11, 1977, as amended at 60
forms that are designed to release the FR 38480, July 27, 1995; 72 FR 69120, Dec. 6,
active ingredients over a prolonged pe- 2007]
riod of time. There is a possibility of
§ 500.27 Methylene blue-containing
unsafe overdosage or ineffective dosage drugs for use in animals.
if such products are improperly made
and the active ingredients are released (a) New information requires a re-
at one time, over too short or too long evaluation of the status of drugs con-
a period of time, or not released at all. taining methylene blue
Drugs marketed in this form, which are (tetramethylthionine chloride) for oral
referred to by such terms as timed-re- use in cats or dogs.
lease, controlled-release, prolonged-re- (1)(i) It has been demonstrated that
lease, sustained-release, or delayed-re- two orally administered urinary anti-
lease drugs, are regarded as new animal septic-antispasmodic preparations that
drugs within the meaning of section contained methylene blue cause Heinz
201(v) of the Federal Food, Drug, and body hemolytic anemia in cats when
Cosmetic Act. used according to label directions. The
(b) Timed-release dosage form animal specific cause of the reaction was de-
drugs that are introduced into inter- termined to be the methylene blue con-
state commerce are deemed to be adul- tained in the preparations. The reac-
terated within the meaning of section tion can be severe enough to cause
501(a)(5) of the act and subject to regu- death of treated animals.
latory action, unless such animal drug (ii) The Heinz body hemolytic anemia
is the subject of an approved new ani- reaction to methylene blue has also
Food and Drug Administration, HHS § 500.45
been demonstrated in dogs under lab- section 512 of the act shall be sub-
oratory conditions. The precise mecha- mitted to the Food and Drug Adminis-
nism by which methylene blue pro- tration. Center for Veterinary Medi-
duces the characteristic erythrocytic cine, Office of New Animal Drug Eval-
inclusion bodies (Heinz bodies) and as- uation (HFV-100), 7500 Standish Pl.,
sociated hemolytic anemia is unclear. Rockville, MD 20855.
(2) The effectiveness of orally admin-
[43 FR 9803, Mar. 10, 1978; 43 FR 12310, Mar. 24,
istered methylene blue as a urinary an- 1978, as amended at 54 FR 18279, Apr. 28, 1989;
tiseptic is open to question. It appears 57 FR 6475, Feb. 25, 1992; 60 FR 38480, July 27,
that following oral administration, 1995]
methylene blue is poorly and errati-
cally absorbed and also slowly and er- § 500.29 Gentian violet for use in ani-
ratically excreted in the urine. Studies mal feed.
in the dog indicate it is excreted in the The Food and Drug Administration
urine essentially as leukomethylene has determined that gentian violet is
blue stabilized in some manner. Meth- not generally recognized as safe for use
ylene blue itself is stepwise in animal feed and is a food additive
demethylated in alkaline solutions (al- subject to section 409 of the Federal
kaline urine being a frequent con- Food, Drug, and Cosmetic Act (the
sequence of urinary infection) to Azure act), unless it is intended for use as a
B, Azure A, and Azure C. The antiseptic new animal drug, in which case it is
efficacy of all of these excretion prod- subject to section 512 of the act. The
ucts is unsubstantiated. Food and Drug Administration has de-
(3) In view of the foregoing, the Com- termined that gentian violet is not
missioner has concluded that animal prior sanctioned for any use in animal
drugs containing methylene blue for feed.
oral use in cats or dogs are neither safe
nor generally recognized as effective [56 FR 40506, Aug. 15, 1991]
within the meaning of section 201(v) of
§ 500.30 Gentian violet for animal drug
the act and are therefore considered use.
new animal drugs. Accordingly, all
prior formal and informal opinions ex- The Food and Drug Administration
pressed by the Food and Drug Adminis- (FDA) has determined that gentian vio-
tration that such drugs are ‘‘not new let is not generally recognized as safe
drugs’’ or ‘‘no longer new drugs’’ are and effective for any veterinary drug
hereby revoked. use in food animals and is a new ani-
(b) Animal drugs that contain meth- mal drug subject to section 512 of the
ylene blue for oral use in cats or dogs Federal Food, Drug, and Cosmetic Act.
and not the subject of an approved new FDA has determined that gentian vio-
animal drug application (NADA) are let is not exempted from new animal
deemed to be adulterated under the drug status under the ‘‘grandfather’’
provisions of section 501(a) (5) and/or (6) provisions of the Drug Amendments of
and/or misbranded under section 502(a) 1962 (21 U.S.C. 342).
of the act and subject to regulatory ac- [56 FR 40507, Aug. 15, 1991]
tion as of April 10, 1978.
(c) Sponsors of animal drugs that § 500.45 Use of polychlorinated
contain methylene blue for oral use in biphenyls (PCB’s) in the produc-
cats or dogs and not the subject of an tion, handling, and storage of ani-
approved new animal drug application mal feed.
(NADA) may submit an application in (a) Polychlorinated biphenyls (PCB’s)
conformity with § 514.1 of this chapter. represent a class of toxic industrial
Such applications will be processed in chemicals manufactured and sold under
accordance with section 512 of the act. a variety of trade names, including:
Submission of an NADA will not con- Aroclor (United States); Phenoclor
stitute grounds for continued mar- (France); Colphen (Germany); and
keting of this drug substance until Kanaclor (Japan). PCB’s are highly sta-
such application is approved. ble, heat resistant, and nonflammable
(d) New animal drug applications re- chemicals. Industrial uses of PCB’s in-
quired by this regulation pursuant to clude, or did include in the past, their
§ 500.45 21 CFR Ch. I (4–1–23 Edition)
use as electrical transformer and ca- (3) On or before Sept. 4, 1973, the
pacitor fluids, heat transfer fluids, hy- management of establishments pro-
draulic fluids, plasticizers, and in for- ducing animal feed shall:
mulations of lubricants, coatings, and (i) Have the heat exchange fluid used
inks. Their unique physical and chemin existing equipment or machinery for
ical properties and widespread, uncon- handling and processing feed sampled
trolled industrial applications have and tested to determine whether it
caused PCB’s to be a persistent and contains PCB’s, or verify the absence
ubiquitous contaminant in the environ- of PCB’s in such formulations by other
ment, causing the contamination of appropriate means. On or before Sept.
certain foods. In addition, incidents 4, 1973, any such fluid formulated with
have occurred in which PCB’s have di- PCB’s must to the fullest extent pos-
rectly contaminated animal feeds as a sible commensurate with current good
result of industrial accidents (leakage manufacturing practices, be replaced
or spillage of PCB fluids from plant with a heat exchange fluid that does
equipment). These accidents in turn not contain PCB’s.
cause the contamination of food in- (ii) Eliminate to the fullest extent
tended for human consumption (meat, possible commensurate with current
milk, and eggs). Investigations by the good manufacturing practices from the
Food and Drug Administration have re- animal feed producing establishment
vealed that heat exchange fluids for any PCB-containing lubricants for
certain pasteurization equipment used equipment or machinery used for han-
in processing animal feed contain dling or processing animal feed.
PCB’s. Although heat exchange fluids (iii) Eliminate to the fullest extent
in such equipment are considered to be possible commensurate with current
in closed systems, leakage has occurred good manufacturing practices from the
that resulted in direct contamination animal feed producing establishment
of animal feed with PCB’s and subse- any other PCB-containing materials,
quently resulted in the transfer of whenever there is a reasonable expecta-
PCB’s to human food produced by ani- tion that such materials could cause
mals consuming the contaminated animal feed to become contaminated
with PCB’s either as a result of normal
feed. The use of PCB-containing coat-
use or as a result of accident, breakage,
ings on the inner walls of silos has re-
or other mishap.
sulted in the contamination of silage
which has in turn caused PCB residues (iv) The toxicity and other character-
istics of fluids selected as PCB replace-
in the milk of dairy cows consuming
ments must be adequately determined
the contaminated silage. Since PCB’s
so that the least potentially hazardous
are toxic chemicals, the PCB contami-
replacement should be used. In making
nation of food as a result of these and
this determination with respect to a
other incidents represent a hazard to
given fluid, consideration should be
public health. It is therefore necessary given to (a) its toxicity; (b) the max-
to place certain restrictions on the in- imum quantity that could be spilled
dustrial uses of PCB’s in the produc- onto a given quantity of food before it
tion, handling, and storage of animal would be noticed, taking into account
feed. its color and odor; (c) possible signaling
(b) The following special provisions devices in the equipment to indicate a
are necessary to preclude accidental loss of fluid, etc.; (d) and its environ-
PCB contamination of animal feed: mental stability and tendency to sur-
(1) Coatings or paints for use on the vive and be concentrated through the
contact surfaces of feed storage areas food chain. The judgment as to wheth-
may not contain PCB’s or any other er a replacement fluid is sufficiently
harmful or deleterious substances like- non-hazardous is to be made on an indi-
ly to contaminate feed. vidual installation and operation basis.
(2) New equipment or machinery for (c) For the purpose of this section,
handling or processing feed in or the provisions do not apply to elec-
around an establishment producing trical transformers and condensers

animal feed shall not contain PCB’s. containing PCB’s in sealed containers.
(d) For the purpose of this section, isting approved application has been
the term animal feed includes all arti- withdrawn.
cles used for food or drink for animals (d) After September 29, 1977, animal
other than man. drugs that contain hexachlorophene
other than for preservative use on non-
§ 500.46 Hexachlorophene in animal food-producing animals at a level not
drugs.
exceeding 0.1 percent that are intro-
(a) The Commissioner of Food and duced into interstate commerce shall
Drugs has determined that there are no be deemed to be adulterated within the
adequate data to establish that animal meaning of section 501(a)(5) of the act
drugs containing hexachlorophene are (21 U.S.C. 351(a)(5)) unless such animal
safe and effective for any animal use drug is the subject of a new animal
other than in topical products for use drug application submitted pursuant to
on non-food-producing animals as part paragraph (c) of this section. Action to
of a product preservative system at a withdraw approval of new animal drug
level not to exceed 0.1 percent; that applications will be initiated if supple-
there is no information on the poten- mental new animal drug applications
tial risk to humans from exposure to have not been submitted in accordance
hexachlorophene by persons who apply with this section.
animal products containing the drug at (e) New animal drug applications sub-
levels higher than 0.1 percent; and that mitted for animal drugs containing
there is likewise no information on hexachlorophene for use in or on food-
human exposure to animals on which producing animals shall include ade-
these animal drugs have been used and quate data to assure that edible prod-
no information on possible residues of ucts from treated animals are safe for
hexachlorophene in edible products of human consumption under the labeled
food-producing animals treated with conditions of use.
new animal drugs that contain any
quantity of hexachlorophene. [42 FR 33725, July 1, 1977; 42 FR 37975, July 26,
(b) Animal drugs containing 1977]
hexachlorophene for other than pre-
§ 500.50 Propylene glycol in or on cat
servative use on non-food-producing food.
animals at levels not exceeding 0.1 per-
cent are considered new animal drugs The Food and Drug Administration
and shall be the subject of new animal has determined that propylene glycol
drug applications (NADA’s). in or on cat food is not generally recog-
(c) Any person currently marketing nized as safe and is a food additive sub-
animal drugs that contain ject to section 409 of the Federal Food,
hexachlorophene other than as part of Drug, and Cosmetic Act (the act). The
a product preservative system for prod- Food and Drug Administration also has
ucts used on non-food-producing ani- determined that this use of propylene
mals at a level not exceeding 0.1 per- glycol is not prior sanctioned.
cent shall submit a new animal drug [61 FR 19544, May 2, 1996]
application, supplement an existing ap-
plication, or reformulate the product
by September 29, 1977. Each application Subpart C—Animal Drug Labeling
or supplemental application shall in- Requirements
clude adequate data to establish that
the animal drug is safe and effective. If § 500.51 Labeling of animal drugs; mis-
the animal drug is currently subject to branding.
an approved new animal drug applica- (a) Among the representations on the
tion, each reformulation shall require label or labeling of an animal drug
an approved supplemental application. which will render the drug misbranded
The interim marketing of these animal are any broad statements suggesting or
drugs may continue until the applica- implying that the drug is not safe and
tion has been approved, until it has effective for use when used in accord-
been determined that the application is ance with labeling direction, or sug-
not approvable under the provisions of gesting or implying that the labeling
§ 514.111 of this chapter, or until an ex- does not contain adequate warnings or
§ 500.52 21 CFR Ch. I (4–1–23 Edition)
adequate directions for use. Such state- (b) The unqualified use of the term
ments include, but are not limited to: conditioner and similar terms in the la-
(1) Any statement that disclaims li- beling of a product intended for use in
ability when the drug is used in accord- or on animals implies that such prod-
ance with directions for use contained uct is capable of a therapeutic effect(s)
on the label or labeling. and causes such a product to be a drug
(2) Any statement that disclaims li- within the meaning of section 201(g) of
ability when the drug is used under the act. The unqualified use of such
‘‘abnormal’’ or ‘‘unforeseeable’’ condi- terms in a product’s labeling fails to
tions. provide adequate directions and indica-
(3) Any statement limiting the war- tions for use of such product and
ranty for the products to a warranty causes it to be misbranded within the
that the drug in the package contains meaning of section 502(a) and (f)(1) of
the ingredients listed on the label. the act. The term conditioner and simi-
(b) This regulation is not intended to lar terms may be used in labeling only
prohibit any liability disclaimer that when appropriately qualified so as to
purports to limit the amount of dam- fully inform the user regarding the in-
ages or that sets forth the legal theory tended use(s) of the product. A product
under which damages are to be recov- labeled as a ‘‘conditioner’’ or with a
ered. similar term can be either a food or
(c) Any person wishing to obtain an drug depending upon the manner in
evaluation of an animal drug liability which the term is qualified in the la-
disclaimer under this regulation may beling to reflect the product’s intended
submit it to Division of Compliance, use.
(HFV–230), Center for Veterinary Medi- (c) An article so qualified as to be
cine, Food and Drug Administration, represented as a drug must be the sub-
7500 Standish Pl., Rockville, MD 20855. ject of an approved new animal drug
A supplemental NADA providing appro- application unless the use of the article
priately revised labeling shall be sub- under the conditions set forth in its la-
mitted for any approved new animal beling is generally recognized as safe
drug the labeling of which is not in and effective among experts qualified
compliance with this regulation. by scientific training and experience to
evaluate the safety and effectiveness of
[41 FR 8473, Feb. 27, 1976, as amended at 54
FR 18279, Apr. 28, 1989; 57 FR 6475, Feb. 25, animal drugs.
1992]
§ 500.55 Exemption from certain drug-
§ 500.52 Use of terms such as ‘‘tonic’’, labeling requirements.
‘‘tone’’, ‘‘toner’’, or ‘‘conditioner’’ in (a) Section 201.105(c) of this chapter
the labeling of preparations in- provides that in the case of certain
tended for use in or on animals. drugs for which directions, hazards,
(a) The use of terms such as tonic, warnings, and use information are
tone, toner, and similar terms in the la- commonly known to practitioners li-
beling of a product intended for use in censed by law, such information may
or on animals implies that such prod- be omitted from the dispensing pack-
uct is capable of a therapeutic effect(s) age. Under this proviso, the Commis-
and causes such a product to be a drug sioner of Food and Drugs will offer an
within the meaning of section 201(g) of opinion, upon written request, stating
the Federal Food, Drug, and Cosmetic reasonable grounds therefore on a pro-
Act. The unqualified use of such terms posal to omit such information from
in a product’s labeling fails to provide the dispensing package.
adequate directions and indications for (b) The Commissioner of Food and
use of such product and causes it to be Drugs has considered submitted mate-
misbranded within the meaning of sec- rial covering a number of drug prod-
tion 502(a) and (f)(1) of the act. The ucts and has offered the opinion that
terms tonic, tone, toner, and similar the following drugs when intended for
terms may be used in labeling only those veterinary uses for which they
when appropriately qualified so as to are now generally employed by the vet-
fully inform the user regarding the in- erinary medical profession, should be
tended use(s) of the product. exempt from the requirements of
10
§ 201.105(c) of this chapter, provided agents. In connection with this prob-

that they meet the conditions pre- lem the Food and Drug Administration
scribed in this paragraph. Preparations has obtained the views of the Advisory
that are not in dosage unit form (for Committee on Veterinary Medicine,
example, solutions) will be regarded as and other experts, and has concluded
meeting the conditions with respect to that adequate directions for over-the-
the maximum quantity of drug per dos- counter sale of epinephrine injection
age unit if they are prepared in a man- 1:1,000 can be prepared.
ner that enables accurate and ready ad- (b) In view of the above, the Commis-
ministration of a quantity of drug not sioner of Food and Drugs has concluded
in excess of the stated maximum per that it is in the public interest to make
dosage unit: epinephrine injection 1:1,000 available
Atropine sulfate. As an injectable for cattle, for sale without a prescription provided
goats, horses, pigs, and sheep, not in excess that it is packaged in vials not exceed-
of 15 milligrams per dosage unit; as an ing 10 milliliters and its label bears, in
injectable for cats and dogs, not in excess addition to other required information,
of 0.6 milligram per dosage unit. the following statements in a promi-
Barbital sodium. For oral use in cats and nent and conspicuous manner: ‘‘For
dogs, not in excess of 300 milligrams per
dosage unit. emergency use only in treating
Epinephrine injection. 1:1,000. For cats, dogs, anaphylactoid shock. Usual Dosage:
cattle, goats, horses, pigs, and sheep (ex- Cattle, horses, sheep, and swine—1
cept as provided in § 500.65). cubic centimeter per 100 pounds of body
Morphine sulfate. As an injectable for dogs, weight. Inject subcutaneously’’.
not in excess of 15 milligrams per dosage (c) The labeling must also bear a de-
unit.
Pentobarbital sodium. For oral use in cats and
scription of the symptoms of
dogs, not in excess of 100 milligrams per anaphylactoid shock including glassy
dosage unit. eyes, increased salivation, grinding of
Phenobarbital sodium. For oral use in cats and the teeth, rapid breathing, muscular
dogs, not in excess of 100 milligrams per tremors, staggering gait, and collapse
dosage unit. with death following. These symptoms
Procaine hydrochloride injection. Containing may appear shortly after injection of a
not in excess of 2 percent procaine hydro-
chloride, with or without epinephrine up to
bacterin, vaccine, or antibiotic.
a concentration of 1:50,000. For use in cats,
dogs, cattle, goats, horses, pigs, and sheep. Subpart E—Regulation of Carcino-
Thyroid. For oral use in dogs, not in excess of genic Compounds Used in
60 milligrams per dosage unit.
Food-Producing Animals
Subpart D—Requirements for
SOURCE: 52 FR 49586, Dec. 31, 1987, unless
Specific Animal Drugs otherwise noted.
§ 500.65 Epinephrine injection 1:1,000
in 10-milliliter containers for emer- § 500.80 Scope of this subpart.
gency treatment of anaphylactoid (a) The Federal Food, Drug, and Cos-
shock in cattle, horses, sheep, and metic Act requires that sponsored com-
swine. pounds intended for use in food-pro-
(a) Anaphylactoid reactions in cattle, ducing animals be shown to be safe and
horses, sheep, and swine occur occa- that food produced from animals ex-
sionally from the injection of anti- posed to these compounds be shown to
biotics, bacterins, and vaccines. Ade- be safe for consumption by people. The
quate directions for use of these anti- statute prohibits the use in food-pro-
biotics, bacterins, and vaccines can ducing animals of any compound found
generally be written for use by the to induce cancer when ingested by peo-
laity and thus are available to live- ple or animals unless it can be deter-
stock producers. Epinephrine injection mined by methods of examination pre-
is effective for the treatment of scribed or approved by the Secretary (a
anaphylactoid reactions in animals and function delegated to the Commis-
would be of value in saving lives of ani- sioner of Food and Drugs) that no res-
mals if it were readily available at the idue of that compound will be found in
time of administration of the causative the food produced from those animals
11
§ 500.82 21 CFR Ch. I (4–1–23 Edition)
under conditions of use reasonably cer- § 500.82 Definitions.

tain to be followed in practice. This
(a) The definitions and interpreta-
subpart identifies the steps a sponsor
tions contained in section 201 of the act
of a compound shall follow to secure apply to those terms when used in this
the approval of the compound. The re- subpart.
quirements of this subpart shall also (b) The following definitions apply to
apply to a request for an import toler- this subpart:
ance under § 510.205 of this chapter. Act means the Federal Food, Drug,
FDA guidance documents contain the and Cosmetic Act (sections 201–901, 52
procedures and protocols FDA rec- Stat. 1040 et seq. as amended (21 U.S.C.
ommends for the implementation of 301–392)).
this subpart. These guidance docu- Essential nutrients means compounds
ments are available from the Division that are found in the tissues of un-
of Dockets Management (HFA–305), treated, healthy target animals and
Food and Drug Administration, 5630 not produced in sufficient quantity to
Fishers Lane, rm. 1061, Rockville, MD support the animal’s growth, develop-
20852. Requests for these guidance doc- ment, function, or reproduction, e.g.,
uments should be identified with Dock- vitamins, essential minerals, essential
et No. 1983D–0288. amino acids, and essential fatty acids.
(b) If FDA concludes on the basis of These compounds must be supplied
the threshold assessment that a spon- from external sources.
sor shall conduct carcinogenicity test- FDA means the Food and Drug Ad-
ing on the sponsored compound, FDA ministration.
will also determine whether and to Limit of detection (LOD) means the
what extent the sponsor shall conduct lowest concentration of analyte that
carcinogenicity testing on metabolites can be confirmed by the approved regu-
of the sponsored compound. The bio- latory method.
assays that a sponsor conducts must be Marker residue means the residue se-
designed to assess carcinogenicity and lected for assay whose concentration is
to determine the quantitative aspects in a known relationship to the con-
of any carcinogenic response. centration of the residue of carcino-
(c) If FDA concludes on the basis of genic concern in the last tissue to de-
the threshold assessment or at a later plete to its Sm.
time during the approval process or No residue means the marker residue
during the review of a request for an is below the limit of detection using
import tolerance that the data show the approved regulatory method. The
that the sponsored compound and its ‘‘no residue’’ designation applies only
metabolites should not be subject to to compounds of carcinogenic concern.
this subpart, FDA will continue to con- Preslaughter withdrawal period or milk
sider the compound for approval under discard time means the time after ces-
the general safety provisions of the sation of administration of the spon-
Federal Food, Drug, and Cosmetic Act sored compound at which no residue is
for risks other than cancer or continue detectable in the edible product using
its review of the import tolerance re- the approved regulatory method (i.e.,
quest under the provisions of §§ 510.201 the marker residue is below the LOD).
through 510.213 of this chapter (Subpart Regulatory method means the aggre-
C—Import Tolerances for Residues of gate of all experimental procedures for
Unapproved New Animal Drugs in measuring and confirming the presence
of the marker residue of the sponsored
Food).
compound in the target tissue of the
(d) This subpart does not apply to es-
target animal.
sential nutrients.
Rm means the concentration of the
[52 FR 49586, Dec. 31, 1987, as amended at 59 marker residue in the target tissue
FR 14365, Mar. 28, 1994; 62 FR 66983, Dec. 23, when the residue of carcinogenic con-
1997; 65 FR 56480, Sept. 19, 2000; 67 FR 78174, cern is equal to Sm.
Dec. 23, 2002; 68 FR 24879, May 9, 2003; 69 FR Residue means any compound present
17292, Apr. 2, 2004; 86 FR 52410, Sept. 21, 2021] in edible tissues of the target animal
12
which results from the use of the spon- concerning the carcinogenicity of the
sored compound, including the spon- compound.
sored compound, its metabolites, and
[52 FR 49586, Dec. 31, 1987, as amended at 67
any other substances formed in or on FR 78174, Dec. 23, 2002; 77 FR 50593, Aug. 22,
food because of the sponsored com- 2012; 84 FR 32992, July 11, 2019; 86 FR 52410,
pound’s use. Sept. 21, 2021]
Residue of carcinogenic concern means
all compounds in the total residue of a § 500.84 Conditions for approval of the
demonstrated carcinogen excluding sponsored compound.
any compounds judged by FDA not to (a) On the basis of the results of the
present a carcinogenic risk. chronic bioassays and other informa-
Sm means the concentration of a res-
tion, FDA will determine whether any
idue of carcinogenic concern in a spe-
of the substances tested are carcino-
cific edible tissue corresponding to no
genic.
significant increase in the risk of can-
cer to the human consumer. For the (b) If FDA concludes that the results
purpose of § 500.84(c)(1), FDA will as- of the bioassays do not establish car-
sume that this Sm will correspond to cinogenicity, then FDA will not sub-
the concentration of residue in a spe- ject the sponsored compound to the re-
cific edible tissue that corresponds to a mainder of the requirements of this
maximum lifetime risk of cancer in the subpart.
test animals of 1 in 1 million. (c) For each sponsored compound
So means the concentration of a res- that FDA decides should be regulated
idue of carcinogenic concern in the as a carcinogen, FDA will either ana-
total human diet that represents no lyze the data from the bioassays using
significant increase in the risk of can- a statistical extrapolation procedure as
cer to the human consumer. For the outlined in paragraph (c)(1) of this sec-
purpose of § 500.84(c)(1), FDA will as- tion or evaluate an alternate procedure
sume that this So will correspond to proposed by the sponsor as provided in
the concentration of test compound in § 500.90. In either case, paragraphs (c)(2)
the total diet of test animals that cor- and (3) of this section apply.
responds to a maximum lifetime risk of (1) For each substance tested in sepa-
cancer in the test animals of 1 in 1 mil- rate bioassays, FDA will calculate the
lion. concentration of the residue of carcino-
Sponsor means the person or organi- genic concern that corresponds to a
zation proposing or holding an ap- maximum lifetime risk to the test ani-
proval by FDA for the use of a spon- mal of 1 in 1 million. FDA will des-
sored compound or the person initi- ignate the lowest value obtained as So.
ating a request for an import tolerance Because the total diet is not derived
under § 510.205 of this chapter. from food-producing animals, FDA will
Sponsored compound means any drug make corrections for food intake. FDA
or food additive or color additive pro- will designate as Sm the concentration
posed for use, or used, in food-pro- of residue in a specific edible tissue
ducing animals or in their feed. corresponding to a maximum lifetime
Target animals means the production risk of cancer in test animals of 1 in 1
class of animals in which a sponsored million.
compound is proposed or intended for (2) From the appropriate residue
use. chemistry data FDA will calculate the
Target tissue means the edible tissue Rm as described in § 500.86(c). The spon-
selected to monitor for residues in the sor must provide a regulatory method
target animals, including, where appro- in accordance with § 500.88(b). FDA will
priate, milk or eggs. calculate the LOD of the method from
Test animals means the species se- data submitted by the sponsor under
lected for use in the toxicity tests. § 500.88. The LOD must be less than or
Threshold assessment means FDA’s re- equal to Rm.
view of data and information about a (3) FDA will conclude that the provi-
sponsored compound to determine sions of this subpart are satisfied when
whether chronic bioassays in test ani- no residue of the compound is detect-

mals are necessary to resolve questions able (that is, the marker residue is
13
§ 500.86 21 CFR Ch. I (4–1–23 Edition)
below the LOD) using the approved reg- residue in the target tissue in accord-
ulatory method under the conditions of ance with the provisions of sections
use of the sponsored compound, includ- 409(c)(3)(A), 512(d)(1)(I), and 721(b)(5)(B)
ing any required preslaughter with- of the act.
drawal period or milk discard time. (d) If the sponsor initially submitted
[52 FR 49586, Dec. 31, 1987, as amended at 67 a request for an import tolerance under
FR 78174, Dec. 23, 2002; 77 FR 50593, Aug. 22, § 510.205 of this chapter, FDA will make
2012] the complete regulatory method for
ascertaining the marker residue in the
§ 500.86 Marker residue and target tis- target tissue publicly available pursu-
sue. ant to § 510.207(b) of this chapter.
(a) For each edible tissue, the spon- (Approved by the Office of Management and
sor shall measure the depletion of the Budget under control number 0910–0228)
residue of carcinogenic concern until
its concentration is at or below Sm. [52 FR 49586, Dec. 31, 1987, as amended at 67
FR 78174, Dec. 23, 2002; 86 FR 52410, Sept. 21,
(b) In one or more edible tissues, the 2021]
sponsor shall also measure the deple-
tion of one or more potential marker § 500.90 Waiver of requirements.
residues until the concentration of the
residue of carcinogenic concern is at or In response to a petition or on the
below Sm. Commissioner’s own initiative, the
(c) From these data, FDA will select Commissioner may waive, in whole or
a target tissue and a marker residue in part, the requirements of this sub-
and designate the concentration of part except those provided under
marker residue (Rm) that the regu- § 500.88. A petition for this waiver may
latory method must be capable of be filed by any person who would be ad-
measuring in the target tissue. FDA versely affected by the application of
will select Rm such that the absence of the requirements to a particular com-
the marker residue in the target tissue pound. The petition shall explain and
above Rm can be taken as confirmation document why the requirements from
that the residue of carcinogenic con- which a waiver is requested are not
cern does not exceed Sm in each of the reasonably applicable to the com-
edible tissues and, therefore, that the pound, and set forth clearly the rea-
residue of carcinogenic concern in the sons why the alternative procedures
diet of people does not exceed So. will provide the basis for concluding
(d) When a compound is to be used in that approval of the compound satisfies
milk- or egg-producing animals, milk the requirements of the anticancer pro-
or eggs must be the target tissue in ad- visions of the act. If the Commissioner
dition to the tissue selected to monitor determines that waiver of any of the
for residues in the edible carcass. requirements of this subpart is appro-
priate, the Commissioner will state the
(Approved by the Office of Management and
basis for that determination in the reg-
Budget under control number 0910–0228)
ulation approving marketing of the
§ 500.88 Regulatory method. sponsored compound.
(a) The sponsor shall submit for eval- (Approved by the Office of Management and
uation and validation a regulatory Budget under control number 0910–0228)
method developed to monitor compli-
ance with FDA’s operational definition § 500.92 Implementation.
of no residue. (a) This subpart E applies to all new
(b) The regulatory method must be animal drug applications, food additive
able to confirm the identity of the petitions, color additive petitions, and
marker residue in the target tissue at requests for import tolerances con-
a minimum concentration cor- cerning any compound intended for use
responding to the Rm. FDA will deter- in food-producing animals (including
mine the LOD from the submitted ana- supplemental applications and amend-
lytical method validation data. ments to petitions).
(c) FDA will publish in the FEDERAL (b) This subpart E also applies in the
REGISTER the complete regulatory following manner to compounds al-

method for ascertaining the marker ready approved:
14
Food and Drug Administration, HHS Pt. 501
(1) For those compounds that FDA method of analysis for uncooked edible
determines may induce cancer when in- tissues of cattle.
gested by man or animals, i.e., suspect (ii) [Reserved]
carcinogens, §§ 500.80(b), 500.82, and (2) Merck Animal Health, 29160
500.90 apply. Intervet Lane, Millsboro, DE 19966, 1–
(2) For those compounds that FDA 800–211–3573.
determines have been shown to induce (i) ‘‘Determinative and Confirmatory
cancer when ingested by man or ani- Procedures for the Analysis of N-Meth-
mals, §§ 500.82 through 500.90 apply. yl-2-pyrrolidone (NMP) in Swine Liver
Tissue using LC–MS/MS,’’ July 20, 2017;
[52 FR 49586, Dec. 31, 1987, as amended at 86 the method of analysis for uncooked
FR 52410, Sept. 21, 2021]
edible tissues of swine.
(ii) [Reserved]
Subpart F—Methods for Detection (c) Related conditions of use. See
of Residues of Carcinogenic §§ 522.814 and 522.955 of this chapter.
Compounds Used in Food- [87 FR 10966, Feb. 28, 2022]
Producing Animals
PART 501—ANIMAL FOOD
SOURCE: 76 FR 72618, Nov. 25, 2011, unless LABELING
otherwise noted.
§ 500.1410 N-methyl-2-pyrrolidone. Subpart A—General Provisions
(a) Standard for residues. No residues Sec.

of n-methyl-2-pyrrolidone may be 501.1 Principal display panel of package
form animal food.
found in the uncooked edible tissues of 501.2 Information panel of package for ani-
cattle and swine as determined by mal food.
methods in paragraph (b) of this sec- 501.3 Identity labeling of animal food in
tion. package form.
(b) Incorporation by reference. The 501.4 Animal food; designation of ingredi-
standards required in this section are ents.
incorporated by reference into this sec- 501.5 Animal food; name and place of busi-
ness of manufacturer, packer, or dis-
tion with the approval of the Director
tributor.
of the Federal Register under 5 U.S.C. 501.8 Labeling of animal food with number
552(a) and 1 CFR part 51. All approved of servings.
material is available for inspection at 501.15 Animal food; prominence of required
the Food and Drug Administration’s statements.
Dockets Management Staff (HFA–305), 501.17 Animal food labeling warning state-
5630 Fishers Lane, Rm. 1061, Rockville, ments.
MD 20852, 240–402–7500, between 9 a.m. 501.18 Misbranding of animal food.
and 4 p.m., Monday through Friday. It
Subpart B—Specific Animal Food Labeling
may be obtained from the sources indi-
Requirements
cated elsewhere in paragraph (b) of this
section and at: https://www.fda.gov/ 501.22 Animal foods; labeling of spices,
about-fda/center-veterinary-medicine/cvm- flavorings, colorings, and chemical pre-
foia-electronic-reading-room. It is also servatives.
available for inspection at the National
Archives and Records Administration Subparts C–E [Reserved]
(NARA). For information on the avail-
Subpart F—Exemptions From Animal Food
ability of this material at NARA, email
Labeling Requirements
fr.inspection@nara.gov, or go to:
www.archives.gov/federal-register/cfr/ibr- 501.100 Animal food; exemptions from label-
locations.html. ing.
(1) Food and Drug Administration, 501.103 Petitions requesting exemptions
Center for Veterinary Medicine, 7500 from or special requirements for label
declaration of ingredients.
Standish Pl., Rockville, MD 20855, 240– 501.105 Declaration of net quantity of con-
402–7002. tents when exempt.
(i) ‘‘Method of Analysis: N-methyl-2- 501.110 Animal feed labeling; collective

pyrrolidone,’’ September 26, 2011; the names for feed ingredients.
15
§ 501.1 21 CFR Ch. I (4–1–23 Edition)
AUTHORITY: 15 U.S.C. 1453, 1454, 1455; 21 within that 40 percent of the circum-
U.S.C. 321, 331, 342, 343, 348, 371. ference which is most likely to be dis-
SOURCE: 41 FR 38619, Sept. 10, 1976, unless played, presented, shown, or examined
otherwise noted. under customary conditions of display
for retail sale.
Subpart A—General Provisions
§ 501.2 Information panel of package
§ 501.1 Principal display panel of pack- for animal food.
age form animal food. (a) The term information panel as it
The term principal display panel as it applies to packaged food means that
applies to food in package form and as part of the label immediately contig-
used in this part, means the part of a uous and to the right of the principal
label that is most likely to be dis- display panel as observed by an indi-
played, presented, shown, or examined vidual facing the principal display
under customary conditions of display panel with the following exceptions:
for retail sale. The principal display (1) If the part of the label imme-
panel shall be large enough to accom- diately contiguous and to the right of
modate all the mandatory label infor- the principal display panel is too small
mation required to be placed thereon to accommodate the necessary infor-
by this part with clarity and conspicu- mation or is otherwise unusable label
ousness and without obscuring design, space, e.g., folded flaps or can ends, the
vignettes, or crowding. Where packages panel immediately contiguous and to
bear alternate principal display panels, the right of this part of the label may
information required to be placed on be used.
the principal display panel shall be du- (2) If the package has one or more al-
plicated on each principal display ternate principal display panels, the in-
panel. For the purpose of obtaining formation panel is immediately contig-
uniform type size in declaring the uous and to the right of any principal
quantity of contents for all packages of display panel.
substantially the same size, the term (3) If the top of the container is the
area of the principal display panel means principal display panel and the pack-
the area of the side or surface that age has no alternate principal display
bears the principal display panel, panel, the information panel is any
which area shall be: panel adjacent to the principal display
(a) In the case of a rectangular pack- panel.
age where one entire side properly can (b) All information required to ap-
be considered to be the principal dis- pear on the label of any package of
play panel side, the product of the food pursuant to §§ 501.4, 501.5, 501.8 and
height times the width of that side; 501.17 shall appear either on the prin-
(b) In the case of a cylindrical or cipal display panel or on the informa-
nearly cylindrical container, 40 percent tion panel, unless otherwise specified
of the product of the height of the con- by regulations in this chapter.
tainer times the circumference; (c) All information appearing on the
(c) In the case of any otherwise principal display panel or the informa-
shaped container, 40 percent of the tion panel pursuant to this section
total surface of the container: Provided, shall appear prominently and conspicu-
however, That where such container ously, but in no case may the letters
presents an obvious principal display and/or numbers be less than 1⁄16 inch in
panel such as the top of a triangular or height unless an exemption pursuant
circular package, the area shall consist to paragraph (f) of this section is estab-
of the entire top surface. In deter- lished. The requirements for conspicu-
mining the area of the principal dis- ousness and legibility shall include the
play panel, exclude tops, bottoms, specifications of §§ 501.15 and 501.105(h)
flanges at tops and bottoms of cans, (1) and (2).
and shoulders and necks of bottles or (1) Packaged foods are exempt from
jars. In the case of cylindrical or near- the type size requirements of this para-
ly cylindrical containers, information graph: Provided, That:
required by this part to appear on the (i) The package is designed such that
principal display panel shall appear it has a surface area that can bear an
16
information panel and/or an alternate (d) All information required to ap-

principal display panel. pear on the principal display panel or
(ii) The area of surface available for on the information panel pursuant to
labeling on the principal display panel this section shall appear on the same
of the package as this term is defined panel unless there is insufficient space.
in § 501.1 is less than 10 square inches. In determining the sufficiency of the
(iii) The label information includes a available space, any vignettes, design,
full list of ingredients in accordance and other nonmandatory label informa-
with regulations in this part. tion shall not be considered. If there is
(iv) The information required by insufficient space for all of this infor-
paragraph (b) of this section appears on mation to appear on a single panel, it
the principal display panel or informa- may be divided between these two pan-
tion panel label in accordance with the els except that the information re-
provisions of this paragraph (c) except quired pursuant to any given section or
that the type size is not less than 3⁄64 part shall all appear on the same panel.
inch in height. A food whose label is required to bear
(2) Packaged foods are exempt from the ingredient statement on the prin-
the type size requirements of this para- cipal display panel may bear all other
graph: Provided, That: information specified in paragraph (b)
(i) The package is designed such that of this section on the information
it has a single obvious principal display panel.
panel as this term is defined in § 501.1 (e) All information appearing on the
and has no other available surface area information panel pursuant to this sec-
for an information panel or alternate tion shall appear in one place without
principal display panel. other intervening material.
(ii) The area of surface available for (f) If the label of any package of food
labeling on the principal display panel is too small to accommodate all of the
of the package as this term is defined information required by §§ 501.4, 501.5,
in § 501.1 is less than 12 square inches 501.8, and 501.17, the Commissioner may
and bears all labeling appearing on the establish by regulation an acceptable
package. alternative method of disseminating
(iii) The label information includes a such information to the public, e.g., a
full list of ingredients in accordance type size smaller than one-sixteenth
with regulations in this part. inch in height, or labeling attached to
(iv) The information required by or inserted in the package or available
paragraph (b) of this section appears on at the point of purchase. A petition re-
the single, obvious principal display questing such a regulation, as an
panel in accordance with the provisions amendment to this paragraph shall be
of this paragraph (c) except that the submitted pursuant to part 10 of this
type size is not less than 1⁄32 inch in chapter.
height. [41 FR 38619, Sept. 10, 1976, as amended at 42
(3) Packaged foods are exempt from FR 4716, Jan. 25, 1977; 42 FR 15675, Mar. 22,
the type size requirements of this para- 1977]
graph: Provided, That:
(i) The package is designed such that § 501.3 Identity labeling of animal food
in package form.
it has a total surface area available to
bear labeling of less than 12 square (a) The principal display panel of a
inches. food in package form shall bear as one
(ii) The label information includes a of its principal features a statement of
full list of ingredients in accordance the identity of the commodity.
with regulations in this part. (b) Such statement of identity shall
(iii) The information required by be in terms of:
paragraph (b) of this section appears on (1) The name now or hereafter speci-
the principal display panel or informa- fied in or required by any applicable
tion panel label in accordance with the Federal law or regulation; or, in the
provisions of this paragraph (c) except absence thereof,
that the type size is not less than 1⁄32 (2) The common or usual name of the
inch in height. food; or, in the absence thereof,
17
§ 501.4 21 CFR Ch. I (4–1–23 Edition)
(3) An appropriately descriptive is not false or misleading. The label

term, or when the nature of the food is may, in addition, bear a fanciful name
obvious, a fanciful name commonly which is not false or misleading.
used by the public for such food. (3) A food for which a common or
(c) Where a food is marketed in var- usual name is established by regulation
ious optional forms (whole, slices, (e.g., in a standard of identity pursuant
diced, etc.), the particular form shall to section 401 of the act, in a common
be considered to be a necessary part of or usual name regulation and may, in
the statement of identity and shall be addition, bear a fanciful name which is
declared in letters of a type size bear- not false or misleading, and established
ing a reasonable relation to the size of
pursuant to part 502 of this chapter),
the letters forming the other compo-
and which complies with all of the ap-
nents of the statement of identity; ex-
cept that if the optional form is visible plicable requirements of such regula-
through the container or is depicted by tion(s), shall not be deemed to be an
an appropriate vignette, the particular imitation.
form need not be included in the state- (4) Nutritional inferiority includes:
ment. This specification does not affect (i) Any reduction in the content of an
the required declarations of identity essential nutrient that is present in a
under definitions and standards for measurable amount.
foods promulgated pursuant to section (ii) If the Commissioner concludes
401 of the act. that a food is a substitute for and re-
(d) This statement of identity shall sembles another food but is inferior to
be presented in bold type on the prin- the food imitated for reasons other
cipal display panel, shall be in a size than those set forth in this paragraph,
reasonably related to the most promi- he may propose appropriate revisions
nent printed matter on such panel, and to this regulation or he may propose a
shall be in lines generally parallel to separate regulation governing the par-
the base on which the package rests as ticular food.
it is designed to be displayed.
(f) A label may be required to bear
(e) Under the provisions of section
the percentage(s) of a characterizing
403(c) of the Federal Food, Drug, and
Cosmetic Act, a food shall be deemed ingredient(s) or information con-
to be misbranded if it is an imitation of cerning the presence or absence of an
another food unless its label bears, in ingredient(s) or the need to add an in-
type of uniform size and prominence, gredient(s) as part of the common or
the word imitation and, immediately usual name of the food pursuant to
thereafter, the name of the food imi- part 502 of this chapter.
tated. [41 FR 38619, Sept. 10, 1976, as amended at 42
(1) A food shall be deemed to be an FR 14091, Mar. 15, 1977; 54 FR 18279, Apr. 28,
imitation and thus subject to the re- 1989]
quirements of section 403(c) of the act
if it is a substitute for and resembles § 501.4 Animal food; designation of in-
another food but is nutritionally infe- gredients.
rior to that food. (a) Ingredients required to be de-
(2) A food that is a substitute for and clared on the label of a food, including
resembles another food shall not be
foods that comply with standards of
deemed to be an imitation provided it
identity that require labeling in com-
meets each of the following require-
ments: pliance with this part 501, except those
(i) It is not nutritionally inferior to exempted by § 501.100, shall be listed by
the food for which it substitutes and common or usual name in descending
which it resembles. order of predominance by weight on ei-
(ii) Its label bears a common or usual ther the principal display panel or the
name that complies with the provisions information panel in accordance with
of § 502.5 of this chapter and that is not the provisions of § 501.2.
false or misleading, or in the absence (b) The name of an ingredient shall
of an existing common or usual name, be a specific name and not a collective

an appropriately descriptive term that (generic) name, except that:
18
(1) Spices, flavorings, colorings and (9) Butteroil and anhydrous butterfat
chemical preservatives shall be de- may be declared as butterfat.
clared according to the provisions of (10) Dried whole eggs, frozen whole
§ 501.22. eggs, and liquid whole eggs may be de-
(2) An ingredient which itself con- clared as eggs.
tains two or more ingredients and (11) Dried egg whites, frozen egg
which has an established common or whites, and liquid egg whites may be
usual name, conforms to a standard es- declared as egg whites.
tablished pursuant to the Meat Inspec-
(12) Dried egg yolks, frozen egg yolks,
tion or Poultry Products Inspection
and liquid egg yolks may be declared as
Acts by the U.S. Department of Agri-
culture, or conforms to a definition and egg yolks.
standard of identity established pursu- (13) A livestock or poultry feed may
ant to section 401 of the Federal Food, be declared by a collective name listed
Drug, and Cosmetic Act, shall be des- in § 501.110 if it is an animal feed within
ignated in the statement of ingredients the meaning of section 201(w) of the act
on the label of such food by either of and meets the requirements for the use
the following alternatives: of a collective name as prescribed in
(i) By declaring the established com- § 501.110 for certain feed ingredients.
mon or usual name of the ingredient (14) [Reserved]
followed by a parenthetical listing of (15) When all the ingredients of a
all ingredients contained therein in de- wheat flour are declared in an ingre-
scending order of predominance except dient statement, the principal ingre-
that, if the ingredient is a food subject dient of the flour shall be declared by
to a definition and standard of identity the name(s) specified in §§ 137.105,
established in this subchapter E, only 137.200, 137.220, 137.225 of this chapter,
the ingredients required to be declared i.e., the first ingredient designated in
by the definition and standard of iden- the ingredient list of flour, or
tity need be listed; or
bromated flour, or enriched flour, or
(ii) By incorporating into the state-
self-rising flour is flour, white flour,
ment of ingredients in descending order
of predominance in the finished food, wheat flour, or plain flour; the first in-
the common or usual name of every gredient designated in the ingredient
component of the ingredient without list of durum flour is durum flour; the
listing the ingredient itself. first ingredient designated in the ingre-
(3) Skim milk, concentrated skim dient list of whole wheat flour, or
milk, reconstituted skim milk, and bromated whole wheat flour is whole
nonfat dry milk may be declared as wheat flour, graham flour, or entire
skim milk or nonfat milk. wheat flour; and the first ingredient
(4) Milk, concentrated milk, reconsti- designated in the ingredient list of
tuted milk, and dry whole milk may be whole durum wheat flour is whole
declared as milk. durum wheat flour.
(5) Bacterial cultures may be de- (c) When water is added to reconsti-
clared by the word cultured followed by tute, completely or partially, an ingre-
the name of the substrate, e.g., made dient permitted by paragraph (b) of
from cultured skim milk or cultured but- this section to be declared by a class
termilk. name, the position of the ingredient
(6) Sweetcream buttermilk, con- class name in the ingredient statement
centrated sweetcream buttermilk, re- shall be determined by the weight of
constituted sweetcream buttermilk, the unreconstituted ingredient plus the
and dried sweetcream buttermilk may weight of the quantity of water added
be declared as buttermilk.
to reconstitute that ingredient, up to
(7) Whey, concentrated whey, recon-
the amount of water needed to recon-
stituted whey, and dried whey may be
declared as whey. stitute the ingredient to single
(8) Cream, reconstituted cream, dried strength. Any water added in excess of
cream, and plastic cream (sometimes the amount of water needed to recon-
known as concentrated milkfat) may stitute the ingredient to single

be declared as cream.
19
§ 501.5 21 CFR Ch. I (4–1–23 Edition)
strength shall be declared as water in number of servings contained in such

the ingredient statement. package shall bear in immediate con-
[41 FR 38619, Sept. 10, 1976, as amended at 42
junction with such statement, and in
FR 14091, Mar. 15, 1977; 60 FR 38480, July 27, the same size type as is used for such
1995] statement, a statement of the net
quantity (in terms of weight, measure,
§ 501.5 Animal food; name and place of or numerical count) of each such serv-
business of manufacturer, packer, ing; however, such statement may be
or distributor. expressed in terms that differ from the
(a) The label of a food in packaged terms used in the required statement
form shall specify conspicuously the of net quantity of contents (for exam-
name and place of business of the man- ple, cupfuls, tablespoonfuls, etc.) when
ufacturer, packer, or distributor. such differing term is common to cook-
(b) The requirement for declaration ery and describes a constant quantity.
of the name of the manufacturer, pack- Such statement may not be misleading
er, or distributor shall be deemed to be in any particular. A statement of the
satisfied, in the case of a corporation, number of units in a package is not in
only by the actual corporate name, itself a statement of the number of
which may be preceded or followed by servings.
the name of the particular division of (b) If there exists a voluntary prod-
the corporation. In the case of an indi- uct standard promulgated pursuant to
vidual, partnership, or association, the the procedures found in 15 CFR part 10
name under which the business is con- by the Department of Commerce, quan-
ducted shall be used. titatively defining the meaning of the
(c) Where the food is not manufac- term serving with respect to a par-
tured by the person whose name ap- ticular food, then any label representa-
pears on the label, the name shall be tion as to the number of servings in
qualified by a phrase that reveals the such packaged food shall correspond
connection such person has with such with such quantitative definition.
food; such as ‘‘Manufactured for (Copies of published standards are
______,’’ ‘‘Distributed by ______,’’ or any available upon request from the Na-
other wording that expresses the facts. tional Bureau of Standards, Depart-
(d) The statement of the place of ment of Commerce, Washington, DC
business shall include the street ad- 20234.)
dress, city, state, and ZIP Code; how-
ever, the street address may be omitted § 501.15 Animal food; prominence of
if it is shown in a current city direc- required statements.
tory or telephone directory. The re- (a) A word, statement, or other infor-
quirement for inclusion of the ZIP mation required by or under authority
Code shall apply only to consumer of the act to appear on the label may
commodity labels developed or revised lack that prominence and conspicuous-
after the effective date of this section. ness required by section 403(f) of the
In the case of nonconsumer packages, act by reason (among other reasons) of:
the ZIP Code shall appear either on the (1) The failure of such word, state-
label or the labeling (including in- ment, or information to appear on the
voice). part or panel of the label which is pre-
(e) If a person manufactures, packs, sented or displayed under customary
or distributes a food at a place other conditions of purchase;
than his principal place of business, the (2) The failure of such word, state-
label may state the principal place of ment, or information to appear on two
business in lieu of the actual place or more parts or panels of the label,
where such food was manufactured or each of which has sufficient space
packed or is to be distributed, unless therefor, and each of which is so de-
such statement would be misleading. signed as to render it likely to be,
under customary conditions of pur-
§ 501.8 Labeling of animal food with chase, the part or panel displayed;
number of servings. (3) The failure of the label to extend
(a) The label of any package of a food over the area of the container or pack-
which bears a representation as to the age available for such extension, so as
20
to provide sufficient label space for the tion in a foreign language, all words,
prominent placing of such word, state- statements, and other information re-
ment, or information; quired by or under authority of the act
(4) Insufficiency of label space (for to appear on the label or labeling shall
the prominent placing of such word, appear on such article of labeling.
statement, or information) resulting
from the use of label space for any § 501.17 Animal food labeling warning
word, statement, design, or device statements.
which is not required by or under au- (a) Self-pressurized containers. (1) The
thority of the act to appear on the label of a food packaged in a self-pres-
label;
surized container and intended to be
(5) Insufficiency of label space (for
expelled from the package under pres-
the prominent placing of such word,
statement, or information) resulting sure shall bear the following warning:
from the use of label space to give ma- Warning Avoid spraying in eyes. Con-
terially greater conspicuousness to any tents under pressure. Do not puncture
other word, statement, or information, or incinerate. Do not store at tempera-
or to any design or device; or ture above 120 °F. Keep out of reach of
(6) Smallness or style of type in children.
which such word, statement, or infor- (2) In the case of products intended
mation appears, insufficient back- for use by children, the phrase ‘‘except
ground contrast, obscuring designs or under adult supervision’’ may be added
vignettes, or crowding with other writ- at the end of the last sentence in the
ten, printed, or graphic matter. warning required by paragraph (a)(1) of
(b) No exemption depending on insuf- this section.
ficiency of label space, as prescribed in (3) In the case of products packaged
regulations promulgated under section in glass containers, the word ‘‘break’’
403(e) or (i) of the act, shall apply if may be substituted for the word
such insufficiency is caused by: ‘‘puncture’’ in the warning required by
(1) The use of label space for any paragraph (a)(1) of this section.
word, statement, design, or device
(4) The words ‘‘Avoid spraying in
which is not required by or under au-
thority of the act to appear on the eyes’’ may be deleted from the warning
label; required by paragraph (a)(1) of this sec-
(2) The use of label space to give tion in the case of a product not ex-
greater conspicuousness to any word, pelled as a spray.
statement, or other information that is (b) Self-pressurized containers with
required by section 403(f) of the act; or halocarbon or hydrocarbon propellants.
(3) The use of label space for any rep- (1) In addition to the warning required
resentation in a foreign language. by paragraph (a) of this section, the
(c)(1) All words, statements, and label of a food packaged in a self-pres-
other information required by or under surized container in which the propel-
authority of the act to appear on the lant consists in whole or in part of a
label or labeling shall appear thereon halocarbon or a hydrocarbon shall bear
in the English language: Provided, how- the following warning:
ever, That in the case of articles dis- Warning Use only as directed. Inten-
tributed solely in the Commonwealth tional misuse by deliberately concen-
of Puerto Rico or in a territory where trating and inhaling the contents can
the predominant language is one other be harmful or fatal.
than English, the predominant lan- (2) The warning required by para-
guage may be substituted for English.
graph (b)(1) of this section is not re-
(2) If the label contains any represen-
quired for the following products:
tation in a foreign language, all words,
statements, and other information re- (i) Products expelled in the form of a
quired by or under authority of the act foam or cream, which contain less than
to appear on the label shall appear 10 percent propellant in the container.
thereon in the foreign language. (ii) Products in a container with a
(3) If any article of labeling (other physical barrier that prevents escape of
than a label) contains any representa- the propellant at the time of use.
21
§ 501.18 21 CFR Ch. I (4–1–23 Edition)
(iii) Products of a net quantity of (3) A part of the name required by ap-
contents of less than 2 ozs that are de- plicable Federal law or regulation.
signed to release a measured amount of (4) A name whose market signifi-
product with each valve actuation. cance is generally understood by the
(iv) Products of a net quantity of consumer to connote a particular class,
contents of less than 1⁄2 oz. kind, type, or style of food rather than
(c) Animal food containing or manufac- to indicate geographical origin.
tured with a chlorofluorocarbon or other
ozone-depleting substance. Labeling re- Subpart B—Specific Animal Food
quirements for animal foods that con- Labeling Requirements
tain or are manufactured with a
chlorofluorocarbon or other ozone-de- § 501.22 Animal foods; labeling of
pleting substance designated by the spices, flavorings, colorings, and
Environmental Protection Agency chemical preservatives.
(EPA) are set forth in 40 CFR part 82. (a)(1) The term artificial flavor or arti-
[41 FR 38619, Sept. 10, 1976, as amended at 42 ficial flavoring means any substance,
FR 22033, Apr. 29, 1977; 61 FR 20101, May 3, the function of which is to impart fla-
1996] vor, which is not derived from a spice,
fruit or fruit juice, vegetable or vege-
§ 501.18 Misbranding of animal food. table juice, edible yeast, herb, bark,
(a) Among representations in the la- bud, root, leaf or similar plant mate-
beling of a food which render such food rial, meat, fish, poultry, eggs, dairy
misbranded is a false or misleading products, or fermentation products
representation with respect to another thereof. Artificial flavor includes the
food or a drug, device, or cosmetic. substances listed in §§ 172.515(b) and
(b) The labeling of a food which con- 582.60 of this chapter except where
tains two or more ingredients may be these are derived from natural sources.
misleading by reason (among other rea- (2) The term spice means any aro-
sons) of the designation of such food in matic vegetable substance in the
such labeling by a name which includes whole, broken, or ground form, except
or suggests the name of one or more for those substances which have been
but not all such ingredients, even traditionally regarded as foods, such as
though the names of all such ingredi- onions, garlic and celery; whose signifi-
ents are stated elsewhere in the label- cant function in food is seasoning rath-
ing. er than nutritional; that is true to
(c) Among representations in the la- name; and from which no portion of
beling of a food which render such food any volatile oil or other flavoring prin-
misbranded is any representation that ciple has been removed. Spices include
expresses or implies a geographical ori- the spices listed in subpart A of part
gin of the food or any ingredient of the 582 of this chapter, such as the fol-
food except when such representation lowing:
is either: Allspice, Anise, Basil, Bay leaves, Caraway
(1) A truthful representation of geo- seed, Cardamon, Celery seed, Chervil, Cin-
graphical origin. namon, Cloves, Coriander, Cumin seed, Dill
(2) A trademark or trade name pro- seed, Fennel seed, Fenugreek, Ginger,
vided that as applied to the article in Horseradish, Mace, Marjoram, Mustard
question its use is not deceptively flour, Nutmeg, Oregano, Paprika, Parsley,
Pepper, black; Pepper, white; Pepper, red;
misdescriptive. A trademark or trade
Rosemary, Saffron, Sage, Savory, Star ani-
name comprised in whole or in part of seed, Tarragon, Thyme, Turmeric.
geographical words shall not be consid-
ered deceptively misdescriptive if it: Paprika, turmeric, and saffron or other
(i) Has been so long and exclusively spices which are also colors, shall be
used by a manufacturer or distributor declared as spice and coloring unless de-
that it is generally understood by the clared by their common or usual name.
consumer to mean the product of a par- (3) The term natural flavor or natural
ticular manufacturer or distributor; or flavoring means the essential oil, oleo-
(ii) Is so arbitrary or fanciful that it resin, essence or extractive, protein hy-
is not generally understood by the con- drolysate, distillate, or any product of

sumer to suggest geographic origin. roasting, heating or enzymolysis,
22
which contains the flavoring constitu- tablishment, is displayed to the pur-

ents derived from a spice, fruit or fruit chaser with either (1) the labeling of
juice, vegetable or vegetable juice, edi- the bulk container plainly in view or
ble yeast, herb, bark, bud, root, leaf or (2) a counter card, sign, or other appro-
similar plant material, meat, seafood, priate device bearing prominently and
poultry, eggs, dairy products, or fer- conspicuously the information required
mentation products thereof, whose sig- to be stated on the label pursuant to
nificant function in food is flavoring section 403(k) of the act.
rather than nutritional. Natural fla- (f) A fruit or vegetable shall be ex-
vors, include the natural essence or exempt from compliance with the re-
tractives obtained from plants listed in quirements of section 403(k) of the act
subpart A of part 582 of this chapter, with respect to a chemical preservative
and the substances listed in § 172.510 of applied to the fruit or vegetable as a
this chapter. pesticide chemical prior to harvest.
(4) The term artificial color or artificial (g) A flavor shall be labeled in the
coloring means any color additive as de- following way when shipped to a food
fined in § 70.3(f) of this chapter. manufacturer or processor (but not a
(5) The term chemical preservative consumer) for use in the manufacture
means any chemical that, when added of a fabricated food, unless it is a fla-
to food, tends to prevent or retard de- vor for which a standard of identity
terioration thereof, but does not in- has been promulgated, in which case it
clude common salt, sugars, vinegars, shall be labeled as provided in the
spices, or oils extracted from spices, standard:
substances added to food by direct ex-
(1) If the flavor consists of one ingre-
posure thereof to wood smoke, or
dient, it shall be declared by its com-
chemicals applied for their insecticidal
mon or usual name.
or herbicidal properties.
(b) A food which is subject to the re- (2) If the flavor consists of two or
quirements of section 403(k) of the act more ingredients, the label either may
shall bear labeling, even though such declare each ingredient by its common
food is not in package form. or usual name or may state ‘‘All flavor
(c) A statement of artificial fla- ingredients contained in this product
voring, artificial coloring, or chemical are approved for use in a regulation of
preservative shall be placed on the the Food and Drug Administration.’’
food, or on its container or wrapper, or Any flavor ingredient not contained in
on any two or all of these, as may be one of these regulations, and any non-
necessary to render such statement flavor ingredient, shall be separately
likely to be read by the ordinary indi- listed on the label.
vidual under customary conditions of (3) In cases where the flavor contains
purchase and use of such food. a solely natural flavor(s), the flavor
(d) A food shall be exempt from com- shall be so labeled, e.g., strawberry fla-
pliance with the requirements of sec- vor, banana flavor, or natural strawberry
tion 403(k) of the act if it is not in flavor. In cases where the flavor con-
package form and the units thereof are tains both a natural flavor and an arti-
so small that a statement of artificial ficial flavor, the flavor shall be so la-
flavoring, artificial coloring, or chem- beled, e.g., natural and artificial straw-
ical preservative, as the case may be, berry flavor. In cases where the flavor
cannot be placed on such units with contains a solely artificial flavor(s),
such conspicuousness as to render it the flavor shall be so labeled, e.g., arti-
likely to be read by the ordinary indi- ficial strawberry flavor.
vidual under customary conditions of (h) The label of a food to which flavor
purchase and use. is added shall declare the flavor in the
(e) A food shall be exempt while held statement of ingredients in the fol-
for sale from the requirements of sec- lowing way:
tion 403(k) of the act (requiring label (1) Spice, natural flavor, and artifi-
statement of any artificial flavoring, cial flavor may be declared as spice,
artificial coloring, or chemical preserv- natural flavor, or artificial flavor, or any
atives) if said food, having been re- combination thereof, as the case may
ceived in bulk containers at a retail es- be.
23
§ 501.22 21 CFR Ch. I (4–1–23 Edition)
(2) An incidental additive in a food, height of the letters used in the name
originating in a spice or flavor used in of the food, except that:
the manufacture of the food, need not (i) If the food is one that is com-
be declared in the statement of ingredi- monly expected to contain a character-
ents if it meets the requirements of izing food ingredient, and the food con-
§ 501.100(a)(3). tains natural flavor derived from such
(3) Substances obtained by cutting, ingredient and an amount of character-
grinding, drying, pulping, or similar izing ingredient insufficient to inde-
processing of tissues derived from fruit, pendently characterize the food, or the
vegetable, meat, fish, or poultry, e.g., food contains no such ingredient, the
powdered or granulated onions, garlic name of the characterizing flavor may
powder, and celery powder, are com- be immediately preceded by the word
monly understood by consumers to be natural and shall be immediately fol-
food rather than flavor and shall be de- lowed by the word flavored in letters
clared by their common or usual name. not less than one-half the height of the
(4) Any salt (sodium chloride) used as letters in the name of the character-
an ingredient in food shall be declared izing flavor.
by its common or usual name salt. (ii) If none of the natural flavor used
(5) Any monosodium glutamate used in the food is derived from the product
as an ingredient in food shall be de- whose flavor is simulated, the food in
which the flavor is used shall be la-
clared by its common or usual name
beled either with the flavor of the prod-
monosodium glutamate.
uct from which the flavor is derived or
(6) Any pyroligneous acid or other ar-
as artificially flavored.
tificial smoke flavors used as an ingre- (iii) If the food contains both a char-
dient in a food may be declared as arti- acterizing flavor from the product
ficial flavor or artificial smoke flavor. No whose flavor is simulated and other
representation may be made, either di- natural flavor which simulates, resem-
rectly or implied, that a food flavored bles or reinforces the characterizing
with pyroligneous acid or other artifi- flavor, the food shall be labeled in ac-
cial smoke flavor has been smoked or cordance with the introductory text
has a true smoked flavor, or that a sea- and paragraph (i)(1)(i) of this section
soning sauce or similar product con- and the name of the food shall be im-
taining pyroligneous acid or other arti- mediately followed by the words with
ficial smoke flavor and used to season other natural flavor in letters not less
or flavor other foods will result in a than one-half the height of the letters
smoked product or one having a true used in the name of the characterizing
smoked flavor. flavor.
(i) If the label, labeling, or adver- (2) If the food contains any artificial
tising of a food makes any direct or in- flavor which simulates, resembles or
direct representations with respect to reinforces the characterizing flavor,
the primary recognizable flavor(s), by the name of the food on the principal
word, vignette, e.g., depiction of a fruit, display panel or panels of the label
or other means, or if for any other rea- shall be accompanied by the common
son the manufacturer or distributor of or usual name(s) of the characterizing
a food wishes to designate the type of flavor, in letters not less than one-half
flavor in the food other than through the height of the letters used in the
the statement of ingredients, such fla- name of the food and the name of the
vor shall be considered the character- characterizing flavor shall be accom-
izing flavor and shall be declared in the panied by the word(s) artificial or artifi-
following way: cially flavored, in letters not less than
(1) If the food contains no artificial one-half the height of the letters in the
flavor which simulates, resembles or name of the characterizing flavor.
reinforces the characterizing flavor, (3) Wherever the name of the charac-
the name of the food on the principal terizing flavor appears on the label
display panel or panels of the label (other than in the statement of ingre-
shall be accompanied by the common dients) so conspicuously as to be easily
or usual name of the characterizing fla- seen under customary conditions of

vor in letters not less than one-half the purchase, the words prescribed by this
24
paragraph shall immediately and con- Services. Such certifications are re-
spicuously precede or follow such garded by the Food and Drug Adminis-
name, without any intervening writ- tration as reports to the government
ten, printed, or graphic matter, except: and as guarantees or other under-
(i) Where the characterizing flavor takings within the meaning of section
and a trademark or brand are pre- 301(h) of the act and subject the certi-
sented together, other written, printed, fying party to the penalties for making
or graphic matter that is a part of or is any false report to the government
associated with the trademark or under 18 U.S.C. 1001 and any false guar-
brand may intervene if the required antee or undertaking under section
words are in such relationship with the 303(a) of the act. The defenses provided
trademark or brand as to be clearly re- under section 303(c)(2) of the act shall
lated to the characterizing flavor; and be applicable to the certifications pro-
(ii) If the finished product contains vided for in this section.
more than one flavor subject to the re-
(ii) Wherever possible, the Food and
quirements of this paragraph, the
Drug Administration shall verify the
statements required by this paragraph
need appear only once in each state- accuracy of a reasonable number of
ment of characterizing flavors present certifications made pursuant to this
in such food. section, constituting a representative
(iii) If the finished product contains sample of such certifications, and shall
three or more distinguishable charac- not request all such certifications.
terizing flavors, or a blend of flavors (iii) Where no person authorized to
with no primary recognizable flavor, provide such information is reasonably
the flavor may be declared by an appro- available at the time of inspection, the
priately descriptive generic term in certifying party shall arrange to have
lieu of naming each flavor. such person and the relevant materials
(4) A flavor supplier shall certify, in and records ready for verification as
writing, that any flavor he supplies soon as practicable; provided that,
which is designated as containing no whenever the Food and Drug Adminis-
artificial flavor does not, to the best of tration has reason to believe that the
his knowledge and belief, contain any supplier or user may utilize this period
artificial flavor, and that he has added to alter inventories or records, such ad-
no artificial flavor to it. The require- ditional time shall not be permitted.
ment for such certification may be sat- Where such additional time is pro-
isfied by a guarantee under section vided, the Food and Drug Administra-
303(c)(2) of the act which contains such tion may require the certifying party
a specific statement. A flavor used to certify that relevant inventories
shall be required to make such a writ- have not been materially disturbed and
ten certification only where he adds to relevant records have not been altered
or combines another flavor with a fla- or concealed during such period.
vor which has been certified by a flavor
(iv) The certifying party shall pro-
supplier as containing no artificial fla-
vide, to an officer or representative
vor, but otherwise such user may rely
upon the supplier’s certification and duly designated by the Secretary, such
need make no separate certification. qualitative statement of the composi-
All such certifications shall be re- tion of the flavor or product covered by
tained by the certifying party through- the certification as may be reasonably
out the period in which the flavor is expected to enable the Secretary’s rep-
supplied and for a minimum of 3 years resentatives to determine which rel-
thereafter, and shall be subject to the evant raw and finished materials and
following conditions: flavor ingredient records are reason-
(i) The certifying party shall make ably necessary to verify the certifi-
such certifications available upon re- cations. The examination conducted by
quest at all reasonable hours to any the Secretary’s representative shall be
duly authorized officer, or employee of limited to inspection and review of in-
the Food and Drug Administration or ventories and ingredient records for
any other employee acting on behalf of those certifications which are to be

the Secretary of Health and Human verified.
25
§ 501.100 21 CFR Ch. I (4–1–23 Edition)
(v) Review of flavor ingredient formative term that makes clear that a
records shall be limited to the quali- color additive has been used in the
tative formula and shall not include food). Alternatively, such color addi-
the quantitative formula. The person tives may be declared as ‘‘Colored with
verifying the certifications may make ____’’ or ‘‘____ color,’’ the blank to be
only such notes as are necessary to en- filled with the name of the color addi-
able him to verify such certification. tive listed in the applicable regulation
Only such notes or such flavor ingre- in part 73 of this chapter.
dient records as are necessary to verify
such certification or to show a poten-
FR 14091, Mar. 15, 1977; 42 FR 15675, Mar. 22,
tial or actual violation may be re- 1977; 76 FR 71254, Nov. 17, 2011]
moved or transmitted from the certi-
fying party’s place of business: Pro-
vided, That, where such removal or Subparts C–E [Reserved]
transmittal is necessary for such pur-
poses the relevant records and notes Subpart F—Exemptions From Ani-
shall be retained as separate docu- mal Food Labeling Require-
ments in Food and Drug Administra- ments
tion files, shall not be copied in other
reports, and shall not be disclosed pub- § 501.100 Animal food; exemptions
licly other than in a judicial pro- from labeling.
ceeding brought pursuant to the act or
(a) The following foods are exempt
18 U.S.C. 1001.
from compliance with the require-
(j) A food to which a chemical pre-
ments of section 403(i)(2) of the act (re-
servative(s) is added shall, except when
quiring a declaration on the label of
exempt pursuant to § 501.100, bear a
the common or usual name of each in-
label declaration stating both the com-
gredient when the food is fabricated
mon or usual name of the ingredient(s)
from two or more ingredients).
and a separate description of its func-
tion, e.g., preservative, to retard spoilage, (1) An assortment of different items
a mold inhibitor, to help protect flavor or of food, when variations in the items
to promote color retention. that make up different packages
(k) The label of an animal food to packed from such assortment normally
which any coloring has been added occur in good packing practice and
shall declare the coloring in the state- when such variations result in vari-
ment of ingredients in the manner ations in the ingredients in different
specified in paragraphs (k)(1) and (k)(2) packages, with respect to any ingre-
of this section. dient that is not common to all pack-
(1) A color additive or the lake of a ages. Such exemption, however, shall
color additive subject to certification be on the condition that the label shall
under section 721(c) of the act shall be bear, in conjunction with the names of
declared by the name of the color addi- such ingredients as are common to all
tive listed in the applicable regulation packages, a statement (in terms that
in part 74 or part 82 of this chapter, ex- are as informative as practicable and
cept that it is not necessary to include that are not misleading) indicating by
the ‘‘FD&C’’ prefix or the term ‘‘No.’’ name other ingredients which may be
in the declaration, but the term present.
‘‘Lake’’ shall be included in the dec- (2) A food having been received in
laration of the lake of the certified bulk containers at a retail establish-
color additive (e.g., Blue 1 Lake). Man- ment, if displayed to the purchaser
ufacturers may parenthetically declare with either (i) the labeling of the bulk
an appropriate alternative name of the container plainly in view or (ii) a
certified color additive following its counter card, sign, or other appropriate
common or usual name as specified in device bearing prominently and con-
part 74 or part 82 of this chapter. spicuously the information required to
(2) Color additives not subject to cer- be stated on the label pursuant to sec-
tification may be declared as ‘‘Artifi- tion 403(i)(2) of the act.
cial Color,’’ ‘‘Artificial Color Added,’’ (3) Incidental additives that are
or ‘‘Color Added’’ (or by an equally in- present in a food at insignificant levels
26
and do not have any technical or func- sign, or other appropriate device bear-
tional effect in that food. For the pur- ing prominently and conspicuously the
poses of this paragraph (a)(3), inci- information required by these provi-
dental additives are: sions.
(i) Substances that have no technical (3) Section 403(i)(1) of the act (requir-
or functional effect but are present in a ing the label to bear the common or
food by reason of having been incor- usual name of the food), if the food is
porated into the food as an ingredient displayed to the purchaser with its
of another food, in which the substance interstate labeling clearly in view, or
did have a functional or technical ef- with a counter card, sign, or other ap-
fect. propriate device bearing prominently
(ii) Processing aids, which are as fol- and conspicuously the common or
lows: usual name of the food, or if the com-
(a) Substances that are added to a mon or usual name of the food is clear-
food during the processing of such food ly revealed by its appearance.
but are removed in some manner from (c) [Reserved]
the food before it is packaged in its fin- (d) Except as provided by paragraphs
ished form. (e) and (f) of this section, a shipment or
(b) Substances that are added to a other delivery of a food which is, in ac-
food during processing, are converted cordance with the practice of the trade,
into constituents normally present in
to be processed, labeled, or repacked in
the food, and do not significantly in-
substantial quantity at an establish-
crease the amount of the constituents
ment other than that where originally
naturally found in the food.
processed or packed, shall be exempt,
(c) Substances that are added to a
during the time of introduction into
food for their technical or functional
and movement in interstate commerce
effect in the processing but are present
and the time of holding in such estab-
in the finished food at insignificant
lishment, from compliance with the la-
levels and do not have any technical or
beling requirements of section 403 (c),
functional effect in that food.
(e), (g), (h), (i), (j) and (k) of the act if:
(iii) Substances migrating to food
from equipment or packaging or other- (1) The person who introduced such
wise affecting food that are not food shipment or delivery into interstate
additives as defined in section 201(s) of commerce is the operator of the estab-
the act; or if they are food additives as lishment where such food is to be proc-
so defined, they are used in conformity essed, labeled, or repacked; or
with regulations established pursuant (2) In case such person is not such op-
to section 409 of the act. erator, such shipment or delivery is
(b) A food repackaged in a retail es- made to such establishment under a
tablishment is exempt from the fol- written agreement, signed by and con-
lowing provisions of the act if the containing the post office addresses of
ditions specified are met. such person and such operator, and
(1) Section 403(e)(1) of the act (requir- containing such specifications for the
ing a statement on the label of the processing, labeling, or repacking, as
name and place of business of the man- the case may be, of such food in such
ufacturer, packer, or distributor). establishment as will ensure, if such
(2) Section 403(g)(2) of the act (requir- specifications are followed, that such
ing the label of a food which purports food will not be adulterated or mis-
to be or is represented as one for which branded within the meaning of the act
a definition and standard of identity upon completion of such processing, la-
has been prescribed to bear the name of beling, or repacking. Such person and
the food specified in the definition and such operator shall each keep a copy of
standard and, insofar as may be re- such agreement until 2 years after the
quired by the regulation establishing final shipment or delivery of such food
the standard the common names of the from such establishment, and shall
optional ingredients present in the make such copies available for inspec-
food), if the food is displayed to the tion at any reasonable hour to any offi-
purchaser with its interstate labeling cer or employee of the Department who
clearly in view, or with a counter card, requests them.
27
§ 501.103 21 CFR Ch. I (4–1–23 Edition)
(e) Conditions affecting expiration of the marker is harmless and that the
exemptions. exemption has been granted.
(1) An exemption of a shipment or
other delivery of a food under para- § 501.103 Petitions requesting exemp-
graph (d)(1) of this section shall, at the tions from or special requirements
for label declaration of ingredients.
beginning of the act of removing such
shipment or delivery, or any part The Commissioner of Food and
thereof, from such establishment be- Drugs, either on his own initiative or
come void ab initio if the food com- on behalf of any interested person who
prising such shipment, delivery, or part has submitted a petition pursuant to
is adulterated or misbranded within part 10 of this chapter may issue a pro-
the meaning of the act when so re- posal to amend § 501.4 to specify the
moved. manner in which an ingredient(s) shall
(2) An exemption of a shipment or be declared, i.e., by specific or class
other delivery of a food under para- name, or § 501.100 to exempt an ingre-
graph (d)(2) of this section shall be- dient(s) from the requirements for
come void ab initio with respect to the label declaration.
person who introduced such shipment [41 FR 38619, Sept. 10, 1976, as amended at 42
or delivery into interstate commerce FR 15675, Mar. 22, 1977]
upon refusal by such person to make
available for inspection a copy of the § 501.105 Declaration of net quantity
agreement, as required by paragraph of contents when exempt.
(d)(2) of this section. (a) The principal display panel of a
(3) An exemption of a shipment or food in package form shall bear a dec-
other delivery of a food under para- laration of the net quantity of con-
graph (d)(2) of this section shall expire: tents. This shall be expressed in the
(i) At the beginning of the act of re- terms of weight, measure, numerical
moving such shipment or delivery, or count, or a combination of numerical
any part thereof, from such establish- count and weight or measure. The
ment if the food comprising such ship- statement shall be in terms of fluid
ment, delivery, or part is adulterated measure if the food is liquid, or in
or misbranded within the meaning of terms of weight if the food is solid,
the act when so removed; or semisolid, or viscous, or a mixture of
(ii) Upon refusal by the operator of solid and liquid; except that such state-
the establishment where such food is to ment may be in terms of dry measure
be processed, labeled, or repacked, to if the food is a fresh fruit, fresh vege-
make available for inspection a copy of table, or other dry commodity that is
the agreement as required by such customarily sold by dry measure. If
paragraph. there is a firmly established general
(f) [Reserved] consumer usage and trade custom of
(g) The label declaration of a harm- declaring the contents of a liquid by
less marker used to identify a par- weight, or a solid, semisolid, or viscous
ticular manufacturer’s product may re- product by fluid measure, it may be
sult in unfair competition through reused. Whenever the Commissioner de-
vealing a trade secret. Exemption from termines that an existing practice of
the label declaration of such a marker declaring net quantity of contents by
is granted, therefore, provided that the weight, measure, numerical count, or a
following conditions are met: combination in the case of a specific
(1) The person desiring to use the packaged food does not facilitate value
marker without label declaration of its comparisons by consumers and offers
presence has submitted to the Commis- opportunity for consumer confusion, he
sioner of Food and Drugs full informa- will by regulation designate the appro-
tion concerning the proposed usage and priate term or terms to be used for
the reasons why he believes label dec- such commodity.
laration of the marker should be sub- (b)(1) Statements of weight shall be
ject to this exemption; and in terms of avoirdupois pound and
(2) The person requesting the exemp- ounce.
tion has received from the Commis- (2) Statements of fluid measure shall
sioner of Food and Drugs a finding that be in terms of the U.S. gallon of 231
28
cubic inches and quart, pint, and fluid formation appearing to the left or right
ounce subdivisions thereof, and shall: of the declaration. It shall not include
(i) In the case of frozen food that is any term qualifying a unit of weight,
sold and consumed in a frozen state, measure, or count (such as jumbo quart
express the volume at the frozen tem- and full gallon) that tends to exag-
perature. gerate the amount of the food in the
(ii) In the case of refrigerated food container. It shall be placed on the
that is sold in the refrigerated state, principal display panel within the bot-
express the volume at 40 °F (4 °C). tom 30 percent of the area of the label
(iii) In the case of other foods, ex- panel in lines generally parallel to the
press the volume at 68 °F (20 °C). base on which the package rests as it is
(3) Statements of dry measure shall designed to be displayed: Provided,
be in terms of the U.S. bushel of That on packages having a principal
2,150.42 cubic inches and peck, dry display panel of 5 square inches or less,
quart, and dry pint subdivisions there- the requirement for placement within
of. the bottom 30 percent of the area of the
(c) When the declaration of quantity label panel shall not apply when the
of contents by numerical count does declaration of net quantity of contents
not give adequate information as to meets the other requirements of this
the quantity of food in the package, it part.
shall be combined with such statement (g) The declaration shall accurately
of weight, measure, or size of the indi- reveal the quantity of food in the pack-
vidual units of the foods as will provide age exclusive of wrappers and other
such information. material packed therewith; provided
(d) The declaration may contain that in the case of foods packed in con-
common or decimal fractions. A com- tainers designed to deliver the food
mon fraction shall be in terms of under pressure, the declaration shall
halves, quarters, eighths, sixteenths, or state the net quantity of the contents
thirty-seconds; except that if there ex- that will be expelled when the instruc-
ists a firmly established general con- tions for use as shown on the container
sumer usage and trade custom of em- are followed. The propellant is included
ploying different common fractions in in the net quantity declaration.
the net quantity declaration of a par- (h) The declaration shall appear in
ticular commodity, they may be em- conspicuous and easily legible boldface
ployed. A common fraction shall be reprint or type in distinct contrast (by
duced to its lowest terms; a decimal typography, layout, color, embossing,
fraction shall not be carried out to or molding) to other matter on the
more than two places. A statement package; except that a declaration of
that includes small fractions of an net quantity blown, embossed, or mold-
ounce shall be deemed to permit small- ed on a glass or plastic surface is per-
er variations than one which does not missible when all label information is
include such fractions. so formed on the surface. Requirements
(e) The declaration shall be located of conspicuousness and legibility shall
on the principal display panel of the include the specifications that:
label, and with respect to packages (1) The ratio of height to width (of
bearing alternate principal panels it the letter) shall not exceed a differen-
shall be duplicated on each principal tial of 3 units to 1 unit (no more than
display panel. 3 times as high as it is wide).
(f) The declaration shall appear as a (2) Letter heights pertain to upper
distinct item on the principal display case or capital letters. When upper and
panel, shall be separated (by at least a lower case or all lower case letters are
space equal to the height of the let- used, it is the lower case letter ‘‘o’’ or
tering used in the declaration) from its equivalent that shall meet the min-
other printed label information appear- imum standards.
ing above or below the declaration and (3) When fractions are used, each
(by at least a space equal to twice the component numeral shall meet one-
width of the letter ‘‘N’’ of the style of half the minimum height standards.
type used in the quantity of contents (i) The declaration shall be in letters
statement) from other printed label in- and numerals in a type size established
29
§ 501.105 21 CFR Ch. I (4–1–23 Edition)
in relationship to the area of the prin- terms of pounds and decimal fractions
cipal display panel of the package and of the pound carried out to not more
shall be uniform for all packages of than two decimal places. When the net
substantially the same size by com- weight does not exceed 1 pound, the
plying with the following type speci- declaration on the random package
fications: may be in decimal fractions of the
(1) Not less than 1⁄16 inch in height on pound in lieu of ounces (see example in
packages the principal display panel of paragraph (m)(5) of this section).
which has an area of 5 square inches or (3) The declaration may appear in
less. more than one line. The term net
(2) Not less than 1⁄8 inch in height on weight shall be used when stating the
packages the principal display panel of net quantity of contents in terms of
which has an area of more than 5 but weight. Use of the terms net or net con-
not more than 25 square inches. tents in terms of fluid measure or nu-
(3) Not less than 3⁄16 inch in height on merical count is optional. It is suffi-
packages the principal display panel of cient to distinguish avoirdupois ounce
which has an area of more than 25 but from fluid ounce through association of
not more than 100 square inches. terms; for example, Net wt. 6 oz. or 6 oz.
(4) Not less than 1⁄4 inch in height on net wt. and 6 fl. oz. or net contents 6 fl.
packages the principal display panel of oz.
which has an area of more than 100 (k) On packages containing 4 pounds
square inches, except not less than 1⁄2 or 1 gallon or more and labeled in
inch in height if the area is more than terms of weight or fluid measure, the
400 square inches. declaration shall be expressed in
Where the declaration is blown, em- pounds for weight units with any re-
bossed, or molded on a glass or plastic mainder in terms of ounces or common
surface rather than by printing, typ- or decimal fraction of the pound, or in
ing, or coloring, the lettering sizes the case of fluid measure, it shall be
specified in paragraphs (i) (1) through expressed in the largest whole unit
(4) of this section shall be increased by (gallons followed by common or dec-
1⁄16 of an inch. imal fraction of a gallon or by the next
(j) On packages containing less than smaller whole unit or units (quarts, or
4 pounds or 1 gallon and labeled in quarts and pints)) with any remainder
terms of weight or fluid measure: in terms of fluid ounces or common or
(1) The declaration shall be expressed decimal fractions of the pint or quart
both in ounces, with identification by (see paragraph (m)(6) of this section).
weight or by liquid measure and, if ap- (l) [Reserved]
plicable (1 pound or 1 pint or more) fol- (m) Examples: (1) A declaration of 11⁄2
lowed in parentheses by a declaration pounds weight shall be expressed as Net
in pounds for weight units, with any re- Wt. 24 oz. (1 lb. 8 oz.), Net Wt. 24 oz. (11⁄2
mainder in terms of ounces or common lb.), or Net Wt. 24 oz. (1.5 lb.).
or decimal fractions of the pound (see (2) A declaration of 3⁄4 pound avoirdu-
examples set forth in paragraphs (m) pois weight shall be expressed as Net
(1) and (2) of this section), or in the Wt. 12 oz.
case of liquid measure, in the largest (3) A declaration of 1 quart liquid
whole units (quarts, quarts and pints, measure shall be expressed as Net 32 fl.
or pints, as appropriate) with any re- oz. (1 qt.).
mainder in terms of fluid ounces or (4) A declaration of 13⁄4 quarts liquid
common or decimal fractions of the measure shall be expressed as Net con-
pint or quart (see examples in para- tents 56 fluid ounces (1 quart 11⁄2 pints) or
graphs (m) (3) and (4) of this section). as Net 56 fluid oz. (1 qt. 1 pt. 8 oz.), but
(2) If the net quantity of contents not in terms of quart and ounce such as
declaration appears on a random pack- Net 56 fluid oz. (1 quart 24 ounces).
age, that is a package which is one of (5) On a random package, declaration
a lot, shipment, or delivery of packages of 3⁄4 pound avoirdupois may be ex-
of the same consumer commodity with pressed as Net Wt. .75 lb.
varying weights and with no fixed (6) A declaration of 21⁄2 gallons liquid
weight pattern, it may, when the net measure shall be expressed as Net con-
weight exceeds 1 pound, be expressed in tents 21⁄2 gallons, Net contents 2.5 gallons,
30
or Net contents 2 gallons 2 quarts and not total quantity of contents of the multi-
as 2 gallons 4 pints. unit package in terms of avoirdupois or
(n) For quantities, the following ab- fluid ounces, except that such declara-
breviations and none other may be em- tion of total quantity need not be fol-
ployed (periods and plural forms are lowed by an additional parenthetical
optional): declaration in terms of the largest
weight wt. pint pt. whole units and subdivisions thereof,
ounce oz. quart qt. as required by paragraph (j)(1) of this
pound lb. fluid fl. section. A multiunit retail package
gallon gal. may thus be properly labeled: 6–16 oz.
(o) Nothing in this section shall pro- bottles—(96 fl. oz.) or 3–16 oz. cans—(net
hibit supplemental statements at loca- wt. 48 oz). For the purposes of this sec-
tions other than the principal display tion, multiunit retail package means a
panel(s) describing in nondeceptive package containing two or more indi-
terms the net quantity of contents; vidually packaged units of the iden-
provided, that such supplemental tical commodity and in the same quan-
statements of net quantity of contents tity, intended to be sold as part of the
shall not include any term qualifying a multiunit retail package but capable of
unit of weight, measure, or count that being individually sold in full compli-
tends to exaggerate the amount of the ance with all requirements of the regu-
food contained in the package; for ex- lations in this part. Open multiunit re-
ample, jumbo quart and full gallon. Dual tail packages that do not obscure the
or combination declarations of net number of units nor prevent examina-
quantity of contents as provided for in tion of the labeling on each of the indi-
paragraphs (a), (c), and (j) of this sec- vidual units are not subject to this
tion (for example, a combination of net paragraph if the labeling of each indi-
weight plus numerical count, net con- vidual unit complies with the require-
tents plus dilution directions of a con- ments of paragraphs (f) and (i) of this
centrate, etc.) are not regarded as sup- section.
plemental net quantity statements and (t) Where the declaration of net
may be located on the principal display quantity of contents is in terms of net
panel. weight and/or drained weight or vol-
(p) A separate statement of the net
ume and does not accurately reflect
quantity of contents in terms of the
the actual quantity of the contents or
metric system is not regarded as a sup-
the product falls below the applicable
plemental statement and an accurate
standard of fill of container because of
statement of the net quantity of con-
equipment malfunction or otherwise
tents in terms of the metric system of
weight or measure may also appear on unintentional product variation, and
the principal display panel or on other the label conforms in all other respects
panels. to the requirements of this chapter,
(q) The declaration of net quantity of the mislabeled food product may be
contents shall express an accurate sold by the manufacturer or processor
statement of the quantity of contents directly to institutions operated by
of the package. Reasonable variations Federal, State or local governments:
caused by loss or gain of moisture dur- Provided, That:
ing the course of good distribution (1) The purchaser shall sign a state-
practice or by unavoidable deviations ment at the time of sale stating that
in good manufacturing practice will be he is aware that the product is mis-
recognized. Variations from stated labeled to include acknowledgement of
quantity of contents shall not be un- the nature and extent of the
reasonably large. mislabeling, e.g., ‘‘Actual net weight
(r) [Reserved] may be as low as __% below labeled
(s) On a multiunit retail package, a quantity’’ and that any subsequent dis-
statement of the quantity of contents tribution by him of said product except
shall appear on the outside of the pack- for his own institutional use is unlaw-
age and shall include the number of in- ful. This statement shall be kept on
dividual units, the quantity of each in- file at the principal place of business of
dividual unit, and, in parentheses, the the manufacturer or processor for 2
31
§ 501.110 21 CFR Ch. I (4–1–23 Edition)
years subsequent to the date of ship- (3) The label of the animal feed oth-
ment of the product and shall be avail- erwise conforms to the requirements of
able to the Food and Drug Administra- section 403(i)(2) of the act.
tion upon request. (4) The ingredients of any feed listed
(2) The product shall be labeled on in paragraph (b) of this section neither
the outside of its shipping container contain nor are food additives as de-
with the statement(s): fined in section 201(s) of the act unless
(i) When the variation concerns net provided for by and in conformity with
weight and/or drained weight of vol- applicable regulations established pur-
ume—‘‘Product Mislabeled. Actual net suant to section 409 of the act.
weight (drained weight or volume (b) Each collective name referred to
where appropriate) may be as low as in this paragraph may be used for the
__% below labeled quantity. This Prod- purpose of labeling where one or more
uct Not for Retail Distribution,’’ the of the ingredients listed for that collec-
blank to be filled in with the maximum tive name are present. The animal feed
percentage variance between the la- ingredients listed under each of the
beled and actual weight or volume of collective names are the products de-
contents of the individual packages in fined by the Association of American
Feed Control Officials. The collective
the shipping container, and
names are as follows:
(ii) When the variation is in regard to
(1) Animal protein products include one
a fill of container standard—‘‘Product
or more of the following: Animal prod-
Mislabeled. Actual fill may be as low ucts, marine products, and milk prod-
as __% below standard of fill. This ucts.
Product Not for Retail Distribution.’’ (2) Forage products include one or
(3) The statements required by para- more of the following: Alfalfa meals,
graphs (t)(2) (i) and (ii) of this section, entire plant meals, hays, and stem
which may be consolidated where ap- meals.
propriate, shall appear prominently (3) Grain products include one or more
and conspicuously as compared to of the following: Barley, grain sor-
other printed matter on the shipping ghums, maize (corn), oats, rice, rye,
container and in boldface print or type and wheat.
on a clear, contrasting background in (4) Plant protein products include one
order to render them likely to be read or more of the following: Algae meals,
and understood by the purchaser under coconut meals (copra), cottonseed
ordinary conditions of purchase. meals, guar meal, linseed meals, pea-
[41 FR 38619, Sept. 10, 1976, as amended at 54 nut meals, safflower meals, soybean
FR 18279, Apr. 28, 1989; 85 FR 72908, Nov. 16, meals, sunflower meals, and yeasts.
2020] (5) Processed grain byproducts include
one or more of the following: Brans,
§ 501.110 Animal feed labeling; collec- brewers dried grains, distillers grains,
tive names for feed ingredients. distillers solubles, flours, germ meals,
(a) An animal feed shall be exempt gluten feeds, gluten meals, grits,
from the requirements of section groats, hominy feeds, malt sprouts,
403(i)(2) of the act with respect to its middlings, pearled, polishings, shorts,
label bearing the common or usual and wheat mill run.
names of the animal feed ingredients (6) Roughage products include one or
listed in paragraph (b) of this section more of the following: Cobs, hulls,
under the following prescribed condi- husks, pulps, and straws.
tions:
(1) The animal feed is intended solely PART 502—COMMON OR USUAL
for livestock and poultry. NAMES FOR NONSTANDARDIZED
(2) The label of the animal feed bears ANIMAL FOODS
the collective name(s) prescribed in
paragraph (b) of this section in lieu of Sec.
the corresponding common or usual 502.5 General principles.
names of the individual feed ingredi- 502.19 Petitions.

ents contained therein. AUTHORITY: 21 U.S.C. 321, 343, 371.
32
§ 502.5 General principles. of the common or usual name of the

(a) The common or usual name of a food required by paragraph (a) of this
food, which may be a coined term, shall section when the word ‘‘containing’’
accurately identify or describe, in as (or ‘‘contains’’) is not used, in easily
simple and direct terms as possible, the legible boldface print or type in dis-
basic nature of the food or its charac- tinct contrast to other printed or
terizing properties or ingredients. The graphic matter, and in a height not
name shall be uniform among all iden- less than the larger of the following al-
tical or similar products and may not ternatives:
be confusingly similar to the name of (i) Not less than one-sixteenth inch
any other food that is not reasonably in height on packages having a prin-
encompassed within the same name. cipal display panel with an area of 5
Each class or subclass of food shall be square inches or less and not less than
given its own common or usual name one-eighth inch in height if the area of
that states, in clear terms, what it is in the principal display panel is greater
a way that distinguishes it from dif- than 5 square inches; or
ferent foods. (ii) Not less than one-half the height
(b) The common or usual name of a of the largest type appearing in the
food shall include the percentage(s) of part of the common or usual name of
any characterizing ingredient(s) or the food required by paragraph (a) of
component(s) when the proportion of this section.
such ingredient(s) or component(s) in (c) The common or usual name of a
the food has a material bearing on food shall include a statement of the
price or consumer acceptance or when presence or absence of any character-
the labeling or the appearance of the izing ingredient(s) or component(s)
food may otherwise create an erro- and/or the need for the user to add any
neous impression that such ingre- characterizing ingredient(s) or compo-
dient(s) or component(s) is present in nent(s) when the presence or absence of
an amount greater than is actually the such ingredient(s) or component(s) in
case. The following requirements shall
the food has a material bearing on
apply unless modified by a specific reg-
price or consumer acceptance or when
ulation in this part.
the labeling or the appearance of the
(1) The percentage of a characterizing
food may otherwise create an erro-
ingredient or component shall be de-
clared on the basis of its quantity in neous impression that such ingre-
the finished product (i.e., weight/ dient(s) or component(s) is present
weight in the case of solids, or volume/ when it is not, and consumers may oth-
volume in the case of liquids). erwise be misled about the presence or
(2) The percentage of a characterizing absence of the ingredient(s) or compo-
ingredient or component shall be de- nent(s) in the food. The following re-
clared by the words ‘‘containing (or quirements shall apply unless modified
contains) __ percent (or %) __’’ or ‘‘__ by a specific regulation in this part.
percent (or %) __’’ with the first blank (1) The presence or absence of a char-
filled in with the percentage expressed acterizing ingredient or component
as a whole number not greater than the shall be declared by the words ‘‘con-
actual percentage of the ingredient or taining (or contains) ____’’ or ‘‘con-
component named and the second taining (or contains) _____’’ or ‘‘no
blank filled in with the common or _____’’ or ‘‘does not contain _____’’, with
usual name of the ingredient or compo- the blank being filled in with the com-
nent. The word ‘‘containing’’ (or ‘‘con- mon or usual name of the ingredient or
tains’’), when used, shall appear on a component.
line immediately below the part of the (2) The need for the user of a food to
common or usual name of the food re- add any characterizing ingredient(s) or
quired by paragraph (a) of this section. component(s) shall be declared by an
For each characterizing ingredient or appropriate informative statement.
component, the words ‘‘__ percent (or (3) The statement(s) required under
%) __’’shall appear following or di- paragraph (c) (1) and/or (2) of this sec-
rectly below the word ‘‘containing’’ (or tion shall appear following or directly
‘‘contains’’), or directly below the part below the part of the common or usual
33
§ 502.19 21 CFR Ch. I (4–1–23 Edition)
name of the food required by para- 507.7 Requirements that apply to a qualified
graphs (a) and (b) of this section, in facility.
easily legible boldface print or type in 507.10 Applicability of subparts C and E of
this part to a facility solely engaged in
distinct contrast to other printed or the storage of unexposed packaged ani-
graphic matter, and in a height not mal food.
less than the larger of the alternatives 507.12 Applicability of this part to the hold-
established under paragraph (b)(2) (i) ing and distribution of human food by-
and (ii) of this section. products for use as animal food.
(d) A common or usual name of a
food may be established by common Subpart B—Current Good Manufacturing
usage or by establishment of a regula- Practice
tion in this part, in a standard of iden- 507.14 Personnel.
tity, or in other regulations in this 507.17 Plant and grounds.
chapter. 507.19 Sanitation.
507.20 Water supply and plumbing.
[41 FR 38627, Sept. 10, 1976. Redesignated at 507.22 Equipment and utensils.
42 FR 14091, Mar. 15, 1977] 507.25 Plant operations.
507.27 Holding and distribution.
§ 502.19 Petitions. 507.28 Holding and distribution of human
food by-products for use as animal food.
(a) The Commissioner of Food and
Drugs, either on his own initiative or Subpart C—Hazard Analysis and Risk-
on behalf of any interested person who Based Preventive Controls
has submitted a petition, may publish
a proposal to issue, amend, or revoke, 507.31 Food safety plan.
under this part, a regulation pre- 507.33 Hazard analysis.
scribing a common or usual name for a 507.34 Preventive controls.
507.36 Circumstances in which the owner,
food, pursuant to part 10 of this chap- operator, or agent in charge of a manu-
ter. facturing/processing facility is not re-
(b) If the principal display panel of a quired to implement a preventive con-
food for which a common or usual trol.
name regulation is established is too 507.37 Provision of assurances required
small to accommodate all mandatory under § 507.36(a)(2), (3), and (4).
requirements, the Commissioner may 507.38 Recall plan.
507.39 Preventive control management com-
establish by regulation an acceptable ponents.
alternative, e.g., a smaller type size. A 507.40 Monitoring.
petition requesting such a regulation, 507.42 Corrective actions and corrections.
which would amend the applicable reg- 507.45 Verification.
ulation, shall be submitted pursuant to 507.47 Validation.
part 10 of this chapter. 507.49 Verification of implementation and
effectiveness.
[42 FR 4716, Jan. 25, 1977; 42 FR 10980, Feb. 25, 507.50 Reanalysis.
1977. Redesignated at 42 FR 14091, Mar. 15, 507.51 Modified requirements that apply to
1977, and amended at 42 FR 15675, Mar. 22, a facility solely engaged in the storage of
1977; 42 FR 24254, May 13, 1977] unexposed packaged animal food.
507.53 Requirements applicable to a preven-
PART 507—CURRENT GOOD MAN- tive controls qualified individual and a
qualified auditor.
UFACTURING PRACTICE, HAZARD 507.55 Implementation records required for
ANALYSIS, AND RISK-BASED PRE- this subpart.
VENTIVE CONTROLS FOR FOOD
FOR ANIMALS Subpart D—Withdrawal of a Qualified
Facility Exemption
Subpart A—General Provisions 507.60 Circumstances that may lead FDA to
withdraw a qualified facility exemption.
Sec. 507.62 Issuance of an order to withdraw a
507.1 Applicability and status. qualified facility exemption.
507.3 Definitions. 507.65 Contents of an order to withdraw a
507.4 Qualifications of individuals who man- qualified facility exemption.
ufacture, process, pack, or hold animal 507.67 Compliance with, or appeal of, an
food. order to withdraw a qualified facility ex-

507.5 Exemptions. emption.
34
507.69 Procedure for submitting an appeal. the food has been manufactured under
507.71 Procedure for requesting an informal such conditions that it is unfit for
hearing. food; or
507.73 Requirements applicable to an infor-
mal hearing. (ii) Section 402(a)(4) of the Federal
507.75 Presiding officer for an appeal and for Food, Drug, and Cosmetic Act in that
an informal hearing. the food has been prepared, packed, or
507.77 Timeframe for issuing a decision on held under insanitary conditions
an appeal. whereby it may have become contami-
507.80 Revocation of an order to withdraw a nated with filth, or whereby it may
qualified facility exemption.
507.83 Final agency action.
have been rendered injurious to health;
507.85 Reinstatement of a qualified facility and
exemption that was withdrawn. (2) In violation of section 361 of the
Public Health Service Act (42 U.S.C.
Subpart E—Supply-Chain Program 264).
507.105 Requirement to establish and imple- (b) The operation of a facility that
ment a supply-chain program. manufactures, processes, packs, or
507.110 General requirements applicable to a holds animal food for sale in the United
supply-chain program. States if the owner, operator, or agent
507.115 Responsibilities of the receiving fa- in charge of such facility is required to
cility. comply with, and is not in compliance
507.120 Using approved suppliers.
507.125 Determining appropriate supplier
with, section 418 of the Federal Food,
verification activities (including deter- Drug, and Cosmetic Act or subparts C,
mining the frequency of conducting the D, E, or F of this part and § 507.7 is a
activity). prohibited act under section 301(uu) of
507.130 Conducting supplier verification ac- the Federal Food, Drug, and Cosmetic
tivities for raw materials and other in- Act.
gredients. (c) Animal food covered by specific
507.135 Onsite audit.
507.175 Records documenting the supply-
current good manufacturing practice
chain program. regulations also is subject to the re-
quirements of those regulations.
Subpart F—Requirements Applying to (d) Except as provided by § 507.12, if a
Records That Must Be Established and facility is required to comply with sub-
Maintained part B of part 507 and is also required
to comply with subpart B of part 117 of
507.200 Records subject to the requirements
of this subpart. this chapter because the facility manu-
507.202 General requirements applying to factures, processes, packs, or holds
records. human food and animal food, then the
507.206 Additional requirements applying to facility may choose to comply with the
the food safety plan. requirements in subpart B of part 117,
507.208 Requirements for record retention. instead of subpart B of part 507, as to
507.212 Use of existing records. the manufacturing, processing, pack-
507.215 Special requirements applicable to a
written assurance. ing, and holding of animal food at that
facility. If a facility is required to com-
AUTHORITY: 21 U.S.C. 331, 342, 343, 350d note, ply with subpart C of part 507 and is
350g, 350g note, 371, 374; 42 U.S.C. 243, 264, 271.
also required to comply with subpart C
SOURCE: 80 FR 56337, Sept. 17, 2015, unless of part 117 of this chapter, then the fa-
otherwise noted. cility may choose to comply with the
requirements in subpart C of part 117
Subpart A—General Provisions as to the manufacturing, processing,
packing, and holding of animal food at
§ 507.1 Applicability and status. the facility, instead of subpart C of
(a) The criteria and definitions in part 507, provided the food safety plan
this part apply in determining whether also addresses hazards for the animal
an animal food is: food, if applicable, that require a pre-
(1) Adulterated within the meaning ventive control. When applying the re-
of: quirements of part 117 of this chapter
(i) Section 402(a)(3) of the Federal to animal food, the term ‘‘food’’ in part
Food, Drug, and Cosmetic Act in that 117 includes animal food.
35
§ 507.3 21 CFR Ch. I (4–1–23 Edition)
§ 507.3 Definitions. Facility means a domestic facility or

a foreign facility that is required to
The definitions and interpretations
register under section 415 of the Fed-
contained in section 201 of the Federal
eral Food, Drug, and Cosmetic Act, in
Food, Drug, and Cosmetic Act apply to
accordance with the requirements of
such terms when used in this part. The
part 1, subpart H of this chapter.
following definitions also apply:
Farm means farm as defined in § 1.227
Adequate means that which is needed of this chapter.
to accomplish the intended purpose in FDA means the Food and Drug Ad-
keeping with good public (human and ministration.
animal) health practice. Food means food as defined in section
Affiliate means any facility that con- 201(f) of the Federal Food, Drug, and
trols, is controlled by, or is under com- Cosmetic Act and includes raw mate-
mon control with another facility. rials and ingredients.
Animal food means food for animals Food-contact surfaces are those sur-
other than man and includes pet food, faces that contact animal food and
animal feed, and raw materials and in- those surfaces from which drainage, or
gredients. other transfer, onto the animal food or
Audit means the systematic, inde- onto surfaces that contact the animal
pendent, and documented examination food ordinarily occurs during the nor-
(through observation, investigation, mal course of operations. ‘‘Food-con-
records review, discussions with em- tact surfaces’’ includes utensils and
ployees of the audited entity, and, as animal food-contact surfaces of equip-
appropriate, sampling and laboratory ment.
analysis) to assess an audited entity’s Full-time equivalent employee is a term
food safety processes and procedures. used to represent the number of em-
Calendar day means every day shown ployees of a business entity for the pur-
on the calendar. pose of determining whether the busi-
Correction means an action to iden- ness qualifies for the small business ex-
tify and correct a problem that oc- emption. The number of full-time
curred during the production of animal equivalent employees is determined by
food, without other actions associated dividing the total number of hours of
with a corrective action procedure salary or wages paid directly to em-
(such as actions to reduce the likeli- ployees of the business entity and of all
hood that the problem will recur, of its affiliates and subsidiaries by the
evaluate all affected animal food for number of hours of work in 1 year, 2,080
safety, and prevent affected animal hours (i.e., 40 hours × 52 weeks). If the
food from entering commerce). result is not a whole number, round
Critical control point means a point, down to the next lowest whole number.
step, or procedure in a food process at Harvesting applies to farms and farm
which control can be applied and is es- mixed-type facilities and means activi-
sential to prevent or eliminate a food ties that are traditionally performed
safety hazard or reduce such hazard to on farms for the purpose of removing
an acceptable level. raw agricultural commodities from the
Environmental pathogen means a place they were grown or raised and
pathogen capable of surviving and per- preparing them for use as animal food.
sisting within the manufacturing, proc- Harvesting is limited to activities per-
essing, packing, or holding environ- formed on raw agricultural commod-
ment such that food for animals may ities, or on processed foods created by
be contaminated and may result in drying/dehydrating a raw agricultural
foodborne illness if that animal food is commodity without additional manu-
not treated to significantly minimize facturing/processing, on a farm. Har-
or prevent the environmental patho- vesting does not include activities that
gen. Examples of environmental patho- transform a raw agricultural com-
gens for the purposes of this part in- modity into a processed food as defined
clude Listeria monocytogenes and Sal- in section 201(gg) of the Federal Food,
monella spp. but do not include the Drug, and Cosmetic Act. Examples of
spores of pathogenic sporeforming bac- harvesting include cutting (or other-

teria. wise separating) the edible portion of
36
the raw agricultural commodity from ties, storage silos, grain elevators, and
the crop plant and removing or trim- liquid-storage tanks.
ming part of the raw agricultural com- Known or reasonably foreseeable haz-
modity (e.g., foliage, husks, roots, or ard means a biological, chemical (in-
stems). Examples of harvesting also including radiological), or physical haz-
clude cooling, field coring, filtering, ard that is known to be, or has the po-
gathering, hulling, shelling, sifting, tential to be, associated with the facil-
threshing, trimming of outer leaves of, ity or the animal food.
and washing raw agricultural commod- Lot means the animal food produced
ities grown on a farm. during a period of time and identified
Hazard means any biological, chem- by an establishment’s specific code.
ical (including radiological), or phys- Manufacturing/processing means mak-
ical agent that has the potential to ing animal food from one or more in-
cause illness or injury in humans or gredients, or synthesizing, preparing,
animals. treating, modifying, or manipulating
Hazard requiring a preventive control animal food, including food crops or in-
means a known or reasonably foresee- gredients. Examples of manufacturing/
able hazard for which a person knowl- processing activities include: Baking,
edgeable about the safe manufacturing, boiling, bottling, canning, cooking,
processing, packing, or holding of ani- cooling, cutting, distilling, drying/de-
mal food would, based on the outcome hydrating raw agricultural commod-
of a hazard analysis (which includes an ities to create a distinct commodity
assessment of the severity of the ill- (such as drying/dehydrating grapes to
ness or injury to humans or animals if produce raisins), evaporating, evis-
the hazard were to occur and the prob- cerating, extracting juice, extruding,
ability that the hazard will occur in formulating, freezing, grinding, homog-
the absence of preventive controls), es- enizing, irradiating, labeling, milling,
tablish one or more preventive controls mixing, packaging (including modified
to significantly minimize or prevent atmosphere packaging), pasteurizing,
the hazard in an animal food and com- peeling, pelleting, rendering, treating
ponents to manage those controls (such to manipulate ripening, trimming,
as monitoring, corrections or correc- washing, or waxing. For farms and
tive actions, verification, and records) farm mixed-type facilities, manufac-
as appropriate to the animal food, the turing/processing does not include ac-
facility, and the nature of the preven- tivities that are part of harvesting,
tive control and its role in the facili- packing, or holding.
ty’s food safety system. Microorganisms means yeasts, molds,
Holding means storage of animal food bacteria, viruses, protozoa, and micro-
and also includes activities performed scopic parasites and includes species
incidental to storage of an animal food that are pathogens. The term ‘‘unde-
(e.g., activities performed for the safe sirable microorganisms’’ includes those
or effective storage of that animal microorganisms that are pathogens,
food, such as fumigating animal food that subject animal food to decomposi-
during storage, and drying/dehydrating tion, that indicate that animal food is
raw agricultural commodities when the contaminated with filth, or that other-
drying/dehydrating does not create a wise may cause animal food to be adul-
distinct commodity (such as drying/de- terated.
hydrating hay or alfalfa)). Holding also Mixed-type facility means an estab-
includes activities performed as a prac- lishment that engages in both activi-
tical necessity for the distribution of ties that are exempt from registration
that animal food (such as blending of under section 415 of the Federal Food,
the same raw agricultural commodity Drug, and Cosmetic Act and activities
and breaking down pallets), but does that require the establishment to be
not include activities that transform a registered. An example of such a facil-
raw agricultural commodity into a ity is a ‘‘farm mixed-type facility,’’
processed food as defined in section which is an establishment that is a
201(gg) of the Federal Food, Drug, and farm, but also conducts activities out-
Cosmetic Act. Holding facilities could side the farm definition that require
include warehouses, cold storage facili- the establishment to be registered.
37
§ 507.3 21 CFR Ch. I (4–1–23 Edition)
Monitor means to conduct a planned diting function. Examples of potential

sequence of observations or measure- qualified auditors include:
ments to assess whether control meas- (1) A government employee, includ-
ures are operating as intended. ing a foreign government employee;
Packing means placing animal food and
into a container other than packaging (2) An audit agent of a certification
the animal food and also includes re- body that is accredited in accordance
packing and activities performed inci- with regulations in part 1, subpart M of
dental to packing or repacking an ani- this chapter.
mal food (e.g., activities performed for Qualified end-user, with respect to
the safe or effective packing or repack- food, means the consumer of the food
ing of that animal food (such as sort- (where the term consumer does not in-
ing, culling, grading, and weighing or clude a business); or a restaurant or re-
conveying incidental to packing or retail food establishment (as those terms
packing)), but does not include activi- are defined in § 1.227 of this chapter)
ties that transform a raw agricultural that:
commodity into a processed food as de- (1) Is located:
fined in section 201(gg) of the Federal (i) In the same State or the same In-
Food, Drug, and Cosmetic Act. dian reservation as the qualified facil-
Pathogen means a microorganism of ity that sold the food to such res-
public (human or animal) health sig- taurant or retail food establishment; or
nificance. (ii) Not more than 275 miles from
Pest refers to any objectionable ani- such facility; and
mals or insects including birds, ro- (2) Is purchasing the food for sale di-
dents, flies, and larvae. rectly to consumers at such restaurant
Plant means the building or struc- or retail food establishment.
ture, or parts thereof, used for or in Qualified facility means (when includ-
connection with the manufacturing, ing the sales by any subsidiary; affil-
processing, packing, or holding of ani- iate; or subsidiaries or affiliates, col-
mal food. lectively, of any entity of which the fa-
Preventive controls means those risk- cility is a subsidiary or affiliate) a fa-
based, reasonably appropriate proce- cility that is a very small business as
dures, practices, and processes that a defined in this part, or a facility to
person knowledgeable about the safe which both of the following apply:
manufacturing, processing, packing, or (1) During the 3-year period preceding
holding of animal food would employ the applicable calendar year, the aver-
to significantly minimize or prevent age annual monetary value of the food
the hazards identified under the hazard manufactured, processed, packed, or
analysis that are consistent with the held at such facility that is sold di-
current scientific understanding of safe rectly to qualified end-users (as defined
food manufacturing, processing, pack- in this part) during such period exceed-
ing, or holding at the time of the anal- ed the average annual monetary value
ysis. of the food sold by such facility to all
Preventive controls qualified individual other purchasers; and
means a qualified individual who has (2) The average annual monetary
successfully completed training in the value of all food sold during the 3-year
development and application of risk- period preceding the applicable cal-
based preventive controls at least endar year was less than $500,000, ad-
equivalent to that received under a justed for inflation.
standardized curriculum recognized as Qualified facility exemption means an
adequate by FDA, or is otherwise exemption applicable to a qualified fa-
qualified through job experience to de- cility under § 507.5(d).
velop and apply a food safety system. Qualified individual means a person
Qualified auditor means a person who who has the education, training, or ex-
is a qualified individual as defined in perience (or a combination thereof)
this part and has technical expertise necessary to manufacture, process,
obtained through education, training, pack, or hold safe animal food as ap-
or experience (or the combination propriate to the individual’s assigned

thereof) necessary to perform the au- duties. A qualified individual may be,
38
but is not required to be, an employee safety plan as a whole, when properly
of the establishment. implemented, is capable of effectively
Raw agricultural commodity has the controlling the identified hazards.
meaning given in section 201(r) of the Verification means the application of
Federal Food, Drug, and Cosmetic Act. methods, procedures, tests and other
Receiving facility means a facility evaluations, in addition to monitoring,
that is subject to subparts C and E of to determine whether a control meas-
this part and that manufactures/proc- ure or combination of control measures
esses a raw material or other ingre- is or has been operating as intended
dient that it receives from a supplier. and to establish the validity of the food
Rework means clean, unadulterated safety plan.
animal food that has been removed Very small business means, for pur-
from processing for reasons other than poses of this part, a business (including
insanitary conditions or that has been any subsidiaries and affiliates) aver-
successfully reconditioned by reproc- aging less than $2,500,000, adjusted for
essing and that is suitable for use as inflation, per year, during the 3-year
animal food. period preceding the applicable cal-
Sanitize means to adequately treat endar year in sales of animal food plus
cleaned surfaces by a process that is ef- the market value of animal food manu-
fective in destroying vegetative cells of factured, processed, packed, or held
pathogens, and in substantially reduc- without sale (e.g., held for a fee or sup-
ing numbers of other undesirable plied to a farm without sale).
microorganisms, but without adversely Water activity (aw) means a measure
affecting the product or its safety for of the free moisture in an animal food
animals or humans. and is the quotient of the water vapor
Significantly minimize means to reduce pressure of the substance divided by
to an acceptable level, including to the vapor pressure of pure water at the
eliminate. same temperature.
Small business means, for purposes of Written procedures for receiving raw
this part, a business (including any materials and other ingredients means
subsidiaries and affiliates) employing written procedures to ensure that raw
fewer than 500 full-time equivalent em- materials and other ingredients are re-
ployees. ceived only from suppliers approved by
Subsidiary means any company which the receiving facility (or, when nec-
is owned or controlled directly or indi- essary and appropriate, on a temporary
rectly by another company. basis from unapproved suppliers whose
Supplier means the establishment raw materials or other ingredients are
that manufactures/processes the ani- subjected to adequate verification ac-
mal food, raises the animal, or grows tivities before acceptance for use).
the food that is provided to a receiving You means, for purposes of this part,
facility without further manufac- the owner, operator, or agent in charge
turing/processing by another establish- of a facility.
ment, except for further manufac- [80 FR 56337, Sept. 17, 2015, as amended at 81
turing/processing that consists solely FR 3717, Jan. 22, 2016]
of the addition of labeling or similar
activity of a de minimis nature. § 507.4 Qualifications of individuals
Supply-chain-applied control means a who manufacture, process, pack, or
preventive control for a hazard in a hold animal food.
raw material or other ingredient when (a)(1) The management of an estab-
the hazard in the raw material or other lishment must ensure that all individ-
ingredient is controlled before its re- uals who manufacture, process, pack,
ceipt. or hold animal food subject to subparts
Unexposed packaged animal food B and F of this part are qualified to
means packaged animal food that is perform their assigned duties; and
not exposed to the environment. (2) The owner, operator, or agent in
Validation means obtaining and eval- charge of a facility must ensure that
uating scientific and technical evi- all individuals who manufacture, proc-
dence that a control measure, combina- ess, pack, or hold animal food subject
tion of control measures, or the food to subparts C, D, E, or F of this part
39
§ 507.5 21 CFR Ch. I (4–1–23 Edition)
are qualified to perform their assigned (c) Subparts C and E of this part do
duties. not apply to activities of a facility that
(b) Each individual engaged in manu- are subject to section 419 of the Federal
facturing, processing, packing, or hold- Food, Drug, and Cosmetic Act (Stand-
ing animal food (including temporary ards for Produce Safety).
and seasonal personnel) or in the super- (d) Except as provided in subpart D of
vision thereof must: this part, subparts C and E of this part
(1) Be a qualified individual as that do not apply to a qualified facility.
term is defined in § 507.3, i.e., have the Qualified facilities are subject to the
education, training, or experience (or a requirements in § 507.7.
combination thereof) necessary to (e) For a farm mixed-type facility
manufacture, process, pack, or hold that is a small or very small business,
safe animal food as appropriate to the subparts C and E of this part do not
individual’s assigned duties; and apply to on-farm packing or holding of
(2) Receive training in the principles processed animal food, and § 507.7 does
of animal food hygiene and animal food not apply to on-farm packing or hold-
safety, including the importance of em- ing of processed animal food by a very
ployee health and personal hygiene, as small business, if the only packing or
appropriate to the animal food, the fa- holding activities subject to section 418
cility and the individual’s assigned du- of the Federal Food, Drug, and Cos-
ties. metic Act that the business conducts
are the following low-risk packing or
(c) Responsibility for ensuring com-
holding activity/animal food combina-
pliance by individuals with the require-
tions—i.e., packing (or repacking) (in-
ments of this part must be clearly as-
cluding weighing or conveying inci-
signed to supervisory personnel who
dental to packing or repacking); sort-
have the education, training, or experi-
ing, culling, or grading incidental to
ence (or a combination thereof) nec-
packing or storing; and storing (ambi-
essary to supervise the production of
ent, cold and controlled atmosphere)
safe animal food.
of:
(d) Records that document training
(1) Roughage products (e.g., alfalfa
required by paragraph (b)(2) of this sec-
meal, entire plant meal, stem meal,
tion must be established and main-
pomace, and pulp);
tained and are subject to the record-
(2) Plant protein meals (e.g., algae,
keeping requirements in subpart F of
coconut (copra), guar, and peanut);
this part.
(3) Grain by-products and processed
§ 507.5 Exemptions. grain products (e.g., bran, flour, germ
meal, grits, groats, hominy feed, malt
(a) This part does not apply to estab- sprouts, middlings, pearled grain, pol-
lishments, including ‘‘farms’’ (as de- ished grain, brewers grain, distillers
fined in § 1.227 of this chapter), that are grain, and gluten meal);
not required to register under section (4) Oilseed products (e.g., oil and meal
415 of the Federal Food, Drug, and Cos- of safflower, soybean, or sunflower);
metic Act. (5) Molasses (e.g., processed sugar
(b)(1) Subparts C and E of this part cane, sugar beets, and citrus);
do not apply with respect to activities (6) Animal protein meals (e.g., blood,
that are subject to § 500.23 and part 113 feather, meat, meat and bone, and ma-
of this chapter (Thermally Processed rine (e.g., crab, fish, shrimp));
Low-Acid Foods Packaged in Hermeti- (7) Milk products (e.g., casein, cheese
cally Sealed Containers) at an animal rind, and lactalbumin);
food facility if you are required to (8) Animal tissue-derived products
comply with, and are in compliance (e.g., fat);
with, part 113 of this chapter with re- (9) Vitamins, minerals, and con-
spect to those activities. centrates;
(2) The exemption in paragraph (b)(1) (10) Processing aids (e.g., enzymes,
of this section is applicable only with preservatives, and stabilizers); and
respect to those microbiological haz- (11) Any other processed animal food
ards regulated under part 113 of this that does not require time/temperature
chapter. control for safety.
40
(f) For a farm mixed-type facility rived products, vitamins, minerals,

that is a small or very small business, concentrates, processing aids, finished
subparts C and E of this part do not animal food, including animal food
apply to on-farm manufacturing/proc- ready for consumption, or any other
essing activities conducted by a small processed animal food that does not re-
or very small business for distribution quire time/temperature control for
into commerce, and § 507.7 does not safety.
apply to on-farm manufacturing/proc- (g) Subparts C and E of this part do
essing activities conducted by a very not apply to facilities that are solely
small business for distribution into engaged in the storage of raw agricul-
commerce, if the only manufacturing/ tural commodities (other than fruits
processing activities subject to section and vegetables) intended for further
418 of the Federal Food, Drug, and Cos- distribution or processing.
metic Act that the business conducts (h) Subpart B of this part does not
consists of the following low-risk man- apply to any of the following:
ufacturing/processing activity/animal (1) Establishments solely engaged in
food combinations: the holding and/or transportation of
(1) Chopping or shredding hay; one or more raw agricultural commod-
(2) Cracking, crimping, flaking, ities;
pearling, peeling, shelling, or (2) Establishments solely engaged in
wafering—grain (e.g., barley, sorghum, hulling, shelling, drying, packing, and/
corn, oats, rice, rye, and wheat) or oil- or holding nuts and hulls (without
seed (e.g., beans, canola, cottonseed, manufacturing/processing, such as
linseed, soybeans, and sunflowers); grinding shells or roasting nuts); and
(3) Crushing, dry rolling, grinding, (3) Establishments solely engaged in
milling, pulverizing—grain, oilseed, ginning of cotton (without manufac-
grain by-products and processed grain turing/processing, such as extracting
products, oilseed products, hay, ensiled oil from cottonseed).
material, culled fruits and vegetables, [80 FR 56337, Sept. 17, 2015, as amended at 81
roughage (e.g., cobs, hulls, husks, and FR 3717, Jan. 22, 2016]
straws), or roughage products;
(4) Ensiling (including chopping, § 507.7 Requirements that apply to a
shredding, mixing, storing, or fer- qualified facility.
menting), that is, making silage or (a) A qualified facility must submit
haylage from forage (e.g., sorghum the following attestations to FDA:
(milo), corn (maize), alfalfa, and grass), (1) An attestation that the facility is
grain, culled fruits and vegetables, or a qualified facility as defined in § 507.3.
roughage; For the purpose of determining wheth-
(5) Extracting (mechanical) or wet er a facility satisfies the definition of
rolling grain, oilseed, brewers grain by- qualified facility, the baseline year for
products, or distillers grain by-prod- calculating the adjustment for infla-
ucts; tion is 2011; and
(6) Labeling roughage products, plant (2)(i) An attestation that you have
protein meals, grain by-products and identified the potential hazards associ-
processed grain products, oilseed prod- ated with the animal food being pro-
ucts, molasses, animal protein meals, duced, are implementing preventive
milk products, animal tissue-derived controls to address the hazards, and
products, vitamins, minerals, con- are monitoring the performance of the
centrates, processing aids, finished ani- preventive controls to ensure that such
mal food, including animal food ready controls are effective; or
for consumption, or any other proc- (ii) An attestation that the facility is
essed animal food that does not require in compliance with State, local, coun-
time/temperature control for safety; ty, tribal, or other applicable non-Fed-
and eral food safety law, including relevant
(7) Packaging roughage products, laws and regulations of foreign coun-
plant protein meals, grain by-products tries, including an attestation based on
and processed grain products, oilseed licenses, inspection reports, certifi-
products, molasses, animal protein cates, permits, credentials, certifi-

meals, milk products, animal tissue-de- cation by an appropriate agency (such
41
§ 507.10 21 CFR Ch. I (4–1–23 Edition)
as a State department of agriculture), ‘‘not a qualified facility’’ based on the

or other evidence of oversight. annual determination required by para-
(b) The attestations required by paragraph (c)(1) of this section, the facility
graph (a) of this section must be sub- must notify FDA of that change in sta-
mitted to FDA by any one of the fol- tus using Form FDA 3942b by July 31 of
lowing means: the applicable calendar year.
(1) Electronic submission. To submit (d) When the status of a facility
electronically, go to http://www.fda.gov/ changes from ‘‘qualified facility’’ to
furls and follow the instructions. This ‘‘not a qualified facility,’’ the facility
Web site is available from wherever the must comply with subparts C and E of
Internet is accessible, including librar- this part no later than December 31 of
ies, copy centers, schools, and Internet the applicable calendar year unless
cafes. FDA encourages electronic sub- otherwise agreed to by FDA and the fa-
mission. cility.
(2) Submission by mail. (i) You must (e) A qualified facility that does not
use Form FDA 3942b. You may obtain a submit attestations under paragraph
copy of this form by any of the fol- (a)(2)(i) of this section must provide
lowing mechanisms: notification to consumers as to the
(A) Download it from http:// name and complete business address of
www.fda.gov/pcafrule; the facility where the animal food was
(B) Write to the U.S. Food and Drug manufactured or processed (including
Administration (HFS–681), 5001 Campus the street address or P.O. Box, city,
Dr., College Park, MD 20740; or state, and zip code for domestic facili-
(C) Request a copy of this form by ties, and comparable full address infor-
phone at 1–800–216–7331 or 301–575–0156. mation for foreign facilities) as fol-
(ii) Send a paper Form FDA 3942b to lows:
the U.S. Food and Drug Administration (1) If an animal food packaging label
(HFS–681), 5001 Campus Dr., College is required, the notification required
Park, MD 20740. We recommend that by paragraph (e) of this section must
you submit a paper copy only if your appear prominently and conspicuously
facility does not have reasonable ac- on the label of the animal food.
cess to the Internet. (2) If an animal food packaging label
(c)(1) A facility must determine and is not required, the notification re-
document its status as a qualified fa- quired by paragraph (e) of this section
cility on an annual basis no later than must appear prominently and conspicu-
July 1 of each calendar year. ously, at the point of purchase, on a
(2) The attestations required by para- label, poster, sign, placard, or docu-
graph (a) of this section must be: ments delivered contemporaneously
(i) Submitted to FDA initially: with the animal food in the normal
(A) By December 16, 2019 for a facility course of business, or in an electronic
that begins manufacturing, processing, notice, in the case of Internet sales.
packing, or holding animal food before (f)(1) A qualified facility must main-
September 17, 2019; tain those records relied upon to sup-
(B) Before beginning operations, for a port the attestations that are required
facility that begins manufacturing, by paragraph (a) of this section.
processing, packing, or holding animal (2) The records that a qualified facil-
food after September 17, 2019; or ity must maintain are subject to the
(C) By July 31 of the applicable cal- requirements of subpart F of this part.
endar year, when the status of a facil- [80 FR 56337, Sept. 17, 2015, as amended at 81
ity changes from ‘‘not a qualified facil- FR 3717, Jan. 22, 2016; 81 FR 49897, July 29,
ity’’ to ‘‘qualified facility’’ based on 2016]
the annual determination required by
paragraph (c)(1) of this section; and § 507.10 Applicability of subparts C
(ii) Beginning in 2020, submitted to and E of this part to a facility solely
FDA every 2 years during the period engaged in the storage of unex-
beginning on October 1 and ending on posed packaged animal food.
December 31. (a) Subparts C and E of this part do
(3) When the status of a facility not apply to a facility solely engaged
changes from ‘‘qualified facility’’ to in the storage of unexposed packaged
42
animal food that does not require time/ Subpart B—Current Good
temperature control to significantly Manufacturing Practice
minimize or prevent the growth of, or
toxin production by, pathogens. § 507.14 Personnel.
(b) A facility solely engaged in the (a) The management of the establish-
storage of unexposed packaged animal ment must take reasonable measures
food, including unexposed packaged and precautions to ensure that all per-
animal food that requires time/tem- sons working in direct contact with
perature control to significantly mini- animal food, animal food-contact sur-
mize or prevent the growth of, or toxin faces, and animal food-packaging ma-
production by, pathogens is subject to terials conform to hygienic practices
the modified requirements in § 507.51 to the extent necessary to protect
for any unexposed packaged animal against the contamination of animal
food that requires time/temperature food.
control to significantly minimize or (b) The methods for conforming to
hygienic practices and maintaining
prevent the growth of, or toxin produc-
cleanliness include:
tion by, pathogens.
(1) Maintaining adequate personal
§ 507.12 Applicability of this part to cleanliness;
the holding and distribution of (2) Washing hands thoroughly in an
human food by-products for use as adequate hand-washing facility as nec-
animal food. essary and appropriate to protect
against contamination;
(a) Except as provided by paragraph (3) Removing or securing jewelry and
(b) of this section, the requirements of other objects that might fall into ani-
this part do not apply to by-products of mal food, equipment, or containers;
human food production, or the off-farm (4) Storing clothing or other personal
packing and holding of raw agricul- belongings in areas other than where
tural commodities, that are packed or animal food is exposed or where equip-
held by that human food facility for ment or utensils are cleaned; and
distribution as animal food if: (5) Taking any other necessary pre-
(1)(i) The human food facility is sub- cautions to protect against the con-
ject to and in compliance with subpart tamination of animal food, animal
B of part 117 of this chapter and in food-contact surfaces, or animal food-
compliance with all applicable human packaging materials.
food safety requirements of the Federal § 507.17 Plant and grounds.
Food, Drug, and Cosmetic Act and im-
plementing regulations; or (a) The grounds around an animal
food plant under the control of the
(ii) For the off-farm packing and
management of the establishment
holding of produce (as defined in part
must be kept in a condition that will
112 of this chapter), the human food fa- protect against the contamination of
cility is subject to and in compliance animal food. Maintenance of grounds
with § 117.8 of this chapter and in com- must include:
pliance with all applicable human food (1) Properly storing equipment, re-
safety requirements of the Federal moving litter and waste, and cutting
Food, Drug, and Cosmetic Act and im- weeds or grass within the immediate
plementing regulations; and vicinity of the plant that may con-
(2) The human food facility does not stitute an attractant, breeding place,
further manufacture or process the by- or harborage for pests;
products intended for use as animal (2) Maintaining driveways, yards, and
food. parking areas so that they do not con-
(b) The human food by-products for stitute a source of contamination in
use as animal food identified in para- areas where animal food is exposed;
graph (a) of this section must be held (3) Adequately draining areas that
and distributed by that facility in ac- may contribute to contamination of
cordance with §§ 507.28 and 117.95 of this animal food; and
(4) Treating and disposing of waste so

chapter.
that it does not constitute a source of
43
§ 507.19 21 CFR Ch. I (4–1–23 Edition)
contamination in areas where animal (b) Animal food-contact and non-con-

food is exposed. tact surfaces of utensils and equipment
(b) The plant must be suitable in size, must be cleaned and maintained and
construction, and design to facilitate utensils and equipment stored as nec-
cleaning, maintenance, and pest con- essary to protect against the contami-
trol to reduce the potential for con- nation of animal food, animal food-con-
tamination of animal food, animal tact surfaces, or animal food-pack-
food-contact surfaces, and animal food- aging materials. When necessary,
packaging materials, including that equipment must be disassembled for
the plant must: thorough cleaning. In addition:
(1) Provide adequate space between (1) When animal food-contact sur-
equipment, walls, and stored materials faces used for manufacturing, proc-
to permit employees to perform their essing, packing, or holding animal food
duties and to allow cleaning and main- are wet-cleaned, the surfaces must,
tenance of equipment; when necessary, be thoroughly dried
(2) Be constructed in a manner such before subsequent use; and
that drip or condensate from fixtures, (2) In wet processing of animal food,
ducts, and pipes does not serve as a when cleaning and sanitizing are nec-
source of contamination; essary to protect against the introduc-
(3) Provide adequate ventilation (me- tion of undesirable microorganisms
chanical or natural) where necessary into animal food, all animal food-con-
and appropriate to minimize vapors tact surfaces must be cleaned and sani-
(e.g., steam) and fumes in areas where tized before use and after any interrup-
they may contaminate animal food and tion during which the animal food-con-
in a manner that minimizes the poten- tact surfaces may have become con-
tial for contaminating animal food; taminated.
(4) Provide adequate lighting in (c) Cleaning compounds and sani-
hand-washing areas, toilet rooms, tizing agents must be safe and ade-
areas where animal food is received, quate under the conditions of use.
manufactured, processed, packed, or (d) The following applies to toxic ma-
held, and areas where equipment or terials:
utensils are cleaned; and (1) Only the following toxic materials
may be used or stored in the plant area
(5) Provide shatter-resistant light
where animal food is manufactured,
bulbs, fixtures, and skylights, or other
processed, or exposed:
glass items suspended over exposed ani-
(i) Those required to maintain clean
mal food in any step of preparation, to
and sanitary conditions;
protect against the contamination of
(ii) Those necessary for use in labora-
animal food in case of glass breakage.
tory testing procedures;
(c) The plant must protect animal
(iii) Those necessary for plant and
food stored outdoors in bulk from con-
equipment maintenance and operation;
tamination by any effective means, in-
and
cluding:
(iv) Those necessary for use in the
(1) Using protective coverings where plant’s operations.
necessary and appropriate; (2) Toxic materials described in para-
(2) Controlling areas over and around graph (d)(1) of this section (e.g., clean-
the bulk animal food to eliminate ing compounds, sanitizing agents, and
harborages for pests; and pesticide chemicals) must be identified,
(3) Checking on a regular basis for used, and stored in a manner that pro-
pests, pest infestation, and product tects against the contamination of ani-
condition related to safety of the animal food, animal food-contact surfaces,
mal food. or animal food-packaging materials;
and
§ 507.19 Sanitation. (3) Other toxic materials (such as fer-
(a) Buildings, structures, fixtures, tilizers and pesticides not included in
and other physical facilities of the paragraph (d)(1) of this section) must
plant must be kept clean and in good be stored in an area of the plant where
repair to prevent animal food from be- animal food is not manufactured, proc-
coming adulterated. essed, or exposed.
44
(e) Effective measures must be taken flooding-type cleaning or where normal

to exclude pests from the manufac- operations release or discharge water
turing, processing, packing, and hold- or other liquid waste on the floor; and
ing areas and to protect against the (5) Ensure that there is no backflow
contamination of animal food by pests. from, or cross-connection between, pip-
The use of pesticides in the plant is ing systems that discharge waste water
permitted only under precautions and or sewage and piping systems that
restrictions that will protect against carry water for animal food or animal
the contamination of animal food, ani- food manufacturing.
mal food-contact surfaces, and animal (c) Sewage and liquid disposal waste
food-packaging materials. must be disposed of through an ade-
(f) Trash must be conveyed, stored, quate sewerage system or through
and disposed of in a way that protects other adequate means.
against the contamination of animal (d) Each plant must provide employ-
food, animal food-contact surfaces, ani- ees with adequate, readily accessible
mal food-packaging materials, water toilet facilities. Toilet facilities must
supplies, and ground surfaces, and be kept clean and must not be a poten-
minimizes the potential for the trash tial source of contamination of animal
to become an attractant and harborage food, animal food-contact surfaces, or
or breeding place for pests. animal food-packaging materials.
[80 FR 56337, Sept. 17, 2015, as amended at 81 (e) Each plant must provide hand-
FR 3717, Jan. 22, 2016] washing facilities designed to ensure
that an employee’s hands are not a po-
§ 507.20 Water supply and plumbing. tential source of contamination of ani-
(a) The following apply to the water mal food, animal food-contact surfaces,
supply: or animal food-packaging materials.
(1) Water must be adequate for the
§ 507.22 Equipment and utensils.
operations and must be derived from an
adequate source; (a) The following apply to plant
(2) Running water at a suitable tem- equipment and utensils used in manu-
perature, and under suitable pressure facturing, processing, packing, and
as needed, must be provided in all areas holding animal food:
where required for the manufacturing, (1) All plant equipment and utensils,
processing, packing, or holding of ani- including equipment and utensils that
mal food, for the cleaning of equip- do not come in contact with animal
ment, utensils, and animal food-pack- food, must be designed and constructed
aging materials, or for employee hand- of such material and workmanship to
washing facilities; be adequately cleanable, and must be
(3) Water that contacts animal food, properly maintained;
animal food-contact surfaces, or ani- (2) Equipment and utensils must be
mal food-packaging materials must be designed, constructed, and used appro-
safe for its intended use; and priately to avoid the adulteration of
(4) Water may be reused for washing, animal food with non-food grade lubri-
rinsing, or conveying animal food if it cants, fuel, metal fragments, contami-
does not increase the level of contaminated water, or any other contami-
nation of the animal food. nants;
(b) Plumbing must be designed, in- (3) Equipment must be installed so as
stalled, and maintained to: to facilitate the cleaning and mainte-
(1) Carry adequate quantities of nance of the equipment and adjacent
water to required locations throughout spaces;
the plant; (4) Animal food-contact surfaces
(2) Properly convey sewage and liquid must be:
disposable waste from the plant; (i) Made of materials that withstand
(3) Avoid being a source of contami- the environment of their use and the
nation to animal food, water supplies, action of animal food, and, if applica-
equipment, or utensils, or creating an ble, the action of cleaning compounds,
unsanitary condition; cleaning procedures, and sanitizing
(4) Provide adequate floor drainage in agents;

all areas where floors are subject to (ii) Made of nontoxic materials; and
45
§ 507.25 21 CFR Ch. I (4–1–23 Edition)
(iii) Maintained to protect animal (7) Animal food that has become
food from being contaminated. adulterated is rejected, disposed of, or
(b) Holding, conveying, manufac- if appropriate, treated or processed to
turing, and processing systems, includ- eliminate the adulteration. If disposed
ing gravimetric, pneumatic, closed, of, it must be done in a manner that
and automated systems, must be de- protects against the contamination of
signed, constructed, and maintained in other animal food; and
a way to protect against the contami- (8) All animal food manufacturing,
nation of animal food. processing, packing, and holding is
(c) Each freezer and cold storage conducted under such conditions and
compartment used to hold animal food controls as are necessary to minimize
must be fitted with an accurate tem- the potential for the growth of undesir-
perature-measuring device.
able microorganisms to protect against
(d) Instruments and controls used for
the contamination of animal food.
measuring, regulating, or recording
temperatures, pH, aw, or other condi- (b) Raw materials and other ingredi-
tions that control or prevent the ents:
growth of undesirable microorganisms (1) Must be examined to ensure that
in animal food must be accurate, pre- they are suitable for manufacturing
cise, adequately maintained, and ade- and processing into animal food and
quate in number for their designated must be handled under conditions that
uses. will protect against contamination and
(e) Compressed air or other gases me- minimize deterioration. In addition:
chanically introduced into animal food (i) Shipping containers (e.g., totes,
or used to clean animal food-contact drums, and tubs) and bulk vehicles
surfaces or equipment must be used in holding raw materials and other ingre-
such a way to protect against the con- dients must be examined upon receipt
tamination of animal food. to determine whether contamination
or deterioration of animal food has oc-
§ 507.25 Plant operations. curred;
(a) Management of the establishment (ii) Raw materials must be cleaned as
must ensure that: necessary to minimize contamination;
(1) All operations in the manufac- and
turing, processing, packing, and hold- (iii) Raw materials and other ingredi-
ing of animal food (including oper- ents, including rework, must be stored
ations directed to receiving, inspect- in containers designed and constructed
ing, transporting, and segregating) are in a way that protects against con-
conducted in accordance with the cur- tamination and deterioration, and held
rent good manufacturing practice re- under conditions, e.g., appropriate tem-
quirements of this subpart; perature and relative humidity, that
(2) Animal food, including raw mate- will minimize the potential for growth
rials, other ingredients, or rework is of undesirable microorganisms and pre-
accurately identified; vent the animal food from becoming
(3) Animal food-packaging materials
adulterated;
are safe and suitable;
(4) The overall cleanliness of the (2) Susceptible to contamination
plant is under the supervision of one or with mycotoxins or other natural tox-
more competent individuals assigned ins must be evaluated and used in a
responsibility for this function; manner that does not result in animal
(5) Adequate precautions are taken so food that can cause injury or illness to
that plant operations do not contribute animals or humans; and
to contamination of animal food, ani- (3) If frozen, must be kept frozen. If
mal food-contact surfaces, and animal thawing is required prior to use, it
food-packaging materials; must be done in a manner that mini-
(6) Chemical, microbial, or extra- mizes the potential for the growth of
neous-material testing procedures are undesirable microorganisms.
used where necessary to identify sani- (c) For the purposes of manufac-
tation failures or possible animal food turing, processing, packing, and hold-
contamination; ing operations, the following apply:
46
(1) Animal food must be maintained (1) Containers used to hold animal
under conditions, e.g., appropriate tem- food before distribution must be de-
perature and relative humidity, that signed, constructed of appropriate ma-
will minimize the potential for growth terial, cleaned as necessary, and main-
of undesirable microorganisms and pre- tained to protect against the contami-
vent the animal food from becoming nation of animal food; and
adulterated during manufacturing, (2) Animal food held for distribution
processing, packing, and holding; must be held in a way that protects
(2) Measures taken during manufac- against contamination from sources
turing, processing, packing, and hold- such as trash.
ing of animal food to significantly min- (b) The labeling for the animal food
imize or prevent the growth of undesir- ready for distribution must contain,
able microorganisms (e.g., heat treat- when applicable, information and in-
ing, freezing, refrigerating, irradiating, structions for safely using the animal
controlling pH, or controlling aw) must food for the intended animal species.
be adequate to prevent adulteration of (c) Shipping containers (e.g., totes,
animal food; drums, and tubs) and bulk vehicles
(3) Work-in-process and rework must used to distribute animal food must be
be handled in such a way that it is pro- examined prior to use to protect
tected against contamination and the against the contamination of animal
growth of undesirable microorganisms; food from the container or vehicle
(4) Steps such as cutting, drying, when the facility is responsible for
defatting, grinding, mixing, extruding, transporting the animal food itself or
pelleting, and cooling, must be per- arranges with a third party to trans-
formed in a way that protects against port the animal food.
the contamination of animal food;
(d) Animal food returned from dis-
(5) Filling, assembling, packaging, tribution must be assessed for animal
and other operations must be per- food safety to determine the appro-
formed in such a way that protects priate disposition. Returned animal
against the contamination of animal
food must be identified as such and seg-
food and the growth of undesirable
regated until assessed.
microorganisms;
(e) Unpackaged or bulk animal food
(6) Animal food that relies prin-
must be held in a manner that does not
cipally on the control of water activity
result in unsafe cross contamination
(aw) for preventing the growth of unde-
with other animal food.
sirable microorganisms must be proc-
essed to and maintained at a safe aw [80 FR 56337, Sept. 17, 2015, as amended at 81
level; FR 3717, Jan. 22, 2016]
(7) Animal food that relies prin-
cipally on the control of pH for pre- § 507.28 Holding and distribution of
venting the growth of undesirable human food by-products for use as
microorganisms must be monitored animal food.
and maintained at the appropriate pH; (a) Human food by-products held for
and distribution as animal food must be
(8) When ice is used in contact with held under conditions that will protect
animal food, it must be made from against contamination, including the
water that is safe and must be used following:
only if it has been manufactured in ac- (1) Containers and equipment used to
cordance with current good manufac- convey or hold human food by-products
turing practice as outlined in this sub- for use as animal food before distribu-
part. tion must be designed, constructed of
appropriate material, cleaned as nec-
§ 507.27 Holding and distribution. essary, and maintained to protect
(a) Animal food held for distribution against the contamination of human
must be held under conditions that will food by-products for use as animal
protect against contamination and food;
minimize deterioration, including the (2) Human food by-products for use as
following: animal food held for distribution must
47
§ 507.31 21 CFR Ch. I (4–1–23 Edition)
be held in a way to protect against con- § 507.33 Hazard analysis.

tamination from sources such as trash; (a)(1) You must conduct a hazard
and analysis to identify and evaluate, based
(3) During holding, human food by- on experience, illness data, scientific
products for use as animal food must reports, and other information, known
be accurately identified. or reasonably foreseeable hazards for
(b) Labeling that identifies the prod-
each type of animal food manufac-
uct by the common or usual name
tured, processed, packed, or held at
must be affixed to or accompany the
your facility to determine whether
human food by-products for use as ani-
there are any hazards requiring a pre-
mal food when distributed.
ventive control; and
(c) Shipping containers (e.g., totes,
(2) The hazard analysis must be writ-
drums, and tubs) and bulk vehicles
ten regardless of its outcome.
used to distribute human food by-prod- (b) The hazard identification must
ucts for use as animal food must be ex- consider:
amined prior to use to protect against (1) Known or reasonably foreseeable
the contamination of animal food from hazards that include:
the container or vehicle when the facil- (i) Biological hazards, including
ity is responsible for transporting the microbiological hazards such as
human food by-products for use as ani- parasites, environmental pathogens,
mal food itself or arranges with a third and other pathogens;
party to transport the human food by- (ii) Chemical hazards, including radi-
products for use as animal food. ological hazards, substances such as
pesticide and drug residues, natural
Subpart C—Hazard Analysis and toxins, decomposition, unapproved food
Risk-Based Preventive Controls or color additives, and nutrient defi-
ciencies or toxicities (such as inad-
§ 507.31 Food safety plan. equate thiamine in cat food, excessive
(a) You must prepare, or have pre- vitamin D in dog food, and excessive
pared, and implement a written food copper in food for sheep); and
safety plan. (iii) Physical hazards (such as stones,
(b) One or more preventive controls glass, and metal fragments); and
qualified individuals must prepare, or (2) Known or reasonably foreseeable
oversee the preparation of, the food hazards that may be present in the ani-
safety plan. mal food for any of the following rea-
(c) The written food safety plan must sons:
include: (i) The hazard occurs naturally;
(1) The written hazard analysis as re- (ii) The hazard may be unintention-
quired by § 507.33(a)(2); ally introduced; or
(2) The written preventive controls as (iii) The hazard may be intentionally
required by § 507.34(b); introduced for purposes of economic
(3) The written supply-chain program gain.
as required by subpart E of this part; (c)(1) The hazard analysis must in-
(4) The written recall plan as re- clude an evaluation of the hazards
quired by § 507.38(a)(1); identified in paragraph (b) of this sec-
(5) The written procedures for moni- tion to assess the severity of the illness
toring the implementation of the pre- or injury to humans or animals if the
ventive controls as required by hazard were to occur and the prob-
§ 507.40(a); ability that the hazard will occur in
(6) The written corrective action pro- the absence of preventive controls.
cedures as required by § 507.42(a)(1); and (2) The hazard evaluation required by
(7) The written verification proce- paragraph (c)(1) of this section must in-
dures as required by § 507.49(b). clude an evaluation of environmental
(d) The food safety plan required by pathogens whenever an animal food is
this section is a record that is subject exposed to the environment prior to
to the requirements of subpart F of packaging and the packaged animal
this part. food does not receive a treatment or
[80 FR 56337, Sept. 17, 2015, as amended at 84 otherwise include a control measure
FR 12491, Apr. 2, 2019] (such as a formulation lethal to the
48
pathogen) that would significantly ture of the applicable control and its
minimize the pathogen. role in the facility’s food safety sys-
(d) The hazard evaluation must con- tem:
sider the effect of the following on the (i) Parameters associated with the
safety of the finished animal food for control of the hazard; and
the intended animal: (ii) The maximum or minimum
(1) The formulation of the animal value, or combination of values, to
food; which any biological, chemical, or
(2) The condition, function, and de- physical parameter must be controlled
sign of the facility and equipment; to significantly minimize or prevent a
(3) Raw materials and other ingredi- hazard requiring a process control.
ents; (2) Sanitation controls. Sanitation
(4) Transportation practices; controls include procedures, practices,
(5) Manufacturing/processing proce- and processes to ensure that the facil-
dures; ity is maintained in a sanitary condi-
(6) Packaging activities and labeling tion adequate to significantly mini-
activities; mize or prevent hazards such as envi-
(7) Storage and distribution; ronmental pathogens and biological
(8) Intended or reasonably foresee- hazards due to employee handling.
able use; Sanitation controls must include, as
(9) Sanitation, including employee appropriate to the facility and the ani-
hygiene; and mal food, procedures, practices, and
(10) Any other relevant factors such processes for the:
as the temporal (e.g., weather-related) (i) Cleanliness of animal food-contact
nature of some hazards (e.g., levels of surfaces, including animal food-contact
some natural toxins). surfaces of utensils and equipment; and
(ii) Prevention of cross-contamina-
FR 3717, Jan. 22, 2016]
tion from insanitary objects and from
personnel to animal food, animal food-
§ 507.34 Preventive controls. packaging material, and other animal
food-contact surfaces and from raw
(a)(1) You must identify and imple-
product to processed product.
ment preventive controls to provide as-
(3) Supply-chain controls. Supply-
surances that any hazards requiring a chain controls include the supply-chain
preventive control will be significantly program as required by subpart E of
minimized or prevented and the animal this part;
food manufactured, processed, packed, (4) A recall plan as required by
or held by your facility will not be § 507.38; and
adulterated under section 402 of the (5) Other preventive controls. These
Federal Food, Drug, and Cosmetic Act; include any other procedures, prac-
and tices, and processes necessary to sat-
(2) Preventive controls required by isfy the requirements of paragraph (a)
paragraph (a)(1) of this section include: of this section. Examples of other con-
(i) Controls at critical control points trols include hygiene training and
(CCPs), if there are any CCPs; and other current good manufacturing
(ii) Controls, other than those at practices.
CCPs, that are also appropriate for ani-
mal food safety. § 507.36 Circumstances in which the
(b) Preventive controls must be writ- owner, operator, or agent in charge
ten. of a manufacturing/processing facil-
(c) Preventive controls include, as ity is not required to implement a
appropriate to the facility and animal preventive control.
food: (a) If you are a manufacturer/proc-
(1) Process controls. Process controls essor, you are not required to imple-
include procedures, practices, and proc- ment a preventive control when you
esses to ensure the control of param- identify a hazard requiring a preven-
eters during operations such as heat tive control (identified hazard) and any
processing, irradiating, and refrig- of the following circumstances apply:
erating animal food. Process controls (1) You determine and document that
must include, as appropriate to the na- the type of animal food could not be
49
§ 507.36 21 CFR Ch. I (4–1–23 Edition)
consumed without application of an ap- that the animal food is ‘‘not processed
propriate control; to control [identified hazard]’’; and
(2) You rely on your customer who is (B) Will only sell to another entity
subject to the requirements for hazard that agrees, in writing, it will:
analysis and risk-based preventive con- (1) Follow procedures (identified in a
trols in this subpart to ensure that the written assurance) that will signifi-
identified hazard will be significantly cantly minimize or prevent the identi-
minimized or prevented; and you: fied hazard (if the entity is subject to
(i) Disclose in documents accom- the requirements for hazard analysis
panying the animal food, in accordance and risk-based preventive controls in
with the practice of the trade, that the subpart C of this part), except as pro-
animal food is ‘‘not processed to con- vided in paragraph (d) of this section,
trol [identified hazard]’’; and or manufacture, process, or prepare the
(ii) Annually obtain from your cus- animal food in accordance with appli-
tomer written assurance, subject to the cable animal food safety requirements
requirements of § 507.37, that the cus- (if the entity is not subject to the re-
tomer has established and is following quirements for hazard analysis and
procedures (identified in the written risk-based preventive controls in sub-
assurance) that will significantly mini- part C of this part); or
mize or prevent the identified hazard (2) Obtain a similar written assur-
(except as provided in paragraph (c) of ance from the entity’s customer, sub-
this section); ject to the requirements of § 507.37, as
(3) You rely on your customer who is in paragraphs (a)(4)(ii)(A) and (B) of
not subject to the requirements for this section, as appropriate; or
hazard analysis and risk-based preven- (5) You have established, docu-
tive controls in this subpart to provide mented, and implemented a system
assurance it is manufacturing, proc- that ensures control, at a subsequent
essing, or preparing the animal food in distribution step, of the hazards in the
accordance with applicable animal food animal food you distribute and you
safety requirements and you: document the implementation of that
(i) Disclose in documents accom- system.
panying the animal food, in accordance (b) You must document any cir-
with the practice of the trade, that the cumstance specified in paragraph (a) of
animal food is ‘‘not processed to con- this section that applies to you, includ-
trol [identified hazard]’’; and ing:
(ii) Annually obtain from your cus- (1) A determination in accordance
tomer written assurance that it is with paragraph (a) of this section that
manufacturing, processing, or pre- the type of animal food could not be
paring the animal food in accordance consumed without application of an ap-
with applicable animal food safety re- propriate control;
quirements; (2) The annual written assurance
(4) You rely on your customer to pro- from your customer in accordance with
vide assurance that the animal food paragraph (a)(2) of this section;
will be processed to control the identi- (3) The annual written assurance
fied hazard by an entity in the dis- from your customer in accordance with
tribution chain subsequent to the cus- paragraph (a)(3) of this section;
tomer and you: (4) The annual written assurance
(i) Disclose in documents accom- from your customer in accordance with
panying the animal food, in accordance paragraph (a)(4) of this section; and
with the practice of the trade, that the (5) Your system, in accordance with
animal food is ‘‘not processed to con- paragraph (a)(5) of this section, that
trol [identified hazard]’’; and ensures control, at a subsequent dis-
(ii) Annually obtain from your cus- tribution step, of the hazards in the
tomer written assurance, subject to the animal food you distribute.
requirements of § 507.37, that your cus- (c) For the written assurance re-
tomer: quired by paragraph (a)(2)(ii) of this
(A) Will disclose in documents ac- section, if your customer has deter-
companying the animal food, in ac- mined that the identified hazard in
cordance with the practice of the trade, paragraph (a) of this section is not a
50
hazard in the animal food intended for (3) Conduct effectiveness checks to
use for a specific animal species, your verify the recall has been carried out;
customer’s written assurance may pro- and
vide this determination (including ani- (4) Appropriately dispose of recalled
mal species and why the identified haz- animal food, e.g., through reprocessing,
ard is not a hazard) instead of pro- reworking, diverting to another use
viding assurance of procedures estab- that would not present a safety con-
lished and followed that will signifi- cern, or destroying the animal food.
cantly minimize or prevent the identi-
fied hazard. § 507.39 Preventive control manage-
(d) For the written assurance re- ment components.
quired by paragraph (a)(4)(ii)(B) of this (a) Except as provided by paragraphs
section, if the entity in the distribu- (b) and (c) of this section, the preven-
tion chain subsequent to your cus- tive controls required under § 507.34 are
tomer is subject to subpart C of this subject to the following preventive
part and has determined that the iden- control management components as
tified hazard in paragraph (a) of this
appropriate to ensure the effectiveness
section is not a hazard in the animal
of the preventive controls, taking into
food intended for use for a specific ani-
account the nature of the preventive
mal species, that entity’s written as-
control and its role in the facility’s
surance may provide this determina-
food safety system:
tion (including animal species and why
the identified hazard is not a hazard) (1) Monitoring in accordance with
instead of providing assurance that the § 507.40;
identified hazard will be significantly (2) Corrective actions and corrections
minimized or prevented. in accordance with § 507.42; and
(3) Verification in accordance with
[80 FR 56337, Sept. 17, 2015, as amended at 81 § 507.45.
FR 3717, Jan. 22, 2016]
(b) The supply-chain program estab-
§ 507.37 Provision of assurances re- lished in subpart E of this part is sub-
quired under § 507.36(a)(2), (3), and ject to the following preventive control
(4). management components as appro-
A facility that provides a written as- priate to ensure the effectiveness of the
surance under § 507.36(a)(2), (3), or (4) supply-chain program, taking into ac-
must act consistently with the assur- count the nature of the hazard con-
ance and document its actions taken to trolled before receipt of the raw mate-
satisfy the written assurance. rial or other ingredient:
(1) Corrective actions and corrections
§ 507.38 Recall plan. in accordance with § 507.42, taking into
account the nature of any supplier non-
(a) For animal food with a hazard re-
conformance;
quiring a preventive control you must:
(2) Review of records in accordance
(1) Establish a written recall plan for
the animal food; and with § 507.49(a)(4)(ii); and
(2) Assign responsibility for per- (3) Reanalysis in accordance with
forming all procedures in the recall § 507.50.
plan. (c) The recall plan established in
(b) The written recall plan must in- § 507.38 is not subject to the require-
clude procedures that describe the ments of paragraph (a) of this section.
steps to perform the following actions
§ 507.40 Monitoring.
as appropriate to the facility:
(1) Directly notify direct consignees As appropriate to the nature of the
about the animal food being recalled, preventive control and its role in the
including how to return or dispose of facility’s food safety system you must:
the affected animal food; (a) Establish and implement written
(2) Notify the public about any haz- procedures, including the frequency
ard presented by the animal food when with which they are to be performed,
appropriate to protect human and ani- for monitoring the preventive controls;
mal health; and
51
§ 507.42 21 CFR Ch. I (4–1–23 Edition)
(b) Monitor the preventive controls (iv) All affected animal food is pre-
with adequate frequency to provide as- vented from entering into commerce if
surance that they are consistently per- you cannot ensure the affected animal
formed. food is not adulterated under section
(c)(1) You must document the moni- 402 of the Federal Food, Drug, and Cos-
toring of preventive controls in accord- metic Act.
ance with this section in records that (b)(1) Except as provided by para-
are subject to verification in accord- graph (c) of this section, you are sub-
ance with § 507.45(a)(2) and records re- ject to the requirements of paragraph
view in accordance with § 507.49(a)(4)(i); (b)(2) of this section if any of the fol-
(2)(i) Records of refrigeration tem-
lowing circumstances apply:
perature during storage of animal food
that requires time/temperature control (i) A preventive control is not prop-
to significantly minimize or prevent erly implemented and a corrective ac-
the growth of, or toxin production by, tion procedure has not been estab-
pathogens may be affirmative records lished;
demonstrating temperature is con- (ii) A preventive control, combina-
trolled or exception records dem- tion of preventive controls, or the food
onstrating loss of temperature control; safety plan as a whole is found to be in-
and effective; or
(ii) Exception records may be ade- (iii) A review of records in accord-
quate in circumstances other than ance with § 507.49(a)(4) finds that the
monitoring of refrigeration tempera- records are not complete, the activities
ture. conducted did not occur in accordance
with the food safety plan, or appro-
§ 507.42 Corrective actions and correc-
tions. priate decisions were not made about
corrective actions.
(a) As appropriate to the nature of (2) If any of the circumstances listed
the hazard and the nature of the pre- in paragraph (b)(1) of this section
ventive control, except as provided by
apply, you must:
paragraph (c) of this section:
(1) You must establish and imple- (i) Take corrective action to identify
ment written corrective action proce- and correct the problem;
dures that must be taken if preventive (ii) Reduce the likelihood that the
controls are not properly implemented, problem will recur;
including procedures to address, as ap- (iii) Evaluate all affected animal food
propriate: for safety;
(i) The presence of a pathogen or ap- (iv) As necessary, prevent affected
propriate indicator organism in animal animal food from entering commerce
food detected as a result of product as would be done following the correc-
testing conducted in accordance with tive action procedure under paragraph
§ 507.49(a)(2); and (a)(2) of this section; and
(ii) The presence of an environmental (v) When appropriate, reanalyze the
pathogen or appropriate indicator or- food safety plan in accordance with
ganism detected through the environ- § 507.50 to determine whether modifica-
mental monitoring conducted in action of the food safety plan is required.
cordance with § 507.49(a)(3). (c) You do not need to comply with
(2) The corrective action procedures
the requirements of paragraphs (a) and
must describe the steps to be taken to
(b) of this section if:
ensure that:
(i) Appropriate action is taken to (1) You take action, in a timely man-
identify and correct a problem that has ner, to identify and correct conditions
occurred with implementation of a pre- and practices that are not consistent
ventive control; with the sanitation controls in
(ii) Appropriate action is taken when § 507.34(c)(2)(i) or (ii); or
necessary, to reduce the likelihood (2) You take action, in a timely man-
that the problem will recur; ner, to identify and correct a minor
(iii) All affected animal food is evalu- and isolated problem that does not di-
ated for safety; and rectly impact product safety.
52
(d) All corrective actions (and, when (ii) Whenever a change to a control
appropriate, corrections) taken in ac- measure or combination of control
cordance with this section must be doc- measures could impact whether the
umented in records. These records are control measure or combination of con-
subject to verification in accordance trol measures, when properly imple-
with § 507.45(a)(3) and records review in mented, will effectively control the
accordance with § 507.49(a)(4)(i). hazards; and
(iii) Whenever a reanalysis of the
§ 507.45 Verification.
food safety plan reveals the need to do
(a) Verification activities must in- so.
clude, as appropriate to the nature of (2) Must include obtaining and evalu-
the preventive control and its role in ating scientific and technical evidence
the facility’s food safety system: (or, when such evidence is not available
(1) Validation in accordance with or is inadequate, conducting studies) to
§ 507.47; determine whether the preventive con-
(2) Verification that monitoring is trols, when properly implemented, will
being conducted as required by § 507.39 effectively control the hazards.
(and in accordance with § 507.40); (c) You do not need to validate:
(3) Verification that appropriate de-
(1) The sanitation controls in
cisions about corrective actions are
§ 507.34(c)(2);
being made as required by § 507.39 (and
in accordance with § 507.42); (2) The recall plan in § 507.38;
(4) Verification of implementation (3) The supply-chain program in sub-
and effectiveness in accordance with part E of this part; and
§ 507.49; and (4) Other preventive controls, if the
(5) Reanalysis in accordance with preventive controls qualified individual
§ 507.50. prepares (or oversees the preparation
(b) All verification activities con- of) a written justification that valida-
ducted in accordance with this section tion is not applicable based on factors
must be documented in records. such as the nature of the hazard, and
the nature of the preventive control
§ 507.47 Validation. and its role in the facility’s food safety
(a) You must validate that the pre- system.
ventive controls identified and imple- [80 FR 56337, Sept. 17, 2015, as amended at 81
mented in accordance with § 507.34 are FR 3718, Jan. 22, 2016]
adequate to control the hazard as ap-
propriate to the nature of the preven- § 507.49 Verification of implementation
tive control and its role in the facili- and effectiveness.
ty’s food safety system.
(a) You must verify that the preven-
(b) The validation of the preventive
tive controls are consistently imple-
controls:
mented and are effectively and signifi-
(1) Must be performed (or overseen)
cantly minimizing or preventing the
by a preventive controls qualified indi-
hazards. To do so, you must conduct
vidual:
(i)(A) Prior to implementation of the activities that include the following, as
food safety plan; or appropriate to the facility, the animal
(B) When necessary to demonstrate food, and the nature of the preventive
the control measures can be imple- control and its role in the facility’s
mented as designed: food safety system:
(1) Within 90 calendar days after pro- (1) Calibration of process monitoring
duction of the applicable animal food and verification instruments (or check-
first begins; or ing them for accuracy);
(2) Within a reasonable timeframe, (2) Product testing for a pathogen (or
provided that the preventive controls appropriate indicator organism) or
qualified individual prepares (or over- other hazard;
sees the preparation of) a written jus- (3) Environmental monitoring, for an
tification for a timeframe that exceeds environmental pathogen or for an ap-
90 calendar days after production of the propriate indicator organism, if con-

applicable animal food first begins; tamination of an animal food with an
53
§ 507.50 21 CFR Ch. I (4–1–23 Edition)
environmental pathogen is a hazard re- (vi) Identify the laboratory con-

quiring a preventive control, by col- ducting the testing; and
lecting and testing environmental sam- (vii) Include the corrective action
ples; and procedures required by § 507.42(a)(1).
(4) Review of the following records (3) Environmental monitoring as re-
within the specified timeframes, by (or quired by paragraph (a)(3) of this sec-
under the oversight of) a preventive tion. Procedures for environmental
controls qualified individual, to ensure monitoring must:
the records are complete, the activities (i) Be scientifically valid;
reflected in the records occurred in ac- (ii) Identify the test microorga-
cordance with the food safety plan, the nism(s);
preventive controls are effective, and (iii) Identify the locations from
appropriate decisions were made about which samples will be collected and the
corrective actions: number of sites to be tested during rou-
(i) Monitoring and corrective action tine environmental monitoring. The
records within 7-working days after the number and location of sampling sites
records are created or within a reason- must be adequate to determine wheth-
able timeframe, provided that the pre- er preventive controls are effective;
ventive controls qualified individual (iv) Identify the timing and fre-
prepares (or oversees the preparation quency for collecting and testing sam-
of) a written justification for a time- ples. The timing and frequency for col-
frame that exceeds 7-working days; and lecting and testing samples must be
(ii) Records of calibration, testing adequate to determine whether preven-
(e.g., product testing, environmental tive controls are effective;
monitoring), and supplier and supply- (v) Identify the test(s) conducted, in-
chain verification activities, and other cluding the analytical method(s) used;
verification activities within a reason- (vi) Identify the laboratory con-
able time after the records are created; ducting the testing; and
and (vii) Include the corrective action
(5) Other activities appropriate for procedures required by § 507.42(a)(1)(ii).
verification of implementation and ef-
fectiveness. § 507.50 Reanalysis.
(b) As appropriate to the facility, the (a) You must conduct a reanalysis of
food, the nature of the preventive con- the food safety plan as a whole at least
trol, and the role of the preventive con- once every 3 years.
trol in the facility’s food safety sys- (b) You must conduct a reanalysis of
tem, you must establish and imple- the food safety plan as a whole, or the
ment written procedures for the fol- applicable portion of the food safety
lowing activities: plan:
(1) The method and frequency of cali- (1) Whenever a significant change in
brating process monitoring instru- the activities conducted at your facil-
ments and verification instruments (or ity creates a reasonable potential for a
checking them for accuracy) as renew hazard or creates a significant in-
quired by paragraph (a)(1) of this sec- crease in a previously identified haz-
tion; ard;
(2) Product testing as required by (2) Whenever you become aware of
paragraph (a)(2) of this section. Proce- new information about potential haz-
dures for product testing must: ards associated with the animal food;
(i) Be scientifically valid; (3) Whenever appropriate after an un-
(ii) Identify the test microorga- anticipated animal food safety problem
nism(s) or other analyte(s); in accordance with § 507.42(b); and
(iii) Specify the procedures for iden- (4) Whenever you find that a preven-
tifying samples, including their relative control, combination of preventive
tionship to specific lots of product; controls, or the food safety plan as a
(iv) Include the procedures for sam- whole is ineffective.
pling, including the number of samples (c) You must complete the reanalysis
and the sampling frequency; required by paragraphs (a) and (b) of
(v) Identify the test(s) conducted, in- this section and validate, as appro-
cluding the analytical method(s) used; priate to the nature of the preventive
54
control and its role in the facility’s (2) Monitor the temperature controls
food safety system, any additional pre- with adequate frequency to provide as-
ventive controls needed to address the surance that the temperature controls
hazard identified: are consistently performed;
(1) Before any change in activities (3) If there is a loss of temperature
(including any change in preventive control that may impact the safety of
control) at the facility is operative; or such refrigerated packaged animal
(2) When necessary to demonstrate food, take appropriate corrective ac-
the control measures can be imple- tions to:
mented as designed: (i) Correct the problem and reduce
(i) Within 90 calendar days after pro- the likelihood that the problem will
duction of the applicable animal food recur;
first begins; or (ii) Evaluate all affected animal food
(ii) Within a reasonable timeframe, for safety; and
provided that the preventive controls
(iii) Prevent the animal food from en-
qualified individual prepares (or over-
tering commerce, if you cannot ensure
sees the preparation of) a written jus-
the affected animal food is not adulter-
tification for a timeframe that exceeds
90 calendar days after production of the ated under section 402 of the Federal
applicable animal food first begins. Food, Drug, and Cosmetic Act;
(d) You must revise the written food (4) Verify that temperature controls
safety plan if a significant change in are consistently implemented by:
the activities conducted at your facil- (i) Calibrating temperature moni-
ity creates a reasonable potential for a toring and recording devices (or check-
new hazard or a significant increase in ing them for accuracy);
a previously identified hazard, or docu- (ii) Reviewing records of calibration
ment the basis for the conclusion that within a reasonable time after the
no revisions are needed. records are created; and
(e) A preventive controls qualified in- (iii) Reviewing records of monitoring
dividual must perform (or oversee) the and corrective actions taken to correct
reanalysis. a problem with the control of tempera-
(f) You must conduct a reanalysis of ture within 7-working days after the
the food safety plan when FDA deter- records are created or within a reason-
mines it is necessary to respond to new able timeframe, provided that the pre-
hazards and developments in scientific ventive controls qualified individual
understanding. prepares (or oversees the preparation
[80 FR 56337, Sept. 17, 2015, as amended at 81 of) a written justification for a time-
FR 3718, Jan. 22, 2016] frame that exceeds 7-working days; and
(5) Establish and maintain the fol-
§ 507.51 Modified requirements that lowing records:
apply to a facility solely engaged in (i) Records (whether affirmative
the storage of unexposed packaged
animal food. records demonstrating temperature is
controlled or exception records dem-
(a) If a facility that is solely engaged onstrating loss of temperature control)
in the storage of unexposed packaged documenting the monitoring of tem-
animal food stores any such refrig-
perature controls for any such refrig-
erated packaged animal food that re-
erated packaged animal food;
quires time/temperature control to sig-
nificantly minimize or prevent the (ii) Records of corrective actions
growth of, or toxin formation by patho- taken when there is a loss of tempera-
gens, the facility must conduct the fol- ture control that may impact the safe-
lowing activities as appropriate to en- ty of any such refrigerated packaged
sure the effectiveness of the tempera- animal food; and
ture controls: (iii) Records documenting the
(1) Establish and implement tempera- verification activities.
ture controls adequate to significantly (b) The records that a facility must
minimize or prevent the growth of, or establish and maintain under para-
toxin formation by, pathogens; graph (a)(5) of this section are subject
55
§ 507.53 21 CFR Ch. I (4–1–23 Edition)
to the requirements of subpart F of pertise obtained through education,

this part. training, or experience (or a combina-
tion thereof) necessary to perform the
FR 3718, Jan. 22, 2016] auditing function.
(d) All applicable training in the de-
§ 507.53 Requirements applicable to a velopment and application of risk-
preventive controls qualified indi- based preventive controls must be doc-
vidual and a qualified auditor. umented in records, including the date
(a) One or more preventive controls of the training, the type of training,
qualified individuals must do or over- and the person(s) trained.
see the following:
(1) Preparation of the food safety § 507.55 Implementation records re-
quired for this subpart.
plan (§ 507.31(b));
(2) Validation of the preventive con- (a) You must establish and maintain
trols (§ 507.47(b)(1)); the following records documenting im-
(3) Written justification for valida- plementation of the food safety plan:
tion to be performed in a timeframe (1) Documentation, as required by
that exceeds the first 90 calendar days § 507.36(b), of the basis for not estab-
of production of the applicable animal lishing a preventive control in accord-
food; ance with § 507.36(a);
(4) Determination that validation is (2) Records that document the moni-
not required (§ 507.47(c)(4)); toring of preventive controls;
(5) Review of records (§ 507.49(a)(4)); (3) Records that document corrective
(6) Written justification for review of actions;
records of monitoring and corrective (4) Records that document
actions within a timeframe that ex- verification, including, as applicable,
ceeds 7-working days; those related to:
(7) Reanalysis of the food safety plan (i) Validation;
(§ 507.50(d)); and (ii) Verification of monitoring;
(8) Determination that reanalysis can (iii) Verification of corrective ac-
be completed, and additional preven- tions;
tive controls validated, as appropriate (iv) Calibration of process moni-
to the nature of the preventive control toring and verification instruments;
and its role in the facility’s food safety (v) Product testing;
system, in a timeframe that exceeds (vi) Environmental monitoring;
the first 90 calendar days of production (vii) Records review; and
of the applicable animal food. (viii) Reanalysis;
(b) A qualified auditor must conduct (5) Records that document the sup-
an onsite audit (§ 507.135(a)). ply-chain program; and
(c)(1) To be a preventive controls (6) Records that document applicable
qualified individual, the individual training for the preventive controls
must have successfully completed qualified individual and the qualified
training in the development and appli- auditor.
cation of risk-based preventive con- (b) The records that you must estab-
trols at least equivalent to that re- lish and maintain are subject to the re-
ceived under a standardized curriculum quirements of subpart F of this part.
recognized as adequate by FDA or be
otherwise qualified through job experi- Subpart D—Withdrawal of a
ence to develop and apply a food safety Qualified Facility Exemption
system. Job experience may qualify an
individual to perform these functions if § 507.60 Circumstances that may lead
such experience has provided an indi- FDA to withdraw a qualified facil-
vidual with knowledge at least equiva- ity exemption.
lent to that provided through the (a) FDA may withdraw a qualified fa-
standardized curriculum. This indi- cility exemption under § 507.5(d):
vidual may be, but is not required to (1) In the event of an active inves-
be, an employee of the facility; and tigation of a foodborne illness outbreak
(2) To be a qualified auditor, a quali- that is directly linked to the qualified

fied individual must have technical ex- facility; or
56
(2) If FDA determines that it is nec- employee of FDA who is issuing the
essary to protect the public (human or order.
animal) health and prevent or mitigate [80 FR 56337, Sept. 17, 2015, as amended at 85
a foodborne illness outbreak based on FR 16554, Mar. 24, 2020]
conditions or conduct associated with
the qualified facility that are material § 507.65 Contents of an order to with-
to the safety of the animal food manu- draw a qualified facility exemption.
factured, processed, packed, or held at An order to withdraw a qualified fa-
such facility. cility exemption under § 507.5(d) must
(b) Before FDA issues an order to include the following information:
withdraw a qualified facility exemp- (a) The date of the order;
tion, FDA: (b) The name, address, and location
(1) May consider one or more other of the qualified facility;
actions to protect the public (human or (c) A brief, general statement of the
animal) health or mitigate a foodborne reasons for the order, including infor-
illness outbreak, including, a warning mation relevant to one or both of the
following circumstances that leads
letter, recall, administrative deten-
FDA to issue the order:
tion, suspension of registration, refusal
(1) An active investigation of a
of animal food offered for import, sei-
foodborne illness outbreak that is di-
zure, and injunction; rectly linked to the facility; or
(2) Must notify the owner, operator, (2) Conditions or conduct associated
or agent in charge of the facility, in with a qualified facility that are mate-
writing of circumstances that may lead rial to the safety of the animal food
FDA to withdraw the exemption, and manufactured, processed, packed, or
provide an opportunity for the owner, held at such facility.
operator, or agent in charge of the fa- (d) A statement that the facility
cility to respond in writing, within 15 must either:
calendar days of the date of receipt of (1) Comply with subparts C and E of
the notification, to FDA’s notification; this part on the date that is 120 cal-
and endar days after the date of receipt of
(3) Must consider the actions taken the order or within a reasonable time-
by the facility to address the cir- frame, agreed to by FDA, based on a
cumstances that may lead FDA to written justification, submitted to
withdraw the exemption. FDA, for a timeframe that exceeds 120
calendar days from the date of receipt
§ 507.62 Issuance of an order to with- of the order; or
draw a qualified facility exemption. (2) Appeal the order within 15 cal-
(a) An FDA Division Director in endar days of the date of receipt of the
whose division the qualified facility is order in accordance with the require-
located (or, in the case of a foreign fa- ments of § 507.69.
cility, the Director of the Division of (e) A statement that a facility may
Compliance in the Center for Veteri- request that FDA reinstate an exemp-
nary Medicine), or an FDA official sen- tion that was withdrawn by following
ior to either such Director, must ap- the procedures in § 507.85;
(f) The text of section 418(l) of the
prove an order to withdraw the exemp-
Federal Food, Drug, and Cosmetic Act
tion before the order is issued.
and of this subpart;
(b) Any officer or qualified employee (g) A statement that any informal
of FDA may issue an order to withdraw hearing on an appeal of the order must
the exemption after it has been ap- be conducted as a regulatory hearing
proved in accordance with paragraph under part 16 of this chapter, with cer-
(a) of this section. tain exceptions described in § 507.73;
(c) FDA must issue an order to with- (h) The mailing address, telephone
draw the exemption to the owner, oper- number, email address, fax number,
ator, or agent in charge of the facility. and name of the FDA Division Director
(d) FDA must issue an order to within whose division the facility is located
draw the exemption in writing, signed (or, in the case of a foreign facility, the
and dated by the officer or qualified same information for the Director of
57
§ 507.67 21 CFR Ch. I (4–1–23 Edition)
the Division of Compliance in the Cen- Center for Veterinary Medicine), at the
ter for Veterinary Medicine); and mailing address, email address, or fax
(i) The name and the title of the FDA number identified in the order within
representative who approved the order. 15 calendar days of the date of receipt
of confirmation of the order; and
FR 3718, Jan. 22, 2016; 85 FR 16554, Mar. 24, (2) Respond with particularity to the
2020] facts and issues contained in the order,
including any supporting documenta-
§ 507.67 Compliance with, or appeal of, tion upon which you rely.
an order to withdraw a qualified fa- (b) In a written appeal of the order
cility exemption. withdrawing an exemption provided
(a) If you receive an order under under § 507.5(d), you may include a
§ 507.65 to withdraw a qualified facility written request for an informal hearing
exemption, you must either: as provided in § 507.71.
(1) Comply with applicable require- [80 FR 56337, Sept. 17, 2015, as amended at 81
ments of this part within 120 calendar FR 3718, Jan. 22, 2016; 85 FR 16554, Mar. 24,
days of the date of receipt of the order, 2020]
or within a reasonable timeframe,
agreed to by FDA, based on a written § 507.71 Procedure for requesting an
justification, submitted to FDA, for a informal hearing.
timeframe that exceeds 120 calendar (a) If you appeal the order, you:
days from the date of receipt of the (1) May request an informal hearing;
order; or and
(2) Appeal the order within 15 cal- (2) Must submit any request for an
endar days of the date of receipt of the informal hearing together with your
order in accordance with the require- written appeal submitted in accordance
ments of § 507.69. with § 507.69 within 15 calendar days of
(b) Submission of an appeal, includ- the date of receipt of the order.
ing submission of a request for an in- (b) A request for an informal hearing
formal hearing, will not operate to may be denied, in whole or in part, if
delay or stay any administrative ac- the presiding officer determines that
tion, including enforcement action by no genuine and substantial issue of ma-
FDA, unless the Commissioner of Food terial fact has been raised by the mate-
and Drugs, as a matter of discretion, rial submitted. If the presiding officer
determines that delay or a stay is in determines that a hearing is not justi-
the public interest. fied, written notice of the determina-
(c) If you appeal the order, and FDA tion will be given to you explaining the
confirms the order: reason for the denial.
(1) You must comply with applicable
requirements of this part within 120 § 507.73 Requirements applicable to an
calendar days of the date of receipt of informal hearing.
the order, or within a reasonable time- If you request an informal hearing,
frame, agreed to by FDA, based on a and FDA grants the request:
written justification, submitted to (a) The hearing will be held within 15
FDA, for a timeframe that exceeds 120 calendar days after the date the appeal
calendar days from the date of receipt is filed or, if applicable, within a time-
of the order; and frame agreed upon in writing by you
(2) You are no longer subject to the and FDA.
requirements in § 507.7. (b) The presiding officer may require
that a hearing conducted under this
§ 507.69 Procedure for submitting an subpart be completed within 1 calendar
appeal. day, as appropriate.
(a) To appeal an order to withdraw a (c) FDA must conduct the hearing in
qualified facility exemption, you must: accordance with part 16 of this chapter,
(1) Submit the appeal in writing to except that:
the FDA Division Director in whose di- (1) The order withdrawing an exemp-
vision the facility is located (or, in the tion under §§ 507.62 and 507.65, rather
case of a foreign facility, the Director than the notice under § 16.22(a) of this
of the Division of Compliance in the chapter, provides notice of opportunity
58
for a hearing under this section and is and 507.73(c)(5) constitutes the exclu-
part of the administrative record of the sive record for the presiding officer’s
regulatory hearing under § 16.80(a) of final decision. For purposes of judicial
this chapter. review under § 10.45 of this chapter, the
(2) A request for a hearing under this record of the administrative pro-
subpart must be addressed to the FDA ceeding consists of the record of the
Division Director (or, in the case of a hearing and the presiding officer’s final
foreign facility, the Director of the Di- decision.
vision of Compliance in the Center for
Veterinary Medicine) as provided in FR 16554, Mar. 24, 2020]
the order withdrawing an exemption.
(3) Section 507.75, rather than § 507.75 Presiding officer for an appeal
§ 16.42(a) of this chapter, describes the and for an informal hearing.
FDA employees who preside at hear- The presiding officer for an appeal,
ings under this subpart. and for an informal hearing, must be
(4) Section 16.60(e) and (f) of this an Office of Regulatory Affairs Pro-
chapter does not apply to a hearing gram Director or another FDA official
under this subpart. The presiding offi- senior to an FDA Division Director.
cer must prepare a written report of
the hearing. All written material pre- [85 FR 16555, Mar. 24, 2020]
sented at the hearing will be attached
to the report. The presiding officer § 507.77 Timeframe for issuing a deci-
must include as part of the report of sion on an appeal.
the hearing a finding on the credibility (a) If you appeal the order without
of witnesses (other than expert wit- requesting a hearing, the presiding offi-
nesses) whenever credibility is a mate- cer must issue a written report that in-
rial issue, and must include a proposed cludes a final decision confirming or
decision, with a statement of reasons. revoking the withdrawal by the 10th
The hearing participant may review calendar day after the appeal is filed.
and comment on the presiding officer’s (b) If you appeal the order and re-
report within 2 calendar days of quest an informal hearing:
issuance of the report. The presiding (1) If FDA grants the request for a
officer will then issue the final deci- hearing and the hearing is held, the
sion. presiding officer must provide a 2 cal-
(5) Section 16.80(a)(4) of this chapter endar day opportunity for the hearing
does not apply to a regulatory hearing participants to review and submit com-
under this subpart. The presiding offi- ments on the report of the hearing
cer’s report of the hearing and any under § 507.73(c)(4), and must issue a
comments on the report by the hearing final decision within 10 calendar days
participant under paragraph (c)(4) of after the hearing is held; or
this section are part of the administra- (2) If FDA denies the request for a
tive record. hearing, the presiding officer must
(6) No party shall have the right, issue a final decision on the appeal
under § 16.119 of this chapter to petition confirming or revoking the withdrawal
the Commissioner of Food and Drugs within 10 calendar days after the date
for reconsideration or a stay of the pre- the appeal is filed.
siding officer’s final decision.
(7) If FDA grants a request for an in- § 507.80 Revocation of an order to
formal hearing on an appeal of an order withdraw a qualified facility ex-
withdrawing an exemption, the hearing emption.
must be conducted as a regulatory An order to withdraw a qualified fa-
hearing under a regulation in accord- cility exemption is revoked if:
ance with part 16 of this chapter, ex- (a) You appeal the order and request
cept that § 16.95(b) does not apply to a an informal hearing, FDA grants the
hearing under this subpart. With re- request for an informal hearing, and
spect to a regulatory hearing under the presiding officer does not confirm
this subpart, the administrative record the order within the 10 calendar days
of the hearing specified in §§ 16.80(a)(1) after the hearing, or issues a decision

through (3), and (a)(5), of this chapter, revoking the order within that time; or
59
§ 507.83 21 CFR Ch. I (4–1–23 Edition)
(b) You appeal the order and request tions and conduct that are material to
an informal hearing, FDA denies the the safety of the animal food manufac-
request for an informal hearing, and tured, processed, packed, or held at
FDA does not confirm the order within your facility, such that continued
the 10 calendar days after the appeal is withdrawal of the exemption is not
filed, or issues a decision revoking the necessary to protect public (human and
order within that time; or animal) health and prevent or mitigate
(c) You appeal the order without re- a foodborne illness outbreak.
questing an informal hearing, and FDA (c) If your exemption was withdrawn
does not confirm the order within the under § 507.60(a)(1) and FDA later deter-
10 calendar days after the appeal is mines, after finishing the active inves-
filed, or issues a decision revoking the tigation of a foodborne illness out-
order within that time. break, that the outbreak is not di-
rectly linked to your facility, FDA will
§ 507.83 Final agency action. reinstate your exemption under
Confirmation of a withdrawal order § 507.5(d), and FDA will notify you in
by the presiding officer is considered a writing that your exempt status has
final agency action for purposes of 5 been reinstated.
U.S.C. 702. (d) If your exemption was withdrawn
under both § 507.60(a)(1) and (2) and
§ 507.85 Reinstatement of a qualified FDA later determines, after finishing
facility exemption that was with- the active investigation of a foodborne
drawn.
illness outbreak, that the outbreak is
(a) If the FDA Division Director in not directly linked to your facility,
whose division your facility is located FDA will inform you of this finding
(or, in the case of a foreign facility, the and you may ask FDA to reinstate
Director of the Division of Compliance your exemption under § 507.5(d) in ac-
in the Center for Veterinary Medicine) cordance with the requirements of
determines that a facility has ade- paragraph (b) of this section.
quately resolved any problems with the
conditions and conduct that are mate- [80 FR 56337, Sept. 17, 2015, as amended at 85
FR 16555, Mar. 24, 2020]
rial to the safety of the animal food
manufactured, processed, packed, or
held at the facility and that continued Subpart E—Supply-Chain Program
withdrawal of the exemption is not
necessary to protect public (human and § 507.105 Requirement to establish and
implement a supply-chain program.
animal) health and prevent or mitigate
a foodborne illness outbreak, the FDA (a)(1) Except as provided by para-
Division Director in whose division graphs (a)(2) and (3) of this section, the
your facility is located (or, in the case receiving facility must establish and
of a foreign facility, the Director of the implement a risk-based supply-chain
Division of Compliance in the Center program for those raw materials and
for Veterinary Medicine) will, on his or other ingredients for which the receiv-
her own initiative or on the request of ing facility has identified a hazard re-
a facility, reinstate the exemption. quiring a supply-chain-applied control.
(b) You may ask FDA to reinstate an (2) A receiving facility that is an im-
exemption that has been withdrawn porter, is in compliance with the for-
under the procedures of this subpart as eign supplier verification requirements
follows: under part 1, subpart L of this chapter,
(1) Submit a request, in writing, to and has documentation of verification
the FDA Division Director in whose di- activities conducted under § 1.506(e) of
vision your facility is located (or, in this chapter (which provides assurance
the case of a foreign facility, the Direc- that the hazards requiring a supply-
tor of the Division of Compliance in chain-applied control for the raw mate-
the Center for Veterinary Medicine); rial or other ingredient have been sig-
and nificantly minimized or prevented)
(2) Present data and information to need not conduct supplier verification
demonstrate that you have adequately activities for that raw material or
resolved any problems with the condi- other ingredient.
60
(3) The requirements in this subpart verification as required by § 507.175, or

do not apply to animal food that is sup- obtaining documentation of an appro-
plied for research or evaluation use, priate verification activity from an-
provided that such animal food: other entity, reviewing and assessing
(i) Is not intended for retail sale and that documentation, and documenting
is not sold or distributed to the public; the review and assessment as required
(ii) Is labeled with the statement by § 507.175.
‘‘Animal food for research or evalua- (b) The following are appropriate sup-
tion use’’; plier verification activities for raw ma-
(iii) Is supplied in a small quantity terials and other ingredients:
that is consistent with a research, (1) Onsite audits;
analysis, or quality assurance purpose, (2) Sampling and testing of the raw
the animal food is used only for this material or other ingredient;
purpose, and any unused quantity is (3) Review of the supplier’s relevant
properly disposed of; and food safety records; and
(iv) Is accompanied with documents, (4) Other appropriate supplier
in accordance with the practice of the verification activities based on sup-
trade, stating that the animal food will plier performance and the risk associ-
be used for research or evaluation pur- ated with the raw material or other in-
poses and cannot be sold or distributed gredient.
to the public.
(c) The supply-chain program must
(b) The supply-chain program must
provide assurance that a hazard requir-
be written.
ing a supply-chain-applied control has
(c) When a supply-chain-applied con-
been significantly minimized or pre-
trol is applied by an entity other than
vented.
the receiving facility’s supplier (e.g.,
when a non-supplier applies controls to (d)(1) Except as provided by para-
certain produce (i.e., produce covered graph (d)(2) of this section, in approv-
by part 112 of this chapter), because ing suppliers and determining the ap-
growing, harvesting, and packing ac- propriate supplier verification activi-
tivities are under different manage- ties and the frequency with which they
ment), the receiving facility must: are conducted, the following must be
(1) Verify the supply-chain-applied considered:
control; or (i) The hazard analysis of the animal
(2) Obtain documentation of an ap- food, including the nature of the haz-
propriate verification activity from an- ard controlled before receipt of the raw
other entity, review and assess the en- material or other ingredient, applica-
tity’s applicable documentation, and ble to the raw material and other in-
document that review and assessment. gredients;
(ii) The entity or entities that will be
§ 507.110 General requirements appli- applying controls for the hazards re-
cable to a supply-chain program. quiring a supply-chain-applied control;
(a) The supply-chain program must (iii) Supplier performance, including:
include: (A) The supplier’s procedures, proc-
(1) Using approved suppliers as re- esses, and practices related to the safe-
quired by § 507.120; ty of the raw material and other ingre-
(2) Determining appropriate supplier dients;
verification activities (including deter- (B) Applicable FDA food safety regu-
mining the frequency of conducting the lations and information relevant to the
activity) as required by § 507.125; supplier’s compliance with those regu-
(3) Conducting supplier verification lations, including an FDA warning let-
activities as required by §§ 507.130 and ter or import alert relating to the safe-
507.135; ty of animal food and other FDA com-
(4) Documenting supplier verification pliance actions related to animal food
activities as required by § 507.175; and safety (or, when applicable, relevant
(5) When applicable, verifying a sup- laws and regulations of a country
ply-chain-applied control applied by an whose food safety system FDA has offi-
entity other than the receiving facili- cially recognized as comparable or has
ty’s supplier and documenting that determined to be equivalent to that of
61
§ 507.115 21 CFR Ch. I (4–1–23 Edition)
the United States, and information rel- activities, and satisfy all documenta-
evant to the supplier’s compliance with tion requirements of this subpart.
those laws and regulations); and (3) An entity other than the receiving
(C) The supplier’s food safety history facility may do any of the following,
relevant to the raw materials or other provided that the receiving facility re-
ingredients that the receiving facility views and assesses the entity’s applica-
receives from the supplier, including ble documentation, and documents
available information about results that review and assessment:
from testing raw materials or other in- (i) Establish written procedures for
gredients for hazards, audit results re- receiving raw materials and other in-
lating to the safety of the animal food, gredients by the entity;
and responsiveness of the supplier in (ii) Document that written proce-
correcting problems; and dures for receiving raw materials and
(iv) Any other factors as appropriate other ingredients are being followed by
and necessary, such as storage and the entity; and
transportation practices. (iii) Determine, conduct, or both de-
(2) Considering supplier performance termine and conduct, the appropriate
can be limited to the supplier’s compli- supplier verification activities, with
ance history as required by paragraph appropriate documentation.
(d)(1)(iii)(B) of this section, if the sup- (4) The supplier may conduct and
plier is: document sampling and testing of raw
(i) A qualified facility as defined by materials and other ingredients, for
§ 507.3; the hazard controlled by the supplier,
(ii) A farm that grows produce and is as a supplier verification activity for a
not a covered farm under part 112 of particular lot of product and provide
this chapter in accordance with such documentation to the receiving
§ 112.4(a), or in accordance with facility, provided that the receiving fa-
§§ 112.4(b) and 112.5; or cility reviews and assesses that docu-
(iii) A shell egg producer that is not mentation, and documents that review
subject to the requirements of part 118 and assessment.
of this chapter because it has less than (b) For the purposes of this subpart, a
3,000 laying hens. receiving facility may not accept any
(e) If the owner, operator, or agent in of the following as a supplier
charge of a receiving facility deter- verification activity:
mines through auditing, verification (1) A determination by its supplier of
testing, document review, relevant the appropriate supplier verification
consumer, customer, or other com- activities for that supplier;
plaints, or otherwise that the supplier (2) An audit conducted by its sup-
is not controlling hazards that the re- plier;
ceiving facility has identified as re- (3) A review by its supplier of that
quiring a supply-chain-applied control, supplier’s own relevant food safety
the receiving facility must take and records; or
document prompt action in accordance (4) The conduct by its supplier of
with § 507.42 to ensure that raw mate- other appropriate supplier verification
rials or other ingredients from the sup- activities for that supplier within the
plier do not cause animal food that is meaning of § 507.110(b)(4).
manufactured or processed by the re- (c) The requirements of this section
ceiving facility to be adulterated under do not prohibit a receiving facility
section 402 of the Federal Food, Drug, from relying on an audit provided by
and Cosmetic Act. its supplier when the audit of the sup-
plier was conducted by a third-party
§ 507.115 Responsibilities of the receiv- qualified auditor in accordance with
ing facility. §§ 507.130(f) and 507.135.
(a)(1) The receiving facility must ap-
prove suppliers. § 507.120 Using approved suppliers.
(2) Except as provided by paragraphs (a) The receiving facility must ap-
(a)(3) and (4) of this section, the receiv- prove suppliers in accordance with the
ing facility must determine and con- requirements of § 507.110(d), and docu-
duct appropriate supplier verification ment that approval, before receiving
62
raw materials and other ingredients re- other verification activities and/or less
ceived from those suppliers; frequent onsite auditing of the supplier
(b)(1) Written procedures for receiv- provide adequate assurance that the
ing raw materials and other ingredi- hazards are controlled.
ents must be established and followed; (c) If a supplier is a qualified facility
(2) The written procedures for receiv- as defined by § 507.3, the receiving facil-
ing raw materials and other ingredi- ity does not need to comply with para-
ents must ensure that raw materials graphs (a) and (b) of this section if the
and other ingredients are received only receiving facility:
from approved suppliers (or, when nec- (1) Obtains written assurance that
essary and appropriate, on a temporary the supplier is a qualified facility as
basis from unapproved suppliers whose defined by § 507.3:
raw materials or other ingredients are
(i) Before first approving the supplier
subjected to adequate verification ac-
for an applicable calendar year; and
tivities before acceptance for use); and
(3) Use of the written procedures for (ii) On an annual basis thereafter, by
receiving raw materials and other in- December 31 of each calendar year, for
gredients must be documented. the following calendar year; and
(2) Obtains written assurance, at
§ 507.125 Determining appropriate least every 2 years, that the supplier is
supplier verification activities (in- producing the raw material or other in-
cluding determining the frequency gredient in compliance with applicable
of conducting the activity). FDA food safety regulations (or, when
Appropriate supplier verification ac- applicable, relevant laws and regula-
tivities (including the frequency of tions of a country whose food safety
conducting the activity) must be deter- system FDA has officially recognized
mined in accordance with the require- as comparable or has determined to be
ments of § 507.110(d). equivalent to that of the United
States). The written assurance must
§ 507.130 Conducting supplier include either:
verification activities for raw mate-
rials and other ingredients. (i) A brief description of the preven-
tive controls that the supplier is imple-
(a) Except as provided by paragraphs menting to control the applicable haz-
(c), (d), or (e) of this section, one or ard in the animal food; or
more of the supplier verification ac-
(ii) A statement that the facility is
tivities specified in § 507.110(b), as de-
in compliance with State, local, coun-
termined under § 507.110(d), must be
ty, tribal, or other applicable non-Fed-
conducted for each supplier before
eral food safety laws, including rel-
using the raw material or other ingre-
evant laws and regulations of foreign
dient from that supplier and periodi-
cally thereafter. countries.
(b)(1) Except as provided by para- (d) If a supplier is a farm that grows
graph (b)(2) of this section, when a haz- produce and is not a covered farm
ard in a raw material or other ingre- under part 112 of this chapter in ac-
dient will be controlled by the supplier cordance with § 112.4(a), or in accord-
and is one for which there is a reason- ance with §§ 112.4(b) and 112.5, the re-
able probability that exposure to the ceiving facility does not need to com-
hazard will result in serious adverse ply with paragraphs (a) and (b) of this
health consequences or death to hu- section for produce that the receiving
mans or animals: facility receives from the farm as a raw
(i) The appropriate supplier material or other ingredient if the re-
verification activity is an onsite audit ceiving facility:
of the supplier; and (1) Obtains written assurance that
(ii) The audit must be conducted be- the raw material or other ingredient
fore using the raw material or other in- provided by the supplier is not subject
gredient from the supplier and at least to part 112 of this chapter in accord-
annually thereafter. ance with § 112.4(a), or in accordance
(2) The requirements of paragraph with §§ 112.4(b) and 112.5:
(b)(1) of this section do not apply if (i) Before first approving the supplier
there is a written determination that for an applicable calendar year; and
63
§ 507.135 21 CFR Ch. I (4–1–23 Edition)
(ii) On an annual basis thereafter, by ulations and include a review of the

December 31 of each calendar year, for supplier’s written plan (e.g., Hazard
the following calendar year; and Analysis and Critical Control Point
(2) Obtains written assurance, at (HACCP) plan or other food safety
least every 2 years, that the farm ac- plan), if any, and its implementation,
knowledges that its food is subject to for the hazard being controlled (or,
section 402 of the Federal Food, Drug, when applicable, an onsite audit may
and Cosmetic Act (or, when applicable, consider relevant laws and regulations
that its food is subject to relevant laws of a country whose food safety system
and regulations of a country whose FDA has officially recognized as com-
food safety system FDA has officially parable or has determined to be equiva-
recognized as comparable or has deter- lent to that of the United States).
mined to be equivalent to that of the (c)(1) The following may be sub-
United States). stituted for an onsite audit, provided
(e) If a supplier is a shell egg pro- that the inspection was conducted
ducer that is not subject to the re- within 1 year of the date that the on-
quirements of part 118 of this chapter site audit would have been required to
because it has less than 3,000 laying be conducted:
hens, the receiving facility does not (i) The written results of an appro-
need to comply with paragraphs (a) and priate inspection of the supplier for
(b) of this section if the receiving facil- compliance with applicable FDA food
ity: safety regulations by FDA, by rep-
(1) Obtains written assurance that resentatives of other Federal Agencies
the shell eggs produced by the supplier (such as the United States Department
are not subject to part 118 because the of Agriculture), or by representatives
shell egg producer has less than 3,000 of State, local, tribal, or territorial
laying hens: agencies; or
(i) Before first approving the supplier (ii) For a foreign supplier, the writ-
for an applicable calendar year; and ten results of an inspection by FDA or
(ii) On an annual basis thereafter, by the food safety authority of a country
December 31 of each calendar year, for whose food safety system FDA has offi-
the following calendar year; and cially recognized as comparable or has
(2) Obtains written assurance, at determined to be equivalent to that of
least every 2 years, that the shell egg the United States.
producer acknowledges that its food is (2) For inspections conducted by the
subject to section 402 of the Federal food safety authority of a country
Food, Drug, and Cosmetic Act (or, whose food safety system FDA has offi-
when applicable, that its food is sub- cially recognized as comparable or de-
ject to relevant laws and regulations of termined to be equivalent, the animal
a country whose food safety system food that is the subject of the onsite
FDA has officially recognized as com- audit must be within the scope of the
parable or has determined to be equiva- official recognition or equivalence de-
lent to that of the United States). termination, and the foreign supplier
(f) There must not be any financial must be in, and under the regulatory
conflicts of interest that influence the oversight of, such country.
results of the verification activities (d) If the onsite audit is solely con-
listed in § 507.110(b) and payment must ducted to meet the requirements of
not be related to the results of the ac- this subpart by an audit agent of a cer-
tivity. tification body that is accredited in ac-
[80 FR 56337, Sept. 17, 2015, as amended at 84 cordance with regulations in part 1,
FR 12491, Apr. 2, 2019] subpart M of this chapter, the audit is
not subject to the requirements in
§ 507.135 Onsite audit. those regulations.
(a) An onsite audit of a supplier must
be performed by a qualified auditor. § 507.175 Records documenting the
(b) If the raw material or other ingre- supply-chain program.
dient at the supplier is subject to one (a) The records documenting the sup-
or more FDA food safety regulations, ply-chain program are subject to the
an onsite audit must consider such reg- requirements of subpart F of this part.
64
(b) The receiving facility must re- (v) Corrective actions taken in re-
view the records listed in paragraph (c) sponse to detection of hazards; and
of this section in accordance with (vi) Information identifying the lab-
§ 507.49(a)(4). oratory conducting the testing;
(c) The receiving facility must docu- (9) Documentation of the review of
ment the following in records as appli- the supplier’s relevant food safety
cable to its supply-chain program: records. This documentation must in-
(1) The written supply-chain pro- clude:
gram; (i) The name of the supplier whose
(2) Documentation that a receiving records were reviewed;
facility that is an importer is in com- (ii) The date(s) of review;
pliance with the foreign supplier (iii) The general nature of the records
verification program requirements reviewed;
under part 1, subpart L of this chapter, (iv) The conclusions of the review;
including documentation of and
verification activities conducted under (v) Corrective actions taken in re-
§ 1.506(e) of this chapter; sponse to significant deficiencies iden-
(3) Documentation of the approval of tified during the review;
a supplier; (10) Documentation of other appro-
(4) Written procedures for receiving priate supplier verification activities
raw materials and other ingredients; based on the supplier performance and
(5) Documentation demonstrating use the risk associated with the raw mate-
of the written procedures for receiving rial or other ingredient;
raw materials and other ingredients; (11) Documentation of any deter-
(6) Documentation of the determina- mination that verification activities
tion of the appropriate supplier other than an onsite audit, and/or less
verification activities for raw mate- frequent onsite auditing of a supplier,
rials and other ingredients; provide adequate assurance that the
(7) Documentation of the conduct of hazards are controlled when a hazard
an onsite audit. This documentation in a raw material or other ingredient
must include: will be controlled by the supplier and is
(i) The name of the supplier subject one for which there is a reasonable
to the onsite audit; probability that exposure to the hazard
(ii) Documentation of audit proce- will result in serious adverse health
dures; consequences or death to humans or
(iii) The dates the audit was con- animals;
ducted; (12) The following documentation of
(iv) The conclusions of the audit; an alternative verification activity for
(v) Corrective actions taken in re- a supplier that is a qualified facility:
sponse to significant deficiencies iden- (i) The written assurance that the
tified during the audit; and supplier is a qualified facility as de-
(vi) Documentation that the audit fined by § 507.3; and
was conducted by a qualified auditor; (ii) The written assurance that the
(8) Documentation of sampling and supplier is producing the raw material
testing conducted as a supplier or other ingredient in compliance with
verification activity. This documenta- applicable FDA food safety regulations
tion must include: (or, when applicable, relevant laws and
(i) Identification of the raw material regulations of a country whose food
or other ingredient tested (including safety system FDA has officially recog-
lot number, as appropriate) and the nized as comparable or has determined
number of samples tested; to be equivalent to that of the United
(ii) Identification of the test(s) con- States);
ducted, including the analytical meth- (13) The following documentation of
od(s) used; an alternative verification activity for
(iii) The date(s) on which the test(s) a supplier that is a farm that supplies
were conducted and the date of the re- a raw material or other ingredient and
port; is not a covered farm under part 112 of

(iv) The results of the testing; this chapter:
65
§ 507.200 21 CFR Ch. I (4–1–23 Edition)
(i) The written assurance that sup- (i) Applicable documentation from an
plier is not a covered farm under part entity other than the receiving facility
112 of this chapter in accordance with that written procedures for receiving
§ 112.4(a), or in accordance with raw materials and other ingredients
§§ 112.4(b) and 112.5; and are being followed;
(ii) The written assurance that the (ii) Applicable documentation, from
farm acknowledges that its food is sub- an entity other than the receiving fa-
ject to section 402 of the Federal Food, cility, of the determination of the ap-
Drug, and Cosmetic Act (or, when appropriate supplier verification activi-
plicable, that its food is subject to rel- ties for raw materials and other ingre-
evant laws and regulations of a coun-
dients;
try whose food safety system FDA has
(iii) Applicable documentation, from
officially recognized as comparable or
has determined to be equivalent to an entity other than the receiving fa-
that of the United States); cility, of conducting the appropriate
(14) The following documentation of supplier verification activities for raw
an alternative verification activity for materials and other ingredients;
a supplier that is a shell egg producer (iv) Applicable documentation, from
that is not subject to the requirements its supplier, of:
established in part 118 of this chapter (A) The results of sampling and test-
because it has less than 3,000 laying ing conducted by the supplier; or
hens: (B) The results of an audit conducted
(i) The written assurance that the by a third-party qualified auditor in
shell eggs provided by the supplier are accordance with §§ 507.130(f) and 507.135;
not subject to part 118 of this chapter and
because the supplier has less than 3,000 (v) Applicable documentation, from
laying hens; and an entity other than the receiving fa-
(ii) The written assurance that the cility, of verification activities when a
shell egg producer acknowledges that supply-chain-applied control is applied
its food is subject to section 402 of the by an entity other than the receiving
Federal Food, Drug, and Cosmetic Act facility’s supplier.
(or, when applicable, that its food is
subject to relevant laws and regula-
tions of a country whose safety system Subpart F—Requirements Apply-
FDA has officially recognized as coming to Records That Must Be
parable or has determined to be equiva- Established and Maintained
lent to that of the United States);
(15) The written results of an appro- § 507.200 Records subject to the re-
priate inspection of the supplier for quirements of this subpart.
compliance with applicable FDA food (a) Except as provided by paragraphs
safety regulations by FDA, by rep- (d) and (e) of this section, all records
resentatives of other Federal Agencies required by this part are subject to all
(such as the United States Department requirements of this subpart.
of Agriculture), or by representatives (b) Records obtained by FDA in ac-
from State, local, tribal, or territorial cordance with this part are subject to
agencies, or the food safety authority the disclosure requirements under part
of another country when the results of
20 of this chapter.
such an inspection is substituted for an
(c) All records required by this part
onsite audit;
(16) Documentation of actions taken must be made promptly available to a
with respect to supplier non-conform- duly authorized representative of the
ance; Secretary of Health and Human Serv-
(17) Documentation of verification of ices for official review and copying
a supply-chain-applied control applied upon oral or written request.
by an entity other than the receiving (d) The requirements of § 507.206 apply
facility’s supplier; and only to the written food safety plan.
(18) When applicable, documentation (e) The requirements of § 507.202(a)(2),
of the receiving facility’s review and (4), and (5) and (b) do not apply to the
assessment of: records required by § 507.7.
66
§ 507.202 General requirements apply- essary to support the status of a facil-

ing to records. ity as a qualified facility during the
(a) Records must: applicable calendar year.
(1) Be kept as original records, true (b) Records that relate to the general
copies (such as photocopies, pictures, adequacy of the equipment or processes
scanned copies, microfilm, microfiche, being used by a facility, including the
or other accurate reproductions of the results of scientific studies and evalua-
original records), or electronic records; tions, must be retained by the facility
(2) Contain the actual values and ob- for at least 2 years after their use is
servations obtained during monitoring discontinued (e.g., because the facility
and as appropriate, during verification has updated the written food safety
activities; plan (§ 507.31) or records that document
(3) Be accurate, indelible, and legible; validation of the written food safety
(4) Be created concurrently with per- plan (§ 507.45(b))).
formance of the activity documented; (c) Except for the food safety plan,
and offsite storage of records is permitted
(5) Be as detailed as necessary to pro- if such records can be retrieved and
vide history of work performed. provided onsite within 24 hours of re-
(b) All records must include: quest for official review. The food safe-
(1) Information adequate to identify ty plan must remain onsite. Electronic
the plant or facility (e.g., the name, records are considered to be onsite if
and when necessary, the location of the they are accessible from an onsite loca-
plant or facility); tion.
(2) The date and, when appropriate, (d) If the plant or facility is closed
the time of the activity documented; for a prolonged period, the food safety
(3) The signature or initials of the plan may be transferred to some other
person performing the activity; and reasonably accessible location but
(4) Where appropriate, the identity of must be returned to the plant or facil-
the product and the lot code, if any. ity within 24 hours for official review
(c) Records that are established or upon request.
maintained to satisfy the requirements
of this part and that meet the defini- § 507.212 Use of existing records.
tion of electronic records in § 11.3(b)(6) (a) Existing records (e.g., records that
of this chapter are exempt from the re- are kept to comply with other Federal,
quirements of part 11 of this chapter. State, or local regulations, or for any
Records that satisfy the requirements other reason) do not need to be dupli-
of this part, but that also are required cated if they contain all of the required
under other applicable statutory provi- information and satisfy the require-
sions or regulations, remain subject to ments of this subpart. Existing records
part 11 of this chapter. may be supplemented as necessary to
include all of the required information
§ 507.206 Additional requirements ap- and satisfy the requirements of this
plying to the food safety plan. subpart.
The owner, operator, or agent in (b) The information required by this
charge of the facility must sign and part does not need to be kept in one set
date the food safety plan upon initial of records. If existing records contain
completion and upon any modification. some of the required information, any
new information required by this part
§ 507.208 Requirements for record re- may be kept either separately or com-
tention. bined with the existing records.
(a)(1) All records required by this
part must be retained at the plant or § 507.215 Special requirements appli-
facility for at least 2 years after the cable to a written assurance.
date they were prepared. (a) Any written assurance required
(2) Records that a facility relies on by this part must contain the following
during the 3-year period preceding the elements:
applicable calendar year to support its (1) Effective date;
status as a qualified facility must be (2) Printed names and signatures of

retained at the facility as long as nec- authorized officials;
67
Pt. 509 21 CFR Ch. I (4–1–23 Edition)
(3) The applicable assurance under: Subpart A—General Provisions

(i) § 507.36(a)(2);
(ii) § 507.36(a)(3); § 509.3 Definitions and interpretations.
(iii) § 507.36(a)(4); (a) Act means the Federal Food,
(iv) § 507.130(c)(2); Drug, and Cosmetic Act.
(v) § 507.130(d)(2); or (b) The definitions of terms con-
(vi) § 507.130(e)(2). tained in section 201 of the act are ap-
(b) A written assurance required plicable to such terms when used in
under § 507.36(a)(2), (3) or (4) must in- this part unless modified in this sec-
clude: tion.
(c) A naturally occurring poisonous or
(1) Acknowledgement that the facil-
deleterious substance is a poisonous or
ity that provides the written assurance
deleterious substance that is an inher-
assumes legal responsibility to act con- ent natural constituent of a food and is
sistently with the assurance and docu- not the result of environmental, agri-
ment its actions taken to satisfy the cultural, industrial, or other contami-
written assurance; and nation.
(2) Provision that if the assurance is (d) An added poisonous or deleterious
terminated in writing by either entity, substance is a poisonous or deleterious
responsibility for compliance with the substance that is not a naturally oc-
applicable provisions of this part re- curring poisonous or deleterious sub-
verts to the manufacturer/processor as stance. When a naturally occurring
of the date of termination. poisonous or deleterious substance is
increased to abnormal levels through
PART 509—UNAVOIDABLE CON- mishandling or other intervening acts,
TAMINANTS IN ANIMAL FOOD it is an added poisonous or deleterious
AND FOOD-PACKAGING MATE- substance to the extent of such in-
RIAL crease.
(e) Food includes pet food, animal
Subpart A—General Provisions feed, and substances migrating to food
from food-contact articles.
Sec.
509.3 Definitions and interpretations. § 509.4 Establishment of tolerances,
509.4 Establishment of tolerances, regu-
regulatory limits, and action levels.
latory limits, and action levels. (a) When appropriate under the cri-
509.5 Petitions. teria of § 509.6, a tolerance for an added
509.6 Added poisonous or deleterious sub- poisonous or deleterious substance,
stances. which may be a food additive, may be
509.7 Unavoidability. established by regulation in subpart B
509.15 Use of polychlorinated biphenyls of this part under the provisions of sec-
(PCB’s) in establishments manufacturing tion 406 of the act. A tolerance may
food-packaging materials.
prohibit any detectable amount of the
Subpart B—Tolerances for Unavoidable substance in food.
(b) When appropriate under the cri-
Poisonous or Deleterious Substances
teria of § 509.6, and under section
509.30 Temporary tolerances for poly- 402(a)(1) of the act, a regulatory limit
chlorinated biphenyls (PCB’s). for an added poisonous or deleterious
substance, which may be a food addi-
Subpart C—Regulatory Limits for Added tive, may be established by regulation
Poisonous or Deleterious Substances in subpart C of this part under the pro-
[Reserved] visions of sections 402(a)(1) and 701(a) of
the act. A regulatory limit may pro-
Subpart D—Naturally Occurring Poisonous hibit any detectable amount of the sub-
or Deleterious Substances [Reserved] stance in food. The regulatory limit es-
tablished represents the level at which
AUTHORITY: 21 U.S.C. 336, 342, 346, 346a, 348, food is adulterated within the meaning
371. of section 402(a)(1) of the act.
SOURCE: 42 FR 52821, Sept. 30, 1977, unless (c)(1) When appropriate under the cri-
otherwise noted. teria of § 509.6, an action level for an
68
added poisonous or deleterious sub- tion. Residues resulting from the use of
stance, which may be a food additive, an added poisonous or deleterious sub-
may be established to define a level of stance that is also a pesticide chemical
contamination at which a food may be will ordinarily be controlled by a toler-
regarded as adulterated. ance established in a regulation issued
(2) Whenever an action level is estab- under sections 406, 408, or 409 of the act
lished or changed, a notice shall be by the U.S. Environmental Protection
published in the FEDERAL REGISTER as Agency (EPA). When such a regulation
soon as practicable thereafter. The no- has not been issued, an action level for
tice shall call attention to the mate- an added poisonous or deleterious sub-
rial supporting the action level which stance that is also a pesticide chemical
shall be on file with the Division of may be established by the Food and
Dockets Management before the notice Drug Administration. The Food and
is published. The notice shall invite Drug Administration will request EPA
public comment on the action level. to recommend such an action level pur-
(d) A regulation may be established suant to the criteria established in
in subpart D of this part to identify a paragraph (d) of this section.
food containing a naturally occurring (b) A tolerance for an added poi-
poisonous or deleterious substance sonous or deleterious substance in any
which will be deemed to be adulterated food may be established when the fol-
under section 402(a)(1) of the act. These lowing criteria are met:
regulations do not constitute a com- (1) The substance cannot be avoided
plete list of such foods. by good manufacturing practice.
[42 FR 52821, Sept. 30, 1977, as amended at 55 (2) The tolerance established is suffi-
FR 20786, May 21, 1990] cient for the protection of the public
health, taking into account the extent
§ 509.5 Petitions. of which the presence of the substance
The Commissioner of Food and cannot be avoided and the other ways
Drugs, either on his own initiative or in which the consumer may be affected
on behalf of any interested person who by the same or related poisonous or
has submitted a petition, may issue a deleterious substances.
proposal to establish, revoke, or amend (3) No technological or other changes
a regulation under this part. Any such are foreseeable in the near future that
petition shall include an adequate fac- might affect the appropriateness of the
tual basis to support the petition, shall tolerance established. Examples of
be in the form set forth in § 10.30 of this changes that might affect the appro-
chapter, and will be published in the priateness of the tolerance include an-
FEDERAL REGISTER for comment if it ticipated improvements in good manu-
contains reasonable grounds for the facturing practice that would change
proposed regulation. the extent to which use of the sub-
stance is unavoidable and anticipated
FR 18280, Apr. 28, 1989] studies expected to provide significant
new toxicological or use data.
§ 509.6 Added poisonous or deleterious (c) A regulatory limit for an added
substances. poisonous or deleterious substance in
(a) Use of an added poisonous or dele- any food may be established when each
terious substance, other than a pes- of the following criteria is met:
ticide chemical, that is also a food ad- (1) The substance cannot be avoided
ditive will be controlled by a regula- by current good manufacturing prac-
tion issued under section 409 of the act tices.
when possible. When such a use cannot (2) There is no tolerance established
be approved under the criteria of sec- for the substance in the particular food
tion 409 of the act, or when the added under sections 406, 408, or 409 of the act.
poisonous or deleterious substance is (3) There is insufficient information
not a food additive, a tolerance, regu- by which a tolerance may be estab-
latory limit, or action level may be es- lished for the substance under section
tablished pursuant to the criteria in 406 of the act or technological changes

paragraphs (b), (c), or (d) of this sec- appear reasonably possible that may
69
§ 509.7 21 CFR Ch. I (4–1–23 Edition)
affect the appropriateness of a toler- practices. Evidence obtained through

ance. The regulatory limit established factory inspection or otherwise indi-
represents the level at which food is cating such a violation renders the
adulterated within the meaning of sec- food unlawful, even though the
tion 402(a)(1) of the act. amounts of poisonous or deleterious
(d) An action level for an added poi- substances are lower than the cur-
sonous or deleterious substance in any rently established tolerances, regu-
food may be established when the cri- latory limits, or action levels. The
teria in paragraph (b) of this section manufacturer of food must at all times
are met, except that technological or utilize quality control procedures
other changes that might affect the ap- which will reduce contamination to the
propriateness of the tolerance are fore- lowest level currently feasible.
seeable in the near future. An action
level for an added poisonous or delete- FR 20786, May 21, 1990]
rious substance in any food may be es-
tablished at a level at which the Food § 509.15 Use of polychlorinated
and Drug Administration may regard biphenyls (PCB’s) in establishments
the food as adulterated within the manufacturing food-packaging ma-
meaning of section 402(a)(1) of the act, terials.
without regard to the criteria in para- (a) Polychlorinated biphenyls (PCB’s)
graph (b) of this section or in section represent a class of toxic industrial
406 of the act. An action level will be chemicals manufactured and sold under
withdrawn when a tolerance or regu- a variety of trade names, including:
latory limit for the same substance and Aroclor (United States); Phenoclor
use has been established. (France); Colphen (Germany); and
(e) Tolerances will be established Kanaclor (Japan). PCB’s are highly sta-
under authority appropriate for action ble, heat resistant, and nonflammable
levels (sections 306, 402(a), and 701(a) of chemicals. Industrial uses of PCB’s in-
the act, together with section 408 or 409 clude, or did include in the past, their
of the act, if appropriate) as well as use as electrical transformer and ca-
under authority appropriate for toler- pacitor fluids, heat transfer fluids, hy-
ances (sections 406 and 701 of the act). draulic fluids, and plasticizers, and in
In the event the effectiveness of a tol- formulations of lubricants, coatings,
erance is stayed pursuant to section and inks. Their unique physical and
701(e)(2) of the act by the filing of an chemical properties and widespread,
objection, the order establishing the uncontrolled industrial applications
tolerance shall be deemed to be an have caused PCB’s to be a persistent
order establishing an action level until and ubiquitous contaminant in the en-
final action is taken upon such objec- vironment, causing the contamination
tion. of certain foods. In addition, incidents
[42 FR 52821, Sept. 30, 1977, as amended at 55 have occurred in which PCB’s have di-
FR 20786, May 21, 1990] rectly contaminated animal feeds as a
result of industrial accidents (leakage
§ 509.7 Unavoidability. or spillage of PCB fluids from plant
(a) Tolerances and action levels in equipment). These accidents in turn
this part are established at levels based caused the contamination of food prod-
on the unavoidability of the poisonous ucts intended for human consumption
or deleterious substance concerned and (meat, milk and eggs). Investigations
do not establish a permissible level of by the Food and Drug Administration
contamination where it is avoidable. have revealed that a significant per-
(b) Compliance with tolerances, regu- centage of paper food-packaging mate-
latory limits, and action levels does rial contains PCB’s which can migrate
not excuse failure to observe either the to the packaged food. The origin of
requirement in section 402(a)(4) of the PCB’s in such material is not fully un-
act that food may not be prepared, derstood. Reclaimed fibers containing
packed, or held under insanitary condi- carbonless copy paper (contains 3 to 5
tions or the other requirements in this percent PCB’s) have been identified as
chapter that food manufacturers must a primary source of PCB’s in paper

observe current good manufacturing products. Some virgin paper products
70
have also been found to contain PCB’s, imum quantity that could be spilled
the source of which is generally attrib- onto a given quantity of food before it
uted to direct contamination from in- would be noticed, taking into account
dustrial accidents from the use of PCB- its color and odor; (c) possible signaling
containing equipment and machinery devices in the equipment to indicate a
in food-packaging manufacturing es- loss of fluid, etc.; and (d) its environ-
tablishments. Since PCB’s are toxic mental stability and tendency to sur-
chemicals, the PCB contamination of vive and be concentrated through the
food-packaging materials as a result of food chain. The judgment as to wheth-
industrial accidents, which can cause er a replacement fluid is sufficiently
the PCB contamination of food, rep- non-hazardous is to be made on an indi-
resents a hazard to public health. It is vidual installation and operation basis.
therefore necessary to place certain re- (c) The provisions of this section do
strictions on the industrial uses of not apply to electrical transformers
PCB’s in establishments manufac- and condensers containing PCB’s in
turing food-packaging materials. sealed containers.
(b) The following special provisions
are necessary to preclude the acci- Subpart B—Tolerances for Un-
dental PCB contamination of food- avoidable Poisonous or Dele-
packaging materials: terious Substances
(1) New equipment or machinery for
manufacturing food-packaging mate- § 509.30 Temporary tolerances for pol-
rials shall not contain or use PCB’s. ychlorinated biphenyls (PCB’s).
(2) On or before September 4, 1973, the (a) Polychlorinated biphenyls (PCB’s)
management of establishments manu- are toxic, industrial chemicals. Be-
facturing food-packaging materials cause of their widespread, uncontrolled
shall: industrial applications, PCB’s have be-
(i) Have the heat exchange fluid used come a persistent and ubiquitous con-
in existing equipment for manufac- taminant in the environment. As a re-
turing food-packaging materials sam- sult, certain foods and animal feeds,
pled and tested to determine whether it principally those of animal and marine
contains PCB’s or verify the absence of origin, contain PCB’s as unavoidable,
PCB’s in such formulations by other environmental contaminants. PCB’s
appropriate means. On or before Sept. are transmitted to the food portion
4, 1973, any such fluid formulated with (meat, milk, and eggs) of food pro-
PCB’s must to the fullest extent pos- ducing animals ingesting PCB con-
sible commensurate with current good taminated animal feed. In addition, a
manufacturing practices be replaced significant percentage of paper food-
with a heat exchange fluid that does packaging materials contain PCB’s
not contain PCB’s. which may migrate to the packaged
(ii) Eliminate to the fullest extent food. The source of PCB’s in paper
possible commensurate with current food-packaging materials is primarily
good manufacturing practices from the of certain types of carbonless copy
establishment any other PCB-con- paper (containing 3 to 5 percent PCB’s)
taining equipment, machinery and main waste paper stocks used for manu-
terials wherever there is a reasonable facturing recycled paper. Therefore,
expectation that such articles could temporary tolerances for residues of
cause food-packaging materials to be- PCB’s as unavoidable environmental or
come contaminated with PCB’s either industrial contaminants are estab-
as a result of normal use or as a result lished for a sufficient period of time
of accident, breakage, or other mishap. following the effective date of this
(iii) The toxicity and other charac- paragraph to permit the elimination of
teristics of fluids selected as PCB re- such contaminants at the earliest prac-
placements must be adequately deter- ticable time. For the purposes of this
mined so that the least potentially paragraph, the term polychlorinated
hazardous replacement is used. In mak- biphenyls (PCB’s) is applicable to mix-
ing this determination with respect to tures of chlorinated biphenyl com-
a given fluid, consideration should be pounds, irrespective of which mixture

given to (a) its toxicity; (b) the max- of PCB’s is present as the residue. The
71
temporary tolerances for residues of Subpart B—Specific Administrative Rulings

PCB’s are as follows: and Decisions
(1) 0.2 part per million in finished 510.105 Labeling of drugs for use in milk-
animal feed for food-producing animals producing animals.
(except the following finished animal 510.106 Labeling of antibiotic and anti-
feeds: feed concentrates, feed supple- biotic-containing drugs intended for use
ments, and feed premixes). in milk-producing animals.
510.110 Antibiotics used in food-producing
(2) 2 parts per million in animal feed animals.
components of animal origin, including 510.112 Antibiotics used in veterinary medi-
fishmeal and other by-products of ma- cine and for nonmedical purposes; re-
rine origin and in finished animal feed quired data.
concentrates, supplements, and pre-
mixes intended for food-producing ani- Subpart C—Import Tolerances for Residues
of Unapproved New Animal Drugs in Food
mals.
(3) 10 parts per million in paper food- 510.201 Scope.
packaging material intended for or 510.202 Definitions.
used with finished animal feed and any 510.203 Initiation of a proceeding to estab-
lish or amend an import tolerance.
components intended for animal feeds. 510.205 Content and administration of a re-
The tolerance shall not apply to paper quest.
food-packaging material separated 510.206 Review of information supporting
from the food therein by a functional actions to establish or amend an import
barrier which is impermeable to migra- tolerance.
510.207 Disclosure of information submitted
tion of PCB’s. in a request.
(b) A compilation entitled ‘‘Analyt- 510.209 Establishment, denial, or amend-
ical Methodology for Polychlorinated ment of an import tolerance.
Biphenyls, February 1973’’ for deter- 510.210 Revocation of an import tolerance.
mining compliance with the tolerances 510.212 Administrative reconsideration of
action.
established in this section is available 510.213 Administrative stay of action.
from the Division of Dockets Manage-
ment, Food and Drug Administration, Subpart D—Records and Reports
5630 Fishers Lane, rm. 1061, Rockville,
510.301 Records and reports concerning ex-
MD 20852. perience with animal feeds bearing or
[42 FR 52821, Sept. 30, 1977, as amended at 46 containing new animal drugs for which
FR 8460, Jan. 27, 1981; 59 FR 14365, Mar. 28, an approved medicated feed mill license
1994; 68 FR 24879, May 9, 2003] application is in effect.
510.305 Maintenance of copies of approved
medicated feed mill licenses to manufac-
Subpart C—Regulatory Limits for ture animal feed bearing or containing
Added Poisonous or Delete- new animal drugs.
rious Substances [Reserved] Subpart E—Requirements for Specific New
Animal Drugs
Subpart D—Naturally Occurring
510.410 Corticosteroids for oral, injectable,
Poisonous or Deleterious Sub- and ophthalmic use in animals; warnings
stances [Reserved] and labeling requirements.
510.440 Injectable iron preparations.
510.455 Requirements for free-choice medi-
PART 510—NEW ANIMAL DRUGS cated feeds.
Subpart A—General Provisions Subpart F [Reserved]

Sec. Subpart G—Sponsors of Approved
510.3 Definitions and interpretations. Applications
510.4 Biologics; products subject to license
control. 510.600 Names, addresses, and drug labeler
510.7 Consignees of new animal drugs for codes of sponsors of approved applica-
use in the manufacture of animal feed. tions.
510.95 [Reserved] AUTHORITY: 21 U.S.C. 321, 331, 351, 352, 353,

360b, 371, 379e.
72
SOURCE: 40 FR 13807, Mar. 27, 1975, unless source of nutrients in the diet of the
otherwise noted. animal, and is not limited to a mixture
intended to be the sole ration of the
Subpart A—General Provisions animal.
(i) The newness of an animal drug, in-
§ 510.3 Definitions and interpretations. cluding a new animal drug intended for
As used in this part: use in or on animal feed, may arise by
(a) The term act means the Federal reason of: (1) The newness for its in-
Food, Drug, and Cosmetic Act, as tended drug use of any substance of
amended (secs. 201–902, 52 Stat. 1040 et which the drug is comprised, in whole
seq., as amended; 21 U.S.C. 321–392). or in part, whether it be an active sub-
(b) Department means the Department stance or a menstruum, excipient, car-
of Health and Human Services. rier, coating, or other component; (2)
(c) Secretary means the Secretary of the newness for its intended drug use of
Health and Human Services. a combination of two or more sub-
(d) Commissioner means the Commis- stances, none of which is itself a new
sioner of Food and Drugs. animal drug; (3) the newness for its in-
(e) Person means individuals, partner- tended drug use of the proportion of a
ships, corporations, and associations. substance in a combination, even
(f) The definitions and interpreta- though such combination containing
tions of terms contained in section 201 such substance in other proportion is
of the act shall be applicable to such not a new animal drug; (4) the newness
terms when used in the regulations in for its intended drug use in a different
this part.
species of animal; (5) the newness of its
(g) The term new animal drug means
intended drug use in diagnosing, cur-
any drug intended for use for animals
ing, mitigating, treating, or preventing
other than man, including any drug in-
a disease, or to affect a structure or
tended for use in animal feed but not
function of the animal body, even
including such animal feed:
though such drug is not a new animal
(1) The composition of which is such
drug when used in another disease or to
that such drug is not generally recog-
affect another structure or function of
nized, among experts qualified by sci-
the body; or (6) the newness of a dos-
entific training and experience to
evaluate the safety and effectiveness of age, or method or duration of adminis-
animal drugs, as safe and effective for tration or application, or any other
use under the conditions prescribed, condition of use prescribed, rec-
recommended, or suggested in the la- ommended, or suggested in the labeling
beling thereof; except that such a drug of such drug, even though such drug or
not so recognized shall not be deemed animal feed containing such drug when
to be a new animal drug if at any time used in another dosage, or another
prior to June 25, 1938, it was subject to method or duration of administration
the Food and Drug Act of June 30, 1906, or application, or different condition,
as amended, and if at such time its la- is not a new animal drug.
beling contained the same representa- (j) Animals used only for laboratory re-
tions concerning the conditions of its search and laboratory research animals
use; or mean individual animals or groups of
(2) The composition of which is such animals intended for use and used sole-
that such drug, as a result of investiga- ly for laboratory research purposes, re-
tions to determine its safety and effec- gardless of species, and does not in-
tiveness for use under such conditions, clude animals intended to be used for
has become so recognized but which any food purposes or animals intended
has not, otherwise than in such inves- to be kept as livestock.
tigations, been used to a material ex- (k) Sponsor means the person request-
tent or for a material time under such ing designation for a minor-use or
conditions. minor-species drug as defined in part
(h) The term animal feed means an ar- 516 of this chapter, who must be the
ticle which is intended for use for food real party in interest of the develop-
for animals other than man and which ment and the intended or actual pro-
is intended for use as a substantial duction and sales of such drug (in this
73
§ 510.4 21 CFR Ch. I (4–1–23 Edition)
context, the sponsor may be an indi- (1) Where such drugs are intended for
vidual, partnership, organization, or export and/or
association). Sponsor also means the (2) When the use of such drug in the
person responsible for an investigation manufacture of a finished feed has been
of a new animal drug. In this context, exempted from the requirements of
the sponsor may be an individual, part- section 512(m) of the act under the con-
nership, corporation, or Government ditions specified by regulations pub-
agency or may be a manufacturer, sci- lished in part 558 of this chapter.
entific institution, or an investigator [40 FR 13807, Mar. 27, 1975, as amended at 64
regularly and lawfully engaged in the FR 63203, Nov. 19, 1999]
investigation of new animal drugs.
Sponsor also means the person submit- § 510.95 [Reserved]
ting or receiving approval for a new
animal drug application (in this con- Subpart B—Specific Administrative
text, the sponsor may be an individual, Rulings and Decisions
partnership, organization, or associa-
tion). In all contexts, the sponsor is re- § 510.105 Labeling of drugs for use in
sponsible for compliance with applica- milk-producing animals.
ble provisions of the act and regula- (a) Part 526 of this chapter provides
tions. for new animal drugs intended for
[40 FR 13807, Mar. 27, 1975, as amended at 50 intramammary use in animals and in-
FR 7517, Feb. 22, 1985; 54 FR 22741, May 26, cludes conditions of use intended to
1989; 64 FR 69190, Dec. 10, 1999; 72 FR 41017, prevent the contamination of milk
July 26, 2007] from the use of such drugs.
(b) Preparations containing anti-
§ 510.4 Biologics; products subject to biotics and other potent drugs labeled
license control. with directions for use in milk-pro-
An animal drug produced and distrib- ducing animals will be misbranded
uted in full conformance with the ani- under section 502(f)(2) of the act unless
mal virus, serum, and toxin law of their labeling bears appropriate warn-
March 4, 1913 (37 Stat. 832; 21 U.S.C. 151 ings and directions for use to avoid
et seq. ) and any regulations issued adulteration of milk under section
thereunder shall not be deemed to be 402(a)(2)(c)(ii) of the act.
subject to section 512 of the Federal (c) It is the position of the Food and
Food, Drug, and Cosmetic Act. Drug Administration that the labeling
for such preparations should bear a
§ 510.7 Consignees of new animal clear warning that either:
drugs for use in the manufacture of (1) The article should not be adminis-
animal feed. tered to animals producing milk, since
(a) A new animal drug intended for to do so would result in contamination
use in the manufacture of animal feed of the milk; or
shall be deemed to be unsafe unless at (2) The label should bear the fol-
the time of its removal from the estab- lowing statement: ‘‘Warning: Milk that
lishment of a manufacturer, packer, or has been taken from animals during
distributor of such drug, such manufac- treatment and for __ hours after the
turer, packer, or distributor has an latest treatment must not be used for
unrevoked written statement from the food’’, the blank being filled in with
consignee of such drug, or a notice the figure that the manufacturer has
from the Secretary, to the effect that determined by appropriate investiga-
with respect to the use of such drug in tion is needed to insure that the milk
animal feed the consignee: will not carry violative residues result-
(1) Holds a license issued under ing from use of the preparation. If the
§ 515.20 of this chapter; or use of the preparation as recommended
(2) Will, if the consignee is not the does not result in contamination of the
user of the drug, ship such drug only to milk, neither of the above warning
a holder of an approved application statements is required.
under § 515.10 of this chapter. [40 FR 13807, Mar. 27, 1975, as amended at 63
(b) The requirements of paragraph (a) FR 32980, June 17, 1998; 64 FR 51241, Sept. 22,
of this section do not apply: 1999]
74
§ 510.106 Labeling of antibiotic and an- with respect to their safety and effec-
tibiotic-containing drugs intended tiveness.
for use in milk-producing animals. (b) Based upon an evaluation of the
Whenever the labeling of an anti- conclusions of said Committee and
biotic drug included in the regulations other relevant material, § 510.112 was
in this chapter suggests or recommends published in the FEDERAL REGISTER of
its use in milk-producing animals, the August 23, 1966 (31 FR 11141), asking
label of such drugs shall bear either the sponsors of drugs containing any anti-
statement ‘‘Warning: Not for use in biotic intended for use in food-pro-
animals producing milk, since this use ducing animals to submit data to es-
will result in contamination of the tablish whether such antibiotic and its
milk’’ or the statement ‘‘Warning: metabolites are present as residues in
Milk that has been taken from animals edible tissues, milk, and eggs from
during treatment and for __hours after treated animals. The data on the resi-
the latest treatment must not be used dues of antibiotics in milk from
for food’’, the blank being filled in with intramammary infusion preparations
the figure that the Commissioner has were requested within 60 days and the
authorized the manufacturer of the data on all other products were re-
drug to use. The Commissioner shall quested within 180 days following the
determine what such figures shall be date of publication of § 510.112 in the
from information submitted by the FEDERAL REGISTER.
manufacturer and which the Commis- (c) An evaluation of the data now
sioner considers is adequate to prove available shows that use of many anti-
that period of time after the latest biotic preparations cause residues in
treatment that the milk from treated edible products of treated animals for
animals will contain no violative resi- varying and, in some cases, for long pe-
dues from use of the preparation. If the riods of time following the last admin-
Commissioner determines from the in- istration. Because of the accumulation
formation submitted that the use of of new information with regard to the
the antibiotic drug as recommended development of resistance of bacteria
does not result in its appearance in the to antibiotics, the ability of bacteria to
milk, the Commissioner may exempt transfer this resistance, and the devel-
the drug from bearing either of the opment of sensitivity to antibiotics in
above warning statements. humans, unauthorized and unsafe resi-
[63 FR 32980, June 17, 1998] dues of antibiotics cannot be permitted
in food obtained from treated animals.
§ 510.110 Antibiotics used in food-pro- (d) Based on evaluation of informa-
ducing animals. tion available, including the conclu-
(a) The Food and Drug Administra- sions of the aforementioned ad hoc
tion in the interest of fulfilling its re- Committee, the Commissioner con-
sponsibilities with regard to protection cludes that antibiotic preparations in-
of the public health has requested an tended for use in food-producing ani-
evaluation of the public health aspects mals, other than topical and oph-
of the use of antibiotics in veterinary thalmic preparations, are not generally
medical and nonmedical uses. There is recognized among qualified experts as
particular concern with regard to the having been shown to be safe for their
potential hazards associated with the intended use(s) within the meaning of
extensive use of antibiotics adminis- section 201(s) of the Federal Food,
tered to food-producing animals. Ac- Drug, and Cosmetic Act.
cordingly, an ad hoc committee on the (e) Therefore, all exemptions from
Veterinary Medical and Nonmedical the provisions of section 409 of the act
Uses of Antibiotics was established by for use of antibiotics in food-producing
the Food and Drug Administration to animals based on sanctions or approv-
study and advise the Commissioner of als granted prior to enactment of the
Food and Drugs on the uses of anti- Food Additives Amendment of 1958
biotics in veterinary medicine and for (Pub. L. 85–929; 72 Stat. 1784) will be re-
various nonmedical purposes as such voked and the uses which are con-
uses may affect the enforcement of the cluded to be safe will be covered by
Federal Food, Drug, and Cosmetic Act food additive regulations. On those
75
§ 510.112 21 CFR Ch. I (4–1–23 Edition)
products for which there are inad- cumulated since the issuance of the
equate residue data, actions will be ini- regulation need be submitted.
tiated to withdraw approval of new- (c) The required data shall be sub-
drug applications under the provisions mitted within 180 days of the date of
of section 505 of the act. Antibiotic publication of this section in the FED-
preparations, other than those for top- ERAL REGISTER; except that in the case
ical and ophthalmic application in of data on intramammary infusion
food-producing animals, which are not preparations the data shall be sub-
covered by food additive regulations mitted within 60 days of such publica-
will be subject to regulatory action tion. Data demonstrating the absence
within 180 days after publication of the in milk of residues of intramammary
forthcoming revocation order. infusion preparations when used as di-
(f) Because of the variation in the pe- rected in their labeling are needed
riod of time that antibiotic residues within the 60-day period because of the
may remain in edible products from importance of milk in the human diet.
treated animals, all injectable, (d) Regulatory proceedings including
intramammary infusion, intrauterine, revocation of prior sanctions, or ac-
and oral preparations, including medi- tions to suspend or amend new drug or
cated premixes intended for use in antibiotic approvals granted prior to
food-producing animals, are deemed to passage of the Food Additives Amend-
be new drugs as well as food additives. ment of 1958 (72 Stat. 1784), may be ini-
tiated with regard to the continued
[40 FR 13807, Mar. 27, 1975, as amended at 54 marketing of any antibiotic prepara-
FR 18280, Apr. 28, 1989; 64 FR 403, Jan. 5, 1999] tion on which the required information
is not submitted within the period of
§ 510.112 Antibiotics used in veteri- time prescribed by paragraph (c) of this
nary medicine and for nonmedical
purposes; required data. section.
(e) Questions relating to the accept-
(a) An ad hoc committee, Committee ability of proposed research protocols
on the Veterinary Medical and Non- and assay methods for determining the
medical Uses of Antibiotics, was amount of antibiotic residues in food
formed by the Food and Drug Adminis- should be directed to the Director, Cen-
tration to study, and advise the Com- ter for Veterinary Medicine, Food and
missioner on, the use of antibiotics in Drug Administration, 7500 Standish
veterinary medicine and for various Pl., Rockville, MD 20855.
nonmedical purposes as such uses may
[40 FR 13807, Mar. 27, 1975, as amended at 46
affect the enforcement of the Federal FR 8460, Jan. 27, 1981; 54 FR 18280, Apr. 28,
Food, Drug, and Cosmetic Act with re- 1989; 57 FR 6475, Feb. 25, 1992]
spect to the safety and effectiveness of
such substances. A copy of the report
may be obtained from the Food and
Subpart C—Import Tolerances for
Drug Administration, Office of Public Residues of Unapproved New
Affairs, Room 15–05, Parklawn Build- Animal Drugs in Food
ing, 5600 Fishers Lane, Rockville, MD
20857. SOURCE: 86 FR 52410, Sept. 21, 2021, unless
(b) On the basis of the report of the otherwise noted.
Committee and other information,
§ 510.201 Scope.
sponsors of drugs containing any anti-
biotic intended for use in food-pro- This subpart applies to tolerances for
ducing animals shall submit data for residues of new animal drugs not ap-
determining whether or not such anti- proved or conditionally approved for
biotics and their metabolites are use in the United States, but lawfully
present as residues in edible tissues, used in another country and present in
milk, and eggs from treated animals; imported, animal-derived food and food
however, in the case of a drug for products.
which such data have already been sub-
mitted and for which a regulation has § 510.202 Definitions.
been promulgated under section 409 of The following definitions of terms

the act, only such data as has been ac- apply when used in this subpart:
76
CNADA means an application for con- electronic format as authorized by

ditional approval of a new animal drug FDA. See FDA′s Electronic Submis-
submitted under section 571 of the Fed- sions Gateway website: https://
eral Food, Drug, and Cosmetic Act, and www.fda.gov/industry/electronic-submis-
includes all amendments and permis- sions-gateway.
sible supplements. (c) Any material submitted in a for-
Import tolerance means a tolerance for eign language shall be accompanied by
a residue of a new animal drug not ap- a complete and accurate English trans-
proved or conditionally approved for lation. Translations of literature print-
use in the United States, but present in ed in a language other than English
any imported edible portion of any ani- shall be accompanied by copies of the
mal. original publication.
NADA means a new animal drug ap- (d) The request must be dated and
plication submitted under section 512 must be signed by the requester or by
of the Federal Food, Drug, and Cos- his or her authorized attorney, agent,
metic Act, including all amendments or official and shall state the request-
and permissible supplements, for ap- er’s correspondence address. If the re-
proval of a new animal drug. quester or such authorized representa-
Request means a request to establish tive does not reside or have a place of
or amend an import tolerance. business within the United States, the
requester must also furnish the name
§ 510.203 Initiation of a proceeding to and post office address of, and the re-
establish or amend an import toler- quest must be countersigned by, an au-
ance. thorized attorney, agent, or official re-
(a) Any interested person may residing or maintaining a place of busi-
quest that the Commissioner establish ness within the United States.
or amend an import tolerance. Such a (e) The request must include the fol-
request must be in the form specified lowing information:
in § 510.205 of this chapter. (1) The established name and all per-
(b) The Commissioner may initiate a tinent information concerning the new
proceeding to establish or amend an animal drug, including chemical iden-
import tolerance on his or her own ini- tity and composition of the new animal
tiative pursuant to § 10.25(b) of this drug, and its physical, chemical, and
chapter. biological properties;
(2) The conditions of use for the new
§ 510.205 Content and administration animal drug, including the route of ad-
of a request. ministration and dosage, together with
(a) Pertinent information previously all labeling, directions, and rec-
submitted to and currently retained in ommendations regarding the uses in
the files of the Food and Drug Adminis- countries in which the new animal
tration (FDA) may be incorporated in, drug is lawfully used;
and will be considered as part of, a re- (3) The proposed import tolerance(s)
quest on the basis of specific reference for residues of the new animal drug;
to such information. If the requester (4) Human food safety information to
refers to any nonpublic information support the proposed import toler-
other than its own, the requester shall ance(s) in either of the following forms:
obtain a written right of reference to (i) If a permanent maximum residue
that nonpublic information and submit limit (MRL) has been established by
the right of reference with the request. the Codex Alimentarius Committee
Any reference to published information (Codex MRL), the requester shall pro-
offered in support of a request should vide the permanent Codex MRL and
be accompanied by reprints or copies of monographs and reports from the Joint
such references. Expert Committee on Food Additives
(b) Requests shall be submitted and (JECFA) of the Food and Agriculture
addressed to the Document Control Organization (FAO) and the World
Unit (HFV–199), Center for Veterinary Health Organization (WHO) of the
Medicine, Food and Drug Administra- United Nations and/or monographs and
tion, 7500 Standish Pl., Rockville, MD reports from the Joint FAO/WHO Meet-
20855. Requests may be submitted in an ing on Pesticide Residues (JMPR) that
77
§ 510.206 21 CFR Ch. I (4–1–23 Edition)
support the development of the perma- ments made in the original request for
nent Codex MRL. FDA may request ad- which no change is proposed.
ditional information as needed. (g) The requester may withdraw the
(ii) If no permanent Codex MRL has request at any time before the notifica-
been established, or upon notification tion provided for in § 510.207(a) of this
by FDA, the requester must provide chapter has been made publicly avail-
full reports of investigations made able.
with respect to the human food safety
of the new animal drug. A request may § 510.206 Review of information sup-
porting actions to establish or
be regarded as incomplete unless it in- amend an import tolerance.
cludes full reports of adequate tests by
all methods reasonably applicable to In establishing or amending an im-
show whether or not any imported edi- port tolerance, the Commissioner shall
ble portion of any animal receiving the rely on data sufficient to demonstrate
new animal drug will be safe for human that a proposed tolerance is safe based
consumption. The reports must include on similar food safety criteria used by
detailed data derived from appropriate the Commissioner to establish toler-
animal and other biological experi- ances for applications for new animal
ments in which the methods used and drugs filed under section 512(b)(1) of the
the results obtained are clearly set Federal Food, Drug, and Cosmetic Act.
forth, including data submitted to the In establishing or amending an import
appropriate regulatory authority in tolerance, the Commissioner will give
any country where the new animal appropriate consideration to the an-
drug is lawfully used. The request must ticipated residue concentrations and
also include a statement that all such conditions of use of the new animal
reports have been submitted or contain drug specified.
an explanation of why such reports § 510.207 Disclosure of information
were not submitted. With respect to submitted in a request.
each nonclinical laboratory study con-
tained in the request, the requestor (a) When a request is determined to
must submit either a statement that be complete for FDA’s consideration,
the study was conducted in compliance the Commissioner will provide public
with the good laboratory practice regu- notification of the request containing
the name of the requester and a brief
lations set forth in part 58 of this chap-
description of the request in general
ter, or, if the study was not conducted
terms. A copy of the notification will
in compliance with such regulations, a
be sent to the requester at the time the
brief statement of the reason for the
information is made available to the
noncompliance, and how this may have
public.
impacted the study;
(b) Any notification establishing,
(5) Other human food safety informa- amending, or revoking an import toler-
tion as deemed necessary by the Com- ance will be made publicly available. A
missioner; summary of the basis for the decision
(6) A description of practicable meth- will be publicly released in accordance
ods for determining the quantity, if with the provisions of part 20 of this
any, of the new animal drug in or on chapter. If FDA determines that the
food, and any substance formed in or new animal drug referred to in the re-
on food because of its use; quest is a new animal drug that in-
(7) An environmental assessment duces cancer when ingested by people
under § 25.40 of this chapter; and or animals, and the requester complies
(8) Any information required under with the requirements of §§ 500.80
§§ 500.80 through 500.92 of this chapter through 500.92 of this chapter (Subpart
(Subpart E, Regulation of Carcinogenic E, Regulation of Carcinogenic Com-
Compounds Used in Food-Producing pounds Used in Food-Producing Ani-
Animals), where applicable. mals), the regulatory method for
(f) A request to amend an established ascertaining the marker residue in the
import tolerance must contain infor- target tissue will be made publicly
mation to support each proposed available. All information and safety

change. The request may omit state- data submitted with the request, or
78
previously submitted information in- sion and will be effective at the time
corporated in, and considered as part the information is made available to
of, a request on the basis of specific ref- the public.
erence to such information, shall be (c) A petition for revocation must be
available for public disclosure, also in submitted in the form specified in
accordance with the provisions of part § 10.30 of this chapter.
20 of this chapter. Trade secrets and
confidential commercial or financial § 510.212 Administrative reconsider-
information are exempted from release ation of action.
under § 20.61 of this chapter. (a) The Commissioner may at any
time, on his or her own initiative or on
§ 510.209 Establishment, denial, or
amendment of an import tolerance. the petition of an interested person
under part 10 of this chapter, recon-
(a) If an import tolerance is estab- sider part or all of a decision to estab-
lished or amended, the Commissioner lish, not establish, amend, or revoke an
will provide public notification of the import tolerance.
action, which will be effective from the
(b) A petition for reconsideration
date of public notification. A copy of
must be submitted in accordance with
the notification will be sent to any re-
§ 10.20 of this chapter and in the form
questor at the time the information is
specified in § 10.33 of this chapter no
made available to the public.
later than 30 days after the date of pub-
(b) If a request to establish or amend
lic notification of the decision in-
an import tolerance is denied, a notifi-
volved. The Commissioner may, for
cation of the denial will be made pub-
good cause, permit a petition to be
licly available, and a copy of the denial
filed more than 30 days after public no-
letter, including the reasons for such
tification of the decision. The petition
action, will be sent to the requester.
for reconsideration must demonstrate
(c) A tolerance established in an ap-
that relevant information contained in
proved NADA or conditionally ap-
the administrative record was not pre-
proved CNADA will supersede an exist-
viously or not adequately considered
ing import tolerance. In the event the
by the Commissioner. No new informa-
conditionally approved CNADA is not
tion may be included in a petition for
renewed or is withdrawn, or such drug
reconsideration.
does not achieve approval under sec-
tion 512 of the Federal Food, Drug, and (c) An interested person who wishes
Cosmetic Act within 5 years following to rely on information not included in
the date of the conditional approval, the administrative record shall submit
the Agency will reinstate the import either a petition to amend an import
tolerance unless § 510.210(a)(1) or (a)(2) tolerance under § 510.205 or to revoke
is applicable at that time. an import tolerance under § 510.210 and
§ 10.25 of this chapter.
§ 510.210 Revocation of an import tol-
erance. § 510.213 Administrative stay of action.
(a) The Commissioner, on his or her (a) The Commissioner may at any
own initiative or on the petition of an time, on his or her own initiative or on
interested person, under § 10.25 of this the request of an interested person
chapter, may revoke an import toler- under part 10 of this chapter, stay or
ance if: extend the effective date of a decision
(1) Scientific evidence shows an im- to establish, not establish, amend, or
port tolerance to be unsafe; or revoke an import tolerance.
(2) Information demonstrates that (b) A request for stay must be sub-
the use of a new animal drug under ac- mitted in accordance with § 10.20 of this
tual use conditions results in food chapter and in the form specified in
being imported into the United States § 10.35 of this chapter no later than 30
with residues exceeding the import tol- days after public notification of the de-
erance. cision involved. The Commissioner
(b) The Commissioner will provide may, for good cause, permit a petition
public notification under § 510.207(b) to be filed more than 30 days after pub-
that will specify the basis for the deci- lic notification of the decision.
79
§ 510.301 21 CFR Ch. I (4–1–23 Edition)
Subpart D—Records and Reports ring at a rate higher than shown by in-
formation previously submitted as part
§ 510.301 Records and reports con- of the new animal drug application or
cerning experience with animal in support of the index listing or at a
feeds bearing or containing new rate higher than encountered during
animal drugs for which an ap- such clinical trials.
proved medicated feed mill license (2) Information concerning any un-
application is in effect. usual failure of the new animal drug to
Records and reports of clinical and exhibit its expected pharmacological
other experience with the new animal activity.
drug will be maintained and reported,
appropriately identified with the new FR 18280, Apr. 28, 1989; 72 FR 69121, Dec. 6,
animal drug application(s) or index 2007]
listing(s) to which they relate, to the
Center for Veterinary Medicine in du- § 510.305 Maintenance of copies of ap-
plicate in accordance with the fol- proved medicated feed mill licenses
lowing: to manufacture animal feed bearing
(a) Immediately upon receipt by the or containing new animal drugs.
applicant, complete records or reports Each applicant shall maintain in a
covering information of the following single accessible location:
kinds: (a) A copy of the approved medicated
(1) Information concerning any feed mill license (Form FDA 3448) on
mixup in the new animal drug or its la- the premises of the manufacturing es-
beling with another article. tablishment; and
(2) Information concerning any bac- (b) Approved or index listed labeling
teriological or any significant chem- for each Type B and/or Type C feed
ical, physical, or other change or dete- being manufactured on the premises of
rioration in the drug, or any failure of the manufacturing establishment or
one or more distributed batches of the the facility where the feed labels are
drug to meet the specifications estab- generated.
lished for it in the new animal drug ap- [64 FR 63203, Nov. 19, 1999, as amended at 72
plication or request for determination FR 69121, Dec. 6, 2007]
of eligibility for indexing.
(b) As soon as possible, and in any Subpart E—Requirements for
event within 15 working days of its re- Specific New Animal Drugs
ceipt by the applicant, complete
records or reports concerning any in- § 510.410 Corticosteroids for oral,
formation of the following kinds: injectable, and ophthalmic use in
(1) Information concerning any unex- animals; warnings and labeling re-
pected side effect, injury, toxicity, or quirements.
sensitivity reaction or any unexpected (a) The Food and Drug Administra-
incidence or severity thereof associ- tion has received reports of side effects
ated with clinical uses, studies, inves- associated with the oral, injectable,
tigations, or tests, whether or not de- and ophthalmic use of corticosteroid
termined to be attributable to the new animal drugs. The use of these drugs
animal drug, except that this require- administered orally or by injection has
ment shall not apply to the submission resulted in premature parturition when
of information described in a written administered during the last trimester
communication to the applicant from of pregnancy. Premature parturition
the Food and Drug Administration as may be followed by dystocia, fetal
types of information that may be sub- death, retained placenta, and metritis.
mitted at other designated intervals. Additionally, corticosteroids used in
Unexpected as used in this paragraph dogs, rabbits, and rodents during preg-
refers to conditions or developments nancy have produced cleft palate in off-
not previously submitted as part of the spring. Use in dogs has resulted in
new animal drug application or in sup- other congenital anomalies, including
port of the index listing or not encoun- deformed forelegs, phocomelia, and
tered during clinical trials of the drug, anasarca. Drugs subject to this section
or conditions or developments occur- are required to carry the veterinary
80
prescription legend and are subject to not limited to, medicated blocks (ag-
the labeling requirements of § 201.105 of glomerated feed compressed or ren-
this chapter. dered into a solid mass and cohesive
(b) In view of these potentially seri- enough to hold its form), mineral
ous side effects, the Food and Drug Ad- mixes, and liquid feed tank supple-
ministration has concluded that the la- ments (‘‘lick tank’’ supplements) con-
beling on or within packaged taining one or more new animal drugs.
corticosteroid-containing preparations The manufacture of medicated free-
intended for animal use shall bear con- choice feeds is subject to the current
spicuously the following warning state- good manufacturing practice regula-
ment: tions in part 225 of this chapter for
Warning: Clinical and experimental data medicated feeds.
have demonstrated that corticosteroids ad- (b) What is required for new animal
ministered orally or by injection to animals drugs intended for use in free-choice feed?
may induce the first stage of parturition if Any new animal drug intended for use
used during the last trimester of pregnancy in free-choice feed must be approved
and may precipitate premature parturition
for such use under section 512 of the
followed by dystocia, fetal death, retained
placenta, and metritis. Federal Food, Drug, and Cosmetic Act
Additionally, corticosteroids administered (the act) (21 U.S.C. 360(b)) or listed in
to dogs, rabbits, and rodents during preg- the index under section 572 of the act
nancy have resulted in cleft palate in off- (21 U.S.C. 360ccc–1). Such approvals
spring. Corticosteroids administered to dogs under section 512 of the act must be:
during pregnancy have also resulted in other (1) An original new animal drug ap-
congenital anomalies, including deformed
plication (NADA),
forelegs, phocomelia, and anasarca.
(2) A supplemental NADA, or
[49 FR 48535, Dec. 13, 1984]
(3) An abbreviated NADA.
§ 510.440 Injectable iron preparations. (c) What are the approval requirements
under section 512 of the act for new ani-
There has been an increasing interest mal drugs intended for use in free-choice
in the use of injectable iron compounds feed? An approval under section 512 of
for the prevention or treatment of the act for a Type A medicated article
iron-deficiency anemia in animals. Al- intended for use in free-choice feed
though some such preparations have must contain the following informa-
been shown to be safe, such articles are tion:
regarded as new animal drugs within
(1) Data, or reference to data in a
the meaning of the Federal Food, Drug,
master file (MF), showing that the tar-
and Cosmetic Act. Accordingly, an ap-
get animal consumes the new animal
proved new animal drug application is
drug in the Type C free-choice feed in
required prior to the marketing of such
an amount that is safe and effective
preparations within the jurisdiction of
(consumption/effectiveness data); and
the act. In addition to the need for
demonstrating the safety of such arti- (2) Data, or reference to data in an
cles, the labeling of such preparations MF, showing the relevant ranges of
should not only recommend appro- conditions under which the drug will be
priate dosages of iron but also declare chemically and physically stable in the
the amount (in milligrams) of available Type C free-choice feed under field con-
iron (Fe) per milliliter of the subject ditions.
product. (d) How are consumption/effectiveness
and/or stability data to be submitted? The
§ 510.455 Requirements for free-choice data must be submitted as follows:
medicated feeds. (1) Directly in the NADA, by a spon-
(a) What is free-choice medicated feed? sor; and/or
For the purpose of this part, free- (2) To an MF that a sponsor may then
choice medicated feed is medicated reference in its NADA with written
feed that is placed in feeding or grazing consent of the MF holder.
areas and is not intended to be con- (e) What will be stated in the published
sumed fully at a single feeding or to approval for a new animal drug intended
constitute the entire diet of the ani- for use in free-choice feed? The approval
mal. Free-choice feeds include, but are of a new animal drug intended for use
81
§ 510.600 21 CFR Ch. I (4–1–23 Edition)
in free-choice feed, as published in this Subpart G—Sponsors of Approved

subchapter, will include: Applications
(1) The formula and/or specifications
of the free-choice medicated feed, § 510.600 Names, addresses, and drug
where the owner of this information relabeler codes of sponsors of ap-
quests such publication, or proved applications.
(2) A statement that the approval has (a) Section 512(i) of the act requires
been granted for a proprietary formula publication of names and addresses of
and/or specifications. sponsors of approved applications for
(f) When is a medicated feed mill license new animal drugs.
required for the manufacture of a free- (b) In this section each name and ad-
choice medicated feed? An approved dress is identified by a numerical drug
medicated feed mill license is required labeler code. The labeler codes identify
for the manufacture of the following the sponsors of the new animal drug
types of feeds: applications associated with the regu-
(1) All free-choice medicated feeds lations published pursuant to section
that contain a Category II drug, and 512(i) of the act. The codes appear in
(2) Free-choice medicated feeds that the appropriate regulations and serve
contain a Category I drug and use a as a reference to the names and ad-
proprietary formula and/or specifica- dresses listed in this section. The drug
tions. labeler code is established pursuant to
section 510 of the act.
[69 FR 30197, May 27, 2004, as amended at 72 (c) The names, addresses, and drug
FR 69121, Dec. 6, 2007] labeler codes of sponsors of approved
new animal drug applications are as
Subpart F [Reserved] follows:
(1) ALPHABETICAL LISTING OF SPONSORS
Drug labeler
Firm name and address code
A & G Pharmaceuticals, Inc., 1030 West Commodore Blvd., Jackson, NJ 08527 .................................................. 057699
Accord Healthcare, Inc., 1009 Slater Rd., suite 210–B, Durham, NC 27703 .......................................................... 016729
ADM Animal Nutrition, Inc., 1000 North 30th St., Quincy, IL 62305–3115 .............................................................. 012286
Agri Laboratories, Ltd., P.O. Box 3103, St. Joseph, MO 64503 .............................................................................. 057561
Agri-Tech, Inc., 4722 Broadway, Kansas City, MO 64112 ....................................................................................... 017762
Aiping Pharmaceutical, Inc., 350W Wireless Blvd., Hauppauge, NY 11788 ............................................................ 011788
Akorn Operating Co. LLC, 5605 Centerpoint Ct., Suite A, Gurnee, IL 60031 ......................................................... 059399
Alexion Pharmaceuticals, Inc., 121 Seaport Blvd., Boston, MA 02210 .................................................................... 069334
American Regent, Inc., Animal Health Division, Shirley, NY 11967 ........................................................................ 010797
Anika Therapeutics Inc., 236 West Cummings Park, Woburn, MA 01801 .............................................................. 060865
Anivive Lifesciences, Inc., 3777 Worsham Ave., Long Beach, CA 90808 ............................................................... 086121
Anzac Animal Health, LLC, 218 Millwell Dr., Suite B, Maryland Heights, MO 63043 ............................................. 086073
AquaBounty Technologies, Inc., 2 Mill and Main Pl., Suite 395, Maynard, MA 01754 ........................................... 086053
Aurora Pharmaceutical, Inc., 1196 Highway 3 South, Northfield, MN 55057–3009 ................................................ 051072
Axcentive SARL, Chemin de Champouse, Quartier Violesi, 13320 Bouc Bel Air, France ...................................... 086009
B.L. Mitchell, Inc., 103 Hwy. 82 E., Leland, MS 38756 ............................................................................................ 067188
Bausch Health US, LLC, 400 Somerset Corporate Blvd., Bridgewater, NJ 08807 .................................................. 099207
Belcher Pharmaceuticals, LLC, 6911 Bryan Dairy Rd., Largo, FL 33777 ................................................................ 062250
Bimeda Animal Health Ltd., 1B The Herbert Building, The Park, Carrickmines, Dublin 18, Ireland ....................... 061133
Boehringer Ingelheim Animal Health USA, Inc., 3239 Satellite Blvd., Duluth, GA 30096 ....................................... 000010
Cephazone Pharma, LLC, 250 East Bonita Ave., Pomona, CA 91767 ................................................................... 068330
Ceva Sante Animale, 10 Avenue de la Ballastière, 33500 Libourne, France .......................................................... 013744
Chanelle Pharmaceuticals Manufacturing Ltd., Loughrea, County Galway, Ireland ................................................ 061651
Cronus Pharma Specialities India Private Ltd., Sy No–99/1, M/s GMR Hyderabad Aviation SEZ Ltd.,
Mamidipalli Village, Shamshabad Mandal, Ranga Reddy, Hyderabad, Telangana, 501218, India ..................... 069043
Dechra, Ltd., Snaygill Industrial Estate, Keighley Rd., Skipton, North Yorkshire, BD23 2RW, United Kingdom .... 043264
Dechra Veterinary Products LLC, 7015 College Blvd., Suite 525, Overland Park, KS 66211 ................................ 017033
ECO LLC, 344 Nassau St., Princeton, NJ 08540 ..................................................................................................... 066916
Elanco US Inc., 2500 Innovation Way, Greenfield, IN 46140 .................................................................................. 058198
Farnam Companies, Inc., 301 West Osborn, Phoenix, AZ 85013–3928 ................................................................. 017135
Felix Pharmaceuticals Pvt. Ltd., 25–28 North Wall Quay, Dublin 1, Ireland ............................................................ 086101
First Priority, Inc., 1590 Todd Farm Dr., Elgin, IL 60123 ......................................................................................... 058829
Fougera Pharmaceuticals, Inc., P.O. Box 2006, 60 Baylis Rd., Melville, NY 11747 ............................................... 025463
GTC Biotherapeutics, Inc., 175 Crossing Blvd., Framingham, MA 01702 ............................................................... 042976
Happy Jack, Inc., Snow Hill, NC 28580 .................................................................................................................... 023851

Hemoglobin Oxygen Therapeutics, LLC, 674 Souder Rd., Souderton, PA 18964 .................................................. 063075
Heska Corp., 1825 Sharp Point Dr., Fort Collins, CO 80525 ................................................................................... 063604
82
(1) ALPHABETICAL LISTING OF SPONSORS—Continued

Drug labeler
Firm name and address code
HQ Specialty Pharma Corp., 120 Rte. 17 North, suite 130, Paramus, NJ 07652 ................................................... 042791
Huvepharma EOOD, 5th Floor, 3A Nikolay Haytov Str., 1113 Sofia, Bulgaria ........................................................ 016592
IMPAX Laboratories, Inc., 30831 Huntwood Ave., Hayward, CA 94544 ................................................................. 000115
Intervet, Inc., 2 Giralda Farms, Madison, NJ 07940 ................................................................................................. 000061
Ishihara Sangyo Kaisha, Ltd., 3–15, Edobori 1-chome, Nishi-ku, Osaka 550–0002, Japan ................................... 064642
Ivaoes Animal Health, 4300 SW 73rd Ave., Suite 110, Miami, FL 33155 ............................................................... 086064
Jaguar Animal Health, 200 Pine St., Suite 600, San Francisco, CA 94104 ............................................................ 086149
Jurox Pty. Ltd., 85 Gardiner St., Rutherford, NSW 2320, Australia ......................................................................... 049480
Kinetic Technologies, LLC, 961 Beasley St., suite 270, Lexington, KY 40509 ........................................................ 051031
Lloyd, Inc., 604 W. Thomas Ave., Shenandoah, IA 51601 ...................................................................................... 061690
Med-Pharmex, Inc., 2727 Thompson Creek Rd., Pomona, CA 91767–1861 .......................................................... 054925
Mizner Bioscience LLC, 225 NE Mizner Blvd., Suite 760, Boca Raton, FL 33432 ................................................. 086039
Modern Veterinary Therapeutics, LLC, 14343 SW 119th Ave., Miami, FL 33186 ................................................... 015914
Mylan Institutional, Inc., 12720 Dairy Ashford Rd., Sugar Land, TX 77478 ............................................................ 051079
Mylan Institutional LLC, a Viatris Company, 3711 Collins Ferry Rd., Morgantown, WV 26505 .............................. 063286
Natchez Animal Supply Co., 201 John R. Junkin Dr., Natchez, MS 39120 ............................................................ 049968
Neogen Corp., 944 Nandino Blvd., Lexington, KY 40511 ........................................................................................ 059051
Norbrook Laboratories Ltd., Carnbane Industrial Estate, Newry, County Down, BT35 6QQ, United Kingdom ...... 055529
Oasmia Pharmaceutical AB, Vallongatan 1, 75228 Uppsala, Sweden .................................................................... 052818
Orion Corp., Orionintie 1, 02200 Espoo, Finland ..................................................................................................... 052483
Parnell Technologies Pty. Ltd., unit 4, 476 Gardeners Rd., Alexandria, New South Wales 2015, Australia .......... 068504
Pegasus Laboratories, Inc., 8809 Ely Rd., Pensacola, FL 32514 ............................................................................ 055246
Pharmaceutical Ventures, Ltd., P.O. Box D1400, Pomona, NY 10970 ................................................................... 050057
Pharmacosmos, Inc., 776 Mountain Blvd., Watchung, NJ 07069 ............................................................................ 042552
Pharmaq AS, Skogmo Industriomrade, N–7863 Overhalla, Norway ........................................................................ 015331
Pharmgate Inc., 1800 Sir Tyler Dr., Wilmington, NC 28405 .................................................................................... 069254
Phibro Animal Health Corp., GlenPointe Centre East, 3d floor, 300 Frank W. Burr Blvd., suite 21, Teaneck, NJ
07666 ..................................................................................................................................................................... 066104
Piramal Critical Care, Inc., 3850 Schelden Circle, Bethlehem, PA 18017 ............................................................... 066794
Piramal Pharma Ltd., Ground Floor, Piramal Ananta, Agastya Corporate Park, Mumbai, Maharashtra, 400070,
India ....................................................................................................................................................................... 065085
Planalquimica Industrial Ltda., Rua das Magnolias nr. 2405, Jardim das Bandeiras, CEP 13053–120,
Campinas, Sao Paulo, Brazil ................................................................................................................................. 060728
Purina Animal Nutrition LLC, 4001 Lexington Ave., North Arden Hills, MN 55126–2910 ....................................... 017800
QBiotics Group Ltd., Suite 3A, Level 1, 165 Moggill Rd., Taringa, Queensland 4068, Australia ............................ 086132
Quo Vademus, LLC, 277 Faison McGowan Rd., Kenansville, NC 28349 ............................................................... 076475
Revivicor, Inc., a wholly owned subsidiary of United Therapeutics Corp., 1700 Kraft Dr., Suite 2400,
Blacksburg, VA 24060 ........................................................................................................................................... 086134
Ridley USA, Inc., 111 W Cherry St., Suite 500, Mankato, MN 56001 ..................................................................... 067949
Sergeant’s Pet Care Products, Inc., 10077 S. 134th St., Omaha, NE 68138 ......................................................... 021091
Sparhawk Laboratories, Inc., 12340 Santa Fe Trail Dr., Lenexa, KS 66215 ........................................................... 058005
Squire Laboratories, Inc., 100 Mill St., Revere, MA 02151 ...................................................................................... 017153
Summit Hill Laboratories, P.O. Box 535, Navesink, NJ 07752 ................................................................................ 037990
Superior Equine Pharmaceuticals, Inc., Pleasant Grove, UT 84062 ....................................................................... 027053
Syndel USA, 1441 W. Smith Rd., Ferndale, WA 98248 .......................................................................................... 050378
Taro Pharmaceuticals U.S.A., Inc., 3 Skyline Dr., Hawthorne, NY 10532 ............................................................... 051672
Therio, Inc., 8801 Anderson Ave., Manhattan, KS 66503 ........................................................................................ 052923
Union Agener, Inc., 1788 Lovers Ln., Augusta, GA 30901 ...................................................................................... 086106
United-AH II LLC, 322 S Main St., Sheridan, IN 46069 ........................................................................................... 051233
VetDC, Inc., 320 E. Vine Dr., suite 218, Fort Collins, CO 80524 ............................................................................ 086072
Vétoquinol N.–A., Inc., 2000 chemin Georges, Lavaltrie (PQ), Canada, J5T 3S5 .................................................. 059320
Vetoquinol USA, Inc., 4250 N Sylvania Ave., Fort Worth, TX 76137 ...................................................................... 017030
Virbac AH, Inc., PO Box 162059, Fort Worth, TX 76161 ......................................................................................... 051311
Wildcat Feeds, 215 NE Strait Ave., Topeka, KS 66616 ........................................................................................... 086113
Wildlife Laboratories, Inc., 1230 W. Ash St., suite D, Windsor, CO 80550 ............................................................. 053923
Zoetis Inc., 333 Portage St., Kalamazoo, MI 49007 ................................................................................................. 054771
ZyVet Animal Health, Inc., 73 Route 31N, Pennington, NJ 08534 .......................................................................... 086117
(2) NUMERICAL LISTING OF SPONSORS

Drug labeler Firm name and address
code
000010 Boehringer Ingelheim Animal Health USA, Inc., 3239 Satellite Blvd., Duluth, GA 30096.
000061 Intervet, Inc., 2 Giralda Farms, Madison, NJ 07940.
000115 IMPAX Laboratories, Inc., 30831 Huntwood Ave., Hayward, CA 94544.
010797 American Regent, Inc., Animal Health Division, Shirley, NY 11967.
011788 Aiping Pharmaceutical, Inc., 350W Wireless Blvd., Hauppauge, NY 11788.
012286 ADM Animal Nutrition, Inc., 1000 North 30th St., Quincy, IL 62305–3115.
012578 Janssen Pharmaceutica NV, Turnhoutseweg 30, B–2340 Beerse, Belgium.
013744 Ceva Sante Animale, 10 Avenue de la Ballastière, 33500 Libourne, France.
83
§ 510.600 21 CFR Ch. I (4–1–23 Edition)
(2) NUMERICAL LISTING OF SPONSORS—Continued

code
015331 Pharmaq AS, Skogmo Industriomrade, N–7863 Overhalla, Norway.

015914 Modern Veterinary Therapeutics, LLC, 14343 SW 119th Ave., Miami, FL 33186.
016592 Huvepharma EOOD, 5th Floor, 3A Nikolay Haytov Str., 1113 Sofia, Bulgaria.
016729 Accord Healthcare, Inc., 1009 Slater Rd., suite 210–B, Durham, NC 27703.
017030 Vetoquinol USA, Inc., 4250 N. Sylvania Ave., Fort Worth, TX 76137.
017033 Dechra Veterinary Products LLC, 7015 College Blvd., Suite 525, Overland Park, KS 66211.
017135 Farnam Companies, Inc., 301 West Osborn, Phoenix, AZ 85013–3928.
017153 Squire Laboratories, Inc., 100 Mill St., Revere, MA 02151.
017762 Agri-Tech, Inc., 4722 Broadway, Kansas City, MO 64112.
017800 Purina Animal Nutrition LLC, 4001 Lexington Ave., North Arden Hills, MN 55126–2910.
021091 Sergeant’s Pet Care Products, Inc., 10077 S. 134th St., Omaha, NE 68138.
023851 Happy Jack, Inc., Snow Hill, NC 28580.
025463 Fougera Pharmaceuticals, Inc., P.O. Box 2006, 60 Baylis Rd., Melville, NY 11747.
027053 Superior Equine Pharmaceuticals, Inc., Pleasant Grove, UT 84062.
037990 Summit Hill Laboratories, P.O. Box 535, Navesink, NJ 07752.
042552 Pharmacosmos, Inc., 776 Mountain Blvd., Watchung, NJ 07069.
042791 HQ Specialty Pharma Corp., 120 Rte. 17 North, suite 130, Paramus, NJ 07652.
042976 GTC Biotherapeutics, Inc., 175 Crossing Blvd., Framingham, MA 01702.
043264 Dechra, Ltd., Snaygill Industrial Estate, Keighley Rd., Skipton, North Yorkshire, BD23 2RW, United Kingdom.
049480 Jurox Pty. Ltd., 85 Gardiner St., Rutherford, NSW 2320, Australia.
049968 Natchez Animal Supply Co., 201 John R. Junkin Dr., Natchez, MS 39120.
050057 Pharmaceutical Ventures, Ltd., P.O. Box D1400, Pomona, NY 10970.
050378 Syndel USA, 1441 W. Smith Rd., Ferndale, WA 98248.
051031 Kinetic Technologies, LLC, 961 Beasley St., suite 270, Lexington, KY 40509.
051072 Aurora Pharmaceutical, Inc., 1196 Highway 3 South, Northfield, MN 55057–3009.
051079 Mylan Institutional, Inc., 12720 Dairy Ashford Rd., Sugar Land, TX 77478.
051233 United-AH II LLC, 322 S Main St., Sheridan, IN 46069.
051311 Virbac AH, Inc., PO Box 162059, Fort Worth, TX 76161.
051672 Taro Pharmaceuticals U.S.A., Inc., 3 Skyline Dr., Hawthorne, NY 10532.
052483 Orion Corp., Orionintie 1, 02200 Espoo, Finland.
052818 Oasmia Pharmaceutical AB, Vallongatan 1, 75228 Uppsala, Sweden.
052923 Therio, Inc., 8801 Anderson Ave., Manhattan, KS 66503.
053923 Wildlife Laboratories, Inc., 1230 W. Ash St., suite D, Windsor, CO 80550.
054771 Zoetis Inc., 333 Portage St., Kalamazoo, MI 49007.
054925 Med-Pharmex, Inc., 2727 Thompson Creek Rd., Pomona, CA 91767–1861.
055246 Pegasus Laboratories, Inc., 8809 Ely Rd., Pensacola, FL 32514.
055529 Norbrook Laboratories Ltd., Carnbane Industrial Estate, Newry, County Down, BT35 6QQ, United Kingdom.
057561 Agri Laboratories, Ltd., P.O. Box 3103, St. Joseph, MO 64503.
057699 A & G Pharmaceuticals, Inc., 1030 West Commodore Blvd., Jackson, NJ 08527.
058005 Sparhawk Laboratories, Inc., 12340 Santa Fe Trail Dr., Lenexa, KS 66215.
058198 Elanco US Inc., 2500 Innovation Way, Greenfield, IN 46140.
058829 First Priority, Inc., 1590 Todd Farm Dr., Elgin, IL 60123.
059051 Neogen Corp., 944 Nandino Blvd., Lexington, KY 40511.
059320 Vétoquinol N.–A., Inc., 2000 chemin Georges, Lavaltrie (PQ), Canada, J5T 3S5.
059399 Akorn Operating Co. LLC, 5605 Centerpoint Ct., Suite A, Gurnee, IL 60031.
060728 Planalquimica Industrial Ltda., Rua das Magnolias nr. Jardim das Bandeiras, CEP 13053–120, Campinas, Sao
Alto, Brazil.
060865 Anika Therapeutics Inc., 236 West Cummings Park, Woburn, MA 01801.
061133 Bimeda Animal Health Ltd., 1B The Herbert Building, The Park, Carrickmines, Dublin 18, Ireland.
061651 Chanelle Pharmaceuticals Manufacturing Ltd., Loughrea, County Galway, Ireland.
061690 Lloyd, Inc., 604 W. Thomas Ave., Shenandoah, IA 51601.
062250 Belcher Pharmaceuticals, LLC, 6911 Bryan Dairy Rd., Largo, FL 33777.
062794 Mylan Bertek Pharmaceuticals, Inc., 12720 Dairy Ashford, Sugar Land, TX 77478.
063075 Hemoglobin Oxygen Therapeutics, LLC, 674 Souder Rd., Souderton, PA 18964.
063286 Mylan Institutional LLC, a Viatris Company, 3711 Collins Ferry Rd., Morgantown, WV 26505.
063604 Heska Corp., 1825 Sharp Point Dr., Fort Collins, CO 80525.
064642 Ishihara Sangyo Kaisha, Ltd., 3–15, Edobori 1-chome, Nishi-ku, Osaka 550–0002, Japan.
065085 Piramal Pharma Ltd., Ground Floor, Piramal Ananta, Agastya Corporate Park, Mumbai, Maharashtra, 400070,
India.
066104 Phibro Animal Health Corp., GlenPointe Centre East, 3d floor, 300 Frank W. Burr Blvd., suite 21, Teaneck, NJ
07666.
066794 Piramal Critical Care, Inc., 3850 Schelden Circle, Bethlehem, PA 18017.
066916 ECO LLC, 344 Nassau St., Princeton, NJ 08540.
067188 B.L. Mitchell, Inc., 103 Hwy. 82 E., Leland, MS 38756.
067949 Ridley USA, Inc., 111 W Cherry St., Suite 500, Mankato, MN 56001.
068330 Cephazone Pharma, LLC, 250 East Bonita Ave., Pomona, CA 91767.
068504 Parnell Technologies Pty. Ltd., unit 4, 476 Gardeners Rd., Alexandria, New South Wales 2015, Australia.
069043 Cronus Pharma Specialities India Private Ltd., Sy No–99/1, M/s GMR Hyderabad Aviation SEZ Ltd.,
Mamidipalli Village, Shamshabad Mandal, Ranga Reddy, Hyderabad, Telangana, 501218, India.
069254 Pharmgate Inc., 1800 Sir Tyler Dr., Wilmington, NC 28405.
069334 Alexion Pharmaceuticals, Inc., 121 Seaport Blvd., Boston, MA 02210.
84
(2) NUMERICAL LISTING OF SPONSORS—Continued

code
076475 Quo Vademus, LLC, 277 Faison McGowan Rd., Kenansville, NC 28349.
086009 Axcentive SARL, Chemin de Champouse, Quartier Violesi, 13320 Bouc Bel Air, France.
086039 Mizner Bioscience LLC, 225 NE Mizner Blvd., Suite 760, Boca Raton, FL 33432.
086053 AquaBounty Technologies, Inc., 2 Mill and Main Pl., Suite 395, Maynard, MA 01754.
086064 Ivaoes Animal Health, 4300 SW 73rd Ave., suite 110, Miami, FL 33155.
086072 VetDC, Inc., 320 E Vine Dr., suite 218, Fort Collins, CO 80524.
086073 Anzac Animal Health, LLC, 218 Millwell Dr., Suite B, Maryland Heights, MO 63043.
086101 Felix Pharmaceuticals Pvt. Ltd., 25–28 North Wall Quay, Dublin 1, Ireland.
086106 Union Agener, Inc., 1788 Lovers Ln., Augusta, GA 30901.
086113 Wildcat Feeds, 215 NE Strait Ave., Topeka, KS 66616.
086117 ZyVet Animal Health, Inc., 73 Route 31N, Pennington, NJ 08534.
086121 Anivive Lifesciences, Inc., 3777 Worsham Ave., Long Beach, CA 90808.
086132 QBiotics Group Ltd., Suite 3A, Level 1, 165 Moggill Rd., Taringa, Queensland 4068, Australia.
086134 Revivicor, Inc., a wholly owned subsidiary of United Therapeutics Corp., 1700 Kraft Dr., Suite 2400,
Blacksburg, VA 24060.
086149 Jaguar Animal Health, 200 Pine St., Suite 600, San Francisco, CA 94104.
099207 Bausch Health US, LLC, 400 Somerset Corporate Blvd., Bridgewater, NJ 08807.
[40 FR 13807, Mar. 27, 1975]

EDITORIAL NOTE: For FEDERAL REGISTER citations affecting § 510.600, see the List of CFR
Sections Affected, which appears in the Finding Aids section of the printed volume and at
www.govinfo.gov.
PART 511—NEW ANIMAL DRUGS gence to assure that the consignee is

FOR INVESTIGATIONAL USE regularly engaged in conducting such
tests and that the shipment of the new
Sec. animal drug will actually be used for
511.1 New animal drugs for investigational tests in vitro or in animals used only
use exempt from section 512(a) of the for laboratory research.
Federal Food, Drug, and Cosmetic Act. (3) The person who introduced such
511.3 Definitions. shipment or who delivered the new ani-
AUTHORITY: 21 U.S.C. 321, 351, 352, 353, 360b, mal drug for introduction into inter-
371. state commerce shall maintain ade-
quate records showing the name and
§ 511.1 New animal drugs for inves- post office address of the expert or ex-
tigational use exempt from section pert organization to whom the new ani-
512(a) of the Federal Food, Drug,
and Cosmetic Act. mal drug is shipped and the date, quan-
tity, and batch or code mark of each
(a) New animal drugs for tests in vitro shipment and delivery for a period of 2
and in laboratory research animals. (1) A years after such shipment and delivery.
shipment or other delivery of a new Upon the request of a properly author-
animal drug or animal feed bearing or ized employee of the Department at
containing a new animal drug intended reasonable times, he shall make such
solely for tests in vitro or in animals records available for inspection and
used only for laboratory research pur- copying.
poses shall be exempt from section 512 (4) The exemption allowed in this
(a) and (m) of the act if it is labeled as paragraph shall not apply to any new
follows:
animal drug intended for in vitro use in
Caution. Contains a new animal drug for the regular course of diagnosing or
investigational use only in laboratory re- treating disease, including anti-
search animals or for tests in vitro. Not for bacterial sensitivity discs impregnated
use in humans. with any new animal drug or drugs,
(2) The person distributing or causing which discs are intended for use in de-
the distribution of new animal drugs termining susceptibility of microorga-
for tests in vitro or in animals used nisms to the new animal drug or drugs.
only for laboratory research purposes (b) New animal drugs for clinical inves-
under this exemption shall use due dili- tigation in animals. A shipment or other
85
§ 511.1 21 CFR Ch. I (4–1–23 Edition)
delivery of a new animal drug or an signed statement containing the fol-

animal feed containing a new animal lowing information:
drug intended for clinical investiga- (i) The identity of the new animal
tional use in animals shall be exempt drug.
from section 512(a) and (m) of the act if (ii) All labeling and other pertinent
all the following conditions are met: information to be supplied to the inves-
(1) The label shall bear the state- tigators. When such pertinent informa-
ments: tion includes nonclinical laboratory
studies, the information shall include,
Caution. Contains a new animal drug for with respect to each nonclinical study,
use only in investigational animals in clin-
either a statement that the study was
ical trials. Not for use in humans. Edible
products of investigational animals are not
conducted in compliance with the re-
to be used for food unless authorization has quirements set forth in part 58 of this
been granted by the U.S. Food and Drug Ad- chapter, or, if the study was not con-
ministration or by the U.S. Department of ducted in compliance with such regula-
Agriculture. tions, a brief statement of the reason
for the noncompliance.
In the case of containers too small or
(iii) The name and address of each
otherwise unable to accommodate a
clinical investigator.
label with sufficient space to bear the
(iv) The approximate number of ani-
caution statements required by para- mals to be treated (or if not available,
graph (a) or (b) of this section, the the amount of new animal drug to be
statements may be included on the car- shipped).
ton label and other labeling on or with- (v) If the new animal drug is given to
in the package from which the new ani- food-producing animals, the statement
mal drug is to be dispensed. shall contain the following additional
(2) The person or firm distributing or information:
causing the distribution of the new ani- (a) A commitment that the edible
mal drug or animal feed containing a products from such animals shall not
new animal drug shall use due dili- be used for food without prior author-
gence to assure that the new animal ization in accordance with the provi-
drug or animal feed containing a new sions prescribed in this section.
animal drug will actually be used for (b) Approximate dates of the begin-
tests in animals and is not used in hu- ning and end of the experiment or se-
mans. ries of experiments.
(3) The person who introduced such (c) The maximum daily dose(s) to be
shipment or who delivered the new ani- administered to a given species, the
mal drug or animal feed containing a size of animal, maximum duration of
new animal drug for introduction into administration, method(s) of adminis-
interstate commerce shall maintain tration, and proposed withdrawal time,
adequate records showing the name if any.
and post office address of the investi- (vi) If a sponsor has transferred any
gator to whom the new animal drug or obligations for the conduct of any clin-
animal feed containing a new animal ical study to a contract research orga-
drug is shipped and the date, quantity, nization, a statement containing the
and batch or code mark of each ship- name and address of the contract re-
ment and delivery for a period of 2 search organization, identification of
years after such shipment and delivery. the clinical study, and a listing of the
Upon the request of a properly author- obligations transferred. If all obliga-
ized employee of the Department at tions governing the conduct of the
reasonable times, such records shall be study have been transferred, a general
made available for inspection and statement of this transfer—in lieu of a
copying. listing of the specific obligations trans-
(4) Prior to shipment of the new ani- ferred—may be submitted.
mal drug for clinical tests in animals, (5) Authorization for use of edible
the sponsor of the investigation shall products derived from a treated food-
submit in triplicate to FDA a ‘‘Notice producing animal may be granted
of Claimed Investigational Exemption under the provisions of this section and

for a New Animal Drug’’ including a when the following specified conditions
86
are met, except that in the case of an and/or effectiveness of the new animal
animal administered any unlicensed drug.
experimental veterinary biological (ii) Shall maintain complete records
product regulated under the viruses, of the investigations, including com-
serums, toxins statute (21 U.S.C., chap- plete records of the receipt and disposi-
ter V, sec. 151 et seq. ) the product shall tion of each shipment or delivery of the
be exempt from the requirements of new animal drug under investigation.
this section when U.S. Department of Copies of all records of the investiga-
Agriculture approval has been obtained tion shall be retained by the investi-
as provided in 9 CFR 103.2. Conditional gator for 2 years after the termination
authorization may be granted in ad- of the investigation or approval of a
vance of identification of the name(s) new animal drug application.
and address(es) of the clinical investi- (iii) Shall furnish adequate and time-
gator(s) as required by paragraph ly reports of the investigation to the
(b)(4)(iii) of this section. Information sponsor.
required for authorization shall in- (8) The sponsor:
clude, in addition to all other require- (i) Shall retain all reports received
ments of this section, the following: from investigators for 2 years after the
(i) Data to show that consumption of termination of the investigation or ap-
food derived from animals treated at proval of a new animal drug applica-
the maximum levels with the min- tion and make such reports available
imum withdrawal periods, if any, speci- to a duly authorized employee of the
fied in accordance with paragraph Department for inspection at all rea-
(b)(4)(v)(c) of this section, will not be sonable times.
inconsistent with the public health; or (ii) Shall provide for current moni-
(ii) Data to show that food derived toring of the investigation by a person
from animals treated at the maximum qualified by scientific training and ex-
levels and with the minimum with- perience to evaluate information ob-
drawal periods, if any, specified in ac- tained from the investigation, and
cordance with paragraph (b)(4)(v)(c) of shall promptly investigate and report
this section, does not contain drug res- to FDA and to all investigators any
idues or metabolites. findings associated with use of the new
(iii) The name and location of the animal drug that may suggest signifi-
packing plant where the animals will cant hazards pertinent to the safety of
be processed, except that this require- the new animal drug.
ment may be waived, on request, by (iii) Shall not unduly prolong dis-
the terms of the authorization. tribution of the new animal drug for
Authorizations granted under this investigational use.
paragraph do not exempt investiga- (iv) Shall not, nor shall any person
tional animals and their products from acting for or on behalf of the sponsor,
compliance with other applicable in- represent that the new animal drug is
spection requirements. Any person who safe or effective for the purposes for
contests a refusal to grant such au- which it is under investigation. This
thorization shall have an opportunity requirement is not intended to restrict
for a regulatory hearing before FDA the full exchange of scientific informa-
pursuant to part 16 of this chapter. tion.
(6) On written request of FDA, the (v) Shall not commercially distribute
sponsor shall submit any additional in- nor test-market the new animal drug
formation reported to or otherwise re- until a new animal drug application is
ceived by him with respect to the in- approved pursuant to section 512(c) of
vestigation deemed necessary to facili- the act.
tate a determination whether there are (9) If the shipment or other delivery
grounds in the interest of public health of the new animal drug is imported or
for terminating the exemption. offered for importation into the United
(7) The sponsor shall assure himself States for clinical investigational use
that the new animal drug is shipped in animals, it shall also meet the fol-
only to investigators who: lowing conditions:
(i) Are qualified by scientific training (i) The importer of all such ship-
and/experience to evaluate the safety ments or deliveries is an agent of the
87
§ 511.1 21 CFR Ch. I (4–1–23 Edition)
foreign exporter residing in the United (2) After evaluating all available in-
States or the ultimate consignee, formation, including any explanation
which person has, prior to such ship- presented by the investigator, if the
ments and deliveries, informed FDA of Commissioner determines that the in-
his intention to import the new animal vestigator has repeatedly or delib-
drug as sponsor in compliance with the erately failed to comply with the con-
conditions prescribed in this subdivi- ditions of the exempting regulations in
sion; or this subchapter, or has repeatedly or
(ii) The new animal drug is shipped deliberately submitted to FDA or to
directly to a scientific institution with the sponsor false information in any
adequate facilities and qualified per- required report, the Commissioner will
sonnel to conduct laboratory or clin- notify the investigator and the sponsor
ical investigations and is intended of any investigation in which the in-
solely for use in such institutions and vestigator has been named as a partici-
which institution has submitted a pant that the investigator is not eligi-
statement as sponsor of the investiga- ble to receive test articles under this
tion. part. The notification to the investi-
(10) The sponsor shall submit either a gator and sponsor will provide a state-
claim for categorical exclusion under ment of the basis for such determina-
§ 25.30 or § 25.33 of this chapter or an en- tion. The notification also will explain
vironmental assessment under § 25.40 of that an investigator determined to be
this chapter. ineligible to receive test articles under
(c) Disqualification of a clinical investi- this part will be ineligible to conduct:
gator. (1) If FDA has information indi- (i) Any clinical investigation that
cating that an investigator (including supports an application for a research
a sponsor-investigator) has repeatedly or marketing permit for products regu-
or deliberately failed to comply with lated by FDA, including drugs, bio-
the conditions of these exempting regu- logics, devices, new animal drugs,
lations or has repeatedly or delib- foods, including dietary supplements,
erately submitted to FDA or to the that bear a nutrient content claim or a
sponsor false information in any re- health claim, infant formulas, food and
quired report, the Center for Veteri- color additives, and tobacco products;
nary Medicine will furnish the investi- and
gator written notice of the matter (ii) Any nonclinical laboratory study
complained of and offer the investi- intended to support an application for
gator an opportunity to explain the a research or marketing permit for a
matter in writing, or, at the option of new animal drug.
the investigator, in an informal con- (3) Each application or submission to
ference. If an explanation is offered and FDA under the provisions of this chap-
accepted by the Center for Veterinary ter containing data reported by an in-
Medicine, the Center will discontinue vestigator who has been determined to
the disqualification proceeding. If an be ineligible to receive FDA-regulated
explanation is offered but not accepted test articles is subject to examination
by the Center for Veterinary Medicine, to determine whether the investigator
the investigator will be given an oppor- has submitted unreliable data that are
tunity for a regulatory hearing under essential to the continuation of an in-
part 16 of this chapter on the question vestigation or essential to the approval
of whether the investigator is eligible of a marketing application, or essen-
to receive test articles under this part tial to the continued marketing of an
and eligible to conduct: FDA-regulated product.
(i) Any clinical investigation that (4) If the Commissioner determines,
supports an application for a research after the unreliable data submitted by
or marketing permit for products regu- the investigator are eliminated from
lated by FDA; and consideration, that the data remaining
(ii) Any nonclinical laboratory study are inadequate to support a conclusion
intended to support an application for that it is reasonably safe to continue
a research or marketing permit for a the investigation, the Commissioner

new animal drug. will notify the sponsor, who shall have
88
an opportunity for a regulatory hear- conditions of the exemption are not

ing under part 16 of this chapter. If a immediately met, the sponsor shall
danger to the public health exists, how- have an opportunity for a regulatory
ever, the Commissioner shall termi- hearing before FDA pursuant of part 16
nate the exemption immediately and of this chapter on whether the exemp-
notify the sponsor of the termination. tion should be terminated. If the ex-
In such case, the sponsor shall have an emption is terminated the sponsor
opportunity for a regulatory hearing shall recall or have destroyed the un-
before FDA under part 16 on the ques- used supplies of the new animal drug.
tion of whether the exemption should (e) Statements and requests. ‘‘Notice(s)
be reinstated. The determination that of Claimed Investigational Exemption
an investigation may not be considered for a New Animal Drug’’ and requests
in support of a research or marketing for authorization to use investigational
application or a notification or peti- animals and their products for food
tion submission does not, however, re- should be addressed to the Department
lieve the sponsor of any obligation of Health and Human Services, Food
under any other applicable regulation and Drug Administration, Center for
to submit to FDA the results of the in- Veterinary Medicine, 7500 Standish Pl.,
vestigation. Rockville, MD 20855.
(5) If the Commissioner determines, (f) Contract research organizations. (1)
after the unreliable data submitted by For purposes of this part and part 514,
the investigator are eliminated from contract research organization means a
consideration, that the continued ap- person that assumes, as an independent
proval of the product for which the contractor with the sponsor, one or
data were submitted cannot be justi- more of the obligations of a sponsor,
fied, the Commissioner will proceed to e.g., design of a protocol, selection or
withdraw approval of the product in ac- monitoring of investigations, evalua-
cordance with the applicable provisions tion of reports, and preparation of ma-
of the relevant statutes. terials to be submitted to FDA.
(6) An investigator who has been de- (2) A sponsor may transfer responsi-
termined to be ineligible under para- bility for any or all of the obligations
graph (c)(2) of this section may be rein- set forth in this part to a contract re-
stated as eligible when the Commis- search organization. Any such transfer
sioner determines that the investigator shall be in writing and, if not all obli-
has presented adequate assurances that gations are transferred, shall describe
the investigator will employ all test each of the obligations being assumed
articles, and will conduct any clinical by the contract research organization.
investigation that supports an applica- If all obligations are transferred, a gen-
tion for a research or marketing per- eral statement that all obligations
mit for products regulated by FDA and have been transferred is acceptable.
any nonclinical laboratory study in- Any obligation not covered by the
tended to support an application for a written description shall be deemed not
research or marketing permit for a new to have been transferred.
animal drug, solely in compliance with (3) A contract research organization
the applicable provisions of this chap- that assumes any obligation of a spon-
ter. sor shall comply with the specific regu-
(d) Termination of exemption. If the lations in this chapter applicable to
Commissioner finds that: this obligation and shall be subject to
(1) The sponsor of the investigation the same regulatory action as a spon-
has failed to comply with any of the sor for failure to comply with any obli-
conditions for the exemption estab- gation assumed under these regula-
lished under this section, or tions. Thus, all references to sponsor in
(2) The continuance of the investiga- this part apply to a contract research
tion is unsafe or otherwise contrary to organization to the extent that it as-
the public interest or the drug is being sumes one or more obligations of the
or has been used for purposes other sponsor.
than bona fide scientific investigation, (g) Index of legally marketed unap-
he shall first notify the sponsor and in- proved new animal drugs for minor spe-
vite his immediate correction. If the cies. All provisions of part 511 apply to
89
§ 511.3 21 CFR Ch. I (4–1–23 Edition)
new animal drugs for investigational plicable to an investigator and a spon-

use in support of indexing, as described sor.
in section 572 of the act, subject to the [77 FR 25359, Apr. 30, 2012]
provisions of § 516.125 of this chapter.
[40 FR 13823, Mar. 27, 1975, as amended at 41 PART 514—NEW ANIMAL DRUG
FR 48268, Nov. 2, 1976; 42 FR 15675, Mar. 22, APPLICATIONS
1977; 50 FR 7517, Feb. 22, 1985; 50 FR 16668,
Apr. 26, 1985; 52 FR 8847, Mar. 19, 1987; 54 FR
18280, Apr. 28, 1989; 57 FR 6475, Feb. 25, 1992;
62 FR 40599, July 29, 1997; 72 FR 69121, Dec. 6, Sec.
2007; 77 FR 25359, Apr. 30, 2012; 82 FR 61446, 514.1 Applications.
Dec. 28, 2017] 514.3 Definitions.
514.4 Substantial evidence.
§ 511.3 Definitions. 514.5 Presubmission conferences.
As used in this part: 514.6 Amended applications.
514.7 Withdrawal of applications without
Contract research organization means a prejudice.
person that assumes, as an independent 514.8 Supplements and other changes to an
contractor with the sponsor, one or approved application.
more of the obligations of a sponsor, 514.11 Confidentiality of data and informa-
e.g., design of a protocol, selection or tion in a new animal drug application
monitoring of investigations, evalua- file.
tion of reports, and preparation of ma- 514.12 Confidentiality of data and informa-
tion in an investigational new animal
terials to be submitted to the Food and drug notice.
Drug Administration. 514.15 Untrue statements in applications.
Investigator means an individual who
actually conducts a clinical investiga- Subpart B—Administrative Actions on
tion (i.e., under whose immediate di- Applications
rection the drug is administered or dis-
514.80 Records and reports concerning expe-
pensed to a subject). In the event an in- rience with approved new animal drugs.
vestigation is conducted by a team of 514.87 Annual reports for antimicrobial ani-
individuals, the investigator is the re- mal drug sales and distribution.
sponsible leader of the team. ‘‘Sub- 514.100 Evaluation and comment on applica-
investigator’’ includes any other indi- tions.
vidual member of that team. 514.105 Approval of applications.
Sponsor means a person who takes re- 514.106 Approval of supplemental applica-
tions.
sponsibility for and initiates a clinical 514.110 Reasons for refusing to file applica-
investigation. The sponsor may be an tions.
individual or pharmaceutical company, 514.111 Refusal to approve an application.
governmental agency, academic insti- 514.115 Withdrawal of approval of applica-
tution, private organization, or other tions.
organization. The sponsor does not ac- 514.116 Notice of withdrawal of approval of
tually conduct the investigation unless application.
the sponsor is a sponsor-investigator. A 514.117 Adequate and well-controlled stud-
ies.
person other than an individual that 514.120 Revocation of order refusing to ap-
uses one or more of its own employees prove an application or suspending or
to conduct an investigation that it has withdrawing approval of an application.
initiated is a sponsor, not a sponsor-in- 514.121 Service of notices and orders.
vestigator, and the employees are in-
vestigators. Subpart C—Hearing Procedures
Sponsor-Investigator means an indi- 514.200 Notice of opportunity for hearing;
vidual who both initiates and conducts notice of participation and requests for
an investigation, and under whose im- hearing; grant or denial of hearing.
mediate direction the investigational 514.201 Procedures for hearings.
drug is administered or dispensed. The
term does not include any person other Subparts D–E [Reserved]
than an individual. The requirements
Subpart F—Judicial Review
applicable to a sponsor-investigator
under this part include both those ap- 514.235 Judicial review.
90
AUTHORITY: 21 U.S.C. 321, 331, 351, 352, 354, new animal drug. Upon receipt, the ap-
356a, 360b, 360ccc, 371, 379e, 381. plication will be assigned a number
SOURCE: 40 FR 13825, Mar. 27, 1975, unless NADA __, which shall be used for all
otherwise noted. correspondence with respect to the ap-
plication.
Subpart A—General Provisions (2) Table of contents and summary. The
application shall be organized in a co-
§ 514.1 Applications. hesive fashion, shall contain a table of
(a) Applications to be filed under sec- contents which identifies the data and
tion 512(b) of the act shall be submitted other material submitted, and shall
in the form and contain the informa- contain a well-organized summary and
tion described in paragraph (b) of this evaluation of the data in the following
section, as appropriate to support the form:
particular submission. If any part of (i) Chemistry:
the application is in a foreign lan- (a) Chemical structural formula or
guage, an accurate and complete description for any new animal drug
English translation shall be appended substance.
to such part. Translations of literature (b) Relationship to other chemically
printed in a foreign language shall be or pharmacologically related drugs.
accompanied by copies of the original (c) Description of dosage form and
publication. The application must be quantitative composition.
signed by the applicant or by an au- (ii) Scientific rationale and purpose
thorized attorney, agent, or official. If the new animal drug is to serve:
the applicant or such authorized rep-
(a) Clinical purpose.
resentative does not reside or have a
place of business within the United (b) Highlights of laboratory studies:
States, the application must also fur- The reasons why certain types of stud-
nish the name and post office address ies were done or omitted as related to
of, and must be countersigned by, an the proposed conditions of use and to
authorized attorney, agent, or official information already known about this
residing or maintaining a place of busi- class of compounds. Emphasize any un-
ness within the United States. Perti- usual or particularly significant phar-
nent information may be incorporated macological effects or toxicological
in, and will be considered as part of, an findings.
application on the basis of specific ref- (c) Highlights of clinical studies: The
erence to such information, including rationale of the clinical study plan
information submitted under the provi- showing why types of studies were
sions of § 511.1 of this chapter, in the done, amended, or omitted as related
files of the Food and Drug Administra- to laboratory studies and prior clinical
tion; however, the reference must be experience.
specific in identifying the information. (d) Conclusions: A short statement of
Any reference to information furnished conclusions combining the major
by a person other than the applicant points of effectiveness and safety as
may not be considered unless its use is they relate to the use of the new ani-
authorized in a written statement mal drug.
signed by the person who submitted it. (3) Labeling. Three copies of each
(b) Applications for new animal drugs piece of all labeling to be used for the
shall be submitted in triplicate and as- article (total of 9).
sembled in the manner prescribed by (i) All labeling should be identified to
paragraph (b)(15) of this section, and show its position on, or the manner in
shall include the following informa- which it is to accompany the market
tion, as appropriate to support the par- package.
ticular submission: (ii) Labeling for nonprescription new
(1) Identification. Whether the submis- animal drugs should include adequate
sion is an original or supplemental ap- directions for use by the layman under
plication; the name and the address of all conditions of use for which the new
the applicant; the date of the applica- animal drug is intended, recommended,
tion; the trade name(s) (if one has been or suggested in any of the labeling or
proposed) and chemical name(s) of the advertising sponsored by the applicant.
91
§ 514.1 21 CFR Ch. I (4–1–23 Edition)
(iii) Labeling for prescription veteri- lowed by a complete quantitative

nary drugs should bear adequate infor- statement of composition. Reasonable
mation for use under which veterinar- alternatives for any listed component
ians can use the new animal drug safe- may be specified.
ly and for the purposes for which it is (ii) A full statement of the composi-
intended, including those purposes for tion of the new animal drug. The state-
which it is to be advertised or rep- ment shall set forth the name and
resented, in accord with § 201.105 of this amount of each ingredient, whether ac-
chapter. tive or not, contained in a stated quan-
(iv) All labeling for prescription or tity of the new animal drug in the form
nonprescription new animal drugs shall in which it is to be distributed (for ex-
be submitted with any necessary use ample, amount per tablet or milliliter)
restrictions prominently and conspicu-
and a batch formula representative of
ously displayed.
that to be employed for the manufac-
(v) Labeling for new animal drugs in-
ture of the finished dosage form. All
tended for use in the manufacture of
components should be included in the
medicated feeds shall include:
(a) Specimens of labeling to be used batch formula regardless of whether
for such new animal drug with ade- they appear in the finished product.
quate directions for the manufacture Any calculated excess of an ingredient
and use of finished feeds for all condi- over the label declaration should be
tions for which the new animal drug is designated as such and percent excess
intended, recommended, or suggested shown. Reasonable variation may be
in any of the labeling, including adver- specified.
tising, sponsored by the applicant. In- (iii) If it is a new animal drug pro-
gredient labeling may utilize collective duced by fermentation:
names as provided in § 501.110 of this (a) Source and type of microorganism
chapter. used to produce the new animal drug.
(b) Representative labeling proposed (b) Composition of media used to
to be used for Type B and Type C medi- produce the new animal drug.
cated feeds containing the new animal (c) Type of precursor used, if any, to
drug. guide or enhance production of the an-
(vi) Draft labeling may be submitted tibiotic during fermentation.
for preliminary consideration of an ap- (d) Name and composition of preserv-
plication. Final printed labeling will ative, if any, used in the broth.
ordinarily be required prior to approval (e) A complete description of the ex-
of an application. Proposed advertising traction and purification processes in-
for veterinary prescription drugs may cluding the names and compositions of
be submitted for comment or approval. the solvents, precipitants, ion ex-
(4) Components and composition. A
change resins, emulsifiers, and all
complete list of all articles used for
other agents used.
production of the new animal drug in-
cluding a full list of the composition of (f) If the new animal drug is produced
each article: by a catalytic hydrogenation process
(i) A full list of the articles used as (such as tetracycline from chlortetra-
components of the new animal drug. cycline), a complete description of each
This list should include all substances chemical reaction with graphic for-
used in the synthesis, extraction, or mulas used to produce the new animal
other method of preparation of any drug, including the names of the cata-
new animal drug and in the prepara- lyst used, how it is removed, and how
tion of the finished dosage form, re- the new animal drug is extracted and
gardless of whether they undergo purified.
chemical change or are removed in the (5) Manufacturing methods, facilities,
process. Each component should be and controls. A full description of the
identified by its established name, if methods used in, and the facilities and
any, or complete chemical name, using controls used for, the manufacture,
structural formulas when necessary for processing, and packing of the new ani-
specific identification. If any propri- mal drug. This description should in-
etary name is used, it should be fol- clude full information with respect to
92
any new animal drug in sufficient de- the raw materials, whether active or
tail to permit evaluation of the ade- not, including:
quacy of the described methods of man- (a) The specifications for acceptance
ufacture, processing, and packing, and and methods of testing for each lot of
the described facilities and controls to raw material.
determine and preserve the identity, (b) A statement as to whether or not
strength, quality, and purity of the each lot of raw materials is given a se-
new animal drug, and the following: rial number to identify it, and the use
(i) If the applicant does not himself made of such numbers in subsequent
perform all the manufacturing, proc- plant operations.
essing, packaging, labeling, and control (vi) The instructions used in the
operations for any new animal drug, he manufacturing, processing, packaging,
shall: Identify each person who will and labeling of each dosage form of the
perform any part of such operations new animal drug, including:
and designate the part; and provide a (a) The method of preparation of the
signed statement from each such per- master formula records and individual
son fully describing, directly or by ref- batch records and the manner in which
erence, the methods, facilities, and these records are used.
controls he will use in his part of the (b) The number of individuals check-
operation. The statement shall include ing weight or volume of each indi-
a commitment that no changes will be vidual ingredient entering into each
made without prior approval by the batch of the new animal drug.
Food and Drug Administration, unless (c) A statement as to whether or not
permitted under § 514.8. the total weight or volume of each
(ii) A description of the qualifica- batch is determined at any stage of the
tions, including educational back- manufacturing process subsequent to
ground and experience, of the technical making up a batch according to the
formula card and, if so, at what stage
and professional personnel who are re-
and by whom it is done.
sponsible for assuring that the new ani-
(d) The precautions used in checking
mal drug has the identity, strength,
the actual package yield produced from
quality, and purity it purports or is
a batch of the new animal drug with
represented to possess, and a statement
the theoretical yield. This should in-
of their responsibilities.
clude a description of the accounting
(iii) A description of the physical fa- for such items as discards, breakage,
cilities including building and equip- etc., and the criteria used in accepting
ment used in manufacturing, proc- or rejecting batches of drugs in the
essing, packaging, labeling, storage, event of an unexplained discrepancy.
and control operations. (e) The precautions used to assure
(iv) The methods used in the syn- that each lot of the new animal drug is
thesis, extraction, isolation, or purifi- packaged with the proper label and la-
cation of any new animal drug. When beling, including provisions for label-
the specifications and controls applied ing storage and inventory control.
to such new animal drugs are inad- (f) Any special precautions used in
equate in themselves to determine its the operations.
identity, strength, quality, and purity, (vii) The analytical controls used
the methods should be described in suf- during the various stages of the manu-
ficient detail, including quantities facturing, processing, packaging, and
used, times, temperature, pH, solvents, labeling of the new animal drug, in-
etc., to determine these characteris- cluding a detailed description of the
tics. Alternative methods or variations collection of samples and the analyt-
in methods within reasonable limits ical procedures to which they are sub-
that do not affect such characteristics jected. The analytical procedures
of the new animal drug may be speci- should be capable of determining the
fied. A flow sheet and indicated equa- active components within a reasonable
tions should be submitted when needed degree of accuracy and of assuring the
to explain the process. identity of such components.
(v) Precautions to insure proper iden- (a) A description of practicable meth-

tity, strength, quality, and purity of ods of analysis of adequate sensitivity
93
§ 514.1 21 CFR Ch. I (4–1–23 Edition)
to determine the amount of the new required for Type B medicated feeds as
animal drug in the final dosage form determined by the Food and Drug Ad-
should be included. The dosage form ministration on a case-by-case basis.
may be a finished pharmaceutical prod- Expiration dates shall be proposed for
uct, a Type A medicated article, a Type finished pharmaceutical dosage forms
B or a Type C medicated feed, or a and Type A medicated articles. If the
product for use in animal drinking data indicate that an expiration date is
water. Where two or more active ingre- needed for Type B or Type C medicated
dients are included, methods should be feeds, the applicant shall propose such
quantitative and specific for each ac- expiration date. If no expiration date is
tive ingredient. proposed for Type B or Type C medi-
(b) If the article is one that is rep- cated feeds, the applicant shall justify
resented to be sterile, the same infor- its absence with data.
mation with regard to the manufac- (xi) Additional procedures employed
turing, processing, packaging, and the which are designed to prevent contami-
collection of samples of the drug nation and otherwise assure proper
should be given for sterility controls. control of the product. An application
Include the standards used for accept- may be refused unless it includes ade-
ance of each lot of the finished drug. quate information showing that the
(viii) An explanation of the exact sig- methods used in, and the facilities and
nificance of any batch control numbers controls used for, the manufacturing,
used in the manufacturing, processing, processing, and packaging of the new
packaging, and labeling of the new ani- animal drug are adequate to preserve
mal drug, including such control num- its identity, strength, quality, and pu-
bers that may appear on the label of rity in conformity with good manufac-
the finished article. State whether turing practice and identifies each es-
these numbers enable determination of tablishment, showing the location of
the complete manufacturing history of the plant conducting these operations.
the product. Describe any methods
(6) Samples. Samples of the new ani-
used to permit determination of the
mal drug and articles used as compo-
distribution of any batch if its recall is
nents and information concerning
required.
them may be requested by the Center
(ix) Adequate information with re-
for Veterinary Medicine as follows:
spect to the characteristics of and the
test methods employed for the con- (i) Each sample shall consist of four
tainer, closure, or other component identical, separately packaged subdivi-
parts of the drug package to assure sions, each containing at least three
their suitability for the intended use. times the amount required to perform
(x) A complete description of, and the laboratory test procedures de-
data derived from, studies of the sta- scribed in the application to determine
bility of the new animal drug in the compliance with its control specifica-
final dosage form, including informa- tions for identity and assays. Each of
tion showing the suitability of the ana- the samples submitted shall be appro-
lytical methods used. A description of priately packaged and labeled to pre-
any additional stability studies under- serve its characteristics, to identify
way or planned. Stability data for the the material and the quantity in each
finished dosage form of the new animal subdivision of the sample, and to iden-
drug in the container in which it is to tify each subdivision with the name of
be marketed, including any proposed the applicant and the new animal drug
multiple dose container, and, if it is to application to which it relates. In-
be put into solution at the time of dis- cluded are:
pensing, for the solution prepared as (a) A sample or samples of any ref-
directed. If the new animal drug is in- erence standard and blank used in the
tended for use in the manufacture of procedures described in the application
Type C medicated feed as defined in for assaying each new animal drug and
§ 558.3 of this chapter, stability data de- other assayed components of the fin-
rived from studies in which representa- ished new animal drug.
tive formulations of the medicated feed (b) A representative sample or sam-

articles are used. Similar data may be ples of each strength of the finished
94
dosage form proposed in the applica- animal drug to become a component of

tion and employed in the clinical in- food at concentrations considered un-
vestigations and a representative sam- safe, a regulatory method is not re-
ple or samples of each new animal drug quired.
from the batch(es) employed in the (i) The kind of information required
production of such dosage form. by this subdivision may include: Com-
(c) A representative sample or sam- plete experimental protocols for deter-
ples of finished market packages of mining drug residue levels in the edible
each strength of the dosage form of the products, and the length of time re-
new animal drug prepared for initial quired for residues to be eliminated
marketing and, if any such sample is from such products following the
not from a representative commercial- drug’s use; residue studies conducted
scale production batch, such a sample under appropriate (consistent with the
from a representative commercial- proposed usage) conditions of dosage,
scale production batch, and a rep- time, and route of administration to
resentative sample or samples of each show levels, if any, of the drug and/or
new animal drug from the batch(es) its metabolites in test animals during
employed in the production of such and upon cessation of treatment and at
dosage form, provided that in the case intervals thereafter in order to estab-
of new animal drugs marketed in large lish a disappearance curve; if the drug
packages the sample should contain is to be used in combination with other
only three times a sufficient quantity drugs, possible effects of interaction
of the new animal drug to allow for demonstrated by the appropriate dis-
performing the control tests for drug appearance curve or depletion patterns
identity and assays. after drug withdrawal under appro-
(ii) The following information shall priate (consistent with the proposed
be included for the samples when re- usage) conditions of dosage, time, and
quested: route of administration; if the drug is
(a) For each sample submitted, full given in the feed or water, appropriate
information regarding its identity and consumption records of the medicated
the origin of any new animal drug con- feed or water and appropriate perform-
tained therein (including a statement ance data in the treated animal; if the
whether it was produced on a labora- drug is to be used in more than one
tory, pilot-plant, or full-production species, drug residue studies or appro-
scale) and detailed results of all labora- priate metabolic studies conducted for
tory tests made to determine the iden- each species that is food-producing. To
tity, strength, quality, and purity of provide these data, a sufficient number
the batch represented by the sample, of birds or animals should be used at
including assays. each sample interval. Appropriate use
(b) For any reference standard sub- of labeled compounds (e.g. radioactive
mitted, a complete description of its tracers), may be utilized to establish
preparation and the results of all lab- metabolism and depletion curves. Drug
oratory tests on it. If the test methods residue levels ordinarily should be de-
used differed from those described in termined in muscle, liver, kidney, and
the application, full details of the fat and where applicable, in skin, milk,
methods employed in obtaining the re- and eggs (yolk and egg white). As a
porting results. part of the metabolic studies, levels of
(7) Analytical methods for residues. Ap- the drug or metabolite should be deter-
plications shall include a description of mined in blood where feasible. Samples
practicable methods for determining may be combined where necessary.
the quantity, if any, of the new animal Where residues are suspected or known
drug in or on food, and any substance to be present in litter from treated ani-
formed in or on food because of its use, mals, it may be necessary to include
and the proposed tolerance or with- data with respect to such residues be-
drawal period or other use restrictions coming components of other agricul-
to ensure that the proposed use of this tural commodities because of use of lit-
drug will be safe. When data or other ter from treated animals.
adequate information establish that it (ii) A new animal drug that has the
is not reasonable to expect the new potential to contaminate human food
95
§ 514.1 21 CFR Ch. I (4–1–23 Edition)
with residues whose consumption could (vi) An application shall include a

present a risk of cancer to people must complete list of the names and post of-
satisfy the requirements of subpart E fice addresses of all investigators who
of part 500 of this chapter. received the new animal drug. This
(8) Evidence to establish safety and ef- may be incorporated in whole or in
fectiveness. (i) An application may be part by reference to information sub-
refused unless it contains full reports mitted under the provisions of § 511.1 of
of adequate tests by all methods rea- this chapter.
sonably applicable to show whether or (vii) Explain any omission of reports
not the new animal drug is safe and ef- from any investigator to whom the in-
fective for use as suggested in the pro- vestigational new animal drug has been
posed labeling. made available. The unexplained omis-
(ii) An application may be refused sion of any reports of investigations
unless it includes substantial evidence made with the new animal drug by the
of the effectiveness of the new animal applicant or submitted to him by an in-
drug as defined in § 514.4. vestigator or the unexplained omission
(iii) An application may be refused of any pertinent reports of investiga-
unless it contains detailed reports of tions or clinical experience received or
the investigations, including studies otherwise obtained by the applicant
made on laboratory animals, in which from published literature or other
the purpose, methods, and results ob- sources that would bias an evaluation
tained are clearly set forth of acute, of the safety of the new animal drug or
subacute, and chronic toxicity, and units effectiveness in use, constitutes
less it contains appropriate clinical grounds for the refusal or withdrawal
laboratory results related to safety and of the approval of an application.
efficacy. Such information should in- (viii) If a sponsor has transferred any
clude identification of the person who obligations for the conduct of any clin-
conducted each investigation, a state-
ical study to a contract research orga-
ment of where the investigations were
nization, the application is required to
conducted, and where the raw data are
include a statement containing the
available in the application.
name and address of the contract re-
(iv) All information pertinent to an
search organization, identifying the
evaluation of the safety and effective-
clinical study, and listing the obliga-
ness of the new animal drug received or
tions transferred. If all obligations gov-
otherwise obtained by the applicant
erning the conduct of the study have
from any source, including information
been transferred, a general statement
derived from other investigations or
commercial marketing (for example, of this transfer—in lieu of a listing of
outside the United States), or reports the specific obligations transferred—
in the scientific literature, both favor- may be submitted.
able and unfavorable, involving the (ix) If original subject records were
new animal drug that is the subject of audited or reviewed by the sponsor in
the application and related new animal the course of monitoring any clinical
drugs shall be submitted. An adequate study to verify the accuracy of the case
summary may be acceptable in lieu of reports submitted to the sponsor, a list
a reprint of a published report that identifying each clinical study so au-
only supports other data submitted. In- dited or reviewed.
clude any evaluation of the safety or (9) Veterinary feed directive. Three
effectiveness of the new animal drug copies of a veterinary feed directive
that has been made by the applicant’s (VFD) must be submitted in a form
veterinary or medical department, ex- that accounts for the information de-
pert committee, or consultants. scribed under § 558.6(b)(3) and 558.6(b)(4)
(v) If the new animal drug is a com- of this chapter.
bination of active ingredients or ani- (10) Supplemental applications. If it is
mal drugs, an application may be re- a supplemental application, full infor-
fused unless it includes substantial evi- mation shall be submitted on each pro-
dence of the effectiveness of the composed change concerning any state-
bination new animal drug as required ment made in the approved applica-
in § 514.4. tion.
96
(11) Applicant’s commitment. It is un- (i) Bind the original or ribbon copy of
derstood that the labeling and adver- the application as copy No. 1.
tising for the new animal drug will pre- (ii) Bind two identical copies as copy
scribe, recommend, or suggest its use No. 2 and copy No. 3.
only under the conditions stated in the (iii) Identify each front cover with
labeling which is part of this applica- the name of the applicant, new animal
tion and if the article is a prescription drug, and the copy number.
new animal drug, it is understood that (iv) Number each page of the applica-
any labeling which furnishes or pur- tion sequentially in the upper right
ports to furnish information for use or hand corner or in another location so
which prescribes, recommends, or sug-
that the page numbers remain legible
gests a dosage for use of the new ani-
after the application has been bound,
mal drug will also contain, in the same
and organize the application consistent
language and emphasis, information
for its use including indications, ef- with paragraphs (b) (1) through (14) of
fects, dosages, routes, methods, and this section. Each copy should bear the
frequency and duration of administra- same page numbering, whether sequen-
tion, any relevant hazards, contra- tial in each volume or continuous and
indications, side effects, and pre- sequential throughout the application.
cautions contained in the labeling (v) Include complete labeling in each
which is part of this application. It is of the copies. It is suggested that label-
understood that all representations in ing be identified by date of printing or
this application apply to the drug pro- date of preparation.
duced until changes are made in con- (vi) Submit separate applications for
formity with § 514.8. each different dosage form of the drug
(12) Additional commitments. (i) New proposed. Repeating basic information
animal drugs as defined in § 510.3 of this pertinent to all dosage forms in each
chapter, intended for use in the manu- application is unnecessary if reference
facture of animal feeds in any State is made to the application containing
will be shipped only to persons who such information. Include in each ap-
may receive such drugs in accordance plication information applicable to the
with § 510.7 of this chapter. specific dosage form, such as labeling,
(ii) The methods, facilities, and con- composition, stability data, and meth-
trols described under item 5 of this ap- od of manufacture.
plication conform to the current good (vii) Submit in folders amendments,
manufacturing practice regulations in supplements, and other correspondence
subchapter C of this chapter. sent after submission of an original ap-
(iii) With respect to each nonclinical plication. The front cover of these sub-
laboratory study contained in the ap- missions should be identified with the
plication, either a statement that the name of the applicant, new animal
study was conducted in compliance drug, copy number, and the new animal
with the good laboratory practice regu- drug application number, if known.
lations set forth in part 58 of this chap- (c) When a new animal drug applica-
ter, or, if the study was not conducted tion is submitted for a new animal
in compliance with such regulations, a drug which has a stimulant, depres-
brief statement of the reason for the
sant, or hallucinogenic effect on the
noncompliance.
central nervous system, if it appears
(13) [Reserved] that the drug has a potential for abuse,
(14) Environmental assessment. The ap- the Commissioner shall forward that
plicant is required to submit either a information to the Attorney General of
claim for categorical exclusion under the United States.
§ 25.30 or § 25.33 of this chapter or an en-
vironmental assessment under § 25.40 of [40 FR 13825, Mar. 27, 1975]
this chapter. EDITORIAL NOTE: For FEDERAL REGISTER ci-
(15) Assembling and binding the appli- tations affecting § 514.1, see the List of CFR
cation. Assemble and bind an original Sections Affected, which appears in the
and two copies of the application as Finding Aids section of the printed volume
follows: and at www.govinfo.gov.
97
§ 514.3 21 CFR Ch. I (4–1–23 Edition)
§ 514.3 Definitions. (2) Investigating a new animal drug

The definition and interpretation of under section 512(j) of the act,
terms contained in this section apply (3) Intending to file a new animal
to those terms as used throughout sub- drug application (NADA) or supple-
chapter E. mental NADA under section 512(b)(1) of
Adverse drug experience is any adverse the act, or
event associated with the use of a new (4) Intending to file an abbreviated
animal drug, whether or not considered new animal drug application (ANADA)
to be drug related, and whether or not under section 512(b)(2) of the act.
the new animal drug was used in ac- Presubmission conference means one or
cordance with the approved labeling more conferences between a potential
(i.e., used according to label directions applicant and FDA to reach a binding
or used in an extralabel manner, in- agreement establishing a submission or
cluding but not limited to different investigational requirement.
route of administration, different spe- Presubmission conference agreement
cies, different indications, or other means that section of the memo-
than labeled dosage). Adverse drug ex- randum of conference headed ‘‘Pre-
perience includes, but is not limited to: submission Conference Agreement’’
(1) An adverse event occurring in ani- that records any agreement on the sub-
mals in the course of the use of an ani- mission or investigational requirement
mal drug product by a veterinarian or reached by a potential applicant and
by a livestock producer or other ani- FDA during the presubmission con-
mal owner or caretaker. ference.
(2) Failure of a new animal drug to Product defect/manufacturing defect is
produce its expected pharmacological the deviation of a distributed product
or clinical effect (lack of expected ef- from the standards specified in the ap-
fectiveness). proved application, or any significant
(3) An adverse event occurring in hu- chemical, physical, or other change, or
mans from exposure during manufac- deterioration in the distributed drug
ture, testing, handling, or use of a new product, including any microbial or
animal drug. chemical contamination. A manufac-
ANADA is an abbreviated new animal turing defect is a product defect caused
drug application including all amend- or aggravated by a manufacturing or
ments and supplements. related process. A manufacturing de-
Applicant is a person or entity who fect may occur from a single event or
owns or holds on behalf of the owner from deficiencies inherent to the man-
the approval for an NADA or an ufacturing process. These defects are
ANADA, and is responsible for compli- generally associated with product con-
ance with applicable provisions of the tamination, product deterioration,
act and regulations. manufacturing error, defective pack-
Increased frequency of adverse drug ex- aging, damage from disaster, or label-
perience is an increased rate of occur- ing error. For example, a labeling error
rence of a particular serious adverse may include any incident that causes a
drug event, expected or unexpected, distributed product to be mistaken for,
after appropriate adjustment for drug or its labeling applied to, another prod-
exposure. uct.
NADA is a new animal drug applica- Serious adverse drug experience is an
tion including all amendments and sup- adverse event that is fatal, or life-
plements. threatening, or requires professional
Nonapplicant is any person other than intervention, or causes an abortion, or
the applicant whose name appears on stillbirth, or infertility, or congenital
the label and who is engaged in manu- anomaly, or prolonged or permanent
facturing, packing, distribution, or la- disability, or disfigurement.
beling of the product. Unexpected adverse drug experience is
Potential applicant means any person: an adverse event that is not listed in
(1) Intending to investigate a new the current labeling for the new animal
animal drug under section 512(j) of the drug and includes any event that may
Federal Food, Drug, and Cosmetic Act be symptomatically and

(the act), pathophysiologically related to an
98
event listed on the labeling, but differs least one adequate and well-controlled
from the event because of greater se- study on the basis of which qualified
verity or specificity. For example, experts could fairly and reasonably
under this definition hepatic necrosis conclude that the new animal drug will
would be unexpected if the labeling re- be effective for the intended use at the
ferred only to elevated hepatic en- lowest dose of the dose range suggested
zymes or hepatitis. in the proposed labeling for that in-
[68 FR 15365, Mar. 31, 2003, as amended at 69 tended use. Substantial evidence to
FR 51170, Aug. 18, 2004] support dose range labeling for a new
animal drug intended to affect the
§ 514.4 Substantial evidence. structure or function of the body of an
(a) Definition of substantial evidence. animal generally must consist of at
Substantial evidence means evidence least one adequate and well-controlled
consisting of one or more adequate and study on the basis of which qualified
well-controlled studies, such as a study experts could fairly and reasonably
in a target species, study in laboratory conclude that the new animal drug will
animals, field study, bioequivalence be effective for the intended use at all
study, or an in vitro study, on the basis doses within the range suggested in the
of which it could fairly and reasonably proposed labeling for the intended use.
be concluded by experts qualified by (ii) [Reserved]
scientific training and experience to (3) Studies—(i) Number. Substantial
evaluate the effectiveness of the new evidence of the effectiveness of a new
animal drug involved that the new ani- animal drug for each intended use and
mal drug will have the effect it pur- associated conditions of use shall con-
ports or is represented to have under sist of a sufficient number of current
the conditions of use prescribed, rec- adequate and well-controlled studies of
ommended, or suggested in the labeling sufficient quality and persuasiveness to
or proposed labeling thereof. Substan- permit qualified experts:
tial evidence shall include such ade- (A) To determine that the param-
quate and well-controlled studies that eters selected for measurement and the
are, as a matter of sound scientific measured responses reliably reflect the
judgment, necessary to establish that a effectiveness of the new animal drug;
new animal drug will have its intended (B) To determine that the results ob-
effect. tained are likely to be repeatable, and
(b) Characteristics of substantial evi- that valid inferences can be drawn to
dence—(1) Qualifications of experts. Any the target animal population; and
study that is intended to be part of (C) To conclude that the new animal
substantial evidence of the effective- drug is effective for the intended use at
ness of a new animal drug shall be con- the dose or dose range and associated
ducted by experts qualified by sci- conditions of use prescribed, rec-
entific training and experience. ommended, or suggested in the pro-
(2) Intended uses and conditions of use. posed labeling.
Substantial evidence of effectiveness of (ii) Types. Adequate and well-con-
a new animal drug shall demonstrate trolled studies that are intended to
that the new animal drug is effective provide substantial evidence of the ef-
for each intended use and associated fectiveness of a new animal drug may
conditions of use for and under which include, but are not limited to, pub-
approval is sought. lished studies, foreign studies, studies
(i) Dose range labeling. Sponsors using models, and studies conducted by
should, to the extent possible, provide or on behalf of the sponsor. Studies
for a dose range because it increases using models shall be validated to es-
the utility of the new animal drug by tablish an adequate relationship of pa-
providing the user flexibility in the se- rameters measured and effects ob-
lection of a safe and effective dose. In served in the model with one or more
general, substantial evidence to sup- significant effects of treatment.
port dose range labeling for a new ani- (c) Substantial evidence for combination
mal drug intended for use in the diag- new animal drugs—(1) Definitions. The
nosis, cure, mitigation, treatment, or following definitions of terms apply to

prevention of disease must consist of at this section:
99
§ 514.4 21 CFR Ch. I (4–1–23 Edition)
(i) Combination new animal drug and do not have disparate dosing regi-
means a new animal drug that contains mens if FDA, based on scientific infor-
more than one active ingredient or ani- mation, has reason to believe the ac-
mal drug that is applied or adminis- tive ingredients or animal drugs are
tered simultaneously in a single dosage physically incompatible or have dis-
form or simultaneously in or on animal parate dosing regimens.
feed or drinking water. (ii) For combination new animal
(ii) Dosage form combination new ani- drugs intended for use in animal feed
mal drug means a combination new ani- or drinking water that contain only ac-
mal drug intended for use other than in tive ingredients or animal drugs that
animal feed or drinking water. have previously been separately ap-
(iii) Antibacterial with respect to a proved for the particular uses and con-
particular target animal species means ditions of use for which they are in-
an active ingredient or animal drug: tended in combination, the sponsor
That is approved in that species for the shall demonstrate:
diagnosis, cure, mitigation, treatment,
(A) By substantial evidence, as de-
or prevention of bacterial disease; or
fined in this section, that any active
that is approved for use in that species
ingredient or animal drug intended
for any other use that is attributable
only for the same use as another active
to its antibacterial properties. But,
ingredient or animal drug in the com-
antibacterial does not include
ionophores or arsenicals intended for bination makes a contribution to the
use in combination in animal feed or effectiveness of the combination new
drinking water. animal drug;
(iv) Appropriate concurrent use exists (B) For such combination new animal
when there is credible evidence that drugs that contain more than one anti-
the conditions for which the combina- bacterial ingredient or animal drug, by
tion new animal drug is intended can substantial evidence, as defined in this
occur simultaneously. section, that each antibacterial makes
(2) Combination new animal drugs that a contribution to labeled effectiveness;
contain only active ingredients or animal (C) That each active ingredient or
drugs that have previously been sepa- animal drug intended for at least one
rately approved. (i) For dosage form use that is different from all other ac-
combination new animal drugs, except tive ingredients or animal drugs used
for those that contain a nontopical in the combination provides appro-
antibacterial, that contain only active priate concurrent use for the intended
ingredients or animal drugs that have target animal population; and
previously been separately approved (D) That the active ingredients or
for the particular uses and conditions animal drugs intended for use in drink-
of use for which they are intended in ing water are physically compatible if
combination, a sponsor shall dem- FDA, based on scientific information,
onstrate: has reason to believe the active ingre-
(A) By substantial evidence, as de- dients or animal drugs are physically
fined in this section, that any active incompatible.
ingredient or animal drug intended (3) Other combination new animal
only for the same use as another active drugs. For all other combination new
ingredient or animal drug in the com- animal drugs, the sponsor shall dem-
bination makes a contribution to the onstrate by substantial evidence, as de-
effectiveness of the combination new fined in this section, that the combina-
animal drug; tion new animal drug will have the ef-
(B) That each active ingredient or fect it purports or is represented to
animal drug intended for at least one have under the conditions of use pre-
use that is different from all the other scribed, recommended, or suggested in
active ingredients or animal drugs used the proposed labeling and that each ac-
in the combination provides appro-
tive ingredient or animal drug contrib-
priate concurrent use for the intended
utes to the effectiveness of the com-
target animal population; and
bination new animal drug.
(C) That the active ingredients or

animal drugs are physically compatible [64 FR 40756, July 28, 1999]
100
§ 514.5 Presubmission conferences. rected primarily at establishing agree-

(a) General principle underlying the ment between FDA and the potential
conduct of a presubmission conference. applicant regarding a submission or in-
The general principle underlying the vestigational requirement. The submis-
conduct of any presubmission con- sion or investigational requirement
ference is that there should be candid, may include, among other things, the
full, and open communication. number, types, and general design of
(b) Requesting a presubmission con- studies that are necessary to dem-
ference. A potential applicant is enti- onstrate the safety and effectiveness of
tled to one or more conferences prior a new animal drug for the intended
to the submission of an NADA, supple- uses and conditions of use prescribed,
mental NADA, or an ANADA to reach recommended, or suggested in the pro-
an agreement establishing part or all posed labeling for the new animal drug.
of a submission or investigational re- (f) Documentation of a presubmission
quirement. A potential applicant’s re- conference—(1) Memorandum of con-
quest for a presubmission conference ference—(i) Preparation. FDA will pre-
must be submitted to FDA in a signed pare a memorandum for each pre-
letter. The letter must include a pro- submission conference that will in-
posed agenda that clearly outlines the clude, among other things, any back-
scope, purpose, and objectives of the
ground pertinent to the request for
presubmission conference and must list
meeting; a summary of the key points
the names and positions of the rep-
resentatives who are expected to at- of discussion; agreements; and action
tend the presubmission conference on items and assignments of responsi-
behalf of the applicant. bility. That portion of the memo-
(c) Timing. A potential applicant may randum of conference that documents
request one or more presubmission con- any agreements reached regarding all
ferences at any time prior to the filing or part of a submission or investiga-
of a NADA, supplemental NADA, or an tional requirement will be included
ANADA. A request for a presubmission under the heading ‘‘Presubmission Con-
conference must be received by FDA at ference Agreement.’’ If the pre-
least 30 calendar days in advance of the submission conference agreement sec-
requested conference date. FDA will tion of the memorandum is silent on an
schedule the presubmission conference issue, including one that was discussed
at a time agreeable to both FDA and in the conference or addressed by mate-
the potential applicant. rials provided for the conference, such
(d) Advance information. The potential silence does not constitute agreement
applicant must provide to FDA, at between FDA and the potential appli-
least 30 calendar days before a sched- cant on the issue.
uled presubmission conference, a de- (ii) Sending a copy to the potential ap-
tailed agenda, a copy of any materials plicant. FDA will send a copy of the
to be presented at the conference, a list memorandum to the potential appli-
of proposed indications and, if avail-
cant for review no later than 45 cal-
able, a copy of the proposed labeling
endar days after the date of the con-
for the product under consideration,
ference
and copies of materials evaluated or
referenced relative to issues listed in (iii) Requests for changes or clarifica-
the agenda for the conference. If the tion. If a potential applicant requests
materials are not provided or are not changes to, or clarification of, the sub-
sufficient to provide the basis for stance of the memorandum, the re-
meaningful discussion, FDA may elect quest must be sent to FDA within 30
to postpone part or all of the meeting calendar days from the date a copy of
until sufficient materials are provided the memorandum is sent to the appli-
to FDA. cant. If the potential applicant re-
(e) Conduct of a presubmission con- quests changes or clarification, FDA
ference. The potential applicant and will send the potential applicant a re-
FDA may each bring consultants to the sponse to their request no later than 45
presubmission conference. The pre- calendar days after the date of receipt
submission conference(s) will be di- of the request.
101
§ 514.6 21 CFR Ch. I (4–1–23 Edition)
(iv) Administrative record. A copy of submission conference, any untrue

FDA’s original memorandum of con- statement of material fact; or
ference and, as appropriate, a copy of (ii) The potential applicant fails to
an amended memorandum to correct or follow any material term of the agree-
clarify the content of the original ment; and
memorandum will be made part of the (2) A presubmission conference may
administrative file. no longer be valid if the potential ap-
(2) Field studies. If FDA requires more plicant submits false or misleading
than one field study to establish by data relating to a new animal drug to
substantial evidence that the new ani- FDA.
mal drug is effective for its intended (i) Dispute resolution. FDA is com-
uses under the conditions of use pre- mitted to resolving differences between
scribed, recommended, or suggested in a potential applicant and FDA review-
the proposed labeling, FDA will provide ing divisions with respect to require-
written scientific justification for re- ments for the investigation of new ani-
quiring more than one field study. mal drugs and for NADAs, supple-
Such justification must be provided no mental NADAs, and ANADAs as quick-
later than 25 calendar days after the ly and amicably as possible through a
date of the conference at which the re- cooperative exchange of information
quirement for more than one field and views. When administrative or pro-
study is established. If FDA does not cedural disputes arise, a potential ap-
believe more than one field study is re- plicant should first attempt to resolve
quired but the potential applicant vol- the matter within the appropriate re-
untarily proposes to conduct more view division beginning with the indi-
than one field study, FDA will not pro- vidual(s) most directly assigned to the
vide such written justification. If FDA review of the application or investiga-
requires one field study to be con- tional exemption. If the dispute cannot
ducted at multiple locations, FDA will be resolved after such attempts, the
provide justification for requiring mul- dispute shall be evaluated and adminis-
tiple locations verbally during the pre- tered in accordance with applicable
submission conference and in writing regulations (21 CFR 10.75). Dispute res-
as part of the memorandum of con- olution procedures may be further ex-
ference. plained by guidance available from the
(g) Modification of presubmission con- Center for Veterinary Medicine.
ference agreements. An agreement made
under a presubmission conference re- [69 FR 51170, Aug. 18, 2004]
quested under section 512(b)(3) of the
§ 514.6 Amended applications.
act and documented in a memorandum
of conference is binding on the poten- The applicant may submit an amend-
tial applicant and FDA and may only ment to an application that is pending,
be modified if: including changes that may alter the
(1) FDA and the potential applicant conditions of use, the labeling, safety,
mutually agree to modify, in part or in effectiveness, identity, strength, qual-
whole, the agreement and such modi- ity, or purity of the drug or the ade-
fication is documented and provided to quacy of the manufacturing methods,
the potential applicant as described in facilities, and controls to preserve
paragraph (f)(1) of this section; or them, in which case the unamended ap-
(2) FDA by written order determines plication may be considered as with-
that a substantiated scientific require- drawn and the amended application
ment essential to the determination of may be considered resubmitted on the
safety or effectiveness of the new ani- date on which the amendment is re-
mal drug appeared after the con- ceived by the Food and Drug Adminis-
ference. tration. The applicant will be notified
(h) When the terms of a presubmission of such date.
conference agreement are not valid. (1) A
presubmission conference agreement § 514.7 Withdrawal of applications
will no longer be valid if: without prejudice.
(i) The potential applicant makes to The sponsor may withdraw his pend-
FDA, before, during, or after the pre- ing application from consideration as a
102
new animal drug application upon writ- means numerical limits, ranges, or
ten notification to the Food and Drug other criteria for the tests described.
Administration. Such withdrawal may (b) Manufacturing changes to an ap-
be made without prejudice to a future proved application—(1) General provi-
filing. Upon resubmission, the time sions. (i) The applicant must notify
limitation will begin to run from the FDA about each change in each condi-
date the resubmission is received by tion established in an approved appli-
the Food and Drug Administration. cation beyond the variations already
The original application will be re- provided for in the application. The no-
tained by the Food and Drug Adminis- tice is required to describe the change
tration although it is considered with- fully. Depending on the type of change,
drawn. The applicant shall be furnished the applicant must notify FDA about it
a copy at cost on request. in a supplement under paragraph (b)(2)
or (b)(3) of this section or by inclusion
§ 514.8 Supplements and other changes
to an approved application. of the information in the annual report
to the application under paragraph
(a) Definitions. (1) The definitions and (b)(4) of this section.
interpretations contained in section 201 (ii) The holder of an approved appli-
of the Federal Food, Drug, and Cos- cation under section 512 of the act
metic Act (the act) apply to those must assess the effects of the change
terms when used in this part. before distributing a drug made with a
(2) The following definitions of terms manufacturing change.
apply to this part:
(iii) Notwithstanding the require-
(i) Assess the effects of the change
ments of paragraphs (b)(2) and (b)(3) of
means to evaluate the effects of a man-
this section, an applicant must make a
ufacturing change on the identity,
change provided for in those para-
strength, quality, purity, and potency
graphs in accordance with a regulation
of a drug as these factors may relate to
or guidance that provides for a less
the safety or effectiveness of the drug.
burdensome notification of the change
(ii) Drug substance means an active
(for example, by submission of a sup-
ingredient as defined under § 210.3(b)(7)
of this chapter. plement that does not require approval
(iii) Minor changes and stability report prior to distribution of the drug, or by
(MCSR) means an annual report that is notification in the next annual report
submitted to the application once each described in paragraph (b)(4) of this
year within 60 days before or after the section).
anniversary date of the application’s (iv) In each supplement and amend-
original approval or on a mutually ment to a supplement providing for a
agreed upon date. The report must in- change under paragraph (b)(2) or (b)(3)
clude minor manufacturing and control of this section, the applicant must in-
changes made according to § 514.8(b)(4) clude a statement certifying that a
or state that no changes were made; field copy has been provided to the ap-
and stability data generated on com- propriate FDA district office. No field
mercial or production batches accord- copy is required for a supplement pro-
ing to an approved stability protocol or viding for a change made to a drug
commitment. manufactured outside of the United
(iv) Specification means the quality States.
standard (i.e., tests, analytical proce- (v) A supplement or annual report de-
dures, and acceptance criteria) pro- scribed in paragraph (b)(4) of this sec-
vided in an approved application to tion must include a list of all changes
confirm the quality of drugs including, contained in the supplement or annual
for example, drug substances, Type A report. For supplements, this list must
medicated articles, drug products, be provided in the cover letter.
intermediates, raw materials, reagents, (2) Changes requiring submission and
components, in-process materials, con- approval of a supplement prior to dis-
tainer closure systems, and other ma- tribution of the drug made using the
terials used in the production of a change (major changes). (i) A supple-
drug. For the purpose of this defini- ment must be submitted for any
tion, the term ‘‘acceptance criteria’’ change in the drug, production process,
103
§ 514.8 21 CFR Ch. I (4–1–23 Edition)
quality controls, equipment, or facili- change under paragraph (b)(2) of this

ties that has a substantial potential to section. The supplement must be la-
have an adverse effect on the identity, beled ‘‘Prior Approval Supplement.’’
strength, quality, purity, or potency of Except for submissions under para-
the drug as these factors may relate to graph (b)(2)(v) of this section, the fol-
the safety or effectiveness of the drug. lowing information must be contained
(ii) These changes include, but are in the supplement:
not limited to: (A) A completed Form FDA 356V;
(A) Except those described in para- (B) A detailed description of the pro-
graphs (b)(3) and (b)(4) of this section, posed change;
changes in the qualitative or quan- (C) The drug(s) involved;
titative formulation of the drug, in-
(D) The manufacturing site(s) or
cluding inactive ingredients, or in the
area(s) affected;
specifications provided in the approved
application; (E) A description of the methods used
(B) Changes requiring completion of and studies performed to assess the ef-
appropriate clinical studies to dem- fects of the change;
onstrate the equivalence of the drug to (F) The data derived from such stud-
the drug as manufactured without the ies;
change; (G) Appropriate documentation (for
(C) Changes that may affect drug example, updated master batch
substance or drug product sterility as- records, specification sheets) including
surance, such as changes in drug sub- previously approved documentation
stance, drug product or component (with the changes highlighted) or ref-
sterilization method(s) or an addition, erences to previously approved docu-
deletion, or substitution of steps in an mentation;
aseptic processing operation; (H) For a natural product, a recom-
(D) Changes in the synthesis or man- binant DNA-derived protein/
ufacture of the drug substance that polypeptide, or a complex or conjugate
may affect the impurity profile and/or of a drug substance with a monoclonal
the physical, chemical, or biological antibody, relevant validation protocols
properties of the drug substance; and standard operating procedures
(E) Changes in a drug product con- must be provided in addition to the re-
tainer closure system that controls the quirements in paragraphs (b)(2)(iii)(E)
drug delivered to the animal or and (b)(2)(iii)(F) of this section;
changes in the type or composition of a (I) For sterilization process and test
packaging component that may affect methodologies related to sterilization
the impurity profile of the drug prod- process validation, relevant validation
uct; protocols and a list of relevant stand-
(F) Changes solely affecting a natural ard operating procedures must be pro-
product, a recombinant DNA-derived
vided in addition to the requirements
protein/polypeptide, or a complex or
in paragraphs (b)(2)(iii)(E) and
conjugate of a drug substance with a
(b)(2)(iii)(F) of this section; and
monoclonal antibody for the following:
(1) Changes in the virus or adven- (J) Any other information as directed
titious agent removal or inactivation by FDA.
method(s), (iv) An applicant may ask FDA to ex-
(2) Changes in the source material or pedite its review of a supplement for
cell line, and public health reasons or if a delay in
(3) Establishment of a new master making the change described in it
cell bank or seed; would impose an extraordinary hard-
(G) Changes to a drug under an appli- ship on the applicant. Such a supple-
cation that is subject to a validity as- ment and its mailing cover must be
sessment because of significant ques- plainly marked: ‘‘Prior Approval Sup-
tions regarding the integrity of the plement-Expedited Review Requested.’’
data supporting that application. (v) Comparability Protocols. An appli-
(iii) The applicant must obtain ap- cant may submit one or more protocols
proval of a supplement from FDA prior describing the specific tests and studies
to distribution of a drug made using a and acceptance criteria to be achieved
104
to demonstrate the lack of adverse ef- (iii) A supplement submitted under

fect for specified types of manufac- paragraph (b)(3)(i) or (b)(3)(vi) of this
turing changes on the identity, section is required to give a full expla-
strength, quality, purity, and potency nation of the basis for the change and
of the drug as these factors may relate identify the date on which the change
to the safety or effectiveness of the is made. The supplement submitted
drug. Any such protocols, if not in- under paragraph (b)(3)(i) must be la-
cluded in the approved application, or beled ‘‘Supplement-Changes Being Ef-
changes to an approved protocol, must fected in 30 Days.’’
be submitted as a supplement requiring (iv) Pending approval of the supple-
approval from FDA prior to distribu- ment by FDA and except as provided in
tion of the drug produced with the paragraph (b)(3)(vi) of this section, dis-
manufacturing change. The supple- tribution of the drug made using the
ment, if approved, may subsequently change may begin not less than 30 days
justify a reduced reporting category for after receipt of the supplement by
the particular change because the use FDA. The information listed in para-
of the protocol for that type of change graphs (b)(2)(iii)(A) through
reduces the potential risk of an adverse (b)(2)(iii)(J) of this section must be
effect. A comparability protocol sup- contained in the supplement.
plement must be labeled ‘‘Prior Ap- (v) The applicant must not distribute
proval Supplement—Comparability the drug made using the change if
Protocol.’’ within 30 days following FDA’s receipt
(3) Changes requiring submission of a of the supplement, FDA informs the
supplement at least 30 days prior to dis- applicant that either:
tribution of the drug made using the (A) The change requires approval
change (moderate changes). (i) A supple- prior to distribution of the drug in ac-
ment must be submitted for any cordance with paragraph (b)(2) of this
change in the drug, production process, section; or
quality controls, equipment, or facili- (B) Any of the information required
ties that has a moderate potential to under paragraph (b)(3)(iv) of this sec-
have an adverse effect on the identity, tion is missing. In this case, the appli-
strength, quality, purity, or potency of cant must not distribute the drug made
the drug as these factors may relate to using the change until the supplement
the safety or effectiveness of the drug. has been amended to provide the miss-
ing information.
(ii) These changes include, but are
(vi) The agency may designate a cat-
not limited to:
egory of changes for the purpose of pro-
(A) A change in the container closure viding that, in the case of a change in
system that does not affect the quality such category, the holder of an ap-
of the drug except as otherwise de- proved application may commence dis-
scribed in paragraphs (b)(2) and (b)(4) of tribution of the drug involved upon re-
this section; ceipt by the agency of a supplement for
(B) Changes solely affecting a natural the change. The information listed in
protein, a recombinant DNA-derived paragraphs (b)(2)(iii)(A) through
protein/polypeptide or a complex or (b)(2)(iii)(J) of this section must be
conjugate of a drug substance with a contained in the supplement. The sup-
monoclonal antibody, including: plement must be labeled ‘‘Supplement-
(1) An increase or decrease in produc- Changes Being Effected.’’ These
tion scale during finishing steps that changes include, but are not limited to:
involves different equipment, and (A) Addition to a specification or
(2) Replacement of equipment with changes in the methods or controls to
that of a different design that does not provide increased assurance that the
affect the process methodology or proc- drug will have the characteristics of
ess operating parameters. identity, strength, quality, purity, or
(C) Relaxation of an acceptance cri- potency that it purports or is rep-
terion or deletion of a test to comply resented to possess; and
with an official compendium that is (B) A change in the size and/or shape
consistent with FDA statutory and reg- of a container for a nonsterile drug
ulatory requirements. product, except for solid dosage forms,
105
§ 514.8 21 CFR Ch. I (4–1–23 Edition)
without a change in the labeled (G) The addition or revision of an al-

amount of drug product or from one ternative analytical procedure that
container closure system to another. provides the same or increased assur-
(vii) If the agency disapproves the ance of the identity, strength, quality,
supplemental application, it may order purity, or potency of the drug being
the manufacturer to cease distribution tested as the analytical procedure de-
of the drug(s) made with the manufac- scribed in the approved application, or
turing change. deletion of an alternative analytical
(4) Changes and updated stability data procedure; and
to be described and submitted in an an- (H) The addition by embossing, de-
nual report (minor changes). (i) Changes bossing, or engraving of a code imprint
in the drug, production process, quality to a solid oral dosage form drug prod-
controls, equipment, or facilities that uct other than a modified release dos-
have a minimal potential to have an age form, or a minor change in an ex-
adverse effect on the identity, isting code imprint.
strength, quality, purity, or potency of (iii) For changes under this category,
the drug as these factors may relate to the applicant is required to submit in
the safety or effectiveness of the drug the annual report:
must be documented by the applicant (A) A completed Form FDA 356V;
in an annual report to the application (B) A statement by the holder of the
as described under paragraph (a)(2)(iii) approved application that the effects of
of this section. The report must be la- the change have been assessed;
beled ‘‘Minor Changes and Stability (C) A detailed description of the
Report.’’ change(s);
(D) The manufacturing site(s) or
(ii) These changes include but are not
area(s) involved;
limited to:
(E) The date each change was imple-
(A) Any change made to comply with mented;
a change to an official compendium, (F) Data from studies and tests per-
except a change in paragraph formed to assess the effects of the
(b)(3)(ii)(C) of this section, that is con- change;
sistent with FDA statutory and regu- (G) For a natural product, recom-
latory requirements; binant DNA-derived protein/
(B) The deletion or reduction of an polypeptide, complex or conjugate of a
ingredient intended to affect only the drug substance with a monoclonal anti-
color of the drug product; body, sterilization process or test
(C) Replacement of equipment with methodology related to sterilization
that of the same design and operating process validation, relevant validation
principles except for those equipment protocols and/or standard operating
changes described in paragraph procedures;
(b)(3)(ii)(B)(2) of this section; (H) Appropriate documentation (for
(D) A change in the size and/or shape example, updated master batch
of a container containing the same records, specification sheets, etc.) in-
number of dosage units for a nonsterile cluding previously approved docu-
solid dosage form drug product, with- mentation (with the changes high-
out a change from one container clo- lighted) or references to previously ap-
sure system to another; proved documentation;
(E) A change within the container (I) Updated stability data generated
closure system for a nonsterile drug on commercial or production batches
product, based upon a showing of according to an approved stability pro-
equivalency to the approved system tocol or commitment; and
under a protocol approved in the appli- (J) Any other information as directed
cation or published in an official com- by FDA.
pendium; (c) Labeling and other changes to an
(F) An extension of an expiration approved application—(1) General provi-
dating period based upon full shelf-life sions. The applicant must notify FDA
data on production batches obtained about each change in each condition
from a protocol approved in the appli- established in an approved application

cation; beyond the variations already provided
106
for in the application. The notice is re- applications must be placed into effect
quired to describe the change fully. immediately:
(2) Labeling changes requiring the sub- (A) The addition to package labeling,
mission and approval of a supplement promotional labeling, or prescription
prior to distribution of the drug made drug advertising of additional warning,
using the change (major changes). (i) Ad- contraindication, adverse reaction, and
dition of intended uses and changes to precaution information;
package labeling require a supplement. (B) The deletion from package label-
These changes include, but are not lim- ing, promotional labeling, or drug ad-
ited to: vertising of false, misleading, or unsup-
(A) Revision in labeling, such as up- ported intended uses or claims for ef-
dating information pertaining to effectiveness; and
fects, dosages, adverse reactions, con- (C) Any other changes as directed by
traindications, which includes informa- FDA.
tion headed ‘‘adverse reactions,’’ (ii) Labeling changes (for example,
‘‘warnings,’’ ‘‘precautions,’’ and ‘‘con- design and style) that do not decrease
traindications,’’ except ones described safety of drug use proposed in supple-
in (c)(3) of this section; mental applications may be placed into
(B) Addition of an intended use; effect prior to written notice of ap-
(C) If it is a prescription drug, any proval from FDA of a supplemental ap-
mailing or promotional piece used plication.
after the drug is placed on the market (iii) A supplement submitted under
is labeling requiring a supplemental paragraph (c)(3) of this section must in-
application, unless: clude the following information:
(1) The parts of the labeling fur- (A) A full explanation of the basis for
nishing directions, warnings, and infor- the changes, the date on which such
mation for use of the drug are the same changes are being effected, and plainly
in language and emphasis as labeling marked on the mailing cover and on
approved or permitted; and the supplement, ‘‘Supplement—Label-
(2) Any other parts of the labeling ing Changes Being Effected’’;
are consistent with and not contrary to (B) Two sets of printed copies of any
such approved or permitted labeling. revised labeling to be placed in use,
identified with the new animal drug ap-
(3) Prescription drug labeling not re-
plication number; and
quiring an approved supplemental ap-
(C) A statement by the applicant
plication is submitted in accordance
that all promotional labeling and all
with § 514.80(b)(5)(ii).
drug advertising will promptly be re-
(D) Any other changes in labeling,
vised consistent with the changes made
except ones described in paragraph
in the labeling on or within the new
(c)(3) of this section.
animal drug package no later than
(ii) The applicant must obtain ap- upon approval of the supplemental ap-
proval of the supplement from FDA plication.
prior to distribution of the drug. The (iv) If the supplemental application
supplement must contain the fol- is not approved and the drug is being
lowing: distributed with the proposed labeling,
(A) A completed Form FDA 356V; FDA may initiate an enforcement ac-
(B) A detailed description of the pro- tion because the drug is misbranded
posed change; under section 502 of the act and/or
(C) The drug(s) involved; adulterated under section 501 of the
(D) The data derived from studies in act. In addition, under section 512(e) of
support of the change; and the act, FDA may, after due notice and
(E) Any other information as di- opportunity for a hearing, issue an
rected by FDA. order withdrawing approval of the ap-
(3) Labeling changes to be placed into plication.
effect prior to receipt of a written notice (4) Changes providing for additional
of approval of a supplemental application. distributors to be reported under Records
(i) Labeling changes of the following and reports concerning experience with
kinds that increase the assurance of approved new animal drugs (§ 514.80).
drug safety proposed in supplemental Supplemental applications as described
107
§ 514.11 21 CFR Ch. I (4–1–23 Edition)
under paragraph (c)(2) of this section (d) If the existence of an NADA file
will not be required for an additional has been publicly disclosed or acknowl-
distributor to distribute a drug that is edged before the application has been
the subject of an approved new animal approved, no data or information con-
drug application or abbreviated new tained in the file is available for public
animal drug application if the condi- disclosure, but the Commissioner may,
tions described under § 514.80(b)(5)(iii) in his discretion, disclose a summary of
are met. such selected portions of the safety and
(d) Patent information. The applicant effectiveness data as are appropriate
must comply with the patent informa- for public consideration of a specific
tion requirements under section pending issue, i.e., at an open session of
512(c)(3) of the act. a Food and Drug Administration advi-
(e) Claimed exclusivity. If an applicant sory committee or pursuant to an ex-
claims exclusivity under section change of important regulatory infor-
512(c)(2)(F) of the act upon approval of mation with a foreign government.
a supplemental application for a (e) After an application has been ap-
change in its previously approved drug, proved, the following data and informa-
the applicant must include such a tion in the NADA file are immediately
statement. available for public disclosure unless
(f) Good laboratory practice for nonclin- extraordinary circumstances are
ical laboratory studies. A supplemental shown:
application that contains nonclinical (1) All safety and effectiveness data
laboratory studies must include, with and information previously disclosed to
respect to each nonclinical study, ei- the public, as defined in § 20.81 of this
ther a statement that the study was chapter.
conducted in compliance with the re- (2) A summary or summaries of the
quirements set forth in part 58 of this safety and effectiveness data and infor-
chapter, or, if the study was not con- mation submitted with or incorporated
ducted in compliance with such regula- by reference in the NADA file. Such
tions, a brief statement of the reason summaries do not constitute the full
for the noncompliance. reports of investigations under section
[71 FR 74782, Dec. 13, 2006] 512(b)(1) of the act (21 U.S.C. 360b(b)(1))
on which the safety or effectiveness of
§ 514.11 Confidentiality of data and in- the drug may be approved. Such sum-
formation in a new animal drug ap- maries shall consist of the following:
plication file. (i) For an NADA approved prior to
(a) For purposes of this section the July 1, 1975, internal agency records
NADA file includes all data and infor- that describe such data and informa-
mation submitted with or incorporated tion, e.g., a summary of basis for ap-
by reference in the NADA, INAD’s in- proval or internal reviews of the data
corporated into the NADA, supple- and information, after deletion of:
mental NADA’s, reports under §§ 514.80 (a) Names and any information that
and 510.301 of this chapter, master files, would identify the investigators.
and other related submissions. The (b) Any inappropriate gratuitous
availability for public disclosure of any comments unnecessary to an objective
record in the NADA file shall be han- analysis of the data and information.
dled in accordance with the provisions (ii) For an NADA approved after July
of this section. 1, 1975, a summary of such data and in-
(b) The existence of an NADA file formation prepared in one of the fol-
will not be disclosed by the Food and lowing two alternative ways shall be
Drug Administration before the appli- publicly released when the application
cation has been approved, unless it has is approved.
been previously disclosed or acknowl- (a) The Center for Veterinary Medi-
edged. cine may at an appropriate time prior
(c) If the existence of an NADA file to approval of the NADA require the
has not been publicly disclosed or ac- applicant to prepare a summary of
knowledged, no data or information in such data and information, which will
the NADA file is available for public be reviewed and, where appropriate, re-
disclosure. vised by the Center.
108
(b) The Center for Veterinary Medi- as defined in § 20.81 of this chapter or
cine may prepare its own summary of they relate to a product or ingredient
such data and information. that has been abandoned and they no
(3) A protocol for a test or study, un- longer represent a trade secret or con-
less it is shown to fall within the ex- fidential commercial or financial infor-
emption established for trade secrets mation as defined in § 20.61 of this chap-
and confidential commercial informa- ter:
tion in § 20.61 of this chapter. (1) Manufacturing methods or proc-
(4) Adverse reaction reports, product esses, including quality control proce-
experience reports, consumer com- dures.
plaints, and other similar data and in- (2) Production, sales, distribution,
formation, after deletion of: and similar data and information, ex-
(i) Names and any information that cept that any compilation of such data
would identify the person using the and information aggregated and pre-
product. pared in a way that does not reveal
(ii) Names and any information that data or information which is not avail-
would identify any third party involved able for public disclosure under this
with the report, such as a physician, provision is available for public disclo-
hospital, or other institution. sure.
(5) A list of all active ingredients and (3) Quantitative or semiquantitative
any inactive ingredients previously formulas.
disclosed to the public as defined in (h) For purposes of this regulation,
§ 20.81 of this chapter. safety and effectiveness data include
(6) An assay method or other analyt- all studies and tests of an animal drug
ical method, unless it serves no regu- on animals and all studies and tests on
latory or compliance purpose and is the animal drug for identity, stability,
shown to fall within the exemption es- purity, potency, and bioavailability.
tablished in § 20.61 of this chapter. [40 FR 13825, Mar. 27, 1975, as amended at 42
(7) All correspondence and written FR 3109, Jan. 14, 1977; 42 FR 15675, Mar. 22,
summaries of oral discussions relating 1977; 54 FR 18280, Apr. 28, 1989; 68 FR 15365,
to the NADA, in accordance with the Mar. 31, 2003; 79 FR 14611, Mar. 17, 2014]
provisions of part 20 of this chapter.
(f) All safety and effectiveness data § 514.12 Confidentiality of data and in-
and information not previously dis- formation in an investigational new
closed to the public are available for animal drug notice.
public disclosure at the time any one of (a) The existence of an INAD notice
the following events occurs unless ex- will not be disclosed by the Food and
traordinary circumstances are known: Drug Administration unless it has pre-
(1) The NADA has been abandoned viously been publicly disclosed or ac-
and no further work is being under- knowledged.
taken with respect to it. (b) The availability for public disclo-
(2) A final determination is made sure of all data and information in an
that the NADA is not approvable, and INAD file shall be handled in accord-
all legal appeals have been exhausted. ance with provisions established in
(3) Approval of the NADA is with- § 514.11.
drawn, and all legal appeals have been
exhausted. § 514.15 Untrue statements in applica-
(4) A final determination has been tions.
made that the animal drug is not a new Among the reasons why an applica-
animal drug. tion for a new animal drug or animal
(5) A final determination has been feed bearing or containing a new ani-
made that the animal drug may be mal drug may contain an untrue state-
marketed without submission of such ment of a material fact are:
safety and/or effectiveness data and in- (a) Differences in:
formation. (1) Conditions of use prescribed, rec-
(g) The following data and informa- ommended, or suggested by the appli-
tion in an NADA file are not available cant for the product from the condi-
for public disclosure unless they have tions of such use stated in the applica-
been previously disclosed to the public tion;
109
§ 514.80 21 CFR Ch. I (4–1–23 Edition)
(2) Articles used as components of (2) Investigations or experience with

the product from those listed in the ap- the product that is the subject of the
plication; application, or any related product,
(3) Composition of the product from available to the applicant from any
that stated in the application; source if such information is pertinent
(4) Methods used in or the facilities to an evaluation of the safety, effec-
and controls used for the manufacture, tiveness, identity, strength, quality, or
processing, or packing of the product purity of the drug, when such omission
from such methods, facilities, and con- would bias an evaluation of the safety
trols described in the application; or effectiveness of the product.
(5) Labeling from the specimens con- (c) Any nonclinical laboratory study
tained in the application; or contained in the application was not
conducted in compliance with the good
(b) The unexplained omission in
laboratory practice regulations as set
whole or in part from an application or
forth in part 58 of this chapter, and the
from an amendment or supplement to
application fails to include a brief
an application or from any record or
statement of the reason for the non-
report required under the provisions of
compliance.
section 512 of the act and § 514.80 or
§ 510.301 of this chapter of any informa- [40 FR 13825, Mar. 27, 1975, as amended at 49
tion obtained from: FR 7226, Feb. 28, 1984; 50 FR 7517, Feb. 22,
(1) Investigations as to the safety, ef- 1985; 68 FR 15365, Mar. 31, 2003]
fectiveness, identity, strength, quality,
or purity of the drug, made by the ap- Subpart B—Administrative Actions
plicant on the drug, or on Applications
§ 514.80 Records and reports concerning experience with approved new animal
drugs.
The following table outlines the purpose for each paragraph of this section:
Purpose 21 CFR Paragraph and Title
What information must be reported concerning approved NADAs or 514.80(a) Applicability.

ANADAs?
What authority does FDA have for requesting records and reports? 514.80(a)(1).
Who is required to establish, maintain, and report required information re-
lating to experiences with a new animal drug?
Is information from foreign sources required?
What records must be established and maintained and what reports filed 514.80(a)(2).
with FDA?
What is FDA’s purpose for requiring reports? 514.80(a)(3).
Do applicants of Type A medicated articles have to establish, maintain, 514.80(a)(4).

and report information required under § 514.80?
How do the requirements under § 514.80 relate to current good manufac- 514.80(a)(5).
turing practices?
514.80(b) Reporting requirements.
What are the requirements for reporting product/manufacturing defects? 514.80(b)(1) Three-day NADA/ANADA field alert re-
port.
514.80(b)(2) Fifteen-day NADA/ANADA alert report.
What are the requirements for reporting serious and unexpected adverse 514.80(b)(2)(i) Initial report.
drug experiences?
What are the requirements for followup reporting of serious and unex- 514.80(b)(2)(ii) Followup report.
pected adverse drug experiences?
What are the requirements for nonapplicants for reporting adverse drug 514.80(b)(3) Nonapplicant report.
experiences?
110
What are the general requirements for submission of periodic drug experi- 514.80(b)(4) Periodic drug experience report.
ence reports, e.g., method of submission, submission date and fre-
quency, when is it to be submitted, how many copies?
How do I petition to change the date of submission or frequency of sub-
missions?
What must be submitted in the periodic drug experience reports? 514.80(b)(4)(i) through (b)(4)(iv).
What distribution data must be submitted? 514.80(b)(4)(i) Distribution data.

How should the distribution data be submitted?
What labeling materials should be submitted? 514.80(b)(4)(ii) Labeling.

How do I report changes to the labeling materials since the last report?
514.80(b)(4)(iii) Nonclinical laboratory studies and

clinical data not previously reported.
What are the requirements for submission of nonclinical laboratory stud- 514.80(b)(4)(iii)(A).
ies?
What are the requirements for submission of clinical laboratory data? 514.80(b)(4)(iii)(B).
When must results of clinical trials conducted by or for the applicant be re- 514.80(b)(4)(iii)(C).
ported?
514.80(b)(4)(iv) Adverse drug experiences.
How do I report product/manufacturing defects and adverse drug experi- 514.80(b)(4)(iv)(A).

ences not previously reported to FDA?
What are the requirements for submitting adverse drug experiences cited 514.80(b)(4)(iv)(B).
in literature?
What are the requirements for submitting adverse drug experiences in 514.80(b)(4)(iv)(C).
postapproval studies and clinical trials?
What are the requirements for reporting increases in the frequency of seri- 514.80(b)(4)(v) Summary report of increased fre-
ous, expected, and unexpected adverse drug experiences? quency of adverse drug experience.
514.80(b)(5) Other reporting.
Can FDA request that an applicant submit information at different times 514.80(b)(5)(i) Special drug experience report.
than stated specifically in this regulation?
What are the requirements for submission of advertisement and pro- 514.80(b)(5)(ii) Advertisements and promotional la-
motional labeling to FDA? beling.
What are the requirements for adding a new distributor to the approved 514.80(b)(5)(iii) Distributor’s statement.
application?
What labels and how many labels need to be submitted for review? 514.80(b)(5)(iii)(A).
What changes are required and allowed to distributor labeling? 514.80(b)(5)(iii)(A)(1).
What are the requirements for making other changes to the distributor la- 514.80(b)(5)(iii)(A)(2).
beling?
What information should be included in each new distributor’s signed 514.80(b)(5)(iii)(B)(1) through (b)(5)(iii)(B)(5).
statement?
What are the conditions for submitting information that is common to more 514.80(c) Multiple applications.
than one application? (i.e., can I submit common information to one ap-
plication?)
What information has to be submitted to the common application and re- 514.80(c)(1) through (c)(4).
lated application?
What reports must be submitted to FDA electronically? 514.80(d) Format for Submissions.
How can I apply for a waiver from the electronic reporting requirements?
How do I obtain Form FDA 1932 and Form FDA 2301?
How long must I maintain records and reports required by this section? 514.80(e) Records to be maintained.
111
§ 514.80 21 CFR Ch. I (4–1–23 Edition)
What are the requirements for allowing access to these records and re- 514.80(f) Access to records and reports.
ports, and copying by authorized FDA officer or employee?
Where do I mail reports that are not required to be submitted electroni- 514.80(g) Mailing addresses.
cally?
What happens if the applicant fails to establish, maintain, or make the re- 514.80(h) Withdrawal of approval.
quired reports?
What happens if the applicant refuses to allow FDA access to, and/or
copying and/or verify records and reports?
Does an adverse drug experience reflect a conclusion that the report or 514.80(i) Disclaimer.
information constitutes an admission that the drug caused an adverse
effect?
(a) Applicability. (1) Each applicant (4) The requirements of this section
must establish and maintain indexed also apply to any approved Type A
and complete files containing full medicated article. In addition, the re-
records of all information pertinent to quirements contained in § 514.80(b)(1),
safety or effectiveness of a new animal (b)(2), (b)(4)(iv), and (b)(4)(v) apply to
drug that has not been previously sub- any approved Type A medicated article
mitted as part of the NADA or ANADA. incorporated in animal feeds.
Such records must include information (5) The records and reports referred
from domestic as well as foreign to in this section are in addition to
sources. Each nonapplicant must estab- those required by the current good
lish and maintain indexed and com-
manufacturing practice regulations in
plete files containing full records of all
parts 211, 225, and 226 of this chapter.
information pertinent to safety or ef-
fectiveness of a new animal drug that (b) Reporting requirements—(1) Three-
is received or otherwise obtained by day NADA/ANADA field alert report.
the nonapplicant. Such records must This report provides information per-
include information from domestic as taining to product and manufacturing
well as foreign sources. defects that may result in serious ad-
(2) Each applicant must submit reverse drug events. The applicant (or
ports of data, studies, and other infor- nonapplicant through the applicant)
mation concerning experience with must submit the report to the appro-
new animal drugs to the Food and Drug priate FDA District Office or local
Administration (FDA) for each ap- FDA resident post within 3 working
proved NADA and ANADA, as required days of first becoming aware that a de-
in this section. A nonapplicant must fect may exist. The information ini-
submit data, studies, and other infor- tially may be provided by telephone or
mation concerning experience with other telecommunication means, with
new animal drugs to the appropriate prompt written followup using Form
applicant, as required in this section. FDA 1932 ‘‘Veterinary Adverse Drug
The applicant, in turn, must report the Reaction, Lack of Effectiveness, Prod-
nonapplicant’s data, studies, and other uct Defect Report.’’ The mailing cover
information to FDA. Applicants and for these reports must be plainly
nonapplicants must submit data, stud- marked ‘‘3-Day NADA/ANADA Field
ies, and other information described in Alert Report.’’ If the applicant elects
this section from domestic, as well as
to also report directly to the FDA’s
foreign sources.
Center for Veterinary Medicine (CVM),
(3) FDA reviews the records and re-
the applicant must submit the report
ports required in this section to facili-
to CVM in electronic format as de-
tate a determination under section
512(e) of the Federal Food, Drug, and scribed in paragraph (d)(1) of this sec-
Cosmetic Act (21 U.S.C. 360b(e)) as to tion, unless the applicant obtains a
whether there may be grounds for sus- waiver under paragraph (d)(2) of this
pending or withdrawing approval of the section or FDA requests the report in

NADA or ANADA. an alternate format.
112
(2) Fifteen-day NADA/ANADA alert re- or FDA requests the report in an alter-
port—(i) Initial report. This report pro- nate format.
vides information on each serious, un- (4) Periodic drug experience report.
expected adverse drug event, regardless This report must be accompanied by a
of the source of the information. The completed Form FDA 2301 ‘‘Trans-
applicant (or nonapplicant through the mittal of Periodic Reports and Pro-
applicant) must submit the report to motional Materials for New Animal
FDA within 15 working days of first re- Drugs.’’ It must be submitted every 6
ceiving the information. The report months for the first 2 years following
must be submitted to FDA in elec- approval of an NADA or ANADA and
tronic format as described in paragraph
yearly thereafter. Reports required by
(d)(1) of this section, unless the appli-
this section must contain data and in-
cant obtains a waiver under paragraph
(d)(2) of this section or FDA requests formation for the full reporting period.
the report in an alternate format. The 6-month periodic drug experience
(ii) Followup report. The applicant reports must be submitted within 30
must promptly investigate all adverse days following the end of the 6-month
drug events that are the subject of 15- reporting period. The yearly periodic
day NADA/ANADA alert reports. If this drug experience reports must be sub-
investigation reveals significant new mitted within 90 days of the anniver-
information, a followup report must be sary date of the approval of the NADA
submitted within 15 working days of or ANADA. Any previously submitted
receiving such information. A followup information contained in the report
report must be submitted to FDA in must be identified as such. For yearly
electronic format as described in para- (annual) periodic drug experience re-
graph (d)(1) of this section, unless the ports, the applicant may petition FDA
applicant obtains a waiver under para- to change the date of submission or fre-
graph (d)(2) of this section or FDA re- quency of reporting, and after approval
quests the report in an alternate for- of such petition, file such reports on
mat. The followup report must state the new filing date or at the new re-
the date of the initial report and pro- porting frequency. Also, FDA may re-
vide the additional information. If ad- quire a report at different times or
ditional information is sought but not more frequently. The periodic drug ex-
obtained within 3 months of the initial
perience report must contain the fol-
report, a followup report is required de-
lowing:
scribing the steps taken and why addi-
tional information was not obtained. (i) Distribution data. (A) Information
(3) Nonapplicant report. Nonapplicants about the distribution of each new ani-
must forward reports of adverse drug mal drug product, including informa-
experiences to the applicant within 3 tion on any distributor-labeled prod-
working days of first receiving the in- uct. This information must include the
formation. The applicant must then total number of distributed units of
submit the report(s) to FDA as re- each size, strength, or potency (e.g.,
quired in this section. The non- 100,000 bottles of 100 5-milligram tab-
applicant must maintain records of all lets; 50,000 10-milliliter vials of 5-per-
nonapplicant reports, including the cent solution). This information must
date the nonapplicant received the in- be presented in two categories: Quan-
formation concerning adverse drug ex- tities distributed domestically and
periences, the name and address of the quantities exported.
applicant, and a copy of the adverse (B) Applicants submitting annual
drug experience report including the sales and distribution reports for anti-
date such report was submitted to the microbial new animal drug products
applicant. If the nonapplicant elects to under § 514.87 have the option not to re-
also report directly to FDA, the non- port distribution data under paragraph
applicant must submit the report to (b)(4)(i)(A) of this section for the ap-
FDA in electronic format as described
proved applications that include these
in paragraph (d)(1) of this section, un-
same products, but only provided each

less the nonapplicant obtains a waiver
under paragraph (d)(2) of this section of the following conditions are met:
113
§ 514.80 21 CFR Ch. I (4–1–23 Edition)
(1) Applicants must have submitted or otherwise obtained by the applicant.

complete periodic drug experience re- Review articles, papers, and abstracts
ports under this section for such appli- in which the drug is used as a research
cations for at least 2 full years after tool, promotional articles, press clip-
the date of their initial approval. pings, and papers that do not contain
(2) Applicants must ensure that the tabulations or summaries of original
beginning of the reporting period for data are not required to be reported.
the annual periodic drug experience re- (C) Descriptions of completed clinical
ports for such applications is January trials conducted by or for the applicant
1. For applications that currently have must be submitted no later than 1 year
a reporting period that begins on a after completion of research. Sup-
date other than January 1, applicants porting information is not to be re-
must request a change in reporting ported.
submission date such that the report- (iv) Adverse drug experiences. (A)
ing period begins on January 1 and Product/manufacturing defects and ad-
ends on December 31, as described in verse drug experiences not previously
paragraph (b)(4) of this section. reported under paragraphs (b)(1) and (2)
(3) Applicants that change their re- of this section must be reported indi-
porting submission date must also sub- vidually to FDA in electronic format
mit a special drug experience report, as as described in paragraph (d)(1) of this
described in paragraph (b)(5)(i) of this section, unless the applicant obtains a
section, that addresses any gaps in dis- waiver under paragraph (d)(2) of this
tribution data caused by the change in section or FDA requests the report in
date of submission. an alternate format.
(4) Applicants who choose not to re- (B) Reports of adverse drug experi-
port under paragraph (b)(4)(i)(A) of this ences in the literature must be noted
section must ensure that full sales and in the periodic drug experience report.
distribution data for each product ap- A bibliography of pertinent references
proved under such applications are al- must be included with the report. Upon
ternatively reported under § 514.87, in- FDA’s request, the applicant must pro-
cluding products that are labeled for vide a full text copy of these publica-
use only in nonfood-producing animals. tions.
(ii) Labeling. Applicant and dis- (C) Reports of previously not re-
tributor current package labeling, in- ported adverse drug experiences that
cluding package inserts (if any). For occur in postapproval studies must be
large-size package labeling or large reported individually to FDA in elec-
shipping cartons, a representative copy tronic format as described in paragraph
must be submitted (e.g., a photocopy of (d)(1) of this section, unless the appli-
pertinent areas of large feed bags). A cant obtains a waiver under paragraph
summary of any changes in labeling (d)(2) of this section or FDA requests
made since the last report (listed by the report in an alternate format.
date of implementation) must be in- (v) Summary report of increased fre-
cluded with the labeling or if there quency of adverse drug experience. The
have been no changes, a statement of applicant must periodically review the
such fact must be included with the la- incidence of reports of adverse drug ex-
beling. periences to determine if there has
(iii) Nonclinical laboratory studies been an increased frequency of serious
and clinical data not previously re- (expected and unexpected) adverse drug
ported. events. The applicant must evaluate
(A) Copies of in vitro studies (e.g., the increased frequency of serious (ex-
mutagenicity) and other nonclinical pected or unexpected) adverse drug
laboratory studies conducted by or oth- events at least as often as reporting of
erwise obtained by the applicant. periodic drug experience reports. The
(B) Copies of published clinical trials applicant must report the increased
of the new animal drug (or abstracts of frequency of serious (expected and un-
them) including clinical trials on safe- expected) adverse drug events in the
ty and effectiveness, clinical trials on periodic drug experience report. Sum-
new uses, and reports of clinical experi- maries of reports of increased fre-
ence pertinent to safety conducted by quency of adverse drug events must be
114
submitted in narrative form. The sum- (B) A signed statement by the dis-
maries must state the time period on tributor stating:
which the increased frequency is based, (1) The category of the distributor’s
time period comparisons in deter- operations (e.g., wholesale or retail),
mining increased frequency, references (2) That the distributor will dis-
to any reports previously submitted tribute the new animal drug only under
under paragraphs (b)(1), (2), and (3) and the approved labeling,
(b)(4)(iv)(A) and (C) of this section, the (3) That the distributor will promote
method of analysis, and the interpreta- the product only for use under the con-
tion of the results. The summaries ditions stated in the approved labeling,
must be submitted in a separate sec- (4) That the distributor will adhere
tion within the periodic drug experi- to the records and reports require-
ence report. ments of this section, and
(5) Other reporting—(i) Special drug ex- (5) That the distributor is regularly
perience report. Upon written request, and lawfully engaged in the distribu-
FDA may require that the applicant tion or dispensing of prescription prod-
submit a report required under § 514.80 ucts if the product is a prescription
at different times or more frequently new animal drug.
than the timeframes stated in § 514.80. (c) Multiple applications. Whenever an
(ii) Advertisements and promotional la- applicant is required to submit a peri-
beling. The applicant must submit at odic drug experience report under the
the time of initial dissemination one provisions of § 514.80(b)(4) with respect
set of specimens of mailing pieces and to more than one approved NADA or
other labeling for prescription and ANADA for preparations containing
over-the-counter new animal drugs. the same new animal drug so that the
For prescription new animal drugs, the same information is required to be re-
applicant must also submit one set of ported for more than one application,
specimens of any advertisement at the the applicant may elect to submit as a
time of initial publication or broad- part of the report for one such applica-
cast. Mailing pieces and labeling de- tion (the primary application) all the
signed to contain product samples information common to such applica-
must be complete except that product tions in lieu of reporting separately
samples may be omitted. Each submis- and repetitively on each. If the appli-
sion of promotional labeling or adver- cant elects to do this, the applicant
tisements must be accompanied by a must do the following:
completed Form FDA 2301. (1) State when a report applies to
(iii) Distributor’s statement. At the multiple applications and identify all
time of initial distribution of a new related applications for which the re-
animal drug product by a distributor, port is submitted by NADA or ANADA
the applicant must submit a special number.
drug experience report accompanied by (2) Ensure that the primary applica-
a completed Form FDA 2301 containing tion contains a list of the NADA or
the following: ANADA numbers of all related applica-
(A) The distributor’s current product tions.
labeling. (3) Submit a completed Form FDA
(1) The distributor’s labeling must be 2301 to the primary application and
identical to that in the approved each related application with reference
NADA/ANADA except for a different to the primary application by NADA/
and suitable proprietary name (if used) ANADA number and submission date
and the name and address of the dis- for the complete report of the common
tributor. The name and address of the information.
distributor must be preceded by an ap- (4) All other information specific to a
propriate qualifying phrase as per- particular NADA/ANADA must be in-
mitted by the regulations such as cluded in the report for that particular
‘‘manufactured for’’ or ‘‘distributed NADA/ANADA.
by.’’ (d) Format for submissions—(1) Elec-
(2) Other labeling changes must be tronic submissions. Except as provided in
the subject of a supplemental NADA or paragraph (d)(2) of this section, reports

ANADA as described under § 514.8. submitted to FDA under paragraphs
115
§ 514.80 21 CFR Ch. I (4–1–23 Edition)
(b)(2)(i) and (ii), (b)(3), and (b)(4)(iv)(A) dress: Food and Drug Administration,
and (C) of this section and reports sub- Center for Veterinary Medicine, Divi-
mitted to CVM under paragraph (b)(1) sion of Surveillance (HFV–210), 7500
of this section must be submitted in an Standish Pl., Rockville, MD 20855–2764.
electronic format that FDA can proc- (e) Records to be maintained. The ap-
ess, review, and archive. Data provided plicants and nonapplicants must main-
in electronic submissions must be in tain records and reports of all informa-
conformance with the data elements in tion required by this section for a pe-
Form FDA 1932 and FDA technical doc- riod of 5 years after the date of submis-
uments describing transmission. As sion.
necessary, FDA will issue updated (f) Access to records and reports. The
technical documents on how to provide applicant and nonapplicant must, upon
the electronic submission (e.g., method request from any authorized FDA offi-
of transmission and processing, media, cer or employee, at all reasonable
file formats, preparation, and organiza- times, permit such officer or employee
tion of files). Unless requested by FDA, to have access to copy and to verify all
paper copies of reports submitted elec- such required records and reports.
tronically should not be submitted to (g) Mailing addresses. Three-day alert
FDA. reports must be submitted to the ap-
(2) Waivers. An applicant or non- propriate FDA District Office or local
applicant may request, in writing, a
FDA resident post. Addresses for Dis-
temporary waiver of the electronic sub-
trict Offices and resident posts may be
mission requirements in paragraph
obtained on the FDA website. Other re-
(d)(1) of this section. The initial re-
ports not required to be submitted to
quest may be by telephone or email to
FDA in electronic format must be sub-
CVM’s Division of Veterinary Product
mitted to the following address: Food
Safety, with prompt written followup
and Drug Administration, Center for
submitted as a letter to the applica-
Veterinary Medicine, Document Con-
tion(s). FDA will grant waivers on a
trol Unit (HFV–199), 7500 Standish Pl.,
limited basis for good cause shown. If
Rockville, MD 20855–2764.
FDA grants a waiver, the applicant or
nonapplicant must comply with the (h) Withdrawal of approval. If FDA
conditions for reporting specified by finds that the applicant has failed to
FDA upon granting the waiver. establish the required records, or has
(3) Paper forms. If approved by FDA failed to maintain those records, or
before use, a computer-generated failed to make the required reports, or
equivalent of Form FDA 1932 may be has refused access to an authorized
used for reports submitted to the ap- FDA officer or employee to copy or to
propriate FDA District Office or local verify such records or reports, FDA
FDA resident post under paragraph may withdraw approval of the applica-
(b)(1) of this section and to FDA under tion to which such records or reports
paragraph (d)(2) of this section, and a relate. If FDA determines that with-
computer-generated equivalent of drawal of the approval is necessary, the
Form FDA 2301 may be used for reports agency shall give the applicant notice
submitted to FDA under paragraph and opportunity for hearing, as pro-
(b)(4) of this section. Form FDA 1932 vided in § 514.200, on the question of
may be obtained on the FDA website, whether to withdraw approval of the
by telephoning CVM’s Division of Vet- application.
erinary Product Safety, or by submit- (i) Disclaimer. Any report or informa-
ting a written request to the following tion submitted under this section and
address: Food and Drug Administra- any release of that report or informa-
tion, Center for Veterinary Medicine, tion by FDA will be without prejudice
Division of Veterinary Product Safety and does not necessarily reflect a con-
(HFV–240), 7500 Standish Pl., Rockville, clusion that the report or information
MD 20855–2764. Form FDA 2301 may be constitutes an admission that the drug
obtained on the FDA website, by tele- caused or contributed to an adverse
phoning CVM’s Division of Surveil- event. A person need not admit, and
lance (HFV–210), or by submitting a may deny, that the report or informa-

written request to the following ad- tion constitutes an admission that a
116
drug caused or contributed to an ad- chickens, turkeys. The total of the spe-
verse event. cies-specific percentages reported for
each product must account for 100 per-
FR 29141, May 11, 2016; 85 FR 45512, July 29, cent of its sales and distribution;
2020] therefore, a fifth category of ‘‘other
species/unknown’’ must also be re-
§ 514.87 Annual reports for anti- ported.
microbial animal drug sales and (d) Each report must:
distribution. (1) Be submitted not later than
(a) The applicant for each new ani- March 31 each year;
mal drug product approved under sec- (2) Cover the period of the preceding
tion 512 of the Federal Food, Drug, and calendar year; and
Cosmetic Act, or conditionally ap- (3) Be submitted using Form FDA
proved under section 571 of the Federal 3744, ‘‘Antimicrobial Animal Drug Dis-
Food, Drug, and Cosmetic Act, and tribution Report.’’
containing an antimicrobial active in- (e) Sales and distribution data and
gredient, must submit an annual report information reported under this sec-
to FDA on the amount of each such tion will be considered to fall within
antimicrobial active ingredient in the the exemption for confidential com-
drug that is sold or distributed in the mercial information established in
reporting year for use in food-pro- § 20.61 of this chapter and will not be
ducing animal species, including infor- publicly disclosed, except that sum-
mation on any distributor-labeled mary reports of such information ag-
product. gregated in such a way that does not
(b) This report must identify the ap- reveal information that is not avail-
proved or conditionally approved appli- able for public disclosure under this
cation and must include the following provision will be prepared by FDA and
information for each new animal drug made available to the public as pro-
product described in paragraph (a) of vided in paragraph (f) of this section.
this section: (f) FDA will publish an annual sum-
(1) A listing of each antimicrobial ac- mary report of the data and informa-
tive ingredient contained in the prod- tion it receives under this section for
uct; each calendar year by December 31 of
(2) A description of each product sold the following year. Such annual re-
or distributed by unit, including the ports must include a summary of sales
container size, strength, and dosage and distribution data and information
form of such product units; by antimicrobial drug class and may
(3) For each such product, a listing of include additional summary data and
the target animal species, indications, information as determined by FDA. In
and production classes that are speci- order to protect confidential commer-
fied on the approved label; cial information, each individual
(4) For each such product, the num- datum appearing in the summary re-
ber of units sold or distributed in the port must:
United States (i.e., domestic sales) for (1) Reflect combined product sales
each month of the reporting year; and and distribution data and information
(5) For each such product, the num- obtained from three or more distinct
ber of units sold or distributed outside sponsors of approved products that
the United States (i.e., quantities ex- were actively sold or distributed that
ported) for each month of the reporting reporting year, and
year. (2) Be reported in a manner con-
(c) Each report must also provide a sistent with protecting both national
species-specific estimate of the per- security and confidential commercial
centage of each product described in information.
paragraph (b)(2) of this section that [81 FR 29141, May 11, 2016]
was sold or distributed domestically in
the reporting year for use in any of the § 514.100 Evaluation and comment on
following animal species categories, applications.
but only for such species that appear (a) After the filed application has
on the approved label: Cattle, swine, been evaluated, the applicant will be
117
§ 514.100 21 CFR Ch. I (4–1–23 Edition)
furnished written comment on any ap- tion concerning hazards, contraindica-

parent deficiencies in the application. tions, side effects, and precautions rel-
(b) When the description of the meth- evant with respect to any uses for
ods used in, and the facilities and con- which such drug is to be prescribed.
trols used for, the manufacture, proc- (2) The application fails to show that
essing, and packing of such new animal the labeling and advertising of such
drug appears adequate on its face, but drug will offer the drug for use only
it is not feasible to reach a conclusion under those conditions for which it is
as to the safety and effectiveness of the offered in the labeling that is part of
new animal drug solely from consider- the application.
ation of this description, the applicant
(3) The application fails to show that
may be notified that an establishment
inspection is required to verify their all labeling that furnishes or purports
adequacy. to furnish information for professional
(c) A request for samples of a new use of such drug will contain, in the
animal drug or any edible tissues and same language and emphasis, the infor-
byproducts of animals treated with mation for use including indications,
such a drug, shall specify the quantity effects, dosages, routes, methods, and
deemed adequate to permit tests of an- frequency and duration of administra-
alytical methods to determine their tion and any relevant warnings, haz-
adequacy for regulatory purposes. The ards, contraindications, side effects,
request should be made as early in the and precautions, which is contained in
180-day period as possible to assure the labeling that is part of the applica-
timely completion. The date used for tion in accordance with § 201.105 of this
computing the 180-day limit for the chapter.
purposes of section 512(c) of the act (e) The information contained in an
shall be moved forward 1 day for each application will be considered insuffi-
day after the mailing date of the re- cient to determine whether a new ani-
quest until all of the requested samples mal drug is safe and effective for use
are received. If the samples are not re- when there is a refusal or failure upon
ceived within 90 days after the request, written notice to furnish inspectors au-
the application will be considered with-
thorized by the Food and Drug Admin-
drawn without prejudice.
istration an adequate opportunity to
(d) The information contained in an
inspect the facilities, controls, and
application may be insufficient to de-
termine whether a new animal drug is records pertinent to the application.
safe or effective in use if it fails to in- (f) On the basis of preliminary con-
clude (among other things) a statement sideration of an application or supple-
showing whether such drug is to be mental application containing type-
limited to prescription sale and exempt written or other draft labeling in lieu
under section 502(f) of the act from the of final printed labeling, an applicant
requirement that its labeling bear ade- may be informed that such application
quate directions for lay use. If such is approvable when satisfactory final
drug is to be exempt, the information printed labeling identical in content to
may also be insufficient if: such draft copy is submitted.
(1) The specimen labeling proposed (g) When an application has been
fails to bear adequate information for found incomplete on the basis of a need
professional use including indications, for the kind of information described
effects, dosages, routes, methods, and in § 514.6, such application shall be con-
frequency and duration of administra- sidered withdrawn without prejudice to
tion and any relevant hazards, contra- future filing on the date of issuance of
indications, side effects, and pre- the letter citing the inadequacies con-
cautions under which practitioners li- tained in the application, unless within
censed by law to administer such drug
30 days the sponsor chooses to avail
can use the drug for the purposes for
himself of the opportunity for hearing
which it is intended, including all pur-
poses for which it is to be advertised, as prescribed by § 514.111.
or represented, in accordance with

§ 201.105 of this chapter, and informa-
118
§ 514.105 Approval of applications. (iv) A change in container, container

style, shape, size, or components.
(a) The Commissioner shall forward
(v) A change in approved labeling
for publication in the FEDERAL REG-
(color, style, format, addition, dele-
ISTER a regulation prescribing the con-
tion, or revision of certain statements,
ditions under which the new animal
e.g., trade name, storage, expiration
drug may be used, including the name
dates, etc).
and address of the applicant; the condi-
(vi) A change in promotional mate-
tions and indications for use covered
rial for a prescription new animal drug
by the application; any tolerance,
not exempted by § 514.8(c)(2)(i)(C)(1)
withdrawal period, or other use restric-
through (c)(2)(i)(C)(3).
tions; any tolerance required for the
(vii) Changes in manufacturing proc-
new animal drug substance or its me-
esses that do not alter the method of
tabolites in edible products of food-pro-
manufacture or change the final dosage
ducing animals; and, if such new ani-
form.
mal drug is intended for use in animal
(viii) A change in bulk drug ship-
feed, appropriate purposes and condi-
ments.
tions of use (including special labeling
(ix) A change in an analytical meth-
requirements) applicable to any animal
od or control procedures that do not
feed; and such other information the
alter the approved standards.
Commissioner deems necessary to as-
(x) A change in an expiration date.
sure safe and effective use.
(xi) Addition of an alternate manu-
(b) He shall notify the applicant by
facturer, repackager, or relabeler of
sending him a copy of the proposed
the drug product.
publication as described in paragraph
(xii) Addition of an alternate supplier
(a)(1) of this section.
of the new drug substance.
[40 FR 13825, Mar. 27, 1975, as amended at 51 (xiii) A change permitted in advance
FR 7392, Mar. 3, 1986; 64 FR 63203, Nov. 19, of approval as described under
1999] § 514.8(b)(3).
(2) Category II. Supplements that may
§ 514.106 Approval of supplemental ap- require a reevaluation of certain safety
plications.
or effectiveness data in the parent ap-
(a) Within 180 days after a supple- plication. Category II supplements in-
ment to an approved application is clude the following:
filed pursuant to § 514.8, the Commis- (i) A change in the active ingredient
sioner shall approve the supplemental concentration or composition of the
application in accordance with proce- final product.
dures set forth in § 514.105(a)(1) and (2) (ii) A change in quality, purity,
if he/she determines that the applica- strength, and identity specifications of
tion satisfies the requirements of ap- the active or inactive ingredients.
plicable statutory provisions and regu- (iii) A change in dose (amount of
lations. drug administered per dose).
(b) The Commissioner will assign a (iv) A change in the treatment regi-
supplemental application to its proper men (schedule of dosing).
category to ensure processing of the (v) Addition of a new therapeutic
application. claim to the approved uses of the prod-
(1) Category I. Supplements that ordi- uct.
narily do not require a reevaluation of (vi) Addition of a new or revised ani-
any of the safety or effectiveness data mal production claim.
in the parent application. Category I (vii) Addition of a new species.
supplements include the following: (viii) A change in the prescription or
(i) A corporate change that alters the over-the-counter status of a drug prod-
identity or address of the sponsor of uct.
the new animal drug application (ix) A change in statements regard-
(NADA). ing side effects, warnings, precautions,
(ii) The sale, purchase, or construc- and contraindications, except the addi-
tion of manufacturing facilities. tion of approved statements to con-
(iii) The sale or purchase of an tainer, package, and promotional label-

NADA. ing, and prescription drug advertising.
119
§ 514.110 21 CFR Ch. I (4–1–23 Edition)
(x) A change in the drug withdrawal that has not been registered or exempt-
period prior to slaughter or in the milk ed from registration under the provi-
discard time. sions of section 510 of the act.
(xi) A change in the tolerance for (6) The sponsor does not reside or
drug residues. maintain a place of business within the
(xii) A change in analytical methods United States and the application has
for drug residues. not been countersigned by an attorney,
(xiii) A revised method of synthesis agent, or other representative of the
or fermentation of the new drug sub-
applicant, which representative resides
stance.
in the United States and has been duly
(xiv) Updating or changes in the
manufacturing process of the new drug authorized to act on behalf of the ap-
substance and/or final dosage form plicant and to receive communications
(other than a change in equipment that on all matters pertaining to the appli-
does not alter the method of manufac- cation.
ture of a new animal drug, or a change (7) The new animal drug is a drug
from one commercial batch size to an- subject to licensing under the animal
other without any change in manufac- virus, serum, and toxin law of March 4,
turing procedure), or changes in the 1913 (37 Stat. 832; 21 U.S.C. 151 et seq. ).
methods, facilities, or controls used for Such applications will be referred to
the manufacture, processing, pack- the U.S. Department of Agriculture for
aging, or holding of the new animal action.
drug (other than use of an establish- (8) It fails to include, with respect to
ment not covered by the approval that each nonclinical laboratory study con-
is in effect) that give increased assur- tained in the application, either a
ance that the drug will have the char- statement that the study was con-
acteristics of identity, strength, qual- ducted in compliance with the good
ity, and purity which it purports or is laboratory practice regulations set
represented to possess. forth in part 58 of this chapter, or, if
[55 FR 46052, Nov. 1, 1990; 55 FR 49973, Dec. 3, the study was not conducted in compli-
1990; 56 FR 12422, Mar. 25, 1991, as amended at ance with such regulations, a brief
71 FR 74785, Dec. 13, 2006] statement of the reasons for the non-
§ 514.110 Reasons for refusing to file compliance.
applications. (9) [Reserved]
(a) The date of receipt of an applica- (10) The applicant fails to submit a
tion for a new animal drug shall be the complete environmental assessment
date on which the application shall be under § 25.40 of this chapter or fails to
deemed to be filed. provide sufficient information to estab-
(b) An application for a new animal lish that the requested action is sub-
drug shall not be considered acceptable ject to categorical exclusion under
for filing for any of the following rea- § 25.30 or § 25.33 of this chapter.
sons: (c) If an application is determined
(1) It does not contain complete and not to be acceptable for filing, the ap-
accurate English translations of any plicant shall be notified within 30 days
pertinent part in a foreign language. of receipt of the application and shall
(2) Fewer than three copies are sub- be given the reasons therefore.
mitted. (d) If the applicant disputes the find-
(3) It is incomplete on its face in that ings that his application is not accept-
it is not properly organized and in- able for filing, he may make written
dexed. request that the application be filed
(4) On its face the information con-
over protest, in which case it will be
cerning required matter is so inad-
filed as of the day originally received.
equate that the application is clearly
not approvable. [40 FR 13825, Mar. 27, 1975, as amended at 50
(5) The new animal drug is to be man- FR 7517, Feb. 22, 1985; 50 FR 16668, Apr. 26,
ufactured, prepared, propagated, com- 1985; 62 FR 40600, July 29, 1997]
pounded, or processed in whole or in

part in any State in an establishment
120
§ 514.111 Refusal to approve an appli- in the proposed labeling are reasonably

cation. certain to be followed in practice; or
(a) The Commissioner shall, within (5) Evaluated on the basis of informa-
180 days after the filing of the application submitted as part of the applica-
tion, inform the applicant in writing of tion and any other information before
his intention to issue a notice of oppor- the Food and Drug Administration
tunity for a hearing on a proposal to with respect to such drug, there is lack
refuse to approve the application, if the of substantial evidence as defined in
Commissioner determines upon the § 514.4.
basis of the application, or upon the (6) Failure to include an appropriate
basis of other information before him proposed tolerance for residues in edi-
with respect to a new animal drug, ble products derived from animals or a
that: withdrawal period or other restrictions
(1) The reports of investigations re- for use of such drug if any tolerance or
quired to be submitted pursuant to sec- withdrawal period or other restrictions
tion 512(b) of the act do not include for use are required in order to assure
adequate tests by all methods reason- that the edible products derived from
ably applicable to show whether or not animals treated with such drug will be
such drug is safe for use under the con- safe.
ditions prescribed, recommended, or (7) Based on a fair evaluation of all
suggested in the proposed labeling material facts, the labeling is false or
thereof; or misleading in any particular; or
(2) The results of such tests show (8) Such drug induces cancer when in-
that such drug is unsafe for use under gested by man or animal or, after ap-
such conditions or do not show that propriate tests for evaluation of the
such drug is safe for use under such safety of such drug, induces cancer in
conditions; or man or animal, except that this sub-
(3) The methods used in and the fa- paragraph shall not apply with respect
cilities and controls used for the manu- to such drug if the Commissioner finds
facture, processing, and packing of that, under the conditions of use speci-
such drug are inadequate to preserve fied in proposed labeling and reason-
its identity, strength, quality, and pu- ably certain to be followed in practice:
rity; or (i) Such drug will not adversely af-
(4) Upon the basis of the information fect the animal for which it is in-
submitted to the Food and Drug Ad- tended; and
ministration as part of the application, (ii) No residue of such drug will be
or upon the basis of any other informa- found (by methods of examination pre-
tion before it with respect to such scribed or approved by the Commis-
drug, it has insufficient information to sioner by regulations) in any edible
determine whether such drug is safe for portion of such animal after slaughter
use under such conditions. In making or in any food yielded by, or derived
this determination the Commissioner from the living animals.
shall consider, among other relevant (9) The applicant fails to submit an
factors: adequate environmental assessment
(i) The probable consumption of such under § 25.40 of this chapter or fails to
drug and of any substance formed in or provide sufficient information to estab-
on food because of the use of such drug; lish that the requested action is sub-
(ii) The cumulative effect on man or ject to categorical exclusion under
animal of such drug, taking into ac- § 25.30 or § 25.33 of this chapter.
count any chemically or pharmacologi- (10) The drug fails to satisfy the re-
cally related substances; quirements of subpart E of part 500 of
(iii) Safety factors which, in the this chapter.
opinion of experts qualified by sci- (11) Any nonclinical laboratory study
entific training and experience to that is described in the application and
evaluate the safety of such drugs, are that is essential to show that the drug
appropriate for the use of animal ex- is safe for use under the conditions pre-
perimentation data; and scribed, recommended, or suggested in
(iv) Whether the conditions of use its proposed labeling, was not con-
prescribed, recommended, or suggested ducted in compliance with the good
121
§ 514.115 21 CFR Ch. I (4–1–23 Edition)
laboratory practice regulations as set (2) That the applicant has made any
forth in part 58 of this chapter and no changes from the standpoint of safety
reason for the noncompliance is pro- or effectiveness beyond the variations
vided or, if it is, the differences be- provided for in the application unless
tween the practices used in conducting he has supplemented the application by
the study and the good laboratory filing with the Secretary adequate in-
practice regulations do not support the formation respecting all such changes
validity of the study. and unless there is in effect an ap-
(12) The drug will be produced in proval of the supplemental application,
whole or in part in an establishment or such changes are those for which
that is not registered and not exempt
written authorization or approval is
from registration under section 510 of
not required as provided for in § 514.8.
the Federal Food, Drug, and Cosmetic
The supplemental application shall be
Act and part 207 of this chapter.
(b) The Commissioner, as provided in treated in the same manner as the
§ 514.200 of this chapter, shall expedi- original application.
tiously notify the applicant of an op- (3) That in the case of an application
portunity for a hearing on the question for use of a new animal drug approved
of whether such application is approv- or deemed approved pursuant to sec-
able, unless by the 30th day following tion 512(c) of the act:
the date of issuance of the letter in- (i) Experience or scientific data show
forming the applicant of the intention that such drug is unsafe for use under
to issue a notice of opportunity for a the conditions of use upon the basis of
hearing the applicant: which the application was approved; or
(1) Withdraws the application; or (ii) New evidence not contained in
(2) Waives the opportunity for a hear- such application or not available to the
ing; or Secretary until after such application
(3) Agrees with the Commissioner on was approved, or tests by new methods,
an additional period to precede or tests by methods not deemed reason-
issuance of such notice of hearing.
ably applicable when such application
[40 FR 13825, Mar. 27, 1975, as amended at 43 was approved, evaluated together with
FR 22675, May 26, 1978; 44 FR 16007, Mar. 16, the evidence available to the Secretary
1979; 50 FR 7517, Feb. 22, 1985; 50 FR 16668,
when the application was approved,
Apr. 26, 1985; 52 FR 49588, Dec. 31, 1987; 54 FR
18280, Apr. 28, 1989; 62 FR 40600, July 29, 1997; shows that such drug is not shown to
63 FR 10770, Mar. 5, 1998; 64 FR 40757, July 28, be safe for use under the conditions of
1999; 64 FR 63204, Nov. 19, 1999; 81 FR 60221, use upon the basis of which the appli-
Aug. 31, 2016] cation was approved or that section 512
(d)(1)(H) of the act applies to such drug;
§ 514.115 Withdrawal of approval of
applications. or
(iii) On the basis of new information
(a) The Secretary may suspend ap- before him with respect to such drug,
proval of an application approved pur- evaluated together with the evidence
suant to section 512(c) of the act and
available to him when the application
give the applicant prompt notice of his
was approved, there is a lack of sub-
action and afford the applicant the op-
portunity for an expedited hearing on a stantial evidence that such drug will
finding that there is an imminent haz- have the effect it purports or is rep-
ard to the health of man or of the ani- resented to have under the conditions
mals for which such new animal drug of use prescribed, recommended, or
or animal feed is intended. suggested in the labeling thereof.
(b) The Commissioner shall notify in (4) That any nonclinical laboratory
writing the person holding an applica- study that is described in the applica-
tion approved pursuant to section tion and that is essential to show that
512(c) of the act and afford an oppor- the drug is safe for use under the condi-
tunity for a hearing on a proposal to tions prescribed, recommended, or sug-
withdraw approval of such application gested in its proposed labeling, was not
if he finds: conducted in compliance with the good
(1) That the application contains any laboratory practice regulations as set
untrue statement of a material fact; or forth in part 58 of this chapter and no
122
reason for the noncompliance is pro- (c) of this section pertain to the sub-
vided or, if it is, the differences be- ject drug. A written request for such
tween the practices used in conducting withdrawal shall be construed as a
the study and the good laboratory waiver of the opportunity for a hearing
practice regulations do not support the as otherwise provided for in this sec-
validity of the study. tion. Withdrawal of approval of an ap-
(c) The Commissioner may notify in plication under the provisions of this
writing the person holding an applica- paragraph shall be without prejudice.
tion approved pursuant to section (e) On the basis of the withdrawal of
512(c) of the act and afford an oppor- approval of an application for a new
tunity for a hearing on a proposal to animal drug approved pursuant to sec-
withdraw approval of such application tion 512(c) of the act, the regulation
if he finds: published pursuant to section 512(i) of
(1) That the applicant has failed to the act covering the conditions of use
establish a system for maintaining re- of such drug as provided for in the ap-
quired records, or has repeatedly or de- plication shall be revoked.
liberately failed to maintain such
records or to make required reports in [40 FR 13825, Mar. 27, 1975, as amended at 50
accordance with a regulation or order FR 7517, Feb. 22, 1985; 64 FR 63204, Nov. 19,
1999]
under section 512(l)(1) of the act, or the
applicant has refused to permit access § 514.116 Notice of withdrawal of ap-
to, or copying, or verification of, such proval of application.
records as required by section 512(l)(2)
of the act; or When an approval of an application
(2) That on the basis of new informa- submitted pursuant to section 512 of
tion before him evaluated together the act is withdrawn by the Commis-
with the evidence before him when the sioner, he will give appropriate public
application was approved, the methods notice of such action by publication in
used in, or the facilities and controls the FEDERAL REGISTER.
used for, the manufacture, processing,
and packing of such drug or animal § 514.117 Adequate and well-controlled
feed are inadequate to assure and pre- studies.
serve its identity, strength, quality, (a) Purpose. The primary purpose of
and purity and were not made adequate conducting adequate and well-con-
within a reasonable time after receipt trolled studies of a new animal drug is
of written notice from the Secretary to distinguish the effect of the new ani-
specifying the matter complained of; or mal drug from other influences, such as
(3) That on the basis of new informa- spontaneous change in the course of
tion before him, evaluated together the disease, normal animal production
with the evidence before him when the performance, or biased observation.
application was approved, the labeling One or more adequate and well-con-
of such drug, based on a fair evaluation trolled studies are required to estab-
of all material facts, is false or mis- lish, by substantial evidence, that a
leading in any particular and was not new animal drug is effective. The char-
corrected within a reasonable time acteristics described in paragraph (b)
after receipt of written notice from the of this section have been developed
Secretary specifying the matter com- over a period of years and are generally
plained of. recognized as the essentials of an ade-
(d) Approval of an application pursu- quate and well-controlled study. Well
ant to section 512(c) of the act will be controlled, as used in the phrase ade-
withdrawn on the basis of a request for quate and well controlled, emphasizes
its withdrawal submitted in writing by an important aspect of adequacy. The
a person holding an approved new ani- Food and Drug Administration (FDA)
mal drug application on the grounds considers these characteristics in de-
that the drug subject to such applica- termining whether a study is adequate
tion is no longer being marketed and and well controlled for purposes of sec-
information is included in support of tion 512 of the Federal Food, Drug, and
this finding, provided none of the con- Cosmetic Act (the act) (21 U.S.C. 360b).
ditions cited in paragraphs (a), (b), and Adequate and well-controlled studies,
123
§ 514.117 21 CFR Ch. I (4–1–23 Edition)
in addition to providing a basis for de- and the study report must describe the
termining whether a new animal drug precise nature of the study design, e.g.,
is effective, may also be relied upon to duration of treatment periods, whether
support target animal safety. The re- treatments are parallel, sequential, or
port of an adequate and well-controlled crossover, and the determination of
study should provide sufficient details sample size. Within the broad range of
of study design, conduct, and analysis studies conducted to support a deter-
to allow critical evaluation and a de- mination of the effectiveness of a new
termination of whether the character- animal drug, certain of the controls
istics of an adequate and well-con- listed below would be appropriate and
trolled study are present. preferred depending on the study con-
(b) Characteristics. An adequate and ducted:
well-controlled study has the following (i) Placebo concurrent control. The new
characteristics: animal drug is compared with an inac-
(1) The protocol for the study (pro- tive preparation designed to resemble
tocol) and the report of the study re- the new animal drug as far as possible.
sults (study report) must include a (ii) Untreated concurrent control. The
clear statement of the study objec- new animal drug is compared with the
tive(s). absence of any treatment. The use of
(2) The study is conducted in accord- this control may be appropriate when
ance with an appropriate standard of objective measurements of effective-
conduct that addresses, among other ness, not subject to observer bias, are
issues, study conduct, study personnel, available.
study facilities, and study documenta- (iii) Active treatment concurrent con-
tion. The protocol contains a state- trol. The new animal drug is compared
ment acknowledging the applicability with known effective therapy. The use
of, and intention to follow, a standard of this control is appropriate when the
of conduct acceptable to FDA. The use of a placebo control or of an un-
study report contains a statement de- treated concurrent control would un-
scribing adherence to the standard. reasonably compromise the welfare of
(3) The study is conducted with a new the animals. Similarity of the new ani-
animal drug that is produced in accord- mal drug and the active control drug
ance with appropriate manufacturing can mean either that both drugs were
practices, which include, but are not effective or that neither was effective.
necessarily limited to, the manufac- The study report should assess the
ture, processing, packaging, holding, ability of the study to have detected a
and labeling of the new animal drug difference between treatments. The
such that the critical characteristics of evaluation of the study should explain
identity, strength, quality, purity, and why the new animal drugs should be
physical form of the new animal drug considered effective in the study, for
are known, recorded, and reproducible, example, by reference to results in pre-
to permit meaningful evaluations of vious placebo-controlled studies of the
and comparisons with other studies active control.
conducted with the new animal drug. (iv) Historical control. The results of
The physical form of a new animal treatment with the new animal drug
drug includes the formulation and are quantitatively compared with expe-
physical characterization (including rience historically derived from the
delivery systems thereof, if any) of the adequately documented natural history
new animal drug as presented to the of the disease or condition, or with a
animal. The protocol and study report regimen (therapeutic, diagnostic, pro-
must include an identification number phylactic) whose effectiveness is estab-
which can be correlated with the spe- lished, in comparable animals. Because
cific formulation and production proc- historical control populations usually
ess used to manufacture the new ani- cannot be as well assessed with respect
mal drug used in the study. to pertinent variables as can concur-
(4) The study uses a design that per- rent control populations, historical
mits a valid comparison with one or control designs are usually reserved for
more controls to provide a quantitative special circumstances. Examples in-

evaluation of drug effects. The protocol clude studies in which the effect of the
124
new animal drug is self-evident or stud- as ‘‘blinding’’ or ‘‘masking,’’ used in

ies of diseases with high and predict- the study for excluding or minimizing
able mortality, or signs and symptoms bias in the observations.
of predictable duration or severity, or, (8) The study uses methods to assess
in the case of prophylaxis, predictable animal response that are well defined
morbidity. and reliable. The protocol and study re-
(5) The study uses a method of select- port describe the methods for con-
ing animals that provides adequate as- ducting the study, including any appro-
surances that the animals are suitable priate analytical and statistical meth-
for the purposes of the study. For ex- ods, used to collect and analyze the
ample, the animals can reasonably be data resulting from the conduct of the
expected to have animal production study, describe the criteria used to as-
characteristics typical of the class(es) sess response, and, when appropriate,
of animals for which the new animal justify the selection of the methods to
drug is intended, there is adequate as- assess animal response.
surance that the animals have the dis- (9) There is an analysis and evalua-
ease or condition being studied, or, in tion of the results of the study in ac-
the case of prophylactic agents, evi- cord with the protocol adequate to as-
dence of susceptibility and exposure to sess the effects of the new animal drug.
the condition against which prophy- The study report evaluates the meth-
laxis is desired has been provided. The ods used to conduct, and presents and
protocol and the study report describe evaluates the results of, the study as to
the method of selecting animals for the their adequacy to assess the effects of
study. the new animal drug. This evaluation
(6) The study uses a method to assign of the results of the study assesses,
a treatment or a control to each exper- among other items, the comparability
imental unit of animals that is random of treatment and control groups with
and minimizes bias. Experimental respect to pertinent variables and the
units of animals are groups of animals effects of any interim analyses per-
that are comparable with respect to formed.
pertinent variables such as age, sex, (c) Field studies. (1) Field conditions
class of animal, severity of disease, du- as used in this section refers to condi-
ration of disease, dietary regimen, tions which closely approximate the
level of animal production, and use of conditions under which the new animal
drugs or therapy other than the new drug, if approved, is intended to be ap-
animal drug. The protocol and the plied or administered.
study report describe the method of as- (2) Studies of a new animal drug con-
signment of animals to an experi- ducted under field conditions shall,
mental unit to account for pertinent consistent with generally recognized
variables and method of assignment of scientific principles and procedures,
a treatment or a control to the experi- use an appropriate control that per-
mental units. When the effect of such mits comparison, employ procedures to
variables is accounted for by an appro- minimize bias, and have the character-
priate design, and when, within the istics generally described in paragraph
same animal, effects due to the test (b) of this section. However, because
drug can be obtained free of the effects field studies are conducted under field
of such variables, the same animal may conditions, it is recognized that the
be used for both the test drug and the level of control over some study condi-
control using the controls set forth in tions need not or should not be the
paragraph (b)(4) of this section. same as the level of control in labora-
(7) The study uses methods to mini- tory studies. While not all conditions
mize bias on the part of observers and relating to a field study need to be or
analysts of the data that are adequate should be controlled, observations of
to prevent undue influences on the re- the conditions under which the new
sults and interpretation of the study animal drug is tested shall be recorded
data. The protocol and study report ex- in sufficient detail to permit evalua-
plain the methods of observation and tion of the study. Adequate and well-
recording of the animal response vari- controlled field studies shall balance
ables and document the methods, such the need to control study conditions
125
§ 514.120 21 CFR Ch. I (4–1–23 Edition)
with the need to observe the true effect pertaining to new animal drug applica-
of the new animal drug under closely tions shall be served:
approximated actual use conditions. (a) In person by any officer or em-
(d) Waiver. The Director of the Center ployee of the Department designated
for Veterinary Medicine (the Director) by the Commissioner; or
may, on the Director’s own initiative (b) By mailing the order by certified
or on the petition of an interested per- mail addressed to the applicant or re-
son, waive in whole or in part any of spondent at his last known address in
the criteria in paragraph (b) of this sec- the records of the Food and Drug Ad-
tion with respect to a specific study. A ministration.
petition for a waiver is required to set
forth clearly and concisely the specific
criteria from which waiver is sought, Subpart C—Hearing Procedures
why the criteria are not reasonably ap-
plicable to the particular study, what § 514.200 Notice of opportunity for
hearing; notice of participation and
alternative procedures, if any, are to requests for hearing; grant or de-
be, or have been employed, and what nial of hearing.
results have been obtained. The peti-
tion is also required to state why the (a) The notice to the applicant of op-
studies so conducted will yield, or have portunity for a hearing on a proposal
yielded, substantial evidence of effec- by the Commissioner to refuse to ap-
tiveness, notwithstanding nonconform- prove an application or to withdraw
ance with the criteria for which waiver the approval of an application will be
is requested. published in the FEDERAL REGISTER to-
(e) Uncontrolled studies. Uncontrolled gether with an explanation of the
studies or partially controlled studies grounds for the proposed action. The
are not acceptable as the sole basis for notice will describe how to request a
the approval of claims of effectiveness hearing. An applicant has 30 days after
or target animal safety. Such studies, publication of the notice to request a
carefully conducted and documented, hearing.
may provide corroborative support of (b) If the applicant fails to request a
adequate and well-controlled studies hearing within the 30-day timeframe,
regarding effectiveness and may yield the Commissioner, without further no-
valuable data regarding safety of the tice, will publish a final order denying
new animal drug. Such studies will be or withdrawing approval of the applica-
considered on their merits in light of tion.
the characteristics listed here. Isolated (c) If the applicant desires to request
case reports, random experience, and a hearing:
reports lacking the details which per- (1) Within 30 days after publication of
mit scientific evaluation will not be the notice of opportunity for hearing,
considered. the applicant must submit to the Divi-
[63 FR 10770, Mar. 5, 1998] sion of Dockets Management written
objections and a request for a hearing
§ 514.120 Revocation of order refusing in accordance with §§ 12.20 and 12.22.
to approve an application or sus- This request for a hearing must include
pending or withdrawing approval each specific objection to the proposal
of an application. on which a hearing is requested, to-
The Commissioner, upon his own ini- gether with a detailed description and
tiative or upon request of an applicant analysis of the factual information (in-
stating reasonable grounds therefor cluding all relevant clinical and other
and if he finds that the facts so require, investigational data) the applicant will
may issue an order approving an appli- present in support of that objection. A
cation that previously has had its ap- request for a hearing may not rest
proval refused, suspended, or with- upon mere allegations or denials or
drawn. general descriptions of positions or
contentions, but must set forth specific
§ 514.121 Service of notices and orders. reliable evidence showing there is a
All notices and orders under this sub- genuine and substantial issue of fact
chapter E and section 512 of the act that requires a hearing.
126
(2) If the Commissioner determines § 514.201 Procedures for hearings.

upon review of the data and informa-
Hearings relating to new animal
tion submitted in the objections and
drugs under section 512(d) and (e) of the
request for a hearing that a hearing is
act shall be governed by part 12 of this
not justified because no genuine and
chapter.
substantial issue of fact precludes the
refusal to approve the application or [64 FR 63204, Nov. 19, 1999]
the withdrawal of approval of the ap-
plication (for example, the applicant Subparts D–E [Reserved]
has not identified any adequate and
well-controlled clinical investigations
to support the claims of effectiveness),
Subpart F—Judicial Review
the Commissioner will enter an order § 514.235 Judicial review.
denying the hearing and stating the
final findings and conclusions. (a) The transcript and record shall be
(3) If the Commissioner determines certified by the Commissioner. In any
upon review of the data and informa- case in which the Commissioner enters
tion submitted in the objections and an order without a hearing pursuant to
request for a hearing that a hearing is § 314.200(g) of this chapter, the re-
justified, the Commissioner will pub- quest(s) for hearing together with the
lish a notice setting forth the fol- data and information submitted and
lowing: the Commissioner’s findings and con-
(i) The regulation or order that is the clusions shall be included in the record
subject of the hearing; certified by the Commissioner.
(ii) A statement specifying any part (b) Judicial review of an order with-
of the regulation or order that has been drawing approval of a new drug appli-
stayed by operation of law or in the cation, whether or not a hearing has
Commissioner’s discretion; been held, may be sought by a manu-
(iii) The parties to the hearing; facturer or distributor of an identical,
related, or similar drug product, as de-
(iv) The specific issues of fact for res-
fined in § 310.6 of this chapter, in a
olution at the hearing;
United States court of appeals pursu-
(v) The presiding officer, or a state-
ant to section 505(h) of the act.
ment that the presiding officer will be
designated in a later notice; and [42 FR 4717, Jan. 25, 1977]
(vi) The date, time, and place of the
prehearing conference, or a statement PART 515—MEDICATED FEED MILL
that the date, time, and place will be LICENSE
announced in a later notice. However,
in the case of a denial of approval, the Subpart A—Applications
hearing must not occur more than 90
days after expiration of the 30-day time Sec.
period in which to request a hearing, 515.10 Medicated feed mill license applica-
unless the presiding officer and the ap- tions.
plicant otherwise agree; and in the case 515.11 Supplemental medicated feed mill li-
of withdrawal of approval, the hearing cense applications.
will occur as soon as practicable.
Subpart B—Administrative Actions on
(d) The hearing will be open to the
Licenses
public; however, if the Commissioner
finds that portions of the application 515.20 Approval of medicated feed mill li-
which serve as a basis for the hearing cense applications.
contain information concerning a 515.21 Refusal to approve a medicated feed
method or process entitled to protec- mill license application.
tion as a trade secret, the part of the 515.22 Suspension and/or revocation of ap-
hearing involving such portions will proval of a medicated feed mill license.
not be public, unless the respondent so 515.23 Voluntary revocation of medicated
specifies in the request for a hearing. feed mill license.
515.24 Notice of revocation of a medicated

[81 FR 52997, Aug. 11, 2016] feed mill license.
127
§ 515.10 21 CFR Ch. I (4–1–23 Edition)
515.25 Revocation of order refusing to ap- tion 501(a)(2)(B) of the act and in part
prove a medicated feed mill license appli- 225 of this chapter.
cation or suspending or revoking a li-
(6) A certification that the facility
cense.
515.26 Services of notices and orders.
will establish and maintain all records
required by regulation or order issued
Subpart C—Hearing Procedures under sections 512(m)(5)(A) or
504(a)(3)(A) of the act, and will permit
515.30 Contents of notice of opportunity for access to, or copying or verification of
a hearing. such records.
515.31 Procedures for hearings.
(7) A commitment that current ap-
Subpart D—Judicial Review proved or index listed Type B and/or
Type C medicated feed labeling for
515.40 Judicial review. each Type B and/or Type C medicated
AUTHORITY: 21 U.S.C. 360b, 371. feed to be manufactured will be in the
possession of the feed manufacturing
SOURCE: 64 FR 63204, Nov. 19, 1999, unless
facility prior to receiving the Type A
otherwise noted.
medicated article containing such
drug.
Subpart A—Applications (8) A commitment to renew registra-
§ 515.10 Medicated feed mill license tion every year with FDA as required
applications. in part 207 of this chapter.
(c) Applications must be completed,
(a) Medicated feed mill license appli- signed, and submitted to the Division
cations (Form FDA 3448) may be ob- of Animal Feeds (HFV–220), Center for
tained from the Public Health Service, Veterinary Medicine, Food and Drug
Consolidated Forms and Publications Administration, 7500 Standish Pl.,
Distribution Center, Washington Com- Rockville, MD 20855.
merce Center, 3222 Hubbard Rd., Land-
(d) Applications that are facially de-
over, MD 20785, or electronically from
ficient will be returned to the appli-
the Center for Veterinary Medicine at:
cant. All reasons for the return of the
https://www.fda.gov/animal-veterinary/
application will be made known to the
animal-food-feeds/medicated-feeds.
applicant.
(b) A completed medicated feed mill
(e) Upon approval, the original copy
license must contain the following in-
of the application will be signed by an
formation:
authorized employee of FDA des-
(1) The full business name and ad-
ignated by the Commissioner of Food
dress of the facility at which the manu-
and Drugs, and a copy will be returned
facturing is to take place.
to the applicant.
(2) The facility’s FDA registration
number as required by section 510 of [64 FR 63204, Nov. 19, 1999, as amended at 72
the Federal Food, Drug, and Cosmetic FR 69121, Dec. 6, 2007; 81 FR 60221, Aug. 31,
Act (the act). 2016; 87 FR 58960, Sept. 29, 2022]
(3) The name, title, and signature of
the responsible individual or individ- § 515.11 Supplemental medicated feed
mill license applications.
uals for that facility.
(4) A certification that the animal (a) After approval of a medicated feed
feeds bearing or containing new animal mill license application to manufac-
drugs are manufactured and labeled in ture animal feed, a supplemental appli-
accordance with the applicable regula- cation shall be submitted for a change
tions published under section 512(i) of in ownership and/or a change in mail-
the act or in accordance with the index ing address of the facility site.
listing published under section 572(e)(2) (b) Each supplemental application
of the act. should be accompanied by a fully com-
(5) A certification that the methods pleted Form FDA 3448 and include an
used in, and the facilities and controls explanation of the change.
used for, manufacturing, processing, (c) Within 30 working days after a
packaging, and holding such animal supplemental application has been
feeds conform to current good manu- filed, if the Commissioner of Food and
facturing practice as described in sec- Drugs determines that the application
128
provides adequate information respect- ity, and purity of the new animal drug
ing the change in ownership and/or therein; or
postal address of the facility site, then (3) The facility manufactures animal
an authorized employee of the Food feeds bearing or containing new animal
and Drug Administration designated by drugs in a manner that does not accord
the Commissioner shall notify the ap- with the specifications for manufac-
plicant that it is approved by signing ture or labels animal feeds bearing or
and mailing to the applicant a copy of containing new animal drugs in a man-
the Form FDA 3448. Supplemental ap- ner that does not accord with the con-
plications that do not provide adequate ditions or indications of use that are
information shall be returned to the published under section 512(i) or
applicant and all reasons for the return 572(e)(2) of the act.
of the application shall be made known (b) The Commissioner, as provided in
to the applicant. § 515.30, shall expeditiously notify the
applicant of an opportunity for a hear-
Subpart B—Administrative Actions ing on the question of whether such ap-
on Licenses plication is approvable, unless by the
30th day following the date of issuance
§ 515.20 Approval of medicated feed of the letter informing the applicant of
mill license applications. the intention to issue a notice of op-
Within 90 days after an application portunity for a hearing the applicant:
has been filed under § 515.10, if the Com- (1) Withdraws the application; or
missioner of Food and Drugs (the Com- (2) Waives the opportunity for a hear-
missioner) determines that none of the ing; or
grounds for denying approval specified (3) Agrees with the Commissioner on
in section 512(m)(3) of the Federal an additional period to precede
Food, Drug, and Cosmetic Act (the act) issuance of such notice of hearing.
applies, an authorized employee of the [64 FR 63204, Nov. 19, 1999, as amended at 72
Food and Drug Administration des- FR 69121, Dec. 6, 2007]
ignated by the Commissioner shall no-
tify the applicant that it is approved § 515.22 Suspension and/or revocation
by signing and mailing to the applicant of approval of a medicated feed mill
a copy of the Form FDA 3448. license.
(a) The Secretary of Health and
§ 515.21 Refusal to approve a medi- Human Services may suspend a medi-
cated feed mill license application. cated feed mill license approved under
(a) The Commissioner of Food and section 512(m)(2) of the Federal Food,
Drugs (the Commissioner) shall within Drug, and Cosmetic Act (the act) and
90 days, or such additional period as give the person holding the medicated
may be agreed upon by the Commis- feed mill license application prompt
sioner and the applicant, after the fil- notice of this action and afford the ap-
ing of an application under § 515.10, in- plicant the opportunity for an expe-
form the applicant in writing of his/her dited hearing on a finding that there is
intention to issue a notice of oppor- an imminent hazard to the health of
tunity for a hearing on a proposal to man or of the animals for which such
refuse to approve the application, if the animal feed is intended.
Commissioner determines upon the (b) The Commissioner of Food and
basis of the application, on the basis of Drugs (the Commissioner) shall notify
a preapproval inspection, or upon the in writing the person holding an appli-
basis of any other information before cation approved under section 512(m)(2)
him that: of the act and afford an opportunity for
(1) The application is incomplete, a hearing on a proposal to revoke ap-
false, or misleading in any particular; proval of such application if the Com-
or missioner finds:
(2) The methods used in and the fa- (1) That the application contains any
cilities and controls used for the manu- untrue statement of a material fact; or
facturing, processing, and packaging of (2) That the applicant has made any
such animal feed are not adequate to changes that would cause the applica-
preserve the identity, strength, qual- tion to contain any untrue statements
129
§ 515.23 21 CFR Ch. I (4–1–23 Edition)
of material fact or that would affect cility did not discontinue the manufac-
the safety or effectiveness of the ani- ture, processing, packing, or holding of
mal feeds manufactured at the facility such animal feed within a reasonable
unless the applicant has supplemented time after receipt of written notice
the application by filing a supple- from the Commissioner specifying the
mental application under § 515.11. matter complained of.
(c) The Commissioner may notify in
writing the person holding an applica- § 515.23 Voluntary revocation of medi-
tion approved under section 512(m)(2) of cated feed mill license.
the act and afford an opportunity for a A license issued under section
hearing on a proposal to revoke ap- 512(m)(2) of the Federal Food, Drug,
proval of such application if the Com- and Cosmetic Act (the act) will be re-
missioner finds: voked on the basis of a request for its
(1) That the applicant has failed to revocation submitted in writing by a
establish a system for maintaining re- responsible individual holding such li-
quired records, or has repeatedly or de- cense on the grounds that the facility
liberately failed to maintain such no longer manufactures any animal
records or to make required reports in feed covered under § 558.4(b) of this
accordance with a regulation or order chapter. A written request for such
under sections 512(m)(5)(A) or revocation shall be construed as a
504(a)(3)(A) of the act, or the applicant waiver of the opportunity for a hearing
has refused to permit access to, or as otherwise provided for in this sec-
copying, or verification of, such tion. Revocation of approval of a medi-
records as required by sections cated feed mill license under the provi-
512(m)(5)(B) or 504(a)(3)(B) of the act; or sions of this paragraph shall be with-
(2) That on the basis of new informa- out prejudice.
tion before him, evaluated together
with the evidence before him when § 515.24 Notice of revocation of a medi-
such license was issued, the methods cated feed mill license.
used in, or the facilities and controls When a license approved under sec-
used for, the manufacture, processing, tion 512 of the Federal Food, Drug, and
packing, and holding of such animal Cosmetic Act (the act) is revoked by
feed are inadequate to assure and pre- the Commissioner of Food and Drugs
serve the identity, strength, quality, (the Commissioner), the Commissioner
and purity of the new animal drug will give appropriate public notice of
therein, and were not made adequate such action by publication in the FED-
within a reasonable time after receipt ERAL REGISTER.
of written notice from the Commis-
sioner specifying the matter com- § 515.25 Revocation of order refusing
plained of; or to approve a medicated feed mill li-
(3) That on the basis of new informa- cense application or suspending or
revoking a license.
with the evidence before him when The Commissioner of Food and Drugs
such license was issued, the labeling of (the Commissioner), upon his/her own
any animal feeds, based on a fair eval- initiative or upon request of an appli-
uation of all material facts, is false or cant stating reasonable grounds there-
misleading in any particular and was for and if the Commissioner finds that
not corrected within a reasonable time the facts so require, may issue an order
after receipt of written notice from the approving a medicated feed mill license
Commissioner specifying the matter application that previously has had its
complained of; or approval refused, suspended, or re-
(4) That on the basis of new informa- voked.
with the evidence before him when § 515.26 Services of notices and orders.
such license was issued, the facility has All notices and orders under this part
manufactured, processed, packed, or 515 and section 512 of the Federal Food,
held animal feed bearing or containing Drug, and Cosmetic Act (the act) per-
a new animal drug adulterated under taining to medicated feed mill licenses
section 501(a)(6) of the act, and the fa- shall be served:
130
(a) In person by any officer or em- upon mere allegations or denials, but
ployee of the Department of Health and must set forth specific facts showing
Human Services designated by the there is a genuine and substantial issue
Commissioner of Food and Drugs; or of fact that requires a hearing. When it
(b) By mailing the order by certified clearly appears from the information
mail addressed to the applicant or rein the application and from the reasons
spondent at the applicant or respond- and factual analysis in the request for
ent’s last known address in the records the hearing that no genuine and sub-
of the Food and Drug Administration. stantial issue of fact precludes the re-
fusal to approve the application or the
Subpart C—Hearing Procedures revocation of approval of the applica-
tion, the Commissioner will enter an
§ 515.30 Contents of notice of oppor- order on this information, stating his/
tunity for a hearing. her findings and conclusions. If a hear-
(a) The notice to the applicant of op- ing is requested and is justified by the
portunity for a hearing on a proposal applicant’s response to the notice of
by the Commissioner of Food and opportunity for a hearing, the issues
Drugs (the Commissioner) to refuse to will be defined, an Administrative Law
approve a medicated feed mill license Judge will be named, and the Judge
application or to revoke the approval shall issue a written notice of the time
of a medicated feed mill license will and place at which the hearing will
specify the grounds upon which the commence. In the case of denial of ap-
Commissioner proposes to issue this proval, such time shall be not more
order. On request of the applicant, the than 90 days after the expiration of
Commissioner will explain the reasons such 30 days unless the Administrative
for the action. The notice of oppor- Law Judge and the applicant otherwise
tunity for a hearing will be published agree; and, in the case of withdrawal of
in the FEDERAL REGISTER and will approval, such time shall be as soon as
specify that the applicant has 30 days practicable.
after issuance of the notice within (d) The hearing will be open to the
which the Commissioner is required to public; however, if the Commissioner
file a written appearance electing finds that portions of the application
whether: which serve as a basis for the hearing
(1) To avail himself of the oppor- contain information concerning a
tunity for a hearing; or method or process entitled to protec-
(2) Not to avail himself of the oppor- tion as a trade secret, the part of the
tunity for a hearing. hearing involving such portions will
(b) If the applicant fails to file a not be public, unless the respondent so
written appearance in answer to the specifies in the appearance.
notice of opportunity for hearing, this
failure will be construed as an election § 515.31 Procedures for hearings.
not to avail himself of the opportunity Hearings relating to new animal
for the hearing, and the Commissioner drugs under section 512(m)(3) and (m)(4)
without further notice may enter a of the Federal Food, Drug, and Cos-
final order. metic Act (the act) shall be governed
(c) If the applicant elects to avail by part 12 of this chapter.
himself of the opportunity for a hear-
ing, the applicant is required to file a
written appearance requesting the Subpart D—Judicial Review
hearing within 30 days after the publi-
cation of the notice, giving the reason § 515.40 Judicial review.
why the application should not be re- The transcript and record shall be
fused or the medicated feed mill license certified by the Commissioner of Food
should not be revoked, together with a and Drugs (the Commissioner). In any
well-organized and full-factual analysis case in which the Commissioner enters
of the information the applicant is pre- an order without a hearing under
pared to prove in support of his opposi- § 314.200(g) of this chapter, the re-
tion to the Commissioner’s proposal. A quest(s) for hearing together with the
request for a hearing may not rest data and information submitted and
131
the Commissioner’s findings and con- 516.125 Investigational use of minor species
clusions shall be included in the record new animal drugs to support indexing.
certified by the Commissioner. 516.129 Content and format of a request for
determination of eligibility for indexing.
516.131 Refuse to file a request for deter-
PART 516—NEW ANIMAL DRUGS mination of eligibility for indexing.
FOR MINOR USE AND MINOR 516.133 Denying a request for determination
of eligibility for indexing.
SPECIES 516.135 Granting a request for determina-
tion of eligibility for indexing.
Subpart A—General Provisions 516.137 Notification of decision regarding
eligibility for indexing.
Sec.
516.141 Qualified expert panels.
516.1 Scope. 516.143 Written report.
516.2 Purpose. 516.145 Content and format of a request for
516.3 Definitions. addition to the index.
516.147 Refuse to file a request for addition
Subpart B—Designation of a Minor Use or to the index.
Minor Species New Animal Drug 516.149 Denying a request for addition to the
index.
516.11 Scope of this subpart. 516.151 Granting a request for addition to
516.12 Purpose. the index.
516.13 Definitions. 516.153 Notification of decision regarding
516.14 Submission of requests for designa- index listing.
tion. 516.155 Labeling of indexed drugs.
516.16 Eligibility to request designation. 516.157 Publication of the index and content
516.20 Content and format of a request for of an index listing.
MUMS-drug designation. 516.161 Modifications to indexed drugs.
516.21 Documentation of minor use status. 516.163 Change in ownership of an index file.
516.22 Permanent-resident U.S. agent for 516.165 Records and reports.
foreign sponsor. 516.167 Removal from the index.
516.23 Timing of requests for MUMS-drug 516.171 Confidentiality of data and informa-
designation. tion in an index file.
516.24 Granting MUMS-drug designation.
516.25 Refusal to grant MUMS-drug designa- Subpart D [Reserved]
tion.
516.26 Amendment to MUMS-drug designa- Subpart E—Conditionally Approved New
tion. Animal Drugs For Minor Use and Minor
516.27 Change in sponsorship. Species
516.28 Publication of MUMS-drug designa-
tions. 516.498 Crofelemer.
516.29 Termination of MUMS-drug designa- 516.812 Enrofloxacin.
tion. 516.1012 Fuzapladib.
516.30 Annual reports for a MUMS-des- 516.1684 Paclitaxel.
ignated drug. 516.1780 Pimobendan.
516.31 Scope of MUMS-drug exclusive mar- 516.1858 Potassium bromide.
keting rights. 516.2980 Verdinexor.
516.34 FDA recognition of exclusive mar-
AUTHORITY: 21 U.S.C. 360ccc–1, 360ccc–2, 371.
keting rights.
516.36 Insufficient quantities of MUMS-des- SOURCE: 72 FR 41017, July 26, 2007, unless
ignated drugs. otherwise noted.
516.52 Availability for public disclosure of
data and information in requests.
Subpart C—Index of Legally Marketed Un- § 516.1 Scope.
approved New Animal Drugs for Minor
Species (a) This part implements section 573
of the Federal Food, Drug, and Cos-
516.111 Scope of this subpart. metic Act (the act) (21 U.S.C. 360ccc–2)
516.115 Definitions. and contains the following subparts:
516.117 Submission of correspondence under (1) Subpart A—General Provisions.
this subpart.
516.119 Permanent-resident U.S. agent for
(2) Subpart B—Designation of a
foreign requestors and holders. Minor Use or Minor Species New Ani-
516.121 Meetings. mal Drug.
516.123 Informal conferences regarding (3) Subpart C [Reserved]

agency administrative actions. (4) Subpart D [Reserved]
132
(b) References in this part to regu- Infrequently, as used in the minor use
latory sections of the Code of Federal definition, means a disease or condi-
Regulations are to Chapter I of Title tion that is uncommon or that occurs
21, unless otherwise noted. only sporadically on an annualized
basis.
§ 516.2 Purpose. Limited geographical areas, as used in
This part establishes standards and the minor use definition, means re-
procedures for implementing section gions of the United States distin-
573 of the act, including designation of guished by physical, chemical, or bio-
minor use or minor species new animal logical factors that limit the distribu-
drugs and associated exclusive mar- tion of a disease or condition.
keting rights. Major species means cattle, horses,
swine, chickens, turkeys, dogs, and
§ 516.3 Definitions. cats.
(a) The definitions and interpreta- Minor species means animals, other
tions contained in section 201 of the than humans, that are not major spe-
Federal Food, Drug, and Cosmetic Act cies.
(the act) (21 U.S.C. 321) apply to those Minor use means the intended use of
terms when used in this part. a drug in a major species for an indica-
(b) The following definitions of terms tion that occurs infrequently and in
apply to all subparts of part 516: only a small number of animals or in
Active moiety means the molecule or limited geographical areas and in only
ion, excluding those appended portions a small number of animals annually.
of the molecule that cause the drug to MUMS drug means a new animal
be an ester, salt (including a salt with drug, as defined in section 201 of the
hydrogen or coordination bonds), or act, intended for a minor use or for use
other noncovalent derivative (such as a in a minor species.
complex, chelate, or clathrate) of the Same dosage form means the same as
molecule, responsible for the pharma- one of the dosage form categories spec-
cological action of the drug substance. ified in the following parts of this
Functionally superior means that a chapter:
drug has been shown to provide a sig- (i) Part 520: Oral dosage form new
nificant therapeutic or physiologic ad- animal drugs (excluding use in animal
vantage over that provided by a condi- feeds as specified in part 558 of this
tionally-approved or approved MUMS chapter).
drug, that is otherwise the same drug, (ii) Part 522: Implantation or
in one or more of the following ways: injectable dosage form new animal
(i) The drug has been shown to be drugs.
more effective, as assessed by effect on (iii) Part 524: Ophthalmic and topical
a clinically meaningful endpoint in dosage form new animal drugs.
adequate and well-controlled clinical (iv) Part 526: Intramammary dosage
trials, than a conditionally approved or forms.
approved MUMS drug, that is other- (v) Part 529: Certain other dosage
wise the same drug. Generally, this form new animal drugs.
would represent the same kind of evi- (vi) Part 558: New animal drugs for
dence needed to support a comparative use in animal feeds.
effectiveness claim for two different Same drug means a MUMS drug for
drugs; in most cases, direct compara- which designation, indexing, or condi-
tive clinical trials will be necessary; or tional approval is sought that meets
(ii) The drug has been shown to be the following criteria:
safer than a conditionally-approved or (i) If it is a MUMS drug composed of
approved MUMS drug, that is other- small molecules and contains the same
wise the same drug, in a substantial active moiety as a prior designated,
portion of the target population, for conditionally-approved, or approved
example, by the elimination of an in- MUMS drug, even if the particular
gredient or contaminant that is associ- ester or salt (including a salt with hy-
ated with relatively frequent adverse drogen or coordination bonds) or other
effects. In some cases, direct compara- noncovalent derivative such as a com-

tive clinical trials will be necessary. plex, chelate or clathrate is not the
133
§ 516.3 21 CFR Ch. I (4–1–23 Edition)
same, it is considered the same drug; same unless the subsequent drug is
except that, if the prior MUMS drug is shown to be functionally superior.
conditionally approved or approved and Same intended use means an intended
the second MUMS drug is shown to be use of a MUMS drug, for which designa-
functionally superior to the condition, indexing, or conditional approval
tionally approved or approved MUMS is sought, that is determined to be the
drug for the same intended use, it is same as (or not different from) a pre-
not considered the same drug. viously designated, conditionally ap-
(ii) If it is a MUMS drug composed of proved, or approved intended use of a
large molecules (macromolecules) and MUMS drug. Same intended use is es-
contains the same principal molecular tablished by comparing two intended
structural features (but not necessarily uses and not by simply comparing the
all of the same structural features) as
specific language by means of which
a prior designated, conditionally ap-
the intent is established in labeling in
proved, or approved MUMS drug, it is
accordance with the following criteria:
considered the same drug; except that,
if the prior MUMS drug is condi- (i) Two intended uses are considered
tionally approved or approved and the the same if one of the intended uses
second MUMS drug is shown to be func- falls completely within the scope of the
tionally superior to the conditionally other.
approved or approved MUMS drug for (ii) For intended uses associated with
the same intended use, it is not consid- diseases or conditions with multiple
ered the same drug. This criterion will causative organisms, two intended uses
be applied as follows to different kinds are not considered the same when they
of macromolecules: involve different causative organisms
(A) Two protein drugs would be con- or different subsets of causative orga-
sidered the same if the only differences nisms of that disease or condition when
in structure between them were due to the causative organisms involved can
post-translational events or infidelity reliably be shown to be clinically sig-
of translation or transcription or were nificant causes of the disease or condi-
minor differences in amino acid se- tion.
quence; other potentially important (iii) Two intended uses of a drug are
differences, such as different glycosyl- not considered the same if they involve
ation patterns or different tertiary different intended species or different
structures, would not cause the drugs definable subpopulations (including
to be considered different unless the ‘‘production classes’’) of a species.
subsequent drug is shown to be func-
Small number of animals means equal
tionally superior.
to or less than 50,000 horses; 80,000 dogs;
(B) Two polysaccharide drugs would
150,000 cats; 310,000 cattle; 1,450,000 pigs;
be considered the same if they had
14,000,000 turkeys; and 72,000,000 chick-
identical saccharide repeating units,
even if the number of units were to ens.
vary and even if there were postpolym- Sponsor means the person requesting
erization modifications, unless the sub- designation for a MUMS drug who
sequent drug is shown to be function- must be the real party in interest of
ally superior. the development and the intended or
(C) Two polynucleotide drugs con- actual production and sales of such
sisting of two or more distinct nucleo- drug (in this context, the sponsor may
tides would be considered the same if be an individual, partnership, organiza-
they had an identical sequence of pu- tion, or association). Sponsor also
rine and pyrimidine bases (or their de- means the person responsible for an in-
rivatives) bound to an identical sugar vestigation of a new animal drug (in
backbone (ribose, deoxyribose, or modi- this context, the sponsor may be an in-
fications of these sugars), unless the dividual, partnership, corporation, or
subsequent drug is shown to be func- Government agency or may be a manu-
tionally superior. facturer, scientific institution, or an
(D) Closely related, complex partly investigator regularly and lawfully en-
definable drugs with similar pharmaco- gaged in the investigation of new ani-
logic intent would be considered the mal drugs). Sponsor also means the
134
person submitting or receiving ap- the approval letter of an application

proval for a new animal drug applica- for a MUMS-designated drug, no condi-
tion (in this context, the sponsor may tional approval or approval will be
be an individual, partnership, organiza- given to a subsequent application for
tion, or association). In all contexts, the same drug, in the same dosage
the sponsor is responsible for compli- form, for the same intended use for 7
ance with applicable provisions of the years, except as otherwise provided by
act and regulations. law or in this subpart.
[72 FR 41017, July 26, 2007, as amended at 74 § 516.14 Submission of requests for
FR 43050, Aug. 25, 2009; 75 FR 69588, Nov. 15, designation.
2010; 87 FR 56589, Sept. 15, 2022]
All correspondence relating to a re-
quest for designation of a MUMS drug
Subpart B—Designation of a Minor must be addressed to the Director of
Use or Minor Species New the Office of Minor Use and Minor Spe-
Animal Drug cies Animal Drug Development. Sub-
missions not including all elements
§ 516.11 Scope of this subpart.
specified in § 516.20 will be returned to
This subpart implements section 573 the sponsor without review.
of the act. Specifically, this subpart
sets forth the procedures and require- § 516.16 Eligibility to request designa-
ments for submissions to FDA of re- tion.
quests for designation of a new animal The person requesting designation
drug for a minor use or a minor spe- must be the sponsor and the real party
cies. in interest of the development and the
intended or actual production and sales
§ 516.12 Purpose. of the drug or the permanent-resident
This subpart establishes standards U.S. agent for such a sponsor.
and procedures for determining eligi-
bility for designation and the associ- § 516.20 Content and format of a re-
ated incentives and benefits described quest for MUMS-drug designation.
in section 573 of the act, including a 7- (a) A sponsor that submits a request
year period of exclusive marketing for designation of a new animal drug
rights. intended for a minor use or minor spe-
cies must submit each request in the
§ 516.13 Definitions. form and containing the information
The following definitions of terms required in paragraph (b) of this sec-
apply only in the context of subpart B tion. While a request for designation
of this part: may involve multiple intended uses,
Director means the Director of the Of- each request for designation must con-
fice of Minor Use and Minor Species stitute a separate submission. A spon-
Animal Drug Development of the FDA sor may request MUMS-drug designa-
Center for Veterinary Medicine. tion of a previously unapproved drug,
Intended use means the intended or a new intended use or dosage form
treatment, control or prevention of a for an already conditionally approved
disease or condition, or the intention or approved drug. Only one sponsor
to affect the structure or function of may receive MUMS-drug designation of
the body of animals within an identi- the same drug, in the same dosage
fied species, subpopulation of a species, form, for the same intended use.
or collection of species. (b) A sponsor must submit two copies
MUMS-designated drug means a new of a completed, dated, and signed re-
animal drug, as defined in section 201 quest for designation that contains the
of the act, intended for a minor use or following information:
for use in a minor species that has been (1) A request for designation of a new
designated under section 573 of the act. animal drug for a minor use or use in
MUMS-drug exclusive marketing rights a minor species, which must be spe-
or exclusive marketing rights means that, cific.
effective on the date of FDA condi- (2) The name and address of the spon-
tional approval or approval as stated in sor; the name of the sponsor’s primary
135
§ 516.21 21 CFR Ch. I (4–1–23 Edition)
contact person and/or permanent-resi- mentation must include the following

dent U.S. agent including title, ad- information:
dress, and telephone number; the estab- (a) The estimated total number of
lished name (and proprietary name, if animals to which the drug could poten-
any) of the active pharmaceutical in- tially be administered on an annual
gredient of the drug; and the name and basis for the treatment, control, or pre-
address of the source of the active vention of the disease or condition for
pharmaceutical ingredient of the drug. which the drug is being developed, in-
(3) A description of the proposed including animals administered the drug
tended use for which the drug is being as part of herd or flock treatment, to-
or will be investigated. gether with a list of the sources (in-
(4) A description of the drug and dos- cluding dates of information provided
age form. and literature citations) for the esti-
(5) A discussion of the scientific ra- mate.
tionale for the intended use of the (b) The estimated total number of
drug; specific reference, including animals referred to in paragraph (a) of
date(s) of submission, to all data from this section may be further reduced to
only a subset of the estimated total
nonclinical laboratory studies, clinical
number of animals if administration of
investigations, copies of pertinent un-
the drug is only medically justified for
published and published papers, and
this subset. To establish this, reques-
other relevant data that are available
tors must demonstrate that adminis-
to the sponsor, whether positive, nega-
tration of the drug to animals subject
tive, or inconclusive.
to the disease or condition for which
(6) A specific description of the prod- the drug is being developed other than
uct development plan for the drug, its the subset is not medically justified.
dosage form, and its intended use. The sponsor must also include a list of
(7) If the drug is intended for a minor the sources (including dates of infor-
use in a major species, documentation mation provided and literature cita-
in accordance with § 516.21, with ap- tions) for the justification that admin-
pended authoritative references, to istration of the drug to animals other
demonstrate that such use is a minor than the targeted subset is medically
use. inappropriate.
(8) A statement that the sponsor sub-
mitting the request is the real party in [72 FR 41017, July 26, 2007, as amended at 74
FR 43050, Aug. 25, 2009]
interest of the development and the in-
tended or actual production and sales § 516.22 Permanent-resident U.S. agent
of the product. for foreign sponsor.
(9) A statement that the sponsor ac-
Every foreign sponsor that seeks
knowledges that, upon granting a re-
MUMS-drug designation shall name a
quest for MUMS designation, FDA will
permanent resident of the United
make information regarding the des-
States as the sponsor’s agent upon
ignation publicly available as specified
whom service of all processes, notices,
in § 516.28.
orders, decisions, requirements, and
[72 FR 41017, July 26, 2007, as amended at 75 other communications may be made on
FR 69588, Nov. 15, 2010; 77 FR 18685, Mar. 28, behalf of the sponsor. Notifications of
2012] changes in such agents or changes of
address of agents should preferably be
§ 516.21 Documentation of minor use provided in advance, but not later than
status. 60 days after the effective date of such
So that FDA can determine whether changes. The permanent-resident U.S.
a drug qualifies for MUMS-drug des- agent may be an individual, firm, or
ignation as a minor use in a major spe- domestic corporation and may rep-
cies under section 573 of the act, the resent any number of sponsors. The
sponsor shall include in its request to name and address of the permanent-
FDA for MUMS-drug designation under resident U.S. agent shall be provided to
§ 516.20 documentation demonstrating the Director of the Office of Minor Use
that the use is limited to a small num- and Minor Species Animal Drug Devel-
ber of animals (annualized). This docu- opment.
136
§ 516.23 Timing of requests for MUMS- (b) FDA may refuse to grant a re-
drug designation. quest for MUMS-drug designation if
A sponsor may request MUMS-drug the request for designation contains an
designation at any time in the drug de- untrue statement of material fact or
velopment process prior to the submis- omits material information.
sion of an application for either condi-
§ 516.26 Amendment to MUMS-drug
tional approval or approval of the designation.
MUMS drug for which designation is
being requested. (a) At any time prior to conditional
approval or approval of an application
§ 516.24 Granting MUMS-drug designa- for a MUMS-designated drug, the spon-
tion. sor may apply for an amendment to the
(a) FDA may grant the request for designated intended use if the proposed
MUMS-drug designation if none of the change is due to new and unexpected
reasons described in § 516.25 for refusal findings in research on the drug, infor-
to grant such a request apply. mation arising from FDA recommenda-
(b) When a request for MUMS-drug tions, or other unforeseen develop-
designation is granted, FDA will notify ments.
the sponsor in writing and will give (b) FDA will grant the amendment if
public notice of the MUMS-drug des- it finds:
ignation in accordance with § 516.28. (1) That the initial designation re-
quest was made in good faith;
§ 516.25 Refusal to grant MUMS-drug (2) That the amendment is intended
designation. to make the MUMS-drug designated in-
(a) FDA will refuse to grant a request tended use conform to the results of
for MUMS-drug designation if any of new and unexpected findings in re-
the following reasons apply: search on the drug, information arising
(1) The drug is not intended for use in from FDA recommendations, or other
a minor species or FDA determines unforeseen developments; and
that there is insufficient evidence to (3) In the case of a minor use, that as
demonstrate that the drug is intended of the date of the submission of the
for a minor use in a major species. amendment request, the amendment
(2) The drug is the same drug in the would not result in the intended use of
same dosage form for the same in- the drug no longer being considered a
tended use as one that already has a minor use.
MUMS-drug designation but has not
yet been conditionally approved or ap- § 516.27 Change in sponsorship.
proved. (a) A sponsor may transfer sponsor-
(3) The drug is the same drug in the ship of a MUMS-designated drug to an-
same dosage form for the same in- other person. A change of sponsorship
tended use as one that is already condi- will also transfer the designation sta-
tionally approved or approved. A drug tus of the drug which will remain in ef-
that FDA has found to be functionally fect for the new sponsor subject to the
superior is not considered the same same conditions applicable to the
drug as an already conditionally ap- former sponsor provided that at the
proved or approved drug even if it is time of a potential transfer, the new
otherwise the same drug in the same and former sponsors submit the fol-
dosage form for the same intended use. lowing information in writing and ob-
(4) The sponsor has failed to provide: tain permission from FDA:
(i) A credible scientific rationale in (1) The former sponsor shall submit a
support of the intended use, letter to FDA that documents the
(ii) Sufficient information about the transfer of sponsorship of the MUMS-
product development plan for the drug, designated drug. This letter shall speci-
its dosage form, and its intended use to fy the date of the transfer. The former
establish that adherence to the plan sponsor shall also certify in writing to
can lead to successful drug develop- FDA that a complete copy of the re-
ment in a timely manner, and quest for MUMS-drug designation, in-
(iii) Any other information required cluding any amendments to the re-
under § 516.20. quest, and correspondence relevant to
137
§ 516.28 21 CFR Ch. I (4–1–23 Edition)
the MUMS-drug designation, has been decision to discontinue active pursuit

provided to the new sponsor. of conditional approval or approval of
(2) The new sponsor shall submit a such MUMS drug. FDA must terminate
letter or other document containing the designation upon such notification.
the following information: (b) A conditionally-approved or ap-
(i) A statement accepting the MUMS- proved MUMS-designated drug sponsor
drug designated file or application; must notify FDA at least 1 year before
(ii) The date that the change in spon- it intends to discontinue the manufac-
sorship is intended to be effective; ture of such MUMS drug. FDA must
(iii) A statement that the new spon- terminate designation upon such noti-
sor has a complete copy of the request fication.
for MUMS-drug designation, including (c) MUMS designation shall termi-
any amendments to the request and nate upon the expiration of any appli-
any correspondence relevant to the cable period of exclusive marketing
MUMS-drug designation; rights under this subpart.
(iv) A statement that the new spon- (d) FDA may terminate designation
sor understands and accepts the re- if it independently determines that the
sponsibilities of a sponsor of a MUMS- sponsor is not actively pursuing condi-
designated drug established elsewhere tional approval or approval with due
in this subpart; diligence. At a minimum, due diligence
(v) The name and address of a new must be demonstrated by:
primary contact person or permanent (1) Submission of annual progress re-
resident U.S. agent; and ports in a timely manner in accordance
(vi) Evidence that the new sponsor is with § 516.30 that demonstrate that the
capable of actively pursuing approval sponsor is progressing in accordance
with due diligence. with the drug development plan sub-
(b) No sponsor may relieve itself of mitted to the agency under § 516.20 and
responsibilities under the act or under (2) Compliance with all applicable re-
this subpart by assigning rights to an- quirements of part 511 of this chapter.
other person without: (e) Designation of a conditionally ap-
(1) Assuring that the new sponsor proved or approved MUMS-designated
will carry out such responsibilities; drug and the associated exclusive mar-
and keting rights may be terminated if the
(2) Obtaining prior permission from sponsor is unable to provide sufficient
FDA. quantities of the drug to meet the
needs for which it is designated.
§ 516.28 Publication of MUMS-drug (f) FDA may also terminate MUMS-
designations. drug designation for any drug if the
FDA will periodically update a pub- agency finds that:
licly available list of MUMS-designated (1) The request for designation con-
drugs. This list will be placed on file at tained an untrue statement of material
the FDA Division of Dockets Manage- fact; or
ment, and will contain the following (2) The request for designation omit-
information for each MUMS-designated ted material information required by
drug: this subpart; or
(a) The name and address of the spon- (3) FDA subsequently finds that the
sor; drug in fact had not been eligible for
(b) The established name and trade MUMS-drug designation at the time of
name, if any, of the drug; submission of the request;
(c) The dosage form of the drug; (4) The same drug, in the same dos-
(d) The species and the proposed in- age form, for the same intended use be-
tended use for which MUMS-drug des- comes conditionally approved or ap-
ignation was granted; and proved for another sponsor; or
(e) The date designation was granted. (5) FDA withdraws the conditional
approval or approval of the application
§ 516.29 Termination of MUMS-drug for the new animal drug.
designation. (g) For a conditionally approved or
(a) The sponsor of a MUMS-des- approved drug, termination of MUMS-

ignated drug must notify FDA of any drug designation also terminates the
138
sponsor’s exclusive marketing rights drug designation has been granted,

for the drug but does not withdraw the FDA will not conditionally approve or
conditional approval or approval of the approve another application or abbre-
drug’s application. viated application for the same drug in
(h) Where a drug has been MUMS-des- the same dosage form for the same in-
ignated for a minor use in a major spe- tended use before the expiration of 7
cies, its designation will not be termi- years after the date of conditional ap-
nated on the grounds that the number proval or approval as stated in the ap-
of animals to which the drug could po- proval letter from FDA, except that
tentially be administered on an annual such an application can be condi-
basis for the treatment, control, or pre- tionally approved or approved sooner
vention of the disease or condition for if, and at such time as, any of the fol-
which the drug is being developed, in- lowing occurs:
cluding animals administered the drug (1) FDA terminates the MUMS-drug
as part of herd or flock treatment, sub- designation and associated exclusive
sequently increases. marketing rights under § 516.29; or
(i) When a MUMS-drug designation is (2) FDA withdraws the conditional
terminated, FDA will notify the spon- approval or approval of the application
sor in writing and will give public no- for the drug for any reason; or
tice of the termination of the MUMS- (3) The sponsor with exclusive mar-
drug designation. keting rights provides written consent
to FDA to conditionally approve or ap-
§ 516.30 Annual reports for a MUMS- prove another application before the
designated drug. expiration of 7 years; or
Within 14 months after the date on (4) The sponsor fails to assure a suffi-
which a MUMS drug is granted des- cient quantity of the drug in accord-
ignation and annually thereafter until ance with section 573 of the act and
approval, the sponsor of a MUMS-des- § 516.36.
ignated drug shall submit a brief (b) If an application for a MUMS drug
progress report on the drug to the in- cannot be approved until the expira-
vestigational new animal drug file ad- tion of the period of exclusive mar-
dressed to the Director of the Office of keting of a MUMS-designated drug,
Minor Use and Minor Species Animal FDA will so notify the sponsor in writ-
Drug Development that includes the ing.
following information:
(a) A short account of the progress of § 516.34 FDA recognition of exclusive
drug development including a descrip- marketing rights.
tion of studies initiated, ongoing, and (a) FDA will send the sponsor (or the
completed, and a short summary of the permanent-resident U.S. agent, if ap-
status or results of such studies; plicable) timely written notice recog-
(b) A description of the investiga- nizing exclusive marketing rights when
tional plan for the coming year, as well an application for a MUMS-designated
as any anticipated difficulties in devel- drug has been conditionally approved
opment, testing, and marketing; and or approved. The written notice will in-
(c) A brief discussion of any changes form the sponsor of the requirements
that may affect the MUMS-designated for maintaining MUMS-designated
drug status of the product. For exam- drug exclusive marketing rights for the
ple, situations in which testing data full 7-year term. This notice will gen-
demonstrate that the proposed in- erally be contained in the letter condi-
tended use is inappropriate due to un- tionally approving or approving the ap-
expected issues of safety or effective- plication.
ness. (b) When an application is condi-
tionally approved or approved for a
§ 516.31 Scope of MUMS-drug exclusive MUMS-designated drug that qualifies
marketing rights. for exclusive marketing rights, FDA
(a) After conditional approval or ap- will publish this information in the
proval of an application for a MUMS- FEDERAL REGISTER at the time of the
designated drug in the dosage form and conditional approval or approval. This
for the intended use for which MUMS- notice will generally be contained in
139
§ 516.36 21 CFR Ch. I (4–1–23 Edition)
the notice of conditional approval or § 516.52 Availability for public disclo-

approval of the application. sure of data and information in re-
quests.
§ 516.36 Insufficient quantities of (a) FDA will not publicly disclose the
MUMS-designated drugs.
existence of a request for MUMS-drug
(a) Under section 573 of the act, designation under section 573 of the act
whenever FDA has reason to believe prior to final FDA action on the re-
that sufficient quantities of a condi- quest unless the existence of the re-
tionally-approved or approved, MUMS- quest has been previously publicly dis-
designated drug to meet the needs for closed or acknowledged.
which the drug was designated cannot (b) Whether or not the existence of a
be assured by the sponsor, FDA will so pending request for designation has
notify the sponsor of this possible in- been publicly disclosed or acknowl-
sufficiency and will offer the sponsor edged, no data or information in the re-
the following options, one of which quest are available for public disclo-
must be exercised by a time that FDA sure prior to final FDA action on the
specifies: request.
(1) Provide FDA information and (c) Except as provided in paragraph
data regarding how the sponsor can as- (d) of this section, upon final FDA ac-
sure the availability of sufficient quan- tion on a request for designation, the
tities of the MUMS-designated drug public availability of data and informa-
within a reasonable time to meet the tion in the request will be determined
needs for which the drug was des- in accordance with part 20 of this chap-
ignated; or ter and other applicable statutes and
regulations.
(2) Provide FDA in writing the spon-
sor’s consent for the conditional ap- (d) In accordance with § 516.28, FDA
will make a cumulative list of all
proval or approval of other applica-
MUMS-drug designations available to
tions for the same drug before the expi-
the public and update such list periodi-
ration of the 7-year period of exclusive
cally. In accordance with § 516.29, FDA
marketing rights. will give public notice of the termi-
(b) If, within the time that FDA nation of all MUMS-drug designations.
specifies, the sponsor fails to consent
to the conditional approval or approval
of other applications and if FDA finds
Subpart C—Index of Legally Mar-
that the sponsor has not shown that it keted Unapproved New Ani-
can assure the availability of sufficient mal Drugs for Minor Species
quantities of the MUMS-designated
drug to meet the needs for which the SOURCE: 72 FR 69121, Dec. 6, 2007, unless
drug was designated, FDA will issue a otherwise noted.
written order terminating designation
§ 516.111 Scope of this subpart.
of the MUMS drug and the associated
exclusive marketing rights. This order This subpart implements section 572
will state FDA’s findings and conclu- of the act and provides standards and
sions and will constitute final agency procedures to establish an index of le-
action. An order terminating designa- gally marketed unapproved new animal
tion and associated exclusive mar- drugs. This subpart applies only to
keting rights may issue whether or not minor species and not to minor use in
there are other sponsors that can as- major species. This index is only avail-
sure the availability of alternative able for new animal drugs intended for
sources of supply. Such an order will use in a minor species for which there
not withdraw the conditional approval is a reasonable certainty that the ani-
mal or edible products from the animal
or approval of an application. Once ter-
will not be consumed by humans or
minated under this section, neither
food-producing animals and for new
designation, nor exclusive marketing
animal drugs intended for use only in a
rights may be reinstated. hatchery, tank, pond, or other similar

contained man-made structure in an
140
early, nonfood life stage of a food-pro- ‘transgenic animal’ does not include an
ducing minor species, where safety for animal of which the nucleotide se-
humans is demonstrated in accordance quence of the genome has been modi-
with the standard of section 512(d) of fied solely by selective breeding.
the act (including, for an antimicrobial (b) The definitions of the following
new animal drug, with respect to anti- terms are given in § 514.3 of this chap-
microbial resistance). The index shall ter:
not include a new animal drug that is Adverse drug experience.
contained in, or a product of, a
Product defect/manufacturing defect.
transgenic animal. Among its topics,
this subpart sets forth the standards Serious adverse drug experience.
and procedures for: Unexpected adverse drug experience.
(a) Investigational exemptions for in- (c) The definitions of the following
dexing purposes; terms are given in § 516.3 of this chap-
(b) Submissions to FDA of requests ter:
for determination of eligibility of a Same dosage form.
new animal drug for indexing; Same drug.
(c) Establishment and operation of Same intended use.
expert panels;
(d) Submissions to FDA of requests § 516.117 Submission of correspond-
for addition of a new animal drug to ence under this subpart.
the index; Unless directed otherwise by FDA,
(e) Modifications to index listings; all correspondence relating to any as-
(f) Publication of the index; and
pect of the new animal drug indexing
(g) Records and reports.
process described in this subpart must
§ 516.115 Definitions. be addressed to the Director, OMUMS.
The initial correspondence for a par-
(a) The following definitions of terms
apply only in the context of subpart C ticular index listing should include the
of this part: name and address of the authorized
Director OMUMS means the Director contact person. Notifications of
of the Office of Minor Use and Minor changes in such person or changes of
Species Animal Drug Development of address of such person should be pro-
the FDA Center for Veterinary Medi- vided in a timely manner.
cine.
Holder means the requestor of an § 516.119 Permanent-resident U.S.
index listing after the request is grant- agent for foreign requestors and
holders.
ed and the new animal drug is added to
the index. Every foreign requestor and holder
Index means FDA’s list of legally shall name a permanent resident of the
marketed unapproved new animal United States as their agent upon
drugs for minor species. whom service of all processes, notices,
Intended use has the same meaning as orders, decisions, requirements, and
that given in § 516.13 of this chapter. other communications may be made on
Qualified expert panel means a panel behalf of the requestor or holder. Noti-
that is composed of experts qualified fications of changes in such agents or
by scientific training and experience to changes of address of agents should
evaluate the target animal safety and preferably be provided in advance, but
effectiveness of a new animal drug not later than 60 days after the effec-
under consideration for indexing.
tive date of such changes. The perma-
Requestor means the person making a
nent resident U.S. agent may be an in-
request for determination of eligibility
dividual, firm, or domestic corporation
for indexing or a request for addition
to the index. and may represent any number of re-
Transgenic animal means an animal questors or holders. The name and ad-
whose genome contains a nucleotide se- dress of the permanent-resident U.S.
quence that has been intentionally agent shall be submitted to the Direc-
modified in vitro, and the progeny of tor, OMUMS, and included in the index
such an animal, provided that the term file.
141
§ 516.121 21 CFR Ch. I (4–1–23 Edition)
§ 516.121 Meetings. scheduled meeting. Generally, this

(a) A requestor or potential requestor written response would be attached to
is entitled to one or more meetings to the request for an informal conference.
discuss the requirements for indexing a At the option of the person requesting
new animal drug. an informal conference, such written
(b) Requests for such meetings should response to FDA’s initial decision may
be in writing, be addressed to the Di- act in lieu of a face-to-face meeting. In
rector, OMUMS, specify the partici- this case, the informal conference will
pants attending on behalf of the re- consist of a review by the presiding of-
questor or potential requestor, and ficer of the submitted written response.
contain a proposed agenda for the (f) The purpose of an informal con-
meeting. ference is to discuss scientific and fac-
(c) Within 30 days of receiving a re- tual issues. It will involve a discussion
quest for a meeting, FDA will attempt of FDA’s initial decision and any writ-
to schedule the meeting at a time ten response to that decision.
agreeable to both FDA and the person (g) Internal agency review of a deci-
making the request. sion must be based on the information
in the administrative file. If the person
§ 516.123 Informal conferences regard- requesting an informal conference pre-
ing agency administrative actions. sents new information not in the file,
(a) Should FDA make an initial deci- the matter will be returned to the ap-
sion denying a request for determina- propriate lower level in the agency for
tion of eligibility for indexing, termi- reevaluation based on the new informa-
nating an investigational exemption, tion.
determining that a qualified expert (h) Informal conferences under this
panel does not meet the selection cri- part are not subject to the separation
teria, denying a request for addition to of functions rules in § 10.55 of this chap-
the index, or removing a new animal ter.
drug from the index, FDA will give (i) The rules of evidence do not apply
written notice that specifies the to informal conferences. No motions or
grounds for the initial decision and objections relating to the admissibility
provides an opportunity for an infor- of information and views will be made
mal conference for review of the deci- or considered, but any party to the
sion. conference may comment upon or
(b) The written notice will include in- rebut all such data, information and
formation for scheduling the informal views.
conference and state that a written re- (j) [Reserved]
quest for a conference must be made
(k) The presiding officer will prepare
within 60 days of the date FDA sends
a written report regarding the subject
its notice.
of the informal conference that states
(c) Within 45 days of receiving a re-
and describes the basis for his or her
quest for an informal conference, FDA
findings. Whenever time permits, the
will schedule and hold the informal
parties to the informal conference will
conference at a time agreeable to both
have 30 days to review and comment on
FDA and the person making the re-
the report.
quest.
(d) Such an informal conference will (l) The administrative record of the
be conducted by a presiding officer who informal conference will consist of:
will be the Director of the Center for (1) The notice providing an oppor-
Veterinary Medicine or his or her des- tunity for an informal conference and
ignee, excluding the Director of the Of- the written response to the notice.
fice of Minor Use and Minor Species (2) All written information and views
Animal Drug Development and other submitted to the presiding officer at
persons significantly involved in the the conference or, at the discretion of
initial decision. the presiding officer, thereafter.
(e) The person requesting an informal (3) The presiding officer’s written re-
conference must provide a written report.
sponse to FDA’s initial decision at (4) All correspondence and memo-

least 2 weeks prior to the date of the randa of any and all meetings between
142
the participants and the presiding offi- laboratory animals or for tests in vitro
cer. in support of index listing. Not for use
(m) The administrative record of the in humans.’’
informal conference is closed to the (2) Under § 511.1(b)(1) of this chapter,
submission of information at the close the label statement is as follows:
of the conference, unless the presiding ‘‘Caution. Contains a new animal
officer specifically permits additional drug for use only in investigational
time for further submission. animals in clinical trials in support of
(n) The administrative record of the index listing. Not for use in humans.
informal conference specified herein Edible products of investigational ani-
constitutes the exclusive record for de- mals are not to be used for food for hu-
cision. mans or other animals unless author-
ization has been granted by the U.S.
§ 516.125 Investigational use of minor Food and Drug Administration or by
species new animal drugs to sup- the U.S. Department of Agriculture.’’
port indexing. (3) Under § 511.1(b)(4) of this chapter,
(a) The investigational use of a new the notice is titled ‘‘Notice of Claimed
animal drug or animal feed bearing or Investigational Exemption for a New
containing a new animal drug intended Animal Drug for Index Listing’’ and is
solely for investigational use in minor submitted in duplicate to the Director,
species shall meet the requirements of OMUMS.
part 511 of this chapter if the investiga- (4) Under § 511.1(c)(3) of this chapter,
tional use is for the purpose of: if an investigator is determined to be
(1) Demonstrating human food safety ineligible to receive new animal drugs,
under section 572(a)(1)(B) of the act; each ‘‘Notice of Claimed Investiga-
(2) Demonstrating safety with re- tional Exemption for a New Animal
spect to individuals exposed to the new Drug for Index Listing’’ and each re-
animal drug through its manufacture quest for indexing shall be examined
and use under section 572(c)(1)(F) of the with respect to the reliability of infor-
act; mation submitted by the investigator.
(3) Conducting an environmental as- (5) Under § 511.1(c)(4) and (d)(2) of this
sessment under section 572(c)(1)(E) of chapter, with respect to termination of
the act; or exemptions, the sponsor of an inves-
(4) Obtaining approval of a new ani- tigation shall not be granted an oppor-
mal drug application or abbreviated tunity for a regulatory hearing before
new animal drug application under sec- FDA pursuant to part 16 of this chap-
tion 512(b) of the act. ter. Instead, the sponsor shall have an
(b) Correspondence and information opportunity for an informal conference
associated with investigations de- as described in § 516.123.
scribed in paragraph (a) of this section (6) Under § 511.1(c)(5) of this chapter,
shall not be sent to the Director, if the Commissioner of Food and Drugs
OMUMS, but shall be submitted to determines, after the unreliable data
FDA in accordance with the provisions submitted by the investigator are
of part 511 of this chapter. eliminated from consideration, that
(c) The investigational use of a new the data remaining are such that a re-
animal drug or animal feed bearing or quest for addition to the index would
containing a new animal drug intended have been denied, FDA will remove the
solely for investigational use in minor new animal drug from the index in ac-
species, other than for an investiga- cordance with § 516.167.
tional use described in paragraph (a) of (d) The investigational use of a new
this section, shall meet the require- animal drug or animal feed bearing or
ments of this section. For such inves- containing a new animal drug subject
tigations, all provisions of part 511 of to paragraph (c) of this section shall
this chapter apply with the following not be subject to the good laboratory
modifications: practice requirements in part 58 of this
(1) Under § 511.1(a)(1) of this chapter, chapter.
the label statement is as follows: (e) Correspondence and information
‘‘Caution. Contains a new animal associated with investigations de-

drug for investigational use only in scribed in paragraph (c) of this section
143
§ 516.129 21 CFR Ch. I (4–1–23 Edition)
shall be sent to the Director, OMUMS, (7) Information to establish that the
in accordance with the provisions of new animal drug is intended for use:
this section. (i) In a minor species for which there
is a reasonable certainty that the ani-
§ 516.129 Content and format of a re- mal or edible products from the animal
quest for determination of eligi- will not be consumed by humans or
bility for indexing. food-producing animals; or
(a) Each request for determination of (ii) In a hatchery, tank, pond, or
eligibility: other similar contained man-made
(1) May involve only one drug (or one structure in (which includes on) an
combination of drugs) in one dosage early, non-food life stage of a food-pro-
form; ducing minor species, and information
(2) May not involve a new animal to demonstrate food safety in accord-
drug that is contained in or a product ance with the standards of section
of a transgenic animal; 512(d) of the act and § 514.111 of this
(3) May not involve the same drug in chapter (including, for an anti-
the same dosage form for the same in- microbial new animal drug, with re-
tended use as a drug that is already ap- spect to antimicrobial resistance);
proved or conditionally approved; and (8) A description of the methods used
(4) Must be submitted separately. in, and the facilities and controls used
(b) A request for determination of eli- for, the manufacture, processing and
gibility for indexing may involve mul- packing of the new animal drug suffi-
tiple intended uses and/or multiple cient to demonstrate that the re-
minor species. However, if a request for questor has established appropriate
determination of eligibility for index- specifications for the manufacture and
ing that contains multiple intended control of the new animal drug and
uses and/or multiple minor species can- that the requestor has an under-
not be granted in any part, the entire standing of current good manufac-
request will be denied. turing practices;
(9) Either a claim for categorical ex-
(c) A requestor must submit two cop-
clusion under § 25.30 or § 25.33 of this
ies of a dated request signed by the au-
chapter or an environmental assess-
thorized contact person for determina-
ment under § 25.40 of this chapter;
tion of eligibility for indexing that
(10) Information sufficient to support
contains the following:
the conclusion that the new animal
(1) Identification of the minor species
drug is safe under section 512(d) of the
or groups of minor species for which
act with respect to individuals exposed
the new animal drug is intended;
to the new animal drug through its
(2) Information regarding drug com- manufacture and use; and
ponents and composition; (11) The name and address of the con-
(3) A statement of the intended use(s) tact person or permanent-resident U.S.
of the new animal drug in the identi- agent.
fied minor species or groups of minor
species; § 516.131 Refuse to file a request for
(4) A statement of the proposed con- determination of eligibility for in-
ditions of use associated with the stat- dexing.
ed intended use(s) of the new animal (a) If a request for determination of
drug, including the proposed dosage, eligibility for indexing contains all of
route of administration, contraindica- the information required by § 516.129,
tions, warnings, and any other signifi- FDA shall file it, and the filing date
cant limitations associated with the shall be the date FDA receives the re-
intended use(s) of the new animal drug; quest.
(5) A brief discussion of the need for (b) If a request for a determination of
the new animal drug for the intended eligibility lacks any of the information
use(s); required by § 516.129, FDA will not file
(6) An estimate of the anticipated an- it, but will inform the requestor in
nual distribution of the new animal writing within 30 days of receiving the
drug, in terms of the total quantity of request as to what information is lack-

active ingredient, after indexing; ing.
144
§ 516.133 Denying a request for deter- (b) FDA may deny a request for de-
mination of eligibility for indexing. termination of eligibility for indexing
(a) FDA will deny a request for deter- if it contains any untrue statement of
mination of eligibility for indexing if it a material fact or omits material infor-
determines upon the basis of the re- mation.
quest evaluated together with any (c) When a request for determination
other information before it with re- of eligibility for indexing is denied,
spect to the new animal drug that: FDA will notify the requestor in ac-
cordance with § 516.137.
(1) The same drug in the same dosage
form for the same intended use is al- § 516.135 Granting a request for deter-
ready approved or conditionally ap- mination of eligibility for indexing.
proved;
(a) FDA will grant the request for de-
(2) There is insufficient information termination of eligibility for indexing
to demonstrate that the new animal if none of the reasons described in
drug is intended for use: § 516.133 for denying such a request ap-
(i) In a minor species for which there plies.
is a reasonable certainty that the ani- (b) When a request for determination
mal or edible products from the animal of eligibility for indexing is granted,
will not be consumed by humans or FDA will notify the requestor in ac-
food-producing animals, or cordance with § 516.137.
(ii) In a hatchery, tank, pond, or
other similar contained man-made § 516.137 Notification of decision re-
structure in (which includes on) an garding eligibility for indexing.
early, non-food life stage of a food-pro- (a) Within 90 days after the filing of
ducing minor species, and there is in- a request for a determination of eligi-
sufficient evidence to demonstrate bility for indexing based on
safety for humans in accordance with § 516.129(c)(7)(i), or 180 days for a re-
the standard of section 512(d) of the act quest based on § 516.129(c)(7)(ii), FDA
and § 514.111 of this chapter (including, shall grant or deny the request, and no-
for an antimicrobial new animal drug, tify the requestor of FDA’s decision in
with respect to antimicrobial resist- writing.
ance); (b) If FDA denies the request, FDA
(3) The new animal drug is contained shall provide due notice and an oppor-
in or is a product of a transgenic ani- tunity for an informal conference as
mal; described in § 516.123 regarding its deci-
(4) There is insufficient information sion. A decision of FDA to deny a re-
to demonstrate that the requestor has quest for determination of eligibility
established appropriate specifications for indexing following an informal con-
for the manufacture and control of the ference shall constitute final agency
new animal drug and that the reaction subject to judicial review.
questor has an understanding of cur-
rent good manufacturing practices; § 516.141 Qualified expert panels.
(5) The requester fails to submit an (a) Establishment of a qualified expert
adequate environmental assessment panel. Establishing a qualified expert
under § 25.40 of this chapter or fails to panel is the first step in the process of
provide sufficient information to estab- requesting the addition of a new ani-
lish that the requested action is sub- mal drug to the index. A qualified ex-
ject to categorical exclusion under pert panel may not be established until
§ 25.30 or § 25.33 of this chapter; FDA has determined that the new ani-
(6) There is insufficient information mal drug is eligible for indexing. The
to determine that the new animal drug requestor must choose members for the
is safe with respect to individuals ex- qualified expert panel in accordance
posed to the new animal drug through with selection criteria listed in para-
its manufacture or use; or graph (b) of this section and submit in-
(7) The request for determination of formation about these proposed mem-
eligibility for indexing fails to contain bers to FDA. FDA must determine
any other information required under whether the proposed qualified expert
the provisions of § 516.129. panel meets the selection criteria prior
145
§ 516.141 21 CFR Ch. I (4–1–23 Edition)
to the panel beginning its work. Quali- he or she has read and understood the
fied expert panels operate external to information. The written statement
FDA and are not subject to the Federal should describe the duties and respon-
Advisory Committee Act, as amended, sibilities of qualified expert panels and
5 U.S.C. App. their members established by para-
(b) Criteria for the selection of a quali- graphs (e) and (f) of this section, in-
fied expert panel. (1) A qualified expert cluding the need to prepare a written
panel member must be an expert quali- report under § 516.143.
fied by training and experience to (iv) Obtain information from each po-
evaluate a significant aspect of target tential expert panel member dem-
animal safety or effectiveness of the onstrating that he or she is qualified
new animal drug under consideration. by training and experience to evaluate
(2) A qualified expert panel member the target animal safety and effective-
must certify that he or she has a work- ness of the new animal drug under con-
ing knowledge of section 572 of the act sideration. This information can be ob-
(the indexing provisions of the statute) tained from a comprehensive cur-
and this subpart, and that he or she has riculum vitae or similar document.
also read and understood a clear writ- (v) Notify each potential expert panel
ten statement provided by the re- member that he or she must submit in-
questor stating his or her duties and formation relating to potential conflict
responsibilities with respect to review- of interest directly to FDA in a timely
ing the new animal drug proposed for manner, as required in paragraph (e)(6)
addition to the index. of this section.
(3) A qualified expert panel member
(2) The requestor must submit, in
may not be an FDA employee.
writing, the names and addresses of the
(4) A qualified expert panel must
proposed qualified expert panel mem-
have at least three members.
bers and sufficient information about
(5) A qualified expert panel must
each proposed member for FDA to de-
have members with a range of expertise
termine whether the panel meets the
such that the panel, as a whole, is
selection criteria listed in paragraphs
qualified by training and experience to
evaluate the target animal safety and (b)(1) through (b)(5) of this section.
effectiveness of the new animal drug (3) After FDA has determined that
under consideration. the qualified expert panel meets the se-
(6) Unless FDA makes a determina- lection criteria, the requestor must
tion to allow participation notwith- provide to the panel all information
standing an otherwise disqualifying fi- known by the requestor that is rel-
nancial interest, a qualified expert evant to a determination of the target
panel member must not have a conflict animal safety and the effectiveness of
of interest or the appearance of a con- the new animal drug at issue. In addi-
flict of interest, as described in para- tion, the requestor must notify FDA of
graph (g) of this section. the name of the qualified expert panel
(c) Requestor responsibilities. (1) The leader.
requestor must: (4) The requestor must immediately
(i) Choose members for the qualified notify FDA if it believes a qualified ex-
expert panel in accordance with selec- pert panel member no longer meets the
tion criteria listed in paragraph (b) of selection criteria listed in paragraph
this section. (b) of this section or is otherwise not in
(ii) Provide each potential expert compliance with the requirements of
panel member a copy of section 572 of this section.
the act (the indexing provisions of the (5) If a qualified expert panel member
statute) and this subpart and obtain cannot complete the review for which
certification that he or she has a work- he or she was selected, the requestor
ing knowledge of the information. must either choose a replacement or
(iii) Provide each potential expert justify the continued work of the panel
panel member a written statement de- in the absence of the lost panelist. In
scribing the purpose and scope of his or either case, the requestor must submit
her participation on the qualified ex- sufficient information for FDA to de-
pert panel and obtain certification that termine whether the proposed revised
146
qualified expert panel meets the selec- (3) Review all information relevant
tion criteria listed in paragraphs (b)(1) to a determination of the target ani-
through (b)(5) of this section. mal safety and effectiveness of the new
(6) The requestor must keep copies of animal drug provided by the requestor.
all information provided to, or received The panel should also consider all rel-
from, qualified expert panel members, evant information otherwise known by
including the written report, for 2 the panel members, including anec-
years after the completion of the re- dotal information.
port, or the product is added to the (4) Participate in the preparation of
index, whichever occurs later, and the written report of the findings of
make them available to a duly author- the qualified expert panel, described in
ized employee of the agency at all rea- § 516.143.
sonable times. (5) Sign, or otherwise approve in
(d) FDA responsibilities. (1) FDA will writing, the written report. Such sig-
determine whether the requestor’s pro- nature or other written approval will
posed qualified expert panel meets the serve as certification that the written
selection criteria listed in paragraph report meets the requirements of the
(b) of this section. FDA will expedi- written report in § 516.143.
tiously inform the requestor, in writ- (6) Provide the information relating
ing, of its determination. If FDA deter- to potential conflict of interest de-
mines that the qualified expert panel scribed in paragraph (g) of this section
does not meet the selection criteria, to FDA for its consideration. Such in-
FDA will provide due notice and an op- formation should be submitted directly
portunity for an informal conference as to the Director, OMUMS, when notified
described in § 516.123. A determination by the requestor.
by FDA that a proposed qualified ex- (7) Immediately notify the requestor
pert panel does not meet the selection and FDA of any change in conflict of
criteria following an informal con- interest status.
ference shall constitute final agency (8) Certify at the time of submission
action subject to judicial review. of the written report that there has
(2) If FDA determines that a qualified been no change in conflict of interest
expert panel no longer meets the selec- status, or identify and document to
tion criteria listed in paragraph (b) of FDA any such change.
this section or that the panel or its (f) Additional responsibilities of a quali-
members are not in compliance with fied expert panel leader. (1) The qualified
the requirements of this section, the expert panel leader must ensure that
agency will expeditiously inform the the activities of the panel are per-
requestor, in writing, of this deter- formed efficiently and in accordance
mination and provide due notice and an with generally accepted professional
opportunity for an informal conference and ethical business practices.
as described in § 516.123. A determina- (2) The qualified expert panel leader
tion by FDA, following an informal serves as the principal point of contact
conference, that a qualified expert between representatives of the agency
panel no longer meets the selection cri- and the panel.
teria listed in paragraph (b) of this sec- (3) The qualified expert panel leader
tion or that the panel or its members is responsible for submitting the writ-
are not in compliance with the require- ten report and all notes or minutes re-
ments of this section shall constitute lating to panel deliberations to the re-
final agency action subject to judicial questor.
review. (4) The qualified expert panel leader
(e) Responsibilities of a qualified expert must maintain a copy of the written
panel member. A qualified expert panel report and all notes or minutes relat-
member must do the following: ing to panel deliberations that are sub-
(1) Continue to meet all selection cri- mitted to the requestor for 2 years
teria described in paragraph (b) of this after the report is submitted. Such
section. records must be made available to a
(2) Act in accordance with generally duly authorized employee of the agen-
accepted professional and ethical busi- cy for inspection at all reasonable

ness practices. times.
147
§ 516.141 21 CFR Ch. I (4–1–23 Edition)
(g) Prevention of conflicts of interest. ber must submit to the Director,

(1) For the purposes of this subpart, OMUMS, the following information re-
FDA will consider a conflict of interest lating to themselves, their spouse,
to be any financial or other interest their minor children, their general
that could impair a person’s objec- partners, or any organizations in which
tivity in serving on the qualified expert they serve as an officer, director, trust-
panel or could create an unfair com- ee, general partner or employee, re-
petitive advantage for a person or orga- garding the following issues to the ex-
nization. tent that they are, in any way, rel-
(2) Factors relevant to whether there evant to the subject of the review of
is a conflict of interest or the appear- the qualified expert panel:
ance of a conflict of interest include (i) Investments (for example, stocks,
whether the qualified expert panel bonds, retirement plans, trusts, part-
member, their spouse, their minor chil- nerships, sector funds, etc.), including
dren, their general partners, or any or- for each the following: Name of the
ganizations in which they serve as an firm, type of investment, owner (self,
officer, director, trustee, general part- spouse, etc.), number of shares / cur-
ner or employee: rent value.
(i) Is currently receiving or seeking (ii) Employment (full or part time,
funding from the requestor through a current or under negotiation), includ-
contract or research grant (either di- ing for each the following: Name of the
rectly or indirectly through another firm, relationship (self, spouse, etc.),
entity, such as a university). position in firm, date employment or
(ii) Has any employment, contrac- negotiation began.
tual, or other financial arrangement (iii) Consultant/advisor (current or
with the requestor other than receiving under negotiation), including for each
a reasonable fee for serving as a mem- the following: Name of the firm, topic/
ber of the qualified expert panel. issue, amount received, date initiated.
(iii) Has any ownership or financial (iv) Contracts, grants, Cooperation
interest in any drug, drug manufac- Research and Development Agreement
turer, or drug distributor which will (CRADAs) (current or under negotia-
benefit from either a favorable or unfa- tion), including for each the following:
vorable evaluation or opinion. Type of agreement, product under
(iv) Has any ownership or financial study and indications, amount of remu-
interest in the new animal drug being neration (institution/self), time period,
reviewed by the qualified expert panel. sponsor (government, firm, institution,
(v) Has participated in the design, individual), role of the person (site in-
manufacture, or distribution of any vestigator, principal investigator, co-
drug that will benefit from either a fa- investigator, partner, no involvement,
vorable or unfavorable opinion of the other), awardee.
qualified expert panel. (v) Patents/royalties/trademarks, in-
(vi) Has provided within 1 year any cluding for each the following: Descrip-
consultative services regarding the new tion, name of firm involved, income re-
animal drug being reviewed by the ceived.
qualified expert panel. (vi) Expert witness (last 12 months or
(vii) Has entered into an agreement under negotiation), including for each
in which fees charged or accepted are the following: For or against, name of
contingent upon the panel member firm, issue, amount received.
making a favorable evaluation or opin- (vii) Speaking/writing (last 12 months
ion. or under negotiation), including for
(viii) Receives payment for services each the following: Firm, topic/issue,
related to preparing information the amount received (honorarium/travel),
requestor presents to the qualified ex- date.
pert panel, other than for services re- (viii) Whether the potential qualified
lated to the written report described in expert panel member, their spouse,
§ 516.143. their minor children, their general
(3) To permit FDA to make a decision partners or any organizations in which
regarding potential conflict of interest, they serve as an officer, director, trust-

a potential qualified expert panel mem- ee, general partner or employee, have
148
had, at any time in the past, involve- proved new animal drug for the minor
ment of the kind noted in paragraph species in question;
(g)(3)(i) through (g)(3)(vii) of this sec- (e) Be signed, or otherwise approved
tion with respect to the animal drug in writing, by all panel members, in ac-
that is the subject of the qualified ex- cordance with § 516.141; and
pert panel review. (f) If the panel unanimously con-
(ix) Whether there are any other includes that the benefits of using the
volvements (other kinds of relation- new animal drug for the proposed use
ships) that would give the appearance in a minor species outweigh its risks to
of a conflict of interest which have not the target animal, taking into account
been described in paragraph (g)(3)(i) the harm being caused by the absence
through (g)(3)(viii) of this section. of an approved or conditionally-ap-
(x) In all cases, a response of ‘‘no,’’ proved new animal drug for the minor
‘‘none,’’ or ‘‘not applicable’’ is satisfac- species in question, the written report
tory when there is no relevant informa- shall:
tion to submit. (1) Provide draft labeling that in-
(xi) A certification statement signed cludes all conditions of use and limita-
by the potential qualified expert panel tions of use of the new animal drug
member to the effect that all informa- deemed necessary by the panel to as-
tion submitted is true and complete to sure that the benefits of use of the new
the best of their knowledge, that they animal drug outweigh the risks, or pro-
have read and understood their obliga- vide narrative information from which
tions as an expert panel member, and such labeling can be written by the re-
that they will notify FDA and the requestor; and
questor of any change in their conflict (2) Include a recommendation regard-
of interest status. ing whether the new animal drug
(4) The fact that a qualified expert should be limited to use under the pro-
panel member receives a reasonable fee fessional supervision of a licensed vet-
for services as a member of the quali- erinarian.
fied expert panel, provided that the fee
is no more than commensurate with § 516.145 Content and format of a re-
the value of the time that the member quest for addition to the index.
devotes to the review process, does not (a) A requestor may request addition
constitute a conflict of interest or the of a new animal drug to the index only
appearance of a conflict of interest. after the new animal drug has been
granted eligibility for indexing.
§ 516.143 Written report. (b) A requestor shall submit two cop-
The written report required in ies of a dated request signed by the au-
§ 516.145(b)(3) shall: thorized contact for addition of a new
(a) Be written in English by a quali- animal drug to the index that contains
fied expert panel meeting the require- the following:
ments of § 516.141; (1) A copy of FDA’s determination of
(b) Describe the panel’s evaluation of eligibility issued under § 516.137;
all available target animal safety and (2) A copy of FDA’s written deter-
effectiveness information relevant to mination that the proposed qualified
the proposed use of the new animal expert panel meets the selection cri-
drug, including anecdotal information; teria provided for in § 516.141(b);
(c) For all information considered, (3) A written report that meets the
including anecdotal information, in- requirements of § 516.143;
clude either a citation to published lit- (4) A proposed index entry that con-
erature or a summary of the informa- tains the information described in
tion; § 516.157;
(d) State the panel’s opinion regard- (5) Proposed labeling, including rep-
ing whether the benefits of using the resentative labeling proposed to be
new animal drug for the proposed use used for Type B and Type C medicated
in a minor species outweigh its risks to feeds if the drug is intended for use in
the target animal, taking into account the manufacture of medicated feeds;
the harm being caused by the absence (6) Anticipated annual distribution of
of an approved or conditionally-ap- the new animal drug, in terms of the
149
§ 516.147 21 CFR Ch. I (4–1–23 Edition)
total quantity of active ingredient, § 516.149 Denying a request for addi-

after indexing; tion to the index.
(7) A written commitment to manu- (a) FDA will deny a request for addi-
facture the new animal drug and ani- tion to the index if it finds the fol-
mal feeds bearing or containing such lowing:
new animal drug according to current (1) The same drug in the same dosage
good manufacturing practices; form for the same intended use is al-
(8) A written commitment to label, ready approved or conditionally ap-
distribute, and promote the new ani- proved;
mal drug only in accordance with the (2) On the basis of new information,
index entry; the new animal drug no longer meets
(9) The name and address of the con- the conditions for eligibility for index-
tact person or permanent-resident U.S. ing;
agent; and (3) The request for indexing fails to
(10) A draft Freedom of Information contain information required under the
summary which includes the following provisions of § 516.145;
information: (4) The qualified expert panel fails to
(i) A general information section meet any of the selection criteria list-
that contains the name and address of ed in § 516.141(b);
the requestor and a description of the (5) The written report of the qualified
drug, route of administration, indica- expert panel and other information
tions, and recommended dosage. available to FDA is insufficient to per-
(ii) A list of the names and affili- mit FDA to determine that the bene-
ations of the members of the qualified fits of using the new animal drug for
expert panel, not including their ad- the proposed use in a minor species
dresses or other contact information. outweigh its risks to the target ani-
(iii) A summary of the findings of the mal, taking into account the harm
qualified expert panel concerning the caused by the absence of an approved
target animal safety and effectiveness or conditionally-approved new animal
of the drug. drug for the minor species in question;
(6) On the basis of the report of the
(iv) Citations of all publicly-available
qualified expert panel and other infor-
literature considered by the qualified
mation available to FDA, the benefits
expert panel.
of using the new animal drug for the
(v) For an early life stage of a food- proposed use in a minor species do not
producing minor species animal, a outweigh its risks to the target ani-
human food safety summary. mal, taking into account the harm
(c) Upon specific request by FDA, the caused by the absence of an approved
requestor shall submit the information or conditionally-approved new animal
described in § 516.141 that it submitted drug for the minor species in question;
to the qualified expert panel. Any such or
information not in English should be (7) The request contains any untrue
accompanied by an English trans- statement of a material fact or omits
lation. material information.
(b) When a request for addition to the
§ 516.147 Refuse to file a request for index is denied, FDA will notify the re-
addition to the index.
questor in accordance with § 516.153.
(a) If a request for addition to the
index contains all of the information § 516.151 Granting a request for addi-
required by § 516.145(b), FDA shall file tion to the index.
it, and the filing date shall be the date (a) FDA will grant the request for ad-
FDA receives the request. dition of a new animal drug to the
(b) If a request for addition to the index if none of the reasons described
index lacks any of the information rein § 516.149 for denying such a request
quired by § 516.145, FDA will not file it, applies.
but will inform the requestor in writ- (b) When a request for addition of a
ing within 30 days of receiving the renew animal drug to the index is grant-
quest as to what information is lack- ed, FDA will notify the requestor in ac-
ing. cordance with § 516.153.
150
§ 516.153 Notification of decision re- (3) Product labeling; and

garding index listing. (4) Conditions and any limitations
(a) Within 180 days after the filing of that FDA deems necessary regarding
a request for addition of a new animal use of the drug.
drug to the index, FDA shall grant or [72 FR 69121, Dec. 6, 2007; 76 FR 31470, June 1,
deny the request and notify the re- 2011, as amended at 79 FR 68115, Nov. 14, 2014]
questor of FDA’s decision in writing.
(b) If FDA denies the request for ad- § 516.161 Modifications to indexed
dition of a new animal drug to the drugs.
index, FDA shall provide due notice (a) After a drug is listed in the index,
and an opportunity for an informal certain modifications to the index list-
conference as described in § 516.123. A ing may be requested. Any modifica-
decision of FDA to deny a request to tion of an index listing may not cause
index a new animal drug following an an indexed drug to be a different drug
informal conference shall constitute (or different combination of drugs) or a
final agency action subject to judicial
different dosage form. If such modifica-
review.
tion is requested, FDA will notify the
§ 516.155 Labeling of indexed drugs. holder that a new index listing is re-
quired for the new drug or dosage form.
(a) The labeling of an indexed drug
(b) Modifications to the indexed drug
that is found to be eligible for indexing
will fall under one of three categories
under § 516.129(c)(7)(i) shall state,
and must be submitted as follows:
prominently and conspicuously: ‘‘NOT
APPROVED BY FDA.—Legally marketed (1) Urgent changes. (i) The following
as an FDA indexed product. Extra-label modifications to an indexed drug or its
use is prohibited.’’ ‘‘This product is not to labeling should be made as soon as pos-
be used in animals intended for use as sible, and a request to modify the in-
food for humans or other animals.’’ dexed drug should be concurrently sub-
(b) The labeling of an indexed drug mitted:
that was found to be eligible for index- (A) The addition to package labeling,
ing for use in an early, non-food life promotional labeling, or prescription
stage of a food-producing minor species drug advertising of additional warning,
animal, under § 516.129(c)(7)(ii), shall contraindication, side effect, or cau-
state, prominently and conspicuously: tionary information.
‘‘NOT APPROVED BY FDA.—Legally (B) The deletion from package label-
marketed as an FDA indexed product. ing, promotional labeling, and drug ad-
Extra-label use is prohibited.’’ vertising of false, misleading, or unsup-
(c) The labeling of an indexed drug ported indications for use or claims for
shall contain such other information as effectiveness.
may be prescribed in the index listing. (C) Changes in manufacturing meth-
ods or controls required to correct
§ 516.157 Publication of the index and product or manufacturing defects that
content of an index listing. may result in serious adverse drug
(a) FDA will make the list of indexed events.
drugs available through the FDA Web (ii) The modifications described in
site at http://www.fda.gov. A printed paragraph (b)(1)(i) of this section must
copy can be obtained by writing to the be submitted to the Director, OMUMS,
Freedom of Information Staff or by vis- in the form of a request for modifica-
iting FDA’s Freedom of Information tion of an indexed drug, and must con-
Staff’s Public Reading Room at the ad- tain sufficient information to permit
dress listed on the Agency’s Web site at FDA to determine the need for the
http://www.fda.gov. modification and whether the modi-
(b) The list will contain the following fication appropriately addresses the
information for each indexed drug: need.
(1) The name and address of the per- (iii) FDA will take no action against
son who holds the index listing; an indexed drug or index holder solely
(2) The name of the drug and the in- because modifications of the kinds de-
tended use and conditions of use for scribed in paragraph (b)(1)(i) of this
which it is indexed; section are placed into effect by the
151
§ 516.163 21 CFR Ch. I (4–1–23 Edition)
holder prior to receipt of a written no- tion, labeling, and manufacturing

tice granting the request if all the fol- methods and controls (at the same
lowing conditions are met: level of detail that these were de-
(A) A request to modify the indexed scribed in the request for determina-
drug providing a full explanation of the tion of eligibility for indexing) must be
basis for the modifications has been submitted as part of the annual in-
submitted, plainly marked on the mail- dexed drug experience report or as oth-
ing cover and on the request as follows: erwise required by § 516.165.
‘‘Special indexing request— modifica- (c) When changes affect the index
tions being effected;’’ listing, it will be updated accordingly.
(B) The holder specifically informs
FDA of the date on which such modi- § 516.163 Change in ownership of an
fications are to be effected and submits index file.
two printed copies of any revised label- (a) A holder may transfer ownership
ing to be placed in use, and of a drug’s index file to another person.
(C) All promotional labeling and all (1) The former owner shall submit in
drug advertising are promptly revised writing to FDA a statement that all
consistent with modifications made in rights in the index file have been trans-
the labeling on or within the indexed ferred, giving the name and address of
drug package. the new owner and the date of the
(2) Significant changes. (i) The fol- transfer. The former owner shall also
lowing modifications to an indexed certify that a complete copy of the fol-
drug or its labeling may be made only lowing, to the extent that they exist at
after a request has been submitted to the time of the transfer of ownership,
and subsequently granted by FDA: has been provided to the new owner:
(A) Addition of an intended use. (i) The request for determination of
(B) Addition of a species. eligibility;
(C) Addition or alteration of an ac- (ii) The request for addition to the
tive ingredient. index;
(D) Alteration of the concentration (iii) Any modifications to the index
of an active ingredient. listing;
(E) Alteration of dose or dosage regi- (iv) Any records and reports under
men. § 516.165; and
(F) Alteration of prescription or (v) All correspondence with FDA rel-
over-the-counter status. evant to the indexed drug and its index
(ii) Each modification described in listing.
paragraph (b)(2)(i) of this section must (2) The new owner shall submit the
go through the same review process as following information in writing to
an original index listing and is subject FDA:
to the same standards for review. (i) The date that the change in own-
(iii) Each submission of a request for ership is effective;
a modification described in paragraph (ii) A statement that the new owner
(b)(2)(i) of this section should contain has a complete copy of all documents
only one type of modification unless listed in paragraph (a)(1) of this section
one modification is actually neces- to the extent that they exist at the
sitated by another, such as a modifica- time of the transfer of ownership;
tion of dose necessitated by a modifica- (iii) A statement that the new owner
tion of the concentration of an active understands and accepts the respon-
ingredient. Submissions relating to ad- sibilities of a holder of an indexed drug;
dition of an intended use for an exist- (iv) The name and address of a new
ing species or addition of a species primary contact person or permanent-
should be submitted separately, but resident U.S. agent; and
each such submission may include mul- (v) A list of labeling changes associ-
tiple additional intended uses and/or ated with the change of ownership
multiple additional species. (e.g., a new trade name) as draft label-
(3) Minor changes. All modifications ing, with complete final printed label-
other than those described in para- ing to be submitted in the indexed drug
graphs (b)(1) and (b)(2) of this section annual report in accordance with
including, but not limited to, formula- §§ 516.161 and 516.165.
152
(b) Upon receiving the necessary in- drug event, regardless of the source of
formation to support a change of own- the information. The holder must sub-
ership of a drug’s index file, FDA will mit the report within 15 working days
update its publicly-available listing in of first receiving the information. The
accordance with § 516.157. mailing cover must be plainly marked
‘‘15–Day Indexed Drug Alert Report.’’
§ 516.165 Records and reports. (3) Annual indexed drug experience re-
(a) Scope and purpose. (1) The record- port. The holder must submit this re-
keeping and reporting requirements of port every year on the anniversary
this section apply to all holders of in- date of the letter granting the request
dexed drugs, including indexed drugs for addition of the new animal drug to
intended for use in medicated feeds. the index, or within 60 days thereafter.
(2) A holder is not required to report The report must contain data and in-
information under this section if the formation for the full reporting period.
holder has reported the same informa- Any previously submitted information
tion under § 514.80 of this chapter. contained in the report must be identi-
(3) The records and reports referred fied as such. The holder may ask FDA
to in this section are in addition to to change the date of submission and,
those required by the current good after approval of such request, file such
manufacturing practice regulations in reports by the new filing date. The re-
parts 211, 225, and 226 of this chapter. port must contain the following:
(4) FDA will review the records and (i) The number of distributed units of
reports required in this section to de- each size, strength, or potency (e.g.,
termine, or facilitate a determination, 100,000 bottles of 100 5-milligram tab-
whether there may be grounds for re- lets; 50,000 10-milliliter vials of 5- per-
moving a drug from the index under cent solution) distributed during the
section 572(f) of the act. reporting period. This information
(b) Recordkeeping requirements. (1) must be presented in two categories:
Each holder of an indexed drug must Quantities distributed domestically
establish and maintain complete files and quantities exported. This informa-
containing full records of all informa-
tion must include any distributor-la-
tion pertinent to the safety or effec-
beled product.
tiveness of the indexed drug. Such
(ii) If the labeling has changed since
records must include information from
foreign and domestic sources. the last report, include a summary of
(2) The holder must, upon request those changes and the holder’s and dis-
from any authorized FDA officer or tributor’s current package labeling, in-
employee, at all reasonable times, per- cluding any package inserts. For large-
mit such officer or employee to have size package labeling or large shipping
access to copy and to verify all such cartons, submit a representative copy
records. (e.g., a photocopy of pertinent areas of
(c) Reporting requirements—(1) Three- large feed bags). If the labeling has not
day indexed drug field alert report. The changed since the last report, include a
holder must inform the appropriate statement of such fact.
FDA District Office or local FDA resi- (iii) A summary of any changes made
dent post of any product or manufac- during the reporting period in the
turing defects that may result in seri- methods used in, and facilities and con-
ous adverse drug events within 3 work- trols used for, manufacture, processing,
ing days of first becoming aware that and packing. This information must be
such a defect may exist. The holder presented in the same level of detail
may initially provide this information that it was presented in the request for
by telephone or other electronic com- determination of eligibility for index-
munication means, with prompt writing. Do not include changes that have
ten followup. The mailing cover must already been submitted under § 516.161.
be plainly marked ‘‘3–Day Indexed (iv) Nonclinical laboratory studies
Drug Field Alert Report.’’ and clinical data not previously re-
(2) Fifteen-day indexed drug alert reported under this section.
port. The holder must submit a report (v) Adverse drug experiences not pre-
on each serious, unexpected adverse viously reported under this section.
153
§ 516.167 21 CFR Ch. I (4–1–23 Edition)
(vi) Any other information pertinent index, the benefits of using the new
to safety or effectiveness of the in- animal drug for the indexed use do not
dexed drug not previously reported outweigh its risks to the target ani-
under this section. mal, taking into account the harm
(4) Distributor’s statement. At the time caused by the absence of an approved
of initial distribution of an indexed or conditionally-approved new animal
drug by a distributor, the holder must drug for the minor species in question;
submit a report containing the fol- (4) Any of the conditions in
lowing: § 516.133(a)(2), (5), or (6) are present;
(i) The distributor’s current product (5) The manufacture of the new ani-
labeling. This must be identical to that mal drug is not in accordance with cur-
in the index listing except for a dif- rent good manufacturing practices;
ferent and suitable proprietary name (6) The labeling, distribution, or pro-
(if used) and the name and address of motion of the new animal drug is not
the distributor. The name and address in accordance with the index listing;
of the distributor must be preceded by (7) The conditions and limitations of
an appropriate qualifying phrase such use associated with the index listing
as ‘‘manufactured for’’ or ‘‘distributed have not been followed; or
by.’’ (8) Any information used to support
(ii) A signed statement by the dis- the request for addition to the index
tributor stating: contains any untrue statement of ma-
(A) The category of the distributor’s terial fact.
operations (e.g., wholesale or retail); (b) The agency may partially remove
(B) That the distributor will dis- an indexing listing if, in the opinion of
tribute the drug only under the indexed the agency, such partial removal would
drug labeling; satisfactorily resolve a safety or effec-
(C) That the distributor will promote tiveness issue otherwise warranting re-
the indexed drug only for use under the moval of the listing under section
conditions stated in the index listing; 572(f)(1)(B) of the act.
and (c) FDA may immediately suspend a
(D) If the indexed drug is a prescrip- new animal drug from the index if FDA
tion new animal drug, that the dis- determines that there is a reasonable
tributor is regularly and lawfully en- probability that the use of the drug
gaged in the distribution or dispensing would present a risk to the health of
of prescription products. humans or other animals. The agency
(5) Other reporting. FDA may by order will subsequently provide due notice
require that a holder submit informa- and an opportunity for an informal
tion in addition to that required by conference as described in § 516.123.
this section or that the holder submit (d) A decision of FDA to remove a
the same information but at different new animal drug from the index fol-
times or reporting periods. lowing an informal conference, if any,
shall constitute final agency action
§ 516.167 Removal from the index. subject to judicial review.
(a) After due notice to the holder of
the index listing and an opportunity § 516.171 Confidentiality of data and
for an informal conference as described information in an index file.
in § 516.123, FDA shall remove a new (a) For purposes of this section, the
animal drug from the index if FDA index file includes all data and infor-
finds that: mation submitted to or incorporated
(1) The same drug in the same dosage by reference into the index file, such as
form for the same intended use has data and information related to inves-
been approved or conditionally ap- tigational use exemptions under
proved; § 516.125, requests for determination of
(2) The expert panel failed to meet eligibility for indexing, requests for ad-
the requirements in § 516.141; dition to the index, modifications to
(3) On the basis of new information indexed drugs, changes in ownership,
before FDA, evaluated together with reports submitted under § 516.165, and
the evidence available to FDA when master files. The availability for public
the new animal drug was listed in the disclosure of any record in the index
154
file shall be handled in accordance with (4) Adverse reaction reports, product
the provisions of this section. experience reports, consumer com-
(b) The existence of an index file will plaints, and other similar data and in-
not be disclosed by FDA before an formation, after deletion of the fol-
index listing has been made public by lowing:
FDA, unless it has previously been pub- (i) Names and any information that
licly disclosed or acknowledged by the would identify the person using the
requestor. product.
(c) If the existence of an index file (ii) Names and any information that
has not been publicly disclosed or ac- would identify any third party involved
knowledged, no data or information in with the report, such as a veterinarian.
the index file are available for public (5) A list of all active ingredients and
disclosure. any inactive ingredients previously
(d) If the existence of an index file disclosed to the public as defined in
has been publicly disclosed or acknowl- § 20.81 of this chapter.
edged before an index listing has been
(6) An assay method or other analyt-
made public by FDA, no data or infor-
ical method, unless it serves no regu-
mation contained in the file will be
latory or compliance purpose and is
available for public disclosure before
shown to fall within the exemption es-
such index listing is made public, but
tablished in § 20.61 of this chapter.
the agency may, at its discretion, dis-
(7) All correspondence and written
close a brief summary of such selected
summaries of oral discussions relating
portions of the safety and effectiveness
to the index file, in accordance with
data as are appropriate for public con-
the provisions of part 20 of this chap-
sideration of a specific pending issue,
ter.
e.g., at an open session of a Food and
Drug Administration advisory com- (f) The following data and informa-
mittee or pursuant to an exchange of tion in an index file are not available
important regulatory information with for public disclosure unless they have
a foreign government. been previously disclosed to the public
(e) After FDA sends a written notice as defined in § 20.81 of this chapter, or
to the requestor granting a request for they relate to a product or ingredient
addition to the index, the following that has been abandoned and they no
data and information in the index file longer represent a trade secret or con-
are available for public disclosure un- fidential commercial or financial infor-
less extraordinary circumstances are mation as defined in § 20.61 of this chap-
shown: ter:
(1) All safety and effectiveness data (1) Manufacturing methods or proc-
and information previously disclosed to esses, including quality control proce-
the public, as defined in § 20.81 of this dures.
chapter. (2) Production, sales, distribution,
(2) A summary or summaries of the and similar data and information, ex-
safety and effectiveness data and infor- cept that any compilation of such data
mation submitted with or incorporated and information aggregated and pre-
by reference in the index file. Such pared in a way that does not reveal
summaries do not constitute the full data or information which is not avail-
information described under section able for public disclosure under this
572(c) and (d) of the act on which the provision is available for public disclo-
safety or effectiveness of the drug may sure.
be determined. Such summaries will be (3) Quantitative or semiquantitative
based on the draft Freedom of Informa- formulas.
tion summary submitted under (g) Subject to the disclosure provi-
§ 516.145, which will be reviewed and, sions of this section, the agency shall
where appropriate, revised by FDA. regard the contents of an index file as
(3) A protocol for a test or study, un- confidential information unless specifi-
less it is shown to fall within the ex- cally notified in writing by the holder
emption established for trade secrets of the right to disclose, to reference, or
and confidential commercial informa- otherwise utilize such information on

tion in § 20.61 of this chapter. behalf of another named person.
155
§ 516.498 21 CFR Ch. I (4–1–23 Edition)
(h) For purposes of this regulation, § 516.812 Enrofloxacin.

safety and effectiveness data include
(a) Specifications. Each milliliter
all studies and tests of an animal drug
(mL) of solution contains 100 milli-
on animals and all studies and tests on
grams (mg) enrofloxacin.
the animal drug for identity, stability,
(b) Sponsor. See No. 058198 in
purity, potency, and bioavailability.
§ 510.600(c) of this chapter.
(i) Safety and effectiveness data and (c) Conditions of use in cattle—(1)
information that have not been pre- Amount. Administer, by subcutaneous
viously disclosed to the public are injection, a single dose of 12.5 mg/kilo-
available for public disclosure at the gram of body weight (5.7 mL/100 pounds
time any of the following events occurs of body weight). Administered dose vol-
unless extraordinary circumstances are ume should not exceed 20 mL per injec-
shown: tion site.
(1) No work is being or will be under- (2) Indications for use. For the treat-
taken to have the drug indexed in ac- ment of clinical anaplasmosis associ-
cordance with the request. ated with Anaplasma marginale in re-
(2) A final determination is made placement dairy heifers under 20
that the drug cannot be indexed and all months of age and all classes of beef
legal appeals have been exhausted. cattle except beef calves less than 2
(3) The drug has been removed from months of age and beef bulls intended
the index and all legal appeals have for breeding (any age). Not for use in
been exhausted. any other class of dairy cattle or in
(4) A final determination has been veal calves.
made that the animal drug is not a new (3) Limitations. Federal law restricts
animal drug. this drug to use by or on the order of a
licensed veterinarian. Federal law pro-
Subpart D [Reserved] hibits the extra-label use of this drug
in food-producing animals. Cattle in-
Subpart E—Conditionally Ap- tended for human consumption must
not be slaughtered within 28 days from
proved New Animal Drugs For the last treatment. This product is not
Minor Use and Minor Species approved for use in female dairy cattle
20 months of age or older including dry
SOURCE: 72 FR 57200, Oct. 9, 2007, unless dairy cows. Use in these cattle may
otherwise noted. cause drug residues in milk and/or in
calves born to these cows. A with-
§ 516.498 Crofelemer. drawal period has not been established
(a) Specifications. Each delayed-re- for this product in pre-ruminating
lease tablet contains 125 milligrams calves. Do not use in calves to be proc-
(mg) crofelemer. essed for veal.
§ 510.600(c) of this chapter. FR 58960, Sept. 29, 2022]
(c) Conditions of use—(1) Amount. Ad-
minister 1 tablet orally twice daily for § 516.1012 Fuzapladib.
3 days for dogs weighing ≤140 pounds. (a) Specifications. The drug is pro-
Administer 2 tablets orally twice daily vided as a powder for injection that is
for 3 days for dogs weighing >140 reconstituted with 3.5 milliliter (mL)
pounds. of provided diluent to a final con-
(2) Indications for use. For the treat- centration of 4 milligrams (mg)
ment of chemotherapy-induced diar- fuzapladib sodium per mL.
rhea in dogs. (b) Sponsor. See No. 064642 in
(3) Limitations. Federal law restricts § 510.600(c) of this chapter.
this drug to use by or on the order of a (c) Conditions of use—(1) Amount. Ad-
licensed veterinarian. It is a violation minister at a dosage of 0.4 mg (0.1 mL)
of Federal law to use this product per kilogram of body weight once daily
other than as directed in the labeling. for 3 consecutive days by intravenous
[87 FR 17944, Mar. 29, 2022. Redesignated at 88 (IV) injection over 15 seconds to 1
FR 16546, Mar. 20, 2023] minute.
156
(2) Indications for use in dogs. For the B2 preclinical myxomatous mitral
management of clinical signs associ- valve disease (MMVD) refers to dogs
ated with acute onset of pancreatitis in with asymptomatic MMVD that have a
dogs. moderate or loud mitral murmur due
(3) Limitations. Federal law restricts to mitral regurgitation and cardio-
this drug to use by or on the order of a megaly.
licensed veterinarian. It is a violation (3) Limitations. Federal law restricts
of Federal law to use this product this drug to use by or on the order of a
other than as directed in the labeling. licensed veterinarian. It is a violation
[88 FR 16546, Mar. 20, 2023] of Federal law to use this product
other than as directed in the labeling.
§ 516.1684 Paclitaxel.
[87 FR 76421, Dec. 14, 2022]
(a) Specifications. Each vial of powder
contains 60 milligrams (mg) paclitaxel. § 516.1858 Potassium bromide.
Each milliliter of constituted solution (a) Specifications. Each chewable tab-
contains 1 mg paclitaxel. let contains 250 or 500 milligrams (mg)
(b) Sponsor. See No. 052818 in potassium bromide.
510.600(c) of this chapter.
(c) Conditions of use in dogs—(1)
Amount. Administer 150 mg per square
meter of body surface area intra- (c) Conditions of use—(1) Amount. Ad-
venously over 15 to 30 minutes, once minister 25 to 68 mg per kilogram (11 to
every 3 weeks, for up to 4 doses. 31 mg per pound) of body weight once
(2) Indications for use. For the treat- daily. The dosage can be divided and
ment of nonresectable stage III, IV, or should be adjusted to clinical response.
V mammary carcinoma in dogs that (2) Indications for use. For the control
have not received previous chemo- of seizures associated with idiopathic
therapy or radiotherapy. For the treat- epilepsy in dogs.
ment of resectable and nonresectable (3) Limitations. Federal law restricts
squamous cell carcinoma in dogs that this drug to use by or on the order of a
have not received previous chemo- licensed veterinarian. It is a violation
therapy or radiotherapy. of Federal law to use this product
(3) Limitations. Federal law restricts other than as directed in the labeling.
this drug to use by or on the order of a [86 FR 57996, Oct. 20, 2021]
licensed veterinarian. It is a violation
of Federal law to use this product § 516.2980 Verdinexor.
(a) Specifications. Each tablet con-
[79 FR 18158, Apr. 1, 2014] tains 2.5, 10, or 50 milligrams (mg)
verdinexor.
§ 516.1780 Pimobendan.
(a) Specifications. Each chewable tab- § 510.600(c) of this chapter.
let contains 1.25, 2.5, 5, or 10 milligrams (c) Conditions of use—(1) Amount. Ad-
(mg) pimobendan. minister verdinexor tablets orally at
(b) Sponsor. See No. 000010 in an initial dose of 1.25 mg per kilogram
§ 510.600(c) of this chapter. (mg/kg) of body weight twice per week
(c) Conditions of use—(1) Amount. Ad- with at least 72 hours between doses. If
minister orally at a total daily dose of tolerated after 2 weeks, increase the
0.23 mg per pound (0.5 mg per kilogram) dose to 1.5 mg/kg twice per week with
body weight, using a suitable combina- at least 72 hours between doses.
tion of whole or half tablets. The total (2) Indications for use. For the treat-
daily dose should be divided into two ment of lymphoma in dogs.
portions administered approximately
(3) Limitations. Federal law restricts
12 hours apart.
this drug to use by or on the order of a
(2) Indications for use in dogs. For the
licensed veterinarian. It is a violation
delay of onset of congestive heart fail-
of Federal law to use this product
ure in dogs with Stage B2 preclinical
myxomatous mitral valve disease (2019

ACVIM Consensus Statement). Stage [86 FR 57996, Oct. 20, 2021]
157
PART 520—ORAL DOSAGE FORM 520.443 Chlortetracycline tablets and

boluses.
NEW ANIMAL DRUGS 520.445 Chlortetracycline and
sulfamethazine powder.
Sec. 520.446 Clindamycin capsules and tablets.
520.23 Acepromazine. 520.447 Clindamycin solution.
520.28 Acetazolamide. 520.452 Clenbuterol syrup.
520.38 Albendazole oral dosage forms. 520.455 Clomipramine.
520.38a Albendazole suspension. 520.462 Clorsulon drench.
520.38b Albendazole paste. 520.522 Cyclosporine.
520.43 Afoxolaner. 520.530 Cythioate oral liquid.
520.48 Altrenogest. 520.531 Cythioate tablets.
520.62 Aminopentamide. 520.534 Decoquinate.
520.82 Aminopropazine oral dosage forms. 520.538 Deracoxib.
520.82a Aminopropazine. 520.540 Dexamethasone oral dosage forms.
520.82b Aminopropazine and neomycin. 520.540a Dexamethasone powder.
520.88 Amoxicillin oral dosage forms. 520.540b Dexamethasone tablets and
520.88a Amoxicillin trihydrate film-coated boluses.
tablets. 520.540c Dexamethasone chewable tablets.
520.88b Amoxicillin trihydrate for oral sus- 520.563 Diatrizoate.
pension. 520.580 Dichlorophene and toluene.
520.88c Amoxicillin trihydrate oral suspen- 520.581 Dichlorophene tablets.
sion. 520.596 Dichlorvos powder.
520.88d Amoxicillin trihydrate soluble pow- 520.598 Dichlorvos tablets.
der. 520.600 Dichlorvos capsules and pellets.
520.88e Amoxicillin trihydrate boluses. 520.602 Dichlorvos gel.
520.88f Amoxicillin trihydrate tablets. 520.606 Diclazuril.
520.88g Amoxicillin trihydrate and 520.608 Dicloxacillin.
clavulanate potassium tablets. 520.620 Diethylcarbamazine oral dosage
520.88h Amoxicillin trihydrate and forms.
clavulanate potassium for oral suspen- 520.622 Diethylcarbamazine citrate oral dos-
sion. age forms.
520.90 Ampicillin oral dosage forms. 520.622a Diethylcarbamazine citrate tablets.
520.90a Ampicillin tablets. 520.622b Diethylcarbamazine citrate syrup.
520.90b Ampicillin capsules. 520.622c Diethylcarbamazine citrate chew-
520.90c Ampicillin boluses. able tablets.
520.100 Amprolium. 520.623 Diethylcarbamazine and
520.110 Apramycin sulfate soluble powder. oxibendazole chewable tablets.
520.154 Bacitracin oral dosage forms. 520.645 Difloxacin.
520.154a Bacitracin methylenedisalicylate. 520.666 Dirlotapide.
520.154b Bacitracin methylenedisalicylate 520.763 Dithiazanine oral dosage forms.
and streptomycin sulfate powder. 520.763a Dithiazanine tablets.
520.154c Bacitracin zinc soluble powder. 520.763b Dithiazanine powder.
520.170 Bexagliflozin. 520.763c Dithiazanine iodide and piperazine
520.222 Bunamidine hydrochloride. citrate suspension.
520.246 Butorphanol tablets. 520.766 Domperidone.
520.260 n-Butyl chloride. 520.784 Doxylamine.
520.284 Cambendazole oral dosage forms. 520.804 Enalapril.
520.284a Cambendazole suspension. 520.812 Enrofloxacin.
520.284b Cambendazole pellets. 520.816 Epsiprantel.
520.284c Cambendazole paste. 520.823 Erythromycin.
520.292 Capromorelin. 520.852 Estriol.
520.301 Caramiphen ethanedisulfonate and 520.863 Ethylisobutrazine.
ammonium chloride tablets. 520.870 Etodolac.
520.302 Carnidazole tablets. 520.903 Febantel oral dosage forms.
520.304 Carprofen. 520.903a Febantel paste.
520.314 Cefadroxil. 520.903b Febantel suspension.
520.370 Cefpodoxime tablets. 520.903c Febantel and praziquantel paste.
520.376 Cephalexin. 520.903d Febantel tablets.
520.390 Chloramphenicol oral dosage forms. 520.905 Fenbendazole oral dosage forms.
520.390a Chloramphenicol tablets. 520.905a Fenbendazole suspension.
520.390b Chloramphenicol capsules. 520.905b Fenbendazole granules.
520.390c Chloramphenicol palmitate oral 520.905c Fenbendazole paste.
suspension. 520.905d Fenbendazole powder.
520.420 Chlorothiazide. 520.928 Firocoxib.
520.434 Chlorphenesin carbamate tablets. 520.930 Firocoxib paste.

520.441 Chlortetracycline powder. 520.955 Florfenicol.
158
520.960 Flumethasone. 520.1367 Meloxicam.
520.970 Flunixin. 520.1372 Methimazole.
520.980 Fluoxetine. 520.1380 Methocarbamol.
520.998 Fluralaner. 520.1408 Methylprednisolone.
520.1010 Furosemide. 520.1409 Methylprednisolone and aspirin.
520.1044 Gentamicin sulfate oral dosage 520.1422 Metoserpate hydrochloride.
forms. 520.1430 Mibolerone.
520.1044a Gentamicin sulfate oral solution. 520.1441 Milbemycin.
520.1044b Gentamicin sulfate pig pump oral 520.1443 Milbemycin oxime and lufenuron.
solution. 520.1445 Milbemycin oxime and
520.1044c Gentamicin sulfate powder. praziquantel.
520.1060 Glucose and glycine. 520.1447 Milbemycin oxime, lufenuron, and
520.1084 Grapiprant. praziquantel tablets.
520.1100 Griseofulvin. 520.1450 Morantel tartrate oral dosage
520.1120 Haloxon oral dosage forms. forms.
520.1120a Haloxon drench. 520.1450a Morantel tartrate bolus.
520.1120b Haloxon boluses. 520.1450b Morantel tartrate cartridge.
520.1130 Hetacillin. 520.1450c Morantel tartrate sustained-re-
520.1150 Imepitoin. lease trilaminate cylinder/sheet.
520.1156 Imidacloprid. 520.1451 Moxidectin tablets.
520.1157 Iodinated casein. 520.1452 Moxidectin gel.
520.1158 Iodochlorhydroxyquin. 520.1453 Moxidectin and praziquantel gel.
520.1189 Itraconazole. 520.1454 Moxidectin solution.
520.1192 Ivermectin paste. 520.1468 Naproxen.
520.1193 Ivermectin tablets and chewables. 520.1484 Neomycin.
520.1194 Ivermectin meal. 520.1510 Nitenpyram.
520.1195 Ivermectin liquid. 520.1604 Oclacitinib.
520.1196 Ivermectin and pyrantel tablets. 520.1615 Omeprazole.
520.1197 Ivermectin sustained-release bolus. 520.1616 Orbifloxacin tablets..
520.1198 Ivermectin and praziquantel paste. 520.1618 Orbifloxacin suspension.
520.1199 Ivermectin, pyrantel, and 520.1628 Oxfendazole powder and pellets.
praziquantel tablets. 520.1629 Oxfendazole paste.
520.1200 Ivermectin, fenbendazole, and 520.1630 Oxfendazole suspension.
praziquantel tablets. 520.1631 Oxfendazole and trichlorfon paste.
520.1204 Kanamycin, bismuth subcarbonate, 520.1638 Oxibendazole.
activated attapulgite. 520.1660 Oxytetracycline.
520.1242 Levamisole. 520.1660a Oxytetracycline and carbomycin.
520.1242a Levamisole powder. 520.1660b Oxytetracycline hydrochloride
520.1242b Levamisole boluses or oblets. capsules.
520.1242c Levamisole and piperazine. 520.1660c Oxytetracycline hydrochloride
520.1242d Levamisole resinate. tablets and boluses.
520.1242e Levamisole hydrochloride effer- 520.1660d Oxytetracycline powder.
vescent tablets. 520.1696 Penicillin.
520.1242f Levamisole gel. 520.1696a Penicillin G powder.
520.1242g Levamisole resinate and famphur 520.1696b Penicillin V powder.
paste. 520.1696c Penicillin V tablets.
520.1248 Levothyroxine. 520.1705 Pergolide.
520.1263 Lincomycin. 520.1720 Phenylbutazone oral dosage forms.
520.1263a Lincomycin tablets and syrup. 520.1720a Phenylbutazone tablets and
520.1263b Lincomycin powder. boluses.
520.1265 Lincomycin and spectinomycin 520.1720b Phenylbutazone granules.
powder. 520.1720c Phenylbutazone paste.
520.1284 Liothyronine. 520.1720d Phenylbutazone gel.
520.1286 Lotilaner. 520.1720e Phenylbutazone powder.
520.1288 Lufenuron tablets. 520.1760 Phenylpropanolamine.
520.1289 Lufenuron suspension. 520.1780 Pimobendan.
520.1310 Marbofloxacin. 520.1802 Piperazine-carbon disulfide complex
520.1315 Maropitant. oral dosage forms.
520.1320 Mebendazole. 520.1802a Piperazine-carbon disulfide com-
520.1326 Mebendazole and trichlorfon oral plex suspension.
dosage forms. 520.1802b Piperazine-carbon disulfide com-
520.1326a Mebendazole and trichlorfon pow- plex boluses.
der. 520.1802c Piperazine-carbon disulfide com-
520.1326b Mebendazole and trichlorfon paste. plex with phenothiazine suspension.
520.1330 Meclofenamic acid granules. 520.1803 Piperazine citrate capsules.
520.1331 Meclofenamic acid tablets. 520.1805 Piperazine phosphate with thenium

520.1341 Megestrol. closylate tablets.
159
520.1806 Piperazine suspension. 520.2280 Sulfamethizole and methenamine.
520.1840 Poloxalene. 520.2325 Sulfaquinoxaline oral dosage forms.
520.1855 Ponazuril. 520.2325a Sulfaquinoxaline powder and solu-
520.1860 Pradofloxacin. tion.
520.1870 Praziquantel tablets. 520.2325b Sulfaquinoxaline drench.
520.1871 Praziquantel and pyrantel. 520.2330 Sulfisoxazole tablets.
520.1872 Praziquantel, pyrantel pamoate, 520.2335 Telmisartan.
and febantel tablets. 520.2340 Tepoxalin.
520.1880 Prednisolone. 520.2345 Tetracycline.
520.1900 Primidone. 520.2345a Tetracycline capsules.
520.1920 Prochlorperazine and isopropamide. 520.2345b Tetracycline tablets.
520.1921 Prochlorperazine, isopropamide, 520.2345c Tetracycline boluses.
and neomycin. 520.2345d Tetracycline powder.
520.1962 Promazine.
520.2345e Tetracycline solution.
520.2002 Propiopromazine.
520.2345f Tetracycline phosphate complex
520.2041 Pyrantel pamoate chewable tablets.
and sodium novobiocin capsules.
520.2042 Pyrantel pamoate tablets.
520.2345g Tetracycline hydrochloride and so-
520.2043 Pyrantel pamoate suspension.
dium novobiocin tablets.
520.2044 Pyrantel pamoate paste.
520.2045 Pyrantel tartrate powder. 520.2345h Tetracycline hydrochloride, so-
520.2046 Pyrantel tartrate pellets. dium novobiocin, and prednisolone tab-
520.2075 Robenacoxib. lets.
520.2086 Sarolaner. 520.2362 Thenium closylate.
520.2090 Sarolaner, moxidectin, and 520.2380 Thiabendazole oral dosage forms.
pyrantel. 520.2380a Thiabendazole top dressing and
520.2098 Selegiline. mineral protein block.
520.2100 Selenium and vitamin E. 520.2380b Thiabendazole drench or paste.
520.2123 Spectinomycin oral dosage forms. 520.2380c Thiabendazole bolus.
520.2123a Spectinomycin tablets. 520.2380d Thiabendazole and piperazine cit-
520.2123b Spectinomycin powder. rate.
520.2123c Spectinomycin solution. 520.2380e Thiabendazole and piperazine
520.2130 Spinosad. phosphate.
520.2134 Spinosad and milbemycin. 520.2380f Thiabendazole and trichlorfon.
520.2138 Spironolactone and benazepril. 520.2455 Tiamulin.
520.2150 Stanozolol. 520.2471 Tilmicosin.
520.2158 Streptomycin. 520.2473 Tioxidazole oral dosage forms.
520.2170 Sulfabromomethazine. 520.2473a Tioxidazole granules.
520.2184 Sulfachloropyrazine. 520.2473b Tioxidazole paste.
520.2200 Sulfachlorpyridazine. 520.2475 Toceranib.
520.2215 Sulfadiazine/pyrimethamine sus- 520.2481 Triamcinolone acetonide tablets.
pension. 520.2482 Triamcinolone acetonide oral pow-
520.2218 Sulfamerazine, sulfamethazine, and der.
sulfaquinoxaline powder. 520.2483 Triamcinolone.
520.2220 Sulfadimethoxine oral dosage 520.2520 Trichlorfon oral dosage forms.
forms. 520.2520a Trichlorfon and atropine.
520.2220a Sulfadimethoxine oral solution 520.2520b Trichlorofon boluses.
and soluble powder. 520.2520c Trichlorofon granules.
520.2220b Sulfadimethoxine suspension. 520.2520d Trichlorfon, phenothiazine, and pi-
520.2220c Sulfadimethoxine tablet. perazine.
520.2220d Sulfadimethoxine bolus. 520.2582 Triflupromazine.
520.2220e Sulfadimethoxine extended-release 520.2598 Trilostane.
bolus. 520.2604 Trimeprazine and prednisolone tab-
520.2220f Sulfadimethoxine and ormetoprim lets.
tablet. 520.2605 Trimeprazine and prednisolone cap-
520.2240 Sulfaethoxypyridazine. sules.
520.2240a Sulfaethoxypyridazine solution. 520.2610 Trimethoprim and sulfadiazine tab-
520.2240b Sulfaethoxypyridazine tablets. lets.
520.2260 Sulfamethazine oral dosage forms. 520.2611 Trimethoprim and sulfadiazine
520.2260a Sulfamethazine oblets and boluses. paste.
520.2260b Sulfamethazine sustained-release
520.2612 Trimethoprim and sulfadiazine sus-
boluses.
pension.
520.2260c Sulfamethazine sustained-release
520.2613 Trimethoprim and sulfadiazine
tablets.
powder.
520.2261 Sulfamethazine sodium oral dosage
520.2640 Tylosin.
forms.
520.2645 Tylvalosin.
520.2261a Sulfamethazine solution.
520.2261b Sulfamethazine powder. AUTHORITY: 21 U.S.C. 360b.
160
Food and Drug Administration, HHS § 520.38a
SOURCE: 40 FR 13838, Mar. 27, 1975, unless (d) Special considerations. See § 500.25
otherwise noted. of this chapter.
(e) Conditions of use—(1) Cattle. Ad-
§ 520.23 Acepromazine.
minister 11.36 percent suspension:
(a) Specifications. Each tablet con- (i) Amount. 4.54 mg/pound (lb) body
tains 5, 10, or 25 milligrams (mg) weight (10 mg/kilogram (kg)) as a sin-
acepromazine maleate. gle oral dose using dosing gun or dos-
(b) Sponsors. See No. 000010 in ing syringe.
§ 510.600(c) of this chapter. (ii) Indications for use. For removal
(c) Conditions of use—(1) Dogs—(i) and control of adult liver flukes
Amount. 0.25 to 1.0 mg per pound (/lb) (Fasciola hepatica); heads and segments
body weight orally. of tapeworms (Moniezia benedeni and M.
(ii) Indications for use. As an aid in expansa); adult and 4th stage larvae of
tranquilization and as a preanesthetic stomach worms (brown stomach worms
agent. including 4th stage inhibited larvae
(iii) Limitations. Federal law restricts (Ostertagia ostertagi), barberpole worm
this drug to use by or on the order of a (Haemonchus contortus and H. placei),
licensed veterinarian. small stomach worm (Trichostrongylus
(2) Cats—(i) Amount. 0.5 to 1.0 mg/lb axei)); adult and 4th stage larvae of in-
body weight orally. testinal worms (thread-necked intes-
(ii) Indications for use. As a tranquil- tinal worm (Nematodirus spathiger and
izer. N. helvetianus), small intestinal worm
(iii) Limitations. Federal law restricts (Cooperia punctata and C. oncophora));
adult stages of intestinal worms
licensed veterinarian.
(hookworm (Bunostomum phlebotomum),
[75 FR 10165, Mar. 5, 2010] bankrupt worm (Trichostrongylus
colubriformis), nodular worm
§ 520.28 Acetazolamide. (Oesophagostomum radiatum)); adult and
(a) Specifications. A powder con- 4th stage larvae of lungworms
taining acetazolamide sodium, USP (Dictyocaulus viviparus).
equivalent to 25 percent acetazolamide (iii) Limitations. Do not slaughter
activity. within 27 days of last treatment. Do
(b) Sponsor. See No. 054771 in not use in female dairy cattle of breed-
§ 510.600(c) of this chapter. ing age: Do not administer to female
(c) Conditions of use in dogs—(1) cattle during first 45 days of pregnancy
Amount. Administer orally at a dosage or for 45 days after removal of bulls.
of 5 to 15 milligrams per pound of body (2) Sheep. Administer 4.45 or 11.36 per-
weight daily. cent suspension:
(2) Indications for use. As an aid in the (i) Amount. 3.4 mg/lb body weight (7.5
treatment of mild congestive heart mg/kg) as a single oral dose using dos-
failure and for rapid reduction of intra- ing gun or dosing syringe.
ocular pressure. (ii) Indications for use. For removal
(3) Limitations. Federal law restricts and control of adult liver flukes
this drug to use by or on the order of a (Fasciola hepatica and Fascioloides
licensed veterinarian. magna); heads and segments of common
[79 FR 28816, May 20, 2014] tapeworms (Moniezia expansa) and
fringed tapeworm (Thysanosoma
§ 520.38 Albendazole oral dosage actinioides); adult and fourth stage lar-
forms. vae of stomach worms (brown stomach
worm (Ostertagia circumcinta and
§ 520.38a Albendazole suspension. Marshallagia marshalli), barberpole
(a) Specifications. Each milliliter of worm (Haemonchus contortus), small
suspension contains 45.5 milligrams stomach worm (Trichostrongylus axei));
(mg) (4.55 percent) or 113.6 mg (11.36 adult and fourth stage larvae of intes-
percent) albendazole. tinal worms (thread-necked intestinal
(b) Sponsor. See No. 054771 in § 510.600 worm (Nematodirus spathiger and N.
of this chapter. filicollis), Cooper’s worm (Cooperia
(c) Related tolerances. See § 556.34 of oncophora), bankrupt worm

this chapter. (Trichostrongylus colubriformis), nodular
161
§ 520.38b 21 CFR Ch. I (4–1–23 Edition)
worm (Oesophagostomum columbianum), 4th stage larvae of lungworms

and large-mouth bowel worm (Chabertia (Dictyocaulus viviparus).
ovina)); adult and larval stages of (3) Limitations. Administer as a single
lungworms (Dictyocaulus filaria). oral dose. Do not slaughter within 27
(iii) Limitations. Do not slaughter days of last treatment. Do not use in
within 7 days of last treatment. Do not female dairy cattle of breeding age. Do
administer to ewes during first 30 days not administer to female cattle during
of pregnancy or for 30 days after re- first 45 days of pregnancy or for 45 days
moval of rams. after removal of bulls. Consult your
(3) Goats. Administer 11.36 percent veterinarian for assistance in the diag-
suspension: nosis, treatment, and control of para-
(i) Amount. 4.54 mg/lb body weight (10 sitism.
mg/kg) as a single oral dose using dos- [54 FR 51385, Dec. 15, 1989, as amended at 56
ing gun or dosing syringe. FR 50653, Oct. 8, 1991; 60 FR 55658, Nov. 2,
(ii) Indications for use. For the treat- 1995. Redesignated at 78 FR 66264, Nov. 5,
ment of adult liver flukes (Fasciola he- 2013, as amended at 79 FR 28816, May 20, 2014]
patica) in nonlactating goats.
§ 520.43 Afoxolaner.
(iii) Limitations. Do not slaughter
within 7 days of last treatment. Do not (a) Specifications. Each chewable tab-
administer to does during the first 30 let contains 11.3, 28.3, 68, or 136 milli-
days of pregnancy or for 30 days after grams (mg) afoxolaner.
removal of bucks. (b) Sponsor. See No. 000010 in
[73 FR 11027, Feb. 29, 2008. Redesignated at 78 (c) Conditions of use—(1) Amount. Ad-
FR 66264, Nov. 5, 2013, as amended at 79 FR minister orally once a month at a min-
28816, May 20, 2014] imum dosage of 1.14 mg/pound (lb) (2.5
mg/kilogram (kg)).
§ 520.38b Albendazole paste.
(2) Indications for use. Kills adult
(a) Specifications. The product con- fleas; for the treatment and prevention
tains 30 percent albendazole. of flea infestations (Ctenocephalides
(b) Sponsor. See No. 054771 in felis); for the treatment and control of
§ 510.600(c) of this chapter. black-legged tick (Ixodes scapularis),
(c) Related tolerances. See § 556.34 of American dog tick (Dermacentor
this chapter. variabilis), lone star tick (Amblyomma
(d) Conditions of use in cattle—(1) americanum), and brown dog tick
Amount. Equivalent to 4.54 milligrams (Rhipicephalus sanguineus) infestations
per 1 pound of body weight (10 milli- in dogs and puppies 8 weeks of age and
grams per kilogram). older, weighing 4 pounds of body
(2) Indications for use. For removal weight or greater, for 1 month; and for
and control of the following internal the prevention of Borrelia burgdorferi
parasites of cattle: adult liver flukes infections as a direct result of killing
(Fasciola hepatica); heads and segments Ixodes scapularis vector ticks.
of tapeworms (Moniezia benedeni, M. (3) Limitations. Federal law restricts
expansa); adult and 4th stage larvae of this drug to use by or on the order of a
stomach worms (brown stomach worms licensed veterinarian.
including 4th stage inhibited larvae [78 FR 66264, Nov. 5, 2013, as amended at 79
(Ostertagia ostertagi); barberpole worm FR 37619, July 2, 2014; 84 FR 8972, Mar. 13,
(Haemonchus contortus, H. placei); small 2019; 84 FR 39182, Aug. 9, 2019]
stomach worm (Trichostrongylus axei));
adult and 4th stages larvae of intes- § 520.48 Altrenogest.
tinal worms (thread-necked intestinal (a) Specifications. Each milliliter
worm (Nematodirus spathiger, N. (mL) of solution contains 2.2 milli-
helvetianus); small intestinal worm grams (mg) altrenogest.
(Cooperia punctata and C. oncophora)); (b) Sponsors. See Nos. 000061, 051072,
adult stages of intestinal worms and 061133 in § 510.600(c) of this chapter.
(hookworm (Bunostomum phlebotmum); (c) Tolerances. See § 556.36 of this
bankrupt worm (Trichostrongylus chapter.
colubriformis), nodular worm (d) Conditions of use—(1) Horses—(i)

(Oesophagostomum radiatum)); adult and Amount. 1.0 mL per 110 pounds body
162
weight (0.044 mg/kg) daily for 15 con- (3) Limitations. Federal law restricts
secutive days. this drug to use by or on the order of a
(ii) Indications for use. For suppres- licensed veterinarian.
sion of estrus in mares. [79 FR 28816, May 20, 2014]
(iii) Limitations. Do not use in horses
intended for human consumption. Fed- § 520.82 Aminopropazine oral dosage
eral law restricts this drug to use by or forms.
on the order of a licensed veterinarian.
§ 520.82a Aminopropazine.
(2) Swine—(i) Amount. Administer 6.8
mL (15 mg altrenogest) per gilt once (a) Specifications. Each tablet con-
daily for 14 consecutive days by top- tains aminopropazine fumarate equiva-
dressing on a portion of each gilt’s lent to 25 percent aminopropazine base.
daily feed. (b) Sponsor. See No. 000061 in
(ii) Indications for use. For synchroni-
(c) Conditions of use in dogs and cats—
zation of estrus in sexually mature
(1) Amount. Administer orally at a dos-
gilts that have had at least one estrous age of 1 to 2 milligrams per pound of
cycle. body weight, repeated every 12 hours as
(iii) Limitations. Do not use in gilts indicated.
having a previous or current history of (2) Indications for use. For reducing
uterine inflammation (i.e., acute, excessive smooth muscle contractions,
subacute or chronic endometritis). such as occur in urethral spasms asso-
Gilts must not be slaughtered for ciated with urolithiasis.
human consumption for 21 days after (3) Limitations. Federal law restricts
the last treatment. this drug to use by or on the order of a
FR 62006, Oct. 31, 2003; 72 FR 9455, Feb. 21, [79 FR 28816, May 20, 2014]
2008; 74 FR 61516, Nov. 25, 2009; 77 FR 32012,
May 31, 2012; 80 FR 34278, June 16, 2015; 82 FR § 520.82b Aminopropazine and neomy-
21690, May 10, 2017; 83 FR 13635, Mar. 30, 2018; cin.
84 FR 8972, Mar. 13, 2019] (a) Specifications. Each tablet con-
tains aminopropazine fumarate equiva-
§ 520.62 Aminopentamide.
lent to 25 percent aminopropazine base
(a) Specifications. Each tablet con- and neomycin sulfate equivalent to 50
tains 0.2 milligram (mg) milligrams (mg) of neomycin base.
aminopentamide hydrogen sulphate. (b) Sponsor. See No. 000061 in
(b) Sponsor. See No. 054771 in § 510.600(c) of this chapter.
§ 510.600(c) of this chapter. (c) Conditions of use in dogs—(1)
(c) Conditions of use in dogs and cats— Amount. Administer orally at a dosage
(1) Amount. Administer orally every 8 of 1 to 2 mg per pound of body weight,
to 12 hours as follows: For animals repeated every 12 hours as indicated.
weighing up to 10 pounds (lbs): 0.1 mg; (2) Indications for use. For control of
for animals weighing 11 to 20 lbs: 0.2 bacterial diarrhea caused by organisms
susceptible to neomycin and to reduce
mg; for animals weighing 21 to 50 lbs:
smooth muscle contractions.
0.3 mg; for animals weighing 51 to 100
lbs: 0.4 mg; for animal weighing over this drug to use by or on the order of a
100 lbs: 0.5 mg. Dosage may be gradu- licensed veterinarian.
ally increased up to a maximum of five
times the suggested dosage. Oral ad- [79 FR 28816, May 20, 2014]
ministration of tablets may be pre-
§ 520.88 Amoxicillin oral dosage forms.
ceded by subcutaneous or
intramuscular use of the injectable § 520.88a Amoxicillin trihydrate film-
form of the drug. coated tablets.
(2) Indications for use. For the treat- (a) Specifications. Each tablet con-
ment of vomiting and/or diarrhea, nau- tains amoxicillin trihydrate equivalent
sea, acute abdominal visceral spasm, to 50, 100, 150, 200, or 400 milligrams
pylorospasm, or hypertrophic gastritis. (mg) amoxicillin.
163
§ 520.88b 21 CFR Ch. I (4–1–23 Edition)
(b) Sponsor. See No. 054771 in caused by Staphylococcus aureus, Strep-

§ 510.600(c) of this chapter. tococcus spp., Escherichia coli, and Pro-
(c) Conditions of use—(1) Dogs—(i) teus mirabilis; genitourinary tract (cys-
Amount. Administer orally 5 mg per titis) caused by S. aureus, Streptococcus
pound (/lb) of body weight, twice a day spp., E. coli, and P. mirabilis; gastro-
for 5 to 7 days. intestinal tract (bacterial
(ii) Indications for use. Treatment of gastroenteritis) caused by S. aureus,
infections of the respiratory tract (ton- Streptococcus spp., E. coli, and P.
sillitis, tracheobronchitis), genito- mirabilis; bacterial dermatitis caused
urinary tract (cystitis), gastro- by S. aureus, Streptococcus spp., and P.
intestinal tract (bacterial
mirabilis; and soft tissues (abscesses,
gastroenteritis), and soft tissues (ab-
lacerations, and wounds) caused by S.
scesses, lacerations, wounds), caused
by susceptible strains of Staphylococcus aureus, Streptococcus spp., E. coli, and P.
aureus, Streptococcus spp., Escherichia mirabilis.
coli, Proteus mirabilis, and bacterial der- (C) Limitations. Federal law restricts
matitis caused by S. aureus, Strepto- this drug to use by or on the order of a
coccus spp., and P. mirabilis. licensed veterinarian.
(iii) Limitations. Federal law restricts (ii) Cats—(A) Amount. Administer
this drug to use by or on the order of a orally 5 to 10 mg/lb of body weight,
licensed veterinarian. once daily for 5 to 7 days.
(2) Cats—(i) Amount. Administer oral- (B) Indications for use. Treatment of
ly 5 to 10 mg/lb of body weight, once infections caused by susceptible strains
daily for 5 to 7 days. of organisms as follows: upper res-
(ii) Indications for use. Treatment of piratory tract due to Staphylococcus
infections caused by susceptible orga- spp., Streptococcus spp., Haemophilus
nisms as follows: upper respiratory spp., E. coli, Pasteurella spp., and P.
tract due to S. aureus, Streptococcus mirabilis; genitourinary tract (cystitis)
spp., and E. coli; genitourinary tract due to S. aureus, Streptococcus spp., E.
(cystitis) due to S. aureus, Streptococcus
coli, P. mirabilis, and Corynebacterium
spp., E. coli, and P. mirabilis; gastro-
spp.; gastrointestinal tract due to E.
intestinal tract due to E. coli; and skin
and soft tissue (abscesses, lacerations, coli, Proteus spp., Staphylococcus spp.,
and wounds) due to S. aureus, Strepto- and Streptococcus spp.; skin and soft tis-
coccus spp., E. coli, and Pasteurella sue (abscesses, lacerations, and
multocida. wounds) due to Staphylococcus spp.,
(iii) Limitations. Federal law restricts Streptococcus spp., E. coli, and
this drug to use by or on the order of a Pasteurella multocida.
licensed veterinarian. (C) Limitations. Federal law restricts
[57 FR 37319, Aug. 18, 1992, as amended at 60
FR 55658, Nov. 2, 1995; 79 FR 28816, May 20, licensed veterinarian.
2014] (2) [Reserved]
(c) Sponsors. See Nos. 000856 and
§ 520.88b Amoxicillin trihydrate for 051311 in § 510.600(c) of this chapter.
oral suspension.
(1) Conditions of use. Dogs—(i) Amount.
(a) Specifications. When reconstituted, Administer orally 5 mg/lb of body
each milliliter contains amoxicillin weight, twice a day for 5 to 7 days.
trihydrate equivalent to 50 milligrams (ii) Indications for use. Treatment of
(mg) amoxicillin. bacterial dermatitis due to S. aureus,
(b) Sponsor. See No. 054771 in Streptococcus spp., Staphylococcus spp.,
and E. coli, and soft tissue infections
(1) Conditions of use—(i) Dogs—(A)
(abscesses, wounds, lacerations) due to
Amount. Administer orally 5 mg per
pound (/lb) of body weight, twice a day S. aureus, Streptococcus spp., E. coli, P.
for 5 to 7 days. mirabilis and Staphylococcus spp.
(B) Indications for use. Treatment of (iii) Limitations. Federal law restricts
infections caused by susceptible strains this drug to use by or on the order of a
of organisms as follows: respiratory licensed veterinarian.

tract (tonsillitis, tracheobronchitis)
164
Food and Drug Administration, HHS § 520.88f
(2) [Reserved] after the latest treatment. Federal law

[57 FR 37319, Aug. 18, 1992; 57 FR 42623, Sept.
restricts this drug to use by or on the
15, 1992, as amended at 60 FR 55658, Nov. 2, order of a licensed veterinarian
1995; 62 FR 13302, Mar. 20, 1997; 67 FR 67521, [57 FR 37319, Aug. 18, 1992; 57 FR 42623, Sept.
Nov. 6, 2002; 68 FR 54658, Sept. 18, 2003; 68 FR 15, 1992; 58 FR 18304, Apr. 8, 1993, as amended
55824, Sept. 29, 2003; 79 FR 28816, May 20, 2014; at 60 FR 55658, Nov. 2, 1995; 62 FR 5525, Feb.
81 FR 17607, Mar. 30, 2016] 6, 1997; 79 FR 28817, May 20, 2014]
§ 520.88c Amoxicillin trihydrate oral § 520.88e Amoxicillin trihydrate
suspension. boluses.
(a) Specifications. Each 0.8-milliliter (a) Specifications. Each bolus contains
dose contains amoxicillin trihydrate amoxicillin trihydrate equivalent to
equivalent to 40 milligrams (mg) 400 milligrams (mg) amoxicillin.
amoxicillin.
(c) Related tolerances. See § 556.38 of
this chapter.
this chapter.
(d) Conditions of use in swine—(1) (d) Conditions of use in cattle—(1)
Amount. Administer 40 mg orally twice Amount. Administer 400 mg per 100
a day using a dosing pump. Treat ani- pounds of body weight twice daily.
mals for 48 hours after all symptoms Treatment should be continued for 48
have subsided but not beyond 5 days. hours after all symptoms have subsided
(2) Indications for use. Treatment of but not to exceed 5 days.
baby pigs under 10 pounds for porcine (2) Indications for use. Treatment of
colibacillosis caused by Escherichia coli bacterial enteritis when due to suscep-
susceptible to amoxicillin. tible Escherichia coli in preruminating
(3) Limitations. Do not slaughter dur- calves including veal calves.
ing treatment or for 15 days after lat- (3) Limitations. Do not slaughter ani-
est treatment. Federal law restricts mals during treatment or for 20 days
this drug to use by or on the order of a after the latest treatment. Federal law
licensed veterinarian. restricts this drug to use by or on the
order of a licensed veterinarian.
FR 55658, Nov. 2, 1995; 79 FR 28817, May 20, [57 FR 37320, Aug. 18, 1992, as amended at 60
2014; 85 FR 18118, Apr. 1, 2020] FR 55659, Nov. 2, 1995; 62 FR 5526, Feb. 6, 1997;
79 FR 28817, May 20, 2014]
§ 520.88d Amoxicillin trihydrate solu-
ble powder. § 520.88f Amoxicillin trihydrate tab-
lets.
(a) Specifications. Each gram of pow-
der contains amoxicillin trihydrate (a) Specifications. Each tablet con-
equivalent to 115.4 milligrams (mg) tains amoxicillin trihydrate equivalent
amoxicillin. to 50, 100, 200, or 400 milligrams (mg)
(b) Sponsor. See No. 054771 in amoxicillin.
§ 510.600(c) of this chapter. (b) Sponsors. See Nos. 051311 and
(c) Related tolerances. See § 556.38 of 054771 in § 510.600(c) of this chapter.
this chapter. (c) Conditions of use in dogs—(1)
(d) Conditions of use in preruminating Amount. Administer 5 mg per pound of
calves including veal calves—(1) Amount. body weight twice daily for 5 to 7 days
Administer 400 mg per 100 pounds of or 48 hours after all symptoms have
body weight twice daily by drench or in subsided.
milk. Treatment should be continued (2) Indications for use. For treatment
for 48 hours after all symptoms have of bacterial dermatitis due to Staphy-
subsided but not to exceed 5 days. lococcus aureus, Streptococcus spp.,
(2) Indications for use. Treatment of Staphylococcus spp., and Escherichia
bacterial enteritis when due to suscep- coli; and soft tissue infections (ab-
tible Escherichia coli in preruminating scesses, wounds, lacerations) due to S.
calves including veal calves. aureus, Enterococcus faecalis, E. coli,
(3) Limitations. Do not slaughter ani- Proteus mirabilis, and Staphylococcus

mals during treatment or for 20 days spp.
165
§ 520.88g 21 CFR Ch. I (4–1–23 Edition)
(3) Limitations. Federal law restricts (ii) Indications for use. Treatment of
this drug to use by or on the order of a skin and soft tissue infections such as
licensed veterinarian. wounds, abscesses, and cellulitis/der-
matitis due to susceptible strains of
[79 FR 28817, May 20, 2014, as amended at 83
FR 64740, Dec. 18, 2018] the following organisms: Beta-
lactamase-producing Staphylococcus
§ 520.88g Amoxicillin trihydrate and aureus, non-beta-lactamase-producing
clavulanate potassium tablets. Staphylococcus aureus, Staphylococcus
(a) Specifications. Each tablet or spp., Streptococcus spp., E. coli, and
chewable tablet contains amoxicillin Pasteurella spp. Urinary tract infec-
trihydrate and clavulanate potassium tions (cystitis) due to susceptible
equivalent to 50 milligrams (mg) of strains of E. coli.
amoxicillin and 12.5 mg clavulanic (iii) Limitations. Federal law restricts
acid, 100 mg of amoxicillin and 25 mg this drug to use by or on the order of a
clavulanic acid, 200 mg amoxicillin and licensed veterinarian.
50 mg clavulanic acid, or 300 mg [57 FR 37320, Aug. 18, 1992, as amended at 60
amoxicillin and 75 mg clavulanic acid. FR 55659, Nov. 2, 1995; 63 FR 13121, Mar. 18,
(b) Sponsors. See sponsors in 1998; 79 FR 28817, May 20, 2014; 80 FR 34278,
§ 510.600(c) of this chapter: June 16, 2015; 82 FR 11508, Feb. 24, 2017; 82 FR
(1) No. 054771 for use of tablets and 43484, Sept. 18, 2017; 82 FR 58556, Dec. 13, 2017;
chewable tablets as in paragraph (c) of 87 FR 58960, Sept. 29, 2022]
this section.
§ 520.88h Amoxicillin trihydrate and
(2) Nos. 017033 and 069043 for use of clavulanate potassium for oral sus-
tablets as in paragraph (c) of this sec- pension.
tion.
(c) Conditions of use—(1) Dogs—(i) (a) Specifications. When constituted,
Amount. 6.25 milligrams (equivalent to each milliliter (mL) of suspension con-
5 milligrams amoxicillin and 1.25 milli- tains amoxicillin trihydrate equivalent
grams clavulanic acid) per pound of to 50 milligrams (mg) amoxicillin and
body weight twice daily for 5 to 7 days clavulanate potassium equivalent to
or for 48 hours after all signs have sub- 12.5 mg clavulanic acid.
sided. Deep pyoderma may require (b) Sponsors. See Nos. 017033, 054771,
treatment for 21 days; do not treat for and 069043 in § 510.600(c) of this chapter.
more than 30 days. (c) Conditions of use—(1) Dogs—(i)
(ii) Indications for use. Treatment of Amount. 6.25 mg/lb (1 mL/10 lb of body
skin and soft tissue infections such as weight) twice a day. Skin and soft tis-
wounds, abscesses, cellulitis, super- sue infections such as abscesses,
ficial/juvenile and deep pyoderma due cellulitis, wounds, superficial/juvenile
to susceptible strains of the following pyoderma, and periodontal infections
organisms: Beta-lactamase-producing should be treated for 5 to 7 days or for
Staphylococcus aureus, non-beta- 48 hours after all signs have subsided.
lactamase-producing Staphylococcus If no response is seen after 5 days of
aureus, Staphylococcus spp., Strepto- treatment, therapy should be discon-
coccus spp., and E. coli. Periodontal in- tinued and the case reevaluated. Deep
fections due to susceptible strains of pyoderma may require treatment for 21
both aerobic and anaerobic bacteria. days; the maximum duration of treat-
(iii) Limitations. Federal law restricts ment should not exceed 30 days.
this drug to use by or on the order of a (ii) Indications for use. Treatment of
licensed veterinarian. skin and soft tissue infections such as
(2) Cats—(i) Amount. 62.5 milligrams wounds, abscesses, cellulitis, super-
(50 milligrams amoxicillin and 12.5 mil- ficial/juvenile and deep pyoderma due
ligrams clavulanic acid) twice daily for to susceptible strains of the following
5 to 7 days or for 48 hours after all organisms: Beta-lactamase-producing
signs have subsided. Urinary tract in- Staphylococcus aureus, non-beta-
fections may require treatment for 10 lactamase-producing Staphylococcus
to 14 days or longer. The maximum du- aureus, Staphylococcus spp., Strepto-
ration of treatment should not exceed coccus spp., and Escherichia coli. Treat-
30 days. ment of periodontal infections due to
166
Food and Drug Administration, HHS § 520.90b
susceptible strains of both aerobic and spp., Staphylococcus spp., E., coli, P.
anaerobic bacteria. mirabilis, and Enterococcus spp.; gastro-
(iii) Limitations. Federal law restricts intestinal infections due to Staphy-
this drug to use by or on the order of a lococcus spp., Streptococcus spp.,
licensed veterinarian. Enterococcus spp., and E. coli. ; infec-
(2) Cats—(i) Amount. 62.5 mg (1 mL) tions associated with abscesses, lacera-
twice daily. Skin and soft tissue infections, and wounds caused by Staphy-
tions such as abscesses and cellulitis/ lococcus spp., and Streptococcus spp.
dermatitis should be treated for 5 to 7 (3) Limitations. Federal law restricts
days or 48 hours after all symptoms this drug to use by or on the order of a
have subsided, not to exceed 30 days. If licensed veterinarian.
no response is seen after 3 days of
treatment, therapy should be discon- [57 FR 37321, Aug. 18, 1992, as amended at 60
tinued and the case reevaluated. Uri- FR 55659, Nov. 2, 1995; 79 FR 28818, May 20,
nary tract infections may require 2014. Redesignated at 85 FR 18118, Apr. 1,
treatment for 10 to 14 days or longer. 2020]
The maximum duration of treatment
§ 520.90b Ampicillin capsules.
should not exceed 30 days.
(ii) Indications for use. Treatment of (a) Specifications. Each capsule con-
skin and soft tissue infections, such as tains ampicillin trihydrate equivalent
wounds, abscesses, and cellulitis/der- to 125, 250, or 500 milligrams of ampi-
matitis due to susceptible strains of cillin.
the following organisms: Beta- (b) Sponsor. See No. 054771 in
lactamase-producing Staphylococcus § 510.600(c) of this chapter.
aureus, non-beta-lactamase-producing (c) Conditions of use—(1) Dogs—(i)
Staphylococcus aureus, Staphylococcus Amount. 5 to 10 milligrams per pound of
spp., Streptococcus spp., Escherichia coli, body weight two or three times daily.
Pasteurella multocida, and Pasteurella In severe or acute conditions, 10 milli-
spp. Urinary tract infections (cystitis) grams per pound of body weight, three
due to susceptible strains of E. coli. times daily. Administer 1 to 2 hours
(iii) Limitations. Federal law restricts prior to feeding.
(ii) Indications for use. Treatment
against strains of gram-negative and
[87 FR 17944, Mar. 29, 2022] gram-positive organisms sensitive to
ampicillin and associated with res-
§ 520.90 Ampicillin oral dosage forms. piratory tract infections
§ 520.90a Ampicillin tablets. (tracheobronchitis and tonsillitis); uri-
nary tract infections (cystitis); bac-
(a) Specifications. Each tablet con- terial gastroenteritis; generalized in-
tains ampicillin trihydrate equivalent
fections (septicemia) associated with
to 50 or 100 milligrams of ampicillin.
abscesses, lacerations, and wounds; and
bacterial dermatitis.
(c) Conditions of use in dogs—(1) (iii) Limitations. Federal law restricts
Amount. 5 milligrams per pound of body this drug to use by or on the order of a
weight, at 8-hour intervals, 1 to 2 hours licensed veterinarian.
prior to feeding, to be continued 36 to (2) Cats—(i) Amount. 10 to 30 milli-
48 hours after all symptoms have sub- grams per pound of body weight or
sided. If no improvement is seen within three times daily. Administer 1 to 2
5 days, stop treatment, reevaluate di- hours prior to feeding.
agnosis, and change therapy. (ii) Indications for use. Treatment
(2) Indications for use. Oral treatment against strains of gram-negative and
of infections caused by susceptible or- gram-positive organisms sensitive to
ganisms as follows: Upper respiratory ampicillin and associated with res-
infections, tonsillitis, and bronchitis piratory tract infections (bacterial
due to Streptococcus spp., Staphylococcus pneumonia); urinary tract infections
spp., Escherichia coli, Proteus mirabilis, (cystitis); and generalized infections
and Pasteurella spp., urinary tract in- (septicemia) associated with abscesses,
fections (cystitis) due to Streptococcus lacerations, and wounds.
167
§ 520.90c 21 CFR Ch. I (4–1–23 Edition)
(iii) Limitations. Federal law restricts (i) Amount. Administer at the 0.012
this drug to use by or on the order of a percent level in drinking water as soon
licensed veterinarian. as coccidiosis is diagnosed and con-
tinue for 3 to 5 days (in severe out-
FR 61016, Nov. 19, 1993; 79 FR 28818, May 20, breaks, give amprolium at the 0.024
2014. Redesignated at 85 FR 18118, Apr. 1, percent level); continue with 0.006 per-
2020] cent amprolium-medicated water for
an additional 1 to 2 weeks.
§ 520.90c Ampicillin boluses. (ii) Indications for use. For the treat-
(a) Specifications. Each bolus contains ment of coccidiosis.
ampicillin trihydrate equivalent to 400 (iii) Limitations. Use as the sole
milligrams of ampicillin. source of amprolium.
(b) Sponsor. See No. 054771 in (2) Calves. Administer concentrate so-
§ 510.600(c) of this chapter. lution or soluble powder as a drench or
(c) Related tolerances. See § 556.40 of in drinking water as follows:
this chapter. (i) Indications for use and amounts—
(d) Conditions of use in nonruminating (A) As an aid in the prevention of coc-
calves—(1) Amount. 5 milligrams per cidiosis caused by Eimeria bovis and E.
pound of body weight twice daily not zurnii, administer 5 mg per kilogram
to exceed 4 days. (mg/kg) body weight for 21 days during
(2) Indications for use. Oral treatment periods of exposure or when experience
of bacterial enteritis (colibacillosis) indicates that coccidiosis is likely to
caused by E. coli. be a hazard.
(3) Limitations. Treated calves must (B) As an aid in the treatment of coc-
not be slaughtered for food during cidiosis caused by E. bovis and E. zurnii,
treatment and for 7 days after the last administer 10 mg/kg body weight for 5
treatment. Federal law restricts this days.
drug to use by or on the order of a li- (ii) Limitations. Withdraw 24 hours be-
censed veterinarian. fore slaughter. A withdrawal period has
[57 FR 37322, Aug. 18, 1992, as amended at 58 not been established for this product in
FR 61016, Nov. 19, 1993; 60 FR 55659, Nov. 2, preruminating calves. Do not use in
1995; 79 FR 28818, May 20, 2014. Redesignated calves to be processed for veal. Use as
and amended at 85 FR 18118, Apr. 1, 2020] the sole source of amprolium.
§ 520.100 Amprolium. [71 FR 56346, Sept. 27, 2006, as amended at 72
FR 60551, Oct. 25, 2007; 73 FR 45611, Aug. 6,
(a) Specifications. (1) Each milliliter 2008; 73 FR 70276, Nov. 20, 2008; 74 FR 10484,
of solution contains 96 milligrams (mg) Mar. 11, 2009; 76 FR 38554, July 1, 2011; 76 FR
amprolium (9.6 percent solution). 40808, July 12, 2011; 78 FR 23, Jan. 2, 2013; 78
(2) Each gram of powder contains 200 FR 17596, Mar. 22, 2013; 78 FR 57058, Sept. 17,
mg amprolium (20 percent). 2013; 81 FR 22523, Apr. 18, 2016; 81 FR 59133,
(b) Sponsors. See sponsors in 510.600(c) Aug. 29, 2016; 84 FR 8972, Mar. 13, 2019; 86 FR
of this chapter. 13184, Mar. 8, 2021]
(1) Nos. 016592 and 061133 for use of
§ 520.110 Apramycin sulfate soluble
products described in paragraph (a) of powder.
this section as in paragraph (d) of this
section. (a) Specifications. A water soluble
(2) No. 066104 for use of product de- powder used to make a medicated
scribed in paragraph (a)(1) of this sec- drinking water containing apramycin
tion as in paragraph (d) of this section. sulfate equivalent to 0.375 gram of
(3) No. 051072 for use of product de- apramycin activity per gallon of drink-
scribed in paragraph (a)(1) of this sec- ing water.
tion as in paragraph (d)(1) of this sec- (b) Sponsor. See No. 058198 in
tion. § 510.600(c) of this chapter.
(c) Related tolerances. See § 556.50 of (c) Related tolerances. See § 556.52 of
this chapter. this chapter.
(d) Conditions of use—(1) Growing (d) Conditions of use in swine—(1)
chickens, turkeys, and laying hens. It is Amount. Administer in drinking water

used in drinking water as follows: at the rate of 12.5 milligrams of
168
apramycin per kilogram (5.7 milli- plicated by organisms susceptible to

grams per pound) of body weight per bacitracin methylenedisalicylate.
day for 7 days. (iii) Limitations. Prepare a fresh solu-
(2) Indications for use. For the control tion daily. Use as the sole source of
of porcine colibacillosis (weanling pig drinking water.
scours) caused by strains of Escherichia (3) Swine—(i) Amount. 1 gram per gal-
coli sensitive to apramycin. lon in drinking water.
(3) Limitations. Do not slaughter (ii) Indications for use. Treatment of
treated swine for 28 days following
swine dysentery associated with
treatment. Federal law restricts this
Brachyspira hyodysenteriae. Administer
drug to use by or on the order of a li-
continuously for 7 days or until signs
censed veterinarian.
of dysentery disappear.
[47 FR 15771, Apr. 13, 1982, as amended at 49 (iii) Limitations. Prepare a fresh solu-
FR 19642, May 9, 1984; 53 FR 37753, Sept. 28, tion daily. Use as the sole source of
1988; 79 FR 28818, May 20, 2014; 81 FR 48702,
July 26, 2016; 81 FR 94989, Dec. 27, 2016] drinking water. Treatment not to ex-
ceed 14 days. Not to be given to swine
§ 520.154 Bacitracin oral dosage forms. that weigh more than 250 pounds.
(4) Growing quail—(i) Amount. 400 mg
§ 520.154a Bacitracin per gal in drinking water.
methylenedisalicylate.
(ii) Indications for use. For prevention
(a) Specifications. Each pound of solu- of ulcerative enteritis due to Clos-
ble powder contains the equivalent of tridium colinum susceptible to baci-
50 grams of bacitracin activity for use tracin methylenedisalicylate.
as in paragraph (d)(1) or (d)(2) of this (iii) Limitations. Prepare fresh solu-
section, or the equivalent of 200 grams tion daily. Use as sole source of drink-
of bacitracin activity for use as in
ing water.
paragraph (d) of this section.
(b) Sponsor. See No. 054771 in [57 FR 37322, Aug. 18, 1992; 57 FR 42623, Sept.
§ 510.600(c) of this chapter. 15, 1992, as amended at 63 FR 38474, July 17,
(c) Related tolerances. See § 556.70 of 1998; 64 FR 13068, Mar. 17, 1999; 76 FR 53050,
this chapter. Aug. 25, 2011; 79 FR 28818, May 20, 2014; 80 FR
(d) Conditions of use—(1) Broiler and 34278, June 16, 2015; 88 FR 14897, Mar. 10, 2023]
replacement chickens—(i) Amount. 100
mg per gal in drinking water. § 520.154b Bacitracin
methylenedisalicylate and strepto-
(A) Indications for use. Aid in the pre- mycin sulfate powder.
vention of necrotic enteritis caused by
Clostridium perfringens susceptible to (a) Specifications. Each gram of pow-
bacitracin methylenedisalicylate. der contains 200 units bacitracin
(B) Limitations. Prepare a fresh solu- methylenedisalicylate and strepto-
tion daily. Use as the sole source of mycin sulfate equivalent to 20 milli-
drinking water. grams of streptomycin.
(ii) Amount. 200 to 400 mg per gal in (b) Sponsor. See No. 054771 in
drinking water. Administer continu- § 510.600(c) of this chapter.
ously 5 to 7 days or as long as clinical (c) Conditions of use in dogs—(1)
signs persist, then reduce to prevention Amount. Administer 1 level teaspoonful
levels (100 mg/gal). per 10 pounds of body weight three
(A) Indications for use. Treatment of times daily, mixed in a small quantity
necrotic enteritis caused by C. of liquid or feed.
perfringens susceptible to bacitracin
(2) Indications for use. For the treat-
ment of bacterial enteritis caused by
(B) Limitations. Prepare a fresh solu-
tion daily. Use as the sole source of pathogens susceptible to bacitracin and
drinking water. streptomycin such as Escherichia coli,
(2) Growing turkeys—(i) Amount. 400 Proteus spp., Staphylococcus spp., and
milligrams (mg) per gallon (gal) in Streptococcus spp., and for the sympto-
drinking water. matic treatment of associated diar-
(ii) Indications for use. Aid in the con- rhea.

trol of transmissible enteritis com-
169
§ 520.154c 21 CFR Ch. I (4–1–23 Edition)
(3) Limitations. Federal law restricts (2) Indications for use. To improve gly-
this drug to use by or on the order of a cemic control in otherwise healthy
licensed veterinarian. cats with diabetes mellitus not pre-
viously treated with insulin.
[71 FR 17702, Apr. 7, 2006, as amended at 79
FR 28818, May 20, 2014; 81 FR 17607, Mar. 30,
2016] this drug to use by or on the order of a
§ 520.154c Bacitracin zinc soluble pow- [88 FR 16547, Mar. 20, 2023]
der.
(a) Specifications. Each pound con- § 520.222 Bunamidine hydrochloride.
tains the equivalent of not less than 5 (a) Chemical name. N,N-Dibutyl-4-
grams of bacitracin. (hexyloxy)-1-naphthamidine hydro-
(b) Sponsor. See No. 054771 in chloride.
§ 510.600(c) of this chapter. (b) Specifications. The drug is an oral
(c) Related tolerances. See § 556.70 of tablet containing 100, 200, or 400 milli-
this chapter. grams of bunamidine hydrochloride.
(d) Conditions of use—(1) Broiler chick- (c) Sponsor. See No. 000061 in
ens—(i) Amount. 100 milligrams per gal- § 510.600(c) of this chapter.
lon in drinking water. (d) Conditions of use. (1) The drug is
(A) Indications for use. Prevention of intended for oral administration to
necrotic enteritis caused by Clostridium dogs for the treatment of the tape-
perfringens susceptible to bacitracin worms Dipylidium caninum, Taenia
zinc. pisiformis, and Echinococcus granulosus,
(B) Limitations. Prepare a fresh solu- and to cats for the treatment of the
tion daily. tapeworms Dipylidium caninum and
(ii) Amount. 200 to 400 milligrams per Taenia taeniaeformis.
gallon in drinking water. (2) It is administered to cats and dogs
(A) Indications for use. Control of ne- at the rate of 25 to 50 milligrams per
crotic enteritis caused by Clostridium kilogram of body weight. The drug
perfringens susceptible to bacitracin should be given on an empty stomach
zinc. and food should not be given for 3
(B) Limitations. Prepare a fresh solu- hours following treatment.
tion daily. (3) Tablets should not be crushed,
(2) Growing quail—(i) Amount. 500 mil- mixed with food, or dissolved in liquid.
ligrams per gallon in drinking water Repeat treatments should not be given
for 5 days followed by 165 milligrams within 14 days. The drug should not be
per gallon in drinking water for 10 given to male dogs within 28 days prior
to their use for breeding. Do not ad-
days.
minister to dogs or cats having known
(ii) Indications for use. Control of ul-
heart conditions.
cerative enteritis caused by Clostridium
(4) For use only by or on the order of
spp. susceptible to bacitracin zinc.
a licensed veterinarian.
(iii) Limitations. Prepare a fresh solu-
tion daily. [40 FR 13838, Mar. 27, 1975, as amended at 42
FR 13018, Mar. 8, 1977; 46 FR 48642, Oct. 2,
[57 FR 37322, Aug. 18, 1992, as amended at 67 1981; 61 FR 8873, Mar. 6, 1996; 62 FR 61624,
FR 78355, Dec. 24, 2002; 79 FR 28818, May 20, Nov. 19, 1997]
2014]
§ 520.246 Butorphanol tablets.
§ 520.170 Bexagliflozin.
(a) Specifications. Each tablet contains butorphanol tartrate equivalent
tains 15 milligrams bexagliflozin. to 1, 5, or 10 milligrams (mg)
(b) Sponsor. See No. 058198 in butorphanol base.
§ 510.600(c) of this chapter. (b) Sponsor. See No. 054771 in
(c) Conditions of use—(1) Amount. Ad- § 510.600(c) of this chapter.
minister one tablet by mouth to cats (c) Conditions of use in dogs—(1)
6.6 lb (3.0 kg) or greater once daily, at Amount. Administer 0.25 mg
approximately the same time each day, butorphanol base per pound of body
with or without food, and regardless of weight. Repeat at intervals of 6 to 12

blood glucose level. hours as required. Treatment should
170
not normally be required for longer narian should be consulted before using
than 7 days. in severely debilitated dogs.
(2) Indications for use. For the relief of [86 FR 10819, Feb. 23, 2021]
chronic nonproductive cough associ-
ated with tracheobronchitis, tracheitis, § 520.284 Cambendazole oral dosage
tonsillitis, laryngitis, and pharyngitis forms.
associated with inflammatory condi-
tions of the upper respiratory tract. § 520.284a Cambendazole suspension.
(3) Limitations. Federal law restricts (a) Specifications. Each fluid ounce
this drug to use by or on the order of a contains 0.9 gram of cambendazole.
licensed veterinarian. (b) Sponsor. No. 000010 in § 510.600(c) of
this chapter.
[79 FR 28818, May 20, 2014]
(c) Conditions of use in horses—(1)
Amount. Administer by stomach tube
§ 520.260 n-Butyl chloride.
or as a drench at a dose of 0.9 gram of
(a) Specifications. Each capsule con- cambendazole per 100 pounds of body
tains 221, 442, 884, or 1,768 milligrams weight (20 milligrams per kilogram).
(mg); or 4.42 grams of n-butyl chloride. (2) Indications for use. For the control
(b) Sponsors. See sponsors in of large strongyles (Strongylus vulgaris,
§ 510.600(c) of this chapter: S. edentatus, S. equinus); small
(1) No. 023851 for capsules containing strongyles (Trichonema, Poteriostomum,
221, 442, 884, or 1,768 mg, or 4.42 grams Cylicobrachytus, Craterostomum,
(g); and Oesophagodontus); roundworms
(2) No. 054771 for capsules containing (Parascaris); pinworms (Oxyuris); and
221 mg. threadworms (Strongyloides).
(c) Conditions of use in dogs—(1) (3) Limitations. Do not use in horses
Amount. Administer capsules orally intended for human consumption. Fed-
based on body weight as follows: eral law restricts this drug to use by or
(i) Capsules containing 221 mg: Under on the order of a licensed veterinarian.
5 pounds, 1 capsule per 11⁄4 pounds of [40 FR 13838, Mar. 27, 1975. Redesignated at 41
body weight. FR 1276, Jan. 7, 1976, and amended at 42 FR
(ii) Capsules containing 442 mg: 3838, Jan. 21, 1977; 62 FR 63270, Nov. 28, 1997;
Under 5 pounds, 1 capsule per 21⁄2 79 FR 28818, May 20, 2014. Redesignated at 81
pounds of body weight. FR 59133, Aug. 29, 2016; 84 FR 39182, Aug. 9,
2019]
(iii) Capsules containing 884 mg:
(A) Under 5 pounds, 1 capsule; § 520.284b Cambendazole pellets.
(B) 5 to 10 pounds, 2 capsules;
(a) Specifications. The drug is in feed
(C) 10 to 20 pounds, 3 capsules; pellets containing 5.3 percent
(D) 20 to 40 pounds, 4 capsules; cambendazole.
(E) Over 40 pounds, 5 capsules. (b) Sponsor. No. 000010 in § 510.600(c) of
(iv) Capsules containing 1,768 mg: this chapter.
Dogs weighing 5 to 10 pounds, 1 capsule. (c) Conditions of use in horses—(1)
(v) Capsules containing 4.42 g: Dogs Amount. Administer 20 milligrams
weighing 40 pounds or over, 1 capsule. cambendazole per kilogram body
(2) Indications for use. For the re- weight (6 ounces per 1,000 pounds) by
moval of ascarids (Toxocara canis and mixing with normal grain ration given
Toxascaris leonina) and hookworms at one feeding. Doses for individual
(Ancylostoma caninum, Ancylostoma horses should be mixed and fed sepa-
braziliense, and Uncinaria stenocephala) rately to assure that each horse will
from dogs. consume the correct amount. For ani-
(3) Limitations. Dogs should not be fed mals maintained on premises where re-
for 18 to 24 hours before being given the infection is likely to occur, re-treat-
drug. Administration of the drug ments may be necessary. For most ef-
should be followed in 1⁄2 to 1 hour with fective results, re-treat in 6 to 8 weeks.
a mild cathartic. Normal feeding may (2) Indications for use. For the control
be resumed 4 to 8 hours after treat- of large strongyles (Strongylus vulgaris,
ment. Animals subject to reinfection S. edentatus, S. equinus); small

may be retreated in 2 weeks. A veteri- strongyles (Trichonema, Poteriostomum,
171
§ 520.284c 21 CFR Ch. I (4–1–23 Edition)
Cylicobrachytus, Craterostomum, (2) 20 mg capromorelin.

Oesophagodontus); roundworms (b) Sponsor. See No. 058198 in
(Parascaris); pinworms (Oxyuris); and § 510.600(c) of this chapter.
threadworms (Strongyloides). (c) Conditions of use—(1) Dogs. Use
(3) Limitations. Do not administer to product described in paragraph (a)(1) of
pregnant mares during first 3 months this section as follows:
of pregnancy. Do not use in horses in- (i) Amount. Administer 3 mg/kg once
tended for human consumption. Con- daily by mouth.
sult your veterinarian for assistance in (ii) Indications for use. For appetite
the diagnosis, treatment, and control stimulation in dogs.
of parasitism. (iii) Limitations. Federal law restricts
[41 FR 1276, Jan. 7, 1976, as amended at 42 FR this drug to use by or on the order of a
3838, Jan. 21, 1977; 62 FR 63270, Nov. 28, 1997; licensed veterinarian.
79 FR 28818, May 20, 2014. Redesignated at 81 (2) Cats. Use product described in
FR 59133, Aug. 29, 2016; 84 FR 39182, Aug. 9, paragraph (a)(2) of this section as fol-
2019] lows:
(i) Amount. Administer 2 mg/kg once
§ 520.284c Cambendazole paste.
daily by mouth.
(a) Specifications. The drug is a paste (ii) Indications for use. For manage-
containing 45 percent cambendazole. ment of weight loss in cats with chron-
(b) Sponsor. No. 000010 in § 510.600(c) of ic kidney disease.
this chapter. (iii) Limitations. Federal law restricts
(c) Conditions of use in horses—(1) this drug to use by or on the order of a
Amount. Administer 20 milligrams licensed veterinarian.
cambendazole per kilogram body
weight (5 grams per 550 pounds (250 [81 FR 59133, Aug. 29, 2016, as amended at 85
kilograms)) by depositing the paste on FR 4207, Jan. 24, 2020; 86 FR 17063, Apr. 1,
2021]
the back of the tongue using a dosing
gun. For animals maintained on prem- § 520.301 Caramiphen
ises where reinfection is likely to ethanedisulfonate and ammonium
occur, re-treatments may be necessary. chloride tablets.
For most effective results, re-treat in 6
to 8 weeks.
tains 10 milligrams of 5st caramiphen
(2) Indications for use. For the control
ethanedisulfonate and 80 milligrams of
of large strongyles (Strongylus vulgaris,
ammonium chloride.
S. edentatus, S. equinus); small
strongyles (Trichonema, Poteriostomum,
Cylicobrachytus, Craterostomum,
Oesophagodontus); roundworms (c) Conditions of use in dogs—(1)
(Parascaris); pinworms (Oxyuris); and Amount. One tablet per 15 to 30 pounds
threadworms (Strongyloides). of body weight every 4 to 6 hours.
(3) Limitations. Do not administer to (2) Indications for use. For relief of
pregnant mares during first 3 months cough.
of pregnancy. Do not use in horses in- [43 FR 55385, Nov. 28, 1978, as amended at 79
tended for human consumption. Con- FR 28819, May 20, 2014. Redesignated at 80 FR
sult your veterinarian for assistance in 13229, Mar. 13, 2015]
the diagnosis, treatment, and control
of parasitism. § 520.302 Carnidazole tablets.
[41 FR 1276, Jan. 7, 1976, as amended at 42 FR

3838, Jan. 21, 1977; 62 FR 63270, Nov. 28, 1997; tains 10 milligrams of carnidazole.
79 FR 28819, May 20, 2014. Redesignated at 81 (b) Sponsor. See 053923 in § 510.600(c) of
FR 59133, Aug. 29, 2016; 84 FR 39182, Aug. 9, this chapter.
2019] (c) Conditions of use—(1) Amount.
Adult pigeons: 1 tablet (10 milligrams);
§ 520.292 Capromorelin. newly weaned pigeons: 1⁄2 tablet (5 mil-
(a) Specifications. Each milliliter of ligrams).
solution contains: (2) Indications for use. For treating
(1) 30 milligrams (mg) capromorelin; trichomoniasis (canker) in ornamental

or and homing pigeons.
172
(3) Limitations. Not for use in pigeons § 520.314 Cefadroxil.

intended for human food. Consult your (a) Specifications. (1) Each tablet con-
veterinarian for assistance in the diag- tains 50, 100, or 200 milligrams (mg) or
nosis, treatment, and control of para- 1 gram of cefadroxil.
sitism or when severely ill birds do not (2) Each milliliter of suspension con-
respond to treatment. stituted from powder contains 50 mg of
[54 FR 32336, Aug. 7, 1989. Redesignated at 80 cefadroxil.
FR 13229, Mar. 13, 2015] (b) Sponsor. See No. 042791 in
§ 520.304 Carprofen. (c) Conditions of use in dogs and cats—
(a) Specifications. (1) Each caplet con- (1) Amount—(i) Dogs. Administer 10 mg
tains 25, 75, or 100 milligrams (mg) per pound (/lb) body weight twice daily
carprofen. orally.
(2) Each chewable tablet contains 25, (ii) Cats. Administer 10 mg/lb body
75, or 100 mg carprofen. weight once daily orally.
(2) Indications for use—(i) Dogs. For
(3) Each chewable tablet contains 25,
the treatment of skin and soft tissue
37.5, 50, 75, or 100 mg carprofen.
infections including cellulitis,
(b) Sponsors. See sponsors in pyoderma, dermatitis, wound infec-
§ 510.600(c) of this chapter for use as in tions, and abscesses due to susceptible
paragraph (c) of this section. strains of Staphylococcus aureus. For
(1) Nos. 017033, 054771, 055529, and the treatment of genitourinary tract
062250 for use of product described in infections (cystitis) due to susceptible
paragraphs (a)(1) and (2) of this section strains of Escherichia coli, Proteus
as in paragraph (c) of this section. mirabilis, and S. aureus.
(2) Nos. 058198 and 086101 for use of (ii) Cats. For the treatment of skin
product described in paragraph (a)(2) as and soft tissue infections including ab-
in paragraph (c) of this section. scesses, wound infections, cellulitis,
(3) No. 069043 for use of product de- and dermatitis caused by susceptible
scribed in paragraph (a)(3) of this sec- strains of Pasteurella multocida, S.
tion as in paragraph (c) of this section. aureus, Staphylococcus epidermidis, and
(c) Conditions of use in dogs—(1) Streptococcus spp.
Amount. 2 mg per pound (/lb) of body (3) Limitations. Federal law restricts
weight once daily or 1 mg/lb twice this drug to use by or on the order of a
daily. For the control of postoperative licensed veterinarian.
pain, administer approximately 2 hours [75 FR 10165, Mar. 5, 2010, as amended at 87
before the procedure. FR 76421, Dec. 14, 2022]
(2) Indications for use. For the relief of
pain and inflammation associated with § 520.370 Cefpodoxime tablets.
osteoarthritis and for the control of (a) Specifications. (1) Each tablet con-
postoperative pain associated with soft tains cefpodoxime proxetil equivalent
tissue and orthopedic surgeries. to 100 or 200 milligrams (mg)
(3) Limitations. Federal Law restricts cefpodoxime.
this drug to use by or on the order of a (2) Each chewable tablet contains
licensed veterinarian. cefpodoxime proxetil equivalent to 100
[61 FR 66581, Dec. 18, 1996, as amended at 64 or 200 mg cefpodoxime.
FR 32181, June 16, 1999; 66 FR 63165, Dec. 5, (b) Sponsors. See sponsors in
2001; 67 FR 6866, Feb. 14, 2002; 67 FR 65038, § 510.600(c) of this chapter for uses as
Oct. 23, 2002; 67 FR 65697, Oct. 28, 2002; 70 FR follows:
30626, May 27, 2005; 71 FR 51995, Sept. 1, 2006; (1) No. 017033 for use of product in
72 FR 68478, Dec. 5, 2007; 74 FR 21768, May 11, paragraph (a)(1) of this section as in
2009; 78 FR 52853, Aug. 27, 2013; 78 FR 66264, paragraph (c) of this section.
Nov. 5, 2013; 79 FR 28819, May 20, 2014. Redes- (2) No. 054771 for use of products in
ignated and amended at 80 FR 13229, Mar. 13,
2015; 80 FR 34278, June 16, 2015; 80 FR 61296,
paragraph (a) of this section as in para-
Oct. 13, 2015; 82 FR 43484, Sept. 18, 2017; 84 FR graph (c) of this section.
12493, Apr. 2, 2019; 85 FR 4207, Jan. 24, 2020; 86 (c) Conditions of use in dogs—(1)
FR 13184, Mar. 8, 2021; 86 FR 14817, Mar. 19, Amount. 5 to 10 mg per kilogram (2.3 to
2021; 86 FR 61684, Nov. 8, 2021] 4.5 mg per pound) body weight daily for
173
§ 520.376 21 CFR Ch. I (4–1–23 Edition)
5 to 7 days, or for 2 to 3 days beyond (i) No. 061133 for 50-, 100-, 250-, and
the cessation of clinical signs, up to a 500-mg; and 1-g tablets;
maximum of 28 days. (ii) [Reserved]
(2) Indications for use. For the treat- (c) Conditions of use in dogs—(1)
ment of skin infections (wounds and Amount. Administer 25 mg per pound of
abscesses) caused by susceptible strains body weight by mouth every 6 hours.
of Staphylococcus pseudintermedius, S. (2) Indications for use—(i) For the
aureus, Streptococcus canis (group G, treatment of bacterial pulmonary in-
beta-hemolytic), Escherichia coli,
fections, bacterial infections of the uri-
Pasteurella multocida, and Proteus
nary tract, bacterial enteritis, and bac-
mirabilis.
terial infections associated with canine
distemper caused by susceptible orga-
licensed veterinarian. nisms.
(ii) For the treatment of bacterial
[69 FR 52815, Aug. 30, 2004, as amended at 78 gastroenteritis associated with bac-
FR 5714, Jan. 28, 2013; 79 FR 28819, May 20,
terial diarrhea, bacterial pulmonary
2014; 80 FR 13229, Mar. 13, 2015; 82 FR 12169,
Mar. 1, 2017; 88 FR 16547, Mar. 20, 2023] infections, and bacterial infections of
the urinary tract caused by susceptible
§ 520.376 Cephalexin. organisms.
(a) Specifications. Each chewable tab- (3) Limitations. Federal law restricts
let contains 75, 150, 300, or 600 milli- this drug to use by or on the order of a
grams (mg) cephalexin. licensed veterinarian. Federal law pro-
(b) Sponsor. See No. 051311 in hibits the extralabel use of this drug in
§ 510.600(c) of this chapter. food-producing animals.
(c) Conditions of use—(1) Dogs—(i) [77 FR 4896, Feb. 1, 2012, as amended at 78 FR
Amount. Administer 22 mg per kilo- 21059, Apr. 9, 2013; 79 FR 28819, May 20, 2014;
gram of body weight twice daily for 28 83 FR 48944, Sept. 28, 2018; 84 FR 8972, Mar. 13,
days. 2019]
(ii) Indications for use. For the treat-
ment of secondary superficial bacterial § 520.390b Chloramphenicol capsules.
pyoderma in dogs caused by susceptible (a) Specifications. Each capsule con-
strains of Staphylococcus tains 50, 100, 250, or 500 milligrams (mg)
pseudintermedius.
chloramphenicol.
(iii) Limitations. Federal law restricts
(b) Sponsors. See Nos. 050057 and
licensed veterinarian. 054771 in § 510.600(c) of this chapter for
(2) [Reserved] use as in paragraph (d) of this section.
(c) Special considerations. Federal law
[77 FR 47512, Aug. 9, 2012] prohibits the extralabel use of this
product in food-producing animals.
§ 520.390 Chloramphenicol oral dosage
forms. (d) Conditions of use in dogs—(1)
Amount. 25 mg per pound of body
§ 520.390a Chloramphenicol tablets. weight every 6 hours.
(a) Specifications. Each tablet con- (2) Indications for use. For treatment
tains 50, 100, 250, or 500 milligrams of bacterial pulmonary infections, bac-
(mg); 1 or 2.5 grams (g) of chloramphen- terial infections of the urinary tract,
icol. bacterial enteritis, and bacterial infec-
(b) Sponsors. See § 510.600(c) of this tions associated with canine distemper
chapter: caused by susceptible organisms.
(1) For use as in paragraphs (c)(1), (3) Limitations. Federal law restricts
(c)(2)(i), and (c)(3) of this section: this drug to use by or on the order of a
(i) No. 069043 for 100-, 250-, and 500-mg; licensed veterinarian.
and 1- and 2.5-g tablets;
(ii) No. 054771 for 100-, 250-, and 500-
FR 18442, Apr. 4, 2008; 75 FR 55676, Sept. 14,
mg tablets; 2010; 79 FR 28819, May 20, 2014]
(2) For use as in paragraphs (c)(1),

(c)(2)(ii), and (c)(3) of this section:
174
§ 520.390c Chloramphenicol palmitate by or on the order of a licensed veteri-

oral suspension. narian.
(a) Specifications. Each milliliter con- [84 FR 39183, Aug. 9, 2019]
tains chloramphenicol palmitate equiv-
alent to 30 milligrams of chloramphen- § 520.434 Chlorphenesin carbamate
icol. tablets.
(b) Sponsor. See No. 054771 in (a) Specifications. Each tablet con-
§ 510.600(c) of this chapter. tains 400 milligrams of chlorphenesin
(c) Conditions of use. Dogs—(1) carbamate.
Amount. 25 milligrams per pound of (b) Sponsor. See No. 054771 in
body weight every 6 hours. If no re- § 510.600(c) of this chapter.
sponse is obtained in 3 to 5 days, dis- (c) Conditions of use in dogs—(1)
continue use and reevaluate diagnosis. Amount. 50 milligrams per pound of
(2) Indications for use. Treatment of body weight on first day; 25 milligrams
bacterial pulmonary infections, infec- per pound of body weight each fol-
tions of the urinary tract, enteritis, lowing day. Divide total daily dose into
and infections associated with canine 2 or 3 equal doses—administer at 12- or
distemper that are caused by orga- 8-hour intervals.
nisms susceptible to chloramphenicol.
(2) Indications for use. For use as an
(3) Limitations. Not for use in animals
adjunct to therapy of acute inflam-
that are raised for food production.
matory and traumatic conditions of
Must not be used in meat-, egg-, or
skeletal muscles. The drug provides re-
milk-producing animals. The length of
lief of the signs of discomfort associ-
time that residues persist in milk or
ated with myositis, muscle sprains,
tissues has not been determined. Fed-
traumatic injuries, stifle injuries—es-
eral law restricts this drug to use by or
pecially when administered before or
after surgery—and invertebral disc
[57 FR 37323, Aug. 18, 1992; 57 FR 42623, Sept. syndrome (can be used concurrently
15, 1992, as amended at 79 FR 28819, May 20, with adrenal corticosteroids).
2014] (3) Limitations. Federal law restricts
§ 520.420 Chlorothiazide.
(a) Specifications. (1) Each tablet con-
tains 0.25 grams chlorothiazide. [44 FR 16009, Mar. 16, 1979, as amended at 79
FR 28819, May 20, 2014]
(2) Each bolus contains 2 grams
chlorothiazide. § 520.441 Chlortetracycline powder.
§ 510.600(c) of this chapter. (a) Specifications. Chlortetracycline
(c) Conditions of use—(1) Dogs—(i) powder contains not less than 15 milli-
Amount. Administer 5 to 10 milligrams grams per gram chlortetracycline hy-
per pound of body weight two or three drochloride, or chlortetracycline bisul-
times daily. fate equivalent to 25.6, 64 or 102.4 grams
(ii) Indications for use. For treatment per pound (56.4, 141 or 225.6 milligrams
of congestive heart failure and renal per gram) chlortetracycline hydro-
edema. chloride.
(iii) Limitations. Federal law restricts (b) Sponsors. See sponsors in
this drug to use by or on the order of a § 510.600(c) of this chapter for use as in
licensed veterinarian. paragraph (d) of this section.
(2) Cows—(i)—Amount. Administer 2 (1) No. 069254 for use as in paragraph
grams once or twice daily for 3 or 4 (d) of this section.
days. (2) No. 066104 for use as in paragraphs
(ii) Indications for use. As an aid in re- (d)(4)(i)(A), (d)(4)(i)(B), and (d)(4)(ii)
duction of postparturient udder edema. through (d)(4)(iv) of this section.
(iii) Limitations. Milk taken from (3) Nos. 069043 and 076475 for use as in
dairy animals during treatment and for paragraphs (d)(4)(i)(A), (d)(4)(i)(B), and
72 hours (six milkings) after latest (d)(4)(ii) and (iii) of this section.
treatment must not be used for food. (c) Related tolerances. See § 556.150 of
Federal law restricts this drug to use this chapter.
175
§ 520.441 21 CFR Ch. I (4–1–23 Edition)
(d) Conditions of use. (1) Use as chlor- (1) Indications for use. Control of in-
tetracycline hydrochloride in drinking fectious synovitis caused by Myco-
water as follows: plasma synoviae.
(i) Swine—(A) Amount. Ten milli- (2) Limitations. Prepare fresh solution
grams per pound of body weight daily daily; as sole source of chlortetra-
in divided doses. cycline; do not use for more than 14
(1) Indications for use. Control and days; do not slaughter animals for food
treatment of bacterial enteritis within 24 hours of treatment; do not
(scours) caused by Escherichia coli and use in laying chickens. Federal law re-
bacterial pneumonia associated with stricts this drug to use by or on the
Pasteurella spp., Actinobacillus order of a licensed veterinarian.
pleuropneumoniae (Haemophilus spp.), (B) Amount. 400 to 800 milligrams per
and Klebsiella spp. gallon.
(2) Limitations. Prepare a fresh solu- (1) Indications for use. Control of
tion twice daily; as sole source of chronic respiratory disease and air-sac
chlortetracycline; administer for not infections caused by M. gallisepticum
more than 5 days. Federal law restricts and E. coli.
this drug to use by or on the order of a (2) Limitations. Prepare fresh solution
licensed veterinarian. daily; as sole source of chlortetra-
(B) [Reserved] cycline; do not use for more than 14
(ii) [Reserved] days; do not slaughter animals for food
(2) Use as chlortetracycline hydro- within 24 hours of treatment; do not
chloride in a drench or drinking water use in laying chickens. Federal law re-
as follows: stricts this drug to use by or on the
(i) Calves—(A) Amount. Ten milli- order of a licensed veterinarian.
grams per pound of body weight daily (C) Amount. One thousand milligrams
in divided doses. per gallon.
(1) Control and treatment of bac-
(1) Indications for use. Control of mor-
terial enteritis (scours) caused by E.
tality due to fowl cholera caused by
coli and bacterial pneumonia (shipping
Pasteurella multocida susceptible to
fever) associated with Pasteurella spp.,
chlortetracycline.
A. pleuropneumoniae (Haemophilus spp.),
(2) Limitations. See paragraph
and Klebsiella spp.
(d)(4)(i)(A)(2) of this section.
(2) Limitations. Prepare fresh solution
daily; as sole source of chlortetra- (ii) Growing turkeys—(A) Amount. 400
cycline; administer for not more than 5 milligrams per gallon.
days; do not slaughter animals for food (1) Indications for use. Control of in-
within 24 hours of treatment; do not fectious synovitis caused by M.
administer this product with milk or synoviae.
milk replacers; administer 1 hour be- (2) Limitations. Prepare fresh solution
fore or 2 hours after feeding milk or daily; as sole source of chlortetra-
milk replacers; a withdrawal period has cycline; do not use for more than 14
not been established in preruminating days; do not slaughter animals for food
calves; do not use in calves to be proc- within 24 hours of treatment. Federal
essed for veal. Federal law restricts law restricts this drug to use by or on
this drug to use by or on the order of a the order of a licensed veterinarian.
licensed veterinarian. (B) Amount. 25 milligrams per pound
(B) [Reserved] of body weight daily.
(ii) [Reserved] (1) Indications for use. Control of com-
(3) [Reserved] plicating bacterial organisms associ-
(4) The following uses of chlortetra- ated with bluecomb (transmissible en-
cycline hydrochloride or chlortetra- teritis, coronaviral enteritis).
cycline bisulfate in drinking water or (2) Limitations. Prepare fresh solution
drench were reviewed by the National daily; as sole source of chlortetra-
Academy of Sciences/National Re- cycline; do not use for more than 14
search Council (NAS/NRC) and found days; do not slaughter animals for food
effective: within 24 hours of treatment. Federal
(i) Chickens—(A) Amount. 200 to 400 law restricts this drug to use by or on
milligrams per gallon. the order of a licensed veterinarian.
176
(iii) Swine—(A) Amount. 10 milligrams ing chickens; do not administer to

per pound body weight daily in divided chickens within 24 hours of slaughter.
doses. Federal law restricts this drug to use
(B) Indications for use. Control and by or on the order of a licensed veteri-
treatment of bacterial enteritis narian.
(scours) caused by E. coli and Sal- (B) Amount. 400 to 800 mg/gal, for 7 to
monella spp. and bacterial pneumonia 14 days.
associated with Pasteurella spp., (1) Indications for use. Control of
Actinobacillus pleuropneumoniae chronic respiratory disease (CRD) and
(Haemophilus spp.), and Klebsiella spp. air-sac infections caused by M.
(C) Limitations. Prepare fresh solution gallisepticum and E. coli susceptible to
daily as the sole source of chlortetra- chlortetracycline.
cycline. Do not use for more than 5 (2) Limitations. As in paragraph
days. For Nos. 066104, 069043, 069254, and (d)(5)(i)(A)(2) of this section.
076475: Do not slaughter animals for (C) Amount. One thousand mg/gal, for
food within 5 days of treatment. For 7 to 14 days.
No. 069254: Do not slaughter animals (1) Indications for use. Control of mor-
for food within 24 hours of treatment. tality due to fowl cholera caused by
Federal law restricts this drug to use Pasteurella multocida susceptible to
by or on the order of a licensed veteri- chlortetracycline.
narian. (2) Limitations. As in paragraph
(iv) Calves, beef cattle, and nonlac- (d)(5)(i)(A)(2) of this section.
tating dairy cattle—(A) Amount. 10 milli- (ii) Growing Turkeys—(A) Amount. 400
grams per pound daily in divided doses. mg/gal, for 7 to 14 days.
(B) Indications for use. Control and (1) Indications for use. Control of in-
treatment of bacterial enteritis fectious synovitis caused by Myco-
(scours) caused by E. coli and Sal- plasma synoviae susceptible to chlor-
monella spp. and bacterial pneumonia tetracycline.
(shipping fever complex) associated (2) Limitations. Prepare fresh solution
with Pasteurella spp., A. daily; use as the sole source of chlor-
pleuropneumoniae (Haemophilus spp.), tetracycline; do not use for more than
and Klebsiella spp. 14 consecutive days; do not administer
(C) Limitations. Prepare fresh solution to growing turkeys within 24 hours of
daily; use as a drench; as sole source of slaughter. Federal law restricts this
chlortetracycline; do not use for more drug to use by or on the order of a li-
than 5 days; do not slaughter animals censed veterinarian.
for food within 24 hours of treatment; (B) Amount. 25 mg/lb body weight
do not use in lactating cattle; do not daily, for 7 to 14 days.
administer this product with milk or (1) Indications for use. Control of com-
milk replacers; administer 1 hour be- plicating bacterial organisms associ-
fore or 2 hours after feeding milk or ated with bluecomb (transmissible en-
milk replacers; a withdrawal period has teritis, coronaviral enteritis) suscep-
not been established in preruminating tible to chlortetracycline.
calves; do not use in calves to be proc- (2) Limitations. As in paragraph
essed for veal. Federal law restricts (d)(5)(ii)(A)(2) of this section.
this drug to use by or on the order of a (iii) Swine—(A) Amount. 10 mg/lb body
licensed veterinarian. weight daily, for 3 to 5 days.
(5) Use in a drench or drinking water (B) Indications for use. Control and
as follows: treatment of bacterial enteritis
(i) Chickens—(A) Amount. 200 to 400 (scours) caused by E. coli and Sal-
mg/gal, for 7 to 14 days. monella spp., and bacterial pneumonia
(1) Indications for use. Control of in- associated with Pasteurella spp., A.
fectious synovitis caused by M. pleuropneumoniae, and Klebsiella spp.
synoviae susceptible to chlortetra- susceptible to chlortetracycline.
cycline. (C) Limitations. Prepare fresh solution
(2) Limitations. Prepare fresh solution daily; use as the sole source of chlor-
daily; use as the sole source of chlortetracycline; do not use for more than
tetracycline; do not use for more than 5 days; do not administer to swine
14 consecutive days; do not use in lay- within 24 hours of slaughter. Federal
177
§ 520.443 21 CFR Ch. I (4–1–23 Edition)
law restricts this drug to use by or on Escherichia coli and bacterial pneu-
the order of a licensed veterinarian. monia associated with Pasteurella spp.,
(iv) Calves, beef cattle, and nonlac- Klesbsiella spp., and Haemophilus spp.
tating dairy cattle—(A) Amount. 10 mg/lb (ii) Limitations. Administer bolus di-
body weight daily in divided doses, for rectly by mouth or crush and dissolve
3 to 5 days. in milk or water for drenching or buck-
(B) Indications for use. Control and et feeding; if no improvement is noted
treatment of bacterial enteritis after 3 days of treatment, consult a
(scours) caused by Escherichia coli and veterinarian; do not use for more than
Salmonella spp., and bacterial pneu- 5 days; do not administer within 24
monia associated with Pasteurella spp., hours of slaughter.
Histophilus spp., and Klebsiella spp. sus- (2) Amount. One 25 milligram tablet
ceptible to chlortetracycline. for each 5 pounds of body weight every
(C) Limitations. Prepare fresh solution 12 hours daily for 3 to 5 days.
daily; use as a drench; use as the sole (i) Indications for use. Control and
source of chlortetracycline; do not use treatment of bacterial enteritis
for more than 5 days; do not administer (scours) caused by E. coli and Sal-
to cattle within 24 hours of slaughter; monella spp. and bacterial pneumonia
do not use in lactating dairy cattle; do associated with Pasteurella spp.,
not administer this product with milk Haemophilus spp., and Klebsiella spp.,
or milk replacers; administer 1 hour susceptible to chlortetracycline.
before or 2 hours after feeding milk or (ii) Limitations. Administer tablet di-
milk replacers; a withdrawal period has rectly by mouth or crush and dissolve
not been established in preruminating in water for drenching; if no improve-
calves; do not use in calves to be proc- ment is noted after 3 days of treat-
essed for veal. Federal law restricts ment, consult a veterinarian; do not
this drug to use by or on the order of a use for more than 5 days; when feeding
licensed veterinarian. milk or milk replacer, administration 1
[57 FR 37324, Aug. 18, 1992] hour before or 2 hours after feeding; do
not administer within 24 hours of
EDITORIAL NOTE: For FEDERAL REGISTER ci- slaughter.
tations affecting § 520.441, see the List of CFR
Sections Affected, which appears in the
(3) Amount. One 500 milligram bolus
Finding Aids section of the printed volume per 100 pounds of body weight twice a
and at www.govinfo.gov. day for 3 to 5 days.
(i) Indications for use. Treatment of
§ 520.443 Chlortetracycline tablets and bacterial enteritis (scours) caused by E.
boluses. coli and Salmonella spp., and bacterial
(a) Specifications. Each tablet con- pneumonia associated with Pasteurella
tains 25 milligrams (mg) chlortetra- spp., Haemophilus spp., and Klebsiella
cycline hydrochloride; each bolus con- spp., susceptible to chlortetracycline.
tains 250 or 500 mg chlortetracycline (ii) Limitations. Do not use for more
hydrochloride. than 5 days. Do not administer within
(b) Sponsors. See sponsors in 24 hours of slaughter. Federal law re-
§ 510.600(c) of this chapter for use as in stricts this drug to use by or on the
paragraph (d) of this section. order of a licensed veterinarian.
(1) No. 069043 for use of a 250-mg bolus [57 FR 37325, Aug. 18, 1992, as amended at 67
as in paragraph (d)(1) of this section. FR 78355, Dec. 24, 2002. Redesignated and
(2) No. 016592 for use of a 25-mg tablet amended at 76 FR 49649, Aug. 11, 2011; 78 FR
as in paragraph (d)(2) of this section. 21059, Apr. 9, 2013; 81 FR 17607, Mar. 30, 2016;
(3) No. 016592 for use of a 500-mg bolus 88 FR 16547, Mar. 20, 2023]
as in paragraph (d)(3) of this section.
(c) Related tolerances. See § 556.150 of § 520.445 Chlortetracycline and
this chapter. sulfamethazine powder.
(d) Conditions of use in calves—(1) (a) Specifications. Each pound of solu-
Amount. One 250 milligram bolus per 50 ble powder contains chlortetracycline
pounds of body weight twice a day for bisulfate equivalent to 102.4 grams (g)
3 to 5 days. of chlortetracycline hydrochloride and
(i) Indications for use. Treatment of sulfamethazine bisulfate equivalent to

bacterial enteritis (scours) caused by 102.4 g of sulfamethazine.
178
(b) Sponsor. See No. 016592 in abscesses) due to susceptible strains of

§ 510.600(c) of this chapter. coagulase-positive staphylococci
(c) Related tolerances. See §§ 556.150 (Staphylococcus aureus or S.
and 556.670 of this chapter. intermedius), deep wounds and abscesses
(d) Conditions of use in swine. Admin- due to susceptible strains of Bacteroides
ister in drinking water as follows: fragilis, Prevotella melaninogenicus,
(1) Amount. 250 milligrams (mg) of Fusobacterium necrophorum, and Clos-
chlortetracycline and 250 mg of tridium perfringens, dental infections
sulfamethazine per gallon. due to susceptible strains of S. aureus,
(2) Indications for use. For the preven- B. fragilis, P. melaninogenicus, F.
tion and treatment of bacterial enter- necrophorum, and C. perfringens, and os-
itis; as an aid in the reduction of the teomyelitis due to susceptible strains
incidence of cervical abscesses; and as of S. aureus, B. fragilis, P.
an aid in the maintenance of weight melaninogenicus, F. necrophorum, and C.
gains in the presence of bacterial en- perfringens.
teritis and atrophic rhinitis. (3) Limitations. Federal law restricts
(3) Limitations. Use as the sole source this drug to use by or on the order of a
of chlortetracycline and sulfonamide. licensed veterinarian.
Not to be used for more than 28 con-
secutive days. Withdraw 15 days before [67 FR 54954, Aug. 27, 2002, as amended at 68
slaughter. Federal law restricts this FR 55824, Sept. 29, 2003; 69 FR 32273, June 9,
drug to use by or on the order of a li- 2004; 71 FR 39204, July 12, 2006; 73 FR 4077,
Jan. 24, 2008; 78 FR 17596, Mar. 22, 2013; 79 FR
28819, May 20, 2014; 80 FR 76386, Dec. 9, 2015;
[76 FR 49649, Aug. 11, 2011, as amended at 81 81 FR 17607, Mar. 30, 2016]
FR 17607, Mar. 30, 2016; 81 FR 94989, Dec. 27,
2016] § 520.447 Clindamycin solution.
§ 520.446 Clindamycin capsules and (a) Specifications. Each milliliter of
tablets. solution contains the equivalent of 25
milligrams (mg) clindamycin as the
(a) Specifications. (1) Each capsule
hydrochloride salt.
contains the equivalent of 25, 75, 150, or
300 milligrams (mg) clindamycin as the (b) Sponsors. See Nos. 051311, 054771,
hydrochloride salt. 058829, 061133, and 069043 in § 510.600(c) of
(2) Each tablet contains the equiva- this chapter.
lent of 25, 75, or 150 mg clindamycin as (c) Special considerations. Federal law
the hydrochloride salt. restricts this drug to use by or on the
(3) Each capsule contains the equiva- order of a licensed veterinarian.
lent of 25, 75, or 150 mg clindamycin as (d) Conditions of use—(1) Dogs—(i)
the hydrochloride salt. Amount. Wounds, abscesses, and dental
(b) Sponsors. See sponsors in infections: 2.5 to 15 mg per pound (/lb)
§ 510.600(c) of this chapter as follows: body weight every 12 hours for a max-
(1) Nos. 054771 and 069043 for use of imum of 28 days. Osteomyelitis: 5.0 to
capsules described in paragraph (a)(1) 15 mg/lb body weight every 12 hours for
of this section. a minimum of 28 days.
(2) No. 051311 for use of tablets de- (ii) Indications for use. For the treat-
scribed in paragraph (a)(2) of this sec- ment of skin infections (wounds and
tion. abscesses) due to susceptible strains of
(3) No. 043806 for use of tablets de- coagulase-positive staphylococci
scribed in paragraph (a)(3) of this sec- (Staphylococcus aureus or S.
tion. intermedius), deep wounds and abscesses
(c) Conditions of use in dogs—(1) due to susceptible strains of Bacteroides
Amount. Wounds, abscesses, and dental fragilis, Prevotella melaninogenicus,
infections: 2.5 to 15 mg per pound (/lb) Fusobacterium necrophorum, and Clos-
body weight every 12 hours for a max- tridium perfringens; dental infections
imum of 28 days. Osteomyelitis: 5.0 to due to susceptible strains of S. aureus,
15 mg/lb body weight every 12 hours for B. fragilis, P. melaninogenicus, F.
a minimum of 28 days. necrophorum, and C. perfringens; and os-
(2) Indications for use. For the treat- teomyelitis due to susceptible strains
ment of skin infections (wounds and of S. aureus, B. fragilis, P.
179
§ 520.452 21 CFR Ch. I (4–1–23 Edition)
melaninogenicus, F. necrophorum, and C. age schedule should be repeated. The

perfringens. effect of this drug on breeding stallions
(2) Cats—(i) Amount. 5.0 to 15.0 mg/lb and brood mares has not been deter-
body weight every 24 hours for a max- mined. Treatment starting with dos-
imum of 14 days. ages higher than the initial dose is not
(ii) Indications for use. For the treat- recommended. Federal law prohibits
ment of skin infections (wounds and the extralabel use of this drug in food
abscesses) due to susceptible strains of animals. Federal law restricts this
Staphylococcus aureus, S. intermedius, drug to use by or on the order of a li-
Streptococcus spp.; deep wounds and ab- censed veterinarian.
scesses due to susceptible strains of (2) [Reserved]
Clostridium perfringens and Bacteroides [63 FR 41419, Aug. 4, 1998]
fragilis; and dental infections due to
susceptible strains of S. aureus, S. § 520.455 Clomipramine.
intermedius, Streptococcus spp., C.
perfringens, and B. fragilis.
tains 5, 20, 40, or 80 milligrams (mg)
[67 FR 54954, Aug. 27, 2002, as amended at 67 clomipramine hydrochloride.
FR 78684, Dec. 26, 2002; 68 FR 55824, Sept. 29, (b) Sponsors. See Nos. 051311 and
2003; 69 FR 31734, June 7, 2004; 71 FR 39543, 086039 in § 510.600(c) of this chapter.
July 13, 2006; 72 FR 19796, Apr. 20, 2007; 78 FR
(c) Conditions of use—(1) Amount. 2 to
17596, Mar. 22, 2013; 78 FR 30197, May 22, 2013;
79 FR 28819, May 20, 2014; 81 FR 17607, Mar. 30, 4 milligrams of clomipramine hydro-
2016; 84 FR 8972, Mar. 13, 2019] chloride per kilogram (0.9 to 1.8 milli-
grams per pound) of body weight per
§ 520.452 Clenbuterol syrup. day, administered as a single daily dose
(a) Specifications. Each milliliter con- or divided twice daily.
tains 72.5 micrograms of clenbuterol (2) Indications for use. For use as part
hydrochloride. of a comprehensive behavioral manage-
(b) Sponsor. See 000010 in § 510.600(c) of ment program to treat separation anx-
this chapter. iety in dogs greater than 6 months of
(c) [Reserved] age.
(d) Conditions of use—(1) Horses—(i) (3) Limitations. Federal law restricts
Amount. Administer orally twice a day this drug to use by or on the order of a
(b.i.d.). Initial dose is 0.5 milliliter per licensed veterinarian.
100 pounds body weight (0.8 micrograms [64 FR 1762, Jan. 12, 1999, as amended at 72
per kilogram) for 3 days (6 treatments). FR 262, Jan. 4, 2007; 86 FR 57996, Oct. 20, 2021]
If no improvement, administer 1 milli-
liter per 100 pounds (1.6 micrograms per § 520.462 Clorsulon drench.
kilogram) for 3 days (6 treatments). If (a) Specifications. The drug is a sus-
no improvement, administer 1.5 milli- pension containing 8.5 percent
liters per 100 pounds (2.4 micrograms clorsulon (85 milligrams per milliliter).
per kilogram) for 3 days (6 treatments). (b) Sponsor. See No. 000010 in
If no improvement, administer 2.0 mil- § 510.600(c) of this chapter.
liliters per 100 pounds (3.2 micrograms (c) Related tolerances. See § 556.163 of
per kilogram) for 3 days (6 treatments). this chapter.
If no improvement, horse is non- (d) Conditions of use. Cattle—(1)
responder to clenbuterol and treatment Amount. One-quarter fluid ounce per 200
should be discontinued. pounds of body weight (7 milligrams
(ii) Indications for use. Indicated for per kilogram or 3.2 milligrams per
the management of horses affected pound of body weight).
with airway obstruction, such as oc- (2) Indications for use. For the treat-
curs in chronic obstructive pulmonary ment of immature and adult liver fluke
disease (COPD). (Fasciola hepatica) infestations in cat-
(iii) Limitations. Treat at effective tle.
dose for 30 days. At the end of the 30- (3) Limitations. Using dose syringe,
day treatment period, drug should be deposit drench over back of tongue. Do
withdrawn. If signs return, the 30-day not treat cattle within 8 days of
treatment period may be repeated. If slaughter. Because a withdrawal time

repeating treatment, the step-wise dos- in milk has not been established, do
180
not use in female dairy cattle of breed- to maintain the desired therapeutic ef-
ing age. Consult your veterinarian for fect.
assistance in the diagnosis, treatment, (ii) Indications for use. For the control
and control of parasitism. of feline allergic dermatitis in cats at
[50 FR 10221, Mar. 14, 1985, as amended at 62 least 6 months of age and weighing at
FR 63270, Nov. 28, 1997; 84 FR 32992, July 11, least 3 pounds.
2019; 84 FR 39183, Aug. 9, 2019] (iii) Limitations. Federal law restricts
§ 520.522 Cyclosporine. licensed veterinarian.
(a) Specifications. (1) Each
cyclosporine capsule, USP (MODIFIED)
FR 78815, Dec. 20, 2011; 84 FR 12493, Apr. 2,
contains 10, 25, 50, or 100 milligrams 2019; 86 FR 17063, Apr. 1, 2021; 88 FR 16547,
(mg) cyclosporine. Mar. 20, 2023]
(2) Each milliliter of cyclosporine
oral solution, USP (MODIFIED) con- § 520.530 Cythioate oral liquid.
tains 100 mg cyclosporine.
(b) Sponsors. See sponsors in (a) Specifications. Each milliliter con-
§ 510.600(c) of this chapter. tains 15 milligrams of cythioate.
(1) No. 058198 for use of products de- (b) Sponsor. See Nos. 054771 and 058198
scribed in paragraph (a) as in para- in § 510.600 of this chapter.
graph (d) of this section. (c) Conditions of use—(1) Amount. 15
(2) No. 017033 for use of product de- milligrams cythioate per 10 pounds of
scribed in paragraph (a)(1) as in para- body weight every third day or twice a
graph (d)(1) of this section. week.
(3) No. 051311 for use of product de- (2) Indications for use. Dogs, for con-
scribed in paragraph (a)(2) of this sec- trol of fleas.
tion as in paragraph (d)(1) of this sec- (3) Limitations. Federal law restricts
tion. this drug to use by or on the order of a
(c) [Reserved] licensed veterinarian.
(d) Conditions of use—(1) Dogs. Use
capsules described in paragraph (a)(1) [49 FR 5614, Feb. 14, 1984, as amended at 67
of this section as follow: FR 78355, Dec. 24, 2002; 79 FR 28819, May 20,
(i) Amount. Administer 5 mg per kilo- 2014; 86 FR 14818, Mar. 19, 2021; 87 FR 58961,
Sept. 29, 2022]
gram (mg/kg) of body weight given
orally as a single daily dose for 30 days. § 520.531 Cythioate tablets.
Following this initial daily treatment
period, the dosage may be tapered by (a) Specifications. Each tablet con-
decreasing the frequency of adminis- tains 30 or 90 milligrams (mg)
tration to every other day or two times cythioate.
a week, until a minimum frequency is (b) Sponsors. See sponsor numbers in
reached which will maintain the de- § 510.600(c) of this chapter as follows:
sired therapeutic effect. (1) No. 058198 for use of 30- and 90-mg
(ii) Indications for use. For the control tablets.
of atopic dermatitis in dogs weighing (2) No. 054771 for use of the 30-mg tab-
at least 4 pounds. let.
(iii) Limitations. Federal law restricts (c) Conditions of use—(1) Amount. 30
this drug to use by or on the order of a milligrams cythioate per 20 pounds of
licensed veterinarian. body weight every third day or twice a
(2) Cats. Use the solution described in
week.
paragraph (a)(2) of this section as fol-
(2) Indications for use. Dogs, for con-
low:
(i) Amount. Administer 7 mg/kg of trol of fleas.
body weight orally as a single daily (3) Limitations. Federal law restricts
dose for a minimum of 4 to 6 weeks or this drug to use by or on the order of a
until resolution of clinical signs. Fol- licensed veterinarian.
lowing this initial daily treatment pe- [49 FR 5615, Feb. 14, 1984, as amended at 59
riod, the dosage may be tapered by de- FR 26942, May 25, 1994; 67 FR 78355, Dec. 24,
creasing the frequency of administra- 2002; 79 FR 28819, May 20, 2014; 86 FR 14818,
tion to every other day or twice weekly Mar. 19, 2021]
181
§ 520.534 21 CFR Ch. I (4–1–23 Edition)
§ 520.534 Decoquinate. (3) Limitations. Federal law restricts

der contains 8 milligrams (0.8 percent)
decoquinate. [67 FR 68760, Nov. 13, 2002, as amended at 68
(b) Sponsor. See No. 054771 in FR 18882, Apr. 17, 2003; 72 FR 37437, July 10,
2007; 73 FR 33692, June 13, 2008; 77 FR 3928,
§ 510.600(c) of this chapter. Jan. 26, 2012; 84 FR 39183, Aug. 9, 2019; 86 FR
(c) Related tolerances. See § 556.170 of 61684, Nov. 8, 2021]
this chapter.
(d) Conditions of use. Calves—(1) § 520.540 Dexamethasone oral dosage
Amount. Feed 22.7 milligrams per 100 forms.
pounds of body weight (0.5 milligram
§ 520.540a Dexamethasone powder.
per kilogram) per day.
(2) Indications for use. For the preven- (a) Specifications. Each packet con-
tion of coccidiosis in ruminating and tains 10 milligrams (mg) of dexametha-
nonruminating calves, including veal sone.
calves, caused by Eimeria bovis and E. (b) Sponsor. See No. 000061 in
zuernii. § 510.600(c) of this chapter.
(3) Limitations. Feed in whole milk at (c) Conditions of use in cattle and
the rate of 22.7 milligrams per 100 horses—(1) Amount. Administer 5 to 10
mg per animal the first day then 5 mg
pounds body weight daily (0.5 milli-
per day as required by drench or by
gram per kilogram) for at least 28 days.
sprinkling on a small amount of feed.
[64 FR 10103, Mar. 2, 1999, as amended at 64 (2) Indications for use. As supportive
FR 30386, June 8, 1999; 79 FR 28819, May 20, therapy following parenteral steroid
2014] administration for management or in-
flammatory conditions such as acute
§ 520.538 Deracoxib. arthritic lameness, and for various
(a) Specifications. Each tablet con- stress conditions where corticosteroids
tains 12, 25, 50, 75, or 100 milligrams are required while the animal is being
(mg) deracoxib. treated for a specific condition.
(b) Sponsors. See Nos. 013744, 058198, (3) Limitations. Federal law restricts
and 086101 in § 510.600(c) of this chapter. this drug to use by or on the order of a
(c) Conditions of use in dogs—(1) licensed veterinarian. A withdrawal pe-
Amount. Administer orally as needed, riod has not been established for this
product in preruminating calves. Do
as a single daily dose based on body
not use in calves to be processed for
weight:
veal. Do not use in horses intended for
(i) 1 to 2 mg/kilogram (kg) (0.45 to human consumption.
0.91 mg/pound (lb)), for use as in para-
graph (d)(2)(i) of this section. [79 FR 28819, May 20, 2014]
(ii) 1 to 2 mg/kg (0.45 to 0.91 mg/lb) for
§ 520.540b Dexamethasone tablets and
3 days, for use as in paragraph (d)(2)(ii) boluses.
of this section.
(iii) 3 to 4 mg/kg (1.4 to 1.8 mg/lb) for (a)(1) Specifications. Each bolus is
up to 7 days, for use as in paragraph half-scored and contains 10 milligrams
(d)(2)(iii) of this section. of dexamethasone.
(2) Sponsor. See No. 000061 in
(2) Indications for use. (i) For the con-
trol of pain and inflammation associ-
(3) Conditions of use in cattle and
ated with osteoarthritis.
horses—(i) Amount. Administer orally 5
(ii) For the control of postoperative to 10 milligrams on the first day, then
pain and inflammation associated with 5 milligrams per day as required.
dental surgery. (ii) Indications for use. As supportive
(iii) For the control of postoperative therapy following parenteral steroid
pain and inflammation associated with administration for management or in-
orthopedic surgery. flammatory conditions such as acute
arthritic lameness, and for various

stress conditions where corticosteroids
182
are required while the animal is being § 520.563 Diatrizoate.

treated for a specific condition. (a) Specifications. Diatrizoate
(iii) Limitations. Federal law restricts meglumine oral solution is a water
this drug to use by or on the order of a soluble radiopaque medium containing
licensed veterinarian. A withdrawal pe- 66 percent diatrizoate meglumine and
riod has not been established for this 10 percent diatrizoate sodium.
product in preruminating calves. Do (b) Sponsor. See No. 054771 in
not use in calves to be processed for § 510.600(c) of this chapter.
veal. Do not use in horses intended for (c) Conditions of use in dogs and cats—
human consumption. (1) Amount. Administer orally 0.5 to 1.0
(b)(1) Specifications. Each tablet con- milliliter per pound of body weight by
tains 0.25 milligram of dexamethasone. gavage or stomach tube. Administered
(2) Sponsors. See Nos. 000061 and 061133 rectally 0.5 to 1.0 milliliter per pound
in § 510.600(c) of this chapter. of body weight diluted with 1 part of
(3) Conditions of use in dogs and cats— the drug to 5 parts of water.
(i) Amount. Dogs: Administer orally 0.25 (2) Indications for use. For radiog-
to 1.25 milligrams per day for up to 7 raphy of the gastrointestinal tract.
days. Cats: Administer orally 0.125 to (3) Limitations. Federal law restricts
0.5 milligrams per day for up to 7 days.
(ii) Indications for use. As an anti-in-
flammatory agent. [44 FR 12993, Mar. 9, 1979, as amended at 50
(iii) Limitations. Federal law restricts FR 41489, Oct. 11, 1985; 79 FR 28820, May 20,
2014]
licensed veterinarian. § 520.580 Dichlorophene and toluene.
[40 FR 26273, June 23, 1975, as amended at 44 (a) Specifications. Each capsule con-
FR 7130, Feb. 6, 1979; 50 FR 49372, Dec. 2, 1985; tains 50 milligrams (mg) of
52 FR 7832, Mar. 13, 1987; 55 FR 8461, Mar. 8, dichlorophene and 60 mg of toluene, or
1990; 66 FR 14073, Mar. 9, 2001; 68 FR 4914, Jan. multiples thereof.
31, 2003; 70 FR 16934, Apr. 4, 2005; 79 FR 28819, (b) Sponsors. See sponsors in
May 20, 2014; 84 FR 8972, Mar. 13, 2019] § 510.600(c) of this chapter for use as in
§ 520.540c Dexamethasone chewable
(1) Nos. 017135 and 023851 for use only
tablets.
as a single dose.
(a) Specifications. Each half-scored (2) Nos. 000061, 054771, and 069043 for
tablet contains 0.25 milligram of dexa- use in a single dose or divided-dosage
methasone. regimen.
(b) Sponsor. See No. 051031 in (c) Required statement. Consult your
§ 510.600(c) of this chapter. veterinarian for assistance in the diag-
(c) Conditions of use in dogs—(1) nosis, treatment, and control of para-
Amount. Administer by free-choice sitism, and before administering to
feeding or crumbled over food 0.25 to weak or debilitated animals.
1.25 milligrams daily in single or two (d) Conditions of use—(1) Amount. Ad-
divided doses until response is noted or minister as follows:
7 days have elapsed. When response is (i) Single dose: Administer 100 mg of
attained, dosage should be gradually dicholorophene and 120 mg of toluene
reduced by 0.125 milligram per day per pound of body weight.
until maintenance level is achieved. (ii) Divided dose: Administer 100 mg
of dichlorophene and 120 mg of toluene
(2) Indications for use. As supportive
per 5 pounds of body weight (20 and 24
therapy in nonspecific dermatosis and mg per pound) daily for 6 days.
inflammatory conditions. (2) Indications for use. For the re-
(3) Limitations. Federal law restricts moval of ascarids (Toxocara canis and
this drug to use by or on the order of a Toxascaris leonina) and hookworms
licensed veterinarian. (Ancylostoma caninum and Uncinaria
[44 FR 7130, Feb. 6, 1979, as amended at 56 FR stenocephala); and as an aid in remov-
50653, Oct. 8, 1991; 60 FR 55659, Nov. 2, 1995; 79 ing tapeworms (Taenia pisiformis,
FR 28820, May 20, 2014; 82 FR 11508, Feb. 24, Dipylidium caninum, and Echinococcus
2017] granulosus) from dogs and cats.
183
§ 520.581 21 CFR Ch. I (4–1–23 Edition)
(3) Limitations. Withhold solid foods (Taenia pisiformis and Dipylidium

and milk for at least 12 hours prior to caninum).
medication and for 4 hours afterward. (3) Limitations. Withhold solid foods
Repeat treatment in 2 to 4 weeks in and milk for at least 12 hours prior to
animals subject to reinfection. medication and for 4 hours afterward.
[45 FR 10332, Feb. 15, 1980] [45 FR 10333, Feb. 15, 1980]
EDITORIAL NOTE: For FEDERAL REGISTER ci-
tations affecting § 520.580, see the List of CFR § 520.596 Dichlorvos powder.
(a) Specifications—(1) Each 2-ounce
Finding Aids section of the printed volume
and at www.govinfo.gov. packet contains 2.27 grams (4 percent)
dichlorvos.
§ 520.581 Dichlorophene tablets. (2) Each milligram of powder con-
(a) Specifications. Each tablet contains 2.27 milligrams (mg) dichlorvos.
tains 1 gram of dichlorophene. (b) Sponsor. See No. 069043 in
(b) Sponsor. See 023851 in § 510.600(c) of § 510.600(c) of this chapter for use of the
this chapter. product described in paragraph (a)(1) of
(c) Required statement. Consult your this section as in paragraph (d)(1) of
veterinarian for assistance in the diag- this section and the product described
nosis, treatment, and control of para- in paragraph (a)(2) of this section as in
sitism, and before administering to paragraph (d)(2) of this section.
weak or debilitated animals. (c) Related tolerances. See § 556.180 of
(d) Conditions of use. Dogs—(1) this chapter.
Amount. Single dose of 1 tablet (1 gram (d) Conditions of use—(1) Swine (adult
of dichlorophene) for each 10 pounds of gilts, sows, and boars)—(i) Amount. Add
body weight. powder to the indicated amount of feed
(2) Indications for use. It is used as an and administered shortly after mixing,
aid in the removal of tapeworms as follows:
Pounds of feed to Pounds of mixed Number of pigs
be mixed with feed to be to be treated
Weight of animal in pounds each 0.08 administered to per 0.08
ounce of each pig as a ounce of
dichlorvos single treatment dichlorvos
20–30 ............................................................................................... 4 0.33 12

31–40 ............................................................................................... 5 0.56 9
41–60 ............................................................................................... 6 1.00 6
61–80 ............................................................................................... 5 1.00 5
81–100 ............................................................................................. 4 1.00 4
16 4.00 4
(ii) Indications for use. For the re- swine access to feed other than that
moval and control of sexually mature containing the preparation until treat-
(adult), sexually immature and/or 4th ment is complete. Do not treat pigs
stage larvae of the whipworm (Trichuris with signs of scours until these signs
suis), nodular worms (Oesophagostomum subside or are alleviated by proper
spp.), large round-worm (Ascaris suum), medication. Resume normal feeding
and the mature thick stomach worm schedule afterwards. Swine may be re-
(Ascarops strongylina) occurring in the treated in 4 to 5 weeks.
lumen of the gastrointestinal tract of (2) Horses—(i) Amount. Administer in
pigs, boars, and open or bred gilts and the grain portion of the ration at a dos-
sows. age of 14.2 to 18.5 mg per pound of body
(iii) Limitations. Do not use this prod- weight as a single dose. Administered
uct on animals either simultaneously at one-half of the single recommended
or within a few days before or after dosage and repeated 8 to 12 hours later
treatment with or exposure to cholin- in the treatment of very aged, emaci-
esterase inhibiting drugs, pesticides, or ated, or debilitated subjects or those
chemicals. The preparation should be reluctant to consume medicated feed.
mixed thoroughly with the feed on a In suspected cases of severe ascarid in-
clean, impervious surface. Do not allow fection sufficient to cause concern over
184
mechanical blockage of the intestinal (Ancylostoma caninum and Uncinaria

tract, the split dosage should be used. stenocephala).
(ii) Indications for use. For the re- (ii) Cats and kittens: Removal and
moval and control of bots (Gastrophilus control of intestinal roundworms
intestinalis, G. nasalis), large strongyles (Toxocara cati and Toxascaris leonina)
(Strongylus vulgaris, S. equinus, S. and hookworms (Ancylostoma
edentatus), small strongyles (of the gen- tubaeforme and Uncinaria stenocephala).
era Cyathostomum, Cylicocercus, (3) Limitations. Federal law restricts
Cylicocyclus, Cylicodontophorus, this drug to use by or on the order of a
Triodontophorus, Poteriostomum, licensed veterinarian.
Gyalocephalus), pinworms (Oxyuris [83 FR 48945, Sept. 28, 2018]
equi), and large roundworm (Parascaris
equorum) in horses including ponies and § 520.600 Dichlorvos capsules and pel-
mules. Not for use in foals (sucklings lets.
and young weanlings). (a) Specifications. Each capsule con-
(iii) Limitations. Do not use in horses tains 2.27 milligrams (mg) (4 percent)
which are severely debilitated, suf- dichlorvos.
fering from diarrhea or severe con- (b) Sponsor. See No. 069043 in
stipation, infectious disease, toxemia, § 510.600(c) of this chapter.
or colic. Do not administer in conjunc- (c) Conditions of use in dogs—(1)
tion with or within 1 week of adminis- Amount. Administer any combination
tration of muscle relaxant drugs, of capsules and/or pellets so that the
phenothiazine derived tranquilizers or animal receives a single dose equaling
central nervous system depressant 12 to 15 mg of dichlorvos per pound of
drugs. Horses should not be subjected body weight.
to insecticide treatment for 5 days (2) Indications for use. For removal of
prior to or after treating with the drug. Toxocara canis and Toxascaris leonina
Do not administer to horses afflicted (roundworms), Ancylostoma caninum
with chronic alveolar emphysema and Uncinaria stenocephala
(heaves) or related respiratory condi- (hookworms), and Trichuris vulpis
tions. The product is a cholinesterase (whipworm) residing in the lumen of
inhibitor and should not be used simul- the gastrointestinal tract.
taneously or within a few days before (3) Limitations. Federal law restricts
or after treatment with or exposure to this drug to use by or on the order of a
cholinesterase inhibiting drugs, pes- licensed veterinarian.
ticides or chemicals. Do not use in ani-
mals other than horses, ponies, and [83 FR 48945, Sept. 28, 2018]
mules. Do not use in horses, ponies,
§ 520.602 Dichlorvos gel.
and mules intended for food purposes.
Do not allow fowl access to feed con- (a) Specifications. Each milligram
taining this preparation or to fecal ex- (mg) of gel contains 2.27 milligrams
crement from treated animals. (mg) dichlorvos.
[83 FR 48944, Sept. 28, 2018] § 510.600(c) of this chapter.
§ 520.598 Dichlorvos tablets.
Amount. Administer 20 mg per kilo-
(a) Specifications. Each tablet con- gram of body weight for the removal of
tains 2, 5, 10, or 20 milligrams (mg) bots and ascarids. Repeat administra-
dichlorvos. tion every 21 to 28 days for the control
(b) Sponsor. See No. 069043 in of bots and ascarids. For the control of
§ 510.600(c) of this chapter. bots only, the repeat dosage is 10 milli-
(c) Conditions of use in dogs, puppies, grams per kilogram of body weight
cats, and kittens—(1) Amount. Admin- every 21 to 28 days during bot fly sea-
ister orally at 5 mg dichlorvos per son.
pound of body weight. (2) Indications for use. For the re-
(2) Indications for use—(i) Dogs and moval and control of first, second, and
puppies: Removal and control of intes- third instar bots (Gastrophilus
tinal roundworms (Toxocara canis and intestinalis and G. nasalis), sexually ma-
Toxascaris leonina) and hookworms ture and sexually immature (4th stage)
185
§ 520.606 21 CFR Ch. I (4–1–23 Edition)
ascarids (Parascaris equorum) in horses § 520.620 Diethylcarbamazine oral dos-

and foals. age forms.
(3) Limitations. Do not use in horses
intended for human consumption. Fed- § 520.622 Diethylcarbamazine citrate
eral law restricts this drug to use by or oral dosage forms.
§ 520.622a Diethylcarbamazine citrate
[83 FR 48945, Sept. 28, 2018] tablets.
§ 520.606 Diclazuril. (a) Sponsors. (1) [Reserved]
(a) Specifications. Each 100 grams (g) (2) See 054771 in § 510.600(c) of this
of pellets contain 1.56 g diclazuril. chapter for use of 100, 200, and 300 milli-
(b) Sponsor. See No. 000061 in gram tablets for prevention of heart-
§ 510.600(c) of this chapter. worm disease in dogs and as an aid in
(c) Conditions of use in horses—(1) the treatment of ascarid infections in
Amount. Administer 1 milligram (mg) dogs.
per kilogram (0.45 mg per pound) of (3) See 061133 in § 510.600(c) of this
body weight in the daily grain ration chapter for use of 50, 100, 200, 300, or 400
for 28 days. milligram tablets for prevention of
(2) Indications for use. For the treat- heartworm disease in dogs, as an aid in
ment of equine protozoal the control of ascarid infections in
myeloencephalitis (EPM) caused by dogs, and as an aid in the treatment of
Sarcocystis neurona. ascarid infections in dogs and cats.
(3) Limitations. Do not use in horses (4) [Reserved]
intended for human consumption. Fed- (5) See No. 000061 in § 510.600(c) of this
eral law restricts this drug to use by or chapter for use of 60, 120, or 180 milli-
on the order of a licensed veterinarian. gram tablets for prevention of heart-
[72 FR 20943, Apr. 27, 2007] worm disease in dogs, as an aid in the
control of ascarid infections in dogs,
§ 520.608 Dicloxacillin. and as an aid in the treatment of asca-
(a) Specifications. Each capsule con- rid infections in dogs and cats.
tains dicloxacillin sodium (6) See No. 069043 in § 510.600(c) of this
monohydrate equivalent to 50, 100, 200, chapter for use of 50, 100, 200, 300, or 400
or 500 milligrams of dicloxacillin. milligram tablets for prevention of
(b) Sponsor. See No. 054771 in § 510.600 heartworm disease in dogs, as an aid in
(c) of this chapter. the control of ascarid infections in
(c) Conditions of use in dogs—(1) dogs, and as an aid in the treatment of
Amount. Administer orally 5 to 10 milli- ascarid infections in dogs and cats.
grams per pound of body weight, three (b) Conditions of use—(1) Dosage/indi-
times daily. In severe cases, up to 25 cations for use. (i) Three milligrams per
milligrams per pound of body weight pound of body weight daily for preven-
three times daily. tion of heartworm disease (Dirofilaria
(2) Indications for use. For the treat- immitis) in dogs.
ment of pyoderma (pyogenic derma- (ii) Three milligrams per pound of
titis) due to penicillinase-producing body weight daily as an aid in the con-
staphylococci sensitive to trol of ascarid infections (Toxocara
dicloxacillin. canis) in dogs.
(3) Limitations. Federal law restricts (iii) Twenty-five to 50 milligrams per
this drug to use by or on the order of a pound of body weight as an aid in the
licensed veterinarian. treatment of ascarid infections in dogs
[57 FR 37325, Aug. 18, 1992, as amended at 79 (Toxocara canis) and cats (Toxocara
FR 28820, May 20, 2014] canis and Toxascaris leonina).
186
Food and Drug Administration, HHS § 520.622c
(2) Limitations. Federal law restricts (3) Conditions of use. (i) The drug is
this drug to use by or on the order of a used in dogs between 4 weeks and 8
licensed veterinarian. months of age for the removal of
ascarids (Toxacara canis) and in ani-
mals over 4 weeks of age for the pre-
FR 41038, Aug. 14, 1981; 46 FR 46315, Sept. 18,
1981; 46 FR 61653, Dec. 18, 1981; 47 FR 10805, vention of heartworm disease
Mar. 12, 1982; 47 FR 14150, Apr. 2, 1982; 50 FR (Dirofilaria immitis).
41489, Oct. 11, 1985; 50 FR 49372, Dec. 2, 1985; (ii) The drug is administered (a) for
53 FR 40056, Oct. 13, 1988; 53 FR 40727, Oct. 18, removal of ascarids at a dosage of 50
1988; 55 FR 8461, Mar. 8, 1990; 61 FR 34728, milligrams per pound of body weight
July 3, 1996; 62 FR 35076, June 30, 1997; 66 FR divided into two equal doses and ad-
14073, Mar. 9, 2001; 68 FR 4914, Jan. 31, 2003; 76 ministered 8 to 12 hours apart (morning
FR 17777, Mar. 31, 2011; 77 FR 4896, Feb. 1, and night), orally or mixed with either
2012; 78 FR 21059, Apr. 7, 2013; 79 FR 28820,
dry or wet food, and (b) for prevention
May 20, 2014; 83 FR 48945, Sept. 28, 2018; 84 FR
8972, Mar. 13, 2019] of heartworm disease at a dosage of 3
milligrams per pound of body weight
§ 520.622b Diethylcarbamazine citrate daily, orally or in food, in heartworm
syrup. endemic areas, from the beginning of
mosquito activity, during the mosquito
(a)(1) Specifications. Each milliliter of season, and for 2 months following the
syrup contains 60 milligrams of end thereof.
diethylcarbamazine citrate. (iii) Dogs older than 8 months of age
(2) Sponsor. See No. 054771 in may be infected with Dirofilaria immitis.
§ 510.600(c) of this chapter. Use of the drug is contraindicated in
(3) Conditions of use. (i) The drug is dogs with active D. immitis infections.
indicated for use in dogs for the pre- (iv) Federal law restricts this drug to
vention of infection with Dirofilaria use by or on the order of a licensed vet-
immitis and T. canis and T. leonina. It is erinarian.
also indicated for treatment of ascarid
infections of T. canis and T. leonina in FR 28265, July 9, 1976; 44 FR 3967, Jan. 19,
dogs and T. cati in cats. 1979; 47 FR 14150, Apr. 2, 1982; 47 FR 35186,
(ii) For prevention of heartworm and Aug. 13, 1982; 49 FR 33997, Aug. 28, 1984; 50 FR
ascarid infections in dogs, the drug 41489, Oct. 11, 1985; 53 FR 47027, Oct. 18, 1988;
may be added to the daily diet at a dos- 61 FR 34728, July 3, 1996; 62 FR 35076, June 30,
age rate of 3.0 milligrams per pound of 1997; 62 FR 38906, July 21, 1997; 77 FR 4897,
body weight per day or given directly Feb. 1, 2012; 78 FR 21059, Apr. 9, 2013; 79 FR
28820, May 20, 2014; 83 FR 48945, Sept. 28, 2018]
by mouth at the same dosage rate. For
treatment of ascarid infections in dogs § 520.622c Diethylcarbamazine citrate
and cats, the drug is administered at a chewable tablets.
dosage level of 25 to 50 milligrams per
(a) Specifications. Each chewable tab-
pound of body weight preferably ad-
let contains 30, 45, 60, 120, 150, or 180
ministered immediately after feeding.
milligrams of diethylcarbamazine cit-
(iii) Older dogs should be proven neg- rate.
ative for the presence of Dirofilaria (b) Sponsors. See drug listing nos. in
immitis infection before administration § 510.600(c) of this chapter for identi-
of the drug. Those with proven infec- fication of sponsors as follows:
tion of Dirofilaria immitis should be ren- (1) [Reserved]
dered negative using adulticidal and (2) For 054771, use of 60, 120, or 180
microfilaricidal drugs before adminis- milligram tablets as in paragraph
tration of this drug. (c)(2)(ii) of this section.
(iv) Federal law restricts this drug to (3) For 061690, use of 45 or 150 milli-
use by or on the order of a licensed vet- gram tablets as in paragraph (c)(2)(iii)
erinarian. of this section.
(b) [Reserved] (4) For 061133, use of 60-, 120-, or 180-
(c)(1) Specifications. Each milliliter of milligram tablets as in paragraph
syrup contains 60 milligrams of (c)(2)(i) of this section.
diethylcarbamazine citrate. (5) For 000061, use of 60-milligram
(2) Sponsor. See No. 069043 in tablets as in paragraph (c)(2)(i) of this

§ 510.600(c) of this chapter. section.
187
§ 520.623 21 CFR Ch. I (4–1–23 Edition)
(6) For 069043, use of 30, 60, 120, or 180 immature stages of intestinal Toxocara
milligram tablets as in paragraph canis (ascarid infection).
(c)(2)(i) of this section. (3) Limitations. Federal law restricts
(c) Conditions of use—(1) Amount. 3 this drug to use by or on the order of a
milligrams per pound of body weight licensed veterinarian.
per day for prevention of heartworm
disease and control of ascarids; 25 to 50 [50 FR 28768, July 16, 1985, as amended at 53
FR 45759, Nov. 14, 1988; 54 FR 3776, Jan. 26,
milligrams per pound of body weight as
1989; 54 FR 6804, Feb. 14, 1989; 56 FR 50653,
an aid in treatment of ascarid infec- Oct. 8, 1991; 60 FR 55659, Nov. 2, 1995; 79 FR
tions. 28820, May 20, 2014]
(2) Indications for use. (i) For preven-
tion of heartworm disease (Dirofilaria § 520.645 Difloxacin.
immitis) in dogs; as an aid in control of
ascarids (Toxocara canis) in dogs; as an (a) Specifications. Each tablet con-
aid in treatment of ascarid (Toxocara tains 11.4, 45.4, or 136 milligrams (mg)
canis and Toxascaris leonina) infections of difloxacin hydrochloride.
in dogs and cats. (b) Sponsor. See No. 000010 in
(ii) For prevention of infection with § 510.600(c) of this chapter.
Dirofilaria immitis (heartworm disease) (c) [Reserved]
in dogs; as an aid in treatment of asca- (d) Conditions of use—(i) Amount. Ad-
rid (Toxocara canis and Toxascaris minister 5 to 10 mg per kilogram (2.3 to
leonina) infections in dogs. 4.6 mg per pound) of body weight orally
(iii) For prevention of heartworm dis- once a day for 2 to 3 days beyond ces-
ease (Dirofilaria immitis) in dogs. sation of clinical signs of disease up to
(3) Limitations. Federal law restricts a maximum of 30 days.
this drug to use by or on the order of a (ii) Indications for use. For manage-
licensed veterinarian. ment of diseases in dogs associated
[43 FR 6941, Feb. 17, 1978] with bacteria susceptible to difloxacin.
(iii) Limitations. Federal law prohibits
EDITORIAL NOTE: For FEDERAL REGISTER ci- the extra-label use of this drug in food-
tations affecting § 520.622c, see the List of
CFR Sections Affected, which appears in the
producing animals. Federal law re-
Finding Aids section of the printed volume stricts this drug to use by or on the
and at www.govinfo.gov. order of a licensed veterinarian.
(2) [Reserved]
§ 520.623 Diethylcarbamazine and
oxibendazole chewable tablets. [63 FR 8123, Feb. 18, 1998, as amended at 75
FR 10165, Mar. 5, 2010]
tains either 60, 120, or 180 milligrams of § 520.666 Dirlotapide.
diethylcarbamazine citrate with 45, 91,
or 136 milligrams of oxibendazole, re- (a) Specifications. Each milliliter
spectively. (mL) of solution contains 5 milligrams
(mg) dirlotapide.
§ 510.600(c) of this chapter. (b) Sponsor. See No. 054771 in
(c) Conditions of use in dogs—(1) § 510.600(c) of this chapter.
Amount. Administer orally to dogs at a (c) Conditions of use in dogs—(1)
dosage level of 6.6 milligrams of Amount. The initial dosage is 0.01 mL/
diethylcarbamazine citrate per kilo- kg (0.0045 mL/lb) body weight for the
gram of body weight (3 milligrams per first 14 days. After the first 14 days of
pound of body weight) and 5.0 milli- treatment, the dose volume is doubled
grams of oxibendazole per kilogram of to 0.02 mL/kg (0.009 mL/lb) body weight
body weight (2.27 milligrams per pound for the next 14 days (days 15 to 28 of
of body weight). treatment). Dogs should be weighed
(2) Indications for use. For prevention monthly and the dose volume adjusted
of infection with Dirofilaria immitis every month, as necessary, to maintain
(heartworm disease) and Ancylostoma a target percent weight loss until the
caninum (hookworm infection) and for desired weight is achieved.
removal and control of Trichuris vulpis (2) Indications for use. For the man-
(whipworm infection) and mature and agement of obesity.
188
(3) Limitations. Federal law restricts (iii) For Strongyloides (Strongyloides

this drug to use by or on the order of a canis, Strongyloides stercoralis): 10 mg/lb
licensed veterinarian. of body weight for 10 to 12 days;
[72 FR 263, Jan. 4, 2007, as amended at 79 FR (iv) For heartworm microfilariae
28820, May 20, 2014] (Dirofilaria immitus): 3 to 5 mg/lb of
body weight for 7 to 10 days. Treatment
§ 520.763 Dithiazanine oral dosage for heartworm microfilariae should fol-
forms. low 6 weeks after therapy for adult
worms.
§ 520.763a Dithiazanine tablets. (2) Limitations. Federal law restricts
(a) Specifications. Each tablet con- this drug to use by or on the order of a
tains 10, 50, 100, or 200 milligrams (mg) licensed veterinarian.
dithiazanine iodide.
(b) Sponsor. See No. 069043 in [79 FR 28820, May 20, 2014, as amended at 83
FR 48945, Sept. 28, 2018]
(c) Conditions of use in dogs—(1) Indi- § 520.763c Dithiazanine iodide and pi-
cations for use and amount. Administer perazine citrate suspension.
orally immediately after feeding as fol-
lows: (a) Specifications. Each milliliter of
(i) For large roundworms (Toxocara suspension contains 69 milligrams (mg)
canis, Toxascaris leonina): 10 mg per dithiazanine iodide and 83 mg piper-
pound (/lb) of body weight for 3 to 5 azine base (as piperazine citrate).
days; (b) Sponsor. See No. 069043 in
(ii) For hookworms (Ancylostoma § 510.600(c) of this chapter.
caninum, Uncinaria stenocephala) and (c) Conditions of use in horses—(1)
whipworms (Trichuris vulpis): 10 mg/lb Amount. 1 ounce (30 milliliters) per 100
of body weight for 7 days; pounds of body weight for the first 500
(iii) For Strongyloides (Strongyloides pounds; 3⁄4 ounce for each 100 pounds
canis, Strongyloides stercoralis): 10 mg/lb thereafter, up to 1,200 pounds; 101⁄4
of body weight for 10 to 12 days; ounces to animals over 1,200 pounds.
(iv) For heartworm microfilariae (2) Indications for use. For control of
(Dirofilaria immitus): 3 to 5 mg/lb of large roundworms, Parascaris equorum;
body weight for 7 to 10 days. Treatment small strongyles; large strongyles,
for heartworm microfilariae should fol- Strongylus vulgaris; and pinworms,
low 6 weeks after therapy for adult Oxyuris equi.
worms. (3) Limitations. Administer by drench
(2) Limitations. Federal law restricts or mixed with the daily ration as a sin-
this drug to use by or on the order of a gle dose. Treatment is recommended in
licensed veterinarian. spring and fall. In a heavily infested
[79 FR 28820, May 20, 2014, as amended at 83 environment, treatment may be re-
FR 48945, Sept. 28, 2018] peated every 30 days. Not for use in
horses intended for food purposes. Se-
§ 520.763b Dithiazanine powder. verely debilitated animals should not
(a) Specifications. Each tablespoon of be wormed except on the advice of a
powder contains 200 milligrams (mg) veterinarian. If the drug is for adminis-
dithiazanine iodide. tration by stomach tube, it shall be la-
(b) Sponsor. See No. 069043 in beled: ‘‘Federal law restricts this drug
§ 510.600(c) of this chapter. to use by or on the order of a licensed
(c) Conditions of use in dogs—(1) Indi- veterinarian.’’
cations for use and amount. Administer [47 FR 52696, Nov. 23, 1982, as amended at 48
orally by mixing in food as follows: FR 32342, July 15, 1983; 53 FR 40727, Oct. 18,
(i) For large roundworms (Toxocara 1988; 62 FR 35076, June 30, 1997; 78 FR 21059,
canis, Toxascaris leonina): 10 mg per Apr. 9, 2013; 79 FR 28820, May 20, 2014; 83 FR
pound (/lb) of body weight for 3 to 5 48945, Sept. 28, 2018]
days;
(ii) For hookworms (Ancylostoma § 520.766 Domperidone.
caninum, Uncinaria stenocephala) and (a) Specifications. Each milliliter of
whipworms (Trichuris vulpis): 10 mg/lb gel contains 110 milligrams (mg)

of body weight for 7 days; domperidone.
189
§ 520.784 21 CFR Ch. I (4–1–23 Edition)
(b) Sponsor. See No. 043264 in § 510.600 (3) Limitations. Federal law restricts
of this chapter. this drug to use by or on the order of a
(c) Conditions of use in horses—(1) licensed veterinarian.
Amount. Administer 0.5 mg per pound
(mg/lb) (1.1 mg/kilogram (kg)) by FR 34278, June 16, 2015; 84 FR 39183, Aug. 9,
mouth once daily starting 10 to 15 days 2019]
prior to the expected foaling date.
Treatment may be continued for up to § 520.812 Enrofloxacin.
5 days after foaling if mares are not
(a) Specifications. (1) Each tablet con-
producing adequate milk.
tains:
(2) Indications for use. For prevention
of fescue toxicosis in periparturient (i) 22.7, 68.0, or 136.0 milligrams (mg)
mares. enrofloxacin; or
(3) Limitations. Do not use in horses (ii) 22.7, 68.0, 136.0, or 272 mg
intended for human consumption. Fed- enrofloxacin.
eral law restricts this drug to use by or (2) Each chewable tablet contains
on the order of a licensed veterinarian. 22.7, 68.0, or 136.0 mg enrofloxacin.
(3) Each soft chewable tablet con-
[75 FR 67031, Nov. 1, 2010] tains 22.7, 68.0, or 136.0 mg enrofloxacin.
(b) Sponsors. See sponsor numbers in
§ 520.784 Doxylamine.
§ 510.600(c) of this chapter for use as in
(a) Specifications. The drug is in tab- paragraph (c) of this section.
let form and contains doxylamine suc- (1) No. 058198 for use of products de-
cinate as the active drug ingredient. scribed in paragraph (a) of this section.
(b) Sponsor. See No. 000061 in (2) No. 017033 for use of product de-
§ 510.600(c) of this chapter. scribed in paragraph (a)(1)(i) of this
(c) Conditions of use—(1) Amount. section.
Horses: Administer orally 1 to 2 milli- (3) Nos. 055529 and 086101 for use of
grams (mg) per pound (/lb) of body product described in paragraph (a)(2) of
weight per day divided into 3 or 4 equal this section.
doses. Dogs and cats: Administer orally
(4) No. 086101 for use of product de-
2 to 3 mg/lb of body weight per day di-
scribed in paragraph (a)(2) of this sec-
vided into 3 or 4 equal doses.
tion.
(2) Indications for use. For use when
antihistaminic therapy may be ex-
(1) Amount. Administer orally as a sin-
pected to alleviate some signs of dis-
gle, daily dose or divided into two
ease in horses, dogs, and cats.
(3) Limitations. Do not use in horses equal doses at 12-hour intervals.
intended for human consumption. Fed- (i) Dogs. 5 to 20 mg per kilogram (/kg)
eral law restricts this drug to use by or (2.27 to 9.07 mg per pound (/lb)) of body
on the order of a licensed veterinarian. weight.
(ii) Cats. 5 mg/kg (2.27 mg/lb) of body
[40 FR 13838, Mar. 27, 1975, as amended at 42 weight.
FR 60140, Nov. 25, 1977; 46 FR 48642, Oct. 2, (2) Indications for use. For the man-
1981; 61 FR 8873, Mar. 6, 1996; 62 FR 61624,
Nov. 19, 1997; 79 FR 28821, May 20, 2014]
agement of diseases associated with
bacteria susceptible to enrofloxacin.
§ 520.804 Enalapril. (3) Limitations. Federal law restricts
(a) Specifications. Each tablet con- this drug to use by or on the order of a
tains 1.0, 2.5, 5.0, 10, or 20 milligrams licensed veterinarian. Federal law pro-
(mg) of enalapril maleate. hibits the extralabel use of this drug in
(b) Sponsor. See No. 000010 in food-producing animals.
§ 510.600(c) of this chapter. [78 FR 30197, May 22, 2013, as amended at 78
(c) Conditions of use in dogs—(1) FR 52853, Aug. 27, 2013; 84 FR 8972, Mar. 13,
Amount. Administer orally 0.5 to 1.0 mg 2019; 84 FR 53310, Oct. 7, 2019; 86 FR 13184,
of enalapril maleate per kilogram of Mar. 8, 2021; 87 FR 58961, Sept. 29, 2022]
body weight per day.
(2) Indications for use. For the treat- § 520.816 Epsiprantel.
ment of mild, moderate, and severe (a) Specifications. Each tablet con-
(modified New York Heart Association tains either 12.5, 25, 50, or 100 milli-
Class II, III, IV) heart failure in dogs. grams of epsiprantel.
190
(b) Sponsor. See No. 054771 in stricts this drug to use by or on the
§ 510.600(c) of this chapter. order of a licensed veterinarian.
(c) Conditions of use—(1) Dogs—(i) (3) Growing turkeys—(i) Amount. Ad-
Amount. 2.5 milligrams per pound of minister 0.500 gram per gallon for 7
body weight. days.
(ii) Indications for use. Removal of ca- (ii) Indications for use. As an aid in
nine cestodes Dipylidium caninum and the control of blue comb (nonspecific
Taenia pisiformis. infectious enteritis) caused by orga-
(2) Cats—(i) Amount. 1.25 milligrams nisms susceptible to erythromycin.
per pound of body weight. (iii) Limitations. Do not use in tur-
(ii) Indications for use. Removal of fe- keys producing eggs for human con-
line cestodes D. caninum and T. sumption. Withdraw 1 day before
taeniaeformis.
slaughter. Federal law restricts this
FR 56798, Aug. 26, 1980; 66 FR 14073, Mar. 9,
FR 50653, Oct. 8, 1991; 60 FR 55659, Nov. 2,
1995; 79 FR 28821, May 20, 2014; 83 FR 64740, 2001; 68 FR 4914, Jan. 31, 2003; 79 FR 28821,
Dec. 18, 2018] May 20, 2014; 81 FR 17607, Mar. 30, 2016; 81 FR
94989, Dec. 27, 2016; 84 FR 8972, Mar. 13, 2019]
§ 520.823 Erythromycin.
§ 520.852 Estriol.
der contains erythromycin phosphate (a) Specifications. Each tablet con-
equivalent to 0.89 gram of erythro- tains 1 milligram (mg) estriol.
mycin master standard. (b) Sponsor. See No. 000061 in
§ 510.600(c) of this chapter. (c) Conditions of use in dogs—(1)
(c) Related tolerances. See § 556.230 of Amount. Administer at an initial dose
this chapter. of 2 mg per dog per day. The dosage
(d) Conditions of use. It is used in may be titrated to as low as 0.5 mg per
drinking water as follows: dog every second day, depending on re-
(1) Broiler and replacement chickens— sponse.
(i) Amount. Administer 0.500 gram per (2) Indications for use. For the control
gallon for 5 days. of estrogen-responsive urinary inconti-
(ii) Indications for use. As an aid in nence in ovariohysterectomized female
the control of chronic respiratory dis- dogs.
ease due to Mycoplasma gallisepticum (3) Limitations. Federal law restricts
susceptible to erythromycin. this drug to use by or on the order of a
(iii) Limitations. Do not use in re- licensed veterinarian.
placement pullets over 16 weeks of age.
Do not use in chickens producing eggs [76 FR 78150, Dec. 16, 2011]
for human consumption. Withdraw 1
day before slaughter. Federal law re- § 520.863 Ethylisobutrazine.
stricts this drug to use by or on the (a) Specifications. Each tablet con-
order of a licensed veterinarian. tains either 10 milligrams or 50 milli-
(2) Replacement chickens and chicken grams of ethylisobutrazine hydro-
breeders—(i) Amount. Administer 0.500 chloride.
gram per gallon for 7 days. (b) Sponsor. See No. 000061 in
(ii) Indications for use. As an aid in § 510.600(c) of this chapter.
the control of infectious coryza due to (c) Conditions of use in dogs—(1)
Haemophilus gallinarum susceptible to
Amount. Administer orally 2 to 5 milli-
erythromycin.
grams per pound of body weight once
(iii) Limitations. Do not use in re-
daily.
placement pullets over 16 weeks of age.
Do not use in chickens producing eggs (2) Indications for use. As a tranquil-
for human consumption. Withdraw 1 izer.

day before slaughter. Federal law re-
191
§ 520.870 21 CFR Ch. I (4–1–23 Edition)
(3) Limitations. Federal law restricts the diagnosis, treatment, and control
this drug to use by or on the order of a of parasitism.
licensed veterinarian. [79 FR 28821, May 20, 2014, as amended at 86
[40 FR 13838, Mar. 27, 1975, as amended at 46 FR 14818, Mar. 19, 2021]
FR 48642, Oct. 2, 1981; 61 FR 8873, Mar. 6, 1996;
62 FR 61624, Nov. 19, 1997; 79 FR 28821, May 20, § 520.903b Febantel suspension.
2014] (a) Specifications. Each ounce of sus-
pension contains 2.75 grams (9.3 percent
§ 520.870 Etodolac. ounce) febantel.
(a) Specifications. Each tablet con- (b) Sponsor. See No. 058198 in
tains 150, 300, or 500 milligrams (mg) of § 510.600(c) of this chapter.
etodolac. (c) Conditions of use in horses—(1)
(b) Sponsor. See No. 000010 in Amount. 3 milliliters per 100 pounds
§ 510.600(c) of this chapter. body weight or 1 fluid ounce per 1000
pounds (6 milligrams per kilogram
body weight). Administer by stomach
Amount. Administer 10 to 15 mg per
tube or drench, or by mixing well into
kilogram (4.5 to 6.8 mg per pound) of a portion of the normal grain ration.
body weight per day orally. For animals maintained on premises
(2) Indications for use. For the man- where reinfection is likely to occur, re-
agement of pain and inflammation as- treatment may be necessary. For most
sociated with osteoarthritis. effective results, retreat in 6 to 8
(3) Limitations. Federal law restricts weeks.
this drug to use by or on the order of a (2) Indications for use. For removal of
licensed veterinarian. ascarids (Parascaris equorum—adult and
sexually immature), pinworms (Oxyuris
FR 51705, Aug. 28, 2003; 75 FR 10166, Mar. 5, equi—adult and 4th stage larvae), large
2010; 79 FR 28821, May 20, 2014] strongyles (Strongylus vulgaris, S.
edentatus, S. equinus), and various
§ 520.903 Febantel oral dosage forms. small strongyles in horses, breeding
stallions and mares, pregnant mares,
§ 520.903a Febantel paste. foals, and ponies.
(a) Specifications. Each gram of paste
intended for human consumption. Fed-
contains 455 milligrams (45.5 percent)
febantel.
(b) Sponsor. See No. 058198 in (d) Special considerations. Febantel
§ 510.600(c) of this chapter. suspension may be used in combination
(c) Conditions of use in horses—(1) with trichlorfon oral liquid in accord-
Amount. Administer paste orally at 6 ance with the provisions of § 520.2520c,
milligrams per kilogram (2.73 milli- this section, and the following condi-
grams per pound) of body weight on the tions:
base of the tongue or well mixed into a (1) Combine 1 part febantel suspen-
portion of the normal grain ration. For sion with 5 parts trichlorfon liquid.
animals maintained on premises where (2) Allow animal to consume a por-
reinfection is likely to occur, retreat- tion of daily grain ration; administer
ment may be necessary. For most ef- mixture by stomach tube at rate of 18
fective results, retreat in 6 to 8 weeks. milliliters per 100 pounds of body
(2) Indications for use. For removal of weight.
large strongyles (Strongylus vulgaris, S. [45 FR 8587, Feb. 8, 1980, as amended at 79 FR
edentatus, S. equinus); ascarids 28821, May 20, 2014; 86 FR 14818, Mar. 19, 2021]
(Parascaris equorum—sexually mature
and immature); pinworms (Oxyuris § 520.903c Febantel and praziquantel
equi—adult and 4th stage larva); and paste.
various small strongyles in horses, (a) Specifications. Each gram of paste
foals, and ponies. contains 34 milligrams of febantel and
(3) Limitations. Do not use in horses 3.4 milligrams of praziquantel.
intended for human consumption. Con- (b) Sponsor. See No. 058198 in
sult your veterinarian for assistance in § 510.600(c) of this chapter.
192
(c) Conditions of use—(1) Amount—(i) (ii) For removal of hookworms

Dogs and cats (over 6 months of age): 10 (Ancylostoma tubaeforme) and ascarids
milligrams of febantel and 1 milligram (Toxocara cati) in cats and kittens.
of praziquantel per kilogram of body (3) Limitations. Federal law restricts
weight (1 gram of paste per 7.5 pounds this drug to use by or on the order of a
body weight) administered by mouth or licensed veterinarian.
in the food once daily for 3 days.
[56 FR 50655, Oct. 8, 1991, as amended at 79 FR
(ii) Puppies and kittens (less than 6 28821, May 20, 2014. Redesignated at 85 FR
months of age): 15 milligrams of 18119, Apr. 1, 2020, as amended at 86 FR 14818,
febantel and 1.5 milligrams of Mar. 19, 2021]
praziquantel per kilogram of body
weight (1 gram of paste per 5 pounds § 520.905 Fenbendazole oral dosage
body weight) administered by mouth forms.
on a full stomach once daily for 3 days.
§ 520.905a Fenbendazole suspension.
(2) Indications for use. (i) Dogs and
puppies: For removal of hookworms (a) Specifications. Each milliliter of
(Ancylostoma caninum and Uncinaria suspension contains 100 milligrams
stenocephala), whipworms (Trichuris (mg) fenbendazole for use as in para-
vulpis), ascarids (Toxocara canis and graphs (e)(1), (2), (3), and (4) of this sec-
Toxascaris leonina), and tapeworms tion; or 200 mg fenbendazole for use as
(Dipylidium caninum and Taenia in paragraphs (e)(5) and (6) of this sec-
pisiformis). tion.
(ii) Cats and kittens: For removal of (b) Sponsor. See No. 000061 in
hookworms (Ancylostoma tubaeforme), § 510.600(c) of this chapter.
ascarids (Toxocara cati) and tapeworms (c) Related tolerances. See § 556.275 of
(Dipylidium caninum and Taenia this chapter.
taeniaeformis). (d) Special considerations. (1) See
(3) Limitations. Federal law restricts § 500.25 of this chapter.
this drug to use by or on the order of a (2) Fenbendazole suspension 10 per-
licensed veterinarian. cent and approved forms of trichlorfon,
when used concomitantly for treating
[50 FR 19167, May 7, 1985, as amended at 53 the indications provided in paragraph
FR 48533, Dec. 1, 1988; 56 FR 50813, Oct. 9, 1991; (e) of this section and for treating in-
79 FR 28821, May 20, 2014. Redesignated at 85 fections of stomach bot as provided in
FR 18119, Apr. 1, 2020; 86 FR 14818, Mar. 19,
2021]
§ 520.2520, have been shown to be com-
patible and not to interfere with one
§ 520.903d Febantel tablets. another.
(e) Conditions of use—(1) Horses—(i)
(a) Specifications. Each scored tablet Amount. Administer orally 5 mg per
contains 27.2 milligrams of febantel for kilogram (/kg) (2.3 mg per pound (/lb))
use in dogs, puppies, cats, and kittens for the control of large strongyles,
or 163.3 milligrams of febantel for use small strongyles, and pinworms; 10 mg/
in dogs, puppies, and cats. kg for the control of ascarids.
(b) Sponsor. See No. 058198 in (ii) Indications for use. For the treat-
§ 510.600(c) of this chapter. ment and control of large strongyles
(c) Conditions of use—(1) Amount—(i) (Strongylus edentatus, S. equinus, S.
Dogs and cats. Ten milligrams per kilo- vulgaris, Triodontophorus species), small
gram body weight. Administer once strongyles (Cyathostomum species,
daily for 3 consecutive days. Cylicocyclus species, Cylicostephanus
(ii) Puppies and kittens fewer than 6 species, Cylicodontophorus species),
months of age. Fifteen milligrams per pinworms (Oxyuris equi) and ascarids
kilogram body weight. Administer once (Parascaris equorum).
daily for 3 consecutive days. (iii) Limitations. Do not use in horses
(2) Indications for use. (i) For removal intended for human consumption.
of hookworms (Ancylostoma caninum (2) Beef and dairy cattle—(i) Amount.
and Uncinaria stenocephala), ascarids Administer orally 2.3 mg/lb of body
(Toxocara canis and Toxascaris leonina) weight (5 mg/kg).
and whipworms (Trichuris vulpis) in (ii) Indications for use. For the treat-
dogs and puppies. ment and control of: Lungworms:
193
§ 520.905b 21 CFR Ch. I (4–1–23 Edition)
Adult (Dictyocaulus viviparus); Stomach discard time has not been established,
worms: Adult brown stomach worms do not use in lactating goats.
(Ostertagia ostertagi); adult and fourth- (5) Chickens—(i) Amount. Administer
stage larvae barberpole worms orally via drinking water at a daily
(Haemonchus contortus and H. placei); dose of 1 mg/kg body weight (0.454 mg/
adult and fourth-stage larvae small lb) for 5 consecutive days.
stomach worms (Trichostrongylus axei); (ii) Indications for use. For the treat-
Intestinal worms (adult and fourth- ment and control of adult Ascaridia
stage larvae): Hookworms (Bunostomum galli in broiler chickens and replace-
phlebotomum), thread-necked intestinal ment chickens, and for the treatment
worms (Nematodirus helvetianus), small and control of adult A. galli and
intestinal worms (Cooperia punctata Heterakis gallinarum in breeding chick-
and C. oncophora), bankrupt worms ens and laying hens.
(Trichostrongylus colubriformis), and (6) Swine, except for nursing piglets—(i)
nodular worms (Oesophagostomum Amount. Administer orally via the
radiatum). drinking water at a daily dose of 2.2
(iii) Limitations. Milk taken from mg/kg of body weight (1.0 mg/lb) for 3
cows during treatment and for 48 hours consecutive days.
after the last treatment must not be (ii) Indications for use. For the treat-
used for human consumption. Cattle ment and control of: Lungworms:
must not be slaughtered for human Adult Metastrongylus apri, Adult
consumption within 8 days following Metastrongylus pudendotectus; Gastro-
last treatment with this drug product. intestinal worms: Adult and larvae (L3,
Not for use in beef calves less than 2 L4 stages, liver, lung, intestinal forms)
months of age, dairy calves, and veal large roundworms (Ascaris suum), Adult
calves. A withdrawal period has not nodular worms (Oesophagostomum
been established for this product in dentatum, O. quadrispinulatum), Adult
preruminating calves. small stomach worms (Hyostrongylus
(3) Beef cattle—(i) Amount. Administer rubidus), Adult and larvae (L2, L3, L4
orally 4.6 mg/lb of body weight (10 mg/ stages—intestinal mucosal forms)
kg). whipworms (Trichuris suis); and Kidney
(ii) Indications for use. For the treat- worms: Adult and larvae Stephanurus
ment and control of stomach worms dentatus.
(fourth-stage inhibited larvae/type II (iii) Limitations. Swine intended for
ostertagiasis), Ostertagia ostertagi, and human consumption must not be
tapeworms, Moniezia benedeni. slaughtered within 2 days from the last
(iii) Limitations. Cattle must not be treatment.
slaughtered for human consumption [42 FR 59069, Nov. 15, 1977; 43 FR 12311, Mar.
within 8 days following last treatment 24, 1978. Redesignated at 44 FR 1375, Jan. 5,
with this drug product. Not for use in 1979, and amended at 46 FR 29464, June 2,
beef calves less than 2 months of age, 1981; 47 FR 15327, Apr. 9, 1982; 48 FR 42809,
dairy calves, and veal calves. A with- Sept. 20, 1983; 49 FR 1983, Jan. 17, 1984; 53 FR
drawal period has not been established 40058, Oct. 13, 1988; 59 FR 26943, May 25, 1994;
61 FR 29478, June 11, 1996; 63 FR 63983, Nov.
for this product in preruminating 18, 1998; 66 FR 47960, Sept. 17, 2001; 68 FR
calves. Federal law restricts this drug 26205, May 15, 2003; 74 FR 17770, Apr. 17, 2009;
to use by or on the order of a licensed 74 FR 61516, Nov. 25, 2009; 76 FR 17336, Mar.
veterinarian. 29, 2011; 80 FR 76386, Dec. 9, 2015; 81 FR 22523,
(4) Goats—(i) Amount. Administer Apr. 18, 2016; 86 FR 14818, Mar. 19, 2021; 86 FR
orally 2.3 mg/lb of body weight (5 mg/ 61684, Nov. 8, 2021; 87 FR 58961, Sept. 29, 2022]
kg).
§ 520.905b Fenbendazole granules.
ment and control of stomach worms (a) Specifications. Each gram of gran-
(adults) Haemonchus contortus and ules contains 222 milligrams (mg)
Teladorsagia circumcincta. fenbendazole.
(iii) Limitations. Goats must not be (b) Sponsor. See No. 000061 in
slaughtered for human consumption § 510.600(c) of this chapter.
within 6 days following last treatment (c) Special considerations. See § 500.25
with this drug product. Because a milk of this chapter.
194
(d) Conditions of use—(1) Horses—(i) (iii) Limitations. Top dress or mix

Amount. 5 mg/kilogram (kg) for large with a small portion of food. Must be
strongyles, small strongyles, and fully consumed prior to feeding. Fed-
pinworms; 10 mg/kg for ascarids. eral law restricts this drug to use by or
(ii) Indications for use. For the control on the order of a licensed veterinarian.
of infections of large strongyles Do not use 14 days before or during the
(Strongylus edentatus, S. equinus, S. hunting season.
vulgaris), small strongyles, pinworms
[44 FR 1375, Jan. 5, 1979, as amended at 47 FR
(Oxyuris equi), and ascarids (Parascaris 15327, Apr. 9, 1982; 48 FR 50528, Nov. 2, 1983; 59
equorum). FR 35252, July 11, 1994; 66 FR 47960, Sept. 17,
(iii) Limitations. Sprinkle the appro- 2001; 67 FR 47450, July 19, 2002; 71 FR 19429,
priate amount of drug on a small Apr. 14, 2006; 74 FR 61516, Nov. 25, 2009]
amount of the usual grain ration. Pre-
pare for each horse individually. With- § 520.905c Fenbendazole paste.
holding feed or water is not necessary. (a) Specifications. Each gram of paste
Retreat in 6 to 8 weeks if required. Do contains 100 milligrams (mg)
not use in horses intended for food. fenbendazole (10 percent).
(2) Dogs—(i) Amount. 50 mg/kg daily (b) Sponsor. See No. 000061 in
for 3 consecutive days. § 510.600(c) of this chapter.
ment and control of ascarids (Toxocara
this chapter.
canis, Toxascaris leonina), hookworms
(d) Special considerations. See § 500.25
(Ancylostoma caninum, Uncinaria
of this chapter.
stenocephala), whipworms (Trichuris
vulpis), and tapeworms (Taenia (e) Conditions of use—(1) Horses—(i)
pisiformis). Indications for use and amounts. (A) For
(iii) Limitations. Mix the appropriate the treatment and control of large
amount of drug with a small amount of strongyles (Strongylus edentatus, S.
the usual food; dry dog food may re- equinus, S. vulgaris), small strongyles,
quire slight moistening to facilitate and pinworms (Oxyuris equi). For large
mixing. Medicated food must be fully strongyles, small strongyles, and
consumed. pinworms, the recommended dose is 5
(3) Zoo and wildlife animals—(i) mg/kg (2.3 mg/lb).
Amount. 10 mg/kg per day for 3 days. (B) For treatment and control of
(ii) Indications for use. For control of ascarids (Parascaris equorum). For
internal parasites of Felidae and ascarids, the recommended dose is 10
Ursidae as follows: mg/kg (4.6 mg/lb).
(A) Lion (Panthera leo) and Tiger (C) For treatment and control of
(Panthera tigris): Ascarid (Toxocara cati, hypobiotic (encysted early third-
Toxascaris leonina), Hookworm stage), late third-stage, and fourth-
(Ancylostoma spp.). stage cyathostome larvae, as well as
(B) Cheetah (Acinonyx jubatus): Asca- fourth-stage Strongylus vulgaris larvae,
rid (Toxocara cati, Toxascaris leonina). the recommended dose is 10 mg/kg (4.6
(C) Puma (Felis concolor), Panther mg/lb) daily for 5 consecutive days.
(Panthera spp.), Leopard (Panthera (D) For the control of arteritis
pardus), Jaguar (Panthera onca): Asca- caused by fourth-stage larvae of
rid (Toxocara cati, Toxascaris leonina), Strongylus vulgaris in horses.
Hookworm (Ancylostoma spp.), Tape- (E) Fenbendazole paste 10 percent
worm (Taenia hydatigena, T. krabbei, T. may be used concomitantly with ap-
taeniaeformis). proved forms of trichlorfon for the in-
(D) Black Bear (Ursus americanus): dications provided in paragraph
Ascarid (Baylisascaris transfuga, (e)(1)(i)(A) of this section and for treat-
Toxascaris leonina), Hookworm ing infections of stomach bots as pro-
(Ancylostoma caninum), Tapeworm vided in § 520.2520.
(Taenia hydatigena, T. krabbei). (ii) Limitations. Do not use in horses
(E) Polar Bear (Ursus maritimus) and intended for human consumption.
Grizzly Bear (Ursus horribilis): Ascarid (2) Beef and dairy cattle—(i) Amount.
(Baylisascaris transfuga, Toxascaris Administer orally 2.3 mg/lb (5 mg/kg)

leonina). body weight.
195
§ 520.905d 21 CFR Ch. I (4–1–23 Edition)
(ii) Indications for use. For the treat- (3) Limitations. Thoroughly mix the
ment and control of: Lungworms: contents of the packet(s) with swine
Adult (Dictyocaulus viviparus); Stomach ration and administer according to
worms: Adult brown stomach worms label directions. Feed as sole ration for
(Ostertagia ostertagi), adult and fourth- 3 consecutive days. Can be fed to preg-
stage larvae barberpole worms nant sows. No prior withdrawal of feed
(Haemonchus contortus), fourth-stage or water is necessary. Consult your
larvae barberpole worms (H. placei), veterinarian for assistance in the diag-
and adult and fourth-stage larvae small nosis, treatment, and control of para-
stomach worms (Trichostrongylus axei); sitism.
Intestinal worms (adult and fourth-
stage larvae): Hookworms (Bunostomum [49 FR 18090, Apr. 27, 1984, as amended at 49
phlebotomum), thread-necked intestinal FR 20485, May 15, 1984; 66 FR 47960, Sept. 17,
worms (Nematodirus helvetianus), small 2001; 70 FR 32489, June 3, 2005; 74 FR 61516,
intestinal worms (Cooperia punctata Nov. 25, 2009; 83 FR 48945, Oct. 9, 2018]
and C. oncophora), bankrupt worms
(Trichostrongylus colubriformis), and § 520.928 Firocoxib.
nodular worms (Oesophagostomum (a) Specifications. (1) Each chewable
radiatum). tablet contains 57 or 227 milligrams
(iii) Limitations. Milk taken during (mg) firocoxib.
treatment and for 96 hours after the (2) Each tablet contains 57 mg
last treatment must not be used for firocoxib.
human consumption. Cattle must not (b) Sponsors. See sponsors in
be slaughtered for human consumption § 510.600(c) of this chapter as follows:
within 8 days following last treatment
(1) Nos. 000010 and 055529 for use of
with this drug product. Not for use in
products described in paragraph (a)(1)
beef calves less than 2 months of age,
dairy calves, and veal calves. A with- as in paragraph (c)(1) of this section;
drawal period has not been established and
for this product in preruminating (2) Nos. 000010 and 055246 for use of
calves. the product described in paragraph
(a)(2) as in paragraph (c)(2) of this sec-
tion.
FR 61516, Nov. 25, 2009; 76 FR 17337, Mar. 29,
2011; 86 FR 57996, Oct. 20, 2021; 87 FR 10968, (c) Conditions of use—(1) Dogs—(i)
Feb. 28, 2022] Amount. 5 mg/kg (2.27 mg/lb) body
weight. Administer once daily as need-
§ 520.905d Fenbendazole powder. ed for osteoarthritis and for 3 days as
(a) Specifications. Each 2-ounce pack- needed for postoperative pain and in-
et contains 2.27 grams (4 percent) flammation associated with soft-tissue
fenbendazole. and orthopedic surgery. Administer ap-
(b) Sponsor. See No. 000061 in proximately 2 hours before soft tissue
§ 510.600(c) of this chapter. or orthopedic surgery.
(c) Related tolerances. See § 556.275 of (ii) Indications for use. For the control
this chapter. of pain and inflammation associated
(d) Conditions of use. It is adminis- with osteoarthritis; and for the control
tered to swine as follows:
of postoperative pain and inflamma-
(1) Amount. 3 milligrams fenbendazole
tion associated with soft-tissue and or-
per kilogram body weight per day (1.36
thopedic surgery.
milligrams per pound per day).
(2) Indications for use. For removal (iii) Limitations. Federal law restricts
and control of large roundworms this drug to use by or on the order of a
(Ascaris suum); lungworms licensed veterinarian.
(Metastrongylus apri); nodular worms (2) Horses—(i) Amount. Administer
(Oesophagostomum dentatum, O. one 57-mg tablet to horses weighing 800
quadrispinulatum); small stomach to 1,300 lb once daily for up to 14 days.
worms (Hyostrongylus rubidus); (ii) Indications for use. For the control
whipworms (Trichuris suis); and of pain and inflammation associated
kidneyworms (Stephanurus dentatus— with osteoarthritis.

mature and immature).
196
(iii) Limitations. Do not use in horses § 520.960 Flumethasone.

eral law restricts this drug to use by or tains 0.0625 milligram of flumethasone.
on the order of a licensed veterinarian. (b) Sponsor. See No. 054771 in
[69 FR 51171, Aug. 18, 2004, as amended at 73 § 510.600(c) of this chapter.
FR 2808, Jan. 16, 2008; 73 FR 64885, Oct. 31, (c) Conditions of use—(1) Amount—(i)
2008; 81 FR 67151, Sept. 30, 2016; 87 FR 58961, Dogs: Administer orally from 0.0625 to
Sept. 29, 2022; 88 FR 14897, Mar. 10, 2023] 0.25 milligram daily in divided doses.
(ii) Cats: Administer orally from
§ 520.930 Firocoxib paste. 0.03125 to 0.125 milligram daily in di-
(a) Specifications. Each milligram vided doses.
(mg) of paste contains 0.82 mg (2) Indications for use—(i) Dogs: It is
firocoxib. used for musculoskeletal conditions
(b) Sponsors. See No. 000010 in due to inflammation of muscles or
§ 510.600(c) of this chapter. joints and accessory structures, where
(c) Conditions of use in horses—(1) permanent structural changes do not
Amount. 0.1 mg per kilogram (0.045 mg exist, such as arthritis, the disc syn-
per pound) body weight daily for up to drome, and myositis.
14 days. (ii) Dogs and cats: It is used in certain
acute and chronic dermatoses of vary-
ing etiology to help control the pru-
of pain and inflammation associated ritus, irritation, and inflammation as-
with osteoarthritis. sociated with these conditions.
(3) Limitations. Do not use in horses (3) Limitations. Federal law restricts
intended for human consumption. Fed- this drug to use by or on the order of a
eral law restricts this drug to use by or licensed veterinarian.
[44 FR 7131, Feb. 6, 1979, as amended at 61 FR
[71 FR 5788, Feb. 3, 2006, as amended at 84 FR 5506, Feb. 13, 1996; 79 FR 28821, May 20, 2014]
39183, Aug. 9, 2019]
§ 520.970 Flunixin.
§ 520.955 Florfenicol.
(a) Specifications. (1) Each 10-gram (g)
(a) Specifications. Each milliliter packet of granules contains flunixin
(mL) contains 23 milligrams (mg) meglumine equivalent to 250 milli-
florfenicol. grams (mg) of flunixin.
(b) Sponsors. See Nos. 000061, 054925, (2) Each 30-g syringe of paste con-
and 058198 in § 510.600(c) of this chapter. tains flunixin meglumine equivalent to
(c) Related tolerances. See § 556.283 of 1,500 mg of flunixin.
this chapter. (b) Sponsors. See sponsors in
(d) Conditions of use in swine—(1) § 510.600(c) of this chapter for use as in
Amount. Administer in drinking water paragraph (c) of this section.
ad libitum at 400 mg per gallon (100 (1) No. 000061 for use of products de-
parts per million (ppm)) for 5 consecu- scribed in paragraph (a).
tive days. (2) No. 061133 for use of the product
described in paragraph (a)(2).
ment of swine respiratory disease
Amount. 0.5 mg per pound of body
(SRD) associated with Actinobacillus
weight per day for up to 5 days.
pleuropneumoniae, Pasteurella multocida,
(2) Indications for use. For alleviation
Salmonella choleraesuis and Strepto- of inflammation and pain associated
coccus suis. with musculoskeletal disorders.
(3) Limitations. Do not slaughter with- (3) Limitations. Do not use in horses
in 16 days of last treatment. Federal intended for human consumption. Fed-
law restricts this drug to use by or on eral law restricts this drug to use by or
the order of a licensed veterinarian. on the order of a licensed veterinarian.
[67 FR 78357, Dec. 24, 2002, as amended at 72 [76 FR 53051, Aug. 25, 2011, as amended at 79
FR 262, Jan. 4, 2007; 78 FR 52854, Aug. 27, 2013; FR 74020, Dec. 15, 2014; 84 FR 8972, Mar. 13,
82 FR 12169, Mar. 1, 2017] 2019]
197
§ 520.980 21 CFR Ch. I (4–1–23 Edition)
§ 520.980 Fluoxetine. infestations for 8 weeks in dogs and

(a) Specifications. Each chewable tab- puppies 6 months of age and older, and
let contains 8, 16, 32, or 64 milligrams weighing 4.4 lbs or greater.
(mg) fluoxetine hydrochloride. (ii) Chewable tablets described in para-
(b) Sponsor. See No. 055246 in § 510.600 graph (a)(2) of this section. Kills adult
of this chapter. fleas; for the treatment and prevention
(c) Conditions of use in dogs—(1) of flea infestations (C. felis), and the
Amount. 1 to 2 mg per kilogram body treatment and control of tick infesta-
weight once daily. tions [I. scapularis (black-legged tick),
(2) Indications for use. For the treat- D. variabilis (American dog tick), and
ment of canine separation anxiety in R. sanguineus (brown dog tick)] for 1
conjunction with a behavior modifica- month in dogs and puppies 8 weeks of
tion plan. age and older, and weighing 4.4 lbs or
(3) Limitations. Federal law restricts greater; and for the treatment and con-
this drug to use by or on the order of a trol of A. americanum (lone star tick)
licensed veterinarian. infestations for 1 month in dogs and
puppies 6 months of age and older, and
FR 74020, Dec. 15, 2014; 82 FR 21690, May 10, weighing 4.4 lbs or greater.
2017] (3) Limitations. Federal law restricts
§ 520.998 Fluralaner. licensed veterinarian.
(a) Specifications. (1) Each chewable
[86 FR 14818, Mar. 19, 2021]
tablet contains 112.5, 250, 500, 1,000, or
1,400 milligrams (mg) fluralaner. § 520.1010 Furosemide.
(2) Each chewable tablet contains 45,
100, 200, 400, or 560 mg fluralaner. (a) Specifications. (1) Each tablet con-
(b) Sponsor. See No. 000061 in tains 12.5 or 50 milligrams (mg)
§ 510.600(c) of this chapter. furosemide.
(c) Conditions of use in dogs—(1) (2) Each bolus contains 2 grams (g)
Amount. Administer orally as a single furosemide.
dose with food: (3) Each packet of powder contains 2
(i) Chewable tablets described in para- g furosemide.
graph (a)(1) of this section. Administer (4) Each milliliter of syrup contains
every 12 weeks, an appropriate com- 10 mg furosemide.
bination of tablets to provide a min- (b) Sponsors. See sponsor numbers in
imum dose of 11.4 mg per pound (lb) (25 § 510.600(c) of this chapter for use of
mg per kilogram (kg)) body weight. dosage forms and strengths listed in
May be administered every 8 weeks in paragraph (a) of this section for uses as
case of potential exposure to in paragraph (d) of this section.
Amblyomma americanum ticks.
(1) No. 000010 for tablets in paragraph
(ii) Chewable tablets described in para-
graph (a)(2) of this section. Administer (a)(1) of this section for conditions of
monthly, an appropriate combination use in paragraphs (d)(2)(i), (d)(2)(ii)(A),
of tablets to provide a minimum dose and (d)(3) of this section.
of 4.5 mg/lb (10 mg/kg) body weight. (2) No. 000061 for tablets in paragraph
(2) Indications for use—(i) Chewable (a)(1) of this section for conditions of
tablets described in paragraph (a)(1) of use in paragraphs (d)(2)(i), (d)(2)(ii)(A),
this section. Kills adult fleas; for the and (d)(3) of this section; for boluses in
treatment and prevention of flea infes- paragraph (a)(2) of this section and
tations (Ctenocephalides felis), and the powder in paragraph (a)(3) of this sec-
treatment and control of tick infestation for conditions of use in paragraph
tions [Ixodes scapularis (black-legged (d)(1) of this section; and for syrup in
tick), Dermacentor variabilis (American paragraph (a)(4) of this section for con-
dog tick), and Rhipicephalus sanguineus ditions of use in paragraphs (d)(2)(i)
(brown dog tick)] for 12 weeks in dogs and (d)(2)(ii)(A).
and puppies 6 months of age and older, (3) Nos. 058829 and 069043 for use of
and weighing 4.4 lbs or greater; and for syrup in paragraph (a)(4) of this section
the treatment and control of for conditions of use in paragraph

Amblyomma americanum (lone star tick) (d)(2)(i) and (d)(2)(ii)(A) of this section.
198
(c) Special considerations. Federal law gallon of drinking water for 3 consecu-
restricts this drug to use by or on the tive days, to provide 1.0 milligram/
order of a licensed veterinarian. pound/day.
(d) Conditions of use. It is used as fol- (2) Indications for use. In weanling
lows: swine for control and treatment of
(1) Cattle—(i) Amount. 1 to 2 mg per colibacillosis caused by strains of E.
pound (/lb) body weight using powder, coli sensitive to gentamicin, and in
or one 2-g bolus per animal, per day. swine for control and treatment of
(ii) Indications for use. For treatment swine dysentery associated with
of physiological parturient edema of Treponema hyodysenteriae.
the mammary gland and associated (3) Limitations. Do not slaughter
structures. treated swine for food for at least 3
(iii) Limitations. Treatment not to ex- days following treatment. Federal law
ceed 48 hours post-parturition. Milk restricts this drug to use by or on the
taken during treatment and for 48 order of a licensed veterinarian.
hours after the last treatment must
[48 FR 10302, Mar. 11, 1983. Redesignated at 49
not be used for food. Cattle must not be
FR 572, Jan. 5, 1984, and amended at 49 FR
slaughtered for food within 48 hours 14332, Apr. 11, 1984; 52 FR 7832, Mar. 13, 1987;
following last treatment. 62 FR 34169, June 25, 1997; 71 FR 13542, Mar.
(2) Dogs—(i) Amount. 1 to 2 mg/lb body 16, 2006; 81 FR 94989, Dec. 27, 2016]
weight, once or twice daily.
(ii) Indications for use. (A) For treat- § 520.1044b Gentamicin sulfate pig
ment of edema (pulmonary congestion, pump oral solution.
ascites) associated with cardiac insuffi- (a) Specifications. Each milliliter of
ciency and acute noninflammatory tis- pig pump oral solution contains
sue edema. gentamicin sulfate equivalent to 4.35
(B) For treatment of edema (pul- milligrams of gentamicin.
monary congestion, ascites) associated (b) Sponsor. See Nos. 000061 and 016592
with cardiac insufficiency. in § 510.600(c) of this chapter.
(3) Cats—(i) Amount. 1 to 2 mg/lb body (c) Related tolerances. See § 556.300 of
weight, once or twice daily. this chapter.
(ii) Indications for use. For treatment (d) Conditions of use—(1) Amount. Ad-
of edema (pulmonary congestion, asci- minister 1.15 milliliters of pig pump
tes) associated with cardiac insuffi- oral solution (5 milligrams of
ciency and acute noninflammatory tis- gentamicin) orally per pig one time.
sue edema. (2) Indications for use. In neonatal
[66 FR 47960, Sept. 17, 2001, as amended at 69 swine 1 to 3 days of age for control and
FR 74419, Dec. 14, 2004; 70 FR 50182, Aug. 26, treatment of colibacillosis caused by
2005; 70 FR 76396, Dec. 27, 2005; 74 FR 61516, strains of E. coli sensitive to
Nov. 25, 2009; 78 FR 17596, Mar. 22, 2013; 81 FR gentamicin.
17607, Mar. 30, 2016] (3) Limitations. For use in neonatal
§ 520.1044 Gentamicin sulfate oral dos- swine only. Do not slaughter treated
age forms. swine for food for at least 14 days fol-
lowing treatment.
§ 520.1044a Gentamicin sulfate oral so- [49 FR 572, Jan. 5, 1984, as amended at 52 FR
lution. 7832, Mar. 13, 1987; 62 FR 29011, May 29, 1997;
(a) Specifications. Each milliliter of 78 FR 17596, Mar. 22, 2013; 81 FR 22523, Apr. 18,
aqueous solution contains gentamicin 2016]
sulfate equivalent to 50 milligrams of
gentamicin. § 520.1044c Gentamicin sulfate powder.
(b) Sponsor. See Nos. 000061 and 054925 (a) Specifications. Each gram of pow-
in § 510.600(c) of this chapter. der contains gentamicin sulfate equiv-
(c) Related tolerances. See § 556.300 of alent to:
this chapter. (1) 16.7, 66.7, or 333.3 milligrams (mg)
(d) Conditions of use—(1) Amount. gentamicin.
Colibacillosis: 1 milliliter per 2 gallons (2) 333.3 mg gentamicin.
of drinking water for 3 consecutive (b) Sponsors. See sponsors in
days, to provide 0.5 milligram/pound/ § 510.600(c) of this chapter for use as in

day; swine dysentery: 1 milliliter per 1 paragraph (d) of this section as follows:
199
§ 520.1060 21 CFR Ch. I (4–1–23 Edition)
(1) No. 000061 for products described (ii) Newly purchased calves. Feed 2
in paragraph (a)(1) of this section. quarts of solution instead of milk as
(2) Nos. 016592 and 061133 for product the first feed upon arrival. For the next
described in paragraph (a)(2) of this scheduled feeding, use 1 quart of solu-
section. tion mixed together with 1 quart of
(c) Related tolerances. See § 556.300 of milk or milk replacer. Thereafter, feed
this chapter. as normal.
(d) Conditions of use in swine—(1) (2) Indications for use. For control of
Amount. Administer in drinking water dehydration associated with diarrhea
for 3 consecutive days as follows: (scours); and as an early treatment at
(i) For colibacillosis: Gentamicin sul- the first signs of scouring. It may also
fate equivalent to 25 mg of gentamicin be used as followup treatment fol-
per gallon of drinking water to provide lowing intravenous fluid therapy.
0.5 mg per pound of body weight per (3) Limitations. The product should
day; not be used in animals with severe de-
(ii) For swine dysentery: Gentamicin hydration (down, comatose, or in a
sulfate equivalent to 50 mg of state of shock). Such animals need in-
gentamicin per gallon of drinking travenous therapy. A veterinarian
water to provide 1 mg per pound of should be consulted in severely scour-
body weight per day. Treatment may ing calves. The product is not nutri-
be repeated if dysentery recurs. tionally complete if administered by
(2) Indications for use. For control and itself for long periods of time. It should
treatment of colibacillosis in weanling not be administered beyond the rec-
swine caused by strains of Escherichia ommended treatment period without
coli sensitive to gentamicin, and for the addition of milk or milk replacer.
control and treatment of swine dys-
[79 FR 28821, May 20, 2014]
entery associated with Brachyspira
hyodysenteriae. § 520.1084 Grapiprant.
(3) Limitations. Withdrawal period: 10
days. Federal law restricts this drug to (a) Specifications. Each tablet con-
use by or on the order of a licensed vet- tains 20, 60, or 100 milligrams (mg)
erinarian. grapiprant.
[77 FR 4226, Jan. 27, 2012, as amended at 81 § 510.600(c) of this chapter.
FR 94989, Dec. 27, 2016; 83 FR 48945, Sept. 28, (c) Conditions of use in dogs—(1)
2018; 84 FR 8972, Mar. 13, 2019; 87 FR 10968,
Feb. 28, 2022]
Amount. Administer 0.9 mg/lb (2 mg/kg)
once daily by mouth.
§ 520.1060 Glucose and glycine. (2) Indications for use. For the control
of pain and inflammation associated
(a) Specifications. Each packet of pow-
with osteoarthritis in dogs.
der contains 8.82 grams sodium chlo-
ride, 4.20 grams potassium phosphate,
0.5 gram citric acid anhydrous, 0.12
gram potassium citrate, 6.36 grams
aminoacetic acid (glycine), and 44.0 [81 FR 36789, June 8, 2016, as amended at 83
grams glucose. FR 14587, Apr. 5, 2018]
§ 510.600(c) of this chapter. § 520.1100 Griseofulvin.
(c) Conditions of use in calves—(1) (a) Specifications. (1) The powder com-
Amount. Dissolve each packet in 2 plies with U.S.P. for griseofulvin,
quarts of warm water and administer microsize.
to each calf as follows: (2) Each bolus contains 2.5 grams
(i) Scouring and/or dehydrated calves. griseofulvin.
Feed 2 quarts of solution, twice daily (3) Each tablet contains 125 or 500
for 2 days (four feedings). No milk or milligrams griseofulvin.
milk replacer should be fed during this (b) Sponsors. See sponsors in
period. For the next four feedings (days § 510.600(c) of this chapter.
3 and 4), use 1 quart of solution to- (1) No. 000061 for use of products de-
gether with 1 quart of milk replacer. scribed in paragraph (a) for use as in
Thereafter, feed as normal. paragraph (d) of this section.
200
(2) No. 061133 for use of the powder floccosum, Microsporum gypseum, M.
described in paragraph (a)(1) for use as canis, M. audouini.
in paragraphs (d)(1)(i)(A) and (d)(1)(ii) [40 FR 13838, Mar. 27, 1975, as amended at 41
of this section. FR 42948, Sept. 29, 1976; 43 FR 28458, June 30,
(c) Special considerations. Federal law 1978; 52 FR 7832, Mar. 13, 1987; 54 FR 30205,
restricts this drug to use by or on the July 19, 1989; 71 FR 38073, July 5, 2006; 77 FR
order of a licensed veterinarian. 28253, May 14, 2012; 78 FR 28822, May 20, 2014;
84 FR 8972, Mar. 13, 2019]
(d) Conditions of use—(1) Horses—(i)
Amount and indications for use. (A) For § 520.1120 Haloxon oral dosage forms.
equine ringworm infection caused by
Trichophyton equinum or Microsporum § 520.1120a Haloxon drench.
gypseum, administer soluble powder de- (a) Specifications. Each packet con-
scribed in paragraph (a)(1) of this sec- tains 141.5 grams haloxon.
tion daily as a drench or as a top dress- (b) Sponsor. See No. 000061 in
ing on feed for not less than 10 days as § 510.600(c) of this chapter.
follows: adults, 2.5 grams; yearlings, (c) Special considerations. Do not use
1.25 to 2.5 grams; and foals, 1.25 grams. any drug, insecticide, pesticide, or
(B) For treating ringworm infection other chemical having cholinesterase-
caused by T. equinum, administer inhibiting activity either simulta-
boluses described in paragraph (a)(2) of neously or within a few days before or
this section daily for not less than 10 after treatment with haloxon.
days as follows: adults, 1 bolus; year- (d) Related tolerances. See § 556.310 of
lings, one-half to 1 bolus; and foals, this chapter.
one-half bolus. (e) Conditions of use in cattle—(1)
Amount. Dissolve each packet in 32
(ii) Limitations. Do not use in horses
fluid ounces of water and administer as
intended for human consumption.
follows: For animals weighing up to 100
(2) Dogs and cats: (i) Amount. 125- and pounds: 1⁄2 fluid ounce; for animals
500-milligram tablets administered weighing 100 to 150 pounds: 3⁄4 fluid
orally as follows: ounce; for animals weighing 150 to 200
(A) Daily (single or divided) dose as pounds: 1 fluid ounce; for animals
follows: For animals weighing up to 6 weighing 200 to 300 pounds: 1 1⁄2 fluid
pounds: 62.5 milligrams; for animals ounces; for animals weighing 300 to 450
weighing 6 to 18 pounds: 125 milli- pounds: 2 fluid ounces; for animals
grams; for animals weighing 18 to 36 weighing 450 to 700 pounds: 3 fluid
pounds: 250 milligrams; for animals ounces; for animals weighing 700 to
weighing 36 to 48 pounds: 375 milli- 1,000 pounds: 4 fluid ounces; for animals
grams; for animal weighing 48 to 75 weighing 1,000 to 1,200 pounds: 5 fluid
pounds: 500 milligrams. ounces; for animals weighing over 1,200
(B) Weekly (single) dose: If experi- pounds: 6 fluid ounces. Retreat in 3 to
ence indicates that treatment is more 4 weeks.
effective for the drug given in large (2) Indications for use. For control of
doses, administer at intervals of 7 to 10 gastrointestinal roundworms of the
days, a dose equal to 10 milligrams/ genera Haemonchus, Ostertagia,
pound of body weight × body weight × Trichostrongylus, and Cooperia.
(3) Limitations. Do not treat dairy
number of days between treatments.
animals of breeding age. Do not treat
Dosage should be adjusted according to
within 1 week of slaughter.
response. Administer additional dose
after the animal is free of infection. [40 FR 13838, Mar. 27, 1975, as amended at 45
(ii) Indications for use. For treatment FR 10333, Feb. 15, 1980; 46 FR 48642, Oct. 2,
1981; 61 FR 8873, Mar. 6, 1996; 62 FR 61624,
of fungal infections of the skin, hair, Nov. 19, 1997; 78 FR 28822, May 20, 2014]
and claws caused by Trichophyton
mentagrophytes, T. rubrum, T. § 520.1120b Haloxon boluses.
schoenleini, T. sulphurem, T. verrucosum, (a) Specifications. Each bolus contains
T. interdigitale, Epidermophyton 10.1 grams of haloxon.

201
§ 520.1130 21 CFR Ch. I (4–1–23 Edition)
(c) Related tolerances. See § 556.310 of (c) Conditions of use—(1) Amount. Ad-
this chapter. minister orally twice daily, approxi-
(d) Conditions of use in cattle—(1) mately 12 hours apart, at a dose of 13.6
Amount. Administered one bolus per 500 mg per pound (30 mg/kg) of body
pounds body weight (35 to 50 milli- weight. Initiate therapy starting 2 days
grams per kilogram of body weight). prior to the day of the expected noise
Retreat in 3 to 4 weeks. event and continuing through the noise
(2) Indications for use. For control of event.
gastrointestinal roundworms of the (2) Indications for use. For the treat-
genera Haemonchus, Ostertagia, ment of noise aversion in dogs.
Trichostrongylus, and Cooperia.
(3) Limitations. Do not treat dairy
animals of breeding age or older. Do
not treat within 1 week of slaughter.
[40 FR 13838, Mar. 27, 1975, as amended at 44 [84 FR 12494, Apr. 2, 2019]
FR 61591, Oct. 29, 1979; 46 FR 48642, Oct. 2,
1981; 61 FR 8873, Mar. 6, 1996; 62 FR 61625, § 520.1156 Imidacloprid.
Nov. 19, 1997; 78 FR 28822, May 20, 2014] (a) Specifications. Each chewable tab-
let contains 7.5 or 37.5 milligrams (mg)
§ 520.1130 Hetacillin.
imidacloprid.
(a) Specifications. (1) Each capsule or (b) Sponsor. See No. 058198 in
tablet contains hetacillin potassium § 510.600(c) of this chapter.
equivalent to 50, 100, or 200 milligrams (c) Conditions of use in dogs—(1)
(mg) of ampicillin.
Amount. Administer daily one 7.5-mg
(2) Each milliliter of suspension con-
chewable tablet to dogs weighing 4 to
tains hetacillin potassium equivalent
22 pounds (lb) or one 37.5-mg chewable
to 50 mg of ampicillin.
(b) Sponsor. See No. 000010 in table to dogs weighing 23 to 110 lb.
§ 510.600(c) of this chapter. (2) Indications for use. Kills adult fleas
(c) Conditions of use in dogs and cats— and is indicated for the treatment of
(1) Amount—(i) Dogs. Administer 5 mg flea infestations on dogs and puppies 10
per pound (/lb) of body weight orally, weeks of age and older and weighing 4
twice daily. In severe infections, ad- lb or greater.
minister 5 mg/lb three times daily, or (3) Limitations. Do not give to puppies
up to 10 mg/lb twice daily. For stub- younger than 10 weeks of age or to dogs
born urinary tract infections, admin- weighing less than 4 lb. Do not give
ister up to 20 mg/lb twice daily. more than one tablet a day.
(ii) Cats. Administer 50 mg twice
daily.
FR 14818, Mar. 19, 2021]
ment of respiratory tract infections, § 520.1157 Iodinated casein.
urinary tract infections, gastro-
intestinal infections, skin infections, (a) Specifications. Each 1-gram tablet
soft tissue infections, and postsurgical contains 25 milligrams of iodinated ca-
infections associated with strains of or- sein.
ganisms susceptible to hetacillin po- (b) Sponsor. See No. 017762 in
tassium. § 510.600(c) of this chapter.
(3) Limitations. Federal law restricts (c) Conditions of use—(1) Amount. 1⁄5 to
this drug to use only by or on the order 1 tablet per 10 pounds of body weight
of a licensed veterinarian. (equivalent to 0.5 to 2.5 milligrams of
[75 FR 10166, Mar. 5, 2010] iodinated casein per pound of body
weight).
§ 520.1150 Imepitoin. (2) Indications for use. For dogs for ap-
(a) Specifications. Each tablet con- parent decreased thyroid activity
tains 100 or 400 milligrams (mg) where the signs are alopecia, scaliness
imepitoin. of the skin surface, loss of hair, sebor-
(b) Sponsor. See No. 000010 in rhea, thickening of the skin,

§ 510.600(c) of this chapter. hyperpigmentation, and lethargy.
202
(3) Limitations. Federal law restricts use as in paragraph (e)(1) of this sec-
this drug to use by or on the order of a tion.
licensed veterinarian. (c) Related tolerances. See § 556.344 of
this chapter.
FR 28822, May 20, 2014] (d) Special considerations. See § 500.25
of this chapter.
§ 520.1158 Iodochlorhydroxyquin. (e) Conditions of use—(1) Horses—(i)
Amount. 200 micrograms per kilogram
(a) Specifications. Each bolus contains (91 micrograms per pound) of body
10 grams of iodochlorhydroxyquin. weight.
(b) Sponsor. See No. 054771 in § 510.600 (ii) Indications for use. For treatment
(c) of this chapter. and control of Large Strongyles
(c) Conditions of use—(1) Amount. 1 (adults): Strongylus vulgaris (also early
bolus (10 grams) daily for a 1,000-pound forms in blood vessels), S. edentatus
horse. (also tissue stages), S. equinus,
(2) Indications for use. For treatment Triodontophorus spp. including T.
of equine diarrhea. brevicauda and T. serratus, and
(3) Limitations. Do not use in horses Craterostomum acuticaudatum; Small
intended for human consumption. Fed- Strongyles (adults, including those re-
eral law restricts this drug to use by or sistant to some benzimidazole class
on the order of a licensed veterinarian. compounds): Coronocyclus spp. includ-
[48 FR 8054, Feb. 25, 1983, as amended at 50 ing C. coronatus, C. labiatus, and C.
FR 41489, Oct. 11, 1985; 78 FR 28822, May 20, labratus, Cyathostomum spp. including
2014] C. catinatum and C. pateratum,
Cylicocyclus spp. including C. insigne, C.
§ 520.1189 Itraconazole. leptostomum, C. nassatus, and C.
(a) Specifications. Each milliliter brevicapsulatus, Cylicodontophorus spp.,
(mL) of solution contains 10 milligrams Cylicostephanus spp. including C.
(mg) of itraconazole. calicatus, C. goldi, C. longibursatus, and
(b) Sponsor. See No. 051311 in C. minutus, and Petrovinema poculatum;
§ 510.600(c) of this chapter. Small Strongyles (fourth-stage larvae);
(c) Conditions of use—(1) Amount. Ad- Pinworms (adults and fourth-stage lar-
minister 5 mg/kilogram (kg) (0.5 mL/ vae): Oxyuris equi; Ascarids (adults and
kg) of body weight once daily on alter- third- and fourth-stage larvae):
nating weeks for 3 treatment cycles. Parascaris equorum; Hairworms (adults):
(2) Indications for use. For the treat- Trichostrongylus axei; Large mouth
ment of dermatophytosis caused by Stomach Worms (adults): Habronema
Microsporum canis in cats. muscae; Bots (oral and gastric stages):
(3) Limitations. Federal law restricts Gasterophilus spp. including G.
this drug to use by or on the order of a intestinalis and G. nasalis; Lungworms
licensed veterinarian. (adults and fourth-stage larvae):
Dictyocaulus arnfieldi; Intestinal
[82 FR 12169, Mar. 1, 2017, as amended at 86 Threadworms (adults): Strongyloides
FR 57996, Oct. 20, 2021] westeri; Summer Sores caused by
Habronema and Draschia spp. cutaneous
§ 520.1192 Ivermectin paste.
third-stage larvae; Dermatitis caused
(a) Specifications. Each milligram by neck threadworm microfilariae,
(mg) of paste contains 0.0187 mg (1.87 Onchocerca sp.
percent) or 0.00153 mg (0.153 percent) of (iii) Limitations. For oral use only. Do
ivermectin. not use in horses intended for human
(b) Sponsors. See sponsors in consumption.
§ 510.600(c) of this chapter for use as in (2) Cattle—(i) Amount. 23 milligrams
paragraph (e) of this section: per 250 pounds of body weight.
(1) No. 000010 for use of a 1.87 percent (ii) Indications for use. It is used in
paste as in (e)(1) of this section and a cattle for the treatment and control of
0.153 percent paste for use as in para- gastrointestinal roundworms (adults
graph (e)(2) of this section. and fourth-stage larvae) (Ostertagia
(2) Nos. 051311, 054925, 058198, and ostertagi (including inhibited forms), O.
061133 for use of a 1.87 percent paste for lyrata, Haemonchus placei,
203
§ 520.1193 21 CFR Ch. I (4–1–23 Edition)
Trichostrongylus axei, T. colubriformis, priate tablets. Administer at monthly

Cooperia oncophora, C. punctata, dosing intervals.
Nematodirus helvetianus, Bunostomum (ii) Indications for use. To prevent ca-
phlebotomum, Strongyloides papillosus nine heartworm disease by eliminating
(adults only), Oesophagostomum the tissue stage of heartworm larvae
radiatum, Trichuris ovis (adults only)); (Dirofilaria immitis) for 1 month (30
lungworms (adults and fourth-stage days) after infection.
larvae) (Dictyocaulus viviparus); grubs (2) Cats. For use in cats 6 weeks of
(first, second, and third instars) age and older as follows:
(Hypoderma bovis, H. lineatum); and (i) Amount. Up to 2.3 kilograms (up to
sucking lice (Linognathus vituli, 5 lb), 55 mcg; 2.3 to 6.8 kilograms (5 to
Haematopinus eurysternus). 15 lb), 165 mcg; over 6.8 kilograms (15
(iii) Limitations. For oral use only. Do lb), a combination of the appropriate
not treat cattle within 24 days of chewables (recommended minimum
slaughter. Because withdrawal time in dose of 24 mcg/kg of body weight (10.9
milk has not been established, do not mcg/lb)). Administer once a month.
use in female dairy cattle of breeding (ii) Indications for use. To prevent fe-
age. line heartworm disease by eliminating
the tissue stage of heartworm larvae
[49 FR 22275, May 29, 1984, as amended at 50 Dirofilaria immitis for a month (30 days)
FR 27819, July 8, 1985; 51 FR 44449, Dec. 10,
after infection, and for removal and
1986; 53 FR 51273, Dec. 21, 1988; 62 FR 63270,
Nov. 28, 1997; 65 FR 70661, Nov. 27, 2000; 67 FR control of adult and immature (L4)
71820, Dec. 3, 2002; 68 FR 43294, July 22, 2003; hookworms Ancylostoma tubaeforme and
69 FR 59131, Oct. 4, 2004; 70 FR 8514, Feb. 22, A. braziliense.
2005; 71 FR 40010, July 14, 2006; 71 FR 67298,
Nov. 21, 2006; 73 FR 34184, June 17, 2008; 74 FR
FR 21996, May 2, 2002; 69 FR 43735, July 22,
6542, Feb. 10, 2009; 78 FR 17596, Mar. 22, 2013;
2004; 81 FR 17607, Mar. 30, 2016; 84 FR 39183,
84 FR 8972, Mar. 13, 2019; 84 FR 39183, Aug. 9,
Aug. 9, 2019]
2019; 86 FR 14818, Mar. 19, 2021]
§ 520.1194 Ivermectin meal.
§ 520.1193 Ivermectin tablets and
chewables. (a) Specifications. Each gram of meal
contains 6 milligrams ivermectin (0.6
(a) Specifications. (1) Each tablet or
percent).
chewable contains 68, 136, or 272
micrograms (mcg) ivermectin.
(2) Each chewable contains 55 or 165 (c) Special considerations. See § 500.25
mcg ivermectin. of this chapter.
(b) Sponsors. See sponsors in (d) Conditions of use in horses—(1)
§ 510.600(c) of this chapter for use as in Amount. Administer 136 micrograms
paragraph (d) of this section. (mcg) ivermectin per pound (/lb) body
(1) No. 000010 for use of tablets or weight (300 mcg/kilogram) as a single
chewables described in paragraph (a)(1) dose on approximately 2 lb grain or
as in paragraph (d)(1) and chewables de- sweet feed.
scribed in paragraph (a)(2) as in para- (2) Indications for use. For treatment
graph (d)(2) of this section. and control of Large Strongyles
(2) Nos. 051311 and 069043 for use of (adults): Strongylus vulgaris (also early
tablets described in paragraph (a)(1) as forms in blood vessels), S. edentatus
in paragraph (d)(1) of this section. (also tissue stages), S. equinus,
(c) Special considerations. Federal law Triodontophorus spp. including T.
restricts this drug to use by or on the brevicauda and T. serratus, and
order of a licensed veterinarian. Craterostomum acuticaudatum; Small
(d) Conditions of use—(1) Dogs. For use Strongyles (adults, including those re-
in dogs 6 weeks of age and older as fol- sistant to some benzimidazole class
lows: compounds): Coronocyclus spp. includ-
(i) Amount. 6.0 mcg per kilogram (kg) ing C. coronatus, C. labiatus, and C.
of body weight (2.72 mcg per pound labratus, Cyathostomum spp. including
(lb)), minimum. Up to 25 lb, 68 mcg; 26 C. catinatum and C. pateratum,
to 50 lb, 136 mcg; 51 to 100 lb, 272 mcg; Cylicocyclus spp. including C. insigne, C.
over 100 lb, a combination of the appro- leptostomum, C. nassatus, and C.
204
brevicapsulatus, Cylicodontophorus spp., (ii) Indications for use. For treatment

Cylicostephanus spp. including C. and control of:
calicatus, C. goldi, C. longibursatus, and (A) Large Strongyles (adults):
C. minutus, and Petrovinema poculatum; Strongylus vulgaris (also early forms in
Small Strongyles (fourth-stage larvae); blood vessels), S. edentatus (also tissue
Pinworms (adults and fourth stage lar- stages), S. equinus, Triodontophorus spp.
vae): Oxyuris equi; Ascarids (adults and including T. brevicauda and T. serratus,
third- and fourth-stage larvae): and Craterostomum acuticaudatum;
Parascaris equorum; Hairworms (adults): Small Strongyles (adults, including
Trichostrongylus axei; Large Mouth those resistant to some benzimidazole
Stomach Worms (adults): Habronema class compounds): Coronocyclus spp. in-
muscae; Bots (oral and gastric stages): cluding C. coronatus, C. labiatus, and C.
Gasterophilus spp. including G. labratus, Cyathostomum spp. including
intestinalis and G. nasalis; Lungworms C. catinatum and C. pateratum,
(adults and fourth-stage larvae): Cylicocyclus spp. including C. insigne, C.
Dictyocaulus arnfieldi; Intestinal leptostomum, C. nassatus, and C.
Threadworms (adults): Strongyloides brevicapsulatus, Cylicodontophorus spp.,
westeri; Summer Sores caused by Cylicostephanus spp. including C.
Habronema and Draschia spp. cutaneous calicatus, C. goldi, C. longibursatus, and
third-stage larvae; Dermatitis caused C. minutus, and Petrovinema poculatum;
by neck threadworm microfilariae, Small Strongyles (fourth-stage larvae);
Onchocerca sp. Pinworms (adults and fourth stage lar-
Limitations. Do not use in horses in- vae): Oxyuris equi; Ascarids (adults and
tended for human consumption. third- and fourth-stage larvae):
Parascaris equorum; Hairworms (adults):
[70 FR 1817, Jan. 11, 2005, as amended at 70
Trichostrongylus axei; Large mouth
FR 19262, Apr. 13, 2005]
Stomach Worms (adults): Habronema
§ 520.1195 Ivermectin liquid. muscae; Bots (oral and gastric stages):
Gasterophilus spp. including G.
(a) Specifications. (1) Each milliliter intestinalis and G. nasalis; Lungworms
(mL) contains 10 milligrams (mg) (adults and fourth-stage larvae):
ivermectin. Dictyocaulus arnfieldi; Intestinal
(2) Each mL of micellar solution con- Threadworms (adults), Strongyloides
tains 0.8 mg ivermectin. westeri; Summer Sores caused by
(b) Sponsors. See sponsor numbers in Habronema and Draschia spp. cutaneous
§ 510.600(c) of this chapter. third-stage larvae; Dermatitis caused
(1) Nos. 000010, 054925, 058005, and by neck threadworm microfilariae,
058198 for use of product described in Onchocerca sp.
paragraph (a)(1) of this section as in (B) Large Strongyles (Strongylus
paragraphs (e)(1)(i), (e)(1)(ii)(A), and equinus (adult), S. vulgaris (adult and
(e)(1)(iii) of this section. arterial larval stages), S. endentatus
(2) No. 058829 for use of product de- (adult and migrating tissue stages),
scribed in paragraph (a)(1) of this sec- Triodontophorus spp. (adult)); Small
tion as in paragraphs (e)(1)(i), Strongyles including those resistant to
(e)(1)(ii)(B), and (e)(1)(iii) of this sec- some benzimidazole class compounds
tion. (Cyathostomum spp. (adult and fourth-
(3) Nos. 000010 and 058829 for use of stage larvae), Cylicocyclus spp.,
product described in paragraph (a)(2) of Cylicodontophorus spp., Cylicostephanus
this section as in paragraph (e)(2) of spp.); Pinworms (Oxyuris equi (adult
this section. and fourth-stage larvae)); Ascarids
(c) Related tolerances. See § 556.344 of (Parascaris equorum (adult and third-
this chapter. and fourth-stage larvae)); Hairworms
(d) Special considerations. See § 500.25 (Trichostongylus axei ( adult)); Large
of this chapter. mouth Stomach Worms (Habronema
(e) Conditions of use—(1) Horses—(i) muscae (adult)); Stomach Bots
Amount. 200 micrograms (mcg) per kilo- (Gastrophilus spp. (oral and gastric
gram (/kg) of body weight as a single stages)); Lungworms (Dictyocaulus
dose by stomach tube or as an oral arnfieldi (adult and fourth-stage lar-

drench. vae)); intestinal threadworms
205
§ 520.1196 21 CFR Ch. I (4–1–23 Edition)
(Strongyloides westeri (adult)); Summer immitis for up to a month (30 days) after
Sores caused by Habronema and infection and treatment and control of
Draschia spp. cutaneous third-stage lar- adult roundworms Toxocara canis and
vae; and Dermatitis caused by neck Toxascaris leonina, and adult
threadworm microfilariae (Onchocerca hookworms Ancylostoma caninum, A.
spp.). braziliense, and Uncinaria stenocephala.
(iii) Limitations. Do not use in horses (iii) Limitations. Federal law restricts
on the order of a licensed veterinarian. (2) [Reserved]
(2) Sheep—(i) Amount. 200 mcg/kg (3
mL/26 pounds) of body weight as a sin- FR 15186, Apr. 5, 1996; 61 FR 59004, Nov. 20,
gle dose oral drench. 1996; 62 FR 63270, Nov. 28, 1997; 66 FR 35756,
(ii) Indications for use. For treatment July 9, 2001; 67 FR 21996, May 2, 2002; 68 FR
and control of the adult and fourth- 55823, Sept. 29, 2003; 78 FR 28822, May 20, 2014;
stage larvae of gastrointestinal 84 FR 39183, Aug. 9, 2019; 88 FR 16547, Mar. 20,
roundworms (Haemonchus contortus, H. 2023]
placei (adults only), Ostertagia
circumcincta, Trichostrongylus axei, T. § 520.1197 Ivermectin sustained-re-
lease bolus.
colubriformis, Cooperia oncophora
(adults only), C. curticei, (a) Specifications. Each sustained-re-
Oesophagostomum columbianum, O. lease bolus contains 1.72 grams of
venulosum (adults only), Nematodirus ivermectin.
battus, N. spathiger, S. papillosus (adults (b) Sponsor. See No. 000010 in
only), Chabertia ovina (adult only), § 510.600(c) of this chapter.
Trichuris ovis (adults only)); lungworms (c) Related tolerances. See § 556.344 of
(D. filaria); and all larval stages of the this chapter.
nasal bot Oestrus ovis. (d) Conditions of use in ruminating
(iii) Limitations. For use in sheep calves—(1) Amount. Administer one
only. Do not use in other animal spe- bolus per calf weighing at least 275
cies as severe adverse reactions, in- pounds (lb) (125 kilograms (kg)) and not
cluding fatalities in dogs, may result. more than 660 lb (300 kg) on the day of
Do not treat sheep within 11 days of administration.
slaughter. (2) Indications. For treatment and
control, throughout the grazing season
FR 57173, Sept. 24, 2004; 71 FR 13542, Mar. 16,
(approximately 130 days), of gastro-
2006; 71 FR 38072, July 5, 2006; 72 FR 9456, Feb. intestinal roundworms Haemonchus
21, 2008; 78 FR 17596, Mar. 22, 2013; 79 FR 10964, placei, Ostertagia ostertagi (including in-
Feb. 27, 2014; 84 FR 39183, Aug. 9, 2019; 86 FR hibited fourth-stage larvae),
14818, Mar. 19, 2021] Trichostrongylus axei, T. colubriformis,
Cooperia spp., Nematodirus helvetianus,
§ 520.1196 Ivermectin and pyrantel Bunostomum phlebotomum,
tablets. Oesophagostomum radiatum; lungworms
(a) Specifications. Each chewable tab- Dictyocaulus viviparus; grubs Hypoderma
let contains either 68 micrograms (μg) spp.; sucking lice Linognathus vituli,
of ivermectin and 57 milligrams (mg) of Solenopotes capillatus; mange mites
pyrantel (as pamoate salt), or 136 μg Psoroptes ovis, Sarcoptes scabiei, and
and 114 mg, or 272 μg and 227 mg, re- ticks Amblyomma americanum.
spectively. (3) Limitations. The bolus was specifi-
(b) Sponsors. See Nos. 000010, 051311, cally designed for use in cattle; do not
and 063604 in § 510.600(c) of this chapter. use in other animal species. Calves
(c) Conditions of use—(1) Dogs—(i) must be ruminating and older than 12
Amount. Administer a minimum of 6 μg weeks of age. Do not administer to
of ivermectin and 5 mg of pyrantel per calves weighing less than 275 lb (125
kilogram (2.72 μg and 2.27 mg per kg). Do not administer a damaged
pound) of body weight monthly. bolus. Because a milk withdrawal time
(ii) Indications for use. To prevent ca- has not been established, do not use in
nine heartworm disease by eliminating female dairy cattle of breeding age. Do

the tissue larval stages of Dirofilaria not slaughter cattle within 180 days of
206
treatment. Consult your veterinarian cluding C. coronatus, C. labiatus, and C.

for assistance in the diagnosis, treat- labratus; Cyathostomum spp. including
ment, and control of parasitism. C. catinatum and C. pateratum;
FR 63270, Nov. 28, 1997; 65 FR 45876, July 26, leptostomum, C. nassatus, and C.
2000; 84 FR 39183, Aug. 9, 2019] brevicapsulatus; Cylicodontophorus spp.;
Cylicostephanus spp. including C.
§ 520.1198 Ivermectin and praziquantel calicatus, C. goldi, C. longibursatus, and
paste. C. minutus, and Petrovinema poculatum;
(a) Specifications. Each milligram Small Strongyles—fourth-stage larvae;
(mg) of paste contains: Pinworms (adults and fourth-stage lar-
(1) 0.0155 mg (1.55 percent) ivermectin vae)—Oxyuris equi; Ascarids (adults and
and 0.0775 mg (7.75 percent) third- and fourth-stage larvae)—
praziquantel. Parascaris equorum; Hairworms
(2) 0.0187 mg (1.87 percent) ivermectin (adults)—Trichostrongylus axei; Large-
and 0.1403 mg (14.03 percent) mouth Stomach Worms (adults)—
praziquantel. Habronema muscae; Bots (oral and gas-
(3) 0.0187 mg (1.87 percent) ivermectin tric stages)—Gasterophilus spp. includ-
and 0.2338 mg (23.38 percent) ing G. intestinalis and G. nasalis;
praziquantel. Lungworms (adults and fourth-stage
(b) Sponsors. See sponsors in larvae)—Dictyocaulus arnfieldi; Intes-
§ 510.600(c) of this chapter for uses as in tinal Threadworms (adults)—
paragraph (d) of this section.— Strongyloides westeri; Summer Sores
(1) No. 000010 for use of product de- caused by Habronema and Draschia spp.
scribed in paragraph (a)(1) of this sec- cutaneous third-stage larvae; Derma-
tion as in paragraphs (d)(1)(i), (d)(2)(i) titis caused by neck threadworm
and (d)(3) of this section. microfilariae of Onchocerca sp.
(2) No. 051311 for use of product de- (ii) For treatment and control of the
scribed in paragraph (a)(2) of this sec- following parasites: Tapeworms—
tion as in paragraphs (d)(1)(ii), Anoplocephala perfoliata; Large
(d)(2)(ii), and (d)(3) of this section. Strongyles (adults)—Strongylus vulgaris
(3) No. 000010 for use of products de- (also early forms in blood vessels), S.
scribed in paragraph (a)(3) of this sec- edentatus (also tissue stages), S.
tion as in paragraphs (d)(1)(iii), equinus, Triodontophorus spp.; Small
(d)(2)(iii) and (d)(3) of this section. Strongyles (adults, including those re-
(c) Special considerations. See § 500.25 sistant to some benzimidazole class
of this chapter. compounds)—Cyathostomum spp.;
(d) Conditions of use in horses—(1) Cylicocyclus spp.; Cylicostephanus spp.,
Amount. (i) 200 micrograms (mcg) per Cylicodontophorus spp.; Small
kilogram (/kg) ivermectin (91 mcg per Strongyles—fourth-stage larvae;
pound (/lb)) and 1 mg/kg praziquantel Pinworms (adults and fourth-stage lar-
(454 mcg/lb) body weight. vae)—Oxyuris equi; Ascarids (adults and
(ii) 200 mcg/kg ivermectin (91 mcg/lb) third- and fourth-stage larvae)—
and 1.5 mg/kg praziquantel (681 mcg/lb) Parascaris equorum; Hairworms
body weight. (adults)—Trichostrongylus axei; Large-
(iii) 200 mcg/kg ivermectin (91 mcg/lb) mouth Stomach Worms (adults)—
and 2.5 mg/kg praziquantel (1.14 mg/lb). Habronema muscae; Bots (oral and gas-
(2) Indications for use. (i) For treat- tric stages)—Gasterophilus spp.;
ment and control of the following Lungworms (adults and fourth-stage
parasites: Tapeworms—Anoplocephala larvae)—Dictyocaulus arnfieldi; Intes-
perfoliata; Large Strongyles (adults)— tinal Threadworms (adults)—
Strongylus vulgaris (also early forms in Strongyloides westeri; Summer Sores
blood vessels), S. edentatus (also tissue caused by Habronema and Draschia spp.
stages), S. equinus, Triodontophorus spp. cutaneous third-stage larvae; Derma-
including T. brevicauda and T. serratus, titis caused by neck threadworm
and Craterostomum acuticaudatum; microfilariae, Onchocerca sp.
Small Strongyles (adults, including (iii) For treatment and control of the
those resistant to some benzimidazole following parasites in horses over 5

class compounds)—Coronocyclus spp. in- months of age: Tapeworms—
207
§ 520.1199 21 CFR Ch. I (4–1–23 Edition)
Anoplocephala perfoliata; Large (4) 272 mcg ivermectin, 228 mg

Strongyles (adults)—Strongylus vulgaris pyrantel pamoate, and 228 mg
(also early forms in blood vessels), S. praziquantel.
edentatus (also tissue stages), S. (b) Sponsor. See No. 051311 in
equinus, Triodontophorus spp. including § 510.600(c) of this chapter.
T. brevicauda and T. serratus, and (c) Conditions of use in dogs—(1)
Craterostomum acuticaudatum; Small Amount. Administer monthly according
Strongyles (adults, including those re- to body weight as follows:
sistant to some benzimidazole class (i) 6 to 12 lb: one tablet as described
compounds)—Coronocyclus spp. includ- in paragraph (a)(1) of this section.
ing C. coronatus, C. labiatus, and C. (ii) 12.1 to 25 lb: one tablet as de-
labratus; Cyathostomum spp. including
tion.
C. catinatum and C. pateratum;
(iii) 25.1 to 50 lb: one tablet as de-
leptostomum, C. nassatus, and C. tion.
brevicapsulatus; Cylicodontophorus spp.; (iv) 50.1 to 100 lb: one tablet as de-
Cylicostephanus spp. including C. scribed in paragraph (a)(4) of this sec-
calicatus, C. goldi, C. longibursatus, and tion.
C. minutus, and Petrovinema poculatum; (v) Greater than 100 lb: use the appro-
Small Strongyles—fourth-stage larvae; priate combination of tablets.
Pinworms (adults and fourth-stage lar- (2) Indications for use. To prevent ca-
vae)—Oxyuris equi; Ascarids (adults and nine heartworm disease by eliminating
third- and fourth-stage larvae)— the tissue stage of heartworm larvae
Parascaris equorum; Hairworms (Dirofilaria immitis) for 1 month (30
(adults)—Trichostrongylus axei; Large- days) after infection and for the treat-
mouth Stomach Worms (adults)— ment and control of roundworm
Habronema muscae; Bots (oral and gas- (Toxocara canis, Toxascaris leonina),
tric stages)—Gasterophilus spp. includ- hookworm (Ancylostoma caninum,
ing G. intestinalis and G. nasalis; Uncinaria stenocephala, Ancylostoma
Lungworms (adults and fourth-stage braziliense) and tapeworm (Dipylidium
larvae)—Dictyocaulus arnfieldi; Intes- caninum, Taenia pisiformis) infections.
tinal Threadworms (adults)— (3) Limitations. Federal law restricts
Strongyloides westeri; Summer Sores this drug to use by or on the order of a
caused by Habronema and Draschia spp. licensed veterinarian.
cutaneous third-stage larvae; Derma- [71 FR 65052, Nov. 7, 2006, as amended at 78
titis caused by neck threadworm FR 28822, May 20, 2014; 83 FR 14587, Apr. 5,
microfilariae of Onchocerca sp. 2018]
(3) Limitations. For oral use only. Do
not use in horses intended for human § 520.1200 Ivermectin, fenbendazole,
consumption. and praziquantel tablets.
[68 FR 55309, Sept. 25, 2003, as amended at 69 let contains either:
FR 49808, Aug. 12, 2004; 70 FR 65835, Nov. 1,
2005; 79 FR 37619, July 2, 2014; 84 FR 39183,
(1) 68 micrograms (μg) ivermectin,
Aug. 9, 2019] 1.134 grams fenbendazole, and 57 milli-
grams (mg) praziquantel; or
§ 520.1199 Ivermectin, pyrantel, and (2) 27 μg ivermectin, 454 mg
praziquantel tablets. fenbendazole, and 23 mg praziquantel.
let or soft chewable tablet contains: (c) Conditions of use in dogs—(1)
(1) 34 micrograms (mcg) ivermectin, Amount. Administer tablets to provide
28.5 milligrams (mg) pyrantel pamoate, 6 μg per kilogram (/kg) ivermectin, 100
and 28.5 mg praziquantel; mg/kg fenbendazole, and 5 mg/kg
(2) 68 mcg ivermectin, 57 mg pyrantel praziquantel.
pamoate, and 57 mg praziquantel; (2) Indications for use. For the treat-
(3) 136 mcg ivermectin, 114 mg ment and control of adult Toxocara
pyrantel pamoate, and 114 mg canis (roundworm), Ancylostoma

praziquantel; or caninum (hookworm), Trichuris vulpis
208
(whipworm), and Dipylidium caninum ages as in paragraph (e)(2)(i),

(tapeworm), and for the prevention of (e)(2)(ii)(B), and (e)(2)(iii) of this sec-
heartworm disease caused by Dirofilaria tion; and for an 18.15-g package as in
immitis in adult dogs. paragraph (e)(3) of this section.
(3) Limitations. Federal law restricts (2) No. 054771 for use of a 46.8-g pack-
this drug to use by or on the order of a age as in paragraph (e)(1)(i),
licensed veterinarian. (e)(1)(ii)(A), and (e)(1)(iii) of this sec-
[73 FR 33692, June 13, 2008, as amended at 74
tion; for 11.7- and 46.8-g packages as in
FR 61516, Nov. 25, 2009] paragraph (e)(2)(i), (e)(2)(ii)(A), and
(e)(2)(iii) of this section; and for 9.075-
§ 520.1204 Kanamycin, bismuth subcar- and 18.15-g packages as in paragraph
bonate, activated attapulgite. (e)(3) of this section.
(a) Specifications. (1) Each 5 milli- (3) No. 016592 for use of 46.8- and 544.5-
liters (mL) of suspension contains 100 g packages as in paragraphs (e)(1)(i),
milligrams (mg) kanamycin (as the (e)(1)(ii)(B), and (e)(1)(iii) and (e)(2)(i),
sulfate), 250 mg bismuth subcarbonate, (e)(2)(ii)(B), and (e)(2)(iii) of this sec-
and 500 mg activated attapulgite (alu- tion.
minum magnesium silicate). (4) No. 061133 for use of 46.8-, 362.7-,
(2) Each tablet contains 100 mg and 544.5-g packages as in paragraphs
kanamycin (as the sulfate), 250 mg bis- (e)(1)(i), (e)(1)(ii)(B), (e)(1)(iii), (e)(2)(i),
muth subcarbonate, and 500 mg acti- (e)(2)(ii)(B), and (e)(2)(iii) of this sec-
vated attapulgite. tion; and for use of an 18.15-g package
(b) Sponsor. See No. 054771 in as in paragraph (e)(3) of this section.
§ 510.600(c) of this chapter. (c) Related tolerances. See § 556.350 of
(c) Conditions of use in dogs—(1) this chapter.
Amount. 5 mL of suspension or 1 tablet (d) Special considerations. See § 500.25
per 20 pounds body weight every 8 of this chapter.
hours. Maximum dose: 5 mL of suspen- (e) Conditions of use. It is used as an
sion or 3 tablets every 8 hours. Dogs anthelmintic as follows:
under 10 pounds: 2.5 mL of suspension (1) Cattle—(i) Amount. 8 milligrams
or 1⁄2 tablet every 8 hours. A rec- per kilogram (mg/kg) body weight as a
ommended initial loading dose should drench.
be twice the amount of a single dose. (ii) Indications for use. (A) Effective
(2) Indications for use. For the treat- against the following nematode infec-
ment of bacterial enteritis caused by tions: Stomach worms (Haemonchus,
organisms susceptible to kanamycin Trichostrongylus, Ostertagia); intestinal
and the symptomatic relief of the asso- worms (Trichostrongylus, Cooperia,
ciated diarrhea. Nematodirus, Bunostomum,
(3) Limitations. Federal law restricts Oesophagostomum); and lungworms
this drug to use by or on the order of a (Dictyocaulus).
licensed veterinarian. (B) Effective against the following
adult nematode infections: Stomach
worms (Haemonchus placei, Ostertagia
FR 27851, July 25, 1988; 56 FR 8710, Mar. 1,
1991; 64 FR 403, Jan. 5, 1999; 71 FR 43968, Aug. ostertagi, Trichostrongylus axei); intes-
3, 2006; 78 FR 28822, May 20, 2014] tinal worms (T. longispicularis, Cooperia
oncophora, C. punctata, Nematodirus
§ 520.1242 Levamisole. spathiger, Bunostomum phlebotomum,
Oesophagostomum radiatum); and
§ 520.1242a Levamisole powder. lungworms (Dictyocaulus viviparus).
(a) Specifications. Each package of (iii) Limitations. Do not slaughter for
powder contains 9.075, 11.7, 18.15, 46.8, food within 48 hours of treatment. Not
362.7, or 544.5 grams (g) levamisole hy- for use in dairy animals of breeding
drochloride. age. Conditions of constant helminth
(b) Sponsors. See sponsors in exposure may require retreatment 2 to
§ 510.600(c) for use as follows: 4 weeks after the first treatment. Con-
(1) No. 000061 for use of 46.8- and 544.5- sult your veterinarian before using in
g packages as in paragraph (e)(1)(i), severely debilitated animals.
(e)(1)(ii)(B), and (e)(1)(iii) of this sec- (2) Sheep—(i) Amount. 8 mg/kg body
tion; for 11.7-, 46.8-, and 544.5-g pack- weight as a drench.
209
§ 520.1242b 21 CFR Ch. I (4–1–23 Edition)
(ii) Indications for use. (A) Effective nosis, treatment, and control of para-
against the following nematode infec- sitism.
tions: Stomach worms (Haemonchus, (d) Related tolerances. See § 556.350 of
Trichostrongylus, Ostertagia); intestinal this chapter.
worms (Trichostrongylus, Cooperia, (e) Conditions of use—(1) Cattle—(i)
Nematodirus, Bunostomum, Amount. Administer orally 2.19-gram
Oesophagostomum, Chabertia); and boluses as a single dose as follows: 250
lungworms (Dictyocaulus). to 450 pounds, 1⁄2 bolus; 450 to 750
(B) Effective against the following pounds, 1 bolus; and 750 to 1,050 pounds,
adult nematode infections: Stomach 11⁄2 boluses.
worms (Haemonchus contortus, (ii) Indications for use. Anthelmintic
Trichostrongylus axei, Teladorsagia effective against the following nema-
circumcincta); intestinal worms tode infections: Stomach worms
(Trichostrongylus colubriformis, Cooperia (Haemonchus, Trichostrongylus,
curticei, Nematodirus spathiger, Ostertagia), intestinal worms
Bunostomum trigonocephalum, (Trichostrongylus, Cooperia,
Oesophagostomum columbianum, Nematodirus, Bunostomum,
Chabertia ovina), and lungworms Oesophagostomum), and lungworms
(Dictyocaulus filaria). (Dictyocaulus).
(iii) Limitations. Do not slaughter for (iii) Limitations. Conditions of con-
food within 72 hours of treatment. Con- stant helminth exposure may require
ditions of constant helminth exposure re-treatment within 2 to 4 weeks after
may require retreatment 2 to 4 weeks the first treatment. Do not slaughter
after the first treatment. Consult vet- for food within 48 hours of treatment.
erinarian before using in severely de- Not for use in dairy animals of breed-
bilitated animals. ing age. Consult veterinarian before
(3) Swine—(i) Amount. 8 mg/kg body using in severely debilitated animals.
weight in drinking water. (2) Sheep—(i) Amount. Administer
(ii) Indications for use. Effective orally one 0.184-gram oblet for each 50
against the following nematode infec- pounds of body weight.
tions: Large roundworms (Ascaris (ii) Indications for use. Anthelmintic
suum), nodular worms effective against the following nema-
(Oesophagostomum spp.), intestinal tode infections: Stomach worms
thread worms (Strongyloides ransomi) (Haemonchus, Trichostrongylus,
and lungworms (Metastrongylus spp. ). Ostertagia), intestinal worms
(iii) Limitations. Do not administer (Trichostrongylus, Cooperia,
within 72 hours of slaughter for food. Nematodirus, Bunostomum,
Pigs maintained under conditions of Oesophagostomum, Chabertia), and
constant exposure to worms may re- lungworms (Dictyocaulus).
quire retreatment within 4 to 5 weeks (iii) Limitations. Conditions of con-
after the first treatment. Consult your stant helminth exposure may require
veterinarian before administering to re-treatment within 2 to 4 weeks after
sick swine. the first treatment. Do not slaughter
[69 FR 9753, Mar. 2, 2004, as amended at 69 FR for food within 72 hours of treatment.
33839, June 17, 2004; 70 FR 2353, Jan. 13, 2005; Consult a veterinarian before using in
77 FR 28253, May 14, 2012; 78 FR 28822, May 20, severely debilitated animals.
2014; 84 FR 8972, Mar. 13, 2019; 87 FR 58961,
Sept. 29, 2022] [78 FR 28822, May 20, 2014]
§ 520.1242b Levamisol boluses or § 520.1242c Levamisol and piperazine.

oblets. (a) Specifications. (1) Each ounce of
(a) Specifications. Each bolus contains solution contains 0.36 gram of
2.19 grams levamisol hydrochloride. levamisole hydrochloride and piper-
Each oblet contains 0.184 grams azine dihydrochloride equivalent to 3.98
levamisol hydrochloride. grams of piperazine base.
(b) Sponsors. See Nos. 000061 and (2) A soluble powder which when con-
054771 in § 510.600(c) of this chapter. stituted with water contains in each
(c) Required labeling. Consult your fluid ounce 0.45 gram of levamisole hy-
veterinarian for assistance in the diag- drochloride and piperazine
210
Food and Drug Administration, HHS § 520.1242e
dihydrochloride equivalent to 5.0 grams levamisole hydrochloride in 40 pounds

of piperazine base. of feed and administer 1 pound of medi-
(b) Sponsor. See No. 054771 in cated feed per 40 pounds of body weight
§ 510.600(c) of this chapter. as sole ration. For breeding swine, mix
(c) Conditions of use in horses—(1) 1 packet of the 10-percent resinate in 16
Amount. Aqueous solution: administer pounds of feed and administer 1 pound
by stomach tube or drench 1 fluid of medicated feed per 100 pounds of
ounce per 100 pounds of body weight. body weight as sole ration. Administer
Reconstituted soluble powder: admin- as single doses. Withhold regular feed
ister by stomach tube 1 fluid ounce per overnight and administer medicated
125 pounds of body weight. If reinfec- feed the following morning. Do not
tion occurs, re-treat animals at 6- to 8- withhold water during fasting. Do not
week intervals. treat within 72 hours of slaughter. Sali-
(2) Indications for use. An anthel-
vation or muzzle foam may be ob-
mintic effective against infections of
served. The reaction will disappear a
large strongyles (Strongylus vulgaris, S.
short time after feeding. If pigs are in-
edentatus), small strongyles
(Cylicocercus spp., Cylicocyclus spp., fected with mature lungworms,
Cylicodontophorus spp., Cylicostephanus coughing and vomiting may be ob-
spp., Cylicotetrapedon spp.), ascarids served. Consult your veterinarian for
(Parascaris equorum), and pinworms assistance in the diagnosis, treatment,
(Oxyuris equi). and control of parasitism.
(3) Limitations. Do not use in horses [43 FR 18171, Apr. 28, 1978, as amended at 45
intended for human consumption. Fed- FR 3574, Jan. 18, 1980]
on the order of a licensed veterinarian. § 520.1242e Levamisole hydrochloride
[78 FR 28823, May 20, 2014]
effervescent tablets.
§ 520.1242d Levamisole resinate. tains 907 milligrams of levamisole hy-
(a) Specifications. The drug is drochloride.
levamisole adsorbed on a resin, in a (b) Sponsor. See No. 054771 in
concentration equivalent to 10 percent § 510.600(c) of this chapter.
levamisole hydrochloride. Each 2.05- (c) Related tolerances. See § 556.350 of
ounce (58.1 gram) packet contains this chapter.
levamisole equivalent to 5.806 grams of (d) Conditions of use. It is used for
levamisole hydrochloride. swine as follows:
(b) Sponsor. See No. 043781 in (1) Amount. The equivalent of 8 milli-
grams of levamisole hydrochloride per
kilogram of body weight, as a single
this chapter.
dose.
(d) Conditions of use. In swine it is
used as follows: (2) Indications for use. See
(1) Amount. The equivalent of 8 milli- § 520.1242a(f)(3)(ii).
grams per kilogram of body weight, as (3) Limitations. Withholding water
a single dose, mixed in the animal’s ra- from pigs before treatment is not nec-
tion. essary. Add one tablet for each 21⁄2 gal-
(2) Indications for use. For the re- lons of water; mix thoroughly. Allow 1
moval of and control of the following gallon of medicated water for each 100
nematode infections: large roundworms pounds body weight of pigs to be treat-
(Ascaris suum), nodular worms ed. No other source of water should be
(Oesophagostomum spp.), lungworms offered. After pigs have consumed
(Metastrongylus spp.), intestinal medicated water, resume use of regular
threadworms (Strongyloides ransomi), water. Pigs maintained under condi-
and swine kidney worms (Stephanurus tions of constant worm exposure may
dentatum). require re-treatment within 4 to 5
(3) Limitations. For pigs from weaning weeks. Consult your veterinarian be-
to market weight, mix one 58.1-gram fore administering to sick swine. Con-
packet of levamisole resinate consult your veterinarian for assistance in

taining the equivalent of 10-percent the diagnosis, treatment, and control
211
§ 520.1242f 21 CFR Ch. I (4–1–23 Edition)
of parasitism. Do not administer with- and in the diagnosis, treatment, and

in 72 hours of slaughter for food. control of parasitism.
[45 FR 6087, Jan. 25, 1980, as amended at 67 [47 FR 22517, May 25, 1982; 47 FR 30242, July
FR 63055, Oct. 10, 2002; 78 FR 28823, May 20, 13, 1982, as amended at 48 FR 11429, Mar. 18,
2014] 1983; 51 FR 29215, Aug. 15, 1986; 67 FR 63055,
Oct. 10, 2002; 78 FR 28823, May 20, 2014]
§ 520.1242f Levamisol gel.
§ 520.1242g Levamisole resinate and
(a) Specifications. Each gram of gel
famphur paste.
contains 115 milligrams (11.5 percent)
levamisol hydrochloride. (a) Specifications. The drug is a paste
(b) Sponsor. See No. 054771 in containing 11.6 percent levamisole res-
§ 510.600(c) of this chapter. inate (50 percent potency) and 23.6 per-
(c) Related tolerances. See § 556.350 of cent famphur.
this chapter. (b) Sponsor. See 000061 in § 510.600(c) of
(d) Conditions of use—(1) Cattle—(i) this chapter.
Amount. Eight milligrams of (c) Special considerations. Do not use
levamisole hydrochloride per kilogram any cholinesterase-inhibiting drugs,
of body weight, as a single oral dose. pesticides, insecticides, or chemicals
(ii) Indications for use. Anthelmintic on cattle simultaneously or within a
effective against the following nema- few days before or after treatment with
tode infections: Stomach worms this product.
(Haemonchus, Trichostrongylus, (d) Related tolerances. See §§ 556.273
Ostertagia), intestinal worms and 556.350 of this chapter.
(Trichostrongylus, Cooperia, (e) Conditions of use in cattle—(1)
Nematodirus, Bunostomum, Amount. 8 milligrams of levamisole hy-
Oesophagostomum), and lungworms drochloride (equivalent) and 30 milli-
(Dictyocaulus). grams of famphur activity per kilo-
(iii) Limitations. Conditions of con- gram of body weight.
stant helminth exposure may require (2) Indications for use. For treatment
re-treatment within 2 to 4 weeks after of cattle infected with the following
the first treatment; do not administer parasites: Stomach worms
to cattle within 6 days of slaughter for (Haemonchus, Trichostrongylus,
food; do not administer to dairy ani- Ostertagia), intestinal worms
mals of breeding age; consult veteri- (Trichostrongylus, Cooperia,
narian before using in severely debili- Nematodirus, Bunostomum,
tated animals. Oesophagostomum), lungworms
(2) Breeding swine—(i) Amount. Eight (Dictyocaulus), cattle grubs
milligrams per kilogram of body (Hypoderma), biting lice (Bovicola), and
weight (3.6 milligrams per pound) as a sucking lice (Linognathus, Solenoptes).
single oral dose. (3) Limitations. Drug is not effective
(ii) Conditions of use. For treating against lice eggs. Conditions of con-
breeding swine infected with the fol- stant helminth and ectoparasitic expo-
lowing nematodes: Large roundworms sure may require retreatment within 2
(Ascaris suum), nodular worms to 4 weeks after first treatment. Do not
(Oesophagostomum spp.), lungworms administer to cattle within 19 days of
(Metastrongylus spp.), intestinal slaughter. Do not administer to dairy
threadworms (Strongyloides ransomi), animals of breeding age. Do not use in
and kidney worms (Stephanurus calves less than 3 months old, or in de-
dentatus). bilitated animals. Do not treat Brah-
(iii) Limitations. May require retreat- man bulls. Consult your veterinarian
ment in 4 to 5 weeks. Do not use within for assistance in the diagnosis, treat-
11 days of slaughter for food. Consult ment, and control of parasitism.
your veterinarian for assistance before [53 FR 23757, June 24, 1988, as amended at 54
using in severely debilitated animals FR 1353, Jan. 13, 1989; 57 FR 7652, Mar. 4, 1992;
62 FR 55160, Oct. 23, 1997; 62 FR 61625, Nov. 19,

1997; 78 FR 28823, May 20, 2014]
212
§ 520.1248 Levothyroxine. (b) Sponsors. See sponsor numbers in

§ 510.600(c) of this chapter as follows:
(1) Nos. 054771 and 061133 for use as in
tains 0.1, 0.2, 0.3, 0.4, 0.5, 0.6, 0.7, 0.8, or
1.0 milligrams (mg) levothyroxine so-
(2) Nos. 016592, 054925, and 076475 for
dium.
use as in paragraphs (d)(1) and (d)(2) of
this section.
061690 in § 510.600(c) of this chapter.
(c) Tolerances. See § 556.360 of this
(c) Conditions of use—(1) Amount. Ad- chapter.
minister by mouth as follows: (d) Conditions of use—(1) Swine—(i)
(i) No. 061690: 0.1 mg/10 pounds (lb) Amount. 250 milligrams per gallon of
body weight (0.022 mg/kilogram (kg)) as drinking water to provide 3.8 milli-
a single dose every 24 hours or as a di- grams per pound of body weight per
vided dose every 12 hours. day.
(ii) No. 059051: 0.1 mg/10 lb (0.01 mg/lb, (ii) Indications for use. For the treat-
0.022 mg/kg) body weight twice daily. ment of swine dysentery (bloody
(2) Indications for use. For replace- scours).
ment therapy for diminished thyroid (iii) Limitations. Discard medicated
function in dogs. drinking water if not used within 2
(3) Limitations. Federal law restricts days. Prepare fresh stock solution
this drug to use by or on the order of a daily. Do not use for more than 10 days.
licensed veterinarian. If clinical signs of disease have not im-
[81 FR 22523, Apr. 18, 2016, as amended at 86 proved within 6 days, discontinue
FR 57996, Oct. 20, 2021] treatment and reevaluate diagnosis.
The safety of lincomycin has not been
§ 520.1263 Lincomycin. demonstrated in pregnant swine or
swine intended for breeding. For No.
§ 520.1263a Lincomycin tablets and 054925: Do not slaughter swine for 6
syrup. days following last treatment. Federal
(a) Specifications. (1) Each ounce of law restricts this drug to use by or on
syrup contains lincomycin hydro- the order of a licensed veterinarian.
chloride equivalent to either 25 or 50 (2) Chickens—(i) Amount. 64 milli-
milligrams (mg) lincomycin. grams per gallon of drinking water.
(2) Each tablet contains lincomycin (ii) Indications for use. For the control
hydrochloride equivalent to either 25 of necrotic enteritis caused by Clos-
or 50 mg lincomycin. tridium perfringens susceptible to linco-
(b) Sponsor. See No. 054771 in mycin in broiler chickens.
§ 510.600(c) of this chapter. (iii) Limitations. Discard medicated
(c) Conditions of use in dogs and cats— drinking water if not used within 2
(1) Amount. Administer orally 10 mg per days. Prepare fresh stock solution
pound of body weight every 12 hours, or daily. Administer for 7 consecutive
7 mg per pound of body weight every 8 days. Do not allow rabbits, hamsters,
hours, for up to 12 days. guinea pigs, horses, or ruminants ac-
(2) Indications for use. For infections cess to water containing lincomycin.
caused by gram-positive organisms Not for use in layer and breeder chick-
which are sensitive to its action, par- ens. Federal law restricts this drug to
ticularly streptococci and use by or on the order of a licensed vet-
staphylococci. erinarian.
(3) Limitations. Federal law restricts (3) Honey bees—(i) Amount. Mix 100
this drug to use by or on the order of a milligrams lincomycin with 20 grams
licensed veterinarian. confectioners’/powdered sugar and dust
over the top bars of the brood chamber
[78 FR 28823, May 20, 2014] once weekly for 3 weeks.
(ii) Indications for use. For the control
§ 520.1263b Lincomycin powder. of American foulbrood (Paenibacillus
(a) Specifications. Each gram of solu- larvae).
ble powder contains lincomycin hydro- (iii) Limitations. The drug should be
chloride equivalent to 0.4 grams of lin- fed early in the spring or late in the
comycin. fall and consumed by the bees before
213
§ 520.1265 21 CFR Ch. I (4–1–23 Edition)
the main honey flow begins to avoid (3) Limitations. Federal law restricts
contamination of production honey. this drug to use by or on the order of a
Complete treatments at least 4 weeks licensed veterinarian.
before main honey flow. Federal law re-
stricts this drug to use by or on the FR 40881, July 15, 2005; 71 FR 71038, Dec. 8,
order of a licensed veterinarian. 2006; 77 FR 56770, Sept. 14, 2012; 78 FR 28823,
[48 FR 3966, Jan. 28, 1983, as amended at 55 May 20, 2014; 81 FR 94989, Dec. 27, 2016; 83 FR
FR 3209, Jan. 31, 1990; 60 FR 14217, Mar. 16, 48945, Sept. 28, 2018; 84 FR 8972, Mar. 13, 2019]
1995; 62 FR 65020, Dec. 10, 1997; 64 FR 13341,
Mar. 18, 1999; 64 FR 13508, Mar. 19, 1999; 64 FR § 520.1284 Liothyronine.
66382, Nov. 26, 1999; 65 FR 10705, Feb. 29, 2000; (a) Specifications. Each tablet con-
67 FR 17284, Apr. 10, 2002; 67 FR 71819, Dec. 3, tains 60 or 120 micrograms (μg)
2002; 67 FR 78356, Dec. 24, 2002; 68 FR 3817,
liothyronine as the sodium salt.
Jan. 27, 2003; 70 FR 1818, Jan. 11, 2005; 77 FR
20988, Apr. 9, 2012; 77 FR 29217, May 17, 2012; (b) Sponsor. See No. 054771 in
78 FR 28823, May 20, 2014; 81 FR 22523, Apr. 18, § 510.600(c) of this chapter.
2016; 81 FR 94989, Dec. 27, 2016; 83 FR 48945, (c) Conditions of use in dogs—(1)
Sept. 28, 2018; 84 FR 8972, Mar. 13, 2019. Redes- Amount. Administer orally to dogs at
ignated at 85 FR 18119, Apr. 1, 2020, as amend- levels up to 12.8 μg per kilogram (/kg)
ed at 88 FR 16547, Mar. 20, 2023] of body weight per day. Dosage should
be adjusted according to the severity of
§ 520.1265 Lincomycin and the condition and the response of the
spectinomycin powder.
patient. Dosage at the total replace-
(a) Specifications. The following salts ment level (12.8 μg/kg of body weight)
of lincomycin and spectinomycin are should be considered for initiating
present in a soluble powder in the ratio therapy and then titrated downward
of 1 to 2 on the basis of equivalency of for optimum maintenance effect. Twice
lincomycin base to equivalency of daily administration is recommended.
spectinomycin base: (2) Indications for use. For treatment
(1) Lincomycin hydrochloride of hypothyroidism in dogs.
monohydrate and spectinomycin sul- (3) Limitations. Federal law restricts
fate tetrahydrate. this drug to use by or on the order of a
(2) Lincomycin hydrochloride licensed veterinarian.
monohydrate and spectinomycin
dihydrochloride pentahydrate. [78 FR 28823, May 20, 2014]
(b) Sponsors. See sponsors in
§ 520.1286 Lotilaner.
§ 510.600(c) of this chapter for use as in
paragraph (d) of this section. (a) Specifications. Each chewable tab-
(1) No. 054771 for use of product de- let contains:
scribed in paragraph (a)(1) of this sec- (1) For use in dogs: 56.25, 112.5, 225,
tion. 450, or 900 milligrams (mg) lotilaner; or
(2) Nos. 016592, 061133, and 066104 for (2) For use in cats: 12 or 48 mg
use of product described in paragraph lotilaner.
(a)(2) of this section. (b) Sponsor. See No. 058198 in
(c) Tolerances. See §§ 556.360 and § 510.600(c) of this chapter.
556.600 of this chapter. (c) Conditions of use—(1) Dogs—(i)
(d) Conditions of use in chickens—(1) Amount. Administer orally once a
Amount. 2 grams of antibiotic activity month at the recommended minimum
per gallon of drinking water; admin- dosage of 9 mg/lb (20 mg/kg).
ister as the sole source of water for the (ii) Indications for use. Kills adult
first 5 to 7 days of life. fleas, and for the treatment and pre-
(2) Indications for use. As an aid in the vention of flea infestations
control of airsacculitis caused by ei- (Ctenocephalides felis), and the treat-
ther Mycoplasma synoviae or M. ment and control of tick infestations
gallisepticum susceptible to lincomycin- (Amblyomma americanum (lone star
spectinomycin and complicated chron- tick), Dermacentor variabilis (American
ic respiratory disease (air sac infec- dog tick), Ixodes scapularis (black-
tion) caused by Escherichia coli and M. legged tick), and Rhipicephalus
gallisepticum susceptible to lincomycin- sanguineus (brown dog tick)) for 1

spectinomycin. month in dogs and puppies 8 weeks of
214
age or older and weighing 4.4 pounds or nitenpyram tablets as in § 520.1510(d)(1)

greater. of this chapter is indicated to kill
(iii) Limitations. Federal law restricts adult fleas and prevent flea eggs from
this drug to use by or on the order of a hatching.
licensed veterinarian. (iii) Limitations. For use in dogs and
(2) Cats—(i) Amount. Administer oral- puppies 4 weeks of age and older.
ly once a month at the recommended (2) Cats—(i) Amount. Minimum of 30
minimum dosage of 2.7 mg/lb (6 mg/kg). mg lufenuron per kilogram (13.6 mg/lb)
(ii) Indications for use. Kills adult of body weight, once a month.
fleas, and for the treatment and pre- (ii) Indications for use—(A) For the
vention of flea infestations control of flea populations.
(Ctenocephalides felis) for 1 month in (B) The concurrent use of flavored
cats and kittens 8 weeks of age and lufenuron tablets described in para-
older, and weighing 2.0 pounds or great- graph (a)(3) of this section as in para-
er; and for the treatment and control graph (c)(2)(ii)(A) of this section with
of Ixodes scapularis (black-legged tick) nitenpyram tablets as in § 520.1510(d)(2)
for 1 month in cats and kittens 6 of this chapter is indicated to kill
months of age and older, and weighing adult fleas and prevent flea eggs from
2.0 pounds or greater. hatching.
(iii) Limitations. Federal law restricts (iii) Limitations. For use in cats and
this drug to use by or on the order of a kittens 4 weeks of age and older.
[68 FR 51905, Aug. 29, 2003]
FR 61685, Nov. 8, 2021] § 520.1289 Lufenuron suspension.
§ 520.1288 Lufenuron tablets. (a) Specifications. Each individual
dose pack contains either 135 or 270
(a) Specifications—(1) Tablets con- milligrams of lufenuron.
taining 45, 90, 204.9, or 409.8 milligrams (b) Sponsor. See No. 058198 in
(mg) lufenuron for use as in paragraphs § 510.600(c) of this chapter.
(c)(1)(i), (c)(1)(ii)(A), (c)(1)(iii), (c)(2)(i), (c) Conditions of use in cats—(1)
(c)(2)(ii)(A), and (c)(2)(iii) of this sec- Amount. Minimum of 13.6 milligrams
tion. per pound of body weight (30 milli-
(2) Flavored tablets containing 45, 90, grams per kilogram). Recommended
204.9, or 409.8 milligrams (mg) dose of 135 milligrams for up to 10
lufenuron for use as in paragraphs pounds of body weight or 270 milli-
(c)(1)(i), (c)(1)(ii)(A) or (c)(1)(ii)(B), and grams for 11 to 20 pounds. Cats over 20
(c)(1)(iii) of this section. pounds are provided the appropriate
(3) Flavored tablets containing 90 or
combination of packs.
204.9 mg lufenuron for use as in para-
(2) Indications for use. For control of
graphs (c)(2)(i), (c)(2)(ii)(A) or
flea populations.
(c)(2)(ii)(B), and (c)(2)(iii) of this sec-
(3) Limitations. For oral use in cats 6
tion.
weeks of age or older, once a month,
(4) Flavored tablets containing 135 or
mixed with food. Administer in con-
270 mg lufenuron for use as in para-
junction with a full meal to ensure ade-
graphs (c)(2)(i), (c)(2)(ii)(A), and
quate absorption. Treat all cats in the
(c)(2)(iii) of this section.
household to ensure maximum bene-
fits. Because the drug has no affect on
adult fleas, the concurrent use of insec-
(c) Conditions of use—(1) Dogs—(i)
ticides that kill adults may be nec-
Amount. Minimum of 10 mg lufenuron
essary depending on the severity of the
per kilogram (4.5 mg per pound (lb)) of
infestation.
body weight, once a month.
(ii) Indications for use—(A) For the [60 FR 20402, Apr. 26, 1995, as amended at 62
prevention and control of flea popu- FR 8371, Feb. 25, 1997]
lations.
(B) The concurrent use of flavored § 520.1310 Marbofloxacin.
lufenuron tablets described in para- (a) Specifications. Each tablet con-
graph (a)(2) of this section as in para- tains 25, 50, 100, or 200 milligrams (mg)
graph (c)(1)(ii)(A) of this section with marbofloxacin.
215
§ 520.1315 21 CFR Ch. I (4–1–23 Edition)
(b) Sponsor. See Nos. 026637 and 054771 (c) Conditions of use—(1) Horses—(i)
in § 510.600(c) of this chapter. Amount. 1 gram of mebendazole per 250
(c) [Reserved] pounds of body weight per dose, as an
(d) Conditions of use—(1) Amount. 1.25 oral powder, paste or suspension.
mg per pound (/lb) of body weight once (ii) Indications for use. For treatment
daily, but may be increased to 2.5 mg/ of infections caused by large
lb of body weight once daily. roundworms (Parascaris equorum); large
(2) Indications for use. For the treat- strongyles (Strongylus edentatus, S.
ment of infections in dogs and cats as- equinus, S. vulgaris); small strongyles;
sociated with bacteria susceptible to and mature and immature (4th larval
marbofloxacin. stage) pinworms (Oxyuris equi).
(3) Limitations. Federal law restricts (iii) Limitations. The drug is compat-
this drug to use by or on the order of a ible with carbon disulfide. Do not use
licensed veterinarian. Federal law pro- in horses intended for human consump-
hibits the extralabel use of this drug in tion. Federal law restricts this drug to
food-producing animals. use by or on the order of a licensed vet-
[64 FR 39919, July 23, 1999, as amended at 66 erinarian.
FR 46369, Sept. 5, 2001; 78 FR 28823, May 20, (2) Dogs—(i) Amount. Administer 100
2014; 85 FR 45307, July 28, 2020] milligrams of mebendazole per 10
pounds of body weight, once daily for 3
§ 520.1315 Maropitant.
days, as an oral powder by mixing with
(a) Specifications. Each tablet con- a small quantity of food, preferably be-
tains 16, 24, 60, or 160 milligrams (mg) fore the regular meal.
maropitant as maropitant citrate. (ii) Indications for use. The drug is
(b) Sponsor. See No. 054771 in used for treatment of infections of
§ 510.600(c) of this chapter. roundworms (Toxocara canis),
(c) Conditions of use in dogs—(1) Indi- hookworms (Ancylostoma caninum,
cations for use and amount. (i) For pre- Uncinaria stenocephala), whipworms
vention of acute vomiting in dogs 2 to (Trichuris vulpis), and tapeworms
7 months of age, administer a min- (Taenia pisiformis).
imum dose of 2.0 mg per kilogram (/kg)
body weight once daily for up to 5 con-
secutive days.
(ii) For prevention of acute vomiting
in dogs 7 months of age and older, ad- [78 FR 28823, May 20, 2014]
minister a minimum dose of 2.0 mg/kg
body weight once daily until resolution § 520.1326 Mebendazole and
of acute vomiting. trichlorfon oral dosage forms.
(iii) For prevention of vomiting due
to motion sickness in dogs 4 months of § 520.1326a Mebendazole and
age and older, administer a minimum trichlorfon powder.
of 8.0 mg/kg body weight once daily for (a) Specifications. Each gram of pow-
up to 2 consecutive days. der contains 83.3 milligrams of
(2) Limitations. Federal law restricts mebendazole and 375.0 milligrams of
this drug to use by or on the order of a trichlorofon.
licensed veterinarian. (b) Sponsor. See No. 000061 in
[72 FR 9243, Mar. 1, 2007, as amended at 78 FR § 510.600(c) of this chapter.
28823, May 20, 2014; 80 FR 53459, Sept. 4, 2015] (c) Conditions of use in horses—(1)
Amount. 8.8 milligrams of mebendazole
§ 520.1320 Mebendazole. and 40 milligrams of trichlorofon per
(a) Specifications. (1) Each gram of kilogram of body weight.
powder contains either 40 or 166.7 milli- (2) Indications for use. It is used in
grams of mebendazole. horses for the treatment of infections
(2) Each gram of paste contains 200 of bots (Gastrophilus intestinalis and G.
milligrams of mebendazole. nasalis), large roundworms (Parascaris
(3) Each milliliter of suspension con- equorum), large strongyles (Strongylus
tains 33.3 milligrams of mebendazole. edentatus, S. equinus, S. vulgaris), small
(b) Sponsor. See No. 000061 in strongyles, and pinworms (Oxyuris

§ 510.600(c) of this chapter. equi.)
216
(3) Limitations. Do not use in horses pounds) once daily for 5 to 7 days by
intended for human consumption. Fed- addition to the daily grain ration.
eral law restricts this drug to use by or (2) Indications for use. For the treat-
on the order of a licensed veterinarian. ment of acute or chronic inflammatory
[45 FR 10759, Feb. 19, 1980, as amended at 46 diseases involving the musculoskeletal
FR 52330, Oct. 27, 1981. Redesignated at 51 FR system.
13212, Apr. 18, 1986, as amended at 62 FR (3) Limitations. Do not use in horses
61625, Nov. 19, 1997; 78 FR 28824, May 20, 2014] intended for human consumption. Fed-
§ 520.1326b Mebendazole and on the order of a licensed veterinarian.
trichlorfon paste.
[78 FR 28824, May 20, 2014]
contains 100 milligrams of mebendazole
§ 520.1331 Meclofenamic acid tablets.
and 454 milligrams of trichlorfon.
§ 510.600(c) of this chapter. tains either 10 or 20 milligrams of
(c) Conditions of use in horses—(1) meclofenamic acid.
Amount. 8.8 milligrams of mebendazole (b) Sponsor. See No. 054771 in
and 40 milligrams of trichlorfon per § 510.600(c) of this chapter.
kilogram of body weight. (c) Conditions of use in dogs—(1)
(2) Indications for use. It is used in Amount. 1.1 milligrams per kilogram
horses for treatment of infections of (0.5 milligram per pound) daily for 5 to
bots (Gastrophilus intestinalis and G. na- 7 days.
salis), large roundworms (Parascaris (2) Indications for use. For the relief of
equorum), large strongyles (Strongylus signs and symptoms of chronic inflam-
edentatus, S. equinus, S. vulgaris), small matory disease involving the musculo-
strongyles, and pinworms (Oxyuris skeletal system.
equi). (3) Limitations. Federal law restricts
(3) Limitations. Do not administer this drug to use by or on the order of a
more than once every 30 days. Do not licensed veterinarian.
treat sick or debilitated animals, foals
under 4 months of age, or mares in the [50 FR 43385, Oct. 25, 1985, as amended at 53
last month of pregnancy. Trichlorfon is FR 23390, June 22, 1988; 78 FR 28824, May 20,
2014]
a cholinesterase inhibitor. Do not ad-
minister simultaneously or within a § 520.1341 Megestrol.
few days before or after treatment
with, or exposure to, cholinesterase-in- (a) Specifications. Each tablet con-
hibiting drugs, pesticides, or chemi- tains 5 or 20 milligrams of megestrol
cals. Do not administer intravenous acetate.
anesthetics, especially muscle relax- (b) Sponsor. See No. 000061 in
ants, concurrently. Not for use in § 510.600(c) of this chapter.
horses intended for food. Consult your (c) Conditions of use in dogs—(1)
veterinarian for assistance in the diag- Amount. Administer orally, intact, or
nosis, treatment, and control of para- crushed and mixed with food as follows:
sitism. (i) For the postponement of estrus by
[51 FR 13212, Apr. 18, 1986, as amended at 62 proestrus treatment: 1 milligram per
FR 61625, Nov. 19, 1997; 78 FR 28824, May 20, pound of body weight per day for 8
2014] days.
(ii) For the postponement of estrus
§ 520.1330 Meclofenamic acid granules. by anestrus treatment: 0.25 milligram
(a) Specifications. Each gram of gran- per pound of body weight per day for 32
ules contains 5 milligrams (5 percent) days.
meclofenamic acid. (iii) For alleviation of false preg-
(b) Sponsor. See No. 054771 in nancy: 1 milligram per pound of body
§ 510.600(c) of this chapter. weight per day for 8 days.
(c) Conditions of use in horses—(1) (2) Indications for use. For the post-
Amount. Administer 1 milligram per ponement of estrus and the alleviation

pound of body weight (1 gram per 1000 of false pregnancy in female dogs.
217
§ 520.1367 21 CFR Ch. I (4–1–23 Edition)
(3) Limitations. Federal law restricts (3) Limitations. Federal law restricts
this drug to use by or on the order of a this drug to use by or on the order of a
licensed veterinarian. licensed veterinarian.
[40 FR 13838, Mar. 27, 1975, as amended at 52 [74 FR 27707, June 11, 2009]
FR 7832, Mar. 13, 1987; 78 FR 28824, May 20,
2014] § 520.1380 Methocarbamol.
§ 520.1367 Meloxicam. tains 500 milligrams (mg) of
(a) Specifications—(1) Each milliliter methocarbamol.
of suspension contains 0.5 milligrams (b) Sponsor. See No. 054771 in
(mg) meloxicam. § 510.600(c) of this chapter.
(2) Each milliliter of suspension con- (c) Conditions of use in dogs and cats—
tains 1.5 mg meloxicam. (1) Amount. Administer 60 mg per pound
(b) Sponsors. See sponsors in of body weight in two or three equally
§ 510.600(c) of this chapter for uses as in divided doses, followed each following
day by 30 to 60 mg per pound of body
weight, usually not to exceed 14 to 21
(1) No. 000010 for use of the products
days.
described in paragraph (a) of this sec- (2) Indications for use. As an adjunct
tion; and to therapy for acute inflammatory and
(2) Nos. 013744 and 055529 for use of traumatic conditions of the skeletal
the product described in paragraph muscles in order to reduce muscular
(a)(2) of this section. spasms.
(c) Conditions of use in dogs—(1) (3) Limitations. Federal law restricts
Amount. Administer orally as a single this drug to use by or on the order of a
dose at 0.09 mg per pound (mg/lb) body licensed veterinarian.
weight (0.2 mg per kilogram (mg/kg))
[78 FR 28824, May 20, 2014]
on the first day of treatment. For all
treatment after day 1, administer 0.045 § 520.1408 Methylprednisolone.
mg/lb (0.1 mg/kg) body weight once
daily.
tains 1, 2, or 4 milligrams (mg) of
(2) Indications for use. For the control methylprednisolone.
of pain and inflammation associated (b) Sponsors. See sponsors in
with osteoarthritis. § 510.600(c) of this chapter.
(3) Limitations. Federal law restricts (1) No. 069043 for use of 1- and 2-mg
this drug to use by or on the order of a tablets.
licensed veterinarian. (2) No. 054771 for use of 1- and 4-mg
[68 FR 42968, July 21, 2003, as amended at 69 tablets.
FR 69523, Nov. 30, 2004. Redesignated and (c) Conditions of use in dogs and cats—
amended at 78 FR 57058, Sept. 17, 2013; 80 FR (1) Amount. 5 to 15 pounds (lbs): 2 mg; 15
53459, Sept. 4, 2015] to 40 lbs: 2 to 4 mg; 40 to 80 lbs: 4 to 8
mg. Administer total daily dose orally
§ 520.1372 Methimazole. in equally divided doses 6 to 10 hours
(a) Specifications. Each tablet con- apart until response is noted or 7 days
tains 2.5 or 5 milligrams (mg) have elapsed.
methimazole. (2) Indications for use. As an anti-in-
flammatory agent.
(b) Sponsor. See No. 043264 in § 510.600
of this chapter.
(c) Conditions of use in cats—(1) licensed veterinarian.
Amount. The starting dose is 2.5 mg
every 12 hours. Following 3 weeks of [78 FR 28824, May 20, 2014, as amended at 83
FR 48946, Sept. 28, 2018]
treatment, the dose should be titrated
to effect based on individual serum § 520.1409 Methylprednisolone and as-
total T4 levels and clinical response. pirin.

ment of hyperthyroidism. tains 0.5 milligram of
218
methylprednisolone and 300 milligrams body weight followed by 2 treatments

of aspirin. at 4-day intervals of 2 milligrams per
(b) Sponsor. See No. 054771 in 2.2 pounds of body weight; not for use
§ 510.600(c) of this chapter. in laying chickens; chickens slaugh-
(c) Conditions of use in dogs—(1) tered within 72 hours following treat-
Amount. Under 15 pounds, 1⁄4 to 1 tablet ment must not be used for food.
daily; 15 to 60 pounds, 1 to 2 tablets
daily; 60 pounds and over, 2 tablets
FR 17337, Mar. 29, 2011; 78 FR 28824, May 20,
daily. Administer total daily dose in 2014]
divided doses 6 to 10 hours apart, with
a light feeding. When response is at- § 520.1430 Mibolerone.
tained, dosage should be gradually re-
(a) Specifications. Each milliliter con-
duced until maintenance level is
tains 100 micrograms of mibolerone.
achieved.
(2) Indications for use. As an anti-in- (b) Sponsor. See No. 054771 in
flammatory and analgesic agent. § 510.600(c) of this chapter.
(3) Limitations. Federal law restricts (c) Conditions of use in dogs—(1)
this drug to use by or on the order of a Amount. 30 micrograms for animals
licensed veterinarian. weighing 1 to 25 pounds; 60 micrograms
for animals weighing 26 to 50 pounds;
[48 FR 21566, May 13, 1983, as amended at 78 120 micrograms for animals weighing 51
FR 28824, May 20, 2014] to 100 pounds; 180 micrograms for ani-
mals weighing over 100 pounds, German
§ 520.1422 Metoserpate hydrochloride.
Shepherds, or German Shepherd mix.
(a) Chemical name. Methyl-o-methyl- Administer daily, orally or in a small
18-epireserpate hydrochloride. amount of food, at least 30 days before
(b) Sponsor. See No. 054771 in expected initiation of heat, and con-
§ 510.600(c) of this chapter. tinue daily as long as desired, but not
(c) Related tolerances. See § 556.410 of for more than 24 months.
this chapter. (2) Indications for use. For the preven-
(d) Conditions of use. It is used in tion of estrus (heat) in adult female
drinking water for replacement chick- dogs not intended primarily for breed-
ens as follows: ing purposes.
(1) Amount. 568.5 milligrams per gal- (3) Limitations. Federal law restricts
lon (0.015 percent). this drug to use by or on the order of a
(i) Indications for use. As a tranquil- licensed veterinarian.
izer for flock treatment of chickens
prior to handling. [43 FR 15625, Apr. 14, 1978, as amended at 78
(ii) Limitations. To be used one time FR 28824, May 20, 2014]
as a treatment for replacement chick-
§ 520.1441 Milbemycin.
ens up to 16 weeks of age; usual drink-
ing water should be withheld prior to (a) Specifications. Each flavored tablet
treatment to provide adequate con- contains 2.3, 5.75, 11.5, or 23.0 milli-
sumption of medicated drinking water; grams (mg) of milbemycin oxime.
not for use in laying chickens; chick- (b) Sponsors. See Nos. 013744 and
ens slaughtered within 72 hours fol- 058198 in § 510.600(c) of this chapter.
lowing treatment must not be used for (c) Conditions of use—(1) Dogs—(i)
food. Amount. For hookworm, roundworm,
(2) Amount. 2 to 4 milligrams per 2.2 and whipworm, administer 0.23 mg per
pounds of body weight. pound (mg/lb) of body weight (0.5 mg
(i) Indications for use. As an aid in per kilogram (mg/kg)). For heartworm,
control of hysteria. administer 0.05 mg/lb of body weight
(ii) Limitations. To be used as a treat- (0.1 mg/kg). Administer once a month.
ment for replacement chickens up to 16 (ii) Indications for use. For prevention
weeks of age; usual drinking water of heartworm disease caused by
should be withheld prior to treatment Dirofilaria immitis, control of hookworm
to provide adequate consumption of infections caused by Ancylostoma
medicated drinking water; the drug caninum, and removal and control of
should be administered at a dosage adult roundworm infections caused by

level of 4 milligrams per 2.2 pounds of Toxocara canis and Toxascaris leonina
219
§ 520.1443 21 CFR Ch. I (4–1–23 Edition)
and whipworm infections caused by lets described in paragraph (a)(2) of

Trichuris vulpis in dogs and puppies 4 this section as in paragraph (d)(1)(ii)(A)
weeks of age or greater and 2 pounds of this section with nitenpyram tablets
body weight or greater. as in § 520.1510(d)(1) of this chapter is
(iii) Limitations. Federal law restricts indicated to kill adult fleas and pre-
this drug to use by or on the order of a vent flea eggs from hatching.
licensed veterinarian. (iii) Limitations. Federal law restricts
(2) Cats—(i) Amount. Administer 0.91 this drug to use by or on the order of a
mg/lb of body weight (2.0 mg/kg) once a
month.
(ii) Indications for use. For prevention (2) [Reserved]
of heartworm disease caused by [62 FR 28629, May 27, 1997, as amended at 63
Dirofilaria immitis and the removal of FR 41190, Aug. 3, 1998; 68 FR 51905, Aug. 29,
adult Toxocara cati (roundworm) and 2003. Redesignated at 77 FR 47512, Aug. 9,
Ancylostoma tubaeforme (hookworm) in- 2012, as amended at 80 FR 18776, Apr. 8, 2015;
fections in cats 6 weeks of age or great- 86 FR 13184, Mar. 8, 2021]
er and 1.5 pounds body weight or great-
er. § 520.1445 Milbemycin oxime and
(iii) Limitations. Federal law restricts praziquantel.
this drug to use by or on the order of a (a) Specifications. Each chewable tab-
licensed veterinarian. let contains:
[84 FR 12494, Apr. 2, 2019] (1) 2.3 milligrams (mg) milbemycin
oxime and 22.8 mg praziquantel;
§ 520.1443 Milbemycin oxime and (2) 5.75 mg milbemycin oxime and 57
lufenuron. mg praziquantel;
(a) Specifications. (1) Tablets con- (3) 11.5 mg milbemycin oxime and 114
taining: 2.3 milligrams (mg) mg praziquantel; or
milbemycin oxime and 46 mg (4) 23 mg milbemycin oxime and 228
lufenuron, 5.75 mg milbemycin oxime mg praziquantel.
and 115 mg lufenuron, 11.5 mg (b) Sponsor. See No. 058198 in
milbemycin oxime and 230 mg § 510.600(c) of this chapter.
lufenuron, or 23 mg milbemycin oxime
and 460 mg lufenuron.
Amount. Administer orally, once a
(2) Flavored tablets containing: 2.3
mg milbemycin oxime and 46 mg month, a minimum dosage of 0.23 mg
lufenuron, 5.75 mg milbemycin oxime per pound (mg/lb) of body weight (0.5
and 115 mg lufenuron, 11.5 mg mg per kilogram (mg/kg)) milbemycin
milbemycin oxime and 230 mg oxime and 2.28 mg/lb of body weight (5
lufenuron, or 23 mg milbemycin oxime mg/kg) praziquantel.
and 460 mg lufenuron. (ii) Indications for use. For the pre-
(b) Sponsor. See No. 000061 in vention of heartworm disease caused
§ 510.600(c) of this chapter. by Dirofilaria immitis and for the treat-
(c) [Reserved] ment and control of adult roundworm
(d) Conditions of use—(1) Dogs—(i) (Toxocara canis, Toxascaris leonina),
Amount. 0.5 mg milbemycin oxime and adult hookworm (Ancylostoma
10 mg lufenuron per kilogram of body caninum), adult whipworm (Trichuris
weight, once a month. vulpis), and adult tapeworm (Taenia
(ii) Indications for use. (A) For use in pisiformis, Echinococcus multilocularis, E.
dogs and puppies for the prevention of granulosus, and Dipylidium caninum) in-
heartworm disease caused by Dirofilaria fections in dogs and puppies 2 pounds of
immitis, for prevention and control of body weight or greater and 6 weeks of
flea populations, for control of adult age and older.
Ancylostoma caninum (hookworm), and (iii) Limitations. Federal law restricts
for removal and control of adult this drug to use by or on the order of a
Toxocara canis, Toxascaris leonina licensed veterinarian.
(roundworm), and Trichuris vulpis
(2) [Reserved]
(whipworm) infections.
(B) The concurrent use of flavored [77 FR 47512, Aug. 9, 2012, as amended at 82
milbemycin oxime and lufenuron tab- FR 58556, Dec. 13, 2017]
220
§ 520.1447 Milbemycin oxime, divided in half for more accurate dos-

lufenuron, and praziquantel tablets. ing as follows: up to 325 pounds, 1⁄2
(a) Specifications. Each tablet con- bolus; 326 to 600 pounds, 1 bolus; 601 to
tains: 900 pounds, 11⁄2 boluses; and 901 to 1,200
(1) 2.3 milligrams (mg) milbemycin pounds, 2 boluses.
oxime, 46 mg lufenuron, and 22.8 mg (2) Indications for use. For removal
praziquantel; and control of mature gastrointestinal
(2) 5.75 mg milbemycin oxime, 115 mg nematode infections of cattle including
lufenuron, and 57 mg praziquantel; stomach worms (Haemonchus spp.,
(3) 11.5 mg milbemycin oxime, 230 mg Ostertagia spp., Trichostrongylus spp.),
lufenuron, and 114 mg praziquantel; or worms of the small intestine (Cooperia
(4) 23 mg milbemycin oxime, 460 mg spp., Trichostrongylus spp., Nematodirus
lufenuron, and 228 mg praziquantel. spp.), and worms of the large intestine
(b) Sponsor. See No. 000061 in (Oesophagostomum radiatum).
(3) Limitations. Conditions of constant
(c) [Reserved]
(d) Conditions of use—(1) Dogs—(i) worm exposure may require retreat-
Amount. 0.5 mg milbemycin oxime, 10 ment in 2 to 4 weeks. Consult your vet-
mg lufenuron, and 5 mg of praziquantel erinarian before administering to se-
per kilogram of body weight, once a verely debilitated animals and for as-
month. sistance in the diagnosis, treatment,
(ii) Indications for use. For the pre- and control of parasitism. Do not treat
vention of heartworm disease caused within 14 days of slaughter.
by Dirofilaria immitis; for the prevention [46 FR 50949, Oct. 16, 1981. Redesignated at 49
and control of flea populations FR 47831, Dec. 7, 1984, and amended at 51 FR
(Ctenocephalides felis); and for the treat- 9005, Mar. 17, 1986; 78 FR 28825, May 20, 2014]
ment and control of adult roundworm
(Toxocara canis, Toxascaris leonina), § 520.1450b Morantel tartrate car-
adult hookworm (Ancylostoma tridge.
caninum), adult whipworm (Trichuris
(a) Specifications. The drug product
vulpis), and adult tapeworm (Dipylidium
consists of a stainless-steel cylinder
caninum, Taenia pisiformis, Echinococcus
multilocularis, and E. granulosus) infec- having both ends closed with poly-
tions in dogs and puppies 2 pounds of ethylene diffusing discs and containing
body weight or greater and 6 weeks of a morantel tartrate paste. The paste
age and older. contains 22.7 grams of morantel tar-
(iii) Limitations. Federal law restricts trate equivalent to 13.5 grams of
this drug to use by or on the order of a morantel base.
(2) [Reserved] § 510.600(c) of this chapter.
[77 FR 4225, Jan. 27, 2012, as amended at 80 (c) Related tolerances. See § 556.425 of
FR 18776, Apr. 8, 2015; 83 FR 13635, Mar. 30, this chapter.
2018; 86 FR 13184, Mar. 8, 2021] (d) Conditions of use—(1) Amount.
Grazing cattle: Administer 1 cartridge
§ 520.1450 Morantel tartrate oral dos- to each animal at the start of the graz-
age forms.
ing season.
§ 520.1450a Morantel tartrate bolus. (2) Indications for use. For control of
the adult stage of the following gastro-
(a) Specifications. Each bolus contains
2.2 grams morantel tartrate equivalent intestinal nematode infections in
to 1.3 grams of morantel base. weaned calves and yearling cattle
(b) Sponsor. See No. 054771 in weighing a minimum of 200 pounds:
§ 510.600(c) of this chapter. Ostertagia spp., Trichostrongylus axei,
(c) Related tolerances. See § 556.425 of Cooperia spp., and Oesophagostomum
this chapter. radiatum.
(d) Conditions of use—(1) Amount. One (3) Limitations. Administer orally
bolus per 500 pounds of body weight (4.4 with the dosing gun to all cattle that
milligrams per pound of body weight)

as a single oral dose. Boluses may be
221
§ 520.1450c 21 CFR Ch. I (4–1–23 Edition)
will be grazing the same pasture. Effec- mals and for assistance in the diag-
tiveness of the drug product is depend- nosis, treatment, and control of para-
ent upon continuous control of the gas- sitism.
trointestinal parasites for approxi-
mately 90 days following administra- FR 28825, May 20, 2014]
tion. Therefore, treated cattle should
not be moved to pastures grazed in the § 520.1451 Moxidectin tablets.
same grazing season/calendar year by
untreated cattle. Do not administer to
tains 30, 68, or 136 micrograms of
cattle within 106 days of slaughter.
moxidectin.
Consult your veterinarian before ad-
ministering to severely debilitated ani-
mals and for assistance in the diag-
(c) Conditions of use—(1) Amount. 3
nosis, treatment, and control of para-
micrograms per kilogram (1.36
sitism.
micrograms per pound) of body weight.
[49 FR 47831, Dec. 7, 1984, as amended at 51 (2) Indications for use. To prevent in-
FR 23415, June 27, 1986; 51 FR 41081, Nov. 13, fection by the canine heartworm
1986; 78 FR 28825, May 20, 2014] Dirofilaria immitis and the subsequent
§ 520.1450c Morantel tartrate sus- development of canine heartworm dis-
tained-release trilaminate cylinder/ ease.
sheet. (3) Limitations. Federal law restricts
(a) Specifications. The drug product
consists of a trilaminated, perforated,
plastic sheet formed into a cylinder [62 FR 37713, July 15, 1997, as amended at 78
having plastic plugs in its ends. The FR 28825, May 20, 2014]
core lamina contains 19.8 grams of
morantel tartrate equivalent to 11.8 § 520.1452 Moxidectin gel.
grams of morantel base. (a) Specifications. Each milliliter of
(b) Sponsor. See 054771 in § 510.600(c) of gel contains 20 milligrams (2 percent)
this chapter. moxidectin.
(c) Related tolerances. See § 556.425 of (b) Sponsor. See No. 054771 in
this chapter. § 510.600(c) of this chapter.
(d) Conditions of use—(1) Amount. (c) Special considerations. See § 500.25
Grazing cattle: Administer 1 cartridge of this chapter.
to each animal at the start of the graz- (d) Conditions of use in horses and
ing season. ponies—(1) Amount. 0.4 milligram
(2) Indications for use. For control of moxidectin per kilogram (2.2 pounds) of
the adult stage of the following gastro- body weight.
intestinal nematode infections in (2) Indications for use. For the treat-
weaned calves and yearling cattle ment and control of large strongyles:
weighing a minimum of 200 pounds: Strongylus vulgaris (adults and L4/L5 ar-
Ostertagia spp., Trichostrongylus axei, terial stages), S. edentatus (adult and
Cooperia spp., and Oesophagostomum tissue stages), Triodontophorus
radiatum. brevicauda (adults), and T. serratus
(3) Limitations. Administer orally (adults); small strongyles (adults):
with the dosing gun to all cattle that Cyathostomum spp., including C.
will be grazing the same pasture. Effec- catinatum and C. pateratum;
tiveness of the drug product is depend- Cylicocyclus. spp., including C. insigne,
ent upon continuous control of the gas- C. leptostomum, C. nassatus, and C.
trointestinal parasites for approxi- radiatus; Cyliocostephanus spp., includ-
mately 90 days following administra- ing C. calicatus, C. goldi, C.
tion. Therefore, treated cattle should longibursatus, and C. minutus;
not be moved to pastures grazed in the Coronocyclus spp., including C.
same grazing season/calendar year by coronatus, C. labiatus, and C. labratus;
untreated cattle. Do not administer to Gyalocephalus capitatus; and
cattle within 102 days of slaughter. Petrovinema poculatus; small
Consult your veterinarian before ad- strongyles: undifferentiated lumenal

ministering to severely debilitated ani- larvae; encysted cyathostomes (late L3
222
and L4 mucosal cyathostome larvae); Habronema muscae (adults); horse stom-

ascarids: Parascaris equorum (adults and ach bots: Gasterophilus intestinalis (2nd
L4 larval stages); pinworms: Oxyuris and 3rd instars) and G. nasalis (3rd
equi (adults and L4 larval stages); instars); and tapeworms: Anoplocephala
hairworms: Trichostrongylus axei perfoliata (adults). One dose also sup-
(adults); large-mouth stomach worms: presses strongyle egg production for 84
Habronema muscae (adults); and horse days.
stomach bots: Gasterophilus intestinalis (3) Limitations. Do not use in horses
(2nd and 3rd instars) and G. nasalis (3rd intended for human consumption.
instars). One dose also suppresses [68 FR 51446, Aug. 27, 2003, as amended at 69
strongyle egg production for 84 days. FR 21956, Apr. 23, 2004; 70 FR 75017, Dec. 19,
(3) Limitations. Do not use in horses 2005; 78 FR 28825, May 20, 2014]
§ 520.1454 Moxidectin solution.
FR 66105, Nov. 24, 1999; 68 FR 51445, Aug. 27, (a) Specifications. Each milliliter
2003; 69 FR 24959, May 5, 2004; 70 FR 75017, (mL) of solution contains 1 milligram
Dec. 19, 2005; 78 FR 28825, May 20, 2014] (mg) moxidectin.
§ 520.1453 Moxidectin and § 510.600(c) of this chapter.
praziquantel gel. (c) Related tolerances. See § 556.426 of
(a) Specifications. Each milliliter of this chapter.
gel contains 20 milligrams (mg) (2.0 (d) Special considerations. See § 500.25
percent) moxidectin and 125 mg (12.5 of this chapter.
percent) praziquantel. (e) Conditions of use in sheep—(1)
(b) Sponsor. See No. 054771 in Amount. Administer 1 mL per 11 pounds
§ 510.600(c) of this chapter. body weight (1 mL per 5 kilograms) by
(c) Special considerations. See § 500.25 mouth.
of this chapter. (2) Indications for use. For the treat-
(d) Conditions of use in horses and ment and control of the adult and L4
ponies—(1) Amount. Administer by larval stages of Haemonchus contortus,
mouth as a single dose: 0.4 mg Teladorsagia circumcincta, T. trifurcata,
moxidectin per kilogram and 2.5 mg Trichostrongylus axei, T. colubriformis, T.
praziquantel per kilogram (2.2 pounds) vitrinus, Cooperia curticei, C. oncophora,
body weight. Oesophagostomum columbianum, O.
(2) Indications for use. For the treat- venulosum, Nematodirus battus, N.
ment and control of large strongyles: filicollis, and N. spathiger.
Strongylus vulgaris (adults and L4/L5 ar- (3) Limitations. Sheep must not be
terial stages), S. edentatus (adult and slaughtered for human consumption
tissue stages), Triodontophorus within 7 days of treatment. Because a
brevicauda (adults), and T. serratus withholding time in milk has not been
(adults); small strongyles (adults): established for this product, do not use
(Cyathostomum spp., including C. in female sheep providing milk for
catinatum and C. pateratum; Cylicocyclus human consumption.
spp., including C. insigne, C. [70 FR 76163, Dec. 23, 2005, as amended at 76
leptostomum, C. nassatus, and C. FR 48714, Aug. 9, 2011; 82 FR 21690, May 10,
radiatus; Cylicostephanus spp., including 2017; 86 FR 14818, Mar. 19, 2021]
C. calicatus, C. goldi, C. longibursatus,
and C. minutus; Coronocyclus spp., in- § 520.1468 Naproxen.
cluding C. coronatus, C. labiatus, and C. (a) Specifications. Each gram of gran-
labratus; Gyalocephalus capitatus; and ules contains 500 milligrams (mg) (50
Petrovinema poculatus; small percent) naproxen.
strongyles: undifferentiated lumenal (b) Sponsor. See No. 054771 in
larvae; encysted cyathostomes (late L3 § 510.600(c) of this chapter.
and L4 mucosal cyathostome larvae); (c) Conditions of use in horses—(1)
ascarids: Parascaris equorum (adults and Amount. 10 mg per kilogram of body
L4 larval stages); pinworms: Oxyuris weight twice daily top dressed on feed
equi (adults and L4 larval stages); for up to 14 consecutive days.
hairworms: Trichostrongylus axei (2) Indications for use. For the relief of
(adults); large-mouth stomach worms: inflammation and associated pain and
223
§ 520.1484 21 CFR Ch. I (4–1–23 Edition)
lameness exhibited with arthritis, as drug to use by or on the order of a li-

well as myositis and other soft tissue censed veterinarian.
diseases of the musculoskeletal sys- (2) Turkeys—(i) Amount. 10 mg/lb of
tem. body weight per day (22 mg/kg) for 5
(3) Limitations. Do not use in horses days.
intended for human consumption. Fed- (ii) Indications for use. For the control
eral law restricts this drug to use by or of mortality associated with E. coli sus-
on the order of a licensed veterinarian. ceptible to neomycin sulfate in grow-
[78 FR 28825, May 20, 2014] ing turkeys.
§ 520.1484 Neomycin. this drug to use by or on the order of a
(a) Specifications. (1) Each ounce of
powder contains 20.3 grams (g) neomy- [71 FR 56866, Sept. 28, 2006, as amended at 71
cin sulfate (equivalent to 14.2 g neomy- FR 68738, Nov. 28, 2006; 78 FR 17596, Mar. 22,
cin base). 2013; 78 FR 28825, May 20, 2014; 81 FR 22523,
(2) Each milliliter of solution con- Apr. 18, 2016; 81 FR 94989, Dec. 27, 2016; 84 FR
8973, Mar. 13, 2019]
tains 200 milligrams (mg) neomycin
sulfate (equivalent to 140 mg neomycin § 520.1510 Nitenpyram.
base).
(b) Sponsors. See sponsors in (a) Specifications. Each tablet con-
§ 510.600(c) of this chapter for use as in tains 11.4 or 57 milligrams (mg)
paragraph (e) of this section. nitenpyram.
(1) Nos. 054771 and 054925 for use of (b) Sponsors. See sponsor numbers in
product described in paragraph (a)(1) as § 510.600(c) of this chapter:
in paragraph (e)(1) of this section. (1) No. 021091 for use as in paragraphs
(2) Nos. 016592, 054771, 058005, and (d)(1)(i)(A), (d)(1)(ii)(A), and (d)(2) of
061133 for use of product described in this section.
paragraph (a)(1) as in paragraphs (e)(1) (2) No. 000061 for use as in paragraphs
and (e)(2) of this section. (d)(1)(i)(B) and (d)(1)(ii)(B) of this sec-
(3) Nos. 016592, 054771, 054925, and tion.
058005 for use of product described in (c) Special considerations. The concur-
paragraph (a)(2) as in paragraph (e)(1) rent use of nitenpyram tablets and fla-
of this section. vored milbemycin/lufenuron tablets as
(c) Related tolerances. See § 556.430 of in paragraph (d)(1)(ii)(B) of this section
this chapter. shall be by or on the order of a licensed
(d) Special labeling considerations. La- veterinarian.
beling shall bear the following warning (d) Conditions of use—(1) Dogs—(i)
statements: ‘‘A withdrawal period has Amount. (A) One 11.4-mg tablet for dogs
not been established for use in weighing less than 25 pounds (lb) or one
preruminating calves. Do not use in 57-mg tablet for dogs weighing more
calves to be processed for veal. Use of than 25 lb, as needed, for use as in para-
more than one product containing neo- graph (d)(1)(ii)(A) of this section.
mycin or failure to follow withdrawal (B) One 11.4-mg tablet for dogs weigh-
times may result in illegal drug resi- ing less than 25 lb or one 57 mg tablet
dues.’’ for dogs weighing more than 25 lbs,
(e) Conditions of use—(1) Cattle, swine, once or twice weekly, for use as in
sheep, and goats—(i) Amount. 10 mg per paragraph (d)(1)(ii)(B) of this section.
pound (/lb) of body weight per day (22 (ii) Indications for use. (A) For the
mg per kilogram (/kg)) in divided doses treatment of flea infestations on dogs
for a maximum of 14 days. and puppies 4 weeks of age and older
(ii) Indications for use. For the treat- and 2 lbs of body weight or greater.
ment and control of colibacillosis (bac- (B) The concurrent use of nitenpyram
terial enteritis) caused by Escherichia tablets as in paragraph (d)(1)(i)(B) of
coli susceptible to neomycin sulfate. this section with either flavored
(iii) Limitations. Discontinue treat- lufenuron tablets as in § 520.1288(c)(1) of
ment prior to slaughter as follows: Cat- this chapter or flavored milbemycin
tle, 1 day; sheep, 2 days; swine and and lufenuron tablets as in

goats, 3 days. Federal law restricts this § 520.1443(d)(1) is indicated to kill adult
224
fleas and prevent flea eggs from hatch- gram (mg/kg)) once daily for 4 weeks.
ing. For prevention of recurrence of gastric
(2) Cats—(i) Amount. (A) One 11.4-mg ulcers, 0.9 mg/lb of body weight (2 mg/
tablet, as needed, for use as in para- kg) once daily for at least an addi-
graph (d)(2)(ii)(A) of this section. tional 4 weeks.
(B) One 11.4-mg tablet, once or twice (ii) For prevention of gastric ulcers
weekly, for use as in paragraph using the premarked syringe, one dose
(d)(2)(ii)(B) of this section. per day for 8 or 28 days. Each dose de-
(ii) Indications for use. (A) For the livers at least 1 mg/kg of body weight.
treatment of flea infestations on cats Horses over 1,200 lb body weight should
and kittens 4 weeks of age and older receive two doses per day.
and 2 lbs of body weight or greater. (2) Indications for use. (i) For treat-
(B) The concurrent use of nitenpyram ment and prevention of recurrence of
tablets as in paragraph (d)(2)(i)(B) of gastric ulcers in horses and foals 4
this section with flavored lufenuron weeks of age and older.
tablets as in § 520.1288(c)(2) of this chap- (ii) For prevention of gastric ulcers
ter is indicated to kill adult fleas and in horses.
prevent flea eggs from hatching. (3) Limitations. Do not use in horses
[68 FR 51906, Aug. 29, 2003, as amended at 80 intended for human consumption.
FR 18776, Apr. 8, 2015; 86 FR 13184, Mar. 8,
2021; 86 FR 57997, Oct. 20, 2021]
FR 59374, Oct. 10, 2006; 84 FR 39183, Aug. 9,
2019]
§ 520.1604 Oclacitinib.
(a) Specifications. Each tablet con- § 520.1616 Orbifloxacin tablets.
tains 3.6, 5.4, or 16 milligrams (mg) of
oclacitinib as oclacitinib maleate.
tains 5.7, 22.7, or 68 milligrams (mg)
orbifloxacin.
minister orally 0.18 to 0.27 mg/per
pound of body weight (0.4 to 0.6 mg/kg (c) Conditions of use in dogs and cats—
body weight) twice daily for up to 14 (1) Amount. 2.5 to 7.5 mg per kilogram
days; then administered once daily for body weight once daily.
maintenance therapy. (2) Indications for use. For manage-
(2) Indications for use. For control of ment of diseases associated with bac-
pruritus associated with allergic der- teria susceptible to orbifloxacin.
matitis and control of atopic derma- (3) Limitations. Federal law restricts
titis in dogs at least 12 months of age. this drug to use by or on the order of a
(3) Limitations. Federal law restricts licensed veterinarian. Federal law pro-
this drug to use by or on the order of a hibits the extralabel use of this drug in
licensed veterinarian. food producing animals.
[78 FR 42007, July 15, 2013] [71 FR 14643, Mar. 23, 2006, as amended at 75
FR 26646, May 12, 2010]
§ 520.1615 Omeprazole.
§ 520.1618 Orbifloxacin suspension.
contains 0.37 gram omeprazole. (a) Specifications. Each milliliter of
(b) Sponsor. See No. 000010 in suspension contains 30 milligrams (mg)
§ 510.600(c) of this chapter. orbifloxacin.
(c) Special considerations. When la- (b) Sponsor. See No. 000061 in
beled for use as in paragraph (d)(2)(i) of 510.600(c) of this chapter.
this section, product labeling shall (c) Special considerations. Federal law
bear: ‘‘Federal law restricts this drug restricts this drug to use by or on the
to use by or on the order of a licensed order of a licensed veterinarian. Fed-
veterinarian.’’ eral law prohibits the extralabel use of
(d) Conditions of use in horses—(1) this drug in food-producing animals.
Amount. (i) For treatment of gastric ul- (d) Conditions of use—(1) Dogs—(i)
cers, 1.8 milligrams per pound (mg/lb) Amount. 1.1 to 3.4 mg/lb (2.5 to 7.5 mg/
of body weight (4 milligrams per kilo- kg) of body weight once daily.
225
§ 520.1628 21 CFR Ch. I (4–1–23 Edition)
(ii) Indications for use. For the treat- (ii) Pellets. The drug is given by sprin-
ment of urinary tract infections (cys- kling on the grain portion of the ra-
titis) in dogs caused by susceptible tion. Withholding feed or water prior
strains of Staphylococcus to administration is not necessary. Ad-
pseudintermedius, Proteus mirabilis, Esch- minister drug with caution to sick or
erichia coli, and Enterococcus faecalis debilitated horses. Not for use in
and skin and soft tissue infections horses intended for food. Consult your
(wounds and abscesses) in dogs caused veterinarian for assistance in the diag-
by susceptible strains of Staphylococcus nosis, treatment, and control of para-
pseudintermedius, Staphylococcus aureus, sitism.
coagulase-positive staphylococci,
Pasteurella multocida, Proteus mirabilis, FR 26301, May 12, 1981; 46 FR 60570, Dec. 11,
Pseudomonas spp., Klebsiella 1981; 49 FR 28549, July 13, 1984; 61 FR 5506,
pneumoniae, E. coli, Enterobacter spp., Feb. 13, 1996; 78 FR 28825, May 20, 2014]
Citrobacter spp., E. faecalis, b-hemolytic
streptococci (Group G), and Strepto- § 520.1629 Oxfendazole paste.
coccus equisimilis. (a)(1) Specifications. Each gram of
(2) Cats—(i) Amount. 3.4 mg/lb (7.5 mg/ paste contains 0.375 gram oxfendazole
kg) of body weight once daily. (37.5 percent).
(ii) Indications for use. For the treat- (2) Sponsor. See No. 054771 in
ment of skin infections (wounds and § 510.600(c) of this chapter.
abscesses) in cats caused by susceptible (3) Conditions of use—(i) Amount. 10
strains of S. aureus, E. coli, and P. milligrams per kilogram (2.2 pounds) of
multocida. body weight.
[75 FR 26646, May 12, 2010] (ii) Indications for use. The drug is
used in horses for removal of the fol-
§ 520.1628 Oxfendazole powder and lowing gastrointestinal worms: Large
pellets. roundworms (Parascaris equorum), ma-
(a) Specifications—(1) Powder for sus- ture and 4th stage larvae pinworms
pension. Each gram of powder contains (Oxyuris equi), large strongyles
7.57 percent oxfendazole. (Strongylus edentatus, S. vulgaris, and S.
(2) Pellets. Each gram of pellets con- equinus), and small strongyles.
tains 6.49 percent oxfendazole. (iii) Limitations. Horses maintained
(b) Sponsor. See No. 054771 in on premises where reinfection is likely
§ 510.600(c) of this chapter. to occur should be retreated in 6 to 8
(c) Conditions of use—(1) Amount. 10 weeks. Withholding feed or water prior
milligrams per kilogram of body to use is unnecessary. Administer drug
weight. with caution to sick or debilitated
(2) Indications for use. The drug is horses. Not for use in horses intended
used in horses for removal of the fol- for food. Consult your veterinarian for
lowing gastrointestinal worms: Large assistance in the diagnosis, treatment,
roundworms (Parascaris equorum), ma- and control of parasitism.
ture and immature pinworms (Oxyuris (b)(1) Specifications. Each gram of
equi), large strongyles (Strongylus paste contains 185 milligrams of
edentatus, Strongylus vulgaris, and oxfendazole (18.5 percent).
Strongylus equinus), and small (2) Sponsor. See No. 054771 in
strongyles. § 510.600(c) of this chapter.
(3) Limitations—(i) Powder for suspen- (3) Related tolerances. See § 556.495 of
sion. For gravity administration via this chapter.
stomach tube or for positive adminis- (4) Conditions of use—(i) Amount. 4.5
tration via stomach tube and dose sy- milligrams per kilogram of body
ringe. Discard unused portions of sus- weight (2.05 milligrams per pound).
pension after 24 hours. Mix drug ac- (ii) Indications for use. The drug is
cording to directions prior to use. Ad- used in cattle for the removal and con-
minister drug with caution to sick or trol of the following worms: lungworms
debilitated horses. Not for use in (Dictyocaulus viviparus—adult, L4);
horses intended for food. Federal law stomach worms: barberpole worms
restricts this drug to use by or on the (Haemonchus contortus and H. placei—

order of a licensed veterinarian. adult), small stomach worms
226
(Trichostrongylus axei—adult), brown (i) Amount. 4.5 mg/kg of body weight

stomach worms (Ostertagia ostertagi— by dose syringe. Treatment may be re-
adult, L4, inhibited L4); intestinal peated in 4 to 6 weeks.
worms; nodular worms (ii) Indications for use. For the re-
(Oesophagostomum radiatum—adult), moval and control of: lungworms
hookworms (Bunostomum (Dictyocaulus viviparus—adult, L4);
phlebotomum—adult), small intestinal stomach worms: barberpole worms
worms (Cooperia punctata, C. oncophora, (Haemonchus contortus and H. placei—
and C. mcmasteri—adult, L4); and tape- adult), small stomach worms
worms (Moniezia benedeni—adult). (Trichostrongylus axei—adult), brown
(iii) Limitations. For use in cattle stomach worms (Ostertagia ostertagi—
only. Treatment may be repeated in 4 adult, L4, inhibited L4); intestinal
to 6 weeks. Cattle must not be slaugh- worms; nodular worms
tered until 11 days after treatment. Do (Oesophagostomum radiatum—adult),
not use in female dairy cattle of breed- hookworms (Bunostomum
ing age. Consult a veterinarian for as- phlebotomum—adult), small intestinal
sistance in the diagnosis, treatment, worms (Cooperia punctata, C. oncophora,
and control of parasitism. and C. surnabada—adult, L4), and tape-
[49 FR 38250, Sept. 28, 1984, as amended at 58 worms (Moniezia benedeni—adult).
FR 39443, July 23, 1993; 61 FR 5506, Feb. 13, (iii) Limitations. Cattle must not be
1996; 78 FR 28825, May 20, 2014] slaughtered until 7 days after treat-
ment. Because a withdrawal time in
§ 520.1630 Oxfendazole suspension. milk has not been established, do not
(a) Specifications. Each milliliter of use in female dairy cattle of breeding
suspension contains: age.
(1) 90.6 milligrams (mg) oxfendazole [55 FR 46943, Nov. 8, 1990, as amended at 56
(9.06 percent). FR 8710, Mar. 1, 1991; 61 FR 5506, Feb. 13, 1996;
(2) 225.0 mg oxfendazole (22.5 percent). 72 FR 10596, Mar. 9, 2007; 73 FR 45610, Aug. 6,
(b) Sponsor. See Nos. 000010 and 054771 2008; 75 FR 10166, Mar. 5, 2010; 78 FR 28825,
in § 510.600(c) of this chapter. May 20, 2014]
this chapter. § 520.1631 Oxfendazole and trichlorfon
paste.
(d) Special considerations. See § 500.25
of this chapter. If labeled for adminis- (a) Specifications. Each gram of paste
tration by stomach tube: Federal law contains 28.5 milligrams oxfendazole
restricts this drug to use by or on the and 454.5 milligrams trichlorfon.
order of a licensed veterinarian. (b) Sponsor. See 054771 in § 510.600(c) of
(e) Conditions of use—(1) Horses. Use this chapter.
the product described in paragraph (c) Conditions of use—(1) Amount. 2.5
(a)(1) of this section as follows: milligrams of oxfendazole and 40 milli-
(i) Amount. 10 mg per kilogram (/kg) grams of trichlorfon per kilogram of
of body weight by stomach tube or dose body weight.
syringe. Horses maintained on prem- (2) Indications for use. The drug is
ises where reinfection is likely to occur used in horses for removal of bots
should be retreated in 6 to 8 weeks. (Gasterophilus intestinalis, 2nd and 3rd
(ii) Indications for use. For removal of instars; G. nasalis, 3rd instar) and the
large roundworms (Parascaris equorum), following gastrointestinal worms:
mature and 4th stage larvae pinworms Large roundworms (Parascaris
(Oxyuris equi), large strongyles equorum), pinworms (Oxyuris equi),
(Strongylus edentatus, S. vulgaris, and S. adult and 4th stage larvae; large
equinus), and small strongyles. strongyles (Strongylus edentatus, S.
(iii) Limitations. Withholding feed or vulgaris, and S. equinus); and small
water prior to use is unnecessary. Ad- strongyles.
minister drug with caution to sick or (3) Limitations. Horses maintained on
debilitated horses. Do not use in horses premises where reinfection is likely to
intended for human consumption. occur should be retreated in 6 to 8
(2) Cattle. Use the products described weeks. Withholding feed or water be-
in paragraphs (a)(1) and (a)(2) of this fore use is unnecessary. Administer

section as follows: with caution to sick or debilitated
227
§ 520.1638 21 CFR Ch. I (4–1–23 Edition)
horses. Not for use in horses intended § 520.1660 Oxytetracycline.

for food. Do not administer to mares
during the last month of pregnancy. § 520.1660a Oxytetracycline and
Trichlorfon is a cholinesterase inhib- carbomycin.
itor. Do not use this product in ani- (a) Specifications. (1) Oxytetracycline:
mals simultaneously with, or within a The antibiotic substance produced by
few days before or after treatment with growth of Streptomyces rimosus or the
or exposure to, cholinesterase-inhib- same antibiotic substance produced by
iting drugs, pesticides, or chemicals. any other means.
Consult your veterinarian for assist- (2) Carbomycin: The antibiotic sub-
ance in the diagnosis, treatment, and stance produced by growth of
control of parasitism. Streptomyces halstedii or the same anti-
[50 FR 50291, Dec. 10, 1985, as amended at 61 biotic substance produced by any other
FR 5506, Feb. 13, 1996; 78 FR 28825, May 20, means.
2014] (b) Sponsor. See No. 054771 in
§ 520.1638 Oxibendazole. (c) Special considerations. The quan-
(a) Specifications. (1) Each gram of tities of oxytetracycline in paragraph
paste contains 227 milligrams (mg) (22.7 (e) of this section refer to the activity
percent) oxibendazole. of oxytetracycline hydrochloride and
(2) Each milliliter of suspension con- the quantities of carbomycin listed
tains 100 mg (10 percent) oxibendazole. refer to the activity of an appropriate
(b) Sponsor. See No. 054771 in standard.
§ 510.600(c) of this chapter. (d) Related tolerances. See §§ 556.110
(c) Special considerations. (1) See and 556.500 of this chapter.
§ 500.25 of this chapter. (e) Conditions of use. It is used as oxy-
(2) Suspension product described in tetracycline hydrochloride plus
paragraph (a)(2) of this section shall be carbomycin base in drinking water of
labeled: ‘‘Federal law restricts this chickens as follows:
drug to use by or on the order of a li- (1) Amount. Administer 1.0 gram of
censed veterinarian.’’ oxytetracycline and 1.0 gram
(d) Conditions of use in horses—(1) carbomycin per gallon for not more
Amount. For uses other than for than 5 days.
threadworms (Strongyloides westeri), 10 (2) Indications for use. As an aid in the
mg oxibendazole per kilogram (/kg) prevention and treatment of com-
body weight; for threadworms plicated chronic respiratory disease
(Strongyloides westeri), 15 mg/kg. Horses (air-sac infection) caused by Myco-
maintained on premises where reinfec- plasma gallisepticum and secondary bac-
tion is likely to occur should be re- terial organisms associated with chron-
treated in 6 to 8 weeks. Administer sus- ic respiratory disease such as E. coli.
pension product by stomach tube in 3 (3) Limitations. Not for use in chick-
to 4 pints of warm water, or by top ens producing eggs for human con-
dressing or mixing into a portion of the sumption. Withdraw 24 hours before
normal grain ration. slaughter. Federal law restricts this
(2) Indications for use. For removal drug to use by or on the order of a li-
and control of large strongyles censed veterinarian.
(Strongylus edentatus, S. equinus, S.
vulgaris); small strongyles (genera
FR 28825, May 20, 2014; 81 FR 94989, Dec. 27,
Cylicostephanus, Cylicocyclus, 2016]
Cyathostomum, Triodontophorus,
Cylicodontophorus, and Gyalocephalus); § 520.1660b Oxytetracycline hydro-
large roundworms (Parascaris equorum); chloride capsules.
pinworms (Oxyuris equi) including var-
(a) Specifications. The drug is in cap-
ious larval stages; and threadworms
sule form with each capsule containing
(Strongyloides westeri).
125 or 250 milligrams of oxytetracycline
hydrochloride. Oxytetracycline is the

antibiotic substance produced by
[78 FR 28825, May 20, 2014] growth of Streptomyces rimosus or the
228
Food and Drug Administration, HHS § 520.1660d
same antibiotic substance produced by (ii) Indications for use. For control of
any other means. bacterial enteritis caused by Salmonella
(b) Sponsor. See No. 054771 in typhimurium and Escherichia coli
§ 510.600(c) of this chapter. (colibacillosis) and bacterial pneu-
(c) Conditions of use. (1) It is used in monia (shipping fever complex,
dogs and cats for the treatment of bac- pasteurellosis) caused by Pasteurella
terial pneumonia caused by Brucella multocida.
bronchiseptica, tonsilitis caused by (2)(i) Amount. 500 milligrams per 100
Streptococcus hemolyticus, bacterial en- pound of body weight every 12 hours (10
teritis caused by Escherichia coli, uri- milligrams per pound of body weight
nary tract infections caused by Esch- daily in two doses).
erichia coli, and wound infections (ii) Indications for use. For treatment
caused by Staphylococcus aureus. of bacterial enteritis caused by Sal-
(2) The drug is administered orally to monella typhimurium and Escherichia coli
dogs and cats at a dosage level of 25–50 (colibacillosis) and bacterial pneu-
milligrams per pound of body weight monia (shipping fever complex,
per day in divided doses at 12-hour in- pasteurellosis) caused by Pasteurella
tervals. The drug can be used for con- multocida.
tinuation of compatible antibiotic (3) Limitations. (i) For No. 000010: Dos-
therapy following parenteral oxytetra- age should continue until the animal
cycline administration where rapidly returns to normal and for 24 hours to 48
attained, sustained antibiotic blood hours after symptoms have subsided.
levels are required. The duration of Treatment should not exceed 4 con-
treatment required to obtain favorable secutive days. Do not exceed 500 milli-
response will depend to some extent on grams per 100 pounds of body weight
the severity and degree of involvement every 12 hours (10 milligrams per pound
and the susceptibility of the infectious daily).
agent. Clinical response to antibiotic (ii) For No. 054771: Discontinue treat-
therapy usually occurs within 48 to 72 ment 7 days prior to slaughter. Not for
hours. If improvement is not observed use in lactating dairy cattle. A with-
within that period, the diagnosis and drawal period has not been established
course of treatment should be reconsid- for this product in preruminating
ered. To assure adequate treatment, calves. Do not use in calves to be proc-
administration of the drug should con- essed for veal. Federal law restricts
tinue for at least 48 hours following fa- this drug to use by or on the order of a
vorable clinical response. licensed veterinarian.
(3) Federal law restricts this drug to
use by or on the order of a licensed vet- FR 1045, Jan. 9, 1985; 63 FR 70334, Dec. 21,
erinarian. 1998; 70 FR 16394, Apr. 4, 2005; 78 FR 28825,
[40 FR 13838, Mar. 27, 1975, as amended at 78 May 20, 2014; 88 FR 14897, Mar. 10, 2023]
FR 28825, May 20, 2014]
§ 520.1660d Oxytetracycline powder.
§ 520.1660c Oxytetracycline hydro- (a) Specifications. The drug is a solu-
chloride tablets and boluses. ble powder distributed in packets or
(a) Specifications. Each tablet or bolus pails having several concentrations of
contains 250, 500, or 1,000 milligrams of oxytetracycline hydrochloride (inde-
oxytetracycline hydrochloride. pendent of the various net weights) as
(b) Sponsors. For sponsors in follows:
§ 510.600(c) of this chapter: See 000010 (1) Each 18.14 grams of powder con-
for use of 500 and 1,000 milligram tains 1 gram of oxytetracycline hydro-
boluses. See No. 054771 for use of 250 chloride (OTC HCl) (packets: 4, 6.4, and
and 500 milligram tablets. 16 oz.).
(c) Tolerances. See § 556.500 of this (2) Each 4.43 grams of powder con-
chapter. tains 1 gram of OTC HCl (packets: 4
(d) Conditions of use in beef and dairy and 16 oz.).
cattle—(1)(i) Amount. 250 milligrams per (3) Each 1.32 grams of powder con-
100 pounds of body weight every 12 tains 1 gram of OTC HCl (packets: 2.39,
hours (5 milligrams per pound of body 4.78, and 9.55 oz.; jars: 2.25 lbs.; and
weight daily in two doses). pails: 4.5 lbs.).
229
§ 520.1660d 21 CFR Ch. I (4–1–23 Edition)
(4) Each 2.73 grams of powder con- (c) Related tolerances. See § 556.500 of
tains 1 gram of OTC HCl (packets: 2.46 this chapter.
and 9.87 oz, 3.09 and 3.91 lb; pail: 3.09 lb). (d) Conditions of use. (1) It is used in
(5) Each 4.2 grams of powder contains drinking water as follows:
1 gram of OTC HCl (packets: 3.8 and (i) Chickens—(A)(1) Amount. Admin-
15.2 oz; pails: 4.74 and 23.7 lb). ister 200 to 400 milligrams/gallon for 7
(6) Each 1.32 grams of powder con- to 14 days. Not to be used for more
tains 1 gram of OTC HCl (packet: 4.78 than 14 consecutive days.
oz.; pail: 5 lb). Each 2.73 grams of pow- (2) Indications for use. Control of in-
der contains 1 gram of OTC HCl (pack- fectious synovitis caused by Myco-
et: 9.87 oz). plasma synoviae susceptible to oxytet-
(7) Each 1.32 grams of powder con- racycline.
tains 1 gram of OTC HCl (packet: 4.78 (3) Do not use in birds producing eggs
and 9.6 oz.; pails: 2 and 5 lb); each 18.1 for human consumption. Federal law
grams of powder contains 1 gram of restricts this drug to use by or on the
OTC HCl (packet: 6.4 oz.; pails: 2 and 5 order of a licensed veterinarian.
lb). (B)(1) Amount. Administer 400 to 800
(8) Each 135.5-gram packet (4.78 milligrams/gallon for 7 to 14 days. Not
ounce) contains 102.4 grams of OTC to be used for more than 14 consecutive
HCl. Each 677.5-gram packet (23.9 days.
ounce) contains 512 grams of OTC HCl. (2) Indications for use. Control of
(9) Each 2.73 grams of powder con- chronic respiratory disease (CRD) and
tains 1 gram of OTC HCl (packets: 9.87 air sac infections caused by Myco-
and, 19.75 oz, and 3.91 lb; pails: 3.09 and plasma gallisepticum and E. coli suscep-
5 lb). tible to oxytetracycline; control of
(10) Each 2.73 grams of powder con- fowl cholera caused by Pasteurella
tains 1 gram of OTC HCl (packets: 9.87 multocida susceptible to oxytetra-
and 19.74 oz; pails: 5 lb). cycline.
(b) Sponsor. See sponsor numbers in (3) Do not use in birds producing eggs
§ 510.600(c) of this chapter as follows: for human consumption. Federal law
(1) No. 054771 for use of OTC HCl con- restricts this drug to use by or on the
centrations in paragraphs (a)(1), (a)(2), order of a licensed veterinarian.
and (a)(3) of this section in chickens, (ii) Turkeys—(A)(1) Amount. Admin-
turkeys, swine, cattle, sheep, and ister 200 to 400 milligrams/gallon for 7
honey bees. to 14 days. Not to be used for more
(2) No. 016592 for use of OTC HCl con- than 14 consecutive days.
centration in paragraph (a)(4) of this (2) Indications for use. Control of
section in chickens, turkeys, and hexamitiasis caused by Hexamita
swine. meleagridis susceptible to oxytetra-
(3) No. 066104 for use of OTC HCl con- cycline.
centration in paragraph (a)(5) of this (3) Do not use in birds producing eggs
section in turkeys and chickens. for human consumption. Withdraw 5
(4) No. 016592 for use of OTC HCl con- days prior to slaughter those products
centration in paragraph (a)(6) of this sponsored by Nos. 054771 and 061133 in
section in chickens, turkeys, and § 510.600(c) of this chapter. Withdraw 4
swine. days prior to slaughter those products
(5) No. 061133 for use of OTC HCl con- sponsored by No. 054628. Zero-day with-
centration in paragraph (a)(7) of this drawal for those products sponsored by
section in chickens, turkeys, swine, Nos. 057561 and 069254. Federal law re-
cattle, sheep, and honeybees. stricts this drug to use by or on the
(6) No. 069254 for use of OTC HCl con- order of a licensed veterinarian.
centrations in paragraph (a)(8) of this (B)(1) Amount. Administer 400 milli-
section in chickens, turkeys, swine, grams/gallon for 7 to 14 days. Not to be
cattle, sheep, and honey bees. used for more than 14 consecutive days.
(7) No. 061133 for use of OTC HCl con- (2) Indications for use. Control of in-
centration in paragraph (a)(9) of this fectious synovitis caused by Myco-
section in chickens, turkeys, and plasma synoviae susceptible to oxytet-

swine. racycline.
230
(3) Do not use in birds producing eggs ister 10 milligrams per pound of body
for human consumption. Withdraw 5 weight daily for up to 14 days. Do not
days prior to slaughter those products use for more than 14 consecutive days.
sponsored by Nos. 054771 and 061133 in (B) Indications for use. Control and
§ 510.600(c) of this chapter. Withdraw 4 treatment of bacterial enteritis caused
days prior to slaughter those products by E. coli and bacterial pneumonia
sponsored by No. 054628. Zero-day with- (shipping fever complex) caused by P.
drawal for those products sponsored by multocida susceptible to oxytetra-
Nos. 057561 and 069254. Federal law re- cycline.
stricts this drug to use by or on the (C) Withdraw 5 days prior to slaugh-
order of a licensed veterinarian. ter. A milk discard period has not been
(C)(1) Amount. Administer 25 milli- established for this product in lac-
grams per pound of body weight daily tating dairy cattle. Do not use in fe-
for 7 to 14 days. Not to be used for more male dairy cattle 20 months of age or
than 14 consecutive days. older. Federal law restricts this drug to
(2) Indications for use. Growing tur- use by or on the order of a licensed vet-
keys. Control of complicating bacterial erinarian.
organisms associated with bluecomb (v) Sheep—(A) Amount. Administer 10
(transmissible enteritis, coronaviral milligrams per pound of body weight
enteritis) susceptible to oxytetra- daily for up to 14 days. Not to be used
cycline. for more than 14 consecutive days.
(3) Do not use in birds producing eggs (B) Indications for use. Control and
for human consumption. Withdraw 5 treatment of bacterial enteritis caused
days prior to slaughter those products by E. coli and bacterial pneumonia
sponsored by Nos. 054771 and 061133 in (shipping fever complex) caused by P.
§ 510.600(c) of this chapter. Withdraw 4 multocida susceptible to oxytetra-
days prior to slaughter those products cycline.
sponsored by No. 054628. Zero-day with- (C) Withdraw 5 days prior to slaugh-
drawal for those products sponsored by ter. Federal law restricts this drug to
Nos. 057561 and 069254. Federal law re- use by or on the order of a licensed vet-
stricts this drug to use by or on the erinarian.
order of a licensed veterinarian. (2) It is used in the food of honey bees
(iii) Swine—(A) Amount. Administer as follows:
10 milligrams per pound of body weight (i) Amount. 200 milligrams per colony,
daily in drinking water. Administer up administered via either a 1:1 sugar
to 14 days; do not use for more than 14 syrup (equal parts of sugar and water
consecutive days those products spon- weight to weight) or dusting with a
sored by Nos. 054771, 061133, and 069254. powdered sugar mixture. The drug is
Administer up to 5 days; do not use for administered in 3 applications of sugar
more than 5 consecutive days those syrup or 3 dustings at 4- to 5-day inter-
products sponsored by Nos. 016592 and vals.
061133.
(ii) Indications for use. For control of
(B) Indications for use. Control and
American foulbrood caused by
treatment of bacterial enteritis caused
Paenibacillus larvae.
by Escherichia coli and Salmonella
(iii) The drug should be fed early in
choleraesuis and bacterial pneumonia
the spring or fall and consumed by the
caused by Pasteurella multocida suscep-
bees before main honey flow begins to
tible to oxytetracycline. For breeding
avoid contamination of production
swine: Control and treatment of lepto-
honey. Remove at least 6 weeks prior
spirosis (reducing the incidence of
to main honey flow. Federal law re-
abortions and shedding of leptospira)
stricts this drug to use by or on the
caused by Leptospira pomona suscep-
tible to oxytetracycline.
(C) Limitations. Withdraw zero days [40 FR 13838, Mar. 27, 1975]
prior to slaughter. Federal law re- EDITORIAL NOTE: For FEDERAL REGISTER ci-
stricts this drug to use by or on the tations affecting § 520.1660d, see the List of
order of a licensed veterinarian. CFR Sections Affected, which appears in the
(iv) Calves, beef cattle, and nonlac- Finding Aids section of the printed volume
tating dairy cattle—(A) Amount. Admin- and at www.govinfo.gov.
231
§ 520.1696 21 CFR Ch. I (4–1–23 Edition)
§ 520.1696 Penicillin. § 520.1696c Penicillin V tablets.
§ 520.1696a Penicillin G powder. (a) Specifications. Each tablet con-

tains penicillin V potassium equivalent
(a) Specifications. Each gram of pow- to 125 milligrams (200,000 units) or 250
der contains penicillin G potassium milligrams (400,000 units) of penicillin
equivalent to 1.54 million units of peni- V.
cillin G. (b) Sponsors. See Nos. 000010 and
(b) Sponsors. See Nos. 016592, 042791, 054771 in § 510.600(c) of this chapter.
054771, 061133, and 076475 in § 510.600(c) of (c) Conditions of use in dogs and cats—
this chapter. (1) Amount. 10 to 15 milligrams per
(c) Related tolerances. See § 556.510 of pound of body weight every 6 to 8
this chapter. hours.
(d) Conditions of use in turkeys—(1) (2) Indications for use. Treatment of
Amount. 1,500,000 units per gallon respiratory, urogenital, skin and soft
drinking water for 5 days. tissue infections and septicemia caused
(2) Indications for use. Treatment of by pathogens susceptible to penicillin
erysipelas caused by Erysipelothrix V potassium.
rhusiopathiae.
(3) Limitations. Discontinue treat-
ment at least 1 day prior to slaughter.
Not for use in turkeys producing eggs
for human consumption. Federal law [57 FR 37327, Aug. 18, 1992, as amended at 59
restricts this drug to use by or on the FR 58775, Nov. 15, 1994; 78 FR 28826, May 20,
order of a licensed veterinarian. 2014; 84 FR 39183, Aug. 9, 2019. Redesignated
at 85 FR 18119, Apr. 1, 2020]
FR 42493, Aug. 18, 1994; 60 FR 26359, May 17, § 520.1705 Pergolide.
1995; 62 FR 55160, Oct. 23, 1997; 65 FR 10705,
Feb. 29, 2000; 66 FR 14073, Mar. 9, 2001; 68 FR (a) Specifications. Each tablet con-
4914, Jan. 31, 2003; 68 FR 26204, May 15, 2003; tains 1 milligram (mg) peroglide (as
69 FR 9946, Mar. 3, 2004; 69 FR 41428, July 9, pergolide mesylate).
2004; 77 FR 20988, Apr. 9, 2012; 78 FR 28825, (b) Sponsor. See No. 000010 in
May 20, 2014; 81 FR 22523, Apr. 18, 2016; 81 FR § 510.600(c) of this chapter.
36789, June 8, 2016; 81 FR 94990, Dec. 27, 2016;
84 FR 8973, Mar. 13, 2019. Redesignated at 85
FR 18119, Apr. 1, 2020, as amended at 86 FR Amount. Administer orally at a start-
57997, Oct. 20, 2021] ing dose of 2 micrograms/kilograms (μ/
kg) once daily. Dosage may be adjusted
§ 520.1696b Penicillin V powder. to effect, not to exceed 4 μg/kg daily.
(a) Specifications. When reconstituted, (2) Indications for use. For the control
each milliliter contains 25 milligrams of clinical signs associated with Pitui-
(40,000 units) of penicillin V. tary Pars Intermedia Dysfunction
(b) Sponsor. See No. 000010 in (Equine Cushing’s Disease).
§ 510.600(c) of this chapter. (3) Limitations. Federal law restricts
(c) Conditions of use in dogs and cats— this drug to use by or on the order of a
(1) Amount. 10 to 15 milligrams per licensed veterinarian.
pound of body weight every 6 to 8 [77 FR 15960, Mar. 19, 2012, as amended at 81
hours. FR 22523, Apr. 18, 2016]
(2) Indications for use. Treatment of
respiratory, urogenital, skin, and soft § 520.1720 Phenylbutazone oral dosage
tissue infections and septicemia caused forms.
by pathogens susceptible to penicillin
V potassium. § 520.1720a Phenylbutazone tablets
(3) Limitations. Federal law restricts and boluses.
this drug to use by or on the order of a (a) Specifications. Each tablet con-
licensed veterinarian. tains 100, 200, or 400 milligrams (mg), or
[57 FR 37326, Aug. 18, 1992; 57 FR 42623, Sept.
1 gram (g) phenylbutazone. Each bolus
15, 1992; 77 FR 20988, Apr. 9, 2012; 78 FR 28826, contains 1, 2, or 4 g phenylbutazone.
May 20, 2014; 84 FR 39183, Aug. 9, 2019. Redes- (b) Sponsors. See sponsor numbers in
ignated at 85 FR 18119, Apr. 1, 2020] § 510.600(c) of this chapter, as follows:
232
(1) No. 000061 for use of 100- or 400-mg (3) Limitations. Do not use in horses
or 1-g tablets, or 2- or 4-g boluses, in intended for human consumption. Fed-
dogs and horses. eral law prohibits the use of this drug
(2) No. 069043 for use of 100- or 200-mg in female dairy cattle 20 months of age
or 1-g tablets in dogs and horses. or older. Federal law restricts this drug
(3) Nos. 054771 and 061133 for use of to use by or on the order of a licensed
100-mg or 1-g tablets in dogs and veterinarian.
horses.
(4) No. 058829 for use of 100-mg or 1-g [78 FR 28826, May 20, 2014]
tablets in dogs and horses.
(5) No. 058198 for use of 1-g tablets in § 520.1720c Phenylbutazone paste.
horses. (a) Specifications. (1) Each gram of
(c) Conditions of use—(1) Dogs—(i) paste contains 0.2 grams
Amount. 20 mg per pound of body phenylbutazone.
weight daily. (2) Each gram of paste contains 0.35
(ii) Indications for use. For the relief grams phenylbutazone.
of inflammatory conditions associated (b) Sponsors. See sponsor numbers in
with the musculoskeletal system. § 510.600(c) of this chapter.
(iii) Limitations. Federal law restricts (1) No. 000061 for use of product de-
this drug to use by or on the order of a scribed in paragraph (a)(1) of this sec-
licensed veterinarian. tion.
(2) Horses—(i) Amount. 1 to 2 g per 500
pounds of body weight daily.
(ii) Indications for use. For the relief
of inflammatory conditions associated tion.
with the musculoskeletal system. (c) Conditions of use in horses—(1)
(iii) Limitations. Do not use in horses Amount. 1 to 2 grams of phenylbutazone
intended for human consumption. Fed- per 500 pounds of body weight, not to
eral law prohibits the use of this drug exceed 4 grams daily.
in female dairy cattle 20 months of age (2) Indications for use. For relief of in-
or older. Federal law restricts this drug flammatory conditions associated with
to use by or on the order of a licensed the musculoskeletal system.
veterinarian. (3) Limitations. Do not use in horses
FR 1146, Jan. 12, 2009; 76 FR 11331, Mar. 2, eral law prohibits the use of this drug
2011; 76 FR 17777, Mar. 31, 2011; 78 FR 21060, in female dairy cattle 20 months of age
Apr. 9, 2013; 78 FR 28826, May 20, 2014; 81 FR or older. Federal law restricts this drug
17607, Mar. 30, 2016; 83 FR 48946, Sept. 28, 2018; to use by or on the order of a licensed
84 FR 8973, Mar. 13, 2019; 85 FR 45307, July 28, veterinarian.
2020; 86 FR 14819, Mar. 19, 2021; 87 FR 58961,
Sept. 29, 2022] [45 FR 84762, Dec. 23, 1980, as amended at 58
FR 29777, May 24, 1993; 61 FR 8873, Mar. 6,
§ 520.1720b Phenylbutazone granules. 1996; 62 FR 61625, Nov. 19, 1997; 68 FR 43926,
July 25, 2003; 72 FR 60550, Oct. 25, 2007; 77 FR
(a) Specifications. Each package of 4897, Feb. 1, 2012; 78 FR 28826, May 20, 2014; 79
granules contains 1 or 8 grams of FR 74020, Dec. 15, 2014]
phenylbutazone.
(b) Sponsors. See sponsors in § 520.1720d Phenylbutazone gel.
(1) No. 000061 for 8-gram package. (a) Specifications. Each 30 grams of gel
(2) No. 059320 for 1-gram package. contains 4 grams of phenylbutazone.
(c) Conditions of use in horses—(1) (b) Sponsor. See No. 061133 in
Amount. Administer 1 to 2 grams per § 510.600(c) of this chapter. require bio-
500 pounds of body weight, not to ex- equivalency and safety information.
ceed 4 grams, daily as required. by add- (c) Conditions of use in horses—(1)
ing to a portion of the usual grain ra- Amount. 1 to 2 grams of phenylbutazone
tion. per 500 pounds of body weight, not to
(2) Indications for use. For the treat- exceed 4 grams daily.
ment of inflammatory conditions asso- (2) Indications for use. For relief of in-
ciated with the musculoskeletal sys- flammatory conditions associated with

tem. the musculoskeletal system of horses.
233
§ 520.1720e 21 CFR Ch. I (4–1–23 Edition)
(3) Limitations. Do not use in horses (ii) Extended-release tablet: 2 to 4

intended for human consumption. Fed- mg/kg of body weight once daily with
eral law prohibits the use of this drug food.
in female dairy cattle 20 months of age (2) Indications for use. For the control
or older. Federal law restricts this drug of urinary incontinence due to urethral
to use by or on the order of a licensed sphincter hypotonus in dogs.
veterinarian. (3) Limitations. Federal law restricts
FR 49372, Dec. 2, 1985; 55 FR 8462, Mar. 8, 1990; licensed veterinarian.
66 FR 14073, Mar. 9, 2001; 68 FR 4915, Jan. 31, [77 FR 15961, Mar. 19, 2012, as amended at 84
2003; 78 FR 28826, May 20, 2014; 84 FR 8973, FR 39183, Aug. 9, 2019]
Mar. 13, 2019]
§ 520.1780 Pimobendan.
§ 520.1720e Phenylbutazone powder.
(a) Specifications. (1) Each 1.15 grams let contains 1.25, 2.5, 5, or 10 milligrams
(g) of powder contains 1 g (mg) pimobendan.
phenylbutazone. (b) Sponsor. See No. 000010 in
(2) Each 10 g of powder contains 1 g § 510.600(c) of this chapter.
phenylbutazone. (c) Conditions of use in dogs—(1)
(b) Sponsors. See sponsor numbers in Amount. Administer orally at a total
daily dose of 0.23 mg per pound (0.5 mg
per kilogram) body weight, using a
suitable combination of whole or half
tion.
tablets. The total daily dose should be
divided into two portions administered
approximately 12 hours apart.
tion.
(2) Indications for use. For the man-
agement of the signs of mild, mod-
Amount. Administer 1 to 2 g (1 to 2 level
scoops, using the scoop provided) per erate, or severe congestive heart fail-
500 pounds of body weight on a small ure in dogs due to clinical myxomatous
amount of palatable feed, not exceed 4 mitral valve disease (MMVD) or dilated
g per animal daily. cardiomyopathy (DCM); for use with
(2) Indications for use. For the relief of concurrent therapy for congestive
inflammatory conditions associated heart failure (e.g., furosemide, etc.) as
with the musculosketetal system. appropriate on a case-by-case basis.
eral law prohibits the extralabel use of licensed veterinarian.
this product in female cattle 20 months [72 FR 27733, May 17, 2007, as amended at 79
of age or older. Federal law restricts FR 18158, Apr. 1, 2014; 87 FR 10968, Feb. 28,
this drug to use by or on the order of a 2022]
§ 520.1802 Piperazine-carbon disulfide
[72 FR 27956, May 18, 2007] complex oral dosage forms.
§ 520.1760 Phenylpropanolamine. § 520.1802a Piperazine-carbon disul-
(a) Specifications. (1) Each chewable fide complex suspension.
tablet contains 25, 50, or 75 milligram (a) Specifications. Each fluid ounce of
(mg) phenylpropanolamine hydro- suspension contains 7.5 grams of piper-
chloride. azine-carbon disulfide complex. The pi-
(2) Each extended-release tablet con- perazine-carbon disulfide complex con-
tains 18, 38, 74, or 145 mg phenyl- tains equimolar parts of piperazine and
propanolamine hydrochloride. carbon disulfide (1 gram contains 530
(b) Sponsors. See No. 055246 in mgs of piperazine and 470 mgs of carbon
§ 510.600(c) of this chapter. disulfide).
(c) Conditions of use in dogs—(1) (b) Sponsor. See No. 054771 in
Amount. Administer orally as follows: § 510.600(c) of this chapter.
(i) Chewable tablet: 2 mg/kg of body (c) Conditions of use in horses and
weight twice daily. ponies—(1) Amount. Administer 1 fluid
234
ounce per 100 pounds of body weight by § 520.1802c Piperazine-carbon disul-

stomach tube or dose syringe after fide complex with phenothiazine
withholding feed overnight or for 8 to suspension.
10 hours. (a) Specifications. Each fluid ounce
(2) Indications for use. For removing contains 5 grams of piperazine-carbon
ascarids (large roundworms, Parascaris disulfide complex and 0.83 gram of
equorum), bots (Gastrophilus spp.), small phenothiazine.
strongyles, large strongyles (Strongyles (b) Sponsor. See No. 054771 in
spp.), and pinworms (Oxyuris equi). § 510.600(c) of this chapter.
(3) Limitations. Do not use in horses (c) Conditions of use in horses and
intended for human consumption. Fed- ponies—(1) Amount. Administer 1 fluid
eral law restricts this drug to use by or ounce per 100 pounds of body weight by
on the order of a licensed veterinarian. stomach tube or dose syringe after
[45 FR 52781, Aug. 8, 1980, as amended at 78 withholding feed overnight or for 8 to
FR 28826, May 20, 2014] 10 hours.
(2) Indications for use. For removing
§ 520.1802b Piperazine-carbon disul- ascarids (large roundworms, Parascaris
fide complex boluses. equorum), bots (Gastrophilus spp.), small
(a) Specifications. Each bolus contains strongyles, and large strongyles
20 grams of piperazine-carbon disulfide (Strongylus spp.).
complex. (3) Limitations. Do not use in horses
(b) Sponsor. See No. 054771 in intended for human consumption. Fed-
§ 510.600(c) of this chapter. eral law restricts this drug to use by or
(c) Conditions of use in horses and on the order of a licensed veterinarian.
ponies—(1) Amount. For removal of [45 FR 52782, Aug. 8, 1980, as amended at 78
ascarids and small strongyles, 1 bolus FR 28826, May 20, 2014]
(20 grams) per 500 pounds body weight;
removal of large strongyles, pinworms, § 520.1803 Piperazine citrate capsules.
and bots, 1 bolus per 250 pounds body (a) Specifications. Each capsule con-
weight. tains piperazine citrate equivalent to
(2) Indications for use. For removing 140 milligrams of piperazine base.
ascarids (large roundworms, Parascaris (b) Sponsor. See No. 021091 in
equorum), large strongyles (Strongylus § 510.600(c) of this chapter.
spp.) bots (Gastrophilus spp.), small (c) Conditions of use in dogs and cats—
strongyles, and pinworms (Oxyuris (1) Amount. The contents of 1 capsule
equi). should be mixed with the food of the
(3) Limitations. Withhold feed over- animal for each 5 pounds, or fraction
night or for 8 to 10 hours. Give water thereof of body weight, except dogs
just before and/or after treatment. Re- weighing over 25 pounds should be
sume regular feeding 4 to 6 hours after given the contents of 6 capsules. The
treatment. Treatment of debilitated or drug should be mixed in 1/2 of the reg-
anemic animals is contraindicated. Do ular feeding and when the animal has
not administer to animals that are or finished eating the dosed food, the re-
were recently affected with colic, diar- mainder of the food may be given. Dogs
rhea, or infected with a serious infec- and cats may be wormed at 6 to 8
tious disease. As with most weeks of age. The first treatment
anthelmintics, drastic cathartics or should be repeated 10 days later. Rein-
other gastrointestinal irritants should fection may occur. Repeat treatment if
not be administered in conjunction indicated.
with this drug. Animals in poor condi- (2) Indications for use. For the re-
tion or heavily parasitized should be moval of large roundworms (Toxocara
given one half the recommended dose canis and Toxascaris leonina).
and treated again in 2 or 3 weeks. Con- (3) Limitations. Severely debilitated
sult your veterinarian for assistance in animals should not be treated except
the diagnosis, treatment, and control on the advice of a veterinarian.
of parasitism.
[45 FR 52782, Aug. 8, 1980, as amended at 78 FR 38515, Sept. 19, 1989; 78 FR 28826, May 20,
FR 28826, May 20, 2014] 2014]
235
§ 520.1805 21 CFR Ch. I (4–1–23 Edition)
§ 520.1805 Piperazine phosphate with unweaned pups or animals less than 3

thenium closylate tablets. weeks of age.
(a) Specifications. Each scored tablet [70 FR 17319, Apr. 6, 2005]
contains the equivalent of 250 milli-
grams piperazine hexahydrate (as pi- § 520.1840 Poloxalene.
perazine phosphate) and 125 milligrams (a) Specifications. Polyoxypropylene-
thenium (as thenium closylate) or 500 polyoxyethylene glycol nonionic block
milligrams piperazine hexahydrate (as polymer.
piperazine phosphate) and 250 milli- (b) Sponsors. See sponsors in
grams thenium (as thenium closylate). § 510.600(c) of this chapter for use as in
(b) Sponsor. See No. 000061 in paragraph (d) of this section.
§ 510.600(c) of this chapter. (1) No. 054771 for use as in paragraphs
(c) Conditions of use—(1) Amount. Ad- (d)(1) and (d)(3) of this section.
minister orally to dogs as follows: (2) No. 067949 for use as in paragraph
(d)(2) of this section.
NUMBER OF TABLETS AT EACH OF THE TWO (3) No. 066104 for use as in paragraph
DOSES (d)(3) of this section.
Animal weight (lb) 375 mg 750 mg (c) Related tolerances. See § 556.517 of
this chapter.
2 but less than 5 ............................... ⁄
12 ................ (d) Conditions of use. (1) For treat-
5 but less than 10 ............................. 1 1⁄2
10 or heavier ..................................... 2 1
ment of legume (alfalfa, clover) bloat
in cattle. Administer as a drench at the
(2) Indications for use. For removal of rate of 25 grams for animals up to 500
immature (fourth stage larvae) and pounds and 50 grams for animals over
adult hookworms (Ancylostoma 500 pounds of body weight.
caninum, A. braziliense, and Uncinaria (2) For control of legume (alfalfa, clo-
stenocephala) and ascarids (Toxocara ver) bloat in cattle. Administer, in mo-
canis) from weaned pups and adult lasses block containing 6.6 percent
dogs. poloxalene, at the rate of 0.8 oz. of
(3) Limitations. Federal law restricts block (1.5 grams poloxalene) per 100 lbs.
this drug to use by or on the order of a of body weight per day.
licensed veterinarian. (3) For prevention of legume (alfalfa,
clover) and wheat pasture bloat in cat-
[43 FR 32747, July 28, 1978, as amended at 47 tle. A 53-percent poloxalene top dress-
FR 55476, Dec. 10, 1982; 61 FR 8873, Mar. 6, ing on individual rations of ground
1996; 62 FR 61625, Nov. 19, 1997; 78 FR 28826,
feed. Dosage is 1 gram of poloxalene
May 20, 2014]
per 100 pounds of body weight daily. If
§ 520.1806 Piperazine suspension. bloating conditions are severe, the dose
is doubled. Treatment should be start-
(a) Specifications. Each milliliter of ed 2 to 3 days before exposure to bloat-
suspension contains piperazine producing conditions. Repeat use of the
monohydrochloride equivalent to 33.5 drug if animals are exposed to bloat-
milligrams (mg) piperazine base. producing conditions for more than 12
(b) Sponsor. See No. 017135 in hours after the last treatment. Do not
§ 510.600(c) of this chapter. exceed the double dose in any 24-hour
(c) Special considerations. See period.
(d) Conditions of use in dogs—(1) Indi- [40 FR 13838, Mar. 27, 1975, as amended at 40
cations for use. For the removal of FR 39857, Aug. 29, 1975; 42 FR 41854, Aug. 19,
roundworms (Toxocara canisand 1977; 50 FR 5385, Feb. 8, 1985; 54 FR 33501, Aug.
15, 1989; 56 FR 50653, Oct. 8, 1991; 58 FR 26523,
Toxascaris leonina). May 4, 1993; 60 FR 55659, Nov. 2, 1995; 66 FR
(2) Dosage. Administer 20 to 30 mg pi- 47963, Sept. 17, 2001; 69 FR 62811, Oct. 28, 2004;
perazine base per pound body weight as 70 FR 32489, June 3, 2005; 78 FR 28826, May 20,
a single dose. 2014; 83 FR 48946, Sept. 28, 2018; 84 FR 32992,
(3) Limitations. Administer by mixing July 11, 2019]
into the animal’s ration to be con-
sumed at one feeding. For animals in § 520.1855 Ponazuril.
heavily contaminated areas, reworm at (a) Specifications. Each gram of paste

monthly intervals. Not for use in contains 150 milligrams (mg) ponazuril.
236
(b) Sponsor. See No. 000010 in paragraph (a)(2) of this section as in

§ 510.600(c) of this chapter. paragraph (c)(2) of this section.
(c) Conditions of use in horses—(1) (2) No. 069043 for use of product de-
Amount. Administer orally 15 mg per scribed in paragraph (a)(1) of this sec-
kilogram (kg) (6.81 mg per pound (lb)) tion as in paragraphs (c)(1) of this sec-
body weight as the first dose, followed tion.
by 5 mg/kg (2.27 mg/lb) body weight (c) Conditions of use—(1) Dogs—(i)
once daily for a period of 27 additional Amount. 5 pounds (lb) and under, 1⁄2 tab-
days.
let (17 mg); 6 to 10 lb, 1 tablet (34 mg);
11 to 15 lb, 11⁄2 tablets (51 mg); 16 to 30
ment of equine protozoal
myeloencephalitis caused by Sarcocystis lb, 2 tablets (68 mg); 31 to 45 lb, 3 tab-
neurona. lets (102 mg); 46 to 60 lb, 4 tablets (136
(3) Limitations. Do not use in horses mg); over 60 lb, 5 tablets maximum (170
intended for human consumption. Fed- mg). Administer directly by mouth or
eral law restricts this drug to use by or crumbled and in feed.
on the order of a licensed veterinarian. (ii) Indications for use—(A) For re-
moval of canine cestodes Dipylidium
FR 28827, May 20, 2014; 80 FR 34278, June 16, caninum and Taenia pisiformis.
2015; 80 FR 53459, Sept. 4, 2015; 84 FR 39183, (B) For removal of the canine cestode
Aug. 9, 2019] Echinococcus granulosus, and for re-
moval and control of the canine
§ 520.1860 Pradofloxacin. cestode Echinococcus multilocularis.
(a) Specifications. Each milliliter of (iii) Limitations—(A) If labeled only
suspension contains 25 milligrams (mg) for use as in paragraph (c)(1)(ii)(A) of
pradofloxacin. this section: Not intended for use in
(b) Sponsor. See No. 058198 in puppies less than 4 weeks of age. Con-
§ 510.600(c) of this chapter. sult your veterinarian before admin-
(c) Conditions of use in cats—(1) istering tablets to weak or debilitated
Amount. Administer 3.4 mg/lb (7.5 mg/ animals and for assistance in the diag-
kg) body weight once daily for 7 con- nosis, treatment, and control of para-
secutive days. sitism.
(B) If labeled for use as in paragraph
ment of skin infections (wounds and
abscesses) in cats caused by susceptible (c)(1)(ii)(B) of this section: Federal law
strains of Pasteurella multocida, Strepto- restricts this drug to use by or on the
coccus canis, Staphylococcus aureus, order of a licensed veterinarian.
Staphylococcus felis, and Staphylococcus (2) Cats—(i) Indications for use. For re-
pseudintermedius. moval of feline cestodes Dipylidium
(3) Limitations. Federal law prohibits caninum and Taenia taeniaeformis.
the extralabel use of this drug in food- (ii) Dosage. Cats 4 pounds and under,
producing animals. Federal law re- 11.5 mg; 5 to 11 pounds, 23 mg; over 11
stricts this drug to use by or on the pounds, 34.5 mg.
order of a licensed veterinarian. (iii) Limitations. Administer directly
by mouth or crumbled and in feed. Not
FR 28827, May 20, 2014; 86 FR 14819, Mar. 19, intended for use in kittens less than 6
2021] weeks of age. For over the counter use:
Consult your veterinarian before ad-
§ 520.1870 Praziquantel tablets. ministering tablets to weak or debili-
(a) Specifications. Each tablet con- tated animals, and for assistance in the
tains: diagnosis, treatment, and control of
(1) 34 milligrams (mg) praziquantel. parasitism.
(2) 11.5 or 23 mg praziquantel.
(b) Sponsors. See sponsors in FR 26377, June 18, 1982; 55 FR 2234, Jan. 23,
§ 510.600(c) of this chapter. 1990; 58 FR 7864, Feb. 10, 1993; 58 FR 42853,
(1) No. 058198 for use of product de- Aug. 12, 1993; 68 FR 57351, Oct. 3, 2003; 69 FR
scribed in paragraph (a)(1) of this sec- 62181, Oct. 25, 2004; 78 FR 17596, Mar. 22, 2013;
tion as in paragraph (c)(1) of this sec- 81 FR 17607, Mar. 30, 2016; 86 FR 14819, Mar.
tion and for use of product described in 19, 2021; 87 FR 58961, Sept. 29, 2022]
237
§ 520.1871 21 CFR Ch. I (4–1–23 Edition)
§ 520.1871 Praziquantel and pyrantel. stenocephala), and tapeworms

(a) Specifications. (1) Each tablet con- (Dipylidium caninum and Taenia
tains 13.6 milligrams (mg) praziquantel pisiformis) in dogs and puppies.
and 54.3 mg pyrantel base (as pyrantel [58 FR 58652, Nov. 3, 1993, as amended at 72
pamoate), 18.2 mg praziquantel and 72.6 FR 16270, Apr. 4, 2007; 75 FR 54018, Sept. 3,
mg pyrantel base (as pyrantel 2010; 86 FR 14819, Mar. 19, 2021]
pamoate), or 27.2 mg praziquantel and
108.6 mg pyrantel base (as pyrantel § 520.1872 Praziquantel, pyrantel
pamoate). pamoate, and febantel tablets.
(2) Each chewable tablet contains 30 (a) Specifications. Each tablet or
mg praziquantel and 30 mg pyrantel chewable tablet contains either:
pamoate or 114 mg praziquantel and 114 (1) Tablet No. 1: 22.7 milligrams
mg pyrantel pamoate. praziquantel, 22.7 milligrams pyrantel
(b) Sponsors. See sponsors in base, and 113.4 milligrams febantel; or
§ 510.600(c) for use as in paragraph (d) of (2) Tablet No. 2: 68 milligrams
this chapter. praziquantel, 68 milligrams pyrantel
(1) See No. 058198 for use of tablets base, and 340.2 milligrams febantel.
described in paragraph (a)(1) of this
(3) Tablet No. 3: 136 milligrams (mg)
section for use as in paragraph (d)(1) of
praziquantel, 136 mg pyrantel base, and
this section.
680.4 mg febantel.
(2) See No. 051311 for use of tablets
described in paragraph (a)(2) of this (b) Sponsor. See No. 058198 in
section for use as in paragraph (d)(2) of § 510.600(c) of this chapter.
this section. (c) Conditions of use—(1) Dogs—(i)
(c) Special considerations. See § 500.25 Amount. Administer as a single dose di-
of this chapter. rectly by mouth or in a small amount
(d) Conditions of use—(1) Cats—(i) Dos- of food as follows:
age. Administer a minimum dose of 2.27 Weight of animal Number of tablets per dose
mg praziquantel and 9.2 mg pyrantel
pamoate per pound of body weight ac- Tablet Tablet Tablet
Kilograms Pounds no. 1 no. 2 no. 3
cording to the dosing tables on label-
ing. May be given directly by mouth or 0.9 to 1.8 ...... 2 to 4 ....... 1/2.
in a small amount of food. Do not with- 2.3 to 3.2 ...... 5 to 7 ....... 1.
3.6 to 5.4 ...... 8 to 12 ..... 1 1/2.
hold food prior to or after treatment. If
5.9 to 8.2 ...... 13 to 18 ... 2.
reinfection occurs, treatment may be 8.6 to 11.4 .... 19 to 25 ... 2 1/2.
repeated. 11.8 to 13.6 .. 26 to 30 ... ......... 1.
(ii) Indications for use. For removal of 14.1 to 20.0 .. 31 to 44 ... ......... 1 1/2.
tapeworms (Dipylidium caninum and 20.4 to 27.2 .. 45 to 60 ... ......... 2 ........... 1
Taenia taeniaeformis), hookworms 27.7 to 40.9 .. 61 to 90 ... ......... ......... 1 1/2
41.3 to 54.5 .. 91 to 120 ......... ......... 2
(Ancylostoma tubaeforme), and large
roundworms (Toxocara cati) in cats and
kittens. (ii) Indications for use. For the re-
(iii) Limitations. Not for use in kit- moval of tapeworms (Dipylidium
tens less than 2 months of age or caninum, Taenia pisiformis, Echinococcus
weighing less than 2.0 pounds. Consult granulosus); hookworms (Ancylostoma
your veterinarian before giving to sick caninum, Uncinaria stenocephala);
or pregnant animals. ascarids (Toxocara canis, Toxascaris
(2) Dogs—(i) Amount. Administer a leonina); and whipworms (Trichuris
minimum dose of 5 mg praziquantel vulpis) and for the removal and control
and 5 mg pyrantel pamoate per kilo- of tapeworm Echinococcus multilocularis
gram body weight (2.27 mg praziquantel in dogs.
and 2.27 mg pyrantel pamoate per (iii) Limitations. Federal law restricts
pound body weight) according to the this drug to use by or on the order of a
dosing tables on labeling. licensed veterinarian.
(ii) Indications for use. For the treat- (2) [Reserved]
ment and control of roundworms [59 FR 33908, July 1, 1994, as amended at 61
(Toxocara canis and Toxascaris leonina), FR 29651, June 12, 1996; 68 FR 22293, Apr. 28,
hookworms (Ancylostoma caninum, 2003; 71 FR 6677, Feb. 9, 2006; 86 FR 14819, Mar.

Ancylostoma braziliense, and Uncinaria 19, 2021; 87 FR 58961, Sept. 29, 2022]
238
§ 520.1880 Prednisolone. § 520.1920 Prochlorperazine and

isopropamide.
tains 5 or 20 milligrams prednisolone. (a) Specifications. Each capsules con-
(b) Sponsor. See No. 061690 in tains either:
§ 510.600(c)(2) of this chapter. (1) 3.33 milligrams of
(c) Conditions of use in dogs—(1) prochlorperazine (as the dimaleate)
Amount. Administer 2.5 milligrams per and 1.67 milligrams of isopropamide (as
4.5 kilograms (10 pounds) body weight the iodide); or
per day. Administer total daily dose (2) 10 milligrams of prochlorperazine
orally in equally divided doses 6 to 10 (as the dimaleate) and 5 milligrams of
hours apart until response is noted or 7 isopropamide (as the iodide).
days have elapsed. When response is at- (b) Sponsor. See No. 054771 in
tained, dosage should be gradually re- § 510.600(c) of this chapter.
duced until maintenance level is (c) Conditions of use in dogs—(1)
achieved. Amount. (i) Capsules described in para-
(2) Indications for use. For use as an graph (a)(1) of this section are adminis-
anti-inflammatory agent. tered orally to dogs weighing from 4 to
(3) Limitations. Federal law restricts 15 pounds at the rate of 1 capsule twice
this drug to use by or on the order of a daily. These capsules are administered
licensed veterinarian. orally to dogs weighing from 16 to 30
pounds at the rate of 1 or 2 capsules
[57 FR 4718, Feb. 7, 1992, as amended at 60 FR twice daily. For dogs weighing less
57832, Nov. 22, 1995; 63 FR 148, Jan. 5, 1998; 79 than 4 pounds, administer orally an ap-
FR 28827, May 20, 2014] propriate fraction of the contents of
one of these capsules.
§ 520.1900 Primidone.
(ii) Capsules described in paragraph
(a) Specifications. Each tablet con- (a)(2) of this section are given to dogs
tains 50 or 250 milligrams of primidone. weighing 30 pounds and over at the rate
(b) Sponsors. See sponsor numbers in of 1 capsule twice daily.
§ 510.600(c) of this chapter. (2) Indications for use. For the treat-
(1) No. 069043 for use of 250 milligram ment of gastrointestinal disturbances
tablets. associated with emotional stress.
(2) No. 054771 for use of 50 and 250 mil- (3) Limitations. Federal law restricts
ligram tablets. this drug to use by or on the order of a
(c) Conditions of use in dogs—(1) licensed veterinarian.
Amount. Twenty-five milligrams of [79 FR 28827, May 20, 2014]
primidone per pound of body weight (55
milligrams per kilogram of body § 520.1921 Prochlorperazine,
weight) daily. isopropamide, and neomycin.
(2) Indications for use. For the control (a) Specifications. Each capsule con-
of convulsions associated with idio- tains either:
pathic epilepsy, epileptiform convul- (1) Capsule No. 1: 3.33 milligrams of
sions, viral encephalitis, distemper, prochlorperazine (as the dimaleate),
and hardpad disease that occurs as a 1.67 milligrams of isopropamide (as the
clinically recognizable lesion in certain iodide), and 25 milligrams of neomycin
entities in dogs. base (as the sulfate); or
(3) Limitations. Federal law restricts (2) Capsule No. 3: 10 milligrams of
this drug to use by or on the order of a prochlorperazine (as the dimaleate), 5
licensed veterinarian. milligrams of isopropamide (as the io-
[42 FR 61594, Dec. 6, 1977, as amended at 43 dide), and 75 milligrams of neomycin
FR 55386, Nov. 28, 1978; 46 FR 8467, Jan. 27, base (as the sulfate).
1981; 46 FR 57477, Nov. 24, 1981; 53 FR 40727, (b) Sponsor. See No. 054771 in
Oct. 18, 1988; 56 FR 37473, Aug. 7, 1991; 62 FR § 510.600(c) of this chapter.
35076, June 30, 1997; 78 FR 21060, Apr. 9, 2013; (c) Conditions of use in dogs—(1)
79 FR 28827, May 20, 2014; 83 FR 48946, Sept. Amount. Administer capsules orally
28, 2018]
twice daily to dogs as follows:
239
§ 520.1962 21 CFR Ch. I (4–1–23 Edition)
Number of cap- (3) Limitations. Federal law restricts

sules per dose this drug to use by or on the order of a
Animal weight (pounds)
Capsule Capsule licensed veterinarian.
No. 1 No. 3
[79 FR 28827, May 20, 2014]
10 to 20 ................................................. 1
20 to 30 ................................................. 2 § 520.2041 Pyrantel pamoate chewable
Over 30 .................................................. 3 1
Over 60 .................................................. 2
tablets.
(2) Indications for use. For the treat- tains pyrantel pamoate equivalent to
ment infectious bacterial 22.7 or 113.5 milligrams pyrantel base.
gastroenteritis associated with emo- (b) Sponsor. See Nos. 017135 and 051311
tional stress. in § 510.600(c) of this chapter.
(3) Limitations. Federal law restricts (c) Conditions of use—(1) Amount. Pro-
this drug to use by or on the order of a vides at least 2.27 milligrams pyrantel
licensed veterinarian. base per pound body weight for dogs
weighing more than 5 pounds, and at
FR 50653, Oct. 8, 1991; 60 FR 55659, Nov. 2, least 4.54 milligrams of pyrantel base
1995; 79 FR 28827, May 20, 2014] per pound body weight for dogs weigh-
ing 5 pounds or less.
§ 520.1962 Promazine. (2) Indications for use—(i) In dogs and
(a) Specifications. Conforms to N.F. puppies. For removal of ascarids
XII for promazine hydrochloride. (Toxocara canis; Toxascaris leonina) and
(b) Sponsor. See No. 054771 in hookworms (Ancylostoma caninum;
§ 510.600(c) of this chapter. Uncinaria stenocephala).
(c) Conditions of use in horses—(1) (ii) In puppies and adult dogs and in
Amount. Administer 0.45 to 0.9 milli- lactating bitches after whelping. To
grams per pound of body weight mixed prevent reinfection of Toxocara canis.
with an amount of feed that will be (3) Limitations. Administer to puppies
readily consumed. at 2, 3, 4, 6, 8, and 10 weeks of age. Ad-
(2) Indications for use. For quieting minister to lactating bitches 2 to 3
weeks after whelping. Retreatment of
excitable, unruly, or intractable
adult dogs may be necessary at month-
horses.
ly intervals as determined by labora-
tory fecal examinations. Consult your
veterinarian for assistance in the diag-
nosis, treatment, and control of para-
sitism.
[79 FR 28827, May 20, 2014]
[52 FR 37937, Oct. 13, 1987, as amended at 57
§ 520.2002 Propiopromazine. FR 48163, Oct. 22, 1992; 58 FR 44611, Aug. 24,
1993; 66 FR 9650, Feb. 9, 2001; 67 FR 21996, May
(a) Specifications. Each chewable tab- 2, 2002; 81 FR 22523, Apr. 18, 2016; 82 FR 12169,
let contains 10 or 20 milligrams of Mar. 1, 2017; 84 FR 8973, Mar. 13, 2019]
propiopromazine hydrochloride.
(b) Sponsor. See No. 054771 in § 520.2042 Pyrantel pamoate tablets.
§ 510.600(c) of this chapter. (a) Specifications. Each tablet con-
(c) Conditions of use in dogs—(1) tains pyrantel pamoate equivalent to
Amount. Administer 0.5 to 2.0 milli- 22.7, 45.4, or 113.5 milligrams of
grams per pound of body weight once pyrantel base.
or twice daily, depending upon the de- (b) Sponsor. See No. 017135 in
gree of tranquilization desired. § 510.600(c) of this chapter.
(2) Indications for use. For oral admin- (c) Conditions of use. It is used for
istration as a tranquilizer. As an aid in dogs as follows:
handling difficult, excited, and unruly (1) Amount. For dogs weighing over 5
dogs, and in controlling excessive ken- pounds, use at least 2.27 milligrams of
nel barking, car sickness, and severe pyrantel base per pound of body
dermatitis. It is also indicated for use weight; for dogs weighing 5 pounds or
in minor surgery and prior to routine less, use at least 4.54 milligrams of
examinations, laboratory procedures, pyrantel base per pound of body

and diagnostic procedures. weight.
240
(2) Indications for use. For removal (i) Amount. 3 mg per pound (/lb) body
and control of large roundworms weight as a single dose mixed with the
(ascarids) (Toxocara canis and usual grain ration, or by stomach tube
Toxascaris leonina), and hookworms or dose syringe.
(Ancylostoma caninum and Uncinaria (ii) Indications for use. For the re-
stenocephala). moval and control of mature infections
(3) Limitations. Administer orally di- of large strongyles (Strongylus vulgaris,
rectly or in a small amount of food. To S. edentatus, S. equinus); pinworms
prevent reinfection of T. canis in pup- (Oxyuris equi); large roundworms
pies, lactating bitches after whelping, (Parascaris equorum); and small
and adult dogs; treat puppies 2, 3, 4, 6, strongyles.
8, and 10 weeks of age; treat lactating (iii) Limitations. Do not use in horses
bitches 2 to 3 weeks after whelping; intended for human consumption.
routinely treat adult dogs monthly. Do When the drug is for administration by
not withhold food prior to or after stomach tube, it shall be labeled:
treatment. The presence of these ‘‘Federal law restricts this drug to use
parasites should be confirmed by lab- by or on the order of a licensed veteri-
oratory fecal examination. A followup narian.’’
fecal examination should be conducted (2) Dogs. It is used as follows:
2 to 4 weeks after first treatment regi- (i) Dogs and puppies—(A) Amount. 2.27
men to determine the need for re-treat- mg/lb body weight as a single dose in
ment. Consult your veterinarian for as- the animal’s feed bowl by itself or
sistance in the diagnosis, treatment, mixed in a small quantity of food.
and control of parasitism. (B) Indications for use. For the re-
moval of large roundworms (Toxocara
[43 FR 52700, Nov. 14, 1978, as amended at 49
FR 22073, May 25, 1984; 57 FR 48163, Oct. 22,
canis and Toxascaris leonina) and
1992; 58 FR 44611, Aug. 24, 1993] hookworms (Ancylostoma caninum and
Uncinaria stenocephala).
§ 520.2043 Pyrantel pamoate suspen- (C) Limitations. Additional treatment
sion. may be required and should be con-
(a) Specifications. (1) Each milliliter firmed by fecal examination within 2
(mL) contains pyrantel pamoate equiv- to 4 weeks.
alent to 50 milligrams (mg) pyrantel (ii) Dogs, puppies, and lactating bitches
base. after whelping—(A) Amount. 2.27 mg/lb
body weight.
(2) Each mL contains pyrantel
(B) Indications for use. To prevent re-
pamoate equivalent to 2.27 or 4.54 mg
infections of T. canis.
pyrantel base.
(C) Limitations. Administer to puppies
(3) Each mL contains pyrantel
at 2, 3, 4, 6, 8, and 10 weeks of age. Ad-
pamoate equivalent to 4.54 mg pyrantel
minister to lactating bitches 2 to 3
base.
weeks after whelping. Adult dogs kept
(b) Sponsors. See sponsors in in heavily contaminated quarters may
§ 510.600(c) of this chapter for uses as in be treated at monthly intervals.
(1) Nos. 054771, 058829, and 069043 for [67 FR 43248, June 27, 2002, as amended at 68
use of the product described in para- FR 54803, Sept. 19, 2003; 68 FR 55199, Sept. 23,
2003; 68 FR 55825, Sept. 29, 2003; 75 FR 52622,
graph (a)(1) as in paragraph (d)(1) of
Aug. 27, 2010; 76 FR 17337, Mar. 29, 2011; 78 FR
this section. 17596, Mar. 22, 2013; 79 FR 28827, May 20, 2014;
(2) Nos. 054771, 058198, and 058829 for 80 FR 76386, Dec. 9, 2015; 81 FR 17607, Mar. 30,
use of the products described in para- 2016; 86 FR 14819, Mar. 19, 2021]
graph (a)(2) of this section as in para-
graph (d)(2) of this section. § 520.2044 Pyrantel pamoate paste.
(3) No. 023851 for use of the product (a) Specifications—(1) Each milliliter
described in paragraph (a)(3) as in para- (mL) contains 180 milligrams (mg)
graph (d)(2) of this section. pyrantel base (as pyrantel pamoate).
(c) Special considerations. See § 500.25 (2) Each mL contains 226 mg pyrantel
of this chapter. base (as pyrantel pamoate).
(d) Conditions of use—(1) Horses and (3) Each mL contains 171 mg pyrantel
ponies. It is used as follows: base (as pyrantel pamoate).
241
§ 520.2045 21 CFR Ch. I (4–1–23 Edition)
(b) Sponsors. See sponsors in edentatus, S. equinus), small strongyles

§ 510.600(c) of this chapter. (Trichonema spp., Triodontophorus),
(1) No. 054771 for use of product de- pinworms (Oxyuris), and large
scribed in paragraph (a)(1) of this sec- roundworms (Parascaris).
tion as in paragraph (d)(1)(i) and (d)(2) (iii) Limitations. Do not treat severely
of this section. debilitated animals with this drug. Do
(2) No. 017135 for use of product de- not use in horses intended for human
scribed in paragraph (a)(2) of this sec- consumption.
tion as in paragraph (d) of this section.
(2) Swine—(i) Amount. Add to feed at
0.4 gram pyrantel tartrate per pound of
tion as in paragraph (d)(1)(i) and (d)(2) non-pelleted ration. The ration is ad-
of this section. ministered as a single treatment as the
(c) Special considerations. See § 500.25 sole ration at the rate of 1 pound per 40
of this chapter. pounds of animal weight for animals up
(d) Conditions of use. It is used in to 200 pounds. Animals 200 pounds and
horses and ponies as follows: over are administered 5 pounds of ra-
(1) Amounts and indications for use. (i) tion per animal.
3 mg per pound (/lb) body weight as sin- (ii) Indications for use. For the re-
gle oral dose for removal and control of moval and control of large roundworms
infections from the following mature (Ascaris suum) and nodular worm
parasites: large strongyles (Strongylus (Oesophagostomum) infections.
vulgaris, S. edentatus, S. equinus); small (iii) Limitations. Consult veterinarian
strongyles; pinworms (Oxyuris equi); before using in severely debilitated
and large roundworms (Parascaris animals. Do not treat within 24 hours
equorum). of slaughter.
(ii) 6 mg/lb body weight as single oral
dose for the removal and control of ma- [79 FR 28827, May 20, 2014]
ture infections of tapeworms
(Anoplocephala perfoliata). § 520.2046 Pyrantel tartrate pellets.
(2) Limitations. Do not use in horses (a) Specifications. (1) Each gram of
intended for human consumption. pellets contains 12.5 milligrams (mg)
[70 FR 29447, May 23, 2005, as amended at 76 (1.25 percent) pyrantel tartrate; or
FR 17337, Mar. 29, 2011; 78 FR 17596, Mar. 22, (2) Each gram of pellets contains 21.1
2013; 79 FR 28827, May 20, 2014; 81 FR 17607, mg (2.11 percent) pyrantel tartrate.
Mar. 30, 2016; 84 FR 8973, Mar. 13, 2019]
§ 520.2045 Pyrantel tartrate powder. § 510.600(c) of this chapter:
(1) No. 054771 for use of products de-
scribed in paragraph (a) as in para-
der contains 106 milligrams (10.6 per-
cent) or 113 milligrams (11.3 percent) graph (c) of this section.
pyrantel tartrate. (2) No. 061133 for use of product de-
(b) Sponsor. See No. 054771 in scribed in paragraph (a)(1) as in para-
§ 510.600(c) of this chapter for use of 11.3 graph (c) of this section.
percent powder as in paragraph (d)(1) (c) Conditions of use in horses—(1)
and 10.6 percent powder as in paragraph Amount. Administer as a single dose at
(d)(2) and of this section. 12.5 mg per 2.2 pounds of body weight
(c) Related tolerances. See § 556.560 of mixed with the usual grain ration.
this chapter. (2) Indications for use. For the re-
(d) Conditions of use—(1) Horses—(i) moval and control of infections from
Amount. Administer as a single dose at the following mature parasites: Large
0.57 gram of pyrantel tartrate per 100 strongyles (Strongylus vulgaris, S.
pounds of body weight mixed with the edentatus, S. equinus), small strongyles
usual grain ration. Do not administer (Trichonema spp., Triodontophorus),
by stomach tube or dose syringe. pinworms (Oxyuris), and large
(ii) Indications for use. For the re- roundworms (Parascaris).
moval and control of infections from
(3) Limitations. Do not treat severely
the following mature parasites: Large

debilitated animals with this drug. Do
strongyles (Strongylus vulgaris, S.
242
not use in horses intended for human Coast tick), Dermacentor variabilis
consumption. (American dog tick), Ixodes scapularis
(black-legged tick), and Rhipicephalus
FR 8973, Mar. 13, 2019] sanguineus (brown dog tick)] for 1
month in dogs 6 months of age or older
§ 520.2075 Robenacoxib. and weighing 2.8 pounds or greater. For
(a) Specifications. Each tablet con- the prevention of Borrelia burgdorferi
tains 10, 20, or 40 milligrams (mg) infections as a direct result of killing
robenacoxib for use in dogs, or 6 mg Ixodes scapularis vector ticks.
robenacoxib for use in cats. (3) Limitations. Federal law restricts
(b) Sponsors. See No. 058198 in this drug to use by or on the order of a
§ 510.600(c) of this chapter. licensed veterinarian.
(c) Conditions of use—(1) Dogs—(i) [81 FR 22523, Apr. 18, 2016, as amended at 82
Amount. Administer 0.91 mg/lb (2 mg/ FR 12169, Mar. 1, 2017; 86 FR 61685, Nov. 8,
kg) orally, once daily, for a maximum 2021]
of 3 days.
(ii) Indications for use. For the control § 520.2090 Sarolaner, moxidectin, and
of postoperative pain and inflamma- pyrantel.
tion associated with soft tissue surgery (a) Specifications. Each chewable tab-
in dogs weighing at least 5.5 lb (2.5 kg) let contains:
and at least 4 months of age for a max- (1) 3.0 mg sarolaner, 0.06 mg
imum of 3 days. moxidectin, and 12.5 milligrams (mg)
(iii) Limitations. Federal law restricts pyrantel (as pamoate salt);
this drug to use by or on the order of a (2) 6.0 mg sarolaner, 0.12 mg
licensed veterinarian. moxidectin, and 25.0 mg pyrantel (as
(2) Cats—(i) Amount. Administer 0.45 pamoate salt);
mg/lb (1 mg/kg) orally, once daily, for a (3) 12.0 mg sarolaner, 0.24 mg
maximum of 3 days. moxidectin, and 50.0 mg pyrantel (as
(ii) Indications for use. For the control pamoate salt);
of postoperative pain and inflamma- (4) 24.0 mg sarolaner, 0.48 mg
tion associated with orthopedic sur- moxidectin, and 100 mg pyrantel (as
gery, ovariohysterectomy, and castra- pamoate salt);
tion in cats weighing at least 5.5 lb (2.5 (5) 48.0 mg sarolaner, 0.96 mg
kg) and at least 4 months of age for a moxidectin, and 200 mg pyrantel (as
maximum of 3 days. pamoate salt); or
(iii) Limitations. Federal law restricts (6) 72.0 mg sarolaner, 1.44 mg
this drug to use by or on the order of a moxidectin, and 300 mg pyrantel (as
licensed veterinarian. pamoate salt).
[76 FR 18648, Apr. 5, 2011, as amended at 79 (b) Sponsor. See No. 054771 in
FR 10964, Feb. 27, 2014; 81 FR 59133, Aug. 29, § 510.600(c) of this chapter.
2016] (c) Conditions of use in dogs—(1)
Amount. Administer orally, once a
§ 520.2086 Sarolaner. month, at the recommended minimum
(a) Specifications. Each chewable tab- dose of 0.54 mg/lb (1.2 mg/kg) sarolaner,
let contains 5, 10, 20, 40, 80, or 120 milli- 0.011 mg/lb (24 μg/kg) moxidectin, and
grams (mg) sarolaner. 2.27 mg/lb (5 mg/kg) pyrantel (as
(b) Sponsor. See No. 054771 in pamoate salt).
§ 510.600(c) of this chapter. (2) Indications for use. For the preven-
(c) Conditions of use in dogs—(1) tion of heartworm disease caused by
Amount. Administer orally once a Dirofilaria immitis and for the treatment
month at the recommended minimum and control of roundworm (immature
dosage of 0.9 mg/lb (2 mg/kg). adult and adult Toxocara canis and
(2) Indications for use. Kills adult adult Toxascaris leonina) and hookworm
fleas, and for the treatment and pre- (L4, immature adult, and adult
vention of flea infestations Ancylostoma caninum and adult
(Ctenocephalides felis), and the treat- Uncinaria stenocephala) infections. Kills
ment and control of tick infestations adult fleas (Ctenocephalides felis) and is
[Amblyomma americanum (lone star indicated for the treatment and pre-
tick), Amblyomma maculatum (Gulf vention of flea infestations, and the
243
§ 520.2098 21 CFR Ch. I (4–1–23 Edition)
treatment and control of tick infesta- minister 1 capsule described in para-

tions with Amblyomma americanum graph (a)(1) per 20 pounds of body
(lone star tick), Amblyomma maculatum weight to a maximum of 5 capsules. Re-
(Gulf Coast tick), Dermacentor variabilis peat at 3 day intervals until a satisfac-
(American dog tick), Ixodes scapularis tory therapeutic response is observed.
(black-legged tick), and Rhipicephalus Maintenance dosage is 1 capsule per 40
sanguineus (brown dog tick) for 1 pounds of body weight every 3 to 7
month in dogs and puppies 8 weeks of days, or longer, as required.
age and older, and weighing 2.8 pounds (ii) Dogs under 20 pounds: Administer
or greater. For the prevention of 1 capsule described in paragraph (a)(2)
Borrelia burgdorferi infections as a di- per 5 pounds of body weight with a
rect result of killing Ixodes scapularis minimum of 1 capsule. Repeat at 3-day
vector ticks. intervals until a satisfactory response
(3) Limitations. Federal law restricts is observed. Maintenance dosage is 1
this drug to use by or on the order of a capsule per 10 pounds of body weight
licensed veterinarian. every 3 to 7 days, or longer, as re-
quired.
[85 FR 45307, July 28, 2020, as amended at 86
FR 57997, Oct. 20, 2021; 87 FR 17945, Mar. 29, (2) Indications for use. As an aid in al-
2022] leviating and controlling inflamma-
tion, pain, and lameness associated
§ 520.2098 Selegiline. with certain arthropathies.
(a) Specifications. Each tablet con- (3) Limitations. Federal law restricts
tains 2, 5, 10, 15, or 30 milligrams (mg) this drug to use by or on the order of a
selegiline hydrochloride. licensed veterinarian.
(b) Sponsor. See No. 054771 in [79 FR 28828, May 20, 2014]
(c) Conditions of use in dogs—(1) § 520.2123 Spectinomycin oral dosage
Amounts and indications for use. (i) Ad- forms.
minister 1 mg per kilogram (0.45 mg
per pound) of body weight once daily § 520.2123a Spectinomycin tablets.
for control of clinical signs associated (a) Specifications. Each tablet con-
with uncomplicated pituitary-depend- tains spectinomycin dihydrochloride
ent hyperadrenocorticism in dogs. equivalent to 100 milligrams (mg)
(ii) Administer 0.5 to 1.0 mg per kilo- spectinomycin.
gram of body weight once daily for the (b) Sponsors. See Nos. 054771 and
control of clinical signs associated 061133 in § 510.600(c) of this chapter.
with canine cognitive dysfunction syn- (c) Conditions of use in dogs—(1)
drome. Amount. Administer orally to provide
(2) Limitations. Federal law restricts 10 mg per pound (lb) of body weight
this drug to use by or on the order of a twice daily. Dosage may be continued
licensed veterinarian. for 4 consecutive days.
[79 FR 28828, May 20, 2014]
ment of infectious diarrhea and
§ 520.2100 Selenium and vitamin E. gastroenteritis caused by organisms
susceptible to spectinomycin.
(a) Specifications. Each capsule con-
tains:
(1) 2.19 milligrams (mg) sodium sele-
nite (equivalent to 1 mg selenium) and
56.2 mg (68 I.U.) vitamin E as d-alpha [73 FR 6607, Feb. 5, 2008, as amended at 79 FR
tocopheryl acid succinate; or 28828, May 20, 2014; 84 FR 8973, Mar. 13, 2019]
(2) 0.548 mg sodium selenite (equiva-
lent to 0.25 mg selenium) and 14 mg (17 § 520.2123b Spectinomycin powder.
I.U.) vitamin E as d-alpha tocopheryl (a) Specifications. Each gram (g) of
acid succinate. powder contains spectinomycin
(b) Sponsor. See No. 000061 in dihydrochloride pentahydrate equiva-
§ 510.600(c) of this chapter. lent to 0.5 g spectinomycin.
(c) Conditions of use in dogs—(1) (b) Sponsor. See No. 061133 in

Amount. (i) Dogs over 20 pounds: Ad- § 510.600(c) of this chapter.
244
(c) Related tolerances. See § 556.600 of § 520.2130 Spinosad.

this chapter. (a) Specifications. Each chewable tab-
(d) Conditions of use in chickens. It is let contains 140, 270, 560, 810, or 1620
administered in the drinking water of milligrams (mg) spinosad.
growing chickens as follows: (b) Sponsor. See No. 058198 in § 510.600
(1) Indications for use and amounts. (i) of this chapter.
As an aid in controlling infectious syn- (c) Special considerations. Federal law
ovitis due to Mycoplasma synoviae in restricts this drug to use by or on the
broiler chickens, administer 1 g per order of a licensed veterinarian.
gallon of water as the only source of (d) Conditions of use—(1) Dogs—(i)
drinking water for the first 3 to 5 days Amount. Administer tablets once a
of life. month at a recommended minimum
(ii) As an aid in the prevention or dosage of 13.5 mg per pound (30 mg per
control of losses due to CRD associated kilogram) of body weight.
with M. gallisepticum (PPLO) in grow- (ii) Indications for use. To kill fleas
ing chickens, administer 2 g per gallon and for the prevention and treatment
of water as the only source of drinking of flea infestations (Ctenocephalides
water for the first 3 days of life and for felis) for 1 month on dogs and puppies
1 day following each vaccination. 14 weeks of age and older and 3.3
(2) Limitations. Do not administer to pounds of body weight or greater.
laying chickens. Do not administer (2) Cats—(i) Amount. Administer tab-
within 5 days of slaughter. Federal law lets once a month at a minimum dos-
age of 22.5 mg per pound (50 mg per
kilogram) of body weight.
(ii) Indications for use. To kill fleas
[73 FR 6607, Feb. 5, 2008, as amended at 81 FR and for the prevention and treatment
94990, Dec. 27, 2016; 84 FR 8973, Mar. 13, 2019] of flea infestations (C. felis) for 1 month
on cats and kittens 14 weeks of age and
§ 520.2123c Spectinomycin solution. older and 2 pounds of body weight or
(a) Specifications. Each milliliter of greater.
solution contains spectinomycin [77 FR 60623, Oct. 4, 2012, as amended at 81 FR
dihydrochloride pentahydrate equiva- 48702, July 26, 2016; 87 FR 10968, Feb. 28, 2022]
lent to 50 milligrams (mg)
spectinomycin. § 520.2134 Spinosad and milbemycin.
(b) Sponsors. See Nos. 016592, 054771, (a) Specifications. Each chewable tab-
and 061133 in § 510.600(c) of this chapter. let contains 140 milligrams (mg)
(c) Related tolerances. See § 556.600 of spinosad and 2.3 mg milbemycin oxime,
this chapter. 270 mg spinosad and 4.5 mg milbemycin
(d) Conditions of use in swine—(1) oxime, 560 mg spinosad and 9.3 mg
Amount. Administer 5 mg per pound (lb) milbemycin oxime, 810 mg spinosad
of body weight orally twice daily for 3 and 13.5 mg milbemycin oxime, or 1,620
to 5 days. mg spinosad and 27 mg milbemycin
(2) Indications for use. For the treat- oxime.
ment and control of porcine enteric (b) Sponsor. See No. 058198 in § 510.600
of this chapter.
colibacillosis (scours) caused by E. coli
susceptible to spectinomycin in pigs
Amount. Administer once a month at a
under 4 weeks of age.
minimum dosage of 13.5 mg/pound (lb)
(3) Limitations. Do not administer to (30 mg/kilogram (kg)) of body weight
pigs over 15 lb body weight or over 4 spinosad and 0.2 mg/lb (0.5 mg/kg) of
weeks of age. Do not administer within body weight milbemycin oxime.
21 days of slaughter. Federal law re- (2) Indications for use. To kill fleas;
stricts this drug to use by or on the for the prevention and treatment of
order of a licensed veterinarian. flea infestations (Ctenocephalides felis);
[73 FR 6607, Feb. 5, 2008, as amended at 78 FR for the prevention of heartworm dis-
17596, Mar. 22, 2013; 79 FR 28828, May 20, 2014; ease (Dirofilaria immitis); and for the
81 FR 22523, Apr. 18, 2016; 84 FR 8973, Mar. 13, treatment and control of adult
2019; 88 FR 14897, Mar. 10, 2023] hookworm (Ancylostoma caninum),
245
§ 520.2138 21 CFR Ch. I (4–1–23 Edition)
adult roundworm (Toxocara canis and (ii) Cats: Administered orally 1⁄2 to 1
Toxascaris leonina), and adult tablet twice daily for several weeks.
whipworm (Trichuris vulpis) infections (2) Indications for use. As an anabolic
in dogs and puppies 8 weeks of age or steroid treatment.
older and 5 lbs of body weight or great- (3) Limitations. Federal law restricts
er. this drug to use by or on the order of a
(3) Limitations. Federal law restricts licensed veterinarian.
this drug to use by or on the order of a [79 FR 28828, May 20, 2014]
§ 520.2158 Streptomycin.
FR 48702, July 26, 2016] (a) Specifications. Each milliliter of
solution contains 250 milligrams (25
§ 520.2138 Spironolactone and percent) streptomycin sulfate.
benazepril. (b) Sponsor. See No. 016592 in
let contains 20 milligrams (mg) (c) Related tolerances. See § 556.610 of
spironolactone and 2.5 mg benazepril this chapter.
hydrochloride, 40 mg spironolactone (d) Conditions of use. Use in drinking
and 5 mg benazepril hydrochloride, or water as follows:
80 mg spironolactone and 10 mg (1) Calves—(i) Amount. 10 to 15 milli-
benazepril hydrochloride. grams per pound (mg/pound) of body
weight (1.0 to 1.5 grams per gallon) for
up to 5 days.
(c) Conditions of use in dogs—(1) ment of bacterial enteritis caused by
Amount. Administer orally once daily, Escherichia coli and Salmonella spp. sus-
with food, at a dose of 0.9 mg per pound ceptible to streptomycin.
(lb) (2 mg per kilogram (kg)) (iii) Limitations. Federal law restricts
spironolactone and 0.11 mg/lb (0.25 mg/ this drug to use by or on the order of a
kg) benazepril hydrochloride, accord- licensed veterinarian.
ing to dog body weight using a suitable (2) Swine—(i) Amount. 10 to 15 mg/
combination of whole and/or half tab- pound of body weight (1.0 to 1.5 grams
lets. per gallon) for up to 4 days.
(2) Indications for use. With concur- (ii) Indications for use. For the treat-
rent therapy (e.g., furosemide, etc.) for ment of bacterial enteritis caused by
the management of clinical signs of Escherichia coli and Salmonella spp. sus-
mild, moderate, or severe congestive ceptible to streptomycin.
heart failure in dogs due to atrio- (iii) Limitations. Federal law restricts
ventricular valvular insufficiency this drug to use by or on the order of a
(AVVI). licensed veterinarian.
(3) Limitations. Federal law restricts (3) Chickens—(i) Amount. 10 to 15 mg/
this drug to use by or on the order of a pound of body weight (0.6 to 0.9 grams
licensed veterinarian. per gallon) for up to 5 days.
[86 FR 14819, Mar. 19, 2021]
ment of nonspecific infectious enteritis
§ 520.2150 Stanozolol. caused by organisms susceptible to
streptomycin.
(a) Specifications. Each tablet or (iii) Limitations. Withdraw 4 days be-
chewable tablet contains 2 milligrams fore slaughter. Do not administer to
stanozolol. chickens producing eggs for human
(b) Sponsor. No. 054771 in § 510.600(c) of consumption. Federal law restricts this
this chapter. drug to use by or on the order of a li-
(c) Conditions of use in dogs and cats— censed veterinarian.
(1) Amount—(i) Dogs: Administered
orally to small breeds, 1⁄2 to 1 tablet
FR 47211, Sept. 8, 1993; 63 FR 51821, Sept. 29,
twice daily for several weeks; to large 1998. Redesignated and amended at 79 FR
breeds, 1 to 2 tablets twice daily for 28828, May 20, 2014; 79 FR 74020, Dec. 15, 2014;
several weeks. The tablets may be 80 FR 18776, Apr. 8, 2015; 80 FR 61296, Oct. 13,
crushed and administered in feed. 2015]
246
§ 520.2170 Sulfabromomethazine. § 520.2200 Sulfachlorpyridazine.

(a) Specifications. Each bolus contains (a) Specifications. (1) Sodium
15 grams of sulfabromomethazine so- sulfachlorpyridazine powder.
dium. (2) Each bolus contains 2 grams
(b) Sponsor. See No. 000010 in sulfachlorpyridazine.
§ 510.600(c) of this chapter. (3) Each tablet contains 250 milli-
(c) Related tolerance. See § 556.620 of grams (mg) sulfachlorpyridazine.
this chapter. (b) Sponsor. See No. 016592 in
(d) Conditions of use in cattle—(1) § 510.600(c) of this chapter.
Amount. Administer 90 milligrams per (c) Related tolerances. See § 556.630 of
pound body weight orally. Repeat in 48 this chapter.
hours if necessary (d) Conditions of use. It is used as fol-
(2) Indications for use. Treatment of lows:
necrotic pododermatitis (foot rot) and (1) Calves—(i) Amount. Administer 30
calf diphtheria caused by Fusobacterium to 45 mg sulfachlorpyridazine powder
necrophorum; colibacillosis (scours) per pound (/lb) of body weight per day
caused by Escherichia coli; bacterial in milk or milk replacer, or in a bolus,
pneumonia and bovine respiratory dis- in divided doses twice daily for 1 to 5
ease complex (shipping fever complex) days.
associated with Pasteurella spp.; acute (ii) Indications for use. For the treat-
metritis and acute mastitis caused by ment of diarrhea caused or complicated
Streptococcus spp. by Escherichia coli (colibacillosis).
(3) Limitations. Milk taken from ani- (iii) Limitations. Treated ruminating
calves must not be slaughtered for food
mals within 96 hours (8 milkings) of
during treatment or for 7 days after
latest treatment must not be used for
the last treatment. A withdrawal pe-
food. Do not administer within 18 days
riod has not been established for this
of slaughter.
[47 FR 30243, July 13, 1982, as amended at 62 not use in calves to be processed for
FR 63270, Nov. 28, 1997; 79 FR 28829, May 20, veal. Federal law restricts this drug to
2014; 84 FR 39183, Aug. 9, 2019] use by or on the order of a licensed vet-
erinarian.
§ 520.2184 Sulfachloropyrazine. (2) Swine—(i) Amount. Administer 20
(a) Specifications. Each gram of pow- to 35 mg/lb body weight per day, in di-
der contains 476 milligrams of sodium vided doses twice daily for 1 to 5 days:
sulfachloropyrazine monohydrate. (A) In drinking water or
(b) Sponsor. See No. 054771 in (B) For individual treatment, in an
§ 510.600(c) of this chapter. oral suspension containing 50 mg per
(c) Related tolerance. See § 556.625 of milliliter.
this chapter. (ii) Indications for use. For the treat-
(d) Conditions of use in chickens. It is ment of diarrhea caused or complicated
used in the drinking water of broilers, by E. coli (colibacillosis).
breeder flocks, and replacement chick- (iii) Limitations. Treated swine must
ens as follows: not be slaughtered for food during
(1) Amount. Administer in drinking treatment or for 4 days after the last
water as 0.03 percent solution for 3 treatment. Federal law restricts this
days. drug to use by or on the order of a li-
(3) Dogs—(i) Amount. Administer tab-
ment of coccidiosis.
lets orally at 500 mg per 10 to 15 lb of
(3) Limitations. Withdraw 4 days prior
body weight daily, in two or three di-
to slaughter. Do not use in chickens
vided doses.
producing eggs for human consump-
(ii) Indications for use. As an aid in
tion. Federal law restricts this drug to
the treatment of infectious
use by or on the order of a licensed vet-
tracheobronchitis and infections
erinarian. caused by E. coli, and in the treatment
[79 FR 28829, May 20, 2014, as amended at 81 of infections caused by other Gram-
FR 94990, Dec. 27, 2016] positive and Gram-negative organisms
247
§ 520.2215 21 CFR Ch. I (4–1–23 Edition)
that are susceptible to sulfonamide multocida susceptible to sulfamerazine,

therapy. sulfamethazine, and sulfaquinoxaline:
(iii) Limitations. Federal law restricts Provide medicated water (0.04 percent
this drug to use by or on the order of a solution) for 2 to 3 days. If disease re-
licensed veterinarian. curs, repeat treatment.
[75 FR 10166, Mar. 5, 2010, as amended at 79 (ii) Limitations. Do not treat chickens
FR 28829, May 20, 2014; 81 FR 17607, Mar. 30, within 14 days of slaughter for food. Do
2016; 81 FR 94990, Dec. 27, 2016] not medicate chickens producing eggs
for human consumption. Federal law
§ 520.2215 Sulfadiazine/pyrimethamine restricts this drug to use by or on the
suspension. order of a licensed veterinarian.
(a) Specifications. Each milliliter (2) Turkeys—(i) Amounts and indica-
(mL) of suspension contains 250 milli- tions for use. (A) As an aid in the con-
grams (mg) sulfadiazine (as the sodium trol of coccidiosis caused by Eimeria
salt) and 12.5 mg pyrimethamine. meleagrimitis and E. adenoeides suscep-
(b) Sponsor. See No. 055246 in tible to sulfamerazine, sulfamethazine,
§ 510.600(c) of this chapter. and sulfaquinoxaline: Provide medi-
(c) Conditions of use in horses—(1) cated water (0.025 percent solution) for
Amount. Administer orally 20 mg sulfa- 2 days, then plain water for 3 days,
diazine per kilogram (kg) body weight then medicated water (0.025 percent so-
and 1 mg/kg pyrimethamine daily. lution) for 2 days, then plain water for
(2) Indications for use. For the treat- 3 days, then medicated water (0.025 per-
ment of equine protozoal cent solution) for 2 days. Repeat if nec-
myeloencephalitis (EPM) caused by essary. Do not change litter.
Sarcocystis neurona. (B) As an aid in the control of acute
(3) Limitations. Do not use in horses fowl cholera caused by Pasteurella
intended for human consumption. Fed- multocida susceptible to sulfamerazine,
eral law restricts this drug to use by or sulfamethazine, and sulfaquinoxaline:
on the order of a licensed veterinarian. Provide medicated water (0.04 percent
solution) for 2 to 3 days. If disease re-
FR 53686, Sept. 17, 2008; 75 FR 69586, Nov. 15, curs, repeat treatment.
2010] (ii) Limitations. Do not treat turkeys
within 14 days of slaughter for food. Do
§ 520.2218 Sulfamerazine, not medicate turkeys producing eggs
sulfamethazine, and for human consumption. Federal law
sulfaquinoxaline powder. restricts this drug to use by or on the
(a) Specifications. Each 195-gram (g) order of a licensed veterinarian.
packet of powder contains 78 g sulfa-
merazine, 78 g sulfamethazine, and 39 g FR 28829, May 20, 2014; 80 FR 34278, June 16,
sulfaquinoxaline. 2015; 81 FR 22523, Apr. 18, 2016; 81 FR 94990,
(b) Sponsor. See No. 016592 in Dec. 27, 2016; 85 FR 18119, Apr. 1, 2020]
(c) Related tolerances. See §§ 556.660, § 520.2220 Sulfadimethoxine oral dos-
556.670, and 556.685 of this chapter. age forms.
(d) Conditions of use—(1) Chickens—(i)
Amounts and indications for use. (A) As § 520.2220a Sulfadimethoxine oral so-
an aid in the control of coccidiosis lution and soluble powder.
caused by Eimeria tenella and E. necatrix (a) Specifications. (1) Each ounce of
susceptible to sulfamerazine, solution contains 3.75 grams (12.5 per-
sulfamethazine, and sulfaquinoxaline: cent) sulfadimethoxine.
Provide medicated water (0.04 percent (2) Each 107 grams of powder contains
solution) for 2 to 3 days, then plain the equivalent of 94.6 grams
water for 3 days, then medicated water sulfadimethoxine as sulfadimethoxine
(0.025 percent solution) for 2 days. If sodium.
bloody droppings appear, repeat at 0.025 (b) Sponsors. See sponsor numbers in
percent level for 2 more days. Do not § 510.600(c) of this chapter:
change litter. (1) Nos. 016592, 054771, 054925, and
(B) As an aid in the control of acute 069043 for use of the product described
fowl cholera caused by Pasteurella in paragraph (a)(1) of this section.
248
(2) Nos. 016592, 054771, 054925, 058829, Federal law prohibits the extralabel
061133, and 066104 for use of the product use of this product in lactating dairy
described in paragraph (a)(2) of this cattle.
section. [79 FR 28829, May 20, 2014, as amended at 81
(c) Related tolerances. See § 556.640 of FR 22523, Apr. 18, 2016; 81 FR 94990, Dec. 27,
this chapter. 2016; 83 FR 48946, Sept. 28, 2018; 84 FR 8973,
(d) Conditions of use—(1) Broiler and Mar. 13, 2019; 87 FR 10968, Feb. 28, 2022]
replacement chickens—(i) Amount. Ad-
minister 1.875 grams per gallon (0.05 § 520.2220b Sulfadimethoxine suspen-
percent) of drinking water for 6 con- sion.
secutive days. (a) Specifications. Each milliliter of
(ii) Indications for use. For treatment suspension contains 50 milligrams (mg)
of outbreaks of coccidiosis, fowl chol- sulfadimethoxine.
era, and infectious coryza. (b) Sponsors. See Nos. 000061 and
(iii) Limitations. Withdraw 5 days be- 054771 in § 510.600(c) of this chapter.
fore slaughter. Do not administer to (c) Conditions of use in dogs and cats—
chickens over 16 weeks (112 days) of (1) Amount. Administer orally 25 mg per
age. Federal law restricts this drug to pound of body weight, followed by 12.5
use by or on the order of a licensed vet- mg per pound of body weight daily.
erinarian. (2) Indications for use. For the treat-
(2) Turkeys—(i) Amount. Administer ment of sulfonamide susceptible bac-
0.938 grams per gallon (0.025 percent) of terial infections in dogs and cats and
drinking water for 6 consecutive days. enteritis associated with coccidiosis in
(ii) Indications for use. Growing tur- dogs.
keys: For treatment of disease out- (3) Limitations. Federal law restricts
breaks of coccidiosis and fowl cholera. this drug to use by or on the order of a
(iii) Limitations. Withdraw 5 days be- licensed veterinarian.
fore slaughter. Do not administer to
[79 FR 28829, May 20, 2014]
turkeys over 24 weeks (168 days) of age.
Federal law restricts this drug to use § 520.2220c Sulfadimethoxine tablet.
by or on the order of a licensed veteri-
narian.
tains 125, 250, or 500 milligrams (mg)
(3) Cattle—(i) Amount. 1.18 to 2.36
sulfadimethoxine.
grams per gallon (0.031 to 0.062 percent)
of drinking water. As a drench, admin-
ister 2.5 grams per 100 pounds of body
(c) [Reserved]
weight for first day, then 1.25 grams
(d) Conditions of use in dogs and cats—
per 100 pounds of body weight per day
(1) Amount. Administer 25 milligrams
for the next 4 consecutive days. If no
(mg) per pound of body weight on the
improvement within 2 to 3 days, re-
first day followed by 12.5 milligrams
evaluate diagnosis. Do not treat be-
(mg) per pound of body weight per day
yond 5 days.
until the animal is free of symptoms
(ii) Indications for use. Dairy calves,
for 48 hours.
dairy heifers, and beef cattle: For the
treatment of shipping fever complex
sulfadimethoxine-susceptible bacterial
and bacterial pneumonia associated
infections.
with Pasteurella spp. sensitive to
sulfadimethoxine; and calf diphtheria
and foot rot associated with
Fusobacterium necrophorum
(Sphaerophorus necrophorus) sensitive [79 FR 28829, May 20, 2014]
to sulfadimethoxine.
(iii) Limitations. Withdraw 7 days be- § 520.2220d Sulfadimethoxine bolus.
fore slaughter. A withdrawal period has (a) Specifications. Each bolus contains
not been established for this product in 2.5, 5, or 15 grams sulfadimethoxine.
preruminating calves. Do not use in (b) Sponsor. See No. 054771 in
calves to be processed for veal. Federal § 510.600(c) of this chapter.
law restricts this drug to use by or on (c) Related tolerances. See § 556.640 of
the order of a licensed veterinarian. this chapter.
249
§ 520.2220e 21 CFR Ch. I (4–1–23 Edition)
(d) Conditions of use in cattle—(1) § 520.2220f Sulfadimethoxine and

Amount. Administer 2.5 grams per 100 ormetoprim tablet.
pounds body weight for 1 day followed (a) Specifications. Each tablet con-
by 1.25 grams per 100 pounds body tains 120 milligrams (mg) (100 mg
weight per day; treat for 4 to 5 days. sulfadimethoxine and 20 mg
(2) Indications for use. For the treat- ormetoprim), 240 mg (200 mg
ment of shipping fever complex and sulfadimethoxine and 40 mg
bacterial pneumonia associated with ormetoprim), 600 mg (500 mg
Pasteurella spp. sensitive to sulfadimethoxine and 100 mg
sulfadimethoxine; and calf diphtheria ormetoprim), or 1200 mg (1000 mg
and foot rot associated with sulfadimethoxine and 200 mg
Fusobacterium necrophorum sensitive to ormetoprim).
sulfadimethoxine. (b) Sponsor. See No. 054771 in
(3) Limitations. Do not administer § 510.600(c) of this chapter.
within 7 days of slaughter. Milk that (c) Conditions of use in dogs—(1)
has been taken from animals during Amount. On the first day of treatment,
treatment and 60 hours (five milkings) administer 25 mg per pound (55 mg per
after the latest treatment must not be kilogram) of body weight. Then follow
used for food. A withdrawal period has with a daily dosage of 12.5 mg per
not been established for this product in pound (27.5 mg per kilogram) of body
preruminating calves. Do not use in weight. Do not exceed a total of 21 con-
calves to be processed for veal. Federal secutive days.
law restricts this drug to use by or on (2) Indications of use. Treatment of
the order of a licensed veterinarian. skin and soft tissue infections (wounds
[79 FR 28829, May 20, 2014, as amended at 88 and abscesses) in dogs caused by
FR 16547, Mar. 20, 2023] strains of Staphylococcus aureus and
Escherichia coli and urinary tract infec-
§ 520.2220e Sulfadimethoxine ex- tions caused by E. coli, Staphylococcus
tended-release bolus. spp., and Proteus mirabilus susceptible
(a) Specifications. Each extended-re- to ormetoprim-potentiated
lease bolus contains 12.5 grams sulfadimethoxine.
sulfadimethoxine. (3) Limitations. Federal law restricts
(b) Sponsor. See No. 054771 in this drug to use by or on the order of a
[79 FR 28830, May 20, 2014]
this chapter.
(d) Conditions of use in beef cattle and § 520.2240 Sulfaethoxypyridazine.
non-lactating dairy cattle—(1) Amount.
Administer one 12.5-gram-sustained-re- § 520.2240a Sulfaethoxypyridazine so-
lease bolus for the nearest 200 pounds lution.
of body weight, i.e., 62.5 milligrams per (a) Specifications. Each milliliter of
pound of body weight. Do not repeat solution contains 62.5 milligrams (mg)
treatment for 7 days. sodium sulfaethoxypyridazine.
(2) Indications for use. For the treat- (b) Sponsor. See No. 054771 § 510.600(c)
ment of shipping fever complex and of this chapter.
bacterial pneumonia associated with (c) Related tolerances. See § 556.650 of
Pasteurella spp. sensitive to this chapter.
sulfadimethoxine; and calf diphtheria (d) Conditions of use—(1) Swine—(i)
and foot rot associated with Amount. Administer 3.8 grams per gal-
Fusobacterium necrophorum sensitive to lon for first day followed by 1.9 grams
sulfadimethoxine. per gallon for not less than 3 days nor
(3) Limitations. Do not use in female more than 9 days. Use as the sole
dairy cattle 20 months of age or older. source of sulfonamide.
Do not administer within 12 days of
(ii) Indications for use. For treatment
slaughter. Federal law restricts this
of bacterial scours pneumonia enter-
itis, bronchitis, septicemia accom-
panying Salmonella choleraesuis infec-
[79 FR 28830, May 20, 2014] tion.
250
(iii) Limitations. Do not treat within (ii) Indications for use. For treatment
10 days of slaughter. Federal law re- of foot rot and respiratory infections
stricts this drug to use by or on the (shipping fever and pneumonia) caused
order of a licensed veterinarian. by sulfonamide-susceptible pathogens
(2) Cattle—(i) Amount. For use at 2.5 (E. coli, Streptococci, Staphylococci,
grams per gallon. Administer at the Sphaerophorus necrophorus and Gram-
rate of 1 gallon per 100 pounds of body negative rods including Pasteurella);
weight per day for 4 days. Use as the and for use prophylactically during pe-
sole source of sulfonamide. riods of stress for reducing losses due
(ii) Indications for use. For treatment to sulfonamide sensitive disease condi-
of respiratory infections (pneumonia, tions.
shipping fever), foot rot, calf scours; (iii) Limitations. Do not treat within
and as adjunctive therapy in septi- 16 days of slaughter. Not for use in lac-
cemia accompanying mastitis and me- tating dairy cows. Federal law restricts
tritis. this drug to use by or on the order of a
(iii) Limitations. Do not treat within licensed veterinarian.
16 days of slaughter. Milk that has [79 FR 28830, May 20, 2014]
been taken from animals during treat-
ment and for 72 hours (6 milkings) after § 520.2260 Sulfamethazine oral dosage
latest treatment must not be used for forms.
food. Federal law restricts this drug to
use by or on the order of a licensed vet- § 520.2260a Sulfamethazine oblets and
erinarian. boluses.
[79 FR 28830, May 20, 2014] (a) Specifications. Each oblet or bolus
contains:
§ 520.2240b Sulfaethoxypyridazine tab- (1) 2.5, 5, or 15 grams sulfamethazine.
lets. (2) 5 grams sulfamethazine.
(a) Specifications. (1) Each tablet con- (b) Sponsors. See sponsors in
tains 2.5 or 15 grams § 510.600(c) of this chapter for use of
sulfaethoxypyridazine. products described in paragraph (a) of
(2) Each extended-release tablet con- this section.
tains 5 grams sulfaethoxypyridazine. (1) No. 016592 for use of products de-
(b) Sponsor. See No. 054771 § 510.600(c) scribed in paragraph (a)(1) of this sec-
of this chapter. tion.
(c) Related tolerances. See § 556.650 of (2) No. 054771 for use of product de-
this chapter. scribed in paragraph (a)(2) of this sec-
(d) Conditions of use in cattle—(1) 2.5- tion.
or 15-gram tablets—(i) Amount. Admin- (c) Related tolerances. See § 556.670 of
ister 25 milligrams per pound of body this chapter.
weight per day for 4 days. Use as the (d) Conditions of use. (1) Oblets and
sole source of sulfonamide. boluses described in paragraph (a)(1) of
(ii) Indications for use. For treatment this section:
of respiratory infections (pneumonia, (i) Amount. Administer as a single
shipping fever), foot rot, calf scours; as dose 100 milligrams per pound (mg/lb)
adjunctive therapy in septicemia ac- of body weight the first day and 50 mg/
companying mastitis and metritis. lb of body weight on each following
(iii) Limitations. Do not treat within day.
16 days of slaughter. Milk that has (ii) Indications for use—(A) Beef cattle
been taken from animals during treat- and nonlactating dairy cattle. For the
ment and for 72 hours (6 milkings) after treatment of bacterial pneumonia and
latest treatment must not be used for bovine respiratory disease complex
food. Federal law restricts this drug to (shipping fever complex) (Pasteurella
use by or on the order of a licensed vet- spp.), colibacillosis (bacterial scours)
erinarian. (Escherichia coli), necrotic
(2) 15-gram extended-release tablets—(i) pododermatitis (foot rot)
Amount. Administer 100 milligrams per (Fusobacterium necrophorum), calf diph-
pound of body weight. Use as the sole theria (Fusobacterium necrophorum),

source of sulfonamide. acute mastitis (Streptococcus spp.),
251
§ 520.2260b 21 CFR Ch. I (4–1–23 Edition)
acute metritis (Streptococcus spp.), and § 520.2260b Sulfamethazine sustained-

coccidiosis (Eimeria bovis and E. zurnii). release boluses.
(B) Horses. For the treatment of bac- (a) Related tolerances. See § 556.670 of
terial pneumonia (secondary infections this chapter.
associated with Pasteurella spp.), stran- (b) [Reserved]
gles (Streptococcus equi), and bacterial (c)(1) Sponsor. See No. 054771 in
enteritis (Escherichia coli). § 510.600(c) of this chapter for use of a
(iii) Limitations. Do not administer 27-gram sulfamethazine sustained-re-
for more than 5 consecutive days. Do lease bolus.
not treat cattle within 10 days of (2) Conditions of use—(i) Amount. 27
slaughter. Do not use in female dairy grams (1 bolus) for each 150 pounds of
cattle 20 months of age or older. Use of body weight as a single dose.
sulfamethazine in this class of cattle (ii) Indications for use. For nonlac-
may cause milk residues. A withdrawal tating cattle for the treatment of in-
period has not been established for this fections caused by organisms sensitive
product in preruminating calves. Do to sulfamethazine such as hemorrhagic
not use in calves to be processed for septicemia (shipping fever complex),
veal. Do not use in horses intended for bacterial pneumonia, foot rot, and calf
human consumption. Federal law re- diphtheria and as an aid in the control
of bacterial diseases usually associated
with shipping and handling of cattle.
(iii) Limitations. If no response within
(2) Boluses described in paragraph 2 to 3 days, reevaluate therapy; do not
(a)(2) of this section: crush tablets; treated animals must
(i) Amount. Administer 10 grams (2 not be slaughtered for food within 28
boluses) of sulfamethazine per 100 days after the latest treatment; Fed-
pounds of body weight the first day, eral law restricts this drug to use by or
then 5 grams (1 bolus) of on the order of a licensed veterinarian.
sulfamethazine per 100 pounds of body (d)(1) Sponsor. See No. 061133 in
weight daily for up to 4 additional con- § 510.600(c) of this chapter for use of a
secutive days. 32.1-gram sustained-release bolus.
(ii) Indications for use—(A) Ruminating (2) Conditions of use—(i) Amount. 32.1
beef and dairy calves. For treatment of grams (1 bolus) per 200 pounds of body
the following diseases caused by orga- weight.
nisms susceptible to sulfamethazine: (ii) Indications for use. For beef and
bacterial scours (colibacillosis) caused nonlactating dairy cattle for the treat-
by Escherichia coli; necrotic ment of diseases caused by
pododermatitis (foot rot) and calf diph- sulfamethazine-sensitive organisms as
theria caused by Fusobacterium follows: bacterial pneumonia and bo-
necrophorum; bacterial pneumonia asso- vine respiratory disease complex (ship-
ciated with Pasteurella spp.; and coc- ping fever complex) caused by
cidiosis caused by Eimeria bovis and E. Pasteurella spp., colibacillosis (bac-
zurnii. terial scours) caused by E. coli, necrotic
(B) [Reserved] pododermatitis (foot rot) and calf diph-
(iii) Limitations. Do not administer theria caused by Fusobacterium
for more than 5 consecutive days. Do necrophorum, and acute mastitis and
not treat calves within 11 days of acute metritis caused by Streptococcus
spp.)
slaughter. Do not use in calves to be
(iii) Limitations. After 72 hours, all
slaughtered under 1 month of age or in
animals should be reexamined for per-
calves being fed an all milk diet. Do
sistence of observable disease signs. If
not use in female dairy cattle 20
signs are present, consult a veteri-
months of age or older; such use may narian. It is strongly recommended
cause drug residues in milk. Federal that a second dose be given to provide
law restricts this drug to use by or on for an additional 72 hours of therapy,
the order of a licensed veterinarian. particularly in more severe cases. The
[87 FR 58961, Sept. 29, 2022, as amended at 88 dosage schedule should be used at each
FR 14897, Mar. 10, 2023; 88 FR 16547, Mar. 20, 72-hour interval. Animals should not
2023] receive more than 2 doses because of
252
the possibility of incurring residue vio- or more of the listed pathogenic orga-
lations. This drug, like all nisms sensitive to sulfamethazine: bo-
sulfonamides, may cause toxic reac- vine respiratory disease complex (ship-
tions and irreparable injury unless ad- ping fever complex) associated with
ministered with adequate and contin- Pasteurella spp.; bacterial pneumonia
uous supervision; follow dosages care- associated with Pasteurell spp.; necrotic
fully. Fluid intake must be adequate at pododermatitis (foot rot) and calf diph-
all times throughout the 3-day ther- theria caused by Fusobacterium
apy, Do not use in female dairy cattle necrophorum; colibacillosis (bacterial
20 months of age or older. Use of
scours) caused by Escherichia coli; coc-
sulfamethazine in this class of cattle
cidiosis caused by Eimeria bovis and E.
may cause milk residues. Do not treat
animals within 12 days of slaughter. zurnii; acute mastitis and metritis
(e) [Reserved] caused by Streptococcus spp.
(f)(1) Sponsor. See No. 061133 in (iii) Limitations. For use in beef cattle
§ 510.600(c) of this chapter for use of an and nonlactating dairy cattle only; if
8.02-gram sulfamethazine sustained-re- symptoms persist for 2 or 3 days after
lease bolus. use, consult a veterinarian; do not
(2) Conditions of use—(i) Amount. Ad- slaughter animals for food for at least
minister 2 boluses (8.02 grams per 8 days after the last dose; do not use in
bolus) per 100 pounds of body weight, as lactating dairy cattle; do not admin-
a single dose. ister more than two consecutive doses.
(ii) Indications for use. Administer (h)(1) Sponsor. See No. 000010 in
orally to ruminating calves for the pro- § 510.600(c) of this chapter for use of an
longed treatment of the following dis- 8.25-gram sulfamethazine sustained-re-
eases when caused by one or more of lease bolus.
the listed pathogenic organisms sen-
(2) Conditions of use—(i) Amount. Ad-
sitive to sulfamethazine: bacterial
pneumonia (Pasteurella spp.), minister at the rate of 1 bolus (8.25
colibacillosis (bacterial scours) (E. grams per bolus) per 50 pounds of body
coli), and calf diphtheria (Fusobacterium weight, as a single dose. If signs of dis-
necrophorum). ease are significantly reduced, it is rec-
(iii) Limitations. For use in rumi- ommended that a second dose be given
nating replacement calves only; 72 to provide an additional 72 hours of
hours after dosing all animals should therapy.
be reexamined for persistence of dis- (ii) Indications for use. Administer
ease signs; if signs are present, consult orally to ruminating beef and dairy
a veterinarian; do not slaughter ani- calves for treatment of the following
mals for food for at least 12 days after diseases when caused by one or more of
the last dose; this product has not been the listed pathogenic organisms sus-
shown to be effective for nonrumi- ceptible to sulfamethazine: bacterial
nating calves; exceeding two consecu- pneumonia associated with Pasteurella
tive doses may cause violative tissue spp.; colibacillosis (bacterial scours)
residue to remain beyond the with-
caused by Escherichia coli; coccidiosis
drawal time; do not use in calves under
caused by Eimeria bovis and E. zurnii;
1 month of age or calves being fed an
all milk diet. and calf diphtheria caused by
(g)(1) Sponsor. See No. 016592 in Fusobacterium necrophorum.
§ 510.600(c) of this chapter for use of a (iii) Limitations. Do not use in calves
30-gram sulfamethazine sustained-re- to be slaughtered under 1 month of age
lease bolus. or calves being fed an all milk diet. Do
(2) Conditions of use—(i) Amount. Ad- not use in female dairy cattle 20
minister at the rate of 1 bolus (30 months of age or older. If symptoms
grams per bolus) per 200 pounds of body persist after 3 days, consult a veteri-
weight, as a single dose. narian. Do not administer more than 2
(ii) Indications for use. Administer consecutive doses. Do not slaughter
orally to beef cattle and nonlactating
dairy cattle for the treatment of the

following diseases when caused by one
253
§ 520.2260c 21 CFR Ch. I (4–1–23 Edition)
animals for food for at least 8 days body weight per day on the first day
after the last dose. Do not crush bolus. and 56.25 milligrams per pound of body
weight on subsequent days; Chickens,
FR 18803, Apr. 26, 1983; 48 FR 32760, July 19, 61 to 89 milligrams of sulfamethazine
1983; 49 FR 29057, July 18, 1984; 50 FR 49372, sodium per pound of body weight per
Dec. 2, 1985; 51 FR 30212, Aug. 25, 1986; 53 FR day, and turkeys 53 to 130 milligrams
40727, Oct. 18, 1988; 54 FR 14341, Apr. 11, 1989; of sulfamethazine sodium per pound of
55 FR 8462, Mar. 8, 1990; 56 FR 50653, Oct. 8, body weight per day, depending upon
1991; 59 FR 22754, May 3, 1994; 61 FR 4875, Feb. the dosage, age, and class of chickens
9, 1996; 62 FR 35076, June 30, 1997; 66 FR 14073, or turkeys, ambient temperature, and
Mar. 9, 2001; 68 FR 4915, Jan. 31, 2003; 70 FR
other factors.
8290, Feb. 18, 2005; 78 FR 17596, Mar. 22, 2013;
79 FR 28830, May 20, 2014; 81 FR 22523, Apr. 18, (2) Indications for use. For treatment
2016; 84 FR 8973, Mar. 13, 2019; 85 FR 18119, and control of diseases caused by orga-
Apr. 1, 2020; 86 FR 14819, Mar. 19, 2021; 87 FR nisms sensitive to sulfamethazine.
10969, Feb. 28, 2022] (i) Beef and nonlactating dairy cattle.
Treatment of bacterial pneumonia and
§ 520.2260c Sulfamethazine sustained- bovine respiratory disease complex
release tablets. (shipping fever complex) (Pasteurella
(a) Specifications. Each extended-re- spp.), colibacillosis (bacterial scours)
lease tablet contains 8 grams (Escherichia coli), necrotic
sulfamethazine. pododermatitis (foot rot)
(b) Sponsor. See No. 054771 in (Fusobacterium necrophorum), calf diph-
§ 510.600(c) of this chapter. theria (Fusobacterium necrophorum),
(c) Related tolerances. See § 556.670 of acute mastitis (Streptococcus spp.), and
this chapter. acute metritis (Streptococcus spp.).
(d) Conditions of use—(1) Amount. 8 (ii) Swine. Treatment of porcine
grams (1 tablet) per 45 pounds of body colibacillosis (bacterial scours)
weight as a single dose. (Escherichia coli), and bacterial pneu-
(2) Indications for use. In calves for monia (Pasteurella spp.).
sustained treatment of pneumonia (iii) Chickens and turkeys. In chickens
caused by Pasteurella spp., for control of infectious coryza
colibacillosis (bacterial scours) caused (Avibacterium paragallinarum), coccidi-
by Escherichia coli; and calf diptheria osis (Eimeria tenella, Eimeria necatrix),
caused by Fusobacterium necrophorum. acute fowl cholera (Pasteurella
(3) Limitations. Treated animals must multocida), and pullorum disease
not be slaughtered for food within 18 (Salmonella Pullorum). In turkeys for
days after the latest treatment. Fed- control of coccidiosis (Eimeria
eral law restricts this drug to use by or meleagrimitis, Eimeria adenoeides). Medi-
on the order of a licensed veterinarian. cate as follows: Infectious coryza in
chickens, medicate for 2 consecutive
FR 50653, Oct. 8, 1991; 59 FR 22754, May 3, 1994;
days; acute fowl cholera and pullorum
61 FR 4875, Feb. 9, 1996; 79 FR 28830, May 20, disease, in chickens, medicate for 6
2014] consecutive days; coccidiosis, in chick-
ens and turkeys, medicate as in para-
§ 520.2261 Sulfamethazine sodium oral graph (c) of this section, then reduce
dosage forms. amount of medication to one-half for 4
additional days.
§ 520.2261a Sulfamethazine solution. (3) Limitations. Add the required dose
(a) Specifications. Each milliliter of to that amount of water that will be
solution contains 125 milligrams (12.5 consumed in 1 day. Consumption
percent) sulfamethazine sodium. should be carefully checked. Have only
(b) Sponsors. See No. 016592 in medicated water available during
§ 510.600(c) of this chapter. treatment. Withdraw medication from
(c) Related tolerances. See § 556.670 of cattle, chickens, and turkeys 10 days
this chapter. prior to slaughter for food. Withdraw
(d) Conditions of use—(1) Amount. Ad- medication from swine 15 days before
minister in drinking water to provide: slaughter for food. Do not medicate
Cattle and swine 112.5 milligrams of chickens or turkeys producing eggs for
sulfamethazine sodium per pound of human consumption. Treatment of all
254
diseases should be instituted early. dosages. Federal law restricts this drug
Treatment should continue 24 to 48 to use by or on the order of a licensed
hours beyond the remission of disease veterinarian.
symptoms, but not to exceed a total of (2) Turkeys—(i) Amount. Administer
5 consecutive days in cattle or swine. in drinking water to provide 50 to 124
Medicated cattle, swine, chickens, and mg/lb of body weight per day
turkeys must actually consume enough (ii) Indications for use. For control of
medicated water which provides the coccidiosis (E. meleagrimitis, E.
recommended dosages. Do not use in fe- adenoeides).
male dairy cattle 20 months of age or (iii) Limitations. Add the required
older. Use of sulfamethazine in this dose to that amount of water that will
class of cattle may cause milk resi- be consumed in 1 day. Consumption
dues. A withdrawal period has not been should be carefully checked. Have only
established in preruminating calves. medicated water available during
Do not use in calves to be processed for treatment. Withdraw medication 10
veal. Federal law restricts this drug to days prior to slaughter for food. Do not
use by or on the order of a licensed vet- medicate turkeys producing eggs for
erinarian. human consumption. Treatment of all
diseases should be instituted early.
FR 25735, June 15, 1982; 67 FR 78355, Dec. 24, Treatment should continue 24 to 48
2002; 70 FR 32489, June 3, 2005; 74 FR 36112, hours beyond the remission of disease
July 22, 2009; 75 FR 10166, Mar. 5, 2010; 76 FR symptoms. Medicated turkeys must ac-
17337, Mar. 29, 2011; 79 FR 28831, May 20, 2014; tually consume enough medicated
81 FR 17607, Mar. 30, 2016; 81 FR 36789, June water which provides the recommended
8, 2016; 81 FR 94990, Dec. 27, 2016] dosages. Federal law restricts this drug
to use by or on the order of a licensed
§ 520.2261b Sulfamethazine powder. veterinarian.
(a) Specifications. A soluble powder (3) Swine—(i) Amount. Administer in
composed of 100 percent sulfamethazine drinking water, or as a drench, to pro-
sodium. vide 108 mg/lb of body weight on the
(b) Sponsors. See Nos. 016592 and first day and 54 mg/lb of body weight
061133 in § 510.600(c) of this chapter. per day on the second, third, and fourth
(c) Related tolerances. See § 556.670 of days of administration.
this chapter. (ii) Indications for use. For treatment
(d) Conditions of use—(1) Chickens—(i) of porcine colibacillosis (bacterial
Amount. Administer in drinking water scours) (E. coli), and bacterial pneu-
to provide 58 to 85 milligrams (mg) per monia (Pasteurella spp.).
pound (/lb) of body weight per day. (iii) Limitations. Add the required
(ii) Indications for use. For control of dose to that amount of water that will
infectious coryza (Avibacterium be consumed in 1 day. Consumption
paragallinarum), coccidiosis (Eimeria should be carefully checked. Have only
tenella, E. necatrix), acute fowl cholera medicated water available during
(Pasteurella multocida), and pullorum treatment. Withdraw medication 15
disease (Salmonella Pullorum). days prior to slaughter for food. Treat-
(iii) Limitations. Add the required ment of all diseases should be insti-
dose to that amount of water that will tuted early. Treatment should con-
be consumed in 1 day. Consumption tinue 24 to 48 hours beyond the remis-
should be carefully checked. Have only sion of disease symptoms, but not to
medicated water available during exceed a total of 5 consecutive days.
treatment. Withdraw medication 10 Medicated swine must actually con-
days prior to slaughter for food. Do not sume enough medicated water which
medicate chickens producing eggs for provides the recommended dosages.
human consumption. Treatment of all Federal law restricts this drug to use
diseases should be instituted early. by or on the order of a licensed veteri-
Treatment should continue 24 to 48 narian.
hours beyond the remission of disease (4) Cattle—(i) Amount. Administer in
symptoms. Medicated chickens must drinking water, or as a drench, to pro-
actually consume enough medicated vide 108 mg/lb of body weight on the
water which provides the recommended first day and 54 mg/lb of body weight
255
§ 520.2280 21 CFR Ch. I (4–1–23 Edition)
per day on the second, third, and fourth lapse, continue therapy for a week to
days of administration. 10 days.
(ii) Indications for use in beef and non- (2) Indications for use. For treatment
lactating dairy cattle. Treatment of bac- of urinary tract infections such as cys-
terial pneumonia and bovine res- titis, nephritis, prostatitis, urethritis,
piratory disease complex (shipping and pyelonephritis. As an aid in the
fever complex) (Pasteurella spp.), management of complications result-
colibacillosis (bacterial scours) (E. ing from surgical manipulations of the
coli), necrotic pododermatitis (foot rot) urinary tract such as removal of
(Fusobacterium necrophorum), calf diph- calculi from the bladder, in
theria (F. necrophorum), acute mastitis ureterostomies, and in instrumenta-
(Streptococcus spp.), and acute metritis tion of the urethra and bladder.
(Streptococcus spp.) (3) Limitations. Federal law restricts
(iii) Limitations. Add the required this drug to use by or on the order of a
dose to that amount of water that will licensed veterinarian.
be consumed in 1 day. Consumption [40 FR 13838, Mar. 27, 1975, as amended at 50
should be carefully checked. Have only FR 13561, Apr. 5, 1985; 79 FR 28831, May 20,
medicated water available during 2014]
treatment. Withdraw medication 10
days prior to slaughter for food. Treat- § 520.2325 Sulfaquinoxaline oral dos-
ment of all diseases should be insti- age forms.
tuted early. Treatment should con-
tinue 24 to 48 hours beyond the remis- § 520.2325a Sulfaquinoxaline powder
sion of disease symptoms, but not to and solution.
exceed a total of 5 consecutive days. (a) Sponsor. See § 510.600(c) of this
Medicated cattle must actually con- chapter for identification of the spon-
sume enough medicated water which sors.
provides the recommended dosages. Do (1) To No. 016592 for use of a 25-per-
not use in female dairy cattle 20 cent sulfaquinoxaline soluble powder
months of age or older. Use of and a 20-percent sulfaquinoxaline so-
sulfamethazine in this class of cattle dium solution as provided for in para-
may cause milk residues. Do not use in graph (c) of this section.
calves under one (1) month of age or (2) To Nos. 016592 and 054771 for use of
calves being fed an all-milk diet. Use in a 31.92-percent sulfaquinoxaline solu-
these classes of calves may cause violation (sodium and potassium salts) as
tive residues to remain beyond the provided for in paragraphs (c)(1), (c)(2),
withdrawal time. Federal law restricts (c)(3), (c)(4)(i), and (c)(4)(ii) of this sec-
this drug to use by or on the order of a tion.
licensed veterinarian. (3) No. 054771 for use of a 28.62-percent
sulfaquinoxaline sodium solution as
FR 10166, Mar. 5, 2010; 79 FR 28831, May 20, provided in paragraphs (c)(1), (c)(2), and
2014; 80 FR 61296, Oct. 13, 2015; 81 FR 17607, (c)(3) of this section.
Mar. 30, 2016; 81 FR 94990, Dec. 27, 2016; 84 FR (b) Related tolerances. See § 556.685 of
8973, Mar. 13, 2019] this chapter.
(c) Conditions of use. It is used in
§ 520.2280 Sulfamethizole and methe- drinking water as follows:
namine.
(1) Chickens. (i) As an aid in the con-
(a) Specifications. Each tablet control of outbreaks of coccidiosis caused
tains 250 milligrams of sulfamethizole by Eimeria tenella, E. necatrix, E.
and 250 milligrams of methenamine acervulina, E. maxima, and E. brunetti.
mandelate. (ii) Administer at the 0.04 percent
(b) Sponsor. See No. 054771 in level for 2 or 3 days, skip 3 days then
§ 510.600(c) of this chapter. administer at the 0.025 percent level for
(c) Conditions of use in dogs and cats— 2 more days. If bloody droppings ap-
(1) Amount. Administer orally 1 tablet pear, repeat treatment at the 0.025 per-
per 20 pounds of body weight 3 times cent level for 2 more days. Do not
per day until clinical signs are allevi- change litter unless absolutely nec-
ated. To reduce the possibility of re- essary. Do not give flushing mashes.
256
(2) Turkeys. (i) As an aid in the con- by or on the order of a licensed veteri-
trol of outbreaks of coccidiosis caused narian.
by Eimeria meleagrimitis and E. [48 FR 3964, Jan. 28, 1983, as amended at 48
adenoeides. FR 26762, June 10, 1983; 55 FR 29843, July 23,
(ii) Administer at the 0.025 percent 1990; 59 FR 28769, June 3, 1994; 59 FR 33197,
level for 2 days, skip 3 days, give for 2 June 28, 1994; 61 FR 24443, May 15, 1996; 61 FR
days, skip 3 days and give for 2 more 63711, Dec. 2, 1996; 62 FR 37712, July 15, 1997;
65 FR 10705, Feb. 29, 2000; 69 FR 41427, July 9,
days. Repeat if necessary. Do not 2004; 69 FR 60547, Oct. 12, 2004; 74 FR 36112,
change litter unless absolutely nec- July 22, 2009; 78 FR 17596, Mar. 22, 2013; 79 FR
essary. Do not give flushing mashes. 28831, May 20, 2014; 81 FR 22523, Apr. 18, 2016;
(3) Chickens and turkeys. (i) As an aid 81 FR 36789, June 8, 2016; 81 FR 59134, Aug. 29,
in the control of acute fowl cholera 2016; 81 FR 94990, Dec. 27, 2016; 87 FR 58962,
Sept. 29, 2022]
caused by Pasteurella multocida suscep-
tible to sulfaquinoxaline and fowl ty- § 520.2325b Sulfaquinoxaline drench.
phoid caused by Salmonella gallinarum (a) Specifications. A soluble powder
susceptible to sulfaquinoxaline. containing 25 percent sulfaquinoxaline.
(ii) Administer at the 0.04 percent (b) Sponsor. See No. 016592 in
level for 2 or 3 days. Move birds to § 510.600(c) of this chapter.
clean ground. If disease recurs, repeat (c) Related tolerances. See § 556.685 of
treatment. If cholera has become es- this chapter.
tablished as the respiratory or chronic (d) Conditions of use in cattle—(1)
form, use feed medicated with Amount. Administer 1 teaspoon of 25
sulfaquinoxaline. Poultry which have percent sulfaquinoxaline soluble pow-
survived typhoid outbreaks should not der for each 125 pounds of body weight
be kept for laying house replacements for 3 to 5 days as a drench.
or breeders unless tests show they are (2) Indications for use. For the control
not carriers. and treatment of outbreaks of coccidi-
(4) Cattle and calves. (i) For the con- osis in cattle and calves caused by
Eimeria bovis or E. zuernii.
trol and treatment of outbreaks of coc-
(3) Limitations. Not for use in lac-
cidiosis caused by Eimeria bovis or E. tating dairy cattle. A withdrawal pe-
zurnii. riod has not been established for this
(ii) Administer at the 0.015-percent product in preruminating calves. Do
level for 3 to 5 days in drinking water not use in calves to be processed for
medicated with sulfaquinoxaline solu- veal. Federal law restricts this drug to
tion. use by or on the order of a licensed vet-
(iii) In lieu of treatment as provided erinarian.
in paragraph (c)(4)(ii) of this section, [79 FR 28831, May 20, 2014, as amended at 82
administer 1 teaspoon of 25 percent FR 12169, Mar. 1, 2017; 84 FR 32992, July 11,
sulfaquinoxaline soluble powder per 2019; 84 FR 53310, Oct. 7, 2019]
day for each 125 pounds of body weight
for 3 to 5 days in drinking water. § 520.2330 Sulfisoxazole tablets.
(d) Limitations. A withdrawal period (a) Specifications. Each tablet con-
has not been established in tains 260 milligrams (4 grains) of
preruminating calves. Do not use in sulfisoxazole.
calves to be processed for veal. Not for (b) Sponsor. See No. 054771 in
use in lactating dairy cattle. Do not § 510.600(c) of this chapter.
give to chickens, turkeys, or cattle (c) Conditions of use—(1) Amount. Ad-
within 10 days of slaughter for food. Do minister one tablet orally per 4 pounds
not medicate chickens or turkeys pro- of body weight.
(2) Indications for use. Use in dogs and
ducing eggs for human consumption.
cats as an aid in treatment of bacterial
Federal law restricts this drug to use
pneumonia and bacterial enteritis
when caused by organisms sensitive to
sulfisoxazole.
(3) Limitations. Repeat dosage at 24-
hour intervals until 2 to 3 days after

disappearance of clinical symptoms.
257
§ 520.2335 21 CFR Ch. I (4–1–23 Edition)
(Administration of one-half daily dos- (c) Conditions of use in dogs—(1)

age at 12-hour intervals or one-third Amount. 25 mg per pound of body
daily dosage at 8-hour intervals will weight per day in divided doses every 6
provide a more constant blood level.) hours.
Provide adequate supply of drinking (2) Indications for use. For treatment
water. If symptoms persist after using of infections caused by organisms sen-
this preparation for 2 or 3 days, consult sitive to tetracycline hydrochloride,
a veterinarian. Federal law restricts such as bacterial gastroenteritis due to
this drug to use by or on the order of a E. coli and urinary tract infections due
licensed veterinarian. to Staphylococcus spp. and E. coli.
[43 FR 60895, Dec. 29, 1978, as amended at 79 (3) Limitations. Federal law restricts
FR 28831, May 20, 2014; 87 FR 76421, Dec. 14, this drug to use by or on the order of a
2022] licensed veterinarian.
§ 520.2335 Telmisartan. FR 18442, Apr. 4, 2008; 79 FR 28831, May 20,
(a) Specifications. Each milliliter of 2014]
solution contains 10 milligrams (mg)
telmisartan. § 520.2345b Tetracycline tablets.
§ 510.600(c) of this chapter. tains 100, 250, or 500 milligrams of tet-
(c) Conditions of use—(1) Amount. Ad- racycline (as the hydrochloride).
minister 1.5 mg/kilogram (kg) (0.68 mg/ (b) Sponsor. See No. 054771 in
pound (lb)) orally twice daily for 14 § 510.600(c) of this chapter.
days, followed by 2 mg/kg (0.91 mg/lb) (c) Conditions of use. Dogs—(1)
orally once daily. Amount. 25 milligrams per pound of
(2) Indications for use. For the control body weight per day in divided doses
of systemic hypertension in cats. every 6 hours.
(3) Limitations. Federal law restricts (2) Indications for use. Treatment of
this drug to use by or on the order of a infections caused by organisms sen-
licensed veterinarian. sitive to tetracycline hydrochloride,
[83 FR 64740, Dec. 18, 2018] such as bacterial gastroenteritis due to
E. coli and urinary tract infections due
§ 520.2340 Tepoxalin. to Staphylococcus spp. and E. coli.
(a) Specifications. Each tablet con- (3) Limitations. Administer orally;
tains 30, 50, 100, or 200 milligrams (mg) continue treatment until symptoms of
tepoxalin. the disease have subsided and tempera-
(b) Sponsor. See No. 000061 in ture is normal for 48 hours; not for use
§ 510.600(c) of this chapter. in animals raised for food production;
(c) Conditions of use in dogs—(1) Federal law restricts this drug to use
Amount. 10 mg per kilogram (/kg) daily; by or on the order of a licensed veteri-
or 20 mg/kg on the initial day of treat- narian.
ment, followed by 10 mg/kg daily. [57 FR 37327, Aug. 18, 1992, as amended at 79
(2) Indications for use. For the control FR 28831, May 20, 2014]
of pain and inflammation associated
with osteoarthritis. § 520.2345c Tetracycline boluses.
(3) Limitations. Federal law restricts (a) Specifications. Each bolus contains
this drug to use by or on the order of a 500 milligrams of tetracycline (as the
licensed veterinarian. hydrochloride).
[68 FR 34795, June 11, 2003] (b) Sponsor. See No. 054771 in
§ 520.2345 Tetracycline. (c) Related tolerances. See § 556.720 of
this chapter.
§ 520.2345a Tetracycline capsules. (d) Conditions of use. Calves—(1)
(a) Specifications. Each capsule con- Amount. 10 milligrams per pound of
tains 50, 100, 125, 250, or 500 milligrams body weight per day in divided doses.
(mg) tetracycline hydrochloride. (i) Indications for use. Control and
(b) Sponsor. See No. 054771 in treatment of bacterial enteritis

§ 510.600(c) of this chapter. (scours) caused by E. coli and bacterial
258
pneumonia caused by Pasteurella spp., spp., Actinobacillus pleuropneumoniae

Hemophilus spp., and Klebsiella spp. (Haemophilus spp.), and Klebsiella spp.,
(ii) Limitations. Administer orally for susceptible to tetracycline.
3 to 5 days; do not slaughter animals (iii) Limitations. Administer for 3 to 5
for food within 14 days of treatment; days; do not slaughter animals for food
use as sole source of tetracycline. within 4 days of treatment for No.
(2) Amount. 10 milligrams per pound 066104 and within 5 days of treatment
of body weight per day in two divided for Nos. 016592, 054771, 054925, 057561, and
doses.
061133; prepare a fresh solution daily;
(i) Indications for use. Treatment of
use as the sole source of tetracycline.
bacterial pneumonia caused by orga-
nisms susceptible to tetracycline, bac- A withdrawal period has not been es-
terial enteritis caused by E. coli, and tablished for this product in
salmonella organisms susceptible to preruminating calves. Do not use in
tetracycline. calves to be processed for veal. Federal
(ii) Limitations. Administer orally for law restricts this drug to use by or on
not more than 5 days; do not slaughter the order of a licensed veterinarian.
animals for food within 12 days of (2) Swine—(i) Amount. 10 milligrams
treatment; use as sole source of tetra- per pound of body weight per day in di-
cycline. vided doses.
[57 FR 37328, Aug. 18, 1992, as amended at 67 (ii) Indications for use. Control and
FR 78355, Dec. 24, 2002; 79 FR 28831, May 20, treatment of bacterial enteritis
2014; 81 FR 67151, Sept. 30, 2016] (scours) caused by E. coli and bacterial
pneumonia associated with Pasteurella
§ 520.2345d Tetracycline powder. spp., A. pleuropneumoniae (Haemophilus
(a) Specifications. Each pound of pow- spp.), and Klebsiella spp., susceptible to
der contains 25, 102.4, or 324 grams tet- tetracycline.
racycline hydrochloride. (iii) Limitations. Administer for 3 to 5
(b) Sponsors. See sponsors listed in days; do not slaughter animals for food
§ 510.600(c) of this chapter for condi- within 7 days of treatment for No.
tions of use as in paragraph (d) of this 066104 and within 4 days of treatment
section: for Nos. 016592, 054771, 054925, 057561, and
(1) No. 054771: 25 grams per pound as 061133; prepare a fresh solution daily;
in paragraphs (d)(3) and (d)(4) of this
use as the sole source of tetracycline.
section.
Federal law restricts this drug to use
(2) No. 066104: 25, 102.4, and 324 grams
per pound as in paragraph (d) of this by or on the order of a licensed veteri-
section. narian.
(3) Nos. 016592 and 054771: 25, 102.4, and (3) Chickens—(i) Amount. Chronic res-
324 grams per pound as in paragraph (d) piratory disease: 400 to 800 milligrams
of this section. per gallon. Infectious synovitis: 200 to
(4) Nos. 016592, 054925, 061133, and 400 milligrams per gallon.
076475: 324 grams per pound as in para- (ii) Indications for use. Control of
graph (d) of this section. chronic respiratory disease (CRD or
(5) No. 016592: 25 grams per pound as air-sac disease) caused by Mycoplasma
in paragraphs (d)(1) and (d)(2) of this gallisepticum and E. coli; control of in-
section. fectious synovitis caused by M.
(c) Related tolerances. See § 556.720 of synoviae susceptible to tetracycline.
this chapter. (iii) Limitations. Administer for 7 to
(d) Conditions of use. It is adminis- 14 days; do not slaughter for food with-
tered in drinking water as follows: in 4 days of treatment; not for use in
(1) Calves—(i) Amount. 10 milligrams
chickens producing eggs for human
per pound of body weight per day in di-
consumption; prepare a fresh solution
vided doses.
(ii) Indications for use. Control and daily; use as the sole source of tetra-
treatment of bacterial enteritis cycline. Federal law restricts this drug
(scours) caused by Escherichia coli and to use by or on the order of a licensed
bacterial pneumonia (shipping fever veterinarian.

complex) associated with Pasteurella
259
§ 520.2345e 21 CFR Ch. I (4–1–23 Edition)
(4) Turkeys—(i) Amount. For infec- use by or on the order of a licensed vet-
tious synovitis: 400 milligrams per gal- erinarian.
lon. For complicating bacterial orga- (2) Dogs and cats—(i) Amount. 25 milli-
nisms associated with bluecomb (trans- grams per pound of body weight per
missible enteritis or coronaviral enter- day in divided doses every 6 hours.
itis): 25 milligrams per pound of body (ii) Indications for use. Treatment of
weight per day. infections caused by organisms suscep-
(ii) Indications for use. Control of in- tible to tetracycline hydrochloride,
fectious synovitis caused by M. such as bacterial gastroenteritis due to
synoviae; control of bluecomb com- E. coli and urinary tract infections due
plicated by organisms sensitive to tet- to Staphylococcus spp. and E. coli.
racycline. (iii) Limitations. Administer orally;
(iii) Limitations. Administer for 7 to continue treatment until the tempera-
14 days; do not slaughter for food with- ture has been normal for 48 hours; not
in 4 days of treatment; not for use in for use in food-producing animals; Fed-
turkeys producing eggs for human con- eral law restricts this drug to use by or
sumption; prepare a fresh solution on the order of a licensed veterinarian.
daily; use as the sole source of tetra- [57 FR 37329, Aug. 18, 1992, as amended at 79
cycline. Federal law restricts this drug FR 28831, May 20, 2014]
veterinarian. § 520.2345f Tetracycline phosphate
complex and sodium novobiocin
[59 FR 17693, Apr. 14, 1994, as amended at 59 capsules.
FR 19133, Apr. 22, 1994; 62 FR 5319, Feb. 5, (a) Specifications. Each capsule con-
1997; 62 FR 35076, June 30, 1997; 62 FR 46668,
tains the equivalent of 60 milligrams of
Sept. 4, 1997; 62 FR 55160, Oct. 23, 1997; 64 FR
37673, July 13, 1999; 67 FR 78355, Dec. 24, 2002; tetracycline hydrochloride and 60 mil-
70 FR 16934, Apr. 4, 2005; 70 FR 67353, Nov. 7, ligrams of novobiocin.
2005; 71 FR 13542, Mar. 16, 2006; 75 FR 10166, (b) Sponsor. No. 054771 in § 510.600(c) of
Mar. 5, 2010; 75 FR 12981, Mar. 18, 2010; 76 FR this chapter.
17338, Mar. 29, 2011; 77 FR 20988, Apr. 9, 2012; (c) Conditions of use in dogs—(1)
78 FR 21060, Apr. 9, 2013; 79 FR 28831, May 20, Amount. 10 milligrams of each anti-
2014; 81 FR 17607, Mar. 30, 2016; 81 FR 22523, biotic per pound of body weight (1 cap-
Apr. 18, 2016; 81 FR 94990, Dec. 27, 2016; 83 FR sule for each 6 pounds) every 12 hours.
48946, Sept. 28, 2018; 84 FR 8973, Mar. 13, 2019]
acute or chronic canine respiratory in-
§ 520.2345e Tetracycline solution.
fections such as tonsillitis, bronchitis,
(a) Specifications. Each milliliter con- and tracheobronchitis when caused by
tains the equivalent of either 25 or 100 pathogens susceptible to tetracycline
milligrams of tetracycline hydro- and/or novobiocin, such as Staphy-
chloride. lococcus spp. and Escherichia coli.
(b) Sponsor. See No. 054771 in (3) Limitations. Federal law restricts
§ 510.600(c) of this chapter. this drug to use by or on the order of a
(c) Conditions of use—(1) Dogs—(i) licensed veterinarian.
Amount. 25 milligrams per pound of [57 FR 37329, Aug. 18, 1992, as amended at 79
body weight per day in divided doses FR 28831, May 20, 2014]
every 6 hours.
(ii) Indications for use. Treatment of § 520.2345g Tetracycline hydrochloride
infections caused by organisms sen- and sodium novobiocin tablets.
sitive to tetracycline hydrochloride, (a) Specifications. Each tablet con-
such as bacterial gastroenteritis due to tains the equivalent of 60 milligrams of
Escherichia coli and urinary tract infec- tetracycline hydrochloride and 60 mil-
tions due to Staphylococcus spp. and E. ligrams of novobiocin, or 180 milli-
coli. grams of tetracycline hydrochloride
(iii) Limitations. Administer orally; and 180 milligrams of novobiocin.
continue treatment until symptoms (b) Sponsor. See No. 054771 in
have subsided and the temperature is § 510.600(c) of this chapter.
normal for 48 hours; not for use in ani- (c) Conditions of use in dogs—(1)
mals which are raised for food produc- Amount. 10 milligrams of each anti-
tion; Federal law restricts this drug to biotic per pound of body weight (one
260
single-strength tablet for each 6 pounds § 520.2362 Thenium closylate.

or one triple-strength tablet for each 18 (a) Specifications. Each tablet con-
pounds). tains thenium closylate equivalent to
(2) Indications for use. Treatment of 500 milligrams thenium base.
acute or chronic canine respiratory in- (a) Specifications. Thenium closylate
fections such as tonsillitis, bronchitis, tablets contain thenium closylate
and tracheobronchitis when caused by equivalent to 500 milligrams thenium
pathogens susceptible to tetracycline as base in each tablet.
and/or novobiocin, such as Staphy- (b) Sponsor. See No. 000061 in
lococcus spp. and Escherichia coli. § 510.600(c) of this chapter.
(3) Limitations. Federal law restricts (c) Conditions of use in dogs—(1)
this drug to use by or on the order of a Amount. Dogs weighing over 10 pounds:
licensed veterinarian. Administer 1 tablet as a single dose.
Dogs weighing 5 to 10 pounds: Adminis-
[57 FR 37329, Aug. 18, 1992, as amended at 79 tered one-half tablet twice during a
FR 28831, May 20, 2014] single day. Repeat treatment after 2 or
3 weeks.
§ 520.2345h Tetracycline hydro- (2) Indications for use. For treatment
chloride, sodium novobiocin, and
prednisolone tablets. of canine ancylostomiasis by the re-
moval from the intestines of the adult
(a) Specifications. Each tablet conforms of the species Ancylostoma
tains the equivalent of 60 milligrams of caninum and Uncinaria stenocephala
tetracycline hydrochloride, 60 milli- (hookworms).
grams of novobiocin, and 1.5 milli- (3) Limitations. Federal law restricts
grams of prednisolone or 180 milli- this drug to use by or on the order of a
grams of tetracycline hydrochloride, licensed veterinarian.
180 milligrams of novobiocin, and 4.5 [40 FR 13838, Mar. 27, 1975, as amended at 41
milligrams of prednisolone. FR 53477, Dec. 7, 1976; 46 FR 48642, Oct. 2, 1981;
(b) Sponsor. See No. 054771 in 61 FR 8873, Mar. 6, 1996; 62 FR 61625, Nov. 19,
§ 510.600(c) of this chapter. 1997; 79 FR 28832, May 20, 2014]
§ 520.2380 Thiabendazole oral dosage
Amount. 10 milligrams of each anti- forms.
biotic and 0.25 milligram of prednis-
olone per pound of body weight (one § 520.2380a Thiabendazole top dress-
single-strength tablet for each 6 pounds ing and mineral protein block.
or one triple-strength tablet for each 18 (a) Specifications. Conforms to N.F.
pounds) every 12 hours for 48 hours. XII.
Treatment is to be continued with (b) Sponsors. See sponsors in
novobiocin and tetracycline alone at § 510.600(c) of this chapter for use as in
the same dose schedule for an addi- paragraph (d) of this section.
tional 3 days or longer as needed. (1) [Reserved]
(2) Indications for use. Treatment of (2) No. 000010 for use as in paragraph
acute and chronic canine respiratory (d)(1)(ii) of this section.
infections such as tonsillitis, bron- (3) No. 012286 for use as in paragraph
chitis, and tracheobronchitis when (d)(2) of this section.
caused by pathogens susceptible to tet- (c) Related tolerances. See § 556.730 of
this chapter.
racycline and/or novobiocin, such as
(d) Conditions of use. It is used as fol-
Staphylococcus spp. and Escherichia coli,
lows:
when it is necessary to initially reduce (1) Horses. (i) [Reserved]
the severity of associated clinical (ii) Route of administration. In feed.
signs. (a) Amount. 2 grams per 100 pounds of
(3) Limitations. Federal law restricts body weight.
this drug to use by or on the order of a (1) Indications for use. For control of
licensed veterinarian. large and small strongyles,
Strongyloides, and pinworms of the gen-
FR 28832, May 20, 2014] era Strongylus, Cyathostomum,

Cylicobrachytus and related genera,
261
§ 520.2380b 21 CFR Ch. I (4–1–23 Edition)
Craterostomum, Oesophagodontus, (d) Conditions of use. It is used as fol-

Poteriostomum, Oxyuris, and lows:
Strongyloides. (1) Horses. As a single liquid oral
(2) Limitations. Administer in a single dose, administered as a drench or by
dosage mixed with the normal grain ra- stomach tube; or as an oral paste.
tion given at one feeding. Warning: Not (i) Amount. 2 grams per 100 pounds of
for use in horses intended for food. body weight.
(b) Amount. 4 grams per 100 pounds of (a) Indications for use. For the control
body weight. of infections of large strongyles
(1) Indications for use. For control of (Strongylus vulgaris, Strongylus
ascarids of the genus Parascaris. endentatus), small strongyles
(2) Limitations. Administer in a single (Cyathastomum, Cylicobrachytus and re-
dosage mixed with the normal grain ra- lated genera, Craterostomum,
tion given at one feeding. Warning: Not Oesophagodontus, Poteriostomum),
for use in horses intended for food. pinworms (Oxyuris), and threadworms
(2) Cattle—(i) Route of administration. (Strongyloides).
In feed block. (b) Limitations. Not for use in horses
to be slaughtered for food purposes.
(ii) Amount. 3.3 percent block con-
When administered by stomach tube,
sumed at the recommended level of 0.11
for use only by or on the order of a li-
pound per 100 pounds of body weight
censed veterinarian. When for use as a
per day.
liquid oral drench or an oral paste, con-
(iii) Indications for use. For control of
sult your veterinarian for assistance in
infections of gastrointestinal
the diagnosis, treatment, and control
roundworms (Trichostrongylus,
of parasitism.
Haemonchus, Ostertagia and Cooperia).
(ii) Amount. 4 grams per 100 pounds of
(iv) Limitations. Administer to cattle body weight.
on pasture or range accustomed to (a) Indications for use. For control of
mineral protein block feeding for 3 infections of ascardis (Parascaris).
days. Milk taken from animals during (b) Limitations. Not for use in horses
treatment and within 96 hours (8 to be slaughtered for food purposes.
milkings) after the latest treatment When administered by stomach tube,
must not be used for food. Do not treat use only by or on the order of a li-
cattle within 3 days of slaughter. For a censed veterinarian. When for use as a
satisfactory diagnosis, a microscopic liquid oral drench or an oral paste, con-
fecal examination should be performed sult your veterinarian for assistance in
by a veterinarian or diagnostic labora- the diagnosis, treatment, and control
tory prior to worming. Animals main- of parasitism.
tained under conditions of constant (2) Pigs. As an oral paste.
worm exposure may require re-treat- (i) Amount. 200 milligrams for each 5
ment within 2 to 3 weeks. Animals that to 7 pounds of body weight per dose.
are severely parasitized, sick, or off (ii) Indications for use. For control of
feed should be isolated and a veteri- infections with Strongyloides ransomi.
narian consulted for advice concerning These infections are commonly found
treatment. in Southeastern United States.
[40 FR 13838, Mar. 27, 1975, as amended at 41 (iii) Limitations. Administer to baby
FR 9149, Mar. 3, 1976; 62 FR 63271, Nov. 28, pigs (1 to 8 weeks of age). Treatment
1997; 70 FR 32489, June 3, 2005; 73 FR 35340, may be repeated in 5 to 7 days if nec-
June 23, 2008; 79 FR 28832, May 20, 2014; 83 FR essary. Before treatment, obtain an ac-
48946, Sept. 28, 2018; 84 FR 39183, Aug. 9, 2019] curate diagnosis from a veterinarian or
diagnostic laboratory. Do not treat
§ 520.2380b Thiabendazole drench or within 30 days of slaughter.
paste.
(3) Cattle. Orally as a drench and in
(a) Specifications. Conforms to N.F. paste form using a dosing gun designed
XII. for the product.
(b) Sponsor. See No. 000010 in (i) Amount. 3 grams per 100 pounds of
§ 510.600(c) of this chapter. body weight.
(c) Related tolerances. See § 556.730 of (a) Indications for use. Control of in-
this chapter. fections of gastrointestinal
262
roundworms (Trichostrongylus spp., used for food; in severe infections in

Haemonchus spp., Nematodirus spp., sheep, treatment should be repeated in
Ostertagia spp., and Oesophagostomum 2 to 3 weeks.
radiatum). (5) Goats. Orally, as a drench.
(b) Limitations. For most effective re- (i) Amount. 3 grams per 100 pounds of
sults, severely parasitized animals or body weight.
those constantly exposed to helminth (ii) Indications for use. Control of se-
infection should be re-treated every 2 vere infections of gastrointestinal
to 3 weeks. Milk taken from treated roundworms (Trichostrongylus spp.,
animals within 96 hours (8 milkings) Haemonchus spp., Ostertagia spp.,
after the latest treatment must not be Cooperia spp., Nematodirus spp.,
used for food. Do not treat cattle with- Bunostomum spp., Strongyloides spp.,
in 3 days of slaughter. For a satisfac- Chabertia spp., and Oesophagostomum
tory diagnosis, a microscopic fecal ex- spp.).
amination should be performed prior to (iii) Limitations. As a single oral dose;
worming. do not treat animals within 30 days of
(ii) Amount. 5 grams per 100 pounds of slaughter; milk taken from treated
body weight. animals within 96 hours (8 milkings)
(a) Indications for use. Control of in- after the latest treatment must not be
fections of Cooperia spp. or severe infec- used for food; treatment should be re-
tions of other species in paragraph peated in 2 to 3 weeks.
(e)(3)(i)(a) of this section.
(b) Limitations. For most effective re- [40 FR 13838, Mar. 27, 1975, as amended at 41
sults, severely parasitized animals or FR 9149, Mar. 3, 1976; 41 FR 47424, Oct. 29,
1976; 62 FR 63271, Nov. 28, 1997; 79 FR 28832,
those constantly exposed to helminth May 20, 2014; 84 FR 39183, Aug. 9, 2019]
infection should be re-treated every 2
to 3 weeks. Milk taken from treated § 520.2380c Thiabendazole bolus.
animals within 96 hours (8 milkings)
after the latest treatment must not be (a) Specifications. Conforms to N.F.
used for food. Do not treat cattle with- XII.
in 3 days of slaughter. For a satisfac- (b) Sponsor. See No. 000010 in
tory diagnosis, a microscopic fecal ex- § 510.600(c) of this chapter.
amination should be performed prior to (c) Related tolerances. See § 556.730 of
worming. this chapter.
(4) Sheep and goats. Orally, as a (d) Conditions of use. It is used as fol-
drench. lows:
(i) Amount. 2 grams per 100 pounds of (1) Cattle. In a bolus.
body weight. (i) Amount. 3 grams per 100 pounds of
(ii) Indications for use. Control of in- body weight.
fections of gastrointestinal (a) Indications for use. Control of in-
roundworms in sheep and goats. fections of gastrointestinal
(Trichostrongylus spp., Haemonchus spp., roundworms (general Trichostrongylus
Ostertagia spp., Cooperia spp., spp., Haemonchus spp., Nematodirus spp.,
Nematodirus spp., Bunostomum spp., Ostertagia spp., and Oesophagostomum
Strongyloides spp., Chabertia spp., and radiatum).
Oesophagostomum spp.); also active (b) Limitations. As a single oral dose;
from 3 hours to 3 days following treat- may repeat once in 2 to 3 weeks; do not
ment against ova and larvae passed by treat animals within 3 days of slaugh-
sheep (good activity against ter; milk taken from treated animals
Trichostrongylus colubriformis and axei, within 96 hours (8 milkings) after the
Ostertagia spp., Bunostomum spp., latest treatment must not be used for
Nematodirus spp., and Strongyloides spp.; food.
less effective against Haemonchus (ii) Amount. 5 grams per 100 pounds of
contortus and Oesophagostomum spp.). body weight.
(iii) Limitations. As a single oral dose; (a) Indications for use. Control of se-
do not treat animals within 30 days of vere infections of gastrointestinal
slaughter; milk taken from treated roundworms (genera Trichostrongylus
animals within 96 hours (8 milkings) spp., Haemonchus spp., Nematodirus spp.,

after the latest treatment must not be Ostertagia spp., and Oesophagostomum
263
§ 520.2380d 21 CFR Ch. I (4–1–23 Edition)
radiatum). Control of infections with § 520.2380d Thiabendazole and piper-

Cooperia spp. azine citrate.
(b) Limitations. As a single oral dose; (a) Specifications. Each fluid ounce of
as a drench or bolus; may repeat once suspension contains 2 grams of
in 2 to 3 weeks; do not treat animals thiabendazole and 2.5 grams of piper-
within 3 days of slaughter; milk taken azine (from piperazine citrate).
from treated animals within 96 hours (8 (b) Sponsor. See No. 000010 in
milkings) after the latest treatment § 510.600(c) of this chapter.
must not be used for food. (c) Conditions of use in horses—(1)
(2) Sheep and goats. In a bolus. Amount. Administer 1 ounce of suspen-
(i) Amount. 2 grams per 100 pounds of sion per 100 pounds of body weight by
body weight. stomach tube or as a drench.
(ii) Indications for use. Control of in- (2) Indications for use. For the control
fections of gastrointestinal of large strongyles, small strongyles,
roundworms in sheep and goats (gen- pinworms, Strongyloides and ascarids
eral Trichostrongylus spp., Haemonchus (including members of the genera
spp., Ostertagia spp., Cooperia spp., Strongylus spp., Cyathostomum spp.,
Nematodirus spp., Bunostomum spp., Cylicobrachytus spp. and related genera
Strongyloides spp., Chabertia spp., and Craterostomum spp., Oesophagodontus
Oesophagostomum spp.); also active spp., Poteriostomum spp., Oxyuris spp.,
from 3 hours to 3 days following treat- Strongyloides spp., and Parascaris spp.).
ment against ova and larvae passed by (3) Limitations. Do not use in horses
sheep (good activity against T. intended for human consumption. Fed-
colubriformis and axei, Ostertagia spp., eral law restricts this drug to use by or
Bunostomum spp., Nematodirus spp., and on the order of a licensed veterinarian.
Strongyloides spp.; less effective against [40 FR 13838, Mar. 27, 1975, as amended at 62
Haemonchus contortus and FR 63271, Nov. 28, 1997; 79 FR 28832, May 20,
Oesophagostomum spp.). 2014; 84 FR 39183, Aug. 9, 2019]
(iii) Limitations. As a single oral dose;
§ 520.2380e Thiabendazole and piper-
do not treat animals within 30 days of azine phosphate.
slaughter; milk taken from treated
animals within 96 hours (8 milkings) (a) Specifications. Each ounce of water
after the latest treatment must not be dispersible powder contains 6.67 grams
used for food; in severe infections in of thiabendazole and 8.33 grams of pi-
sheep, treatment should be repeated in perazine (as piperazine phosphate).
2 to 3 weeks. (b) Sponsor. See No. 000010 in
(3) Goats. In a bolus.
(i) Amount. 3 grams per 100 pounds of Amount. 2 grams of thiabendazole and
body weight. 2.5 grams of piperazine (0.3 ounce of
(ii) Indications for use. Control of se- powder) per 100 pounds of body weight.
vere infections of gastrointestinal Use a single oral dose. Administer as a
roundworms (genera Trichostrongylus drench or by stomach tube suspended
spp., Haemonchus spp., Ostertagia spp., in 1 pint of warm water; by dose sy-
Cooperia spp., Nematodirus spp., ringe suspended in 1⁄2 ounce of water for
Bunostomum spp., Strongyloides spp., each 100 pounds of body weight; or
Chabertia spp., and Oesophagostomum sprinkled over a small amount of daily
spp.). feed.
(iii) Limitations. As a single oral dose; (2) Indications for use. Treatment of
do not treat animals within 30 days of infections of large strongyles (genus
slaughter; milk taken from treated Strongylus), small strongyles (genera
animals within 96 hours (8 milkings) Cyathostomum, Cylicobrachytus, and re-
after the latest treatment must not be lated genera Craterostomum,
used for food; treatment should be re- Oesophagodontus, Poteriostomum),
peated in 2 to 3 weeks. pinworms (Oxyuris), threadworms
[40 FR 13838, Mar. 27, 1975, as amended at 41 (Strongyloides), and ascarids (Parascaris)
FR 9149, Mar. 3, 1976; 62 FR 63271, Nov. 28, in horses.
1997; 79 FR 28832, May 20, 2014; 84 FR 39183, (3) Limitations. Do not use in horses
Aug. 9, 2019] intended for human consumption. If
264
the label bears directions for adminis- (3) Each mL of solution contains 123
tration by stomach tube or drench, it mg (12.3 percent) tiamulin hydrogen fu-
shall also bear the statement ‘‘Caution: marate.
Federal law restricts this drug to use (b) Sponsors. See sponsor numbers in
by or on the order of a licensed veteri- § 510.600(c) of this chapter for use as in
narian.’’; if not labeled for use by stom- paragraph (d) of this section.
ach tube or drench, the label shall bear (1) No. 058198 for products described
the statement, ‘‘Consult your veteri- in paragraph (a) of this section.
narian for assistance in the diagnosis, (2) No. 066104 for product described in
treatment, and control of parasitism.’’ paragraph (a)(1) of this section.
(3) Nos. 016592, 051072, 051311, and
[46 FR 18963, Mar. 27, 1981, as amended at 46 061133 for product described in para-
FR 52330, Oct. 27, 1981; 62 FR 63271, Nov. 28, graph (a)(2) of this section.
1997; 79 FR 28832, May 20, 2014. Redesignated
(4) No. 054771 for product described in
and amended at 84 FR 39183, Aug. 9, 2019]
paragraph (a)(3) of this section.
§ 520.2380f Thiabendazole and (c) Related tolerances. See § 556.732 of
triclorfon. this chapter.
(d) Conditions of use in swine—(1)
(a) Specifications. The drug contains 5 Amounts and indications for use. Admin-
grams of thiabendazole with 4.5 grams ister in drinking water for 5 consecu-
of trichlorfon, or 20 grams of tive days:
thiabendazole with 18 grams of (i) 3.5 mg per (/) lb of body weight
trichlorfon. daily for treatment of swine dysentery
(b) Sponsor. See No. 017135 in associated with Brachyspira
§ 510.600(c) of this chapter. hyodysenteriae susceptible to tiamulin.
(c) Conditions of use in horses—(1) (ii) 10.5 mg/lb of body weight daily for
Amount. Administer 2 grams of treatment of swine pneumonia due to
thiabendazole with 1.8 grams of Actinobacillus pleuropneumoniae suscep-
trichlorfon per 100 pounds of body tible to tiamulin.
weight sprinkled on the animals’ usual (2) Limitations. Use as only source of
daily ration of feed, or may be mixed in drinking water. Prepare fresh medi-
5 to 10 fluid ounces of water and admin- cated water daily. Withdraw medica-
istered by stomach tube or drench. tion 3 days before slaughter following
(2) Indications for use. For the treat- treatment at 3.5 mg/lb and 7 days be-
ment and control of bots (Gasterophilus fore slaughter following treatment at
spp.), large strongyles (Strongylus spp.), 10.5 mg/lb of body weight. Swine being
small strongyles (genera treated with tiamulin should not have
Cyathostomum, Cylicobrachytus, access to feeds containing polyether
Craterostomum, Oesophagodontus, ionophores (e.g., lasalocid, monensin,
Poteriostomum), pinworms (Oxyuris spp., narasin, salinomycin, or
Strongyloides spp.), and ascarids semduramicin) as adverse reactions
(Parascaris spp.). may occur. The effects of tiamulin on
(3) Limitations. Do not use in horses swine reproductive performance, preg-
intended for human consumption. Fed- nancy, and lactation have not been de-
eral law restricts this drug to use by or termined.
on the order of a licensed veterinarian. [70 FR 75017, Dec. 19, 2005, as amended at 74
FR 7180, Feb. 13, 2009; 75 FR 54492, Sept. 8,
[40 FR 23071, May 28, 1975, as amended at 48 2010; 77 FR 56770, Sept. 14, 2012; 78 FR 17596,
FR 48229, Oct. 18, 1983; 79 FR 28832, May 20, Mar. 22, 2013; 80 FR 13229, Mar. 13, 2015; 85 FR
2014. Redesignated at 84 FR 39183, Aug. 9, 18119, Apr. 1, 2020; 87 FR 17945, Mar. 29, 2022;
2019] 87 FR 58962, Sept. 29, 2022]
§ 520.2455 Tiamulin. § 520.2471 Tilmicosin.
(a) Specifications. (1) Each gram of (a) Specifications. Each milliliter of
soluble powder contains 450 milligrams concentrate solution contains 250 milli-
(mg) tiamulin hydrogen fumarate. grams (mg) tilmicosin as tilmicosin
(2) Each milliliter (mL) of solution phosphate.
contains 125 mg (12.5 percent) tiamulin (b) Sponsors. See Nos. 016592 and
hydrogen fumarate. 058198 in § 510.600(c) of this chapter.
265
§ 520.2473 21 CFR Ch. I (4–1–23 Edition)
(c) Tolerances. See § 556.735 of this mined. Consult your veterinarian for
chapter. assistance in the diagnosis, treatment,
(d) Conditions of use in swine—(1) and control of parasitism. It is rec-
Amount. Administer in drinking water ommended that this drug be adminis-
at a concentration of 200 mg per liter tered with caution to sick or debili-
for 5 consecutive days. tated horses.
(2) Indications for use. (i) For the con- (2) [Reserved]
trol of swine respiratory disease associ- [50 FR 52772, Dec. 26, 1985; 51 FR 2693, Jan. 21,
ated with Pasteurella multocida and 1986, as amended at 52 FR 7832, Mar. 13, 1987]
Haemophilus parasuis in groups of swine
in buildings where a respiratory dis- § 520.2473b Tioxidazole paste.
ease outbreak is diagnosed. (a) Specifications. Each plastic syringe
(ii) For the control of swine res- contains 6.25 grams of tioxidazole.
piratory disease associated with Myco- (b) Sponsor. See No. 000061 in
plasma hyopneumoniae in the presence § 510.600(c) of this chapter.
of Porcine Reproductive and Res- (c) Conditions of use—(1) Horses—(i)
piratory Syndrome Virus (PRRSV) in Amount. 5 milligrams of tioxidazole per
groups of swine in buildings where a pound of body weight as a single dose.
respiratory disease outbreak is diag- (ii) Indications for use. Removal of
nosed. mature large strongyles (Strongylus
(3) Limitations. Swine intended for edentatus, S. equinus, and S. vulgaris),
human consumption must not be mature ascarids (Parascaris equorum),
slaughtered within 7 days of the last mature and immature (4th larval
treatment with this product. Federal stage) pinworms (Oxyuris equi), and ma-
law restricts this drug to use by or on ture small strongyles (Triodontophorus
the order of a licensed veterinarian. spp.).
[79 FR 18158, Apr. 1, 2014, as amended at 81 (iii) Limitations. Administer orally by
FR 17608, Mar. 30, 2016; 81 FR 48702, July 26, inserting the nozzle of the syringe
2016; 87 FR 58962, Sept. 29, 2022] through the space between front and
back teeth and deposit the required
§ 520.2473 Tioxidazole oral dosage dose on the base of the tongue. Before
forms.
dosing, make sure the horse’s mouth
§ 520.2473a Tioxidazole granules. contains no feed. Not for use in horses
intended for food. The reproductive
(a) Specifications. Each gram of gran- safety of tioxidazole in breeding ani-
ules contains 200 milligrams of mals has not been determined. Consult
tioxidazole. your veterinarian for assistance in the
(b) Sponsor. See No. 000061 in diagnosis, treatment, and control of
§ 510.600(c) of this chapter. parasitism. It is recommended that
(c) Conditions of use—(1) Horses—(i) this drug be administered with caution
Amount. 5 milligrams per pound of body to sick or debilitated horses.
weight as a single dose. (2) [Reserved]
(ii) Indications for use. Removal of
mature large strongyles (Strongylus [52 FR 43059, Nov. 9, 1987]
edentatus, S. equinus, and S. vulgaris),
mature ascarids (Parascaris equorum), § 520.2475 Toceranib.
mature and immature (4th larval (a) Specifications. Each tablet con-
stage) pinworms (Oxyuris equi), and ma- tains 10, 15, or 50 milligrams (mg)
ture small strongyles (Triodontophorus toceranib as toceranib phosphate.
spp.). (b) Sponsor. See No. 054771 in § 510.600
(iii) Limitations. For administration of this chapter.
with feed: Sprinkle required amount of (c) Conditions of use—(1) Dogs—(i)
granules on a small amount of the Amount. Administer an initial dose of
usual grain ration and mix. Prepare for 3.25 mg per kilogram (1.48 mg per
each horse individually. Withholding of pound) body weight, orally every other
feed or water not necessary. Not for day.
use in horses intended for food. The re- (ii) Indications for use. For the treat-
productive safety of tioxidazole in ment of Patnaik grade II or III, recur-

breeding animals has not been deter- rent, cutaneous mast cell tumors with
266
or without regional lymph node in- horses intended for human consump-
volvement. tion.
(iii) Limitations. Federal law restricts [75 FR 10166, Mar. 5, 2010]
licensed veterinarian. § 520.2520 Trichlorfon oral dosage
(2) [Reserved] forms.
[74 FR 28875, June 18, 2009, as amended at 79 § 520.2520a Trichlorfon and atropine.
FR 28832, May 20, 2014]
(a) Specifications. (1) For trichlorfon:
§ 520.2483 Triamcinolone. O,O-Dimethyl 2,2,2-trichloro-1-hydroxy-
ethyl phosphonate.
(a) Specifications. (1) Each tablet con- (2) For atropine: Atropine N.F.
tains 0.5 milligram (mg) or 1.5 mg (b) Sponsor. See No. 054771 in
triamcinolone acetonide. § 510.600(c) of this chapter.
(2) Each 15 grams of powder contains (c) Conditions of use in mice—(1)
10 mg triamcinolone acetonide. Amount. Administer 1.67 grams of
(b) Sponsor. See No. 000010 in trichlorfon and 7.7 milligrams of atro-
§ 510.600(c) of this chapter. pine per liter continuously for 7 to 14
(c) Special considerations. See § 510.410 days as the sole source of drinking
of this chapter. water.
(d) Conditions of use—(1) Dogs and (2) Indications for use. For the treat-
ment of Syphacia obvelata (pinworm) in
cats. Use tablets described in paragraph
laboratory mice.
(a)(1) of this section as follows:
(i) Amount. Administer 0.05 mg per this drug to use by or on the order of a
pound (/lb) of body weight daily by licensed veterinarian.
mouth; up to 0.1 mg per pound (/lb) of
body weight daily, if response to the [79 FR 28832, May 20, 2014]
smaller dose is inadequate. Therapy
§ 520.2520b Trichlorfon boluses.
may be initiated with a single injec-
tion of triamcinolone acetonide sus- (a) Specifications. Each bolus contains
pension as in § 522.2483 of this chapter, either 7.3, 10.9, 14.6, or 18.2 g of
in which case triamcinolone acetonide trichlorfon.
tablets should be administered begin- (b) Sponsor. See No. 054771 in
ning 5 to 7 days after the injection. § 510.600(c) of this chapter.
(ii) Indications for use. As an anti-in-
Amount. 18.2 milligrams per pound of
flammatory agent.
body weight, except for strongyles use
(iii) Limitations. Federal law restricts 36.4 milligrams per pound of body
this drug to use by or on the order of a weight.
licensed veterinarian. (2) Indications for use. For horses for
(2) Horses. Use oral powder described removal of bots (Gastrophilus nasalis,
in paragraph (a)(2) of this section as Gastrophilus intestinalis), large
follows: strongyles (Strongylus vulgaris), small
(i) Amount. Administer 0.005 to 0.01 strongyles, large roundworms
mg/lb of body weight twice daily, sprin- (ascarids, Parascaris equorum), and
kled (top-dressed) on a small portion of pinworms (Oxyuris equi).
feed. Therapy may be initiated with a (3) Limitations. Do not use in horses
single injection of triamcinolone intended for human consumption. Fed-
acetonide suspension as in § 522.2483 of eral law restricts this drug to use by or
this chapter, in which case on the order of a licensed veterinarian.
triamcinolone acetonide oral powder [45 FR 48127, July 18, 1980. Redesignated and
should be administered beginning 3 or 4 amended at 79 FR 28833, May 20, 2014]
days after the injection.
(ii) Indications for use. As an anti-in- § 520.2520c Trichlorfon granules.
flammatory agent. (a) Specifications. Each package con-
(iii) Limitations. Federal law restricts tains either 18.2 or 36.4 g of trichlorfon.
this drug to use by or on the order of a (b) Sponsor. See No. 054771 in
licensed veterinarian. Do not use in § 510.600(c) of this chapter.
267
§ 520.2520d 21 CFR Ch. I (4–1–23 Edition)
(c) Conditions of use in horses—(1) (2) Indications for use. For relief of
Amount. 18.2 milligrams per pound of anxiety, to help control psychomotor
body weight. over-activity, and to increase the toler-
(2) Indications for use. For horses for ance of animals to pain and pruritus.
removal of bots (Gastrophilus nasalis, For use in various clinical procedures
Gastrophilus intestinalis), large which require the aid of a tranquilizer,
roundworms (ascarids, Parascaris antiemetic, or preanesthetic.
equorum), and pinworms (Oxyuris equi). (3) Limitations. Federal law restricts
(3) Limitations. Do not use in horses this drug to use by or on the order of a
on the order of a licensed veterinarian. [79 FR 28833, May 20, 2014]
[45 FR 48128, July 18, 1980. Redesignated and
amended at 79 FR 28833, May 20, 2014]
§ 520.2598 Trilostane.
(a) Specifications. Each capsule con-
§ 520.2520d Trichlorfon, tains 5, 10, 30, 60, or 120 milligrams
phenothiazine, and piperazine.
(mg) trilostane.
(a) Specifications. Each 54.10 grams (b) Sponsor. See No. 043264 in § 510.600
(1.91 ounces) of water dispersible pow- of this chapter.
der contains 9.10 grams of trichlorfon, (c) Conditions of use in dogs—(1)
6.25 grams of phenothiazine, and the Amount. The starting dose is 1.0 to 3.0
equivalent of 20.0 grams of piperazine milligrams per pound (2.2 to 6.7 milli-
base (as piperazine dihydrochloride).
grams per kilogram) once a day.
§ 510.600(c) of this chapter. (2) Indications for use. For the treat-
(c) Conditions of use in horses—(1) ment of pituitary-dependent and adre-
Amount. 18.2 milligrams (mg) of nal-dependent hyperadrenocorticism in
trichlorfon, 12.5 mg of phenothiazine, dogs.
and 40 mg of piperazine base per pound (3) Limitations. Federal law restricts
of body weight. this drug to use by or on the order of a
(2) Indications for use. For removal of licensed veterinarian.
bots (Gastrophilus nasalis, Gastrophilus [74 FR 21767, May 11, 2009, as amended at 74
intestinalis), large strongyles FR 30464, June 26, 2009; 80 FR 53460, Sept. 4,
(Strongylus vulgaris), small strongyles, 2015; 87 FR 58962, Sept. 29, 2022]
large roundworms (ascarids, Parascaris
equorum), and pinworms (Oxyuris equi). § 520.2604 Trimeprazine and prednis-
(3) Limitations. Do not use in horses olone tablets.
intended for human consumption. Fed- (a) Specifications. Each tablet con-
tains 5 milligrams (mg) trimeprazine
tartrate and 2 mg prednisolone.
[48 FR 2757, Jan. 21, 1983. Redesignated and (b) Sponsor. See No. 054771 in
amended at 79 FR 28833, May 20, 2014; 85 FR § 510.600(c) of this chapter.
4208, Jan. 24, 2020]
EDITORIAL NOTE: At 79 FR 28833, May 20, Amount. Administer orally an initial
2014, § 520.2520d was amended in part by redes- dosage: for dogs weighing up to 10
ignating paragraph (e) as (c). This action
could not be performed because paragraph (e)
pounds, 1⁄2 tablet twice daily; for dogs
did not exist. weighing 11 to 20 pounds, 1 tablet twice
daily; for dogs weighing 21 to 40
§ 520.2582 Triflupromazine. pounds, 2 tablets twice daily; and for
(a) Specifications. Each tablet con- dogs weighing over 40 pounds, 3 tablets
tains 10 or 25 milligrams (mg) twice daily. After 4 days, reduce dosage
triflupromazine hydrochloride. to one-half the initial dose or to an
(b) Sponsor. See No. 054771 in amount sufficient to maintain remis-
§ 510.600(c) of this chapter. sion of symptoms.
(c) Conditions of use in dogs and cats— (2) Indications for use. For the relief of
(1) Amount. Administer orally 1 to 2 mg itching regardless of cause; and for re-
per pound of body weight daily, fol- duction of inflammation commonly as-
lowed by 1 mg daily. sociated with most skin disorders of
268
dogs such as eczema, caused by inter- (3) Limitations. Federal law restricts
nal disorders, otitis, and dermatitis, al- this drug to use by or on the order of a
lergic, parasitic, pustular, and nonspe- licensed veterinarian.
cific origins. As adjunctive therapy in
[79 FR 28833, May 20, 2014]
various cough conditions including
treatment of ‘‘kennel cough’’ or § 520.2610 Trimethoprim and sulfa-
tracheobronchitis, bronchitis including diazine tablets.
allergic bronchitis, infections, and
coughs of nonspecific origin.
tains 30 milligrams (mg) (5 mg
trimethoprim and 25 mg sulfadiazine),
120 mg (20 mg trimethoprim and 100 mg
sulfadiazine), 480 mg (80 mg
[79 FR 28833, May 20, 2014, as amended at 87 trimethoprim and 400 mg sulfadiazine)
FR 10969, Feb. 28, 2022] or 960 mg (160 mg trimethoprim and 800
mg sulfadiazine).
§ 520.2605 Trimeprazine and prednis-
olone capsules. (b) Sponsors. See Nos. 000061 and
(a) Specifications. Each capsule con- (c) Conditions of use in dogs—(1)
tains: Amount. Administer orally at 30 mg per
(1) 3.75 milligrams (mg) trimeprazine kilogram of body weight (14 milligrams
in sustained released form (as per pound) once daily. Alternatively,
trimeprazine tartrate) and 1 mg pred- especially in severe infections, the ini-
nisolone (Capsule No. 1); or tial dose may be followed by one-half
(2) 7.5 mg trimeprazine in sustained the recommended daily dose every 12
release form (as trimeprazine tartrate) hours. Administer for 2 to 3 days after
and 2 mg prednisolone (Capsule No. 2). symptoms have subsided. Do not treat
(b) Sponsor. See No. 054771 in for more than 14 consecutive days.
§ 510.600(c) of this chapter. (2) Indications for use. The drug is
(c) Conditions of use in dogs—(1) used in dogs where systemic anti-
Amount. Administer orally once daily bacterial action against sensitive orga-
an initial dosage: nisms is required, either alone or as an
(i) For dogs weighing up to 10 pounds: adjunct to surgery or debridement with
one Capsule No. 1; associated infection. The drug is indi-
(ii) For dogs weighing 11 to 20
cated where control of bacterial infec-
pounds, one Capsule No. 2 or two Cap-
tion is required during the treatment
sule No. 1;
of acute urinary tract infections, acute
(iii) For dogs weighing 21 to 40
bacterial complications of distemper,
pounds, two Capsule No. 2 or four Cap-
acute respiratory tract infections,
sule No. 1; and
acute alimentary tract infections,
(iv) For dogs weighing over 40
wound infections, and abscesses.
pounds, three Capsule No. 2 or six Cap-
sule No. 1. After 4 days, the dosage is
reduced to approximately 1⁄2 the initial
dosage or to an amount just sufficient
to maintain remission of symptoms. [79 FR 28833, May 20, 2014]
itching regardless of cause; and for re- § 520.2611 Trimethoprim and sulfa-
duction of inflammation commonly as- diazine paste.
sociated with most skin disorders of (a) Specifications. Each gram (g) of
dogs such as eczema, caused by inter- paste contains 67 milligrams (mg)
nal disorders, otitis, and dermatitis, al- trimethoprim and 333 mg sulfadiazine.
lergic, parasitic, pustular and nonspe- (b) Sponsors. See sponsors in
cific. As adjunctive therapy in various § 510.600(c) of this chapter:
cough conditions including treatment (1) No. 054771 for product adminis-
of ‘‘kennel cough’’ or tered as in paragraph (c)(1)(i) of this
tracheobronchitis, bronchitis including section.
allergic bronchitis, in tonsillitis, acute (2) No. 000061 for product adminis-
upper respiratory infections and tered as in paragraph (c)(1)(ii) of this

coughs of nonspecific origin. section.
269
§ 520.2612 21 CFR Ch. I (4–1–23 Edition)
(c) Conditions of use in horses—(1) acute respiratory tract infections,

Amount. Administer orally as a single acute alimentary tract infections,
daily dose for 5 to 7 days: wound infections, and abscesses.
(i) 5 g of paste (335 mg trimethoprim (iii) Limitations. Federal law restricts
and 1,665 mg sulfadiazine) per 150 this drug to use by or on the order of a
pounds (68 kilograms) of body weight licensed veterinarian.
per day. (2) Horses—(i) Amount. Administer
(ii) 3.75 g of paste (250 mg orally at a dosage of 24 mg combined
trimethoprim and 1,250 mg sulfa- active ingredients per kilogram body
diazine) per 110 pounds (50 kilograms) weight (10.9 mg/lb) twice daily for 10
of body weight per day. days. Administered by volume at 2.7
(2) Indications for use. For use where mL per 45.4 kilograms of body weight
systemic antibacterial action against (2.7 mL/100 lb).
sensitive organisms is required during (ii) Indications for use. For the treat-
treatment of acute strangles, res- ment of lower respiratory tract infec-
piratory infections, acute urogenital tions in horses caused by susceptible
infections, and wound infections and strains of Streptococcus equi subsp.
abscesses. zooepidemicus.
(3) Limitations. Not for use in horses (iii) Limitations. Do not use in horses
intended for human consumption. Fed- intended for human consumption. Fed-
eral law restricts this drug to use by or eral law restricts this drug to use by or
on the order of a licensed veterinarian. on the order of a licensed veterinarian.
[71 FR 30802, May 31, 2006, as amended at 79 [78 FR 63872, Oct. 25, 2013, as amended at 85
FR 28834, May 20, 2014] FR 4208, Jan. 24, 2020]
§ 520.2612 Trimethoprim and sulfa- § 520.2613 Trimethoprim and sulfa-
diazine suspension. diazine powder.
(a) Specifications. Each milliliter (a) Specifications. Each gram of pow-
(mL) of suspension contains: der contains 67 milligrams (mg)
(1) 10 milligrams (mg) trimethoprim trimethoprim and 333 mg sulfadiazine.
and 50 mg sulfadiazine; or (b) Sponsors. See Nos. 054771 and
(2) 400 mg combined active ingredi- 059051 in § 510.600(c) of this chapter.
ents (67 mg trimethoprim and 333 mg (c) Conditions of use in horses—(1)
sulfadiazine). Amount. Administer orally 3.75 grams
(b) Sponsors. See sponsor numbers in of powder per 110 pounds (50 kilograms)
§ 510.600 of this chapter: of body weight in a small amount of
feed, as a single daily dose, for 5 to 7
scribed in paragraph (a)(1) for use as in
days.
paragraph (c)(1) of this section.
bacterial infections of horses during
scribed in paragraph (a)(2) for use as in
treatment of acute strangles, res-
paragraph (c)(2) of this section.
piratory tract infections, acute uro-
genital infections, wound infections,
Amount. Administer 1 mL (10 mg
and abscesses.
trimethoprim and 50 mg sulfadiazine)
per 5 pounds (lb) of body weight once
daily, or one-half the recommended
daily dose every 12 hours, for up to 14
consecutive days.
(ii) Indications for use. The drug is [58 FR 36135, July 6, 1993, as amended at 64
used in dogs where systemic anti- FR 68289, Dec. 7, 1999; 79 FR 28834, May 20,
bacterial action against sensitive orga- 2014; 79 FR 64116, Oct. 28, 2014]
nisms is required, either alone or as an
adjunct to surgery or debridement with § 520.2640 Tylosin.
associated infection. The drug is indi- (a) Specifications. Each container of
cated where control of bacterial infec- soluble powder contains tylosin tar-
tion is required during the treatment trate equivalent to:
of acute urinary tract infections, acute (1) 100 grams (g) tylosin base, or
bacterial complications of distemper, (2) 256 g tylosin base.
270
(b) Sponsors. See sponsors in (3) Swine—(i) Amount. 250 mg per gal-
§ 510.600(c) of this chapter for use as in lon (66 ppm) as the only source of
paragraph (e) of this section: drinking water for 3 to 10 days, depend-
(1) Nos. 016592 and 058198 for use of ing on the severity of the condition
the 100-g container as in paragraph (e) being treated.
of this section (ii) Indications for use. (A) For the
(2) No. 061133 for use of the 100-or 256- treatment and control of swine dys-
g container as in paragraphs entery associated with Brachyspira
(e)(1)(i)(A), (e)(1)(ii), (e)(2), (e)(3), and hyodysenteriae when followed imme-
(e)(4) of this section. diately by tylosin phosphate medicated
(3) No. 061133 for use of a 100-g con- feed; and for the control of porcine pro-
tainer as in paragraphs (e)(1)(i)(B) and liferative enteropathies (PPE, ileitis)
(e)(1)(ii) of this section. associated with Lawsonia intracellularis
(c) Related tolerances. See § 556.746 of when followed immediately by tylosin
this chapter. phosphate medicated feed.
(d) Special considerations. Federal law (B) For the treatment and control of
restricts this drug to use by or on the swine dysentery associated with
order of a licensed veterinarian. Brachyspira hyodysenteriae.
(e) Conditions of use—(1) Chickens—(i) (iii) Limitations. Do not administer
Amounts and indications for use. (A) Ad- within 48 hours of slaughter. As indi-
minister 2 grams per gallon (528 parts cated in paragraph (d)(3)(ii)(A) of this
per million (ppm)) for 1 to 5 days as an section, follow with tylosin phosphate
aid in the treatment of chronic res- medicated feed as in § 558.625(f)(1)(vi)(c)
piratory disease (CRD) associated with of this chapter.
Mycoplasma gallisepticum in broiler and (4) Honey bees—(i) Amount. Mix 200
replacement chickens. For the control milligrams tylosin in 20 grams confec-
of CRD associated with M. gallisepticum tioners’/powdered sugar. Use imme-
at time of vaccination or other stress diately. Apply (dust) this mixture over
in chickens. For the control of CRD as- the top bars of the brood chamber once
sociated with Mycoplasma synoviae in weekly for 3 weeks.
broiler chickens. Treated chickens (ii) Indications for use. For the control
should consume enough medicated of American foulbrood (Paenibacillus
drinking water to provide 50 milli- larvae).
grams (mg) tylosin per pound of body (iii) Limitations. The drug should be
weight per day. fed early in the spring or fall and con-
(B) Administer 851 to 1,419 mg/gallon sumed by the bees before the main
(225 to 375 ppm) for 5 days for the con- honey flow begins, to avoid contamina-
trol of mortality caused by necrotic en- tion of production honey. Complete
teritis associated with Clostridium treatments at least 4 weeks before
perfringens in broiler chickens. main honey flow.
(ii) Limitations. Do not use in layers
producing eggs for human consump- [40 FR 13838, Mar. 27, 1975, as amended at 50
tion. Do not administer within 24 hours FR 49841, Dec. 5, 1985; 59 FR 14365, Mar. 28,
of slaughter. 1994; 62 FR 39443, July 23, 1997; 68 FR 24879,
May 9, 2003; 70 FR 69439, Nov. 16, 2005; 73 FR
(2) Turkeys—(i) Amount. 2 grams per
76946, Dec. 18, 2008; 75 FR 76259, Dec. 8, 2010;
gallon (528 ppm) for 2 to 5 days as the 76 FR 59024, Sept. 23, 2011; 77 FR 29217, May
sole source of drinking water. Treated 17, 2012; 79 FR 37620, July 2, 2014; 79 FR 53136,
turkeys should consume enough medi- Sept. 8, 2014; 79 FR 64116, Oct. 28, 2014; 80 FR
cated drinking water to provide 60 mg 34278, June 16, 2015; 83 FR 14587, Apr. 5, 2018;
tylosin per pound of body weight per 84 FR 8973, Mar. 13, 2019; 84 FR 32992, July 11,
day. 2019; 87 FR 76421, Dec. 14, 2022; 88 FR 16547,
(ii) Indications for use. For the reduc- Mar. 20, 2023]
tion in severity of effects of infectious
§ 520.2645 Tylvalosin.
sinusitis associated with Mycoplasma
gallisepticum. (a) Specifications. Granules containing
(iii) Limitations. Do not use in layers 62.5 percent tylvalosin (w/w) as
producing eggs for human consump- tylvalosin tartrate.
tion. Do not administer within 5 days (b) Sponsor. See No. 066916 in
of slaughter. § 510.600(c) of this chapter.
271
(c) Related tolerances. See § 556.748 of 522.313b Ceftiofur hydrochloride.

this chapter. 522.313c Ceftiofur sodium.
(d) Conditions of use in swine—(1) 522.380 Chloral hydrate, pentobarbital, and
magnesium sulfate.
Amount. Administer 50 parts per mil- 522.390 Chloramphenicol.
lion (ppm) tylvalosin continuously in 522.454 Clodronate.
drinking water for 5 consecutive days. 522.460 Cloprostenol.
(2) Indications for use. For control of 522.468 Colistimethate sodium powder for
porcine proliferative enteropathy injection.
(PPE) associated with Lawsonia 522.480 Corticotropin.
intracellularis infection in groups of 522.522 Danofloxacin.
522.533 Deslorelin.
swine intended for slaughter in build-
522.535 Desoxycorticosterone.
ings experiencing an outbreak of PPE; 522.536 Detomidine.
and for control of swine respiratory 522.540 Dexamethasone solution.
disease (SRD) associated with 522.542 Dexamethasone suspension.
Bordetella bronchiseptica, Haemophilus 522.558 Dexmedetomidine.
parasuis, Pasteurella multocida, Strepto- 522.563 Diatrizoate.
coccus suis, and Mycoplasma 522.650 Dihydrostreptomycin sulfate injec-
hyopneumoniae in groups of swine in- tion.
522.690 Dinoprost.
tended for slaughter in buildings expe- 522.723 Diprenorphine.
riencing an outbreak of SRD. 522.728 Dipyrone.
(3) Limitations. Federal law restricts 522.770 Doramectin.
this drug to use by or on the order of a 522.772 Doramectin and levamisole.
licensed veterinarian. 522.775 Doxapram.
522.784 Doxylamine.
[77 FR 55415, Sept. 10, 2012, as amended at 83 522.800 Droperidol and fentanyl.
FR 13635, Mar. 30, 2018; 86 FR 57997, Oct. 20, 522.810 Embutramide, chloroquine, and lido-
2021] caine solution.
522.812 Enrofloxacin.
PART 522—IMPLANTATION OR 522.814 Eprinomectin.
522.820 Erythromycin.
INJECTABLE DOSAGE FORM NEW 522.840 Estradiol.
ANIMAL DRUGS 522.850 Estradiol valerate and norgestomet
in combination.
Sec. 522.863 Ethylisobutrazine.
522.23 Acepromazine. 522.870 Etodolac.
522.52 Alfaxalone. 522.883 Etorphine.
522.56 Amikacin. 522.914 Fenprostalene.
522.62 Aminopentamide. 522.930 Firocoxib.
522.82 Aminopropazine. 522.955 Florfenicol.
522.88 Amoxicillin. 522.956 Florfenicol and flunixin.
522.90 Ampicillin injectable dosage forms. 522.960 Flumethasone injectable dosage
522.90a Ampicillin trihydrate suspension. forms.
522.90b Ampicillin trihydrate powder for in- 522.960a Flumethasone suspension.
jection. 522.960b Flumethasone acetate solution.
522.90c Ampicillin sodium. 522.960c Flumethasone solution.
522.144 Arsenamide. 522.970 Flunixin.
522.147 Atipamezole. 522.995 Fluprostenol.
522.150 Azaperone. 522.1002 Follicle stimulating hormone.
522.161 Betamethasone. 522.1008 Frunevetmab.
522.163 Betamethasone dipropionate and 522.1010 Furosemide.
betamethasone sodium phosphate aque- 522.1014 Gamithromycin.
ous suspension. 522.1020 Gelatin.
522.167 Betamethasone sodium phosphate 522.1044 Gentamicin.
and betamethasone acetate. 522.1055 Gleptoferron.
522.204 Boldenone. 522.1066 Glycopyrrolate.
522.224 Bupivacaine. 522.1077 Gonadorelin.
522.230 Buprenorphine. 522.1079 Serum gonadotropin and chorionic
522.234 Butamisole. gonadotropin.
522.246 Butorphanol. 522.1081 Chorionic gonadotropin for injec-
522.275 N-Butylscopolammonium. tion; chorionic gonadotropin suspension.
522.304 Carprofen. 522.1083 Gonadotropin releasing factor ana-
522.311 Cefovecin. log-diphtheria toxoid conjugate.
522.313 Ceftiofur injectable dosage forms. 522.1085 Guaifenesin powder for injection.
522.313a Ceftiofur crystalline free acid. 522.1086 Guaifenesin solution.
272
522.1125 Hemoglobin glutamer-200 (bovine). 522.1883 Prednisolone sodium phosphate.
522.1145 Hyaluronate. 522.1884 Prednisolone sodium succinate.
522.1150 Hydrochlorothiazide. 522.1885 Prednisolone tertiary butylacetate.
522.1155 Imidocarb powder for injection. 522.1890 Prednisone suspension.
522.1156 Imidocarb solution. 522.1920 Prochlorperazine and isopropamide.
522.1160 Insulin. 522.1940 Progesterone and estradiol ben-
522.1182 Iron injection. zoate.
522.1185 Isoflupredone. 522.1962 Promazine.
522.1192 Ivermectin. 522.2002 Propiopromazine.
522.1193 Ivermectin and clorsulon. 522.2005 Propofol.
522.1204 Kanamycin. 522.2012 Prostalene.
522.1222 Ketamine. 522.2063 Pyrilamine.
522.1223 Ketamine, promazine, and 522.2065 Rabacfosadine.
aminopentamide. 522.2075 Robenacoxib.
522.1225 Ketoprofen. 522.2076 Romifidine.
522.1242 Levamisole. 522.2092 Secobarbital and dibucaine.
522.1260 Lincomycin. 522.2100 Selenium and vitamin E.
522.1289 Lufenuron. 522.2112 Sometribove zinc suspension.
522.1290 Luprostiol. 522.2120 Spectinomycin hydrochloride.
522.1315 Maropitant. 522.2121 Spectinomycin sulfate.
522.1335 Medetomidine. 522.2150 Stanozolol.
522.1338 Medetomidine and vatinoxan. 522.2200 Sulfachlorpyridazine.
522.1350 Melatonin implant. 522.2220 Sulfadimethoxine.
522.1362 Melarsomine powder for injection. 522.2240 Sulfaethoxypyridazine.
522.1367 Meloxicam. 522.2260 Sulfamethazine.
522.1372 Mepivacaine. 522.2340 Sulfomyxin.
522.1380 Methocarbamol. 522.2343 Testosterone propionate and estra-
522.1410 Methylprednisolone. diol benzoate.
522.1450 Moxidectin solution. 522.2404 Thialbarbitone sodium for injec-
522.1451 Moxidectin microspheres for injection.
tion. 522.2424 Thiamylal.
522.1452 Nalorphine. 522.2444 Thiopental injectable dosage forms.
522.1465 Naltrexone. 522.2444a Thiopental powder for injection.
522.1468 Naproxen for injection. 522.2444b Thiopental and pentobarbital pow-
522.1484 Neomycin. der for injection.
522.1503 Neostigmine. 522.2450 Tigilanol.
522.1610 Oleate sodium. 522.2460 Tildipirosin.
522.1660 Oxytetracycline injectable dosage 522.2470 Tiletamine and zolazepam for injec-
forms. tion.
522.1660a Oxytetracycline solution, 200 mil- 522.2471 Tilmicosin.
ligrams/milliliter. 522.2473 Tiludronate.
522.1660b Oxytetracycline solution, 300 mil- 522.2474 Tolazoline.
ligrams/milliliter. 522.2476 Trenbolone acetate.
522.1662 Oxytetracycline. 522.2477 Trenbolone acetate and estradiol.
522.1663 Oxytetracycline hydrochloride with 522.2478 Trenbolone acetate and estradiol
lidocaine injection. benzoate.
522.1664 Oxytetracycline and flunixin. 522.2483 Triamcinolone.
522.1680 Oxytocin. 522.2582 Triflupromazine.
522.1684 Pegbovigrastim. 522.2610 Trimethoprim and sulfadiazine.
522.1696 Penicillin G procaine injectable 522.2615 Tripelennamine.
dosage forms. 522.2630 Tulathromycin.
522.1696a Penicillin G benzathine and peni- 522.2632 Tulathromycin and ketoprofen.
cillin G procaine suspension. 522.2640 Tylosin.
522.1696b Penicillin G procaine aqueous sus- 522.2662 Xylazine.
pension. 522.2670 Yohimbine.
522.1696c Penicillin G procaine in oil. 522.2680 Zeranol.
522.1698 Pentazocine. 522.2690 Zinc gluconate.
522.1700 Pentobarbital and phenytoin.
522.1703 Pentobarbital. AUTHORITY: 21 U.S.C. 360b.
522.1704 Pentosan polysulfate sodium. SOURCE: 40 FR 13858, Mar. 27, 1975, unless
522.1720 Phenylbutazone. otherwise noted.
522.1820 Pituitary luteinizing hormone pow-
der for injection. § 522.23 Acepromazine.
522.1850 Polysulfated glycosaminoglycan.
522.1862 Pralidoxime powder for injection. (a) Specifications. Each milliliter of
522.1870 Praziquantel. solution contains 10 milligrams (mg)

522.1881 Prednisolone acetate. acepromazine maleate.
273
§ 522.52 21 CFR Ch. I (4–1–23 Edition)
(b) Sponsors. See Nos. 000010 and (2) Indications for use. For the induc-
058198 in § 510.600(c) of this chapter. tion and maintenance of anesthesia
(c) Conditions of use in dogs, cats, and and for induction of anesthesia fol-
horses—(1) Amount. Dogs: 0.25 to 0.5 mg lowed by maintenance with an inhalant
per pound (/lb) of body weight; Cats: 0.5 anesthetic, in dogs and cats.
to 1.0 mg/lb of body weight; Horses: 2.0 (3) Limitations. Federal law restricts
to 4.0 mg per 100 lbs of body weight. this drug to use by or on the order of a
(2) Indications for use. For use as a licensed veterinarian. Alfaxalone is a
tranquilizer and as a preanesthetic Class IV controlled substance.
agent.
(3) Limitations. Do not use in horses FR 64116, Oct. 28, 2014]
eral law restricts this drug to use by or § 522.56 Amikacin.
(a) Specifications. Each milliliter of
[75 FR 10167, Mar. 5, 2010; 78 FR 17597, Mar. 22, solution contains 50 milligrams (mg) of
2013; 79 FR 16182, Mar. 25, 2014; 86 FR 14819, amikacin as amikacin sulfate.
Mar. 19, 2021]
§ 522.52 Alfaxalone. § 510.600(c) of this chapter.
(a) Specifications. Each milliliter con- Amount. 5 mg/pound (lb) of body weight
tains 10 milligrams (mg) alfaxalone. twice daily by intramuscular or sub-
(b) Sponsor. See No. 049480 in cutaneous injection.
§ 510.600(c) of this chapter. (2) Indications for use. For treatment
(c) Conditions of use in cats and dogs— of genitourinary tract infections (cys-
(1) Amount—(i) Cats—(A) Induction of titis) caused by susceptible strains of
general anesthesia. Administer by intra- Escherichia coli and Proteus spp. and
venous injection over approximately 60 skin and soft tissue infections caused
seconds or until clinical signs show the by susceptible strains of Pseudomonas
onset of anesthesia, 2.2 to 9.7 mg/kilo- spp. and E. coli.
gram (kg) for cats that did not receive (3) Limitations. Do not use in horses
a preanesthetic or 1.0 to 10.8 mg/kg for intended for human consumption. Fed-
cats that received a preanesthetic. eral law restricts this drug to use by or
(B) Maintenance of general anesthesia on the order of a licensed veterinarian.
following induction. Administer an in-
travenous bolus containing 1.1 to 1.3 [76 FR 17338, Mar. 29, 2011, as amended at 78
mg/kg to provide an additional 7 to 8 FR 17597, Mar. 22, 2013; 79 FR 16183, Mar. 25,
minutes of anesthesia in 2014; 81 FR 17608, Mar. 30, 2016]
preanesthetized cats; a dose containing
§ 522.62 Aminopentamide.
1.4 to 1.5 mg/kg provides an additional
3 to 5 minutes anesthesia in (a) Specifications. Each milliliter of
unpreanesthetized cats. solution contains 0.5 milligram (mg)
(ii) Dogs—(A) Induction of general an- aminopentamide hydrogen sulfate.
esthesia. Administer by intravenous in- (b) Sponsor. See No. 054771 in
jection over approximately 60 seconds § 510.600(c) of this chapter.
or until clinical signs show the onset of (c) Conditions of use in dogs and cats—
anesthesia, 1.5 to 4.5 mg/kg for dogs (1) Amount. Administer by subcuta-
that did not receive a preanesthetic or neous or intramuscular injection every
0.2 to 3.5 mg/kg for dogs that received 8 to 12 hours as follows: For animals
a preanesthetic. weighing up to 10 pounds (lbs): 0.1 mg;
(B) Maintenance of general anesthesia For animals weighing 11 to 20 lbs: 0.2
following induction. Administer an in- mg; For animals weighing 21 to 50 lbs:
travenous bolus containing 1.2 to 1.4 0.3 mg; For animals weighing 51 to 100
mg/kg to provide an additional 6 to 8 lbs: 0.4 mg; For animals weighing over
minutes of anesthesia in 100 lbs: 0.5 mg. Dosage may be gradu-
preanesthetized dogs; a dose of 1.5 to ally increased up to a maximum of five
2.2 mg/kg provides an additional 6 to 8 times the suggested dosage. Following
minutes of anesthesia in parenteral use, dosage may be contin-

unpreanesthetized dogs. ued by oral administration of tablets.
274
(2) Indications for use. For the treat- (c) Related tolerance. See § 556.38 of
ment of vomiting and/or diarrhea, nau- this chapter.
sea, acute abdominal visceral spasm, (d) Conditions of use—(1) Dogs and
pylorospasm, or hypertrophic gastritis. cats—(i) Amount. Administer 5 mg per
(3) Limitations. Federal law restricts pound of body weight daily for up to 5
this drug to use by or on the order of a days by intramuscular or subcutaneous
licensed veterinarian. injection.
[79 FR 16183, Mar. 25, 2014] (ii) Indications for use—(A) Dogs. For
treatment of infections caused by sus-
§ 522.82 Aminopropazine. ceptible strains of organisms as fol-
lows: Respiratory infections (tonsil-
litis, tracheobronchitis) due to Staphy-
solution contains aminopropazine fu-
lococcus aureus, Streptococcus spp., Esch-
marate equivalent to 25 milligrams
erichia coli, and Proteus mirabilis; geni-
(mg) aminopropazine base.
tourinary infections (cystitis) due to S.
aureus, Streptococcus spp., E. coli, and P.
mirabilis; gastrointestinal infections
(c) Conditions of use—(1) Dogs and
(bacterial gastroenteritis) due to S.
cats—(i) Amount. 1 to 2 mg per pound of
aureus, Streptococcus spp., E. coli, and P.
body weight, repeated every 12 hours as
mirabilis; bacterial dermatitis due to S.
indicated, by intramuscular or intra-
aureus, Streptococcus spp., and P.
venous injection.
mirabilis; soft tissue infections (ab-
(ii) Indications for use. For reducing
scesses, lacerations, and wounds), due
excessive smooth muscle contractions,
to S. aureus, Streptococcus spp., E. coli,
such as occur in urethral spasms asso-
and P. mirabilis.
ciated with urolithiasis.
(B) Cats. For treatment of infections
caused by susceptible strains of orga-
nisms as follows: Upper respiratory in-
fections due to S. aureus, Staphy-
(2) Horses—(i) Amount. Administer
lococcus spp., Streptococcus spp.,
0.25 mg per pound of body weight, re-
Haemophilus spp., E. coli, Pasteurella
peated every 12 hours as indicated, by
spp., and P. mirabilis; genitourinary in-
intramuscular or intravenous injec-
fections (cystitis) due to S. aureus,
tion.
Streptococcus spp., E. coli, P. mirabilis,
(ii) Indications for use. For reducing
and Corynebacterium spp.; gastro-
excessive smooth muscle contractions,
intestinal infections due to E. coli, Pro-
such as occur in colic spasms.
teus spp., Staphylococcus spp., and Strep-
tococcus spp.; skin and soft tissue infec-
tions (abscesses, lacerations, and
wounds) due to S. aureus, Staphy-
lococcus spp., Streptococcus spp., E. coli,
[79 FR 16183, Mar. 25, 2014] and Pasteurella multocida.
§ 522.88 Amoxicillin. this drug to use by or on the order of a
(a) Specifications. (1) Each vial con- licensed veterinarian.
tains 3 grams (g) of amoxicillin tri- (2) Cattle—(i) Amount. Administer 3 to
hydrate. Each milliliter of constituted 5 mg per pound of body weight daily for
suspension contains 100 or 250 milli- up to 5 days by intramuscular or sub-
grams (mg) amoxicillin trihydrate for cutaneous injection.
use as in paragraph (d)(1) of this sec- (ii) Indications for use. For treatment
tion. of diseases due to amoxicillin-suscep-
(2) Each vial contains 25 g of tible organisms as follows: Respiratory
amoxicillin trihydrate. Each milliliter tract infections (shipping fever, pneu-
of constituted suspension contains 250 monia) due to P. multocida, P.
mg amoxicillin trihydrate for use as in hemolytica, Haemophilus spp., Staphy-
paragraph (d)(2) of this section. lococcus spp., and Streptococcus spp. and
(b) Sponsor. See No. 054771 in acute necrotic pododermatitis (foot

§ 510.600(c) of this chapter. rot) due to Fusobacterium necrophorum.
275
§ 522.90 21 CFR Ch. I (4–1–23 Edition)
(iii) Limitations. Treated animals tion, once or twice daily, for up to 3

must not be slaughtered for food dur- days.
ing treatment and for 25 days after the (ii) Indications for use. Treatment of
last treatment. Milk from treated cows bacterial enteritis (colibacillosis)
must not be used for human consump- caused by E. coli and bacterial pneu-
tion during treatment or for 96 hours (8 monia caused by Pasteurella spp. sus-
milkings) after last treatment. Federal ceptible to ampicillin.
law restricts this drug to use by or on (iii) Limitations. Treated animals
the order of a licensed veterinarian. must not be slaughtered for food use
[79 FR 16183, Mar. 25, 2014] during treatment or for 15 days after
the last treatment. Federal law re-
§ 522.90 Ampicillin injectable dosage stricts this drug to use by or on the
forms. order of a licensed veterinarian.
(3) Dogs—(i) Amount. (A) 3 to 6 mg per
[79 FR 16183, Mar. 25, 2014] pound of body weight by intramuscular
injection, once or twice daily. Usual
§ 522.90a Ampicillin trihydrate suspen-
sion. treatment is 3 to 5 days.
(B) 3 to 5 mg of ampicillin per pound
(a) Specifications. (1) Each milliliter of body weight, once a day for up to 4
contains ampicillin trihydrate equiva- days.
lent to 200 milligrams (mg) of ampi- (ii) Indications for use. (A) Treatment
cillin. of respiratory tract infections due to E.
(2) Each milliliter contains ampi- coli, Pseudomonas spp., Proteus spp.,
cillin trihydrate equivalent to 150 mg Staphylococcus spp., and Streptococcus
of ampicillin. spp.; tonsillitis due to E. coli,
(b) Sponsors. See sponsor numbers in Pseudomonas spp., Streptococcus spp.,
§ 510.600(c) of this chapter. and Staphylococcus spp.; generalized in-
(1) No. 054771 for use of product de- fections (septicemia) associated with
scribed in paragraph (a)(1) as in para- abscesses, lacerations, and wounds due
graphs (d)(1), (d)(2), (d)(3)(i)(A), to Staphylococcus spp. and Streptococcus
(d)(3)(ii)(A), (d)(3)(iii), and (d)(4) of this spp.
section. (B) Treatment of bacterial infections
(2) No. 054771 for use of product de- of the upper respiratory tract (tonsil-
scribed in paragraph (a)(2) as in para- litis) due to Streptococcus spp., Staphy-
graphs (d)(3)(i)(B), (d)(3)(ii)(B), and lococcus spp., E. coli, Proteus spp., and
(d)(3)(iii) of this section. Pasteurella spp., and soft tissue infec-
(c) Related tolerances. See § 556.40 of tions (abscesses, lacerations, and
this chapter. wounds) due to Staphylococcus spp.,
(d) Conditions of use—(1) Cattle—(i) Streptococcus spp., and E. coli, when
Amount. For enteritis: 3 mg per pound caused by susceptible organisms.
of body weight, intramuscularly, once (iii) Limitations. Federal law restricts
or twice daily, for up to 3 days. For this drug to use by or on the order of a
pneumonia: 3 mg per pound of body licensed veterinarian.
weight, intramuscularly, twice daily, (4) Cats—(i) Amount. 5 to 10 mg per
for up to 3 days. pound of body weight by intramuscular
(ii) Indications for use. For treatment or subcutaneous injection, once or
of bacterial enteritis in calves caused twice daily. Usual treatment is 3 to 5
by Escherichia coli and bacterial pneu- days.
monia caused by Pasteurella spp. sus-
(ii) Indications for use. Treatment of
ceptible to ampicillin.
generalized infections (septicemia) as-
(iii) Limitations. Treated animals sociated with abscesses, lacerations,
must not be slaughtered for food use and wounds due to Staphylococcus spp.,
during treatment or for 9 days after Streptococcus spp., and Pasteurella spp.
the last treatment. Federal law re-
(2) Swine—(i) Amount. 3 mg per pound

of body weight by intramuscular injec- [79 FR 16183, Mar. 25, 2014]
276
§ 522.90b Ampicillin trihydrate powder milligrams (mg) ampicillin equiva-

for injection. lents.
(a) Specifications. Each milliliter of (b) See Nos. 042791 and 054771 in
aqueous suspension constituted from § 510.600(c) of this chapter.
ampicillin trihydrate powder contains (c) Conditions of use in horses—(1)
200, 250, or 400 milligrams (mg) ampi- Amount: 3 mg per pound of body weight
cillin equivalents. twice daily by intravenous or
(b) Sponsors. See Nos. 000010 and intramuscular injection.
042791 in § 510.600(c) of this chapter. (2) Indications for use. For the treat-
(c) Related tolerances. See § 556.40 of ment of respiratory tract infections
this chapter. (pneumonia and strangles) due to
Staphylococcus spp., Streptococcus spp.
(d) Conditions of use—(1) Dogs and
(including S. equi), Escherichia coli, and
cats—(i) Amount. 3 mg/pound (lb) of
Proteus mirabilis, and skin and soft tis-
body weight twice daily by subcuta-
sue infections (abscesses and wounds)
neous or intramuscular injection.
due to Staphylococcus spp., Streptococcus
spp., E. coli, and P. mirabilis, when
of strains of organisms susceptible to
caused by susceptible organisms.
ampicillin and associated with res-
piratory tract infections, urinary tract
infections, gastrointestinal infections,
skin infections, soft tissue infections,
and postsurgical infections.
(iii) Limitations. Federal law restricts [72 FR 45158, Aug. 13, 2007, as amended at 79
this drug to use by or on the order of a FR 16184, Mar. 25, 2014; 86 FR 57997, Oct. 20,
licensed veterinarian. 2021]
(2) Cattle—(i) Amount. 2 to 5 mg/lb of § 522.144 Arsenamide.
body weight once daily by
intramuscular injection. (a) Specifications. Each milliliter of
(ii) Indications for use. For treatment solution contains 10.0 milligrams
of respiratory tract infections caused arsenamide sodium.
by organisms susceptible to ampicillin, (b) Sponsor. See No. 000010 in
bacterial pneumonia (shipping fever, § 510.600(c) of this chapter.
calf pneumonia, and bovine pneu- (c) Conditions of use in dogs—(1)
monia) caused by Aerobacter spp., Amount. Administer 0.1 milliliter (mL)
Klebsiella spp., Staphylococcus spp., per pound of body weight (1.0 mL for
Streptococcus spp., Pasteurella multocida, every 10 pounds) by intravenous injec-
and Escherichia coli. tion twice a day for 2 days.
(iii) Limitations. Do not treat cattle (2) Indications for use. For the treat-
for more than 7 days. Milk from treatment and prevention of canine heart-
ed cows must not be used for food dur- worm disease caused by Dirofilaria
ing treatment and for 48 hours (4 immitis.
milkings) after the last treatment. (3) Limitations. Federal law restricts
Cattle must not be slaughtered for food this drug to use by or on the order of a
during treatment and for 144 hours (6 licensed veterinarian.
days) after the last treatment. Federal [79 FR 16184, Mar. 25, 2014, as amended at 84
law restricts this drug to use by or on FR 39183, Aug. 9, 2019]
the order of a licensed veterinarian.
§ 522.147 Atipamezole.
[57 FR 37331, Aug. 18, 1992; 57 FR 42623, Sept.
15, 1992; 58 FR 18304, Apr. 8, 1993; 63 FR 41420, (a) Specifications. Each milliliter of
Aug. 4, 1998; 75 FR 10167, Mar. 5, 2010; 76 FR solution contains 5.0 milligrams
17338, Mar. 29, 2011; 76 FR 53051, Aug. 25, 2011; atipamezole hydrochloride.
82 FR 21690, May 10, 2017; 85 FR 4208, Jan. 24, (b) Sponsor. See Nos. 015914 and 052483
2020] in § 510.600(c) of this chapter.
§ 522.90c Ampicillin sodium. Amount. Inject intramuscularly the
(a) Specifications. Each milliliter of same volume as that of
aqueous solution constituted from am- dexmedetomidine or medetomidine

picillin sodium powder contains 300 used.
277
§ 522.150 21 CFR Ch. I (4–1–23 Edition)
(2) Indications for use. For reversal of injection 0.25 to 0.5 milliliter (mL) per
the sedative and analgesic effects of 20 pounds of body weight, depending on
dexmedetomidine hydrochloride or the severity of the condition. Fre-
medetomidine hydrochloride. quency of dosage depends on recurrence
(3) Limitations. Federal law restricts of pruritic symptoms. Dosage may be
this drug to use by or on the order of a repeated every 3 weeks or when symp-
licensed veterinarian. toms recur, not to exceed a total of
[61 FR 48830, Sept. 17, 1996, as amended at 64 four injections.
FR 71640, Dec. 22, 1999; 72 FR 264, Jan. 4, 2007; (ii) Indications for use. As an aid in
84 FR 8973, Mar. 13, 2019] the control of pruritus associated with
dermatoses.
§ 522.150 Azaperone.
(a) Specifications. Each milliliter of this drug to use by or on the order of a
solution contains 40 milligrams (mg) licensed veterinarian.
azaperone. (2) Horses—(i) Amount. Administer 2.5
(b) Sponsor. See No. 058198 in to 5 mL by intra-articular injection.
(ii) Indications for use. (A) For the
treatment of various inflammatory
this chapter.
(d) Conditions of use—(1) Indications joint conditions; for example, acute
for use. For control of aggressiveness and traumatic lameness involving the
when mixing or regrouping weanling or carpel and fetlock joints.
feeder pigs weighing up to 80 pounds. (B) As an aid in the control of inflam-
(2) Dosage. 2.2 mg per kilogram (1 mg mation associated with various
per pound) by deep intramuscular in- arthropathies.
jection. (iii) Limitations. Do not use in horses
(3) Limitations. Federal law restricts intended for human consumption. Fed-
this drug to use by or on the order of a eral law restricts this drug to use by or
licensed veterinarian. on the order of a licensed veterinarian.
[74 FR 65689, Dec. 11, 2009, as amended at 77 [79 FR 16184, Mar. 25, 2014]
FR 46613, Aug. 6, 2012; 81 FR 48702, July 26,
2016; 84 FR 32992, July 11, 2019] § 522.163 Betamethasone dipropionate
and betamethasone sodium phos-
§ 522.161 Betamethasone. phate aqueous suspension.
(a) Specifications. Each milliliter of (a) Specifications. Betamethasone
suspension contains: dipropionate and betamethasone so-
(1) Betamethasone acetate equivalent dium phosphate aqueous suspension is
to 10.8 milligrams (mg) betamethasone a sterile aqueous suspension. Each mil-
and betamethasone disodium phos- liliter of the suspension contains the
phate equivalent to 3 mg of
equivalent of 5 milligrams of
betamethasone.
betamethasone as betamethasone
(2) Betamethasone dipropionate
dipropionate and 2 milligrams of
equivalent to 5 mg betamethasone and
betamethasone as betamethasone so-
betamethasone sodium phosphate
dium phosphate.
equivalent to 2 mg of betamethasone.
(b) Sponsor. See sponsor numbers in (b) Sponsor. See No. 000061 in
§ 510.600(c) of this chapter: § 510.600(c) of this chapter.
(1) No. 000061 for product described in (c) Conditions of use—(1) Dogs. (i) It is
paragraph (a)(1) of this section for use used as an aid in the control of pru-
as in paragraphs (c)(1), (c)(2)(i), ritus associated with dermatoses.
(c)(2)(ii)(A), and (c)(2)(iii) of this sec- (ii) It is administered by
tion. intramuscular injection at a dosage of
(2) No. 000061 for product described in 0.25 to 0.5 milliliter per 20 pounds of
paragraph (a)(2) of this section for use body weight, depending on the severity
as in paragraphs (c)(1), (c)(2)(i), of the condition. Frequency of dosage
(c)(2)(ii)(B), and (c)(2)(iii) of this sec- depends on recurrence of pruritic
tion. symptoms. Dosage may be repeated
(c) Conditions of use—(1) Dogs—(i) every 3 weeks or when symptoms recur,

Amount. Administer by intramuscular not to exceed a total of 4 injections.
278
(2) Horses. (i) It is used as an aid in (b) Sponsor. See No. 054771 in
the control of inflammation associated § 510.600(c) of this chapter.
with various arthropathies. (c) Conditions of use in horses—(1)
(ii) It is administered aseptically by Amount. 0.5 mg per pound body weight
intraarticular injection at a dosage of by intramuscular injection. Treatment
2.5 to 5 milliliters per joint, depending may be repeated at 3-week intervals.
on the severity of the condition and (2) Indications for use. As an aid for
the joint size. Dosage may be repeated treating debilitated horses when an im-
upon recurrence of clinical signs. Injec- provement in weight, hair coat, or gen-
tion into the joint cavity should be eral physical condition is desired.
preceded by withdrawal of synovial (3) Limitations. Do not administer to
fluid. horses intended for human consump-
(iii) Not for use in horses intended for tion. Federal law restricts this drug to
food. use by or on the order of a licensed vet-
(3) Clinical and experimental data. It erinarian.
has been demonstrated that
corticosteroids administered orally or [70 FR 70998, Nov. 25, 2005, as amended at 79
parenterally to animals may induce FR 16184, Mar. 25, 2014]
the first stage of parturition when ad- § 522.224 Bupivacaine.
ministered during the last trimester of
pregnancy and may precipitate pre- (a) Specifications. Each milliliter
mature parturition followed by (mL) of liposomal suspension contains
dystocia, fetal death, retained pla- 13.3 milligrams (mg) bupivacaine.
centa, and metritis. (b) Sponsor. See No. 058198 in
(4) Restrictions. Federal law restricts § 510.600(c) of this chapter.
this drug to use by or on the order of a (c) Conditions of use—(1) Dogs—(i)
licensed veterinarian. Amount. Administer 5.3 mg/kg (0.4 mL/
kg) by infiltration injection into the
FR 27316, July 2, 1976; 52 FR 7832, Mar. 13,
tissue layers at the time of incisional
1987] closure.
(ii) Indications for use. For single-dose
§ 522.167 Betamethasone sodium phos- infiltration into the surgical site to
phate and betamethasone acetate. provide local postoperative analgesia
(a) Specifications. Each milliliter for cranial cruciate ligament surgery.
(mL) of suspension contains 6 milli- (2) Cats—(i) Amount. Administer 5.3
grams (mg) betamethasone (3.15 mg mg/kg per forelimb (0.4 mL/kg per
betamethasone sodium phosphate and forelimb), for a total dose of 10.6 mg/kg/
2.85 mg betamethasone acetate). cat, as a 4-point nerve block prior to
(b) Sponsor. See No. 010797 in onychectomy.
§ 510.600(c) of this chapter. (ii) Indications for use. For use as a
(c) Conditions of use in horses—(1) peripheral nerve block to provide re-
Amount. Administer 1.5 mL (9 mg total gional postoperative analgesia fol-
betamethasone) per joint by intra-ar- lowing onychectomy.
ticular injection. May be administered [81 FR 67151, Sept. 30, 2016, as amended at 84
concurrently in up to two joints per FR 8973, Mar. 13, 2019; 85 FR 4208, Jan. 24,
horse. 2020]
of pain and inflammation associated § 522.230 Buprenorphine.
with osteoarthritis in horses. (a) Specifications. Each milliliter of
(3) Limitations. Do not use in horses solution contains 1.8 milligrams (mg)
intended for human consumption. Fed- buprenorphine.
eral law restricts this drug to use by or (b) Sponsor. See No. 054771 in
[80 FR 18776, Apr. 8, 2015] (c) Conditions of use in cats—(1)
Amount. Administer 0.24 mg per kilo-
§ 522.204 Boldenone. gram (0.11 mg per pound) by subcuta-
(a) Specifications. Each milliliter of neous injection once daily, for up to 3
solution contains 25 or 50 milligrams days. Administer the first dose ap-

(mg) boldenone undecylenate. proximately 1 hour prior to surgery.
279
§ 522.234 21 CFR Ch. I (4–1–23 Edition)
(2) Indications for use. For the control in paragraph (a)(3) of this section as in
of postoperative pain associated with paragraph (d)(3) of this section.
surgical procedures in cats. (c) Special considerations. Federal law
(3) Limitations. Federal law restricts restricts this drug to use by or on the
this drug to use by or on the order of a order of a licensed veterinarian.
licensed veterinarian. (d) Conditions of use—(1) Dogs—(i)
of body weight by subcutaneous injec-
FR 18776, Apr. 8, 2015]
tion at intervals of 6 to 12 hours, as re-
§ 522.234 Butamisole. quired. If necessary, increase dose to a
maximum of 0.05 mg per pound of body
(a) Specifications. Each milliliter of weight. Treatment should not nor-
solution contains 11 milligrams (mg) mally be required for longer than 7
butamisole hydrochloride. days.
(b) Sponsors. See Nos. 054771 and (ii) Indications for use. For the relief
058198 in § 510.600(c) of this chapter. of chronic nonproductive cough associ-
(c) Conditions of use in dogs—(1) ated with tracheo-bronchitis, tra-
Amount. Administer 0.1 mg per pound cheitis, tonsillitis, laryngitis, and
of body weight by subcutaneous injec- pharyngitis associated with inflam-
tion. In problem cases, retreatment for matory conditions of the upper res-
whipworms may be necessary in ap- piratory tract.
proximately 3 months. For hookworms, (2) Cats—(i) Amount. Administer 0.2
a second injection should be given 21 mg per pound of body weight by sub-
days after the initial treatment. cutaneous injection. Dose may be re-
(2) Indications for use. For the treat- peated up to 4 times per day. Do not
ment of infections with whipworms treat for more than 2 days.
(Trichuris vulpis), and the hookworm (ii) Indications for use. For the relief
(Ancylostoma caninum). of pain in cats caused by major or
(3) Limitations. Federal law restricts minor trauma, or pain associated with
this drug to use by or on the order of a surgical procedures.
licensed veterinarian. (3) Horses—(i) Amount. Administer
0.05 mg per pound of body weight by in-
FR 14819, Mar. 19, 2021] travenous injection. Dose may be re-
peated within 3 to 4 hours. Treatment
§ 522.246 Butorphanol. should not exceed 48 hours.
(ii) Indications for use. For the relief
of pain associated with colic and
solution contains butorphanol (as
postpartum pain in adult horses and
butorphanol tartrate) in the following
yearlings.
amounts:
(1) 0.5 milligrams (mg); intended for human consumption.
(2) 2 mg; or
(3) 10 mg [72 FR 27957, May 18, 2007, as amended at 73
FR 31358, June 2, 2008; 74 FR 61516, Nov. 25,
2009; 75 FR 22524, Apr. 29, 2010; 77 FR 60302,
§ 510.600(c) of this chapter as follows: Oct. 3, 2012; 78 FR 17597, Mar. 22, 2013; 79 FR
(1) No. 054771 for use of the product 16184, Mar. 25, 2014; 79 FR 74020, Dec. 15, 2014;
described in paragraph (a)(1) as in para- 80 FR 13229, Mar. 13, 2015; 87 FR 17945, Mar.
graph (d)(1) of this section; for use of 29, 2022; 88 FR 16547, Mar. 20, 2023]
the product described in paragraph
(a)(2) as in paragraph (d)(2) of this sec- § 522.275 N-Butylscopolammonium.
tion; and for use of the product de- (a) Specifications. Each milliliter of
scribed in paragraph (a)(3) as in para- solution contains 20 milligrams (mg)
graph (d)(3) of this section. N-butylscopolammonium bromide.
(2) No. 043264 for use of the product (b) Sponsor. See No. 000010 in
described in paragraph (a)(2) of this § 510.600(c) of this chapter.
section as in paragraph (d)(2) of this (c) Conditions of use in horses—(1)
section. Amount. 0.3 mg per kilogram of body
(3) Nos. 000061, 017033, 043264, and weight (0.14 mg per pound) slowly in-
059399 for use of the product described travenously.
280
(2) Indications for use. For the control wounds) in dogs caused by susceptible
of abdominal pain (colic) associated strains of Staphylococcus intermedius
with spasmodic colic, flatulent colic, and Streptococcus canis (Group G).
and simple impactions. (2) Cats—(i) Amount. Administer 3.6
(3) Limitations. Federal law restricts mg/lb (8 mg/kg) body weight as a sin-
this drug to use by or on the order of a gle, one-time subcutaneous injection.
licensed veterinarian. (ii) Indications for use. For the treat-
[69 FR 35512, June 25, 2004] ment of skin infections (wounds and
abscesses) in cats caused by susceptible
§ 522.304 Carprofen. strains of Pasteurella multocida.
solution contains 50 milligrams (mg) FR 16185, Mar. 25, 2014]
carprofen.
(b) Sponsors. See Nos. 016729, 017033, § 522.313 Ceftiofur injectable dosage
054771, and 055529 in § 510.600(c) of this forms.
chapter.
(c) [Reserved] § 522.313a Ceftiofur crystalline free
(d) Conditions of use in dogs—(1) acid.
Amount. 2 mg/lb (4.4 mg/kg) body
(a) Specifications. The product is a
weight once daily or 1 mg/lb (2.2 mg/kg)
suspension of ceftiofur crystalline free
twice daily, by subcutaneous injection.
acid.
For the control of postoperative pain,
administer approximately 2 hours be- (1) Each milliliter (mL) contains 100
fore the procedure. milligrams (mg) ceftiofur equivalents.
(2) Conditions of use. For the relief of (2) Each mL contains 200 mg ceftiofur
pain and inflammation associated with equivalents.
osteoarthritis and for the control of (b) Sponsor. See No. 054771 in
postoperative pain associated with soft § 510.600(c) of this chapter.
tissue and orthopedic surgeries. (c) Related tolerances. See § 556.113 of
(3) Limitations. Federal law restricts this chapter.
this drug to use by or on the order of a (d) Conditions of use—(1) Swine. The
licensed veterinarian. formulation described in paragraph
[68 FR 26205, May 15, 2003, as amended at 68 (a)(1) of this section is used as follows:
FR 34796, June 11, 2003; 68 FR 49351, Aug. 18, (i) Amount. 5.0 mg CE per kilogram
2003. Redesignated at 73 FR 29685, May 22, (kg) of body weight by intramuscular
2008, as amended at 79 FR 74020, Dec. 15, 2014; injection in the postauricular region of
82 FR 43484, Sept. 18, 2017; 88 FR 16547, Mar.
the neck.
20, 2023]
§ 522.311 Cefovecin. ment of swine respiratory disease
(a) Specifications. Each milliliter of (SRD) associated with Actinobacillus
constituted solution contains 80 milli- pleuropneumoniae, Pasteurella multocida,
grams (mg) cefovecin as the sodium Haemophilus parasuis, and Streptococcus
salt. suis. For the control of SRD associated
(b) Sponsor. See No. 054771 in with A. pleuropneumoniae, P. multocida,
§ 510.600(c) of this chapter. H. parasuis, and S. suis in groups of pigs
(c) Special considerations. Federal law where SRD has been diagnosed.
restricts this drug to use by or on the (iii) Limitations. Following label use
order of a licensed veterinarian. as a single treatment, a 14-day pre-
(d) Conditions of use—(1) Dogs—(i) slaughter withdrawal period is re-
Amount. Administer 3.6 mg/pound (lb) (8 quired. Federal law restricts this drug
mg/kilograms (kg)) body weight as a to use by or on the order of a licensed
single subcutaneous injection. A sec- veterinarian. Federal law prohibits
ond subcutaneous injection of 3.6 mg/lb extra-label use of this drug in swine for
(8 mg/kg) may be administered if re- disease prevention purposes; at unap-
sponse to therapy is not complete. proved doses, frequencies, durations, or
(ii) Indications for use. For the treat- routes of administration; and in unap-
ment of skin infections (secondary su- proved, major food-producing species/

perficial pyoderma, abscesses, and production classes.
281
§ 522.313b 21 CFR Ch. I (4–1–23 Edition)
(2) Cattle. The formulation described (3) Horses. The formulation described
in paragraph (a)(2) of this section is in paragraph (a)(2) of this section is
used as follows: used as follows:
(i) Amount. For subcutaneous (SC) in- (i) Amount. Two intramuscular injec-
jection in the posterior aspect of the tions, 4 days apart, at a dose of 3.0 mg/
ear where it attaches to the head (base lb (6.6 mg/kg) body weight.
of the ear) in lactating dairy cattle. (ii) Indications for use. For the treat-
For SC injection in the middle third of ment of lower respiratory tract infec-
the posterior aspect of the ear or in the tions in horses caused by susceptible
base of the ear in beef and non-lac- strains of Streptococcus equi ssp.
tating dairy cattle. zooepidemicus.
(A) Single-dose regimen: 6.6 mg (iii) Limitations. Do not use in horses
ceftiofur equivalents per kg of body intended for human consumption. Fed-
weight as a single injection. eral law restricts this drug to use by or
(B) Two-dose regimen: 6.6 mg on the order of a licensed veterinarian.
ceftiofur equivalents per kg of body [68 FR 60296, Oct. 22, 2003, as amended at 69
weight given as two injections in the FR 43892, July 23, 2004. Redesignated and
base of the ear approximately 72 hours amended at 71 FR 39546, July 13, 2006; 73 FR
apart. 58872, Oct. 8, 2008; 75 FR 4692, Jan. 29, 2010; 75
FR 62468, Oct. 12, 2010; 77 FR 26162, May 3,
(ii) Indications for use. (A) Single-dose 2012; 79 FR 16185, Mar. 25, 2014; 79 FR 37620,
regimen: For the treatment of bovine July 2, 2014]
respiratory disease (BRD, shipping
fever, pneumonia) associated with § 522.313b Ceftiofur hydrochloride.
Mannheimia haemolytica, Pasteurella (a) Specifications. Each milliliter of
multocida, and Histophilus somni in beef, suspension contains:
non-lactating dairy, and lactating (1) Ceftiofur hydrochloride equiva-
dairy cattle. For the control of res- lent to 50 milligrams (mg) of ceftiofur
piratory disease in beef and non-lac- equivalents in the inactive vehicles
tating dairy cattle which are at high phospholipan 90H, sorbitan
risk of developing BRD associated with monooleate, and cottonseed oil;
M. haemolytica, P. multocida, and H. (2) Ceftiofur hydrochloride equiva-
somni. For the treatment of bovine foot lent to 50 mg ceftiofur equivalents in
rot (interdigital necrobacillosis) asso- the inactive vehicles polyoxyethylene
ciated with Fusobacterium necrophorum sorbitan monooleate (polysorbate 80) in
and Porphyromonas levii in beef, non- a caprylic/capric triglyceride suspen-
lactating dairy, and lactating dairy sion; or
cattle. (3) Ceftiofur hydrochloride equiva-
(B) Two-dose regimen: For the treat- lent to 50 mg ceftiofur equivalents in
ment of acute metritis (0-to 10-days the inactive vehicles aluminum mono-
postpartum) associated with bacterial stearate, sorbitan monooleate, and me-
organisms susceptible to ceftiofur in dium chain triglycerides.
lactating dairy cattle. (b) Sponsors. See sponsors in
(iii) Limitations. Following label use § 510.600(c) of this chapter as follows:
as either a single-dose or 2-dose regi- (1) No. 054771 for products described
men, a 13-day pre-slaughter withdrawal in paragraphs (a)(1) and (2) of this sec-
period is required after the last treat- tion; and
ment. A withdrawal period has not (2) No. 055529 for the product de-
been established in preruminating scribed in paragraph (a)(3) of this sec-
calves. Do not use in calves to be proc- tion.
essed for veal. Federal law restricts (c) Related tolerances. See § 556.113 of
this drug to use by or on the order of a this chapter.
licensed veterinarian. Federal law pro- (d) Special considerations. Federal law
hibits extra-label use of this drug in restricts this drug to use by or on the
cattle for disease prevention purposes; order of a licensed veterinarian. Fed-
at unapproved doses, frequencies, dura- eral law prohibits extra-label use of
tions, or routes of administration; and this drug in cattle and swine for dis-
in unapproved, major food-producing ease prevention purposes; at unap-

species/production classes. proved doses, frequencies, durations, or
282
routes of administration; and in unap- be slaughtered for 3 days following the

proved major food-producing species/ last treatment. For products described
production classes. in paragraph (a)(2) of this section:
(e) Conditions of use—(1) Swine—(i) Treated cattle must not be slaughtered
Amount. 3 to 5 mg per kilogram (/kg) of for 4 days following the last treatment.
body weight by intramuscular injec- (B) A withdrawal period has not been
tion. Treatment should be repeated at established in preruminating calves.
24-hour intervals for a total of 3 con- Do not use in calves to be processed for
secutive days. veal.
and control of swine bacterial res- FR 53578, Oct. 6, 1998; 67 FR 45901, July 11,
piratory disease (swine bacterial pneu- 2002; 69 FR 47362, Aug. 5, 2004. Redesignated
monia) associated with Actinobacillus and amended at 71 FR 39544, July 13, 2006; 73
pleuropneumoniae, Pasteurella multocida, FR 45612, Aug. 6, 2008; 76 FR 17338, Mar. 29,
Salmonella Choleraesuis, and Strepto- 2011; 78 FR 66264, Nov. 5, 2013; 84 FR 39183,
coccus suis. Aug. 9, 2019; 84 FR 53311, Oct. 7, 2019]
(iii) Limitations. For products de-
scribed in paragraphs (a)(1) and (3) of § 522.313c Ceftiofur sodium.
this section: Treated swine must not be (a) Specifications. Each milliliter of
slaughtered for 4 days following the aqueous solution constituted from
last treatment. For products described ceftiofur sodium powder contains 50
in paragraph (a)(2) of this section: milligrams (mg) ceftiofur equivalents.
Treated swine must not be slaughtered (b) Sponsors. See Nos. 054771 and
for 6 days following the last treatment 068330 in § 510.600(c) of this chapter.
when injection site volumes are greater (c) Related tolerances. See § 556.113 of
than 5 mL up to the maximum injec- this chapter.
tion site volume of 15 mL. Treated (d) Special considerations. Federal law
swine must not be slaughtered for 4 restricts this drug to use by or on the
days when injection site volumes are order of a licensed veterinarian. Fed-
less than or equal to 5 mL. eral law prohibits extra-label use of
(2) Cattle—(i) Amount. Administer by this drug in cattle, swine, chickens,
subcutaneous or intramuscular injec- and turkeys for disease prevention pur-
tion as follows: poses; at unapproved doses, fre-
(A) For bovine respiratory disease quencies, durations, or routes of ad-
and acute bovine interdigital ministration; and in unapproved major
necrobacillosis: 1.1 to 2.2 mg/kg of body food-producing species/production
weight at 24-hour intervals for 3 to 5 classes.
consecutive days. (e) Conditions of use—(1) Swine—(i)
(B) For bovine respiratory disease: 2.2 Amount. 3 to 5 mg per kilogram (/kg)
mg/kg of body weight administered body weight by intramuscular injec-
twice at a 48 hour interval. tion for 3 consecutive days.
(C) For acute metritis: 2.2 mg/kg of (ii) Indications for use. For treatment
body weight at 24-hour intervals for 5 and control of swine bacterial res-
consecutive days. piratory disease (swine bacterial pneu-
(ii) Indications for use. For treatment monia) associated with Actinobacillus
of bovine respiratory disease (BRD, pleuropneumoniae, Pasteurella multocida,
shipping fever, pneumonia) associated Salmonella choleraesuis, and Strepto-
with Mannheimia haemolytica, P. coccus suis.
multocida, and Histophilus somni; acute (iii) Limitations. Treated pigs must
bovine interdigital necrobacillosis not be slaughtered for 4 days following
(foot rot, pododermatitis) associated the last treatment.
with Fusobacterium necrophorum and (2) Cattle—(i) Amount. 0.5 to 1.0 mg/lb
Bacteroides melaninogenicus; and acute body weight by intramuscular or sub-
metritis (0 to 14 days post-partum) as- cutaneous injection for 3 days. Addi-
sociated with bacteria susceptible to tional treatments may be given on
ceftiofur. days 4 and 5 for animals which do not
(iii) Limitations. (A) For products de- show satisfactory response.
scribed in paragraphs (a)(2) and (3) of (ii) Indications for use. For treatment
this section: Treated cattle must not of bovine respiratory disease (shipping
283
§ 522.380 21 CFR Ch. I (4–1–23 Edition)
fever, pneumonia) associated with (iii) Limitations. Do not use in horses

Mannheimia haemolytica, Pasteurella intended for human consumption.
multocida, and Histophilus somni. Also, (8) Dogs—(i) Amount. 1.0 mg/lb (2.2 mg/
for the treatment of acute bovine kg) body weight by subcutaneous injec-
interdigital necrobacillosis (foot rot, tion. Treatment should be repeated at
pododermatitis) associated with 24-hour intervals for 5 to 14 days.
Fusobacterium necrophorum and (ii) Indications for use. For treatment
Bacteroides melaninogenicus. of canine urinary tract infections asso-
(iii) Limitations. Treated cattle must ciated with E. coli and Proteus mirabilis.
not be slaughtered for 4 days following
the last treatment. [53 FR 5369, Feb. 24, 1988, as amended at 55
(3) Sheep—(i) Amount. 0.5 to 1.0 mg/lb FR 13768, Apr. 12, 1990; 56 FR 12119, Mar. 22,
body weight by intramuscular injec- 1991; 57 FR 41862, Sept. 14, 1992; 59 FR 41666,
tion for 3 days. Additional treatments Aug. 15, 1994; 59 FR 54518, Nov. 1, 1994; 60 FR
51719, Oct. 3, 1995; 61 FR 35130, July 5, 1996; 61
may be given on days 4 and 5 for ani-
FR 66583, Dec. 18, 1996; 66 FR 21283, Apr. 30,
mals which do not show satisfactory 2001; 66 FR 32540, June 15, 2001; 69 FR 47362,
response. Aug. 5, 2004. Redesignated and amended at 71
(ii) Indications for use. For treatment FR 39544, July 13, 2006; 74 FR 34236, July 15,
of sheep respiratory disease (sheep 2009; 77 FR 29218, May 17, 2012; 79 FR 16185,
pneumonia) associated with Mar. 25, 2014; 79 FR 21127, Apr. 15, 2014; 82 FR
Mannheimia haemolytica and Pasteurella 12169, Mar. 1, 2017]
multocida.
(4) Goats—(i) Amount. 0.5 to 1.0 mg/lb § 522.380 Chloral hydrate, pento-
body weight by intramuscular injec- barbital, and magnesium sulfate.
tion for 3 days. Additional treatments (a) Specifications. Each milliliter of
may be given on days 4 and 5 for ani- solution contains 42.5 milligrams (mg)
mals which do not show satisfactory of chloral hydrate, 8.86 mg of pento-
response. barbital, and 21.2 mg of magnesium sul-
(ii) Indications for use. For treatment fate.
of caprine respiratory disease (goat (b) Sponsor. See No. 054771 in
pneumonia) associated with § 510.600(c) of this chapter.
Mannheimia haemolytica and Pasteurella (c) Conditions of use—(1) Amount. For
multocida.
general anesthesia: Administer 20 to 50
(5) Chickens—(i) Amount. 0.08 to 0.20
milliliters per 100 pounds of body
mg as a single subcutaneous injection
weight by intravenous injection until
in the neck.
the desired effect is produced. Cattle
(ii) Indications for use. For control of
usually require a lower dosage on the
early mortality associated with Esch-
erichia coli organisms susceptible to basis of body weight. As a sedative-re-
ceftiofur in day-old chicks. laxant: Administer at a level of one-
(6) Turkeys—(i) Amount. 0.17 to 0.5 mg fourth to one-half of the anesthetic
as a single subcutaneous injection in dosage level.
the neck. (2) Indications for use. For general an-
(ii) Indications for use. For control of esthesia and as a sedative-relaxant in
early mortality associated with E. coli cattle and horses.
organisms susceptible to ceftiofur in (3) Limitations. Federal law restricts
day-old poults. this drug to use by or on the order of a
(7) Horses—(i) Amount. 2.2 to 4.4 mg/kg licensed veterinarian.
(1.0 to 2.0 mg/lb) body weight by [79 FR 16185, Mar. 25, 2014]
intramuscular injection. Treatment
should be repeated every 24 hours, con- § 522.390 Chloramphenicol.
tinued for 48 hours after clinical signs
have disappeared, and should not ex- (a) Specifications. Each milliliter of
ceed 10 days. A maximum of 10 mL solution contains 100 milligrams of
should be administered per injection chloramphenicol.
site. (b) Sponsor. See Nos. 054771 and 069043
(ii) Indications for use. For treatment in § 510.600(c) of this chapter.
of respiratory infections in horses asso- (c) Conditions of use. Dogs—(1)

ciated with Streptococcus zooepidemicus. Amount. 5 to 15 milligrams per pound of
284
body weight, intramuscularly or intra- (3) No. 000061 for use of product de-
venously, every 6 hours. In severe in- scribed in paragraph (a)(2) as in para-
fections, use 4 to 6 hour treatment in- graphs (c)(1)(iv) and (c)(2) of this sec-
tervals the first day. If no response is tion.
obtained in 3 to 5 days, discontinue use (c) Conditions of use in cattle—(1)
and reevaluate diagnosis. Amount and indications for use. (i) Ad-
(2) Indications for use. Treatment of minister 375 μg by intramuscular injec-
infections of the respiratory tract, the tion to induce abortion in pregnant
urinary tract, and enteritis and tonsil- feedlot heifers from 1 week after mat-
litis caused by organisms susceptible ing until 41⁄2 months of gestation.
to chloramphenicol. (ii) Administer 500 μg by
(3) Limitations. Federal law restricts intramuscular injection for abortion of
this drug to use by or on the order of a unwanted pregnancies from
licensed veterinarian. Federal law pro- mismatings from 1 week after mating
hibits the extralabel use of this drug in until 5 months after conception; for
food-producing animals. unobserved (non-detected) estrus; for
treatment of mummified fetus, luteal
[57 FR 37331, Aug. 18, 1992, as amended at 65 cysts, and pyometra or chronic endo-
FR 45877, July 26, 2000; 78 FR 17597, Mar. 22,
metritis in beef cows, lactating dairy
2013; 79 FR 16185, Mar. 25, 2014; 81 FR 17608,
Mar. 30, 2016] cows, and replacement beef and dairy
heifers.
§ 522.454 Clodronate. (iii) Administer 500 μg by
intramuscular injection as a single in-
jection regimen or double injection
regimen with a second injection 11 days
clodronate disodium.
after the first, for estrus synchroni-
zation in beef cows, lactating dairy
cows, and replacement beef and dairy
heifers.
Amount. Administer 1.8 mg per kilo- (iv) For use with gonadorelin acetate
gram of body weight by intramuscular to synchronize estrous cycles to allow
injection up to a maximum dose of 900 for fixed time artificial insemination
mg per horse. (FTAI) in lactating dairy cows: Admin-
(2) Indications for use. For the control ister to each cow 86 μg gonadorelin by
of clinical signs associated with navic- intramuscular injection, followed 6 to 8
ular syndrome. days later by 500 μg cloprostenol by
(3) Limitations. Do not use in horses intramuscular injection, followed 30 to
intended for human consumption. Fed- 72 hours later by 86 μg gonadorelin by
eral law restricts this drug to use by or intramuscular injection.
on the order of a licensed veterinarian. (2) Limitations. Gonadorelin acetate
[79 FR 37620, July 2, 2014] for use in paragraph (c)(1)(iv) of this
section as provided by No. 000061 in
§ 522.460 Cloprostenol. § 510.600(c) of this chapter.
(a) Specifications. Each milliliter of [79 FR 16185, Mar. 25, 2014, as amended at 85
solution contains cloprostenol sodium FR 4208, Jan. 24, 2020]
equivalent to:
(1) 125 micrograms (μg) of § 522.468 Colistimethate sodium pow-
cloprostenol; or der for injection.
(2) 250 μg of cloprostenol. (a) Specifications. Each vial contains
(b) Sponsors. See sponsors in colistimethate sodium equivalent to 10
§ 510.600(c) of this chapter. grams colistin activity and mannitol
(1) No. 000061 for use of product de- to be reconstituted with 62.5 milliliters
scribed in paragraph (a)(1) of this sec- sterile saline or sterile water for injec-
tion as in paragraphs (c)(1)(i) and (c)(2) tion. The resulting solution contains
of this section. colistimethate sodium equivalent to
(2) Nos. 000061 and 068504 for use of 133 milligrams per milliliter colistin
product described in paragraph (a)(2) as activity.
in paragraphs (c)(1)(ii), (c)(1)(iii), and (b) Sponsor. See 054771 in § 510.600(c) of

(c)(2) of this section. this chapter.
285
§ 522.480 21 CFR Ch. I (4–1–23 Edition)
(c) Related tolerances. See § 556.167 of (ii) Indications for use. As a thera-
this chapter. peutic agent for primary bovine keto-
(d) Conditions of use. (1) 1- to 3-day- sis; and for stimulation of the adrenal
old chickens. cortex where there is a general defi-
(i) Dosage. 0.2 milligram colistin ac- ciency of ACTH.
tivity per chicken. (iii) Limitations. Federal law restricts
(ii) Indications for use. Control of this drug to use by or on the order of a
early mortality associated with Esch- licensed veterinarian.
erichia coli organisms susceptible to [79 FR 16185, Mar. 25, 2014, as amended at 84
colistin. FR 8973, Mar. 13, 2019; 85 FR 45308, July 28,
(iii) Limitations. For subcutaneous in- 2020]
jection in the neck of 1- to 3-day-old
chickens. Not for use in laying hens § 522.522 Danofloxacin.
producing eggs for human consump- (a) Specifications. Each milliliter of
tion. Do not use in turkeys. Federal solution contains 180 milligrams (mg)
law restricts this drug to use by or on danofloxacin as the mesylate salt.
the order of a licensed veterinarian. (b) Sponsor. See No. 054771 in
(2) [Reserved] § 510.600(c) of this chapter.
[63 FR 13123, Mar. 18, 1998, as amended at 79 this chapter.
FR 16185, Mar. 25, 2014; 84 FR 32992, July 11,
(d) Conditions of use in cattle—(1)
2019]
Amount and indications for use. Admin-
§ 522.480 Corticotropin. ister by subcutaneous injection either:
(i) 6 mg per kilogram (/kg) of body
(a) Specifications. Each milliliter of weight, repeated in 48 hours, for the
aqueous solution contains 40 or 80 treatment of bovine respiratory disease
U.S.P. (I.U.) units of repository (BRD) associated with Mannheimia
corticotropin. haemolytica and Pasteurella multocida;
(b) Sponsor. See sponsors in or
§ 510.600(c) of this chapter. (ii) 8 mg/kg of body weight as a single
(1) No. 061133 for use as in paragraphs dose for the treatment of BRD associ-
(c)(1) and (2) of this section. ated with M. haemolytica and P.
(2) No. 043264 for use as in paragraph multocida and for the control of BRD in
(c)(2) and (3) of this section. beef cattle at high risk of developing
(c) Conditions of use—(1) Dogs—(i) BRD associated with M. haemolytica
Amount. Administer one unit per pound and P. multocida.
of body weight by intramuscular injec- (2) Limitations. Animals intended for
tion. human consumption should not be
(ii) Indications for use. As a diagnostic slaughtered within 4 days from the last
aid to test for adrenal dysfunction. treatment. Do not use in cattle in-
(iii) Limitations. Federal law restricts tended for dairy production. A with-
this drug to use by or on the order of a drawal period has not been established
licensed veterinarian. for this product in pre-ruminating
(2) Dogs and cats—(i) Amount. Admin- calves. Do not use in calves to be proc-
ister one unit per pound of body weight essed for veal. Federal law restricts
by intramuscular or subcutaneous in- this drug to use by or on the order of a
jection, to be repeated as indicated. licensed veterinarian. Federal law pro-
(ii) Indications for use. For stimula- hibits the extra-label use of this drug
tion of the adrenal cortex where there in food-producing animals.
is a general deficiency of corticotropin [67 FR 78972, Dec. 27, 2002, as amended at 77
(ACTH). FR 4227, Jan. 27, 2012; 79 FR 16185, Mar. 25,
(iii) Limitations. Federal law restricts 2014; 79 FR 53136, Sept. 8, 2014]
licensed veterinarian. § 522.533 Deslorelin.
(3) Cattle—(i) Amount. Administer 200 (a) Specifications. (1) Each implant
to 600 units by intramuscular or sub- contains 2.1 milligrams (mg) deslorelin
cutaneous injection as an initial dose, acetate.
followed by a dose daily or every other (2) Each milliliter (mL) of suspension
day of 200 to 300 units. contains 1.8 mg deslorelin acetate.
286
(b) Sponsors. See sponsor numbers in every 25 days, intramuscularly. Usual

§ 510.600(c) of this chapter as follows: dose is 0.75 to 1.0 milligram per pound
(1) No. 051311 for use of product de- of body weight every 21 to 30 days.
scribed in paragraph (a)(1) as in para- (2) Indications for use—(i) For use as
graph (c)(1) of this section. replacement therapy for
(2) No. 043264 for use of product de- mineralocorticoid deficiency in dogs
scribed in paragraph (a)(2) as in para- with primary hypoadrenocorticism
graph (c)(2) of this section. (Addison’s Disease).
(c) Conditions of use—(1) Horses and (ii) For use as replacement therapy
ponies—(i) Amount. One implant per for the mineralocorticoid deficit in
mare subcutaneously in the neck. dogs with primary adrenocortical in-
(ii) Indications for use. For inducing sufficiency.
ovulation within 48 hours in estrous (3) Limitations. Federal law restricts
mares with an ovarian follicle greater this drug to use by or on the order of a
than 30 millimeters (mm) in diameter. licensed veterinarian.
or ponies intended for human consump- [81 FR 22524, Apr. 18, 2016]
use by or on the order of a licensed vet- § 522.536 Detomidine.
erinarian. (a) Specification. Each milliliter of so-
(2) Horses—(i) Amount. Administer 1.8 lution contains 10 milligrams of
mg (1 mL) by intramuscular injection detomidine hydrochloride.
in the neck. (b) Sponsor. See Nos. 015914 and 052483
(ii) Indications for use. For inducing in § 510.600(c) of this chapter.
ovulation within 48 hours in cyclic es- (c) Conditions of use in horses—(1)
trous mares with an ovarian follicle be- Amount. For sedation, analgesia, or se-
tween 30 and 40 mm in diameter. dation and analgesia: 20 or 40
(iii) Limitations. Do not use in horses micrograms per kilogram (0.2 or 0.4
intended for human consumption. Fed- milliliter per 100 kilogram or 220
eral law restricts this drug to use by or pounds) by body weight, depending on
on the order of a licensed veterinarian. depth and duration required. For seda-
[75 FR 81456, Dec. 28, 2010, as amended at 79 tion, administer by intraveneous (IV)
FR 18158, Apr. 1, 2014; 87 FR 17945, Mar. 29, or intramuscular (IM) injection; for an-
2022; 87 FR 58962, Sept. 29, 2022] algesia, administer by IV injection; for
both sedation and analgesia, admin-
§ 522.535 Desoxycorticosterone. ister by IV injection.
(a) Specifications. Each milliliter of (2) Indication for use. As a sedative
suspension contains 25 milligrams (mg) and analgesic to facilitate minor sur-
of desoxycorticosterone pivalate. gical and diagnostic procedures in ma-
(b) Sponsors. See sponsor numbers in ture horses and yearlings.
§ 510.600(c) of this chapter. (3) Limitations. Do not use in horses
(1) No. 043264 for use as in paragraphs intended for human consumption. Fed-
(c)(1)(i), (c)(2)(i), and (c)(3) of this sec- eral law restricts this drug to use by or
tion. on the order of a licensed veterinarian.
(2) No. 058198 for use as in paragraphs
(c)(1)(ii), (c)(2)(ii), and (c)(3) of this sec- [79 FR 16186, Mar. 25, 2014, as amended at 86
FR 13184, Mar. 8, 2021]
tion.
(c) Conditions of use—(1) Amount. (i) § 522.540 Dexamethasone solution.
Administer an initial dose of 2.2 mg/
kilogram (1 mg/lb) of body weight by (a)(1) Specifications. Each milliliter of
subcutaneous injection. Subsequent solution contains 2 milligrams (mg)
dosages should be individualized ac- dexamethasone.
cording to label instructions based on (2) Sponsors. See sponsors in
patient response to therapy. § 510.600(c) of this chapter:
(ii) Dosage requirements are variable (i) Nos. 000061, 016592, and 061133 for
and must be individualized on the basis use as in paragraph (a)(3) of this sec-
of the response of the patient to ther- tion.
apy. Initial dose of 1 milligram per (ii) Sponsors. See Nos. 054925 and
pound (0.45 kilogram) of body weight 058005 for use as in paragraphs
287
§ 522.540 21 CFR Ch. I (4–1–23 Edition)
(a)(3)(i)(C), (a)(3)(i)(D), (a)(3)(ii)(A), and (iii) Limitations. Do not use in horses

(a)(3)(iii) of this section. intended for human consumption. Fed-
(3) Conditions of use—(i) Amount. The eral law restricts this drug to use by or
drug is administered intravenously or on the order of a licensed veterinarian.
intramuscularly and dosage may be re- (d)(1) Specifications. Each milliliter of
peated if necessary, as follows: solution contains 2.0 mg of dexametha-
(A) Dogs. 0.25 to 1 mg. sone or 4.0 mg of dexamethasone so-
(B) Cats. 0.125 to 0.5 mg. dium phosphate (equivalent to 3.0 mg
(C) Horses. 2.5 to 5 mg. of dexamethasone).
(D) Cattle. 5 to 20 mg, depending on (2) Sponsors. See the following num-
the severity of the condition. bers in § 510.600(c) of this chapter:
(ii) Indications for use. The drug is in- (i) Nos. 016592 and 051031 for intra-
dicated: venous or intramuscular use of 2.0 mil-
(A) For the treatment of primary bo- ligrams dexamethasone injection.
vine ketosis and as an anti-inflam- (ii) No. 054771 for intravenous use of
matory agent in cattle and horses;
2.0 milligrams dexamethasone injec-
(B) As an anti-inflammatory agent in tion.
dogs and cats.
minister by intravenous or
eral law restricts this drug to use by or intramuscular injection as follows:
on the order of a licensed veterinarian. (A) Dogs: 0.25 to 1 mg.
(b)(1) Specifications. Each milliliter of (B) Cats: 0.125 to 0.5 mg.
solution contains 2.0 mg of dexametha- (C) Horses: 2.5 to 5 mg.
sone or 4.0 mg of dexamethasone so- (ii) Indications for use. For use in
dium phosphate (equivalent to 3.0 mg dogs, cats, and horses as an anti-in-
dexamethasone). flammatory agent.
(2) Sponsor. See No. 061133 in (iii) Limitations. Do not use in horses
§ 510.600(c) of this chapter. intended for human consumption. Fed-
(3) Conditions of use—(i) Amount. Ad- eral law restricts this drug to use by or
minister 0.25 to 1 mg by intravenous in- on the order of a licensed veterinarian.
jection, repeated for 3 to 5 days or until (e)(1) Specifications. Each milliliter of
a response is noted. solution contains 4.0 mg of dexametha-
(ii) Indications for use. For use in dogs sone sodium phosphate (equivalent to
for the treatment of inflammatory con- 3.0 mg dexamethasone).
ditions, as supportive therapy in ca- (2) Sponsor. See No. 069043 in
nine posterior paresis, as supportive § 510.600(c) of this chapter.
therapy before or after surgery to en-
hance recovery of poor surgical risks,
minister by intravenous injection as
and as supportive therapy in nonspe-
follows:
cific dermatosis.
(iii) Limitations. Federal law restricts (A) Dogs: 0.25 to 1 mg; may be re-
this drug to use by or on the order of a peated for 3 to 5 days.
licensed veterinarian. (B) Horses: 2.5 to 5 mg.
(c)(1) Specifications. Each milliliter of (ii) Indications for use. For use in dogs
solution contains 2.0 mg of dexametha- and horses for glucocorticoid and anti-
sone or 4.0 mg of dexamethasone so- inflammatory effect.
dium phosphate (equivalent to 3.0 mg (iii) Limitations. Do not use in horses
of dexamethasone). intended for human consumption. Fed-
(2) Sponsor. See No. 061133 in eral law restricts this drug to use by or
§ 510.600(c) of this chapter. on the order of a licensed veterinarian.
[41 FR 28265, July 9, 1976]
minister 2.5 to 5.0 mg by intravenous
injection. EDITORIAL NOTE: For FEDERAL REGISTER ci-
(ii) Indications for use. For use in tations affecting § 522.540, see the List of CFR
horses as a rapid adrenal Sections Affected, which appears in the
glucocorticoid and/or anti-inflam- Finding Aids section of the printed volume

and at www.govinfo.gov.
matory agent.
288
§ 522.542 Dexamethasone suspension. (ii) Indications for use. For use as a

(a) Specifications. Each milliliter of sedative and analgesic to facilitate
suspension contains 1 milligram (mg) clinical examinations, clinical proce-
of dexamethasone-21-isonicotinate. dures, minor surgical procedures, and
(b) Sponsor. No. 000010 in § 510.600(c) of minor dental procedures; and as a
this chapter. preanesthetic to general anesthesia.
(c) Conditions of use—(1) Amount. Ad- (iii) Limitations. Federal law restricts
minister by intramuscular injection as this drug to use by or on the order of a
follows: Dogs: 0.25 to 1 mg; cats: 0.125 to licensed veterinarian.
0.5 mg; horses: 5 to 20 mg. Dosage may [72 FR 263, Jan. 4, 2007, as amended at 72 FR
be repeated. 19797, Apr. 20, 2007; 72 FR 51365, Sept. 7, 2007;
(2) Indications for use. For the treat- 75 FR 60308, Sept. 30, 2010; 78 FR 25183, Apr.
ment of various inflammatory condi- 30, 2013; 78 FR 33699, June 5, 2013; 80 FR 13229,
tions associated with the musculo- Mar. 13, 2015; 86 FR 57997, Oct. 20, 2021; 87 FR
skeletal system in dogs, cats, and 10969, Feb. 28, 2022]
horses.
(3) Limitations. Do not use in horses § 522.563 Diatrizoate.
intended for human consumption. Fed- (a) Specifications. Each milliliter of
eral law restricts this drug to use by or solution contains 34.3 percent dia-
on the order of a licensed veterinarian. trizoate meglumine and 35 percent dia-
[79 FR 16186, Mar. 25, 2014] trizoate sodium, or 66 percent dia-
trizoate meglumine and 10 percent dia-
§ 522.558 Dexmedetomidine. trizoate sodium.
(a) Specifications. Each milliliter of (b) Sponsor. See No. 054771 in
solution contains: § 510.600(c) of this chapter.
(1) 0.1 milligrams (mg) (c) Conditions of use in dogs and cats—
dexmedetomidine hydrochloride; or (1) Amount. For excretion urography,
(2) 0.5 mg dexmedetomidine hydro- administer 0.5 to 1.0 milliliter (mL) per
chloride. pound of body weight to a maximum of
(b) Sponsors. See sponsors in in 30 mL intravenously. For cystography,
§ 510.600(c) of this chapter for use as in remove urine, administer 5 to 25 mL di-
paragraph (c) of this section: rectly into the bladder via catheter.
(1) Nos. 017033 and 059399 for use of For urethrography, administer 1.0 to 5
product described in paragraph (a)(2) of mL via catheter into the urethra to
this section. provide desired contrasts delineation.
(2) No. 052483 for use of products de- For angiocardiography (including
scribed in paragraph (a) of this section. aortography) rapidly inject 5 to 10 mL
(c) Conditions of use—(1) Dogs—(i) In- directly into the heart via catheter or
dications for use and amount. (A) For intraventricular puncture. For cerebral
use as a sedative and analgesic to fa- angiography, rapid injection of 3 to 10
cilitate clinical examinations, clinical mL via carotid artery. For peripheral
procedures, minor surgical procedures, arteriography and/or venography and
and minor dental procedures, admin- selective coronary arteriography, rap-
ister 375 micrograms (μg) per square idly inject 3 to 10 mL intravascularly
meter (/m2) of body surface area by in- into the vascular bed to be delineated.
travenous injection or 500 μg/m2 of body For lymphography, slowly inject 1.0 to
surface area by intramuscular injec- 10 mL directly into the lymph vessel to
tion. be delineated. For arthrography, slow-
(B) For use as a preanesthetic to gen- ly inject 1.0 to 5 mL directly into the
eral anesthesia, administer 125 μg/m2 of joint to be delineated. For discography,
body surface area or 375 μg/m2 of body slowly inject 0.5 to 1.0 mL directly into
surface area by intramuscular injec- the disc to be delineated. For sialog-
tion. raphy, slowly inject 0.5 to 1.0 mL into
(ii) Limitations. Federal law restricts the duct to be delineated. For delinea-
this drug to use by or on the order of a tion of fistulous tracts, slowly inject
licensed veterinarian. quantity necessary to fill the tract.
(2) Cats—(i) Amount. 40 μg/killogram For delineation of peritoneal hernias,

by intramuscular injection. inject 0.5 to 1.0 mL per pound of body
289
§ 522.650 21 CFR Ch. I (4–1–23 Edition)
weight directly into the peritoneal cav- (b) Sponsors. See sponsors in
ity. § 510.600(c) of this chapter as follows:
(2) Indications for use. For visualiza- (1) Nos. 054771 and 061133 for use of
tion in excretion urography, including product described in paragraph (a)(1) as
renal angiography, uretography, in paragraph (d) of this section.
cystography, and urethrography; (2) No. 054771 for use of product de-
aortography; angiocardiography, pe- scribed in paragraph (a)(2) as in para-
ripheral arteriography, and graph (d)(1) of this section.
venography; selective coronary arteri-
(c) Special considerations. Federal law
ography; cerebral angiography;
lymphography; arthrography; discog-
raphy; and sialography; and as an aid
in delineating peritoneal hernias and (d) Conditions of use—(1) Cattle. Ad-
fistulous tracts. minister products described in para-
(3) Limitations. Federal law restricts graph (a) of this section as follows:
this drug to use by or on the order of a (i) Amount. 25 mg as an
licensed veterinarian. intramuscular injection of the 5 mg/mL
product or as an intramuscular or sub-
[79 FR 16186, Mar. 25, 2014]
cutaneous injection of the 12.5 mg/mL
§ 522.650 Dihydrostreptomycin sulfate product.
injection. (ii) Indications for use. As a luteolytic
(a) Specifications. Each milliliter con- agent; effective only in those cattle
tains dihydrostreptomycin sulfate having a corpus luteum, i.e., those
equivalent to 500 milligrams of dihy- which ovulated at least 5 days prior to
drostreptomycin. treatment.
(b) Sponsor. See No. 054771 in (A) For estrus synchronization in
§ 510.600(c) of this chapter. beef cows, beef heifers and replacement
(c) Related tolerance. See § 556.200 of dairy heifers.
this chapter. (B) For unobserved (silent) estrus in
(d) Conditions of use—(1) Amount. Ad- lactating dairy cows with a corpus
minister 5 milligrams per pound of luteum.
body weight by deep intramuscular in- (C) For treatment of pyometra
jection every 12 hours, for 3 to 5 days or (chronic endometritis) in cattle.
until the urine is free of leptospira for (D) For abortion in beef cows, beef
at least 72 hours as measured by heifers and replacement dairy heifers.
darkfield microscopic examination.
(E) For use with gonadorelin injec-
tion as in § 522.1077 of this chapter to
leptospirosis in dogs and horses due to
synchronize estrous cycles to allow
Leptospira canicola, L.
fixed-time artificial insemination
icterohemorrhagiae, and L. pomona; in
cattle due to L. pomona; and in swine (FTAI) in lactating dairy cows.
due to L. pomona; and L. grippotyphosa. (F) For use with progesterone
(3) Limitations. Discontinue use 30 intravaginal inserts as in § 529.1940 of
days before slaughter for food. Not for this chapter for synchronization of
use in animals producing milk because estrus in lactating dairy cows.
use of the drug will contaminate the (G) For use with progesterone
milk. Federal law restricts this drug to intravaginal inserts as in § 529.1940 of
use by or on the order of a licensed vet- this chapter for synchronization of
erinarian. estrus in suckled beef cows and re-
placement beef and dairy heifers, ad-
[57 FR 37331, Aug. 18, 1992; 57 FR 42623, Sept.
15, 1992; 79 FR 16187, Mar. 25, 2014; 85 FR 18119, vancement of first postpartum estrus
Apr. 1, 2020] in suckled beef cows, and advancement
of first pubertal estrus in beef heifers.
§ 522.690 Dinoprost. (2) Horses. Administer product de-
(a) Specifications. Each milliliter scribed in paragraph (a)(1) of this sec-
(mL) of solution contains dinoprost tion as follows:
tromethamine equivalent to: (i) Amount. 1 mg per 100 pounds of
(1) 5 milligrams (mg) dinoprost; or body weight as a single intramuscular

(2) 12.5 mg dinoprost. injection.
290
(ii) Indications for use. (A) For con- (c) Conditions of use in horses—(1)
trolling the timing of estrus in estrous Amount. Administer 30 mg per kilo-
cycling mares. gram of body weight (13.6 mg per
(B) For difficult-to-breed mares pound) by intravenous injection, once
(clinically anestrous mares that have a or twice daily at a 12-hour interval for
corpus luteum). up to 3 days.
(iii) Limitations. Do not use in horses (2) Indications for use. For control of
intended for human consumption. pyrexia in horses.
(3) Swine. Administer product de- (3) Limitations. Do not use in horses
scribed in paragraph (a)(1) of this sec- intended for human consumption. Do
tion as follows: not use in any food-producing animals,
(i) Amount. 10 mg as a single including lactating dairy animals. Fed-
intramuscular injection.
(ii) Indications for use. For parturi-
tion induction in swine.
FR 14898, Mar. 10, 2023]
FR 16187, Mar. 25, 2014; 79 FR 44278, July 31,
2014; 79 FR 64116, Oct. 28, 2014; 80 FR 61296,
Oct. 13, 2015; 80 FR 76386, Dec. 9, 2015; 81 FR § 522.770 Doramectin.
36789, June 8, 2016; 84 FR 8973, Mar. 13, 2019; (a) Specifications. Each milliliter of
87 FR 17945, Mar. 29, 2022] solution contains 10 milligrams of
§ 522.723 Diprenorphine. doramectin.
(a) Specifications. Each milliliter of (c) of this chapter.
solution contains 2 milligrams of
diprenorphine hydrochloride.
this chapter.
(b) Sponsors. See No. 053923 in
§ 510.600(c) of this chapter. (d) Conditions of use—(1) Cattle—(i)
(c) Conditions of use—(1) Amount. It is Amount. 200 micrograms per kilogram
administered intramuscularly or intra- (10 milligrams per 110 pounds).
venously at a suitable dosage level de- (ii) Indications for use. For treatment
pending upon the species. and control of gastrointestinal
(2) Indications for use. The drug is roundworms, lungworms, eyeworms,
used for reversing the effects of grubs, sucking lice, and mange mites.
etorphine hydrochloride injection, vet- To control infections and to protect
erinary, the use of which is provided from reinfection with Cooperia
for in § 522.883, in wild and exotic ani- oncophora and Haemonchus placei for 14
mals. days, Ostertagia ostertagi for 21 days,
(3) Limitations. For use in wild or ex- and C. punctata, Oesophagostomum
otic animals only. Do not use in domes- radiatum, and Dictyocaulus viviparus for
tic food-producing animals. Do not use 28 days after treatment.
30 days before, or during, the hunting (iii) Limitations. Administer as a sin-
season in free-ranging wild animals gle subcutaneous or intramuscular in-
that might be used for food. Federal jection. Do not slaughter cattle within
law restricts this drug to use by or on 35 days of treatment. Not for use in fe-
the order of a licensed veterinarian. male dairy cattle 20 months of age or
Distribution is restricted to veterinar-
older. Do not use in calves to be proc-
ians engaged in zoo and exotic animal
essed for veal.
practice, wildlife management pro-
grams, and researchers. (2) Swine—(i) Amount. 300 micrograms
per kilogram (10 milligrams per 75
[79 FR 16187, Mar. 25, 2014] pounds).
§ 522.728 Dipyrone.
and control of gastrointestinal
(a) Specifications. Each milliliter of roundworms, lungworms, kidney
solution contains 500 milligrams (mg) worms, sucking lice, and mange mites.
dipyrone. (iii) Limitations. Administer as a sin-
(b) Sponsor. See No. 043264 in gle intramuscular injection. Do not

291
§ 522.772 21 CFR Ch. I (4–1–23 Edition)
slaughter swine within 24 days of treat- cows or heifers. Not for use in beef
ment. Consult your veterinarian for as- calves less than 2 months of age, dairy
sistance in the diagnosis, treatment, calves, and veal calves. A withdrawal
and control of parasitism. period has not been established for this
product in pre-ruminating calves.
FR 44410, Aug. 21, 1997; 62 FR 62242, Nov. 21, (2) [Reserved]
1997; 63 FR 68183, Dec. 10, 1998; 64 FR 13509,
[88 FR 14898, Mar. 10, 2023]
Mar. 19, 1999; 79 FR 16187, Mar. 25, 2014; 84 FR
32992, July 11, 2019]
§ 522.775 Doxapram.
§ 522.772 Doramectin and levamisole. (a) Specifications. Each milliliter of
(a) Specifications. Each milliliter of solution contains 20 milligrams (mg)
solution contains 5 milligrams (mg) of doxapram hydrochloride.
doramectin and 150 mg levamisole hy- (b) Sponsor. See No. 000010 in
drochloride. § 510.600(c) of this chapter.
(b) Sponsor. See No. 054771 in (c) Conditions of use—(1) Amount. For
§ 510.600(c) of this chapter. intravenous use in dogs and cats at a
(c) Related tolerances. See §§ 556.222 dose of 21⁄2 to 5 mg per pound (/lb) body
and 556.350 of this chapter. weight in barbiturate anesthesia, 0.5
(d) Conditions of use—(1) Cattle—(i) mg/lb in inhalation anesthesia; for in-
Amount. Inject subcutaneously in the travenous use in horses at 0.25 mg/lb
neck as a single dose at a dosage of 0.2 body weight in barbiturate anesthesia,
mg doramectin (0.91 mg/lb) and 6 mg of 0.2 mg/lb in inhalation anesthesia, 0.25
levamisole hydrochloride per kg (2.72 mg/lb with chloral hydrate with or
mg/lb) of body weight. without magnesium sulfate; for sub-
(ii) Indications for use. For treatment cutaneous, sublingual, or umbilical
and control of gastrointestinal vein administration in neonate puppies
roundworms (adults and fourth stage at a dose rate of 1 to 5 mg; for subcuta-
larvae): Ostertagia ostertagi (including neous or sublingual use in neonate kit-
inhibited larvae), O. lyrata, Haemonchus tens at 1 to 2 mg. Dosage may be re-
placei, Trichostrongylus axei, T. peated in 15 to 20 minutes if necessary.
colubriformis, T. longispicularis, Cooperia (2) Indications for use. Administer to
oncophora, C. pectinata, C. punctata, C. dogs, cats, and horses to stimulate res-
surnabada, Bunostomum phlebotomum piration during and after general anes-
(adults only), Strongyloides papillosus thesia; or to speed awakening and re-
(adults only), Oesophagostomum turn of reflexes after anesthesia. Ad-
radiatum, Trichuris spp. (adults only) minister to neonate dogs and cats to
and Nematodirus helvetianus (adults initiate respiration following dystocia
only); lungworms (adults and fourth or caesarean section; or to stimulate
stage larvae): Dictyocaulus viviparus; respiration following dystocia or cae-
eyeworms (adults): Thelazia spp.; grubs sarean section.
(parasitic stages): Hypoderma bovis and (3) Limitations. Federal law restricts
H. lineatum; sucking lice: Haematopinus this drug to use by or on the order of a
eurysternus, Linognathus vituli, and licensed veterinarian.
Solenopotes capillatus; mange mites:
Psoroptes bovis and Sarcoptes scabiei in [72 FR 261, Jan. 4, 2007, as amended at 75 FR
10167, Mar. 5, 2010; 77 FR 60302, Oct. 3, 2012]
beef cattle 2 months of age and older
and replacement dairy heifers less than § 522.784 Doxylamine.
20 months of age. Not for use in beef
bulls intended for breeding over 1 year (a) Specifications. Each milliliter con-
of age, dairy calves, and veal calves. tains 11.36 milligrams (mg) of
(iii) Limitations. Cattle must not be doxylamine succinate.
slaughtered for human consumption (b) Sponsor. See No. 000061 in
within 15 days following last treatment § 510.600(c) of this chapter.
with this drug product. Not for use in (c) Conditions of use—(1) Amount—(i)
female dairy cattle 20 months of age or Horses: Administer 25 mg per hundred
older, including dry dairy cows; use in pounds of body weight by
these cattle may cause drug residues in intramuscular, subcutaneous, or slow

milk and/or in calves born to these intravenous injection.
292
(ii) Dogs and cats: Administer 0.5 to 1 (2) Indications for use. As an analgesic
mg per pound of body weight by and tranquilizer and for general anes-
intramuscular or subcutaneous injec- thesia.
tion. Doses may be repeated at 8 to 12 (3) Limitations. Federal law restricts
hours, if necessary, to produce desired this drug to use by or on the order of a
effect. licensed veterinarian.
(2) Indications for use. For use in con- [79 FR 16187, Mar. 25, 2014]
ditions in which antihistaminic ther-
apy may be expected to alleviate some § 522.810 Embutramide, chloroquine,
signs of disease in horses, dogs, and and lidocaine solution.
cats. (a) Specifications. Each milliliter
(3) Limitations. Do not use in horses (mL) of solution contains 135 milli-
intended for human consumption. Fed- grams (mg) embutramide; 45 mg
eral law restricts this drug to use by or chloroquine phosphate, U.S.P.; and 1.9
on the order of a licensed veterinarian. mg lidocaine, U.S.P.
[79 FR 16187, Mar. 25, 2014] (b) Sponsor. See No. 069043 in
§ 522.800 Droperidol and fentanyl. (c) Conditions of use in dogs—(1)
Amount. One mL per 5 pounds of body
(a) Specifications. Each milliliter of weight.
solution contains 20 milligrams (mg) of (2) Indications for use. For euthanasia.
droperidol and 0.4 mg of fentanyl cit- (3) Limitations. Not for use in animals
rate. intended for food. Federal law restricts
(c) Conditions of use—(1) Amount. (i)
For analgesia and tranquilization, ad- [70 FR 36337, June 23, 2005, as amended at 78
FR 17597, Mar. 22, 2013; 81 FR 17608, Mar. 30,
minister as follows:
2016]
(A) 1 milliliter (mL) per 15 to 20
pounds (lbs) of body weight by § 522.812 Enrofloxacin.
intramuscular injection in conjunction
with atropine sulfate administered at
(mL) of solution contains:
the rate of 0.02 mg per pound of body (1) 22.7 milligrams (mg) enrofloxacin
weight; or or
(B) 1 mL per 25 to 60 lbs of body (2) 100 mg enrofloxacin.
weight by intravenous injection in con- (b) Sponsors. See sponsor numbers in
junction with atropine sulfate adminis- § 510.600(c) of this chapter:
tered at the rate of 0.02 mg per pound (1) Nos. 016729, 017033, 055529, 058198,
of body weight. and 086101 for use of product described
(ii) For general anesthesia, admin- in paragraph (a)(1) as in paragraph
ister as follows: (e)(1) of this section; and
(A) Administer 1 mL per 40 lbs of (2) Nos. 051311, 055529, 058005, 058198,
body weight by intramuscular injec- and 061133 for use of product described
tion in conjunction with atropine sul- in paragraph (a)(2) of this section as in
fate administered at the rate of 0.02 mg paragraphs (e)(2) and (3) of this section.
per pound of body weight and followed (c) Related tolerance. See § 556.226 of
in 10 minutes by an intravenous admin- this chapter.
istration of sodium pentobarbital at (d) Special considerations. Federal law
the rate of 3 mg per pound of body restricts this drug to use by or on the
weight; or order of a licensed veterinarian. Fed-
(B) Administer 1 mL per 25 to 60 lbs eral law prohibits the extra-label use of
of body weight by intravenous injec- this drug in food-producing animals.
tion in conjunction with atropine sul- (e) Conditions of use—(1) Dogs. Use the
fate administered at the rate of 0.02 mg product described in paragraph (a)(1) of
per pound of body weight and followed this section as follows:
within 15 seconds by an intravenous ad- (i) Amount. 2.5 mg per kilogram (/kg)
ministration of sodium pentobarbital of body weight (1.13 mg per pound) as a
at the rate of 3 mg per pound of body single, intramuscular, initial dose fol-
weight. lowed by use of tablets twice daily for
293
§ 522.814 21 CFR Ch. I (4–1–23 Edition)
2 to 3 days beyond cessation of clinical (i) Amounts and indications for use. (A)
signs to a maximum of 30 days. Administer 7.5 mg/kg of body weight
(ii) Indications for use. For the man- once, by intramuscular or subcuta-
agement of diseases associated with neous injection behind the ear, for the
bacteria susceptible to enrofloxacin. treatment and control of swine res-
(2) Cattle. Use the product described piratory disease (SRD) associated with
in paragraph (a)(2) of this section as Actinobacillus pleuropneumoniae,
follows: Pasteurella multocida, Haemophilus
(i) Amount—(A) Single-dose therapy: parasuis, Streptococcus suis, Bordetella
For treatment of bovine respiratory bronchiseptica, and Mycoplasma
hyopneumoniae.
disease (BRD), administer 7.5 to 12.5
(B) Administer 7.5 mg/kg of body
mg/kg of body weight (3.4 to 5.7 mL per
weight once, by intramuscular or sub-
100 pounds (/100 lb)) once by subcuta-
cutaneous injection behind the ear, for
neous injection. For control of BRD,
the control of colibacillosis in groups
administer 7.5 mg/kg of body weight or pens of weaned pigs where
(3.4 mL/100 lb) once by subcutaneous in- colibacillosis associated with Esch-
jection. erichia coli has been diagnosed.
(B) Multiple-day therapy: For treat- (ii) Limitations. Animals intended for
ment of BRD, administer 2.5 to 5.0 mg/ human consumption must not be
kg of body weight (1.1 to 2.3 mL/100 lb) slaughtered within 5 days of receiving
by subcutaneous injection. Treatment a single-injection dose.
should be repeated at 24-hour intervals
for 3 days. Additional treatments may
FR 17890, Apr. 2, 2008; 73 FR 21819, Apr. 23,
be given on days 4 and 5 to animals 2008; 76 FR 22611, Apr. 22, 2011; 77 FR 55415,
that have shown clinical improvement Sept. 10, 2012; 77 FR 76863, Dec. 31, 2012; 78 FR
but not total recovery. 19987, Apr. 3, 2013; 79 FR 37620, July 2, 2014; 80
(ii) Indications for use—(A) Single-dose FR 13229, Mar. 13, 2015; 80 FR 18776, Apr. 8,
therapy: For the treatment of BRD as- 2015; 80 FR 61296, Oct. 13, 2015; 84 FR 8973,
sociated with Mannheimia haemolytica, Mar. 13, 2019; 84 FR 53311, Oct. 7, 2019; 86 FR
14819, Mar. 19, 2021; 86 FR 61685, Nov. 8, 2021;
Pasteurella multocida, Histophilus somni, 87 FR 10969, Feb. 28, 2022; 87 FR 58962, Sept.
and Mycoplasma bovis in beef and non- 29, 2022]
lactating dairy cattle; for the control
of BRD in beef and non-lactating dairy § 522.814 Eprinomectin.
cattle at high risk of developing BRD (a) Specifications. Each milliliter of
associated with M. haemolytica, P. solution contains 50 milligrams (mg)
multocida, H. somni and M. bovis. eprinomectin.
(B) Multiple-day therapy: For the (b) Sponsor. See No. 000010 in
treatment of bovine respiratory disease § 510.600(c) of this chapter.
(BRD) associated with Mannheimia (c) Related tolerances. See §§ 500.1410
haemolytica, Pasteurella multocida, and and 556.227 of this chapter.
Histophilus somni in beef and non-lac- (d) Conditions of use in cattle on pas-
tating dairy cattle. ture—(1) Amount. Administer 1 mg/kilo-
(iii) Limitations. Animals intended for gram of body weight by subcutaneous
human consumption must not be injection.
slaughtered within 28 days from the (2) Indications for use. For the treat-
last treatment. This product is not ap- ment and control of the following in-
proved for female dairy cattle 20 ternal and external parasites: Gastro-
months of age or older, including dry intestinal roundworms (adults and
dairy cows. Use in these cattle may fourth-stage larvae) Bunostomum
cause drug residues in milk and/or in phlebotomum, Cooperia oncophora, C.
calves born to these cows. A with- punctata, C. surnabada, Trichostrongylus
drawal period has not been established axei, Ostertagia ostertagi (including in-
for this product in preruminating hibited stage); (adults) Haemonchus
calves. Do not use in calves to be proc- placei, Oesophagostomum radiatum, O.
essed for veal. lyrata, T. colubriformis; lungworms
(3) Swine. Use the product described (adults) Dictyocaulus viviparus; cattle
in paragraph (a)(2) of this section as grubs Hypoderma bovis; mites Sarcoptes

follows: scabiei var. bovis. Prevents reinfection
294
with C. oncophora, C. punctata, and T. (i) Amount. 3 to 5 mg/lb body weight,

axei for 100 days following treatment; intramuscularly, two to three times
H. placei, O. radiatum, O. lyrata, and O. daily, for up to 5 days.
ostertagi for 120 days following treat- (ii) Indications for use. For the treat-
ment; and B. phlebotomum and D. ment of bacterial pneumonia, upper
viviparus for 150 days following treat- respiratory infections (rhinitis, bron-
ment. chitis), secondary infections associated
(3) Limitations. Federal law restricts with panleukopenia, and bacterial
this drug to use by or on the order of a wound infections caused by Staphy-
licensed veterinarian. Animals in- lococcus spp. and Streptococcus spp., sus-
tended for human consumption must ceptible to erythromycin.
not be slaughtered within 48 days of (iii) Limitations. Federal law restricts
the last treatment. This drug product this drug to use by or on the order of a
is not approved for use in female dairy licensed veterinarian.
(3) Cattle. Administer products de-
cattle 20 months of age or older, in-
scribed in paragraph (a) of this section
cluding dry dairy cows. Use in these
as follows:
cattle may cause drug residues in milk
(i) Amount. 4 mg/lb body weight by
and/or in calves born to these cows. A
deep intramuscular injection once
withdrawal period has not been estab-
daily for up to 5 days.
lished for pre-ruminating calves. Do (ii) Indications for use. For the treat-
not use in calves to be processed for ment of bovine respiratory disease
veal. (shipping fever complex and bacterial
[76 FR 72618, Nov. 25, 2011, as amended at 79 pneumonia) associated with Pasteurella
FR 37620, July 2, 2014; 84 FR 39184, Aug. 9, multocida susceptible to erythromycin.
2019] (iii) Limitations. Do not use in female
dairy cattle over 20 months of age. Do
§ 522.820 Erythromycin. not slaughter treated animals within 6
(a) Specifications—(1) Each milliliter days of last treatment. A withdrawal
(mL) of solution contains 100 milli- period has not been established for this
grams (mg) erythromycin base. product in pre-ruminating calves. Do
(2) Each mL of solution contains 200 not use in calves to be processed for
mg erythromycin base. veal. To avoid excess trim, do not
slaughter within 21 days of last injec-
tion.
(c) Related tolerances. See § 556.230 of [72 FR 69142, Dec. 7, 2007, as amended at 79
this chapter. FR 16187, Mar. 25, 2014; 84 FR 8973, Mar. 13,
2019]
(d) Conditions of use—(1) Dog. Admin-
ister product described in paragraph § 522.840 Estradiol.
(a)(1) of this section as follows:
(a) Specifications. Each silicone rub-
(i) Amount. 3 to 5 mg per pound (/lb)
ber implant contains 25.7 or 43.9 milli-
body weight, intramuscularly, two to
grams (mg) estradiol and is coated with
three times daily, for up to 5 days.
not less than 0.5 mg oxytetracycline
(ii) Indications for use. For the treat- powder.
ment of bacterial pneumonia, upper (b) Sponsor. See No. 058198 in
respiratory infections (tonsillitis, § 510.600(c) of this chapter.
bronchitis, tracheitis, pharyngitis, (c) Related tolerances. See § 556.240 of
pleurisy), endometritis and metritis, this chapter.
and bacterial wound infections caused (d) Conditions of use. For implanta-
by Staphylococcus spp., Streptococcus tion in steers and heifers as follows:
spp., and Corynebacterium spp., sen- (1) Amounts and indications for use—(i)
sitive to erythromycin. 25.7-mg extended-release implant. Insert
(iii) Limitations. Federal law restricts one implant for increased rate of
this drug to use by or on the order of a weight gain for up to 200 days in beef
licensed veterinarian. steer calves 2 months of age and older;
(2) Cats. Administer product de- for increased rate of weight gain for up
scribed in paragraph (a)(1) of this sec- to 200 days in growing beef steers and
tion as follows: heifers on pasture (stocker, feeder, and
295
§ 522.850 21 CFR Ch. I (4–1–23 Edition)
slaughter); and for increased rate of (d) Conditions of use—(1) Amount. One
weight gain and improved feed effi- implant and 2 milliliters of injection at
ciency for up to 200 days in growing time of implantation.
beef steers and heifers fed in confine- (2) Indications for use. For synchroni-
ment for slaughter. zation of estrus/ovulation in cycling
(ii) 43.9-mg extended-release implant. beef cattle and non-lactating dairy
Insert one implant for increased rate of heifers.
weight gain for up to 400 days in beef (3) Limitations. Insert implant
steer calves 2 months of age and older; subcutaneously in the ear only; then
for increased rate of weight gain for up immediately inject solution
to 400 days in growing beef steers and intramuscularly only. Counting the
heifers on pasture (stocker, feeder, and day of implantation as day 1, remove
slaughter); and for increased rate of the implant on day 10. Collect all im-
weight gain and improved feed effi- plants as they are removed and burn
ciency for up to 400 days in growing them. While animals are restrained for
beef steers and heifers fed in confine- artificial insemination, avoid other
ment for slaughter.
treatments such as vaccinations, dip-
(2) Limitations. For subcutaneous ear ping, pour-on grub and louse preven-
implantation only. Not approved for re-
tion, spraying, etc. When inseminating
peated implantation (reimplantation)
without estrus detection, the entire
with this or any other cattle ear im-
treated group should be started at 48
plant within each separate production
hours after the last implant has been
phase (beef steer calves 2 months of age
and older, growing beef steers on pas- removed and should be completed with-
ture (stocker, feeder, and slaughter), in 6 hours. Where estrus detection is
growing beef steers and heifers fed in preferred, insemination should be ap-
confinement for slaughter). Safety and proximately 12 hours after first detec-
effectiveness following reimplantation tion of estrus. Those that do not con-
have not been evaluated. Do not use in ceive can be re-bred when they return
beef calves less than 2 months of age, to estrus approximately 17 to 25 days
dairy calves, and veal calves. A with- after implant removal. Do not use in
drawal period has not been established cows producing milk for human con-
for this product in pre-ruminating sumption.
calves. Do not use in dairy cows or in [47 FR 55477, Dec. 10, 1982, as amended at 48
animals intended for subsequent breed- FR 49656, Oct. 27, 1983; 51 FR 33592, Sept. 22,
ing. Use in these cattle may cause drug 1986; 54 FR 1165, Jan. 12, 1989; 84 FR 39184,
residues in milk and/or in calves born Aug. 9, 2019; 84 FR 32992, July 11, 2019]
to these cows.
§ 522.863 Ethylisobutrazine.
FR 31723, May 30, 2012; 81 FR 48702, July 26, (a) Specifications. Each milliliter of
2016; 87 FR 10969, Feb. 28, 2022; 88 FR 14898, solution contains 50 milligrams (mg) of
Mar. 10, 2023] ethylisobutrazine hydrochloride.
§ 522.850 Estradiol valerate and
norgestomet in combination. § 510.600(c) of this chapter.
(a) Specifications. The product is a Amount. Administer 2 to 5 mg per
two-component drug consisting of the pound of body weight by intramuscular
following:
injection for profound tranquilization.
(1) An implant containing 6.0 milli- Administer 1 to 2 mg per pound of body
grams of norgestomet. weight by intravenous injection to ef-
(2) An injectable solution (sesame fect.
oil) containing 3.0 milligrams of
(2) Indications for use. For use as a
norgestomet and 5.0 milligrams of es-
tranquilizer.
tradiol valerate per 2 milliliters.
(b) Sponsor. See 000010 in § 510.600(c) of
this chapter.

this chapter. [79 FR 16187, Mar. 25, 2014]
296
§ 522.870 Etodolac. in paragraph (e)(1) of this section; and

(a) Specifications. Each milliliter con- for use of product described in para-
tains 100 milligrams (mg) etodolac. graph (a)(2) as in paragraph (e)(2) of
(b) Sponsor. See No. 000010 in § 510.600 this section.
of this chapter. (c) Related tolerances. See § 556.277 of
Amount. Administer 4.5 to 6.8 mg/pound (d) Special considerations. Labeling
(10 to 15 mg/kilogram) body weight as a shall bear the following statements:
single, dorsoscapular subcutaneous in- Women of childbearing age,
jection. If needed, the daily dose of asthmatics, and persons with bronchial
etodolac tablets as in § 520.870 of this and other respiratory problems should
chapter may be given 24 hours after the exercise extreme caution when han-
injection. dling this product. It is readily ab-
(2) Indications for use. For the control sorbed through the skin and may cause
of pain and inflammation associated abortion and/or bronchiospasms. Acci-
with osteoarthritis. dental spillage on the skin should be
(3) Limitations. Federal law restricts washed off immediately with soap and
this drug to use by or on the order of a water.
licensed veterinarian. (e) Conditions of use—(1) Cattle—(i) In-
[72 FR 51365, Sept. 7, 2007, as amended at 75 dications for use and amount. (A) For
FR 10167, Mar. 5, 2010] feedlot heifers to induce abortion when
pregnant 150 days or less, administer 1
§ 522.883 Etorphine. mg (2 milliliter (mL)) subcutaneously.
(a) Specifications. Each milliliter of (B) For beef or nonlactating dairy
solution contains 1 milligram of cattle for estrus synchronization, ad-
etorphine hydrochloride. minister a single or two 1-mg (2-mL)
(b) Sponsor. See No. 053923 in doses subcutaneously, 11 to 13 days
§ 510.600(c) of this chapter. apart.
(c) Special considerations. Distribution (ii) Limitations. Federal law restricts
is restricted to veterinarians engaged this drug to use by or on the order of a
in zoo and exotic animal practice, wild- licensed veterinarian.
life management programs, and re- (2) Swine—(i) Amount. Administer a
searchers. single injection of 0.25 mg (1 mL)
(d) Conditions of use—(1) Amount. Ad- subcutaneously.
ministered intramuscularly by hand (ii) Indications for use. For the induc-
syringe or syringe dart at a suitable tion of parturition in sows and gilts
dosage level depending upon the spe- pregnant at least 112 days.
cies. (iii) Limitations. Federal law restricts
(2) Indications for use. For the immo- this drug to use by or on the order of a
bilization of wild and exotic animals. licensed veterinarian.
(3) Limitations. Do not use in domes-
tic food-producing animals. Do not use [79 FR 16188, Mar. 25, 2014]
30 days before, or during, the hunting
season in free-ranging wild animals § 522.930 Firocoxib.
that might be used for food. Federal (a) Specifications. Each milliliter of
law restricts this drug to use by or on solution contains 20 milligrams (mg)
the order of a licensed veterinarian. firocoxib.
[79 FR 16188, Mar. 25, 2014] (b) Sponsors. See No. 000010 in
§ 522.914 Fenprostalene. (c) Conditions of use in horses—(1)
(a) Specifications. (1) Each milliliter Amount. Administer 0.04 mg/pound (lb)
of solution contains 0.5 milligram (mg) (0.09 mg/kilogram (kg)) of body weight
fenprostalene. (BW) intravenously, once daily, for up
(2) Each milliliter of solution con- to 5 days. If further treatment is need-
tains 0.25 mg fenprostalene. ed, firocoxib oral paste can be adminis-
(b) Sponsor. See No. 054771 in tered at a dosage of 0.045 mg/lb (0.1 mg/
§ 510.600(c) of this chapter for use of kg) of BW for up to an additional 9

product described in paragraph (a)(1) as days of treatment.
297
§ 522.955 21 CFR Ch. I (4–1–23 Edition)
(2) Indications for use. For the control cause milk residues. A withdrawal pe-
of pain and inflammation associated riod has not been established in pre-ru-
with osteoarthritis. minating calves. Do not use in calves
(3) Limitations. Do not use in horses to be processed for veal. Federal law re-
intended for human consumption. Fed- stricts this drug to use by or on the
eral law restricts this drug to use by or order of a licensed veterinarian.
on the order of a licensed veterinarian. (ii) 300 mg/mL florfenicol in the inac-
[75 FR 59611, Sept. 28, 2010, as amended at 84 tive vehicles n-methyl-2- pyrrolidone,
FR 39184, Aug. 9, 2019] propylene glycol, and polyethylene gly-
col, or in 2-pyrrolidone and glycerol
§ 522.955 Florfenicol. formal:
(a) Specifications. Each milliliter of (A)(1) Amount. 20 mg/kg of body
solution contains: weight as an intramuscular injection.
(1) 300 milligrams (mg) florfenicol in A second dose should be administered
the inactive vehicles 2-pyrrolidone and 48 hours later. Alternatively, 40 mg/kg
triacetin. of body weight as a single subcuta-
(2) 300 mg florfenicol in the inactive neous injection may be used.
vehicles n-methyl-2-pyrrolidone, pro- (2) Indications for use. For treatment
pylene glycol, and polyethylene glycol. of BRD associated with Mannheimia
(3) 300 mg florfenicol in the inactive haemolytica, Pasteurella multocida, and
vehicles 2-pyrrolidone and glycerol for- Histophilus somni. For treatment of bo-
mal. vine interdigital phlegmon (foot rot,
(b) Sponsors. See sponsor numbers in acute interdigital necrobacillosis, in-
§ 510.600(c) of this chapter: fectious pododermatitis) associated
(1) No. 000061 for use of product de- with Fusobacterium necrophorum and
scribed in paragraph (a)(1) as in para- Bacteroides melaninogenicus.
graph (d)(1)(i); and (B)(1) Amount. 40 mg/kg of body
weight as a single subcutaneous injec-
tion.
tion as in paragraphs (d)(1)(ii) and
(3) Nos. 058005 and 058198 for use of respiratory disease in cattle at high
product described in paragraph (a)(2) of risk of developing BRD associated with
this section as in paragraph (d)(1)(ii) of Mannheimia haemolytica, Pasteurella
this section. multocida, and Histophilus somni.
(4) No. 055529 for use of product de- (C) Limitations. Animals intended for
scribed in paragraph (a)(3) as in para- human consumption must not be
graph (d)(1)(ii). slaughtered within 28 days of the last
(c) Related tolerances. See §§ 500.1410 intramuscular treatment. Nos. 000061,
and 556.283 of this chapter. 058005, and 058198: Animals intended for
(d) Conditions of use—(1) Beef and non- human consumption must not be
lactating dairy cattle. (i) 300 mg per mil- slaughtered within 38 days of subcuta-
liliter (mL) florfenicol in the inactive neous treatment. No. 055529: Animals
vehicles 2-pyrrolidone and triacetin: intended for human consumption must
(A) Amount. 40 mg/kilogram (kg) body not be slaughtered within 33 days of
weight as a single subcutaneous injec- subcutaneous treatment. This product
tion. is not approved for use in female dairy
(B) Indications for use. For treatment cattle 20 months of age or older, in-
of bovine respiratory disease (BRD) as- cluding dry dairy cows. Use in these
sociated with Mannheimia haemolytica, cattle may cause drug residues in milk
Pasteurella multocida, Histophilus somni, and/or in calves born to these cows. A
and Mycoplasma bovis in beef and non- withdrawal period has not been estab-
lactating dairy cattle. lished in pre-ruminating calves. Do not
(C) Limitations. Animals intended for use in calves to be processed for veal.
human consumption must not be Federal law restricts this drug to use
slaughtered within 44 days of treat- by or on the order of a licensed veteri-
ment. Do not use in female dairy cattle narian.
20 months of age or older. Use of (2) Swine. (i) 300 mg/mL florfenicol in
florfenicol in this class of cattle may the inactive vehicles n-methyl-2-
298
pyrrolidone, propylene glycol, and pol- months of age or older, including dry
yethylene glycol: dairy cows. Use in these cattle may
(A) Amount. 15 mg/kg of body weight cause drug residues in milk and/or in
as an intramuscular injection. A sec- calves born to these cows. A with-
ond dose should be administered 48 drawal period has not been established
hours later. in preruminating calves. Do not use in
(B) Indications for use. For the treat- calves to be processed for veal. Federal
ment of swine respiratory disease asso- law restricts this drug to use by or on
ciated with Actinobacillus the order of a licensed veterinarian.
pleuropneumoniae, Pasteurella multocida, [75 FR 1275, Jan. 11, 2010, as amended at 75
Salmonella Choleraesuis, Streptococcus FR 54018, Sept. 3, 2010; 79 FR 18158, Apr. 1,
suis, Bordetella bronchiseptica, and 2014]
Glaesserella (Haemophilus) parasuis in
swine except for nursing piglets and § 522.960 Flumethasone injectable dos-
swine of reproductive age intended for age forms.
breeding.
§ 522.960a Flumethasone suspension.
(C) Limitations. Swine intended for
human consumption must not be (a) Specifications. Each milliliter of
slaughtered within 11 days of the last suspension contains 2 milligrams (mg)
intramuscular treatment. Federal law of flumethasone.
restricts this drug to use by or on the (b) Sponsor. See No. 054771 in
order of a licensed veterinarian. § 510.600(c) of this chapter.
(ii) [Reserved] (c) Conditions of use in horses—(1)
Amount. Administer 6 to 10 mg by
[73 FR 21041, Apr. 18, 2008, as amended at 74 intra-articular injection. Dosage is
FR 66574, Dec. 16, 2009; 79 FR 18158, Apr. 1, limited to a single injection per week
2014; 79 FR 53136, Sept. 8, 2014; 80 FR 61296,
in any one synovial structure.
Oct. 13, 2015; 80 FR 76386, Dec. 9, 2015; 86 FR
14819, Mar. 19, 2021; 87 FR 10969, Feb. 28, 2022; (2) Indications for use. For use in the
87 FR 17945, Mar. 29, 2022; 87 FR 76421, Dec. 14, various disease states involving
2022] synovial structures (joints) of horses
where excessive synovial fluid of in-
§ 522.956 Florfenicol and flunixin. flammatory origin is present and where
(a) Specifications. Each milliliter permanent structural changes do not
(mL) of solution contains 300 milli- exist. Such conditions include arthri-
grams (mg) florfenicol and 16.5 mg tis, carpitis, and osselets.
flunixin (27.37 mg flunixin meglumine). (3) Limitations. Do not use in horses
§ 510.600(c) of this chapter for use as in eral law restricts this drug to use by or
paragraph (d) of this section. on the order of a licensed veterinarian.
(c) Tolerances. See §§ 556.283 and [79 FR 16188, Mar. 25, 2014]
556.286 of this chapter.
(d) Conditions for use in cattle—(1) § 522.960b Flumethasone acetate solu-
Amount. 40 mg florfenicol/kg body tion.
weight (BW) and 2.2 mg flunixin/kg BW (a) Specifications. Each milliliter of
(equivalent to 2 mL/15 kg BW or 6 mL/ solution contains 2 milligrams (mg) of
100 lbs) once, by subcutaneous injec- flumethasone acetate.
tion. (b) Sponsor. See No. 054771 in
(2) Indications for use. For treatment § 510.600(c) of this chapter.
of bovine respiratory disease (BRD) as- (c) Conditions of use in dogs—(1)
sociated with Mannheimia haemolytica, Amount. Administer by intramuscular
Pasteurella multocida, Histophilus somni, injection as follows: Dogs weighing up
and Mycoplasma bovis, and control of to 10 pounds (lbs): 2 mg; dogs weighing
BRD-associated pyrexia in beef and 10 to 25 lbs: 4 mg; dogs weighing over 25
non-lactating dairy cattle. lbs: 8 mg. Dosage should be adjusted
(3) Limitations. Animals intended for according to the weight of the animal,
human consumption must not be the severity of the symptoms, and the
slaughtered within 38 days of treat- response noted. Dosage by injection
ment. This drug product is not ap- should not exceed 3 days of therapy.
proved for use in female dairy cattle 20 With chronic conditions intramuscular
299
§ 522.960c 21 CFR Ch. I (4–1–23 Edition)
therapy may be followed by oral ad- control associated pruritus, irritation,

ministration of flumethasone tablets and inflammation; otitis externa in
at a daily dose of from 0.0625 to 0.25 mg conjunction with topical medication;
per animal. allergic states, e.g., hives, urticaria,
(2) Indications for use. For use in cer- and insect bites; and shock and shock-
tain acute and chronic canine like states by intravenous administra-
dermatoses of varying etiology to help tion.
control the pruritus, irritation, and in- (iii) Limitations. Federal law restricts
flammation associated with these con- this drug to use by or on the order of a
ditions. licensed veterinarian.
(3) Limitations. Federal law restricts (3) Cats—(i) Amount. Administer
this drug to use by or on the order of a 0.03125 to 0.125 mg daily by intravenous,
licensed veterinarian. intramuscular, or subcutaneous injec-
[79 FR 16188, Mar. 25, 2014] tion.
(ii) Indications for use. For use in the
§ 522.960c Flumethasone solution. treatment of certain acute and chronic
(a) Specifications. Each milliliter of dermatoses of varying etiology to help
solution contains 0.5 milligrams (mg) control associated pruritus, irritation,
of flumethasone. and inflammation.
(b) Sponsor. See No. 054771 in (iii) Limitations. Federal law restricts
(c) Conditions of use. It is used as fol- licensed veterinarian.
lows: [79 FR 16188, Mar. 25, 2014]
(1) Horses—(i) Amount. Administer
1.25 to 2.5 milligrams (mg) daily by in- § 522.970 Flunixin.
travenous, intramuscular, or intra-ar-
ticular injection. (a) Specifications. Each milliliter of
(ii) Indications for use. For use in the solution contains flunixin meglumine
treatment of musculoskeletal condi- equivalent to 50 milligrams (mg)
tions due to inflammation, where per- flunixin.
manent structural changes do not (b) Sponsors. See sponsors in
exist, e.g., bursitis, carpitis, osselets, § 510.600(c) of this chapter for use as in
and myositis; and allergic states, e.g., paragraph (e) of this section.
hives, urticaria, and insect bites. (1) See Nos. 000061, 055529, 058198, and
(iii) Limitations. Do not use in horses 061133 for use as in paragraph (e) of this
intended for human consumption. Fed- section.
eral law restricts this drug to use by or (2) See No. 054771 for use as in para-
on the order of a licensed veterinarian. graph (e)(1) of this section.
(2) Dogs—(i) Amount. Administer (3) See No. 016592 for use as in para-
0.0625 to 0.25 mg daily by intravenous, graphs (e)(1) and (e)(2) of this section.
intramuscular, or subcutaneous injec- (c) Related tolerances. See § 556.286 of
tion; 0.125 to 1.0 mg daily by intra- this chapter.
lesional injection, depending on the (d) Special considerations. Federal law
size and location of the lesion; or 0.166 restricts this drug to use by or on the
to 1.0 mg daily by intra-articular injec- order of a licensed veterinarian.
tion, depending on the severity of the (e) Conditions of use—(1) Horses—(i)
condition and the size of the involved Amount. 0.5 mg per pound (/lb) of body
joint. weight per day, intravenously or
(ii) Indications for use. For use in the intramuscularly, for up to 5 days.
treatment of musculoskeletal condi- (ii) Indications for use. For alleviation
tions due to inflammation of muscles of inflammation and pain associated
or joints and accessory structures with musculoskeletal disorders, and al-
where permanent structural changes do leviation of visceral pain associated
not exist, e.g., arthritis, osteoarthritis, with colic.
disc syndrome, and myositis (in septic (iii) Limitations. Do not use in horses
arthritis, appropriate antibacterial intended for human consumption.
therapy should be concurrently admin- (2) Cattle—(i) Amounts and indications
istered); certain acute and chronic for use—(A) Administer 1.1 to 2.2 mg/
dermatoses of varying etiology to help kilogram (kg) (0.5 to 1.0 mg/lb) of body
300
weight per day intravenously, as a sin- per kilogram of body weight by

gle dose or divided into two doses ad- intramuscular injection.
ministered at 12-hour intervals, for up (2) Indications for use. For use in
to 3 days for control of pyrexia associ- mares for its luteolytic effect to con-
ated with bovine respiratory disease trol the timing of estrus in estrous cy-
and endotoxemia or for control of in- cling and in clinically anestrous mares
flammation in endotoxemia. that have a corpus luteum.
(B) Administer 2.2 mg/kg (1.0 mg/lb) (3) Limitations. Do not use in horses
of body weight once intravenously for intended for human consumption. Fed-
control of pyrexia associated with eral law restricts this drug to use by or
acute bovine mastitis. on the order of a licensed veterinarian.
(ii) Limitations. Approved only for in- [79 FR 16189, Mar. 25, 2014, as amended at 86
travenous administration in cattle. FR 14820, Mar. 19, 2021]
Intramuscular administration has re-
sulted in violative residues in the edi- § 522.1002 Follicle stimulating hor-
ble tissues of cattle sent to slaughter. mone.
Cattle must not be slaughtered for (a)(1) Specifications. Each package
human consumption within 4 days of contains 2 vials. One vial contains dry,
last treatment. Milk that has been powdered, porcine pituitary gland
taken during treatment and for 36 equivalent to 75 units (NIH-FSH-S1) of
hours after the last treatment must follicle stimulating hormone. The
not be used for food. Do not use in dry other vial contains 10 milliliters of
dairy cows. A withdrawal period has aqueous diluent.
not been established for use in (2) Sponsor. See No. 052923 in
preruminating calves. Do not use in § 510.600(c) of this chapter.
calves to be processed for veal. (3) Conditions of use—(i) Dosage. 12.5
(B) [Reserved] units of follicle stimulating hormone
(3) Swine—(i) Amount. Administer 2.2 twice a day for 3 days (a total of 75
mg/kg (1.0 mg/lb) of body weight as a units). To effect regression of the cor-
single intramuscular injection. pus luteum, prostaglandin should be
(ii) Indications for use. For the control given with the 5th dose.
of pyrexia associated with swine res- (ii) Indications for use. For induction
piratory disease. of superovulation in cows for proce-
(iii) Limitations. Swine must not be dures requiring the production of mul-
slaughtered for human consumption tiple ova at a single estrus.
within 12 days of last treatment. (iii) Limitations. For intramuscular
use in cows that are not pregnant and
[42 FR 39103, Aug. 2, 1977, as amended at 52 have a normal corpus luteum. Federal
FR 7832, Mar. 13, 1987; 60 FR 54942, Oct. 27, law restricts this drug to use by or on
1995; 62 FR 22888, Apr. 28, 1997; 63 FR 38749, the order of a licensed veterinarian.
July 20, 1998; 67 FR 9400, Mar. 1, 2002; 68 FR
(b)(1) Specifications—(i) Single pack.
70701, Dec. 19, 2003; 69 FR 53618, Sept. 2, 2004;
69 FR 60308, Oct. 8, 2004; 70 FR 48868, Aug. 22, Each package contains 2 vials. One vial
2005; 70 FR 70998, Nov. 25, 2005; 71 FR 15564, contains 700 international units (IU)
Mar. 29, 2006; 71 FR 16222, Mar. 31, 2006; 73 FR porcine-pituitary-derived follicle stim-
2809, Jan. 16, 2008; 73 FR 28037, May 15, 2008; ulating hormone (FSH) equivalent to
74 FR 6994, Feb. 12, 2009; 74 FR 34236, July 15, 400 milligrams NIH–FSH–P1, as a dry
2009; 75 FR 13225, Mar. 19, 2010; 75 FR 76260, powder. The other vial contains 20 mil-
Dec. 8, 2010; 79 FR 16189, Mar. 25, 2014; 82 FR liliters (mL) of bacteriostatic sodium
43484, Sept. 18, 2017; 86 FR 57997, Oct. 20, 2021]
chloride injection. When constituted,
each milliliter of solution contains 35
§ 522.995 Fluprostenol.
IU FSH.
(a) Specifications. Each milliliter of (ii) Dual pack. Each package contains
solution contains fluprostenol sodium 2 vials. Each vial contains 700 inter-
equivalent to 50 micrograms (μg) of national units (IU) porcine-pituitary-
fluprostenol. derived FSH equivalent to 400 milli-
(b) Sponsor. See No. 058198 in grams NIH–FSH–P1, as a dry powder.
§ 510.600(c) of this chapter. Constitute with 20 mL bacteriostatic
(c) Conditions of use in horses—(1) sodium chloride injection, using strict

Amount. Administer 0.55 μg fluprostenol aseptic technique. When constituted,
301
§ 522.1008 21 CFR Ch. I (4–1–23 Edition)
each milliliter of solution contains 35 this section for use as in paragraph (d)
IU FSH. of this section.
(2) Sponsor. See No. 017030 in (1) No. 000010 as described in para-
§ 510.600(c) of this chapter. graph (a)(1) of this section for use as in
(3) Conditions of use—(i) Dosage. Ad- paragraphs (d)(1) and (d)(2)(ii) of this
minister 2.5 mL (87.5 IU) section.
intramuscularly, twice daily at 12-hour (2) No. 061133 as described in para-
intervals, for 4 consecutive days. In graph (a)(2) of this section for use as in
conjunction with the 6th dose, admin- paragraph (d)(2)(ii) of this section.
ister an approved prostaglandin prod- (3) No. 058198 as described in para-
uct for cattle (cloprostenol sodium or graph (a)(2) of this section for use as in
dinoprost tromethamine), using the la- paragraphs (d)(1), (d)(2)(i), and (d)(3) of
beled dosage and administration in- this section.
structions to cause luteolysis and in- (4) No. 000061 as described in para-
duce estrus. See § 522.460 for use of
graph (a)(2) for use as in paragraphs
cloprostenol sodium or § 522.690 for use
(d)(1), (d)(2)(iii), and (d)(3) of this sec-
of dinoprost tromethamine.
tion.
(ii) Indications for use. For the induc-
tion of superovulation in beef and dairy (c) Special considerations. Federal law
heifers and cows. restricts this drug to use by or on the
(iii) Limitations. Federal law restricts order of a licensed veterinarian.
this drug to use by or on the order of a (d) Conditions of use—(1) Dogs and
licensed veterinarian. cats—(i) Amount. 1.25 to 2.5 mg per
pound (/lb) body weight once or twice
[58 FR 47377, Sept. 9, 1993, as amended at 62 daily, intramuscularly or intra-
FR 62242, Nov. 21, 1997; 76 FR 2808, Jan. 18, venously.
2011; 79 FR 53136, Sept. 8, 2014; 79 FR 74020,
Dec. 15, 2014; 82 FR 21690, May 10, 2017; 82 FR (ii) Indications for use. For the treat-
43484, Sept. 18, 2017] ment of edema (pulmonary congestion,
ascites) associated with cardiac insuffi-
§ 522.1008 Frunevetmab. ciency and acute noninflammatory tis-
(a) Specifications. Each milliliter sue edema.
(mL) of solution contains 7 milligrams (2) Horses—(i) Amount. 250 to 500 mg
(mg) frunevetmab. per animal once or twice daily,
(b) Sponsor. See No. 054771 in intramuscularly or intravenously.
§ 510.600(c) of this chapter. (A) Indications for use. For the treat-
(c) Conditions of use—(1) Cats—(i) ment of edema (pulmonary congestion,
Amount. Administer once a month by ascites) associated with cardiac insuffi-
subcutaneous injection the full con- ciency, and acute noninflammatory tis-
tents of one or two 1-mL vials to sue edema.
achieve a minimum dosage of 0.45 mg/ (B) Limitations. Do not use in horses
lb (1 mg/kg) body weight. intended for human consumption.
(ii) Indications for use. For the control (ii) Amount. 0.5 mg/lb body weight
of pain associated with osteoarthritis once or twice daily, intramuscularly or
in cats. intravenously.
(iii) Limitations. Federal law restricts (A) Indications for use. For treatment
this drug to use by or on the order of a of acute noninflammatory tissue
licensed veterinarian. edema.
(2) [Reserved] (B) Limitations. Do not use in horses
[87 FR 58962, Sept. 29, 2022] intended for human consumption.
(iii) Amount. 250 to 500 mg/animal
§ 522.1010 Furosemide. once or twice daily, intramuscularly or
(a) Specifications. (1) Each milliliter intravenously.
(mL) of solution contains 50 milligrams (A) Indications for use. For the treat-
(mg) furosemide monoethanolamine. ment of edema (pulmonary congestion,
(2) Each mL of solution contains 50 ascites) associated with cardiac insuffi-
mg furosemide diethanolamine. ciency, and acute noninflammatory tis-
(b) Sponsors. See sponsors in sue edema.
§ 510.600(c) of this chapter for use of (B) Limitations. Do not use in horses
products described in paragraph (a) of intended for human consumption.
302
(3) Cattle—(i) Amount. 500 mg/animal law restricts this drug to use by or on
once daily, intramuscularly or intra- the order of a licensed veterinarian.
venously; or 250 mg/animal twice daily (2) [Reserved]
at 12-hour intervals, intramuscularly
or intravenously. [76 FR 57906, Sept. 19, 2011, as amended at 77
FR 26162, May 3, 2012; 84 FR 39184, Aug. 9,
(ii) Indications for use. For the treat- 2019]
ment of physiological parturient
edema of the mammary gland and asso- § 522.1020 Gelatin.
ciated structures.
(iii) Limitations. Treatment not to ex- (a) Specifications. Each 100 milliliters
ceed 48 hours post-parturition. Milk contains 8 grams of gelatin in a 0.85
taken during treatment and for 48 percent sodium chloride solution.
hours (four milkings) after the last (b) Sponsor. See No. 054771 in
treatment must not be used for food. § 510.600(c) of this chapter.
Cattle must not be slaughtered for food (c) Conditions of use—(1) Amount. The
within 48 hours following last treat- exact dosage to be administered must
ment. be determined after evaluating the ani-
mal’s condition and will vary according
to the size of the animal and the degree
FR 18086, Apr. 15, 2002; 68 FR 59881, Oct. 20,
2003; 69 FR 17585, Apr. 5, 2004; 71 FR 39548, of shock. A suggested dosage range for
July 13, 2006; 74 FR 61516, Nov. 25, 2009; 76 FR small animals such as dogs is 4 to 8
17338, Mar. 29, 2011; 78 FR 17597, Mar. 22, 2013; cubic centimeters per pound body
79 FR 16189, Mar. 25, 2014; 84 FR 8973, Mar. 13, weight. The suggested dosage range for
2019; 86 FR 14820, Mar. 19, 2021] large animals such as sheep, calves,
cows, or horses is 2 to 4 cubic centi-
§ 522.1014 Gamithromycin.
meters per pound of body weight.
(a) Specifications. Each milliliter (2) Indications for use. For use to re-
(mL) of solution contains 150 milli- store circulatory volume and maintain
grams (mg) gamithromycin. blood pressure in animals being treated
(b) Sponsor. See No. 000010 in for shock.
(c) Related tolerances. See § 556.292 of this drug to use by or on the order of a
this chapter. licensed veterinarian.
(d) Conditions of use—(1) Cattle—(i)
Amount. Administer 6 mg/kilogram of [79 FR 16189, Mar. 25, 2014]
body weight (2 mL per 110 pounds) one
time by subcutaneous injection in the § 522.1044 Gentamicin.
neck. (a) Specifications. Each milliliter of
(ii) Indications for use. For the treat- solution contains gentamicin sulfate
ment of bovine respiratory disease equivalent to 5, 50, or 100 milligrams
(BRD) associated with Mannheimia (mg) gentamicin.
haemolytica, Pasteurella multocida, (b) Sponsors. See sponsors in
Histophilus somni, and Mycoplasma bovis § 510.600(c) of this chapter for use as in
in beef and non-lactating dairy cattle; paragraph (d) of this section.
and for the control of respiratory dis- (1) No. 000061 for use of 5 mg per mil-
ease in beef and non-lactating dairy liliter (/mL) solution in swine as in
cattle at high risk of developing BRD paragraph (d)(4), 50 mg/mL solution in
associated with M. haemolytica and P.
dogs and cats as in paragraph (d)(1), 50
multocida.
mg/mL and 100 mg/mL solution in
(iii) Limitations. Cattle intended for
chickens and turkeys as in paragraphs
human consumption must not be
(d)(2) and (d)(3) of this section.
slaughtered within 35 days from the
last treatment. Do not use in female (2) No. 058005 for use of 5 mg/mL solu-
dairy cattle 20 months of age or older. tion in swine as in paragraph (d)(4) of
A withdrawal period has not been es- this section.
tablished for this product in (3) No. 069043 for use of 50 mg/mL so-
preruminating calves. Do not use in lution in dogs as in paragraph (d)(5) of

calves to be processed for veal. Federal this section.
303
§ 522.1055 21 CFR Ch. I (4–1–23 Edition)
(4) Nos. 016592 and 061133 for use of 100 caused by Escherichia coli, Salmonella
mg/mL solution in turkeys as in para- typhimurium, and Pseudomonas
graph (d)(2) and in chickens as in para- aeruginosa susceptible to gentamicin.
graph (d)(3) of this section. (iii) Limitations. Injected chicks must
(c) Related tolerances. See § 556.300 of not be slaughtered for food for at least
this chapter. 5 weeks after treatment. Federal law
(d) Conditions of use—(1) Dogs and restricts this drug to use by or on the
cats—(i) Amount. Two milligrams of order of a licensed veterinarian.
gentamicin per pound of body weight, (4) Swine—(i) Amount. Administer 5
twice daily on the first day, once daily mg of gentamicin as a single
thereafter, using a 50 milligram-per- intramuscular dose using the 5 mg/mL
milliliter solution. solution.
(ii) Indications for use—(a) Dogs. For (ii) Indications for use. For treatment
the treatment of infections of urinary of porcine colibacillosis in piglets up to
tract (cystitis, nephritis), respiratory 3 days old caused by strains of Esch-
tract (tonsillitis, pneumonia, erichia coli sensitive to gentamicin.
tracheobronchitis), skin and soft tissue (iii) Limitations. For single
(pyodermatitis, wounds, lacerations, intramuscular dose in pigs up to 3 days
peritonitis). of age only. Do not slaughter treated
(b) Cats. For the treatment of infec- animals for food for at least 40 days fol-
tions of urinary tract (cystitis, nephri- lowing treatment. Federal law restricts
tis), respiratory tract (pneumonitis, this drug to use by or on the order of a
pneumonia, upper respiratory tract in- licensed veterinarian.
fections), skin and soft tissue (wounds, (5) Dogs—(i) Amount. 2 milligrams of
lacerations, peritonitis), and as sup- gentamicin per pound of body weight,
portive therapy for secondary bacterial twice daily on the first day, then once
infections associated with daily.
panleucopenia. (ii) Indications for use. For use in the
(iii) Limitations. Administer treatment of urinary tract infections
intramuscularly or subcutaneously. If (cystitis) caused by Proteus mirabilis,
response is not noted after 7 days, the Escherichia coli, and Staphylococcus
antibiotic sensitivity of the infecting aureus.
organism should be retested. Federal (iii) Limitations. Administer
law restricts this drug to use by or on intramuscularly or subcutaneously. If
the order of a licensed veterinarian. no improvement is seen after 3 days,
(2) Turkeys—(i) Amount. Administer treatment should be discontinued and
subcutaneously in the neck 1 mg of the diagnosis reevaluated. Treatment
gentamicin per 0.2 mL dose, using the not to exceed 7 days. Federal law re-
50- or 100-mg/mL product diluted with stricts this drug to use by or on the
sterile saline to a concentration of 5 order of a licensed veterinarian.
mg/mL. [43 FR 1942, Jan. 13, 1978, as amended at 48
(ii) Indications for use. As an aid in FR 791, Jan. 7, 1983; 51 FR 15606, Apr. 25, 1986;
the prevention of early mortality in 1- 52 FR 7832, Mar. 13, 1987; 53 FR 40727, Oct. 18,
to 3-day old turkey poults due to Ari- 1988; 60 FR 29985, June 7, 1995; 61 FR 24441,
zona paracolon infections susceptible to May 15, 1996; 62 FR 45157, Aug. 26, 1997; 63 FR
59714, Nov. 5, 1998; 63 FR 68182, Dec. 10, 1998;
gentamicin.
65 FR 45877, July 26, 2000; 71 FR 76901, Dec. 22,
(iii) Limitations. Injected poults must 2006; 78 FR 17597, Mar. 22, 2013; 78 FR 21060,
not be slaughtered for food for at least Apr. 9, 2013; 79 FR 21127, Apr. 15, 2014; 81 FR
9 weeks after treatment. Federal law 22524, Apr. 18, 2016; 83 FR 48946, Sept. 28, 2018;
restricts this drug to use by or on the 84 FR 8973, Mar. 13, 2019; 88 FR 16547, Mar. 20,
order of a licensed veterinarian. 2023]
(3) Chickens—(i) Amount. Administer
subcutaneously in the neck 0.2 mg of § 522.1055 Gleptoferron.
gentamicin per 0.2 mL dose, using the (a) Specifications. Each milliliter
50- or 100-mg/mL product diluted with (mL) contains the equivalent of 200
sterile saline to a concentration of 1.0 milligrams of elemental iron as
mg/mL. gleptoferron, a complex of ferric hy-
(ii) Indications for use. For prevention droxide and dextran glucoheptonic
of early mortality in day-old chickens acid.
304
(b) Sponsors. See No. 013744 in (2) No. 068504 for use of the 100-μg/mL
§ 510.600(c) of this chapter. product described in paragraph (a)(2) as
(c) Conditions of use in swine—(1) Indi- in paragraph (e)(1)(iv) of this section.
cations for use and amounts. (i) Preven- (3) Nos. 000010 and 061133 for use of
tion of anemia due to iron deficiency: the 50-μg/mL product described in para-
Administer 1 mL (200 mg iron) per pig graph (a)(3) of this section as in para-
by intramuscular injection on or before graphs (e)(1)(i) and (v) of this section.
3 days of age. (4) No. 054771 for use of the 50-μg/mL
(ii) Treatment of anemia due to iron product described in paragraph (a)(4) as
deficiency: Administer 1 mL (200 mg in paragraphs (e)(1)(ii) and (vi) of this
iron) per pig by intramuscular injec- section.
tion as soon as signs of deficiency ap- (c) Related tolerances. See § 556.304 of
pear. this chapter.
(2) [Reserved] (d) Special considerations. (1) Concur-
rent luteolytic drug use is approved as
FR 11508, Feb. 24, 2017; 82 FR 21690, May 10,
follows:
2017] (i) Cloprostenol injection for use as
in paragraph (e)(1)(iii) of this section
§ 522.1066 Glycopyrrolate. as provided by No. 000061 in § 510.600(c)
of this chapter.
(ii) Cloprostenol injection for use as
solution contains 0.2 milligram
in paragraph (e)(1)(iv) of this section as
glycopyrrolate.
provided by No. 068504 in § 510.600(c) of
this chapter.
(iii) Cloprostenol injection for use as
in paragraph (e)(1)(v) of this section as
(1) Amount. 5 micrograms per pound of
provided by Nos. 000010 in § 510.600(c) of
body weight (0.25 milliliter per 10
this chapter.
pounds of body weight) by intravenous,
(iv) Dinoprost injection for use as in
intramuscular, or subcutaneous injec-
paragraph (e)(1)(vi) of this section as
tion in dogs or by intramuscular injec-
provided by Nos. 054771 and 061133 in
tion in cats.
(2) Indications for use. As a
preanesthetic agent.
(3) Limitations. Federal law restricts erinarian.
this drug to use by or on the order of a (e) Conditions of use in cattle—(1) Indi-
licensed veterinarian. cations for use and amounts. (i) For the
[71 FR 64451, Nov. 2, 2006, as amended at 78 treatment of ovarian follicular cysts in
FR 17597, Mar. 22, 2013; 79 FR 16189, Mar. 25, dairy cattle: Administer 86 μg
2014; 81 FR 17608, Mar. 30, 2016] gonadorelin (No. 000061) or 100 μg
gonadorelin diacetate tetrahydrate
§ 522.1077 Gonadorelin. (Nos. 000010 and 061133) by
(a) Specifications. Each milliliter intramuscular or intravenous injec-
(mL) of solution contains: tion.
(1) 43 micrograms (μg) of gonadorelin (ii) For the treatment of ovarian fol-
as gonadorelin acetate; licular cysts in cattle: Administer 100
(2) 100 μg of gonadorelin as μg gonadorelin hydrochloride by
gonadorelin acetate; intramuscular injection.
(3) 50 μg of gonadorelin as (iii) For use with cloprostenol sodium
gonadorelin diacetate tetrahydrate to synchronize estrous cycles to allow
(equivalent to 43 μg gonadorelin); or for fixed-time artificial insemination
(4) 50 μg of gonadorelin as (FTAI) in beef cows and lactating dairy
gonadorelin hydrochloride. cows: Administer to each cow 86 μg
(b) Sponsors. See sponsor numbers in gonadorelin by intramuscular injec-
§ 510.600(c) of this chapter. tion, followed 6 to 8 days later by 500 μg
(1) No. 000061 for use of the 43-μg/mL cloprostenol by intramuscular injec-
product described in paragraph (a)(1) as tion, followed 30 to 72 hours later by 86
in paragraphs (e)(1)(i) and (iii) of this μg gonadorelin by intramuscular injec-

section. tion.
305
§ 522.1079 21 CFR Ch. I (4–1–23 Edition)
(iv) For use with cloprostenol sodium (2) Indications for use—(i) Gilts. For
to synchronize estrous cycles to allow induction of fertile estrus (heat) in
for fixed-time artificial insemination healthy prepuberal (noncycling) gilts.
(FTAI) in lactating dairy cows and beef (ii) Sows. For induction of estrus in
cows: Administer to each cow 100 μg healthy weaned sows experiencing de-
gonadorelin by intramuscular injec- layed return to estrus.
tion, followed 6 to 8 days later by 500 μg (3) Limitations. For subcutaneous use
cloprostenol by intramuscular injec- only.
tion, followed 30 to 72 hours later by 100 (i) Gilts. For use only in gilts over 51⁄2
μg gonadorelin by intramuscular injec- months of age and weighing at least 85
tion. kilograms (187 pounds).
(ii) Sows. Delayed return to estrus is
(v) For use with cloprostenol sodium
most prevalent after the first litter.
to synchronize estrous cycles to allow
The effectiveness has not been estab-
for fixed-time artificial insemination lished after later litters. Delayed re-
(FTAI) in lactating dairy cows and beef turn to estrus often occurs during peri-
cows: Administer to each cow 100 μg ods of adverse environmental condi-
gonadorelin diacetate tetrahydrate by tions, and sows mated under such con-
intramuscular injection, followed 6 to 8 ditions may farrow smaller than nor-
days later by 500 μg cloprostenol by mal litters.
intramuscular injection, followed 30 to
72 hours later by 100 μg gonadorelin di- [55 FR 1405, Jan. 16, 1990, as amended at 58
FR 52222, Oct. 7, 1993; 74 FR 61516, Nov. 25,
acetate tetrahydrate by intramuscular 2009; 84 FR 32992, July 11, 2019]
injection.
(vi) For use with dinoprost injection § 522.1081 Chorionic gonadotropin.
to synchronize estrous cycles to allow (a) Specifications. Each vial contains
fixed-time artificial insemination 5,000, 10,000 or 20,000 USP units of
(FTAI) in lactating dairy cows: Admin- lyophilized powder for constitution
ister to each cow 100 to 200 μg with accompanying diluent to a 10-mil-
gonadorelin by intramuscular injec- liliter solution.
tion, followed 6 to 8 days later by 25 mg (b) Sponsors. See sponsors in
dinoprost by intramuscular injection, § 510.600(c) of this chapter for use as in
followed 30 to 72 hours later by 100 to paragraph (d) of this section.
200 μg gonadorelin by intramuscular in- (1) No. 054771 for use as in paragraphs
jection. (d)(1)(i)(A), (d)(1)(i)(B) and (d)(1)(i)(C) of
(2) [Reserved] this section.
(2) [Reserved]
FR 8973, Mar. 13, 2019; 84 FR 39184, Aug. 9,
2019; 84 FR 32992, July 11, 2019; 86 FR 13184,
(d)(1)(i)(A) and (d)(2) of this section.
Mar. 8, 2021; 86 FR 14820, Mar. 19, 2021; 87 FR (c) Related tolerances. See § 556.304 of
(d) Conditions of use—(1) Cattle—(i)
§ 522.1079 Serum gonadotropin and Amount. As a single dose. Dosage may
chorionic gonadotropin. be repeated in 14 days if the animal’s
behavior or examination of the ovaries
(a) Specifications. Each dose consists
per rectum indicates retreatment.
of 400 international units (I.U.) serum
(A) 10,000 USP units by
gonadotropin and 200 I.U. chorionic
intramuscular injection.
gonadotropin as a freeze-dried powder
(B) 500 to 2,500 USP units by
to be reconstituted with 5 milliliters of intrafollicular injection.
sterile aqueous diluent. (C) 2,500 to 5,000 USP units by intra-
(b) Sponsor. See No. 000061 in venous injection.
§ 510.600(c) of this chapter. (ii) Indications for use. For parenteral
(c) Related tolerances. See § 556.304 of use in cows for treatment of nympho-
this chapter. mania (frequent or constant heat) due
(d) Conditions of use in swine—(1) to cystic ovaries.
Amount. 400 I.U. serum gonadotropin (iii) Limitations. Federal law restricts
with 200 I.U. chorionic gonadotropin this drug to use by or on the order of a
per 5 milliliters dose per animal. licensed veterinarian.
306
(2) Finfish—(i) Amount. 50 to 510 IU drug in sterile water for injection to

per pound of body weight for males, 67 make a solution containing 50 milli-
to 1,816 IU per pound of body weight for grams of guaifenesin per milliliter of
females, by intramuscular injection. solution.
Up to three doses may be administered. (b) Sponsors. See Nos. 037990 and
(ii) Indications for use. An aid in im- 054771 in § 510.600(c) of this chapter.
proving spawning function in male and (c) Conditions of use in horses—(1)
female brood finfish. Amount. Administer 1 milliliter of pre-
(iii) Limitations. In fish intended for pared solution per pound of body
human consumption, the total dose ad- weight by rapid intravenous infusion.
ministered per fish (all injections com- (2) Indications for use. For use as a
bined) should not exceed 25,000 IU muscle relaxant.
chorionic gonadotropin. Federal law re- (3) Limitations. Do not use in horses
stricts this drug to use by or on the intended for human consumption. Fed-
order of a licensed veterinarian. eral law restricts this drug to use by or
[74 FR 61516, Nov. 25, 2009, as amended at 76 on the order of a licensed veterinarian.
FR 17778, Mar. 31, 2011; 77 FR 55414, Sept. 10, [79 FR 16189, Mar. 25, 2014]
2012; 79 FR 16189, Mar. 25, 2014; 83 FR 13635,
Mar. 30, 2018] § 522.1086 Guaifenesin solution.
§ 522.1083 Gonadotropin releasing fac- (a) Specifications. Each milliliter of
tor analog-diphtheria toxoid con- solution contains 50 milligrams (mg) of
jugate. guaifenesin and 50 mg of dextrose.
(a) Specifications. Each milliliter (b) Sponsors. See Nos. 037990 and
(mL) of solution contains 0.2 milli- 058198 in § 510.600(c) of this chapter.
grams (mg) gonadotropin releasing fac- (c) Conditions of use in horses—(1)
tor analog-diphtheria toxoid conjugate. Amount. Administer 1 milliliter per
(b) Sponsor. See No. 054771 in pound of body weight by rapid intra-
§ 510.600(c) of this chapter. venous infusion.
(c) Conditions of use in swine—(1) (2) Indications for use. For use as a
Amount. Each intact male pig or gilt skeletal muscle relaxant.
should receive two 2-mL (0.4 mg) doses (3) Limitations. Do not use in horses
by subcutaneous injection. Administer intended for human consumption. Fed-
the first dose no earlier than 9 weeks of eral law restricts this drug to use by or
age. Administer the second dose at on the order of a licensed veterinarian.
least 4 weeks after the first dose. [79 FR 16189, Mar. 25, 2014, as amended at 86
(2) Indications for use—(i) Intact male FR 14820, Mar. 19, 2021]
pigs intended for slaughter: For the tem-
porary immunological castration (sup- § 522.1125 Hemoglobin glutamer-200
pression of testicular function) and re- (bovine).
duction of boar taint. (a) Specifications. Each 125 milliliter
(ii) Gilts intended for slaughter: For bag contains 13 grams per deciliter of
the temporary suppression of estrus. polymerized hemoglobin of bovine ori-
(3) Limitations. Federal law restricts gin in modified Lactated Ringer’s Solu-
this drug to use by or on the order of a tion. It is a sterile, clear, dark purple
licensed veterinarian. For reduction of solution.
boar taint, intact male pigs should be (b) Sponsor. See No. 063075 in
slaughtered no earlier than 3 weeks § 510.600(c) of this chapter.
and no later than 10 weeks after the (c) [Reserved]
second dose. (d) Conditions of use—(1) Amount. One-
[76 FR 27889, May 13, 2011, as amended at 77 time dose of 10 to 30 milliliters per
FR 4227, Jan. 27, 2012; 79 FR 16189, Mar. 25, kilogram of body weight administered
2014; 85 FR 45308, July 28, 2020] intravenously at a rate of up to 10 mil-
liliters per kilogram per hour.
§ 522.1085 Guaifenesin powder for in- (2) Indications for use. For the treat-
jection. ment of anemia in dogs by increasing
(a) Specifications. The product is a systemic oxygen content (plasma he-
sterile powder containing guaifenesin. moglobin concentration) and improv-

A solution is prepared by dissolving the ing the clinical signs associated with
307
§ 522.1145 21 CFR Ch. I (4–1–23 Edition)
anemia, regardless of the cause of ane- (ii) Indications for use. For the intra-
mia (hemolysis, blood loss, or ineffec- articular treatment of carpal or fet-
tive erythropoiesis). lock joint dysfunction in horses due to
(3) Limitations. Federal law restricts acute or chronic, non-infectious syno-
this drug to use by or on the order of a vitis associated with equine osteo-
licensed veterinarian. arthritis.
[63 FR 11598, Mar. 10, 1998, as amended at 65 (iii) Limitations. Do not use in horses
FR 20732, Apr. 18, 2000; 79 FR 16189, Mar. 25, intended for human consumption. Fed-
2014] eral law restricts this drug to use by or
§ 522.1145 Hyaluronate. (d)(1) Specifications. Each milliliter of
(a)(1) Specifications. Each milliliter of sterile aqueous solution contains 10
sterile aqueous solution contains 10 milligrams of hyaluronate sodium.
milligrams of hyaluronate sodium. (2) Sponsor. See 000061 in § 510.600(c) of
(2) Sponsor. See 054771 in § 510.600(c). this chapter.
(3) Conditions of use—(i) Amount. (3) Conditions of use—(i) Amount. 50
Small and medium-size joints (carpal, milligrams in carpal and fetlock joints.
fetlock): 20 mg; larger joint (hock): 40 (ii) Indications for use. For treatment
mg. Treatment may be repeated at of equine carpal and fetlock joint dys-
weekly intervals for a total of three function caused by traumatic and/or
treatments. degenerative joint disease of mild to
(ii) Indications for use. Treatment of moderate severity.
joint dysfunction in horses due to non- (iii) Limitations. Do not use in horses
infectious synovitis associated with intended for human consumption. Fed-
equine osteoarthritis. eral law restricts this drug to use by or
(iii) Limitations. Do not use in horses on the order of a licensed veterinarian.
intended for human consumption. Fed- (e)(1) Specifications. Each milliliter of
eral law restricts this drug to use by or solution contains:
on the order of a licensed veterinarian. (i) 10 milligrams (mg) hyaluronate
(b)(1) Specifications. Each milliliter of sodium; or
sterile aqueous solution contains 5 mil-
(ii) 10 mg hyaluronate sodium with
ligrams of hyaluronate sodium.
benzyl alcohol as a preservative.
(2) Sponsor. See 054771 in § 510.600(c) of
(2) Sponsors. See sponsors in
this chapter.
(3) Conditions of use—(i) Amount. § 510.600(c) of this chapter:
Small and medium-size joints (carpal, (i) No. 000010 for use of products de-
fetlock): 10 mg; larger joint (hock): 20 scribed in paragraph (e)(1) as in para-
mg. Treatment may be repeated at graph (e)(3) of this section.
weekly intervals for a total of four (ii) No. 017030 for use of product de-
treatments. scribed in paragraph (e)(1)(i) as in para-
(ii) Indications for use. Treatment of graph (e)(3) of this section.
joint dysfunction in horses due to non- (3) Conditions of use—(i) Amount. 20
infectious synovitis associated with mg of the product described in para-
equine osteoarthritis. graph (e)(1)(i) of this section by intra-
(iii) Limitations. Do not use in horses articular injection into the carpus or
intended for human consumption. Fed- fetlock; or 40 mg of the product de-
eral law restricts this drug to use by or scribed in paragraph (e)(1)(i) or (e)(1)(ii)
on the order of a licensed veterinarian. of this section by slow intravenous in-
(c)(1) Specifications. Each milliliter of jection into the jugular vein. Treat-
sterile aqueous solution contains 10 ment may be repeated at weekly inter-
milligrams of hyaluronate sodium. vals for a total of three treatments.
(2) Sponsor. See No. 000010 in (ii) Indications for use. For treatment
§ 510.600(c) of this chapter. of carpal or fetlock joint dysfunction
(3) Conditions of use—(i) Amount. due to noninfectious synovitis associ-
Small and medium-size joints (carpal, ated with equine osteoarthritis.
fetlock): 20 mg. Treatment may be re- (iii) Limitations. Do not use in horses
peated after 1 or more weeks but not to intended for human consumption. Fed-
exceed 2 injections per week for a total eral law restricts this drug to use by or
of 4 weeks. on the order of a licensed veterinarian.
308
(f)(1) Specifications. Each milliliter of § 522.1155 Imidocarb powder for injec-

sterile aqueous solution contains 11 tion.
milligrams of hyaluronate sodium. (a) Specifications. The product is a
(2) Sponsor. See 060865 in § 510.600(c). sterile powder containing imidocarb
(3) Conditions of use—(i) Amount. dipropionate. Each milliliter of con-
Small and medium-size joints (carpal, stituted solution contains 100 milli-
fetlock): 22 mg; larger joint (hock): 44 grams (mg) of imidocarb base.
mg. Treatment may be repeated at (b) Sponsor. See No. 000061 in
weekly intervals for a total of three § 510.600(c) of this chapter.
treatments. (c) Special considerations. Imidocarb
(ii) Indications for use. Treatment of dipropionate is sold only under permit
joint dysfunction in horses due to non- issued by the Director of the National
infectious synovitis associated with Program Planning Staff, Veterinary
equine osteoarthritis. Services, Animal and Plant Health In-
(iii) Limitations. Do not use in horses spection Service, U.S. Department of
intended for human consumption. Fed- Agriculture, to licensed or full-time
eral law restricts this drug to use by or State, Federal, or military veterinar-
on the order of a licensed veterinarian. ians.
[49 FR 45124, Nov. 15, 1984, as amended at 51 (d) Conditions of use in horses and ze-
FR 11438, Apr. 3, 1986; 51 FR 25032, July 10, bras—(1) Amount. For Babesia caballi in-
1986; 53 FR 19773, May 31, 1988; 53 FR 22297, fections, administer 2 mg of imidocarb
June 15, 1988; 56 FR 50814, Oct. 9, 1991; 57 FR base per kilogram of body weight by
2837, Jan. 24, 1992; 59 FR 33198, June 28, 1994; intramuscular injection in the neck re-
61 FR 59003, Nov. 20, 1996; 63 FR 59216, Nov. 3, gion, repeating dosage once after 24
1998; 71 FR 1689, Jan. 11, 2006; 71 FR 39204, hours. For Babesia equi infections, ad-
July 12, 2006; 75 FR 1274, Jan. 11, 2010; 75 FR minister 4 mg of imidocarb base per
10167, Mar. 5, 2010; 78 FR 73698, Dec. 9, 2013; 79 kilogram of body weight by
FR 16189, Mar. 25, 2014; 79 FR 74020, Dec. 15,
intramuscular injection in the neck re-
2014; 80 FR 34279, June 16, 2015; 84 FR 39184,
Aug. 9, 2019]
gion, repeating dosage four times at 72-
hour intervals.
§ 522.1150 Hydrochlorothiazide. (2) Indications for use. For the treat-
ment of babesiosis (piroplasmosis)
caused by Babesia caballi and Babesia
solution contains 25 milligrams of equi.
hydrochlorothiazide.
§ 510.600(c) of this chapter. eral law restricts this drug to use by or
(c) Conditions of use—(1) Amount. 5 to on the order of a licensed veterinarian.
10 milliliters (125 to 250 milligrams) in-
travenously or intramuscularly once or [79 FR 16190, Mar. 25, 2014]
twice a day. After onset of diuresis,
§ 522.1156 Imidocarb solution.
treatment may be continued with an
orally administered maintenance dose. (a) Specifications. Each milliliter of
(2) Indications for use. For use in cat- solution contains 120 milligrams (mg)
tle as an aid in the treatment of of imidocarb dipropionate.
postparturient udder edema. (b) Sponsor. See No. 000061 in
(3) Limitations. Milk taken from dairy § 510.600(c) of this chapter.
animals during treatment and for 72 (c) Conditions of use in dogs—(1)
hours (6 milkings) after the latest Amount. Administer 6.6 mg per kilo-
treatment must not be used for food. gram (3 mg per pound) of body weight
Federal law restricts this drug to use by intramuscular or subcutaneous in-
by or on the order of a licensed veteri- jection. Repeat the dose after 2 weeks
narian. for a total of two treatments.
[43 FR 59058, Dec. 19, 1978, as amended at 62 ment of clinical signs of babesiosis and/
FR 63271, Nov. 28, 1997; 79 FR 16190, Mar. 25,

or demonstrated Babesia organisms in
2014; 84 FR 39184, Aug. 9, 2019]
the blood.
309
§ 522.1160 21 CFR Ch. I (4–1–23 Edition)
(3) Limitations. Federal law restricts if the duration of insulin action is de-
this drug to use by or on the order of a termined to be inadequate. If twice-
licensed veterinarian. daily treatment is initiated, the two
doses should be 25 percent less than the
FR 10969, Feb. 28, 2022] once daily dose required to attain an
acceptable nadir.
§ 522.1160 Insulin. (ii) Indications for use. For the reduc-
(a) Specifications. (1) Each milliliter tion of hyperglycemia and hyper-
(mL) of porcine insulin zinc suspension glycemia-associated clinical signs in
contains 40 international units (IU) of dogs with diabetes mellitus.
insulin. (iii) Limitations. Federal law restricts
(2) Each mL of protamine zinc recom- this drug to use by or on the order of a
binant human insulin suspension con- licensed veterinarian.
tains 40 IU of insulin. (2) Cats—(i) Amount—(A) Porcine insu-
(b) Sponsors. See sponsors in § 510.600 lin zinc. Administer an initial dose of 1
of this chapter for use as in paragraph to 2 IU by subcutaneous injection. In-
(c) of this section. jections should be given twice daily at
(1) No. 000061 for use of product de- approximately 12-hour intervals. For
scribed in paragraph (a)(1) as in para- cats fed twice daily, the injections
graphs (c)(1)(i)(A), (c)(1)(ii), (c)(1)(iii), should be concurrent with or right
(c)(2)(i)(A), (c)(2)(ii), and (c)(2)(iii) of after a meal. For cats fed ad libitum,
this section. no change in feeding is needed. Adjust
(2) No. 000010 for use of product de- the dose at appropriate intervals based
scribed in paragraph (a)(2) as in para- on clinical signs, urinalysis results,
graphs (c)(1)(i)(B), (c)(1)(ii), (c)(1)(iii), and glucose curve values until ade-
(c)(2)(i)(B), (c)(2)(ii), and (c)(2)(iii) of quate glycemic control has been at-
this section. tained.
(c) Conditions of use—(1) Dogs—(i) (B) Protamine zinc recombinant human
Amount—(A) Porcine zinc insulin zinc. insulin. Administer an initial dose of
Administer an initial once-daily dose 0.1 to 0.3 IU/pound of body weight (0.2
of 0.5 IU per kilogram of body weight to 0.7 IU/kilogram) every 12 hours. The
by subcutaneous injection concur- dose should be given concurrently with
rently with or right after a meal. Ad- or right after a meal. Re-evaluate the
just this once-daily dose at appropriate cat at appropriate intervals and adjust
intervals based on clinical signs, uri- the dose based on both clinical signs
nalysis results, and glucose curve val- and glucose nadirs until adequate gly-
ues until adequate glycemic control cemic control has been attained.
has been attained. Twice-daily therapy (ii) Indications for use. For the reduc-
should be initiated if the duration of tion of hyperglycemia and hyper-
insulin action is determined to be inad- glycemia-associated clinical signs in
equate. If twice-daily treatment is ini- cats with diabetes mellitus.
tiated, the two doses should be 25 per- (iii) Limitations. Federal law restricts
cent less than the once daily dose re- this drug to use by or on the order of a
quired to attain an acceptable nadir. licensed veterinarian.
(B) Protamine zinc recombinant human
insulin. Administer a starting dose of [69 FR 25827, May 10, 2004, as amended at 73
0.2 to 0.5 IU/pound of body weight (0.5 FR 21042, Apr. 18, 2008; 74 FR 61517, Nov. 25,
to 1.0 IU/kg) once daily. When 2009; 74 FR 66048, Dec. 14, 2009; 84 FR 39184,
Aug. 9, 2019]
transitioning from another insulin
product, this form of insulin should be § 522.1182 Iron injection.
started once daily, regardless of the
frequency of prior insulin use. The dose (a) Specifications. See § 510.440 of this
should be given concurrently with or chapter. Each milliliter (mL) of solu-
right after a meal. Reevaluate the dog tion contains the equivalent of:
at appropriate intervals and adjust the (1) 100 milligrams (mg) of elemental
dose based on both clinical signs and iron derived from:
laboratory test results until adequate (i) Ferric hydroxide;
glycemic control has been attained. (ii) Ferric oxide; or

Twice-daily therapy should be initiated (iii) Elemental iron.
310
(2) 200 mg of elemental iron derived intramuscular or subcutaneous injec-

from ferric hydroxide. tion at 2 to 4 days of age.
(b) Sponsors and conditions of use. It is (ii) For treatment of anemia due to
used in young piglets by sponsors in iron deficiency, administer 100 mg by
§ 510.600(c) of this chapter as follows: intramuscular or subcutaneous injec-
(1) Nos. 016592 and 042552 for use of tion up to 4 weeks of age.
product described in paragraph (a)(1)(i) (6) Nos. 016592 and 058005 for use of
of this section as follows: product described in paragraph
(i) For prevention of iron deficiency (a)(1)(iii) of this section as follows:
anemia, inject 100 mg (1 mL) by (i) For prevention of anemia due to
intramuscular injection at 2 to 4 days iron deficiency, administer 100 mg by
of age. intramuscular injection at 2 to 4 days
(ii) For treatment of iron deficiency of age.
anemia, inject 100 mg (1 mL) by (ii) For treatment of anemia due to
intramuscular injection. Dosage may iron deficiency, administer 100 mg by
be repeated in approximately 10 days. intramuscular injection. Treatment
(2) No. 054771 for use of product de- may be repeated in 10 days.
scribed in paragraph (a)(1)(i) of this (7) Nos. 016592 and 042552 for use of
section as follows: product described in paragraph (a)(2) of
(i) For the prevention of anemia due this section as follows:
to iron deficiency, administer an ini- (i) For prevention of anemia due to
tial intramuscular injection of 100 mg iron deficiency, intramuscularly inject
at 2 to 4 days of age. Dosage may be re- 200 mg of elemental iron (1 mL) at 1 to
peated in 14 to 21 days. 3 days of age.
(ii) For the treatment of anemia due (ii) For treatment of anemia due to
to iron deficiency, administer an iron deficiency, intramuscularly inject
intramuscular injection of 200 mg. 200 mg of elemental iron at the first
sign of anemia.
(3) Nos. 000061 and 013744 for use of
product described in paragraph (a)(1)(i) [73 FR 12635, Mar. 10, 2008, as amended at 73
of this section as follows: FR 14385, Mar. 18, 2008; 78 FR 17597, Mar. 22,
(i) For the prevention of iron defi- 2013; 78 FR 44433, July 24, 2013; 79 FR 16190,
Mar. 25, 2014; 81 FR 22524, Apr. 18, 2016; 81 FR
ciency anemia, administer
59134, Aug. 29, 2016; 82 FR 11508, Feb. 24, 2017;
intramuscularly an amount of drug 83 FR 48946, Sept. 28, 2018; 86 FR 14820, Mar.
containing 100 to 150 mg of elemental 19, 2021]
iron to animals from 1 to 3 days of age.
(ii) For the treatment of iron defi- § 522.1185 Isoflupredone.
ciency anemia, administer (a) Specifications. Each milliliter of
intramuscularly an amount of drug suspension contains 2 milligrams (mg)
containing 100 to 200 mg of elemental of isoflupredone acetate.
iron per animal. Dosage may be re- (b) Sponsor. See No. 054771 in
peated in 10 days to 2 weeks. § 510.600(c) of this chapter.
(4) No. 054771 for use of product de- (c) Conditions of use—(1) Cattle—(i)
scribed in paragraph (a)(1)(ii) of this Amount. Administer 10 to 20 mg by
section as follows: intramuscular injection.
(i) For prevention of iron deficiency (ii) Indications for use. For use in the
anemia, administer 1 mL by treatment of bovine ketosis. For allevi-
intramuscular injection at 2 to 5 days ation of pain associated with general-
of age. Dosage may be repeated at 2 ized and acute localized arthritic con-
weeks of age. ditions; for treating acute hyper-
(ii) For treatment of iron deficiency sensitivity reactions; and as an aid in
anemia, administer 1 to 2 mL by correcting circulatory defects associ-
intramuscular injection at 5 to 28 days ated with severe toxicity and shock.
of age. (iii) Limitations. Animals intended for
(5) No. 054771 for use of product de- human consumption should not be
scribed in paragraph (a)(1)(iii) of this slaughtered within 7 days of last treat-
section as follows: ment. A withdrawal period has not
(i) For prevention of anemia due to been established for this product in
iron deficiency, administer 100 mg by preruminating calves. Do not use in
311
§ 522.1192 21 CFR Ch. I (4–1–23 Edition)
calves to be processed for veal. Federal be used in other animal species as se-
law restricts this drug to use by or on vere adverse reactions, including fa-
the order of a licensed veterinarian. talities in dogs, may result.’’
(2) Horses and swine—(i) Amount—(A) (e) Conditions of use—(1) Horses—(i)
Horses. Administer 5 to 20 mg by Amount. 200 micrograms per kilogram
intramuscular injection for systemic (μg/kg) of body weight by
effect or by intrasynovial injection intramuscular injection.
into a joint cavity, tendon sheath, or (ii) Indications for use. For the treat-
bursa for local effect. ment and control of large strongyles
(B) Swine. The usual dose for a 300- (adult) (Strongylus vulgaris, S. edentatus,
pound animal is 5 mg by intramuscular Triodontophorus spp.), small strongyles
injection. (adult and fourth stage larvae)
(ii) Indications for use. For alleviation (Cyathostomum spp., Cylicocyclus spp.,
of pain associated with generalized and Cylicostephanus spp.), pinworms (adult
acute localized arthritic conditions; for and fourth-stage larvae) (Oxyuris equi),
treating acute hypersensitivity reac- large roundworms (adult) (Parascaris
tions; and as an aid in correcting cir- equorum), hairworms (adult)
culatory defects associated with severe (Trichostrongylus axei), large mouth
toxicity and shock. stomach worms (adult) (Habronema
(iii) Limitations. Animals intended for muscae), neck threadworms
human consumption should not be (microfilariae) (Onchocerca spp.), and
slaughtered within 7 days of last treat- stomach bots (Gastrophilus spp.).
ment. Federal law restricts this drug (iii) Limitations. Not for use in horses
to use by or on the order of a licensed intended for human consumption. Fed-
veterinarian. eral law restricts this drug to use by or
[79 FR 16190, Mar. 25, 2014] on the order of a licensed veterinarian.
(2) Cattle—(i) Amount. 200 μg/kg of
§ 522.1192 Ivermectin. body weight by subcutaneous injection.
(a) Specifications. (1) Each milliliter (ii) Indications for use. For the treat-
(mL) of solution contains 20 milligrams ment and control of gastrointestinal
(mg) ivermectin. nematodes (adults and fourth-stage lar-
(2) Each mL of solution contains 10 vae) (Haemonchus placei, Ostertagia
mg ivermectin. ostertagi (including inhibited larvae), O.
(3) Each mL of solution contains 2.7 lyrata, Trichostrongylus axei, T.
mg ivermectin. colubriformis, Cooperia oncophora, C.
(b) Sponsors. See sponsors in punctata, C. pectinata, Oesophagostomum
§ 510.600(c) of this chapter for use as in radiatum, Nematodirus helvetianus
paragraph (e) of this section. (adults only), N. spathiger (adults only),
(1) No. 000010 for use of the product Bunostomum phlebotomum); lungworms
described in paragraph (a)(1) of this (adults and fourth-stage larvae)
section as in paragraph (e)(1) of this (Dictyocaulus viviparus); grubs (para-
section; the product described in parasitic stages) (Hypoderma bovis, H.
graph (a)(2) of this section as in para- lineatum); sucking lice (Linognathus
graphs (e)(2), (e)(3), (e)(4), and (e)(5) of vituli, Haematopinus eurysternus,
this section; and the product described Solenopotes capillatus); mites (scabies)
in paragraph (a)(3) of this section as in (Psoroptes ovis (syn. P. communis var.
paragraphs (e)(3) and (e)(6) of this sec- bovis), Sarcoptes scabiei var. bovis). For
tion. control of infections and to protect
(2) Nos. 016592, 055529, 058005, and from reinfection with D. viviparus and
061133 for use of the product described O. radiatum for 28 days after treatment;
in paragraph (a)(2) of this section as in O. ostertagi, T. axei, and C. punctata for
paragraphs (e)(2), (e)(3), (e)(4), and (e)(5) 21 days after treatment; H. placei and
of this section. C. oncophora for 14 days after treat-
(c) Related tolerances. See § 556.344 of ment.
this chapter. (iii) Limitations. Do not treat cattle
(d) Special considerations. (1) See within 35 days of slaughter. Because a
§ 500.25 of this chapter. withdrawal time in milk has not been
(2) Labeling shall bear the following established, do not use in female dairy
precaution: ‘‘This product should not cattle of breeding age. A withdrawal
312
period has not been established for this (e) Conditions of use in cattle—(1)
product in pre-ruminating calves. Do Amount. Administer 1 mL (10 mg
not use in calves to be processed for ivermectin and 100 mg clorsulon) per 50
veal. kilograms (110 pounds) by subcuta-
(3) Swine—(i) Amount. 300 μg/kg of neous injection.
body weight by subcutaneous injection. (2) Indications for use. For the treat-
(ii) Indications for use. For the treatment and control of gastrointestinal
ment and control of gastrointestinal nematodes (adults and fourth-stage lar-
roundworms (adults and fourth-stage vae) (Haemonchus placei, Ostertagia
larvae) (large roundworm, Ascaris suum; ostertagi (including inhibited larvae), O.
red stomach worm, Hyostrongylus lyrata, Trichostrongylus axei, T.
rubidus; nodular worm, colubriformis, Cooperia oncophora, C.
Oesophagostomum spp.; threadworm, punctata, C. pectinata, Oesophagostomum
Strongyloides ransomi (adults only)); so- radiatum, Nematodirus helvetianus
matic roundworm larvae (threadworm, (adults only), N. spathiger (adults only),
S. ransomi (somatic larvae)); lungworms Bunostomum phlebotomum; lungworms
(Metastrongylus spp. (adults only)); lice (adults and fourth-stage larvae)
(H. suis); and mites (S. scabiei var. suis). (Dictyocaulus viviparus); liver flukes
(iii) Limitations. Do not treat swine (adults only) (Fasciola hepatica); cattle
within 18 days of slaughter. grubs (parasitic stages) (Hypoderma
(4) American bison—(i) Amount. 200 μg/ bovis, H. lineatum); sucking lice
kg of body weight by subcutaneous in- (Linognathus vituli, Haematopinus
jection. eurysternus, Solenopotes capillatus);
(ii) Indications for use. For the treat- mange mites (cattle scab) (Psoroptes
ment and control of grubs (H. bovis). ovis (syn. P. communis var. bovis),
(iii) Limitations. Do not slaughter Sarcoptes scabiei var. bovis); and for con-
within 56 days of last treatment. trol of infections of D. viviparus and O.
(5) Reindeer—(i) Amount. 200 μg/kg of radiatum for 28 days after treatment; O.
body weight by subcutaneous injection. ostertagi, T. axei, and C. punctata for 21
(ii) Indications for use. For the treat- days after treatment; and H. placei and
ment and control of warbles C. oncophora for 14 days after treat-
(Oedemagena tarandi).
ment.
(iii) Limitations. Do not treat reindeer
(3) Limitations. Do not treat cattle
within 56 days of slaughter.
within 21 days of slaughter. Because a
(6) Ranch-raised foxes—(i) Amount. 200
μg/kg of body weight by subcutaneous withdrawal time in milk has not been
injection. Repeat in 3 weeks. established, do not use in female dairy
(ii) Indications for use. For treatment cattle of breeding age. A withdrawal
and control of ear mites (Otodectes period has not been established for this
cynotis). product in preruminating calves. Do
[72 FR 27735, May 17, 2007, as amended at 72 veal.
FR 62771, Nov. 7, 2007; 74 FR 9049, Mar. 2, 2009;
75 FR 26647, May 12, 2010; 76 FR 57906, Sept. [55 FR 38984, Sept. 24, 1990, as amended at 62
19, 2011; 78 FR 17597, Mar. 22, 2013; 81 FR 59134, FR 14302, Mar. 26, 1997; 62 FR 63271, Nov. 28,
Aug. 29, 2016; 84 FR 8974, Mar. 13, 2019; 84 FR 1997; 64 FR 26671, May 17, 1999; 69 FR 31735,
32992, July 11, 2019; 84 FR 39184, Aug. 9, 2019] June 7, 2004; 72 FR 27734, May 17, 2007; 77 FR
64717, Oct. 23, 2012; 79 FR 64116, Oct. 28, 2014;
§ 522.1193 Ivermectin and clorsulon. 84 FR 39184, Aug. 9, 2019; 86 FR 14820, Mar. 19,
2021; 86 FR 57997, Oct. 20, 2021]
(mL) of solution contains 10 milligrams EDITORIAL NOTE: At 81 FR 22524, Apr. 18,
(mg) (1 percent) ivermectin and 100 mg 2016, § 522.1193 was amended; however, the
(10 percent) clorsulon. amendment could not be incorporated due to
(b) Sponsors. See Nos. 000010, 055529, inaccurate amendatory instruction.
058005, 061133, and 061651 in § 510.600(c) of
§ 522.1204 Kanamycin.
this chapter.
(c) Related tolerances. See §§ 556.163 (a) Specifications. Each milliliter of
and 556.344 of this chapter. solution contains 50 or 200 milligrams
(d) Special considerations. See § 500.25 (mg) of kanamycin as kanamycin sul-

of this chapter. fate.
313
§ 522.1222 21 CFR Ch. I (4–1–23 Edition)
(b) Sponsor. See No. 054771 in (b) Sponsor. See No. 054771 in
§ 510.600(c) of this chapter. § 510.600(c) of this chapter.
(c) Conditions of use in dogs and cats— (c) Conditions of use in cats—(1)
(1) Amount. Administer by subcuta- Amount. Administer by intramuscular
neous or intramuscular injection 5 mg injection 15 to 20 mg ketamine base per
per pound of body weight per day in pound of body weight, depending on the
equally divided doses at 12-hour inter- effect desired.
vals. (2) Indications for use. It is used in
(2) Indications for use. For the treat- cats as the sole anesthetic agent for
ment of bacterial infections due to ovariohysterectomy and general sur-
kanamycin sensitive organisms in dogs gery.
and cats. (3) Limitations. Federal law restricts
(3) Limitations. Federal law restricts this drug to use by or on the order of a
this drug to use by or on the order of a licensed veterinarian.
licensed veterinarian. [79 FR 16191, Mar. 25, 2014]
[79 FR 16190, Mar. 25, 2014]
§ 522.1225 Ketoprofen.
§ 522.1222 Ketamine. (a) Specifications. Each milliliter of
(a) Specifications. Each milliliter con-
ketoprofen.
tains ketamine hydrochloride equiva-
lent to 100 milligrams (mg) ketamine
base activity.
(b) Sponsors. See Nos. 017033, 054771, (d)(1) and (d)(2) of this section.
058198, 059399, 063286, and 069043 in (2) No. 061133 for use as in paragraph
§ 510.600(c) of this chapter. (d)(1) of this section.
(c) Special considerations. Federal law (c) Related tolerances. See § 556.345 of
restricts this drug to use by or on the this chapter.
order of a licensed veterinarian. (d) Conditions of use—(1) Horses—(i)
(d) Conditions of use—(1) Cats—(i) Amount. Administer by intravenous in-
Amount. 5 to 15 mg/pound body weight jection 1.0 mg per pound (/lb) of body
intramuscularly, depending on the ef- weight once daily for up to 5 days.
fect desired. (ii) Indications for use. For alleviation
(ii) Indications for use. For restraint of inflammation and pain associated
or as the sole anesthetic agent in diag- with musculoskeletal disorders in
nostic or minor, brief surgical proce- horses.
dures that do not require skeletal mus- (iii) Limitations. Do not use in horses
cle relaxation. intended for human consumption. Fed-
(2) Subhuman primates—(i) Amount. 3 eral law restricts this drug to use by or
to 15 mg/kilogram body weight on the order of a licensed veterinarian.
intramuscularly, depending upon the (2) Cattle—(i) Amount. Administer by
species, general condition, and age of subcutaneous injection 3 mg per kilo-
the subject. gram (1.36 mg/lb) of body weight once
(ii) Indications for use. For restraint. daily for up to 3 days.
[67 FR 17283, Apr. 10, 2002, as amended at 73 (ii) Indications for use. For the control
FR 8192, Feb. 13, 2008. Redesignated at 79 FR of pyrexia associated with bovine res-
16191, Mar. 25, 2014, as amended at 80 FR piratory disease (BRD) in beef heifers,
13229, Mar. 13, 2015; 83 FR 48946, Sept. 28, 2018; beef steers, beef calves 2 months of age
86 FR 14820, Mar. 19, 2021] and older, beef bulls, replacement dairy
heifers, and dairy bulls.
§ 522.1223 Ketamine, promazine, and (iii) Limitations. Not for use in repro-
aminopentamide. ducing animals over 1 year of age. Cat-
(a) Specifications. Each milliliter of tle must not be slaughtered for human
solution contains ketamine hydro- consumption within 48 hours following
chloride equivalent to 100 milligrams last treatment with this drug product.
(mg) ketamine base activity, 7.5 (mg) Not for use in female dairy cattle 1
of promazine hydrochloride, and 0.0625 year of age or older, including dry
mg of aminopentamide hydrogen sul- dairy cows; use in these cattle may

fate. cause drug residues in milk and/or in
314
calves born to these cows or heifers. slaughter. Do not administer to dairy

Not for use in beef calves less than 2 animals of breeding age.
months of age, dairy calves, and veal
calves. A withdrawal period has not FR 29289, July 7, 1978; 43 FR 60895, Dec. 29,
been established for this product in 1978; 47 FR 10807, Mar. 12, 1982; 62 FR 61625,
pre-ruminating calves. Federal law re- Nov. 19, 1997; 65 FR 61090, Oct. 16, 2000; 67 FR
stricts this drug to use by or on the 63055, Oct. 10, 2002. Redesignated and amend-
order of a licensed veterinarian. ed at 79 FR 16191, Mar. 25, 2014; 83 FR 48946,
Sept. 28, 2018; 84 FR 32992, July 11, 2019]
[86 FR 61685, Nov. 8, 2021]
§ 522.1260 Lincomycin.
§ 522.1242 Levamisole.
(a) Specifications. Each milliliter of solution contains lincomycin hydro-
solution contains levamisole phosphate chloride monohydrate equivalent to:
equivalent to 136.5 or 182 milligrams of (1) 25, 50, 100, or 300 milligrams (mg)
levamisole hydrochloride (13.65 or 18.2 lincomycin.
percent).
(2) 25, 100, or 300 mg lincomycin.
(b) Sponsor. See Nos. 000061 and 016592
(3) 300 mg lincomycin.
in § 510.600 of this chapter for use of
13.65 percent injection, and see No. (4) 100 or 300 mg lincomycin.
054771 for use of 13.65 and 18.2 percent (b) Sponsors. See sponsors in
injection. § 510.600(c) of this chapter for uses as in
(c) Related tolerances. See § 556.350 of paragraph (e) of this section.
this chapter. (1) No. 054771 for use of concentra-
(d) Conditions of use—(1) Amount. 2 tions in paragraph (a)(1) of this section
milliliters per 100 pounds of body as in paragraph (e) of this section.
weight, subcutaneously in the neck. (2) Nos. 016592 and 058005 for use of
(2) Indications for use. (i) The 13.65 concentrations in paragraph (a)(2) of
percent injection is used as an anthel- this section as in paragraph (e)(2) of
mintic in cattle for treatment of the this section.
following parasites: stomach worms (3) No. 054771 for use of concentration
(Haemonchus, Trichostrongylus, in paragraph (a)(3) of this section as in
Ostertagia), intestinal worms paragraph (e)(2) of this section.
(Trichostrongylus, Cooperia, (4) No. 061133 for use of concentra-
Nematodirus, Bunostomum, tions in paragraph (a)(4) of this section
Oesophagostomum, Chabertia), and as in paragraph (e)(2) of this section.
lungworms (Dictyocaulus). (c) Special considerations. When com-
(ii) The 18.2 percent injection is used mon labeling for use of the drug in
as an anthelmintic in cattle for treat- dogs, cats, and swine is included with
ment of the following parasites: stom- the drug, all such uses are subject to
ach worms (Haemonchus, the labeling requirements of § 201.105 of
Trichostrongylus, Ostertagia), intestinal this chapter.
worms (Trichostrongylus, Cooperia, (d) Related tolerances. See § 556.360 of
Nematodirus, Bunostomum, this chapter.
Oesophagostomum) and lungworms (e) Conditions of use. It is used for ani-
(Dictyocaulus). mals as follows:
(3) Limitations. Do not administer (1) Dogs and cats—(i) Amount. 5 mg
more than 10 milliliters per site. Cattle per pound (/lb) of body weight twice
that are severely parasitized or main- daily or 10 mg/lb body weight once
tained under conditions of constant daily by intramuscular injection; 5 to
helminth exposure may require re- 10 mg/lb body weight one or two times
treatment within 2 to 4 weeks after daily by slow intravenous injection.
first treatment. Consult your veteri- (ii) Indications for use. Infections
narian for assistance in the diagnosis, caused by Gram-positive organisms,
treatment, and control of parasitism. particularly streptococci and
Consult your veterinarian before using staphylococci.
in severely debilitated animals or ani- (iii) Limitations. Federal law restricts
mals under severe stress. Do not ad- this drug to use by or on the order of a
minister to cattle within 7 days of licensed veterinarian.
315
§ 522.1289 21 CFR Ch. I (4–1–23 Edition)
(2) Swine—(i) Amount. 5 mg/lb body skin should be washed off immediately
weight once daily by intramuscular in- with soap and water.
jection for 3 to 7 days. (d) Conditions of use in horses—(1)
(ii) Indications for use. Treatment of Amount. 7.5 mg by intramuscular injec-
infectious arthritis and mycoplasma tion.
pneumonia. (2) Indications for use. For estrus
(iii) Limitations. Do not treat within control and termination of pregnancy
48 hours of slaughter. For No 054771: in mares.
Federal law restricts this drug to use (3) Limitations. Federal law restricts
by or on the order of a licensed veteri- this drug to use by or on the order of a
narian. licensed veterinarian. Do not use in
horses intended for human consump-
FR 31351, Aug. 2, 1985; 67 FR 34388, May 14,
tion.
2002; 68 FR 51705, Aug. 28, 2003; 69 FR 11507, [55 FR 1185, Jan. 12, 1990, as amended at 56
Mar. 11, 2004; 69 FR 47361, Aug. 5, 2004; 71 FR FR 50653, Oct. 8, 1991; 60 FR 55659, Nov. 2,
51996, Sept. 1, 2006; 78 FR 17597, Mar. 22, 2013; 1995; 61 FR 66582, Dec. 18, 1996; 74 FR 25146,
79 FR 16191, Mar. 25, 2014; 81 FR 59134, Aug. May 27, 2009]
29, 2016; 84 FR 8974, Mar. 13, 2019; 88 FR 16548,
Mar. 20, 2023] § 522.1315 Maropitant.
§ 522.1289 Lufenuron. (a) Specifications. Each milliliter of
(a) Specifications. Each milliliter of maropitant as maropitant citrate.
suspension contains 100 milligrams (b) Sponsor. See No. 054771 in
(mg) of lufenuron. § 510.600(c) of this chapter.
(b) Sponsor. See No. 058198 in (c) Conditions of use—(1) Dogs—(i)
§ 510.600(c) of this chapter. Amount. Administer 1.0 mg per kilo-
(c) Conditions of use in cats—(1) gram (mg/kg) of body weight by sub-
Amount. 10 mg per kilogram (4.5 mg per cutaneous or intravenous injection
pound) of body weight every 6 months, once daily for up to 5 consecutive days.
by subcutaneous injection. (ii) Indications for use. For the pre-
(2) Indications for use. For control of vention and treatment of acute vom-
flea populations in cats 6 weeks of age iting.
and older. (iii) Limitations. Federal law restricts
licensed veterinarian. (2) Cats—(i) Amount. Administer 1.0
[79 FR 16191, Mar. 25, 2014, as amended at 80 mg/kg of body weight by subcutaneous
FR 61297, Oct. 13, 2015] or intravenous injection once daily for
up to 5 consecutive days.
§ 522.1290 Luprostiol. (ii) Indications for use. For the treat-
(a) Specifications. Each milliliter of ment of vomiting.
solution contains 7.5 milligrams (mg) (iii) Limitations. Federal law restricts
luprostiol. this drug to use by or on the order of a
(b) Sponsor. See No. 051311 in licensed veterinarian.
§ 510.600(c) of this chapter. [72 FR 9243, Mar. 1, 2007, as amended at 77 FR
(c) Special considerations. Labeling 39391, July 3, 2012; 79 FR 16191, Mar. 25, 2014;
shall bear the following statements: 81 FR 22524, Apr. 18, 2016]
Warning: Women of childbearing age,
asthmatics, and persons with bronchial § 522.1335 Medetomidine.
and other respiratory problems should (a) Specifications. Each milliliter of
exercise extreme caution when han- solution contains 1.0 milligrams of
dling this product. In the early stages, medetomidine hydrochloride.
women may be unaware of their preg- (b) Sponsor. See Nos. 015914 and 052483
nancies. Luprostiol is readily absorbed in § 510.600(c) of this chapter.
through the skin and can cause abor- (c) Conditions of use—(1) Amount. 750
tion and/or bronchiospasms. Direct micrograms intravenously (IV) or 1,000
contact with the skin should therefore micrograms intramuscularly per

be avoided. Accidental spillage on the square meter of body surface. The IV
316
route is more efficacious for dental plant potential breeding stock. Do not
care. use in food-producing animals.
(2) Indications for use. As a sedative [59 FR 37422, July 22, 1994]
and analgesic in dogs over 12 weeks of
age to facilitate clinical examinations, § 522.1362 Melarsomine powder for in-
clinical procedures, minor surgical pro- jection.
cedures not requiring muscle relax- (a) Specifications. The drug consists of
ation, and minor dental procedures not a vial of lyophilized powder containing
requiring intubation. The intravenous 50 milligrams of melarsomine
route of administration is more effica- dihydrochloride which is reconstituted
cious for dental care. with the provided 2 milliliters of ster-
(3) Limitations. Federal law restricts ile water for injection.
this drug to use by or on the order of a (b) Sponsor. See Nos. 000010 and 086073
licensed veterinarian. in § 510.600(c) of this chapter.
[61 FR 21075, May 9, 1996, as amended at 79 (c) Conditions of use—(1) Amount. Ad-
FR 16191, Mar. 25, 2014; 82 FR 58556, Dec. 13, minister only by deep intramuscular
2017] injection in the lumbar muscles (L3–
L5).
§ 522.1338 Medetomidine and (2) Indications. Treatment of sta-
vatinoxan. bilized, class 1, 2, and 3 heartworm dis-
(a) Specifications. Each milliliter of ease (asymptomatic to mild, moderate,
solution contains 0.5 milligrams (mg) and severe, respectively) caused by im-
medetomidine hydrochloride and 10 mg mature (4 month-old, stage L5) to ma-
vatinoxan hydrochloride. ture adult infections of Dirofilaria
(b) Sponsor. See No. 043264 in immitis in dogs.
(c) Conditions of use—(1) Amount. Ad- this drug to use by or on the order of a
minister by intramuscular injection a licensed veterinarian.
dose based on body surface area (BSA). [60 FR 49340, Sept. 25, 1995, as amended at 79
Calculate the dose using 1 mg FR 16191, Mar. 25, 2014; 82 FR 21690, May 10,
medetomidine per square meter (/m2) 2017; 84 FR 39184, Aug. 9, 2019]
BSA or use the dosing table provided in
labeling. § 522.1367 Meloxicam.
(2) Indications for use. For use as a (a) Specifications. Each milliliter of
sedative and analgesic in dogs to facili- solution contains 5.0 milligrams (mg)
tate clinical examination, clinical pro- meloxicam.
cedures, and minor surgical procedures. (b) Sponsors. See Nos. 000010, 016729,
(3) Limitations. Federal law restricts 017033, 055529, and 086101 in § 510.600(c) of
this drug to use by or on the order of a this chapter.
licensed veterinarian. (c) Conditions of use—(1) Dogs—(i)
(mg/lb) body weight (0.2 mg per kilo-
FR 76421, Dec. 14, 2022]
gram (mg/kg)) by intravenous or sub-
§ 522.1350 Melatonin implant. cutaneous injection on the first day of
treatment. For treatment after day 1,
(a) Specifications. The drug is a sili- administer meloxicam suspension oral-
cone rubber elastomer implant con- ly at 0.045 mg/lb (0.1 mg/kg) body
taining 2.7 milligrams of melatonin. weight once daily as in § 520.1367(c) of
(b) Sponsor. See No. 053923 in this chapter.
§ 510.600(c) of this chapter. (ii) Indications for use. For the control
(c) Conditions of use—(1) Amount. One of pain and inflammation associated
implant per mink. with osteoarthritis.
(2) Indications for use. For use in (iii) Limitations. Federal law restricts
healthy male and female kit and adult this drug to use by or on the order of a
female mink (Mustela vison) to accel- licensed veterinarian.
erate the fur priming cycle. (2) Cats—(i) Amount. Administer 0.14
(3) Limitations. For subcutaneous im- mg/lb (0.3 mg/kg) body weight as a sin-
plantation in mink only. Do not im- gle, one-time subcutaneous injection.
317
§ 522.1372 21 CFR Ch. I (4–1–23 Edition)
(ii) Indications for use. For the control of body weight for moderate conditions
of postoperative pain and inflamma- or 10 to 25 mg per pound of body weight
tion associated with orthopedic sur- for severe conditions (tetanus). Addi-
gery, ovariohysterectomy, and castra- tional amounts may be needed to re-
tion when administered prior to sur- lieve residual effects and to prevent re-
gery. currence of symptoms.
(iii) Limitations. Federal law restricts (2) Indications for use. As an adjunct
this drug to use by or on the order of a for treating acute inflammatory and
licensed veterinarian. traumatic conditions of the skeletal
[68 FR 68724, Dec. 10, 2003, as amended at 69 muscles and to reduce muscular
FR 69523, Nov. 30, 2004; 78 FR 5715, Jan. 28, spasms.
2013; 79 FR 74020, Dec. 15, 2014; 85 FR 18119,
Apr. 1, 2020; 88 FR 14898, Mar. 10, 2023]
§ 522.1372 Mepivacaine. eral law restricts this drug to use by or
(mL) of solution contains 20 milligrams [79 FR 16191, Mar. 25, 2014, as amended at 82
mepivacaine hydrochloride. FR 11508, Feb. 24, 2017]
§ 510.600(c) of this chapter. § 522.1410 Methylprednisolone.
(c) Conditions of use in horses—(1) (a) Specifications. Each milliliter of
Amount. For nerve block, 3 to 15 mL; suspension contains 20 or 40 milligrams
for epidural anesthesia, 5 to 20 mL; for
(mg) of methylprednisolone acetate.
intra-articular anesthesia, 10 to 15 mL;
for infiltration, as required; for anes- (b) Sponsors. See Nos. 054771 and
thesia of the laryngeal mucosa prior to 069043 in § 510.600(c) of this chapter.
ventriculectomy, by topical spray, 25 (c) [Reserved]
to 40 mL, by infiltration, 20 to 50 mL. (d) Conditions of use—(1) Dogs—(i)
(2) Indications for use. For use as a Amount. Administer 2 to 40 mg (up to
local anesthetic for infiltration, nerve 120 mg in extremely large breeds or
block, intra-articular and epidural an- dogs with severe involvement) by
esthesia, and topical and/or infiltration intramuscular injection or up to 20 mg
anesthesia of the laryngeal mucosa by intrasynovial injection.
prior to ventriculectomy. (ii) Indications for use. For treatment
(3) Limitations. Not for use in horses of inflammation and related disorders;
intended for human consumption. Fed- treatment of allergic and dermatologic
eral law restricts this drug to use by or disorders; and as supportive therapy to
on the order of a licensed veterinarian. antibacterial treatment of severe infec-
[71 FR 39547, July 13, 2006, as amended at 79 tions.
FR 16191, Mar. 25, 2014; 88 FR 14898, Mar. 10, (iii) Limitations. Federal law restricts
2023] this drug to use by or on the order of a
§ 522.1380 Methocarbamol.
(2) Cats—(i) Amount. Administer 10 to
(a) Specifications. Each milliliter of 20 mg by intramuscular injection.
solution contains 100 milligrams (mg) (ii) Indications for use. For treatment
of methocarbamol.
of inflammation and related disorders;
treatment of allergic and dermatologic
(c) Conditions of use—(1) Amount—(i) disorders; and as supportive therapy to
Dogs and cats. Administer by intra- antibacterial treatment of severe infec-
venous injection 20 mg per pound of tions.
body weight for moderate conditions or (iii) Limitations. Federal law restricts
25 to 100 mg per pound of body weight this drug to use by or on the order of a
for severe conditions (tetanus and licensed veterinarian.
strychnine poisoning). The total cumu- (3) Horses—(i) Amount. Administer 200
lative dose should not to exceed 150 mg mg by intramuscular injection or 40 to
per pound of body weight. 240 mg by intrasynovial injection.
(ii) Horses. Administer by intra- (ii) Indications for use. For treatment
venous injection 2 to 10 mg per pound of inflammation and related disorders.
318
(iii) Limitations. Do not use in horses older. A withdrawal period has not
intended for human consumption. Fed- been established for pre-ruminating
eral law restricts this drug to use by or calves. Do not use in calves to be proc-
on the order of a licensed veterinarian. essed for veal.
[43 FR 59058, Dec. 19, 1978, as amended at 51 [70 FR 36337, June 23, 2005, as amended at 71
FR 741, Jan. 8, 1986; 53 FR 40728, Oct. 18, 1988; FR 7414, Feb. 13, 2006; 76 FR 48714, Aug. 9,
62 FR 35076, June 30, 1997; 76 FR 53051, Aug. 2011; 82 FR 21690, May 10, 2017; 86 FR 14820,
25, 2011; 78 FR 21060, Apr. 9, 2013; 79 FR 16191, Mar. 19, 2021]
Mar. 25, 2014; 83 FR 48946, Sept. 28, 2018]
§ 522.1451 Moxidectin microspheres
§ 522.1450 Moxidectin solution. for injection.
(a) Specifications. Each milliliter of (a) Specifications. The drug product
solution contains 10 milligrams (mg) consists of two separate vials. One vial
moxidectin. contains 10 percent moxidectin micro-
(b) Sponsor. See No. 058198 in spheres and the second vial contains a
§ 510.600(c) of this chapter. vehicle for constitution of the
(c) Related tolerances. See § 556.426 of moxidectin microspheres.
this chapter. (1) Each milliliter (mL) of con-
(d) Special considerations. See § 500.25 stituted suspension contains 3.4 milli-
of this chapter. grams (mg) moxidectin.
(e) Conditions of use in beef and non- (2) Each mL of constituted suspen-
lactating dairy cattle—(1) Amount. Ad- sion contains 10 mg moxidectin.
minister 0.2 mg/kg of body weight (0.2 (b) Sponsor. See No. 54771 in
mg/2.2 pound) as a single, subcutaneous § 510.600(c) of this chapter.
injection. (c) Conditions of use in dogs—(1)
(2) Indications for use. For treatment Amount. (i) Using the suspension de-
and control of gastrointestinal scribed in paragraph (a)(1) of this sec-
roundworms: Ostertagia ostertagi tion, administer 0.05 mL of the con-
(adults, fourth-stage larvae, and inhib- stituted suspension per kilogram (kg)
ited larvae), Haemonchus placei of body weight (0.023 mL per pound (lb))
(adults), Trichostrongylus axei (adults as a single subcutaneous injection to
and fourth-stage larvae), provide 0.17 mg/kg body weight (0.0773
Trichostrongylus colubriformis (adults mg/lb).
and fourth-stage larvae), Cooperia (ii) Using the suspension described in
oncophora (adults), Cooperia pectinata paragraph (a)(2) of this section, admin-
(adults), Cooperia punctata (adults and ister 0.05 mL of the constituted suspen-
fourth-stage larvae), Cooperia spatulata sion/kg of body weight (0.023 mL/lb) as
(adults), Cooperia surnabada (adults and a single subcutaneous injection to pro-
fourth-stage larvae), Nematodirus vide 0.5 mg/kg body weight (0.23 mg/lb).
helvetianus (adults), Oesophagostomum (2) Indications for use—(i) Suspension
radiatum (adults and fourth-stage lar- described in paragraph (a)(1) of this sec-
vae), Trichuris spp. (adults); tion. For prevention of heartworm dis-
lungworms: Dictyocaulus viviparus ease caused by Dirofilaria immitis in
(adults and fourth-stage larvae); grubs: dogs 6 months of age and older; and for
Hypoderma bovis and Hypoderma treatment of existing larval and adult
lineatum; mites: Psoroptes ovis hookworm (Ancylostoma caninum and
(Psoroptes communis var. bovis); lice: Uncinaria stenocephala) infections.
Linognathus vituli and Solenopotes (ii) Suspension described in paragraph
capillatus; for protection of cattle from (a)(2) of this section. For prevention of
reinfection with D. viviparus and O. heartworm disease caused by Dirofilaria
radiatum for 42 days after treatment, immitis for 12 months in dogs 12 months
with H. placei for 35 days after treat- of age and older; and for treatment of
ment, and with O. ostertagi and T. axei existing larval and adult hookworm
for 14 days after treatment. (Ancylostoma caninum and Uncinaria
(3) Limitations. Do not slaughter cat- stenocephala) infections.
tle within 21 days of treatment. Be- (3) Limitations. Federal law restricts
cause a withholding time for milk has this drug to use by or on the order of a
not been established, do not use in fe- licensed veterinarian.

male dairy cattle 20 months of age and [85 FR 4208, Jan. 24, 2020]
319
§ 522.1452 21 CFR Ch. I (4–1–23 Edition)
§ 522.1452 Nalorphine. (b) Sponsor. See 054771 in § 510.600(c) of

this chapter.
solution contains 5 milligrams of (c) Conditions of use in horses—(1) Dos-
nalorphine hydrochloride. age. Five milligrams per kilogram of
body weight intravenously followed by
maintenance oral therapy of 10 milli-
grams per kilogram of body weight
(c) Conditions of use in dogs—(1) twice daily for up to 14 consecutive
Amount. One milligram per 5 pounds; days.
intravenously, intramuscularly, or
subcutaneously.
inflammation and associated pain and
(2) Indications for use. Respiratory lameness exhibited with arthritis, as
and circulatory depression in dogs re- well as myositis and other soft tissue
sulting from overdosage of, or unusual diseases of the musculoskeletal system
sensitivity to, morphine and certain of the horse.
other narcotics. Not for depression due
(3) Limitations. Not for use in horses
to any other cause.
intended for food. Federal law restricts
[46 FR 26763, May 15, 1981. Redesignated and
[44 FR 6707, Feb. 2, 1979, as amended at 47 FR amended at 51 FR 24525, July 7, 1986; 61 FR
36418, Aug. 20, 1982; 62 FR 63271, Nov. 28, 1997; 5507, Feb. 13, 1996; 79 FR 16192, Mar. 25, 2014]
79 FR 16191, Mar. 25, 2014; 84 FR 39184, Aug. 9,
2019]
§ 522.1484 Neomycin.
§ 522.1465 Naltrexone. (a) Specifications. Each milliliter of
(a) Specifications. Each milliliter of solution contains 50 milligrams (mg) of
solution contains 50 milligrams of neomycin sulfate (equivalent to 35 mg
naltrexone hydrochloride. of neomycin base).
(b) Sponsor. See 053923 in § 510.600(c) of (b) Sponsor. See No. 054771 in
(c) Conditions of use in elk and moose— (c) Conditions of use in dogs and cats—
(1) Amount. 100 milligrams of (1) Amount. Administer 5 mg per pound
naltrexone hydrochloride for each mil- of body weight daily by intramuscular
ligram of carfentanil citrate adminis- or intravenous injection, divided into
tered. One-quarter of the dose should portions administered every 6 to 8
be administered intravenously and hours for 3 to 5 days.
three-quarters of the dose should be ad- (2) Indications for use. For the treat-
ministered subcutaneously. ment of acute and chronic bacterial in-
(2) Indications for use. As an antago- fections due to organisms susceptible
nist to carfentanil citrate immobiliza- to neomycin.
tion in free-ranging or confined elk and (3) Limitations. Not for parenteral use
moose (Cervidae). in food-producing animals because of
(3) Limitations. Do not use in domes- prolonged residues in edible tissues.
tic food-producing animals. Do not use Federal law restricts this drug to use
in free-ranging animals for 45 days be- by or on the order of a licensed veteri-
fore or during hunting season. Federal narian.
law restricts this drug to use by or on [79 FR 16192, Mar. 25, 2014]
the order of a licensed veterinarian.
[62 FR 5320, Feb. 5, 1997, as amended at 79 FR
§ 522.1503 Neostigmine.
16191, Mar. 25, 2014] (a) Specifications. Each milliliter of
solution contains 2 milligrams (mg) ne-
§ 522.1468 Naproxen for injection. ostigmine methylsulfate.
(a) Specifications. The drug is a (b) Sponsor. See No. 000061 in
lyophilized powder which is reconsti- § 510.600(c) of this chapter.
tuted with sterile water for injection (c) Conditions of use—(1) Amount. Ad-
to form a 10 percent sterile aqueous so- minister to cattle and horses at a dos-
lution (100 milligrams per milliliter). age level of 1 mg per (/) 100 pounds (lbs)
320
of body weight subcutaneously. Admin- (b) Sponsors. See Nos. 000010, 016592,
ister to sheep at a dosage level of 1 to 054771, 055529, 061133, and 069254 in
11⁄2 mg/100 lbs body weight § 510.600(c) of this chapter.
subcutaneously. Administer to swine (c) Related tolerances. See § 556.500 of
at a dosage level of 2 to 3 mg/100 lbs this chapter.
body weight intramuscularly. These (d) Special considerations. When la-
doses may be repeated as indicated. beled for the treatment of
(2) Indications for use. For treating anaplasmosis or anthrax, labeling shall
rumen atony; initiating peristalsis also bear the following: ‘‘Federal law
which causes evacuation of the bowel; restricts this drug to use by or on the
emptying the urinary bladder; and order of a licensed veterinarian.’’
stimulating skeletal muscle contrac- (e) Conditions of use—(1) Beef cattle,
tions. dairy cattle, and calves including
(3) Limitations. Not for use in animals prerumenative (veal) calves—(i) Amounts
producing milk, since this use will re- and indications for use. (A) 3 to 5 mg per
sult in contamination of the milk. Fed- pound of body weight (mg/lb BW) per
eral law restricts this drug to use by or day (/day) intramuscularly,
on the order of a licensed veterinarian. subcutaneously, or intravenously for
[40 FR 13858, Mar. 27, 1975, as amended at 62 treatment of pneumonia and shipping
FR 61625, Nov. 19, 1997; 79 FR 16192, Mar. 25, fever complex associated with
2014] Pasteurella spp. and Haemophilus spp.,
foot-rot and diphtheria caused by
§ 522.1610 Oleate sodium. Fusobacterium necrophorum, bacterial
(a) Specifications. Each milliliter of enteritis (scours) caused by Escherichia
solution contains 50 milligrams (mg) of coli, wooden tongue caused by
sodium oleate. Actinobacillus lignieresii, leptospirosis
(b) Sponsor. See No. 037990 in caused by Leptospira pomona, wound in-
§ 510.600(c) of this chapter. fections and acute metritis caused by
(c) Conditions of use in horses—(1) Staphylococcus spp. and Streptococcus
Amount. Administer by parenteral in- spp., and anthrax caused by Bacillus
jection depending on the area of re- anthracis.
sponse desired. An injection of 1 milli- (B) 5 mg/lb BW/day intramuscularly
liter (mL) will produce a response of or intravenously for treatment of
approximately 15 square centimeters. anaplasmosis caused by Anaplasma
Do not inject more than 2 mL per in- marginale, severe foot-rot, and ad-
jection site. Regardless of the number vanced cases of other indicated dis-
of injection sites, the total volume eases.
used should not exceed 10 mL. (C) 9 mg/lb BW intramuscularly or
(2) Indications for use. It is used in subcutaneously as single dosage where
horses to stimulate infiltration of cel- retreatment of calves and yearlings for
lular blood components that subse- bacterial pneumonia is impractical, for
quently differentiate into fibrous and/ treatment of infectious bovine
or fibrocartilagenous tissue. keratoconjunctivitis (pinkeye) caused
(3) Limitations. Do not use in horses by Moraxella bovis, or where retreat-
intended for human consumption. Fed- ment for anaplasmosis is impractical.
eral law restricts this drug to use by or (ii) Limitations. Exceeding the highest
on the order of a licensed veterinarian. recommended level of drug per pound
of bodyweight per day, administering
more than the recommended number of
FR 40966, Oct. 8, 1985; 79 FR 16192, Mar. 25,
2014] treatments, and/or exceeding 10 mL
intramuscularly or subcutaneously per
§ 522.1660 Oxytetracycline injectable injection site in adult beef and dairy
dosage forms. cattle may result in antibiotic residues
beyond the withdrawal time. Rapid in-
§ 522.1660a Oxytetracycline solution, travenous administration in cattle
200 milligrams/milliliter. may result in animal collapse. Oxytet-
(a) Specifications. Each milliliter of racycline should be administered intra-
sterile solution contains 200 milligrams venously slowly over a period of at

of oxytetracycline base. least 5 minutes. Discontinue treatment
321
§ 522.1660b 21 CFR Ch. I (4–1–23 Edition)
at least 28 days prior to slaughter. BW) per day (/day) intramuscularly,

Milk taken from animals during treat- subcutaneously, or intravenously for
ment and for 96 hours after the last treatment of pneumonia and shipping
treatment must not be used for food. fever complex associated with
For No. 054771: Federal law restricts Pasteurella spp. and Histophilus spp.,
this drug to use by or on the order of a foot-rot and diphtheria caused by
licensed veterinarian. Fusobacterium necrophorum, bacterial
(2) Swine—(i) Amounts and indications enteritis (scours) caused by Escherichia
for use. (A) Sows: 3 mg/lb BW coli, wooden tongue caused by
intramuscularly once, approximately 8 Actinobacillus lignieresii, leptospirosis
hours before farrowing or immediately caused by Leptospira pomona, wound in-
after completion of farrowing, as an aid fections and acute metritis caused by
in control of infectious enteritis (baby Staphylococcus spp. and Streptococcus
pig scours, colibacillosis) in suckling spp.
pigs caused by E. coli. (B) 5 mg/lb BW/day intramuscularly,
(B) 3 to 5 mg/lb BW/day subcutaneously, or intravenously for
intramuscularly for treatment of bac- treatment of severe foot-rot, and ad-
terial enteritis (scours, colibacillosis) vanced cases of other indicated dis-
caused by E. coli, pneumonia caused by eases.
Pasteurella multocida, and leptospirosis (C) 9 mg/lb BW intramuscularly or
caused by Leptospira pomona. subcutaneously as single dosage where
(C) 9 mg/lb BW as a single dosage retreatment of calves and yearlings for
where retreatment for pneumonia is bacterial pneumonia is impractical or
impractical. for treatment of infectious bovine
(ii) Limitations. Administer keratoconjunctivitis (pinkeye) caused
intramuscularly. Do not inject more by Moraxella bovis.
than 5 mL per site in adult swine. Dis- (D) 9 to 13.6 mg/lb BW
continue treatment at least 28 days intramuscularly or subcutaneously as
prior to slaughter. For No. 054771: Fed- single dosage where retreatment of
eral law restricts this drug to use by or calves and yearlings for bacterial pneu-
on the order of a licensed veterinarian. monia is impractical or for treatment
[45 FR 16479, Mar. 14, 1980. Redesignated and of infectious bovine
amended at 69 FR 31879, June 8, 2004] keratoconjunctivitis (pinkeye) caused
by Moraxella bovis.
tations affecting § 522.1660a, see the List of
(E) 13.6 mg/lb BW intramuscularly or
CFR Sections Affected, which appears in the subcutaneously as a single dosage for
Finding Aids section of the printed volume control of respiratory disease in cattle
and at www.govinfo.gov. at high risk of developing BRD associ-
ated with Mannheimia (Pasteurella)
§ 522.1660b Oxytetracycline solution, haemolytica.
300 milligrams/milliliter. (ii) Limitations. Treatment should be
(a) Specifications. Each milliliter continued 24 to 48 hours following re-
(mL) of solution contains 300 milli- mission of disease signs, however, not
grams (mg) oxytetracycline base. to exceed a total of four consecutive
(b) Sponsor. See No. 055529 in days. Do not inject more than 10 mL
§ 510.600(c) of this chapter. per site in adult cattle, reducing the
(c) Related tolerances. See § 556.500 of volume according to age and body size
this chapter. to 1 to 2 mL in small calves. Exceeding
(d) Special considerations. When la- the highest recommended level of drug/
beled for use as in paragraph (e)(1)(i)(D) lb BW/day, administering more than
or (e)(1)(i)(E) of this section, labeling the recommended number of treat-
shall also bear the following: ‘‘Federal ments, and/or exceeding 10 mL
law restricts this drug to use by or on intramuscularly or subcutaneously per
the order of a licensed veterinarian.’’. injection site may result in antibiotic
(e) Conditions of use—(1) Beef cattle, residues beyond the withdrawal time.
nonlactating dairy cattle, and calves in- Rapid intravenous administration may
cluding preruminating (veal) calves—(i) result in animal collapse. Oxytetra-
Amounts and indications for use. (A) 3 to cycline should be administered intra-
5 mg per pound of bodyweight (mg/lb venously slowly over a period of at
322
least 5 minutes. Discontinue treatment pneumonia and shipping fever complex

at least 28 days prior to slaughter. Not (Pasteurella spp.; Hemophilis spp.;
for use in lactating dairy animals. For Klebsiella spp. ), bacterial enteritis
No. 055529: Federal law restricts this (scours) (E. coli), foot-rot (Spherophorus
drug to use by or on the order of a li- necrophorus), diphtheria (Spherophorus
censed veterinarian. necrophorus), wooden tongue
(2) Swine—(i) Amounts and indications (Actinobacillus lignieresi), leptospirosis
for use. (A) Sows: 3 mg/lb BW (Leptospira pomona), and wound infec-
intramuscularly once, approximately 8 tions; acute metritis; traumatic injury
hours before farrowing or immediately (caused by a variety of bacterial orga-
after completion of farrowing, as an aid nisms (such as streptococcal and
in control of infectious enteritis (baby staphylococcal organisms).)
pig scours, colibacillosis) in suckling (ii) Indications for use. It is adminis-
pigs caused by E. coli. tered by intramuscular injection of 3 to
(B) 3 to 5 mg/lb BW/day 5 milligrams of oxytetracycline hydro-
intramuscularly for treatment of bac- chloride per pound of body weight per
terial enteritis (scours, colibacillosis) day. Leptospirosis, severe foot-rot and
caused by E. coli, pneumonia caused by severe forms of the indicated diseases
Pasteurella multocida, and leptospirosis should be treated with 5 milligrams per
caused by Leptospira pomona. pound of body weight per day. Treat-
(C) 9 mg/lb BW as a single dosage ment should be continued for 24 to 48
where retreatment for pneumonia is hours following remission of disease
impractical. symptoms; however, not to exceed a
(ii) Limitations. Administer total of 4 consecutive days. Only 2 mil-
intramuscularly. Treatment should be liliters of the drug should be injected
continued 24 to 48 hours beyond remis- per site in case of calves weighing 100
sion of disease signs, however, not to pounds or less and not more than 10
exceed a total of 4 consecutive days. milliliters should be injected per site
Exceeding the highest recommended in adult cattle.
level of drug/lb BW/day, administering (iii) Limitations. Discontinue treat-
more than the recommended number of ment with the drug at least 20 days
treatments, and/or exceeding 5 mL prior to slaughter of the animal. When
intramuscularly per injection site may administered to animals within 30 days
result in antibiotic residues beyond the of slaughter, muscle discoloration may
withdrawal time. Discontinue treat- necessitate trimming of injection site
ment at least 28 days prior to slaugh- and surrounding tissues.
ter. For No. 055529: Federal law re- (c)(1) Specifications. Each milliliter of
stricts this drug to use by or on the sterile solution contains 50 or 100 milli-
order of a licensed veterinarian. grams of oxytetracycline (as oxytetra-
[68 FR 54805, Sept. 19, 2003. Redesignated and cycline hydrochloride).
amended at 69 FR 31879, June 8, 2004; 73 FR (2) Sponsor. See 069043 in § 510.600(c) of
14926, Mar. 20, 2008; 88 FR 16548, Mar. 20, 2023] this chapter.
(3) Conditions of use—(i) Beef cattle
§ 522.1662 Oxytetracycline. and nonlactating dairy cattle—(A)
(a) For related tolerances see § 556.500 Amount. Three to 5 milligrams of oxy-
of this chapter. tetracycline per pound of body weight
(b)(1) Specifications. The drug con- per day; 5 milligrams per pound of body
tains 50 milligrams of oxytetracycline weight per day for the treatment of
hydrochloride in each milliliter of ster- anaplasmosis, severe foot-rot, and se-
ile solution. vere cases of other indicated diseases.
(2) Sponsor. See No. 069043 in (B) Indications for use. Treatment of
§ 510.600(c) of this chapter. diseases due to oxytetracycline-suscep-
(3) Conditions of use—(i) Amount. The tible organisms as follows: Pneumonia
drug is intended for use in beef cattle, and shipping fever complex associated
beef calves, nonlactating dairy cattle, with Pasteurella spp., Haemophilus spp.,
and dairy calves for treatment of dis- and Klebsiella spp., foot-rot and diph-
ease conditions caused by one or more theria caused by Spherophorus
of the following oxytetracycline sen- necrophorus, bacterial enteritis (scours)

sitive pathogens listed as follows: caused by Escherichia coli, wooden
323
§ 522.1662 21 CFR Ch. I (4–1–23 Edition)
tongue caused by Actinobacillus (d)(1) Specifications. Each milliliter of

lignieresi, leptospirosis caused by solution contains 100 mg of oxytetra-
Leptospira pomona, and wound infec- cycline hydrochloride.
tions and acute metritis caused by (2) Sponsor. See No. 054771 in
Staphylococcus spp. and Streptococcus § 510.600(c) of this chapter.
spp. If labeled for use by or on the (3) Conditions of use in beef cattle and
order of a licensed veterinarian, it may nonlactating dairy cattle—(i) Amount.
be used for the treatment of Administer 3 to 5 mg of oxytetra-
anaplasmosis caused by Anaplasma cycline per pound of body weight per
marginale. day by intramuscular injection, not to
(C) Limitations. For 50-milligram-per- exceed a total of 4 consecutive days.
milliliter solution, administer Administer 5 mg/lb of body weight per
intramuscularly or intravenously; for day for treatment of anaplasmosis, se-
100-milligram-per-milliliter solution, vere foot-rot, or severe cases of other
administer intramuscularly only. indicated diseases, not to exceed a
Treatment of all diseases should be in- total of 4 consecutive days.
stituted early and continue for 24 to 48 (ii) Indications for use. For treatment
hours beyond remission of disease of diseases due to oxytetracycline-sus-
symptoms, but not to exceed a total of ceptible organisms as follows: Pneu-
4 consecutive days. Consult your vet- monia and shipping fever complex asso-
erinarian if no improvement is noted ciated with Pasteurella spp. and
within 48 hours. Do not inject more Haemophilus spp., foot-rot and diph-
than 10 milliliters per site in adult cat- theria caused by Fusobacterium
tle, reducing the volume according to necrophorum, bacterial enteritis
age and body size to 0.5 to 2 milliliters (scours) caused by Escherichia coli,
in small calves. Exceeding the highest wooden tongue caused by Actinobacillus
recommended dose of 5 milligrams per lignieresii, leptospirosis caused by
pound of body weight, administering at Leptospira pomona, and wound infec-
recommended levels for more than 4 tions and acute metritis caused by
Staphylococcus spp. and Streptococcus
consecutive days, and/or exceeding 10
spp. For treatment of anaplasmosis
milliliters intramuscularly per injec-
caused by Anaplasma marginale and an-
tion site may result in antibiotic resi-
thrax caused by Bacillus anthracis.
dues beyond the withdrawal time. Dis-
(iii) Limitations. This drug product is
continue treatment at least 18 days
not approved for use in female dairy
prior to slaughter. Not for use in lac-
tating dairy cattle.
(ii) Swine—(A) Amount. Three to 5 cattle may cause drug residues in milk
milligrams of oxytetracycline per and/or in calves born to these cows.
pound of body weight per day. Sows: 3 Discontinue treatment at least 15 days
milligrams of oxytetracycline per prior to slaughter. Federal law re-
pound of body weight, approximately 8 stricts this drug to use by or on the
hours before farrowing or immediately order of a licensed veterinarian.
after completion of farrowing. (e)(1) Specifications. Each milliliter of
(B) Indications for use. For treatment solution contains 50 mg of oxytetra-
of bacterial enteritis (scours, cycline hydrochloride.
colibacillosis) caused by Escherichia (2) Sponsor. See No. 054771 in
coli, pneumonia caused by Pasteurella § 510.600(c) of this chapter.
multocida, and leptospirosis caused by (3) Conditions of use in beef cattle and
Leptospira pomona. Sows: as an aid in nonlactating dairy cattle. It is used as
control of infectious enteritis (baby pig follows:
scours, colibacillosis) in suckling pigs (i) Amount. Administer by intra-
caused by Escherichia coli. venous or intramuscular injection at 3
(C) Limitations. Administer to 5 mg/lb of body weight per day, not
intramuscularly. Do not inject more exceed a total of 4 consecutive days.
than 5 milliliters per site. Do not use (ii) Indications for use. For treatment
for more than 4 consecutive days. Dis- of pneumonia and shipping fever com-
continue treatment at least 26 days be- plex associated with Pasteurella spp.
fore slaughter. and Haemophilus spp.; foot-rot and
324
diphtheria caused by Spherophorus and infectious synovitis caused by

necrophorus; bacterial enteritis (scours) Mycoplasma synoviae.
caused by Escherichia coli; wooden (iii) Limitations. Do not administer to
tongue caused by Actinobacillus laying hens unless the eggs are used for
lignieresii; leptospirosis caused by hatching only. Discontinue treatment
Leptospira pomona; wound infections at least 5 days prior to slaughter. Fed-
and acute metritis caused by staphy- eral law restricts this drug to use by or
lococcal and streptococcal organisms; on the order of a licensed veterinarian.
and treatment of anaplasmosis caused (f)(1) Specifications. Each milliliter of
by Anaplasma marginale and anthrax solution contains 100 mg of oxytetra-
caused by Bacillus anthracis. cycline hydrochloride.
cattle 20 months of age or older, in- § 510.600(c) of this chapter.
cluding dry dairy cows. Use in these (3) Conditions of use in beef cattle and
cattle may cause drug residues in milk nonlactating dairy cattle—(i) Amount.
and/or in calves born to these cows. Administer 3 to 5 mg of oxytetra-
Discontinue treatment at least 22 days cycline per pound of body weight per
prior to slaughter. Federal law re- day by intramuscular injection, not to
stricts this drug to use by or on the exceed a total of 4 consecutive days.
order of a licensed veterinarian. Administer 5 mg/lb of body weight per
(4) Conditions of use in swine. It is day for treatment of anaplasmosis, se-
used in swine as follows: vere foot-rot, or severe cases of other
(i) Amount. Administer by indicated diseases, not to exceed a
intramuscular injection at 3 to 5 mg/lb total of 4 consecutive days.
of body weight per day to swine, not to (ii) Indications for use. For treatment
exceed a total of 4 consecutive days. of diseases due to oxytetracycline-sus-
Administered to sows at 3 mg/lb of ceptible organisms as follows: Pneu-
body weight approximately 8 hours be- monia and shipping fever complex asso-
fore farrowing or immediately after ciated with Pasteurella spp. and
farrowing. Haemophilus spp., foot-rot and diph-
(ii) Indications for use. It is used for theria caused by Fusobacterium
the treatment of bacterial enteritis necrophorum, bacterial enteritis
(scours, colibacillosis) caused by Esch- (scours) caused by Escherichia coli,
erichia coli; pneumonia caused by wooden tongue caused by Actinobacillus
Pasteurella multocida; and leptospirosis lignieresii, leptospirosis caused by
caused by Leptospira pomona. Adminis- Leptospira pomona, and wound infec-
tered to sows as an aid in the control of tions and acute metritis caused by
infectious enteritis (baby pig scours, Staphylococcus spp. and Streptococcus
colibacillosis) in suckling pigs caused spp. For treatment of anaplasmosis
by Escherichia coli. caused by Anaplasma marginale and an-
(iii) Limitations. Discontinue treat- thrax caused by Bacillus anthracis.
ment at least 22 days prior to slaugh-
ter. Federal law restricts this drug to
erinarian. cattle 20 months of age or older, in-
(5) Poultry (broilers, turkeys, and breed- cluding dry dairy cows. Use in these
ing chickens). It is used as follows: cattle may cause drug residues in milk
(i) Amount. Administer and/or in calves born to these cows.
subcutaneously to chickens and tur- Discontinue treatment at least 15 days
keys according to age as directed on la- prior to slaughter. Federal law re-
beling. stricts this drug to use by or on the
(ii) Indications for use. For the treat- order of a licensed veterinarian.
ment of air sacculitis (air-sac disease, (g)(1) Specifications. Each milliliter of
chronic respiratory disease) caused by sterile solution contains 100 milligrams
Mycoplasma gallisepticum and Esch- of oxytetracycline as oxytetracycline
erichia coli; fowl cholera caused by hydrochloride.
Pasteurella multocida; infectious sinus- (2) Sponsor. See No. 069043 in

itis caused by Mycoplasma gallisepticum; § 510.600(c) of this chapter.
325
§ 522.1662 21 CFR Ch. I (4–1–23 Edition)
(3) Conditions of use. The drug is used noted within 24 hours, consult a veteri-
for the treatment of diseases due to ox- narian. Do not inject more than 5 mil-
ytetracycline-susceptible organisms as liliters per site. Discontinue treatment
follows: at least 20 days prior to slaughter.
(i) Beef cattle, beef calves, nonlactating (h)(1) Specifications. Each milliliter of
dairy cattle, and dairy calves—(A) sterile solution contains 50 or 100 milli-
Amount. 3 to 5 milligrams of oxytetra- grams of oxytetracycline hydro-
cycline per pound of body weight per chloride.
day. (2) Sponsors. See No. 069043 in
(B) Indications for use. For the treat- § 510.600(c) of this chapter for use of 50
ment of pneumonia and shipping fever and 100 milligrams per milliliter solu-
complex associated with Pasteurella tion; and Nos. 016592 and 055529 in
spp., Haemophilus spp., or Klebsiella spp. § 510.600(c) for use of 100 milligrams per
(C) Limitations. Administer by milliliter solution.
intramuscular, intravenous, or sub- (3) Conditions of use—(i) Amount. The
cutaneous injection. In severe forms of drug is used in beef cattle, beef calves,
the indicated diseases, administer 5 nonlactating dairy cattle, and dairy
milligrams of oxytetracycline per calves as follows: 3 to 5 milligrams of
pound of body weight per day. Continue oxytetracycline hydrochloride per
treatment 24 to 48 hours following re- pound of body weight per day; 5 milli-
mission of disease symptoms, not to
grams per pound of body weight per
exceed a total of 4 consecutive days. If
day for treatment of severe forms of
no improvement is noted within 48
the indicated diseases.
hours, consult a veterinarian. Do not
inject more than 10 milliliters per in- (ii) Indications for use. The drug is
jection site intramuscularly in adult used for treatment of bacterial pneu-
cattle; no more than 1 milliliter per monia and shipping fever complex asso-
site in calves weighing 100 pounds or ciated with Pasteurella spp.; foot-rot
less. Do not slaughter cattle for 13 days and calf diphtheria caused by
after intramuscular or intravenous Fusobacterium necrophorum bacterial
treatment, or 2 days after subcuta- enterities (scours) caused by Esch-
neous treatment. Exceeding the high- erichia coli; wooden tongue caused by
est recommended dosage or duration of Actinobacillus lignieresi; wound infec-
treatment (not more than 4 consecu- tions, acute metrities, and traumatic
tive days) may result in residues be- injury caused by staphylococcal and
yond the withdrawal period. A with- streptococcal organisms.
drawal period has not been established (iii) Limitations. Administer 50-milli-
for use of this product in gram-per-milliliter solution
preruminating calves. Do not use in intramuscularly; administer 100-milli-
calves to be processed for veal. gram-per-milliliter solution intra-
(ii) Swine—(A) Amount. 3 to 5 milli- venously. Continue treatment 24 to 48
grams of oxytetracycline per pound of hours following remission of disease
body weight per day. Sows: Administer symptoms, not to exceed a total of 4
once 3 milligrams of oxytetracycline consecutive days. If no improvement is
per pound of body weight, approxi- noted within 24 to 48 hours, consult a
mately 8 hours before farrowing or im- veterinarian for diagnosis and therapy.
mediately after completion of When injecting the drug
farrowing. intramuscularly, do no inject more
(B) Indications for use. For treatment than 10 milliliters per site in adult cat-
of bacterial enteritis (scours, tle. Reduce the volume administered
colibacillosis) caused by Escherichia per injection site according to age and
coli, pneumonia caused by Pasteurella body size. In calves weighing 100
multocida, and leptospirosis caused by pounds or less, do no inject more than
Leptospira pomona. Sows: As an aid in 2 milliliters intramuscularly per site.
control of infectious enteritis (baby pig Discontinue treatment at least 22 days
scours, colibacillosis) in suckling pigs before slaughter. Not for use in lac-
caused by Escherichia coli. tating dairy animals. A withdrawal pe-
(C) Limitations. Administer riod has not been established for this
intramuscularly. If no improvement is product in preruminating calves. Do
326
not use in calves to be processed for coli; wooden tongue caused by

veal. Actinobacillus lignieresii; leptospirosis
(i)(1) Specifications. Each milliliter of caused by Leptospira pomona; acute me-
solution contains 50 milligrams (mg) of tritis and wound infections caused by
oxytetracycline hydrochloride. staphylococcal and streptococcal orga-
(2) Sponsor. See No. 016592 in nisms; if labeled for use by or on the
§ 510.600(c) of this chapter. order of a licensed veterinarian, it may
(3) Conditions of use in beef cattle, beef be used for treatment of anaplasmosis
calves, nonlactating dairy cattle, and caused by Anaplasma marginale and an-
dairy calves—(i) Amount. Administer 3 thrax caused by Bacillus anthracis.
to 5 mg/lb body weight per day by
(iii) Limitations. Not for use in lac-
intramuscular injection not to exceed a
tating dairy cattle. Discontinue use at
total of 4 consecutive days.
(ii) Indications for use. For treatment least 19 days prior to slaughter. Fed-
of bacterial pneumonia and shipping eral law restricts this drug to use by or
fever complex associated with on the order of a licensed veterinarian.
Pasteurella spp.; foot-rot and diphtheria [40 FR 13858, Mar. 27, 1975. Redesignated at 88
caused by Spherophorus necrophorus; FR 14898, Mar. 10, 2023]
bacterial enteritis (scours) caused by
Escherichia coli; wooden tongue caused
tations affecting § 522.1662, see the List of
by Actinobacillus lignieresii; wound in- CFR Sections Affected, which appears in the
fections and acute metritis caused by Finding Aids section of the printed volume
staphylococcal and streptococcal orga- and at www.govinfo.gov.
nisms susceptible to oxytetracycline.
(iii) Limitations. This drug product is § 522.1663 Oxytetracycline hydro-
not approved for use in female dairy chloride with lidocaine injection.
(a) Specifications. The drug contains
50 or 100 milligrams of oxytetracycline
cattle may cause drug residues in milk
and/or in calves born to these cows. hydrochloride and 2 percent lidocaine
Discontinue treatment at least 18 days in each milliliter of sterile aqueous so-
before slaughter. Federal law restricts lution.
this drug to use by or on the order of a (b) Sponsor. See No. 054771 in
licensed veterinarian. § 510.600(c) of this chapter.
(j)(1) Specifications. Each milliliter of (c) Conditions of use. (1) The drug is
sterile solution contains either 50 or indicated for use in the treatment of
100 milligrams of oxytetracycline hy- diseases of dogs caused by pathogens
drochloride. sensitive to oxytetracycline hydro-
(2) Sponsor. See No. 061133 in chloride including treatment for the
§ 510.600(c) of this chapter. following conditions in dogs caused by
(3) Conditions of use in beef cattle and susceptible microorganisms: Bacterial
nonlactating dairy cattle—(i) Amount. infections of the urinary tract caused
Administer by intravenous injection 3 by Hemolytic staphylococcus, Strepto-
to 5 milligrams per pound of body coccus spp., Bacterial pulmonary infec-
weight daily. Administer 5 milligrams tions caused by Brucella bronchiseptica,
per pound for anaplasmosis, severe foot Streptococcus pyogenes, Staphylococcus
rot, and severe forms of other diseases. aureus, secondary bacterial infections
Treatment should be continued 24 to 48
caused by Micrococcus pyogenes var.
hours following remission of disease
albus, Brucella bronchiseptica, Strepto-
symptoms, but not to exceed a total of
4 consecutive days. coccus spp.
(ii) Indications for use. Treatment of (2) The drug is administered
diseases due to oxytetracycline-suscep- intramuscularly at a recommended
tible organisms as follows: pneumonia daily dosage to dogs at 5 milligrams
and shipping fever complex associated per pound of body weight administered
with Pasteurella spp. and Haemophilus in divided doses at 6 to 12 hour inter-
spp.; foot rot and diphtheria caused by vals. Therapy should be continued for
Fusobacterium necrophorum; bacterial at least 24 hours after all symptoms

enteritis (scours) caused by Escherichia have subsided.
327
§ 522.1664 21 CFR Ch. I (4–1–23 Edition)
(3) Federal law restricts this drug to venously, intramuscularly, or

use by or on the order of a licensed vet- subcutaneously under aseptic condi-
erinarian. tions as indicated. The following dos-
ages are recommended and may be re-
FR 30615, July 5, 1983; 79 FR 16192, Mar. 25, peated as conditions require:
2014. Redesignated at 88 FR 14898, Mar. 10,
mL U.S.P. units
2023]
Cats ...................... 0.25 to 0.5 ............ 5 to 10.
§ 522.1664 Oxytetracycline and Dogs ..................... 0.25 to 1.5 ............ 5 to 30.
flunixin. Ewes, Sows .......... 1.5 to 2.5 .............. 30 to 50.
Cows, Horses ....... 5.0 ........................ 100.
(ii) Milk letdown. Intravenous admin-
grams (mg) oxytetracycline base as
istration is desirable. The following
amphoteric oxytetracycline and 20 mg
flunixin base as flunixin meglumine. dosage is recommended and may be re-
(b) Sponsor. See No. 055529 in peated as conditions require:
§ 510.600(c) of this chapter. mL U.S.P. units
(c) Related tolerances. See §§ 556.286
and 556.500 of this chapter. Cows ..................... 0.5 to 1.0 .............. 10 to 20.
Sows ..................... 0.25 to 1.0 ............ 5 to 20.
(d) Conditions of use cattle—(1)
Amount. Administer once as an
(2) Indications for use. Oxytocin may
intramuscular or subcutaneous injec-
tion of 1 mL per 22 pounds (lb) body be used as a uterine contractor to pre-
weight (BW) (13.6 mg oxytetracycline cipitate and accelerate normal parturi-
and 0.9 mg flunixin per lb BW) where tion and postpartum evacuation of
retreatment of calves and yearlings for uterine debris. In surgery it may be
bacterial pneumonia is impractical due used postoperatively following cesar-
to husbandry conditions, such as cattle ean section to facilitate involution and
on range, or where their repeated re- resistance to the large inflow of blood.
straint is inadvisable. It will contract smooth muscle cells of
(2) Indications for use. For the treat- the mammary gland for milk letdown
ment of bacterial pneumonia associ- if the udder is in proper physiological
ated with Pasteurella spp. and for the state.
control of associated pyrexia in beef (3) Limitations. Federal law restricts
and nonlactating dairy cattle. this drug to use by or on the order of a
(3) Limitations. Discontinue treat- licensed veterinarian.
ment at least 21 days prior to slaughter [44 FR 63097, Nov. 2, 1979; 45 FR 1019, Jan. 4,
of cattle. This drug product is not ap- 1980]
proved for use in female dairy cattle 20
months of age or older, including dry tations affecting § 522.1680, see the List of
dairy cows. Use in these cattle may CFR Sections Affected, which appears in the
cause drug residues in milk and/or in Finding Aids section of the printed volume
calves born to these cows. A with- and at www.govinfo.gov.
drawal period has not been established
in preruminating calves. Do not use in § 522.1684 Pegbovigrastim.
calves to be processed for veal. Federal (a) Specifications. Each pre-filled, sin-
law restricts this drug to use by or on gle-dose syringe contains 15 milligrams
the order of a licensed veterinarian. of pegbovigrastim.
[76 FR 3489, Jan. 20, 2011, as amended at 79 (b) Sponsor. See No. 058198 in
FR 16192, Mar. 25, 2014] § 510.600(c) of this chapter.
(c) Conditions of use in cattle—(1)
§ 522.1680 Oxytocin. Amount. Administer the first dose (sy-
(a) Specifications. Each milliliter ringe) by subcutaneous injection 7 days
(mL) of solution contains 20 USP units prior to the cow’s or heifer’s antici-
oxytocin. pated calving date. If necessary, the
(b) Sponsors. See Nos. 054771 and first dose may be administered within
061133 in § 510.600(c) of this chapter. a range of 4 to 10 days prior to the an-
(c) Conditions of use—(1) Amount—(i) ticipated calving date to accommodate

Obstetrical. Administer drug intra- management schedules. Administer the
328
second dose (syringe) by subcutaneous drug to use by or on the order of a li-

injection within 24 hours after calving. censed veterinarian.
(2) Indications for use. For the reduc- (2) Beef cattle—(i) Amount. 2 milli-
tion in the incidence of clinical mas- liters per 150 pounds of body weight
titis in the first 30 days of lactation in subcutaneously. Repeat dosage in 48
periparturient dairy cows and hours.
periparturient replacement dairy heif- (ii) Indications for use. (A) Treatment
ers. of bacterial pneumonia (Streptococcus
(3) Limitations. Federal law restricts spp., Actinomyces pyogenes, Staphy-
this drug to use by or on the order of a lococcus aureus); upper respiratory in-
licensed veterinarian. fections such as rhinitis or pharyngitis
(A. pyogenes); blackleg (Clostridium
[81 FR 36789, June 8, 2016, as amended at 81 chauvoei).
FR 48702, July 26, 2016]
(B) As in paragraph (d)(2)(ii)(A) of
§ 522.1696 Penicillin G procaine this section; and prophylaxis of bovine
injectable dosage forms. shipping fever in 300- to 500-pound beef
calves.
§ 522.1696a Penicillin G benzathine (iii) Limitations. Not for use within 30
and penicillin G procaine suspen- days of slaughter. For No. 016592: A
sion. withdrawal period has not been estab-
(a) Specifications. Each milliliter of lished for this product in pre-rumi-
aqueous suspension contains penicillin nating calves. Do not use in calves to
G benzathine and penicillin G procaine, be processed for veal. For No. 016592:
each equivalent to 150,000 units of peni- Federal law restricts this drug to use
cillin G. by or on the order of a licensed veteri-
(b) Sponsors. See sponsors in narian.
§ 510.600(c) of this chapter for the condi- [66 FR 711, Jan. 4, 2001, as amended at 68 FR
tions of use in paragraph (d) of this sec- 34534, June 10, 2003; 70 FR 21947, Apr. 28, 2005;
tion as follows: 70 FR 50182, Aug. 26, 2005; 73 FR 16754, Mar.
(1) Nos. 054771 and 061133 for use as in 31, 2008; 75 FR 54017, Sept. 3, 2010; 77 FR 4897,
paragraph (d)(1) of this section. Feb. 1, 2012; 78 FR 17597, Mar. 22, 2013; 79 FR
16192, Mar. 25, 2014; 81 FR 22524, Apr. 18, 2016;
(2) Nos. 016592 and 061133 for use as in 84 FR 8974, Mar. 13, 2019; 85 FR 18120, Apr. 1,
paragraphs (d)(2)(i), (d)(2)(ii)(A), and 2020; 88 FR 16548, Mar. 20, 2023]
(d)(2)(iii) of this section.
(3) No. 054771 for use as in paragraphs § 522.1696b Penicillin G procaine aque-
(d)(2)(i), (d)(2)(ii)(B), and (d)(2)(iii) of ous suspension.
this section. (a) Specifications. Each milliliter con-
(c) Related tolerances. See § 556.510 of tains penicillin G procaine equivalent
this chapter. to 300,000 units of penicillin G.
(d) Conditions of use—(1) Horses, dogs, (b) Sponsors. See sponsor numbers in
and beef cattle—(i) Amount—(A) Beef § 510.600(c) of this chapter as follows:
cattle. 2 milliliters per 150 pounds of (1) Nos. 016592 and 054771 for use as in
body weight intramuscularly or paragraph (d) of this section.
subcutaneously. Repeat dosage in 48 (2) Nos. 055529 and 061133 for use as in
hours. paragraph (d)(2) of this section.
(B) Horses. 2 milliliters per 150 pounds (c) Related tolerances. See § 556.510 of
of body weight intramuscularly. Re- this chapter.
peat dosage in 48 hours. (d) Conditions of use—(1) Dogs and
(C) Dogs. 1 milliliter per 10 to 25 cats—(i) Amount. 10,000 units per pound
pounds of body weight intramuscularly body weight daily by intramuscular in-
or subcutaneously. Repeat dosage in 48 jection.
hours. (ii) Indications for use. Treatment of
(ii) Indications for use. Treatment of infections caused by penicillin-sen-
bacterial infections susceptible to peni- sitive organisms.
cillin G. (iii) Limitations. Federal law restricts
(iii) Limitations. Not for use in beef this drug to use by or on the order of a
cattle within 30 days of slaughter. Do licensed veterinarian.
not use in horses intended for human (2) Cattle, sheep, swine, and horses—(i)
consumption. Federal law restricts this Amount. 3,000 units per pound body
329
§ 522.1696c 21 CFR Ch. I (4–1–23 Edition)
weight (1 milliliter per 100 pounds body nisms such as Streptococci,

weight) daily by intramuscular injec- Staphylococci, and Corynebacteria.
tion. (3) Limitations. Not for use in food-
(ii) Indications for use. Treatment of producing animals. Federal law re-
cattle and sheep for bacterial pneu- stricts this drug to use by or on the
monia (shipping fever) caused by order of a licensed veterinarian.
Pasteurella multocida; swine for erysipe-
las caused by Erysipelothrix FR 16193, Mar. 25, 2014]
rhusiopathiae; and horses for strangles
caused by Streptococcus equi. § 522.1698 Pentazocine.
(iii) Limitations. Not for use in horses
intended for food. Milk that has been
solution contains pentazocine lactate
taken during treatment and for 48
equivalent to 30 milligrams (mg) of
hours after the last treatment must
pentazocine base.
not be used for food.
(A) For Nos. 054771 and 061133: Do not
exceed 7 days of treatment in nonlac-
tating dairy and beef cattle, sheep, and (c) Conditions of use—(1) Horses—(i)
swine, or 5 days in lactating cattle. Amount. Administer 0.15 mg
Discontinue treatment for the fol- pentazocine base per pound of body
lowing number of days before slaugh- weight daily by intravenous or
ter: Nonruminating cattle (calves)—7; intramuscular injection. In cases of se-
all other cattle—4; sheep—8; and vere pain, a second dose is rec-
swine—6. ommended by intramuscular injection
10 to 15 minutes after the initial dose
(B) For Nos. 016592 and 055529: Treat-
at the same level.
ment should not exceed 4 consecutive
days. A withdrawal period has not been (ii) Indications for use. For sympto-
established for this product in pre-ru- matic relief of pain due to colic.
minating calves. Discontinue treat- (iii) Limitations. Do not use in horses
ment for the following number of days intended for human consumption. Fed-
before slaughter: Cattle—10; sheep—9; eral law restricts this drug to use by or
and swine—7. on the order of a licensed veterinarian.
(C) For Nos. 054771 and 055529: Federal (2) Dogs—(i) Amount. Administer 0.75
law restricts this drug to use by or on to 1.50 mg of pentazocine base per
the order of a licensed veterinarian. pound of body weight by intramuscular
injection.
[66 FR 712, Jan. 4, 2001, as amended at 68 FR (ii) Indications for use. For ameliora-
34534, June 10, 2003; 68 FR 42589, July 18, 2003; tion of pain accompanying post-
69 FR 17586, Apr. 5, 2004; 70 FR 16935, Apr. 4,
operative recovery, fracture, trauma,
2005; 73 FR 14177, Mar. 17, 2008; 75 FR 54017,
Sept. 3, 2010; 78 FR 17597, Mar. 22, 2013; 79 FR and spinal disorders.
16192, Mar. 25, 2014; 81 FR 22524, Apr. 18, 2016; (iii) Limitations. Federal law restricts
84 FR 8974, Mar. 13, 2019; 85 FR 18120, Apr. 1, this drug to use by or on the order of a
2020; 88 FR 14899, Mar. 10, 2023; 88 FR 16548, licensed veterinarian.
Mar. 20, 2023]
§ 522.1696c Penicillin G procaine in FR 36995, July 19, 1977; 47 FR 5409, Feb. 5,
oil. 1982; 55 FR 23076, June 6, 1990; 79 FR 16193,
Mar. 25, 2014. Redesignated at 86 FR 61685,
(a) Specifications. Each milliliter con- Nov. 8, 2021, and further redesignated at 88
tains penicillin G procaine equivalent FR 14899, Mar. 10, 2023]
to 300,000 units of penicillin G.
(b) Sponsor. See No. 054771 in § 522.1700 Pentobarbital and phe-
§ 510.600(c) of this chapter. nytoin.
(c) Conditions of use—(1) Amount. Dogs (a) Specifications. Each milliliter
and cats—10,000 units per pound of body (mL) of solution contains 390 milli-
weight once daily. Horses—3,000 units grams (mg) pentobarbital sodium and
per pound of body weight once daily. 50 mg phenytoin sodium.
(2) Indications for use. Treatment of (b) Sponsors. See Nos. 000061, 051311,
infections of dogs, cats, and horses 054925, and 059399 in § 510.600(c) of this
caused by penicillin-susceptible orga- chapter.
330
(c) Special considerations. Product la- eral law restricts this drug to use by or
beling shall bear the following warning on the order of a licensed veterinarian.
statements: ‘‘ENVIRONMENTAL HAZ-
[79 FR 16193, Mar. 25, 2014. Redesignated at 86
ARD: This product is toxic to wildlife.
FR 61685, Nov. 8, 2021]
Birds and mammals feeding on treated
animals may be killed. Euthanized ani- § 522.1704 Pentosan polysulfate so-
mals must be properly disposed of by dium.
deep burial, incineration, or other
method in compliance with State and (a) Specifications. Each milliliter of
local laws, to prevent consumption of solution contains 250 milligrams (mg)
carcass material by scavenging wild- of pentosan polysulfate sodium.
life.’’ (b) Sponsor. See No. 086073 in
(d) Conditions of use in dogs—(1) § 510.600(c) of this chapter.
Amount. Administer 1 mL per 10 pounds (c) Conditions of use—(1) Amount. Ad-
of body weight as a single, bolus intra- minister 3 mg per kilogram of body
venous or intracardiac injection. weight (1.4 mg per pound) by
(2) Indications for use. For humane, intramuscular injection once weekly
painless, and rapid euthanasia. for 4 weeks for a total of four doses.
(3) Limitations. Do not use in animals (2) Indications for use. For the control
intended for food. Federal law restricts of clinical signs associated with osteo-
this drug to use by or on the order of a arthritis in horses.
licensed veterinarian. (3) Limitations. Federal law restricts
[85 FR 18120, Apr. 1, 2020, as amended at 85 this drug to use by or on the order of a
FR 45308, July 28, 2020. Redesiganted at 86 FR licensed veterinarian.
61685, Nov. 8, 2021]
[88 FR 16548, Mar. 20, 2023]
§ 522.1703 Pentobarbital.
(a) Specifications. Each milliliter of § 522.1720 Phenylbutazone.
solution contains 64.8 milligrams (mg) (a) Specifications. (1) Each milliliter
of sodium pentobarbital. of solution contains 100 milligrams
(b) Sponsor. See No. 000061 in (mg) of phenylbutazone.
§ 510.600(c) of this chapter. (2) Each milliliter of solution con-
(c) Conditions of use—(1) Amount. The tains 200 mg of phenylbutazone.
drug is administered intravenously ‘‘to (b) Sponsors. See sponsor numbers in
effect’’. For general surgical anes- § 510.600(c) of this chapter for use as in
thesia, the usual dose is 11 to 13 mg per paragraph (c) of this section:
pound of body weight. For sedation, (1) No. 054771 for use of product de-
the usual dose is approximately 2 mg scribed in paragraph (a)(1) as in para-
per pound of body weight. For relieving graph (c) of this section.
convulsive seizures caused by strych-
(2) Nos. 000061, 054771, 058198, and
nine in dogs, the injection should be
061133 for use of product described in
administered intravenously ‘‘to ef-
paragraph (a)(2) of this section as in
fect’’. The drug may be administered
paragraph (c) of this section.
intraperitoneally. When given
intraperitoneally, it is administered at (3) Nos. 058005 and 069043 for use of
the same dosage level as for intra- product described in paragraph (a)(2) as
venous administration. in paragraph (c)(2) of this section.
(2) Indications for use. The drug is in- (c) Conditions of use—(1) Dogs—(i)
dicated for use as a general anesthetic Amount. Administer by intravenous in-
in dogs and cats. Although it may be jection 10 mg per pound of body weight
used as a general surgical anesthetic daily in three divided doses, not to ex-
for horses, it is usually given at a ceed 800 mg daily regardless of weight.
lower dose to cause sedation and hyp- Limit intravenous administration to 2
nosis and may be supplemented with a successive days. Oral medication may
local anesthetic. It may also be used in follow.
dogs for the symptomatic treatment of (ii) Indications for use. It is used for
strychnine poisoning. the relief of inflammatory conditions
(3) Limitations. Do not use in horses associated with the musculoskeletal

intended for human consumption. Fed- system.
331
§ 522.1820 21 CFR Ch. I (4–1–23 Edition)
(iii) Limitations. Federal law restricts (2) Each mL of solution packaged in

this drug to use by or on the order of a 5-mL ampules or 20-, 30-, or 50-mL vials
licensed veterinarian. contains 100 mg polysulfated
(2) Horses—(i) Amount. Administer by glycosaminoglycan.
intravenous injection 1 to 2 grams (g) (b) Sponsor. See No. 010797 in
per 1,000 pounds of body weight daily in § 510.600(c) of this chapter.
three divided doses, not to exceed 4 g (c) Special considerations. Federal law
daily. Limit intravenous administra- restricts this drug to use by or on the
tion to not more than 5 successive order of a licensed veterinarian.
days. (d) Conditions of use—(1) Horses—(i)
(ii) Indications for use. For the relief Indications for use. For the treatment of
of inflammatory conditions associated noninfectious degenerative and/or trau-
with the musculoskeletal system. matic joint dysfunction and associated
(iii) Limitations. Do not use in horses lameness of the carpal and hock joints
intended for human consumption. Fed- in horses.
eral law restricts this drug to use by or (ii) Amount—(A) Intra-articular use
on the order of a licensed veterinarian. (carpal): 250 mg once a week for 5
weeks.
FR 48946, Sept. 28, 2018; 84 FR 8974, Mar. 13, (B) Intramuscular use (carpal and
2019; 86 FR 14820, Mar. 19, 2021] hock): 500 mg every 4 days for 28 days.
§ 522.1820 Pituitary luteinizing hor- intended for human consumption.
mone powder for injection. (2) Dogs—(i) Indications for use. For
(a) Specifications. The drug is a control of signs associated with non-
lyophilized pituitary extract. Each 6- infectious degenerative and/or trau-
milliliter vial contains an amount matic arthritis of canine synovial
equivalent to 25 milligrams of standard joints.
pituitary luteinizing hormone and is (ii) Amount. 2 mg per pound of body
reconstituted for use by addition of 5 weight by intramuscular injection
milliliters of 0.9 percent aqueous so- twice weekly for up to 4 weeks (max-
dium chloride solution. imum of 8 injections).
(b) Sponsor. No. 000061 in § 510.600(c) of [72 FR 56896, Oct. 5, 2007, as amended at 74 FR
this chapter. 67816, Dec. 21, 2009]
(c) Conditions of use—(1) Amount. Cat-
tle and horses: 25 milligrams; swine: 5 § 522.1862 Pralidoxime powder for in-
milligrams; sheep: 2.5 milligrams; and jection.
dogs: 1.0 milligram. Preferably given (a) Specifications. Each vial contains 1
by intravenous injection, it may be ad- gram (g) of pralidoxime chloride pow-
ministered subcutaneously. Treatment der for mixing with 20 cubic centi-
may be repeated in 1 to 4 weeks, or as meters of sterile water for injection.
indicated. Each milliliter of constituted solution
(2) Indications for use. As an aid in the contains 50 milligrams (mg)
treatment of breeding disorders related pralidoxime chloride.
to pituitary hypofunction in cattle, (b) Sponsor. See No. 054771 in
horses, swine, sheep, and dogs. § 510.600(c) of this chapter.
(3) Limitations. Federal law restricts (c) Conditions of use—(1) Amount. Ad-
this drug to use by or on the order of a minister as soon as possible after expo-
licensed veterinarian. sure to the poison. Before administra-
[40 FR 13858, Mar. 27, 1975, as amended at 52 tion of the sterile pralidoxime chloride,
FR 7832, Mar. 13, 1987; 79 FR 16193, Mar. 25, atropine is administered intravenously
2014] at a dosage rate of 0.05 mg per pound of
body weight, followed by administra-
§ 522.1850 Polysulfated tion of an additional 0.15 mg of atro-
glycosaminoglycan. pine per pound of body weight adminis-
(a) Specifications. (1) Each 1-milliliter tered intramuscularly. Then the appro-
(mL) ampule of solution contains 250 priate dosage of sterile pralidoxime
milligrams (mg) polysulfated chloride is administered slowly intra-

glycosaminoglycan. venously. The dosage rate for sterile
332
pralidoxime chloride when adminis- (iii) Limitations. Federal law restricts

tered to horses is 2 g per horse. When the drug to use by or on the order of a
administered to dogs and cats, it is 25 licensed veterinarian.
mg per pound of body weight. For [46 FR 10464, Feb. 3, 1981, as amended at 47
small dogs and cats, sterile FR 6617, Feb. 16, 1982; 58 FR 42853, Aug. 12,
pralidoxime chloride may be adminis- 1993; 67 FR 79853, Dec. 31, 2002; 78 FR 17868,
tered either intraperitoneally or Mar. 25, 2013; 81 FR 67151, Sept. 30, 2016; 84 FR
intramuscularly. A mild degree of 8974, Mar. 13, 2019; 86 FR 14820, Mar. 19, 2021]
atropinization should be maintained § 522.1881 Prednisolone acetate.
for at least 48 hours. Following severe
poisoning, a second dose of sterile (a) Specifications. Each milliliter of
pralidoxime chloride may be given suspension contains 25 milligrams (mg)
of prednisolone acetate.
after 1 hour if muscle weakness has not
been relieved.
(2) Indications for use. It is used in (c) Conditions of use—(1) Amount. The
horses, dogs, and cats as an antidote in drug is administered to horses intra-
the treatment of poisoning due to articularly at a dosage level of 50 to 100
those pesticides and chemicals of the mg. The dose may be repeated when
organophosphate class which have necessary. The drug is administered to
anticholinesterase activity in horses, dogs and cats intramuscularly at a dos-
dogs, and cats. age level of 10 to 50 mg. The dosage
(3) Limitations. Federal law restricts may be repeated when necessary. If the
this drug to use by or on the order of a condition is of a chronic nature, an
licensed veterinarian. oral corticosteroid may be given as a
maintenance dosage. The drug may be
[79 FR 16193, Mar. 25, 2014] given intra-articularly to dogs and cats
at a dosage level of 5 to 25 mg. The dose
§ 522.1870 Praziquantel.
may be repeated when necessary after 7
(a) Specifications. Each milliliter days for two or three doses.
(mL) of solution contains 56.8 milli- (2) Indications for use. The drug is in-
grams of praziquantel. dicated in the treatment of dogs, cats,
(b) Sponsors. See Nos. 058198 and and horses for conditions requiring an
061133 in § 510.600(c) of this chapter. anti-inflammatory agent. The drug is
(c) Conditions of use—(1) Dogs—(i) indicated for the treatment of acute
Amount. Administer by subcutaneous musculoskeletal inflammations such as
or intramuscular injection for dogs and bursitis, carpitis, and spondylitis. The
puppies 5 pounds (lb) and under, 0.3 mL; drug is indicated as supportive therapy
in nonspecific dermatosis such as sum-
for 6 to 10 lb, 0.5 mL; for 11 to 25 lb, 1.0
mer eczema and atopy. The drug may
mL; if over 25 lb, 0.2 mL/5 lb body
be used as supportive therapy pre- and
weight to a maximum of 3 mL.
postoperatively and for various stress
(ii) Indications for use. For removal of conditions when corticosteroids are re-
canine cestodes Dipylidium caninum, quired while the animal is being treat-
Taenia pisiformis, and Echinococcus ed for a specific condition.
granulosus, and removal and control of (3) Limitations. Do not use in horses
canine cestode Echinococcus intended for human consumption. Fed-
multilocularis. eral law restricts this drug to use by or
(iii) Limitations. Federal law restricts on the order of a licensed veterinarian.
the drug to use by or on the order of a
[79 FR 16194, Mar. 25, 2014]
(2) Cats—(i) Amount. Administer by § 522.1883 Prednisolone sodium phos-
subcutaneous or intramuscular injec- phate.
tion for cats and kittens under 5 lb, 0.2 (a) Specifications. Each milliliter of
mL; 5 to 10 lb, 0.4 mL; 11 lb and over, solution contains 20 milligrams (mg)
0.6 mL maximum. prednisolone sodium phosphate (equiv-
(ii) Indications for use. For removal of alent to 14.88 mg of prednisolone).
feline cestodes Dipylidium caninum and (b) Sponsor. See No. 061133 in
Taenia taeniaeformis. § 510.600(c) of this chapter.
333
§ 522.1884 21 CFR Ch. I (4–1–23 Edition)
(c) Conditions of use in dogs—(1) in 12 to 24 hours and continued for 3 to

Amount. Administer intravenously in a 5 days if necessary. If permanent
dosage of 21⁄2 to 5 mg per pound of body corticosteroid effect is required, oral
weight, initially for shock and shock- therapy with prednisolone tablets may
like states, followed by equal mainte- be substituted.
nance doses at 1-, 3-, 6-, or 10-hour in- (2) Limitations. Do not use in horses
tervals as determined by the condition intended for human consumption. Fed-
of the animal. eral law restricts this drug to use by or
(2) Indications for use. Administer on the order of a licensed veterinarian.
when a rapid adrenal glucocorticoid
[79 FR 16194, Mar. 25, 2014]
and/or anti-inflammatory effect is nec-
essary. § 522.1885 Prednisolone tertiary
(3) Limitations. Federal law restricts butylacetate.
licensed veterinarian. (a) Specifications. Each milliliter of
suspension contains 20 milligrams (mg)
[68 FR 59881, Oct. 20, 2003, as amended at 84 of prednisolone tertiary butylacetate.
FR 8974, Mar. 13, 2019] (b) Sponsor. See No. 000010 in
§ 522.1884 Prednisolone sodium succi- § 510.600(c) of this chapter.
nate. (c) Conditions of use—(1) Amount—(i)
Horses: Administer by intramuscular
(a) Specifications. Each milliliter of injection 100 to 300 mg or by
prednisolone sodium succinate injec- intrasynovial injection at a dosage
tion contains: Prednisolone sodium level of 50 to 100 mg. Retreatment of
succinate equivalent in activity to 10, horses in 24 to 48 hours may be nec-
20, or 50 milligrams (mg) of prednis- essary, depending on the general condi-
olone. tion of the animal and the severity and
duration of the disease.
§ 510.600(c) of this chapter for products
(ii) Dogs and cats: Administer by
containing 10, 20, and 50 mg equivalent
intramuscular injection 1 mg per 5
prednisolone activity per milliliter for
pounds of body weight or
use in horses, dogs, and cats as pro-
intrasynovially at a dosage level of 10
vided in paragraphs (c)(1)(i), (ii), and
to 20 mg.
(iii) of this section.
(2) Indications for use. It is used as an
(c) Conditions of use—(1) Amount and
anti-inflammatory agent in horses,
indications for use—(i) Horses. Admin-
dogs, and cats.
ister 50 to 100 mg as an initial dose by
intravenous injection over a period of
one-half to 1 minute, or by
intramuscular injection, and may be
repeated in inflammatory, allergic, or
other stress conditions at intervals of [79 FR 16194, Mar. 25, 2014, as amended at 84
12, 24, or 48 hours, depending upon the FR 39184, Aug. 9, 2019]
size of the animal, the severity of the
condition and the response to treat- § 522.1890 Prednisone suspension.
ment. (a) Specifications. Each milliliter of
(ii) Dogs. Administer by intravenous suspension contains 10 to 40 milligrams
injection at a range of 2.5 to 5 mg per (mg) of prednisone.
pound of body weight as an initial dose (b) Sponsor. See No. 000061 in
followed by maintenance doses at 1, 3, § 510.600(c) of this chapter.
6, or 10 hour intervals, as determined (c) Conditions of use—(1) Amount—(i)
by the condition of the animal, for Horses. Administer 100 to 400 mg by
treatment of shock. intramuscular injection, repeating if
(iii) Dogs and cats. Administer by necessary.
intramuscular injection for treatment (ii) Dogs and cats. Administer 0.25 to
of inflammatory, allergic, and less se- 1.0 mg per pound of body weight by
vere stress conditions, where imme- intramuscular injection for 3 to 5 days
diate effect is not required, at 1 to 5 mg or until a response is noted. Treatment
ranging upward to 30 to 50 mg in large may be continued with an orally ad-

breeds of dogs. Dosage may be repeated ministered dose.
334
(2) Indications for use. It is used for (1) Suckling beef calves at least 45 days
conditions requiring an anti-inflam- old and up to 400 lb of body weight—(i)
matory agent. Amount. (A) 100 milligrams (mg) pro-
(3) Limitations. Do not use in horses gesterone and 10 mg estradiol benzoate
intended for human consumption. Fed- (one implant consisting of 4 pellets,
eral law restricts this drug to use by or each pellet containing 25 mg progester-
on the order of a licensed veterinarian. one and 2.5 mg estradiol benzoate) per
[79 FR 16194, Mar. 25, 2014]
implant dose.
(B) 100 mg progesterone and 10 mg es-
§ 522.1920 Prochlorperazine and tradiol benzoate (one implant con-
isopropamide. sisting of 5 pellets, each of 4 pellets
(a) Specifications. Each milliliter of containing 25 mg progesterone and 2.5
solution contains prochlorperazine mg estradiol benzoate, and 1 pellet con-
edisylate equivalent to 4 milligrams taining 29 mg tylosin tartrate) per im-
(mg) prochlorperazine and plant dose.
isopropamide iodide equivalent to 0.28 (ii) Indications for use. For increased
mg of isopropamide. rate of weight gain.
(b) Sponsor. See No. 054771 in (iii) Limitations. For subcutaneous ear
§ 510.600(c) of this chapter. implantation, one dose per animal. Do
(c) Conditions of use—(1) Amount. (i) not use in beef calves less than 45 days
Dosage is administered by subcuta- of age, dairy calves, and veal calves be-
neous injection twice daily as follows: cause effectiveness and safety have not
been established. Do not use in animals
Weight of animal in pounds Dosage in intended for subsequent breeding, or in
milliliters
dairy cows. A withdrawal period has
Up to 4 ........................................................... 0.25 not been established for this product in
5 to 14 ........................................................... 0.5–1 preruminating calves. Do not use in
15 to 30 ......................................................... 2–3
30 to 45 ......................................................... 3–4 calves to be processed for veal.
45 to 60 ......................................................... 4–5 (2) Growing beef steers weighing 400 lb
Over 60 .......................................................... 6 or more—(i) Amount. (A) 200 mg pro-
gesterone and 20 mg estradiol benzoate
(ii) Following the last injection, ad- (one implant consisting of 8 pellets,
minister prochlorperazine and each pellet containing 25 mg progester-
isopropamide sustained release cap- one and 2.5 mg estradiol benzoate) per
sules as indicated. implant dose.
(2) Indications for use. For use in dogs (B) 200 mg progesterone and 20 mg es-
and cats in which gastrointestinal dis- tradiol benzoate (one implant con-
turbances are associated with emo- sisting of 9 pellets, each of 8 pellets
tional stress. containing 25 mg progesterone and 2.5
(3) Limitations. Federal law restricts mg estradiol benzoate, and 1 pellet con-
this drug to use by or on the order of a taining 29 mg tylosin tartrate) per im-
licensed veterinarian. plant dose.
[79 FR 16194, Mar. 25, 2014] (ii) Indications for use. For increased
rate of weight gain and improved feed
§ 522.1940 Progesterone and estradiol efficiency.
benzoate. (iii) Limitations. For subcutaneous ear
(a) Sponsors. See sponsors in implantation, one dose per animal. Do
§ 510.600(c) of this chapter for use as in not use in beef calves less than 45 days
paragraph (c) of this section: of age, dairy calves, and veal calves be-
(1) No. 054771 for use as in paragraphs cause effectiveness and safety have not
(c)(1)(i)(A), (c)(1)(ii), (c)(1)(iii), been established. Do not use in animals
(c)(2)(i)(A), (c)(2)(ii), (c)(2)(iii), and intended for subsequent breeding, or in
(c)(3) of this section. dairy cows. A withdrawal period has
(2) No. 058198 for use as in paragraphs not been established for this product in
(c)(1) and (c)(2) of this section. preruminating calves. Do not use in
(b) Related tolerances. See §§ 556.240 calves to be processed for veal.
and 556.540 of this chapter. (3) Steers fed in confinement for slaugh-
(c) Conditions of use in cattle. It is ter—(i) Amount. Reimplant 200 mg pro-

used for implantation as follows: gesterone and 20 mg estradiol benzoate
335
§ 522.1962 21 CFR Ch. I (4–1–23 Edition)
on approximately day 70 following an antiemetic prior to worming; or to pre-

initial implant of 100 mg progesterone vent motion sickness in dogs.
and 10 mg estradiol benzoate or 200 mg (iii) Limitations. Federal law restricts
progesterone and 20 mg estradiol ben- this drug to use by or on the order of a
zoate. licensed veterinarian.
(ii) Indications for use. For additional
improvement in rate of weight gain. [46 FR 18962, Mar. 27, 1981, as amended at 68
FR 59881, Oct. 20, 2003; 70 FR 50183, Aug. 26,
(iii) Limitations. For subcutaneous ear 2005; 79 FR 16194, Mar. 25, 2014; 84 FR 8974,
implantation. Safety and effectiveness Mar. 13, 2019]
have not been established in veal
calves. A withdrawal period has not § 522.2002 Propiopromazine.
been established for this product in
preruminating calves. Do not use in (a) Specifications. Each milliliter of
calves to be processed for veal. solution contains 5 or 10 milligrams
(mg) propiopromazine hydrochloride.
[69 FR 70055, Dec. 2, 2004, as amended at 77 (b) Sponsor. See No. 054771 in
FR 31723, May 30, 2012; 79 FR 16194, Mar. 25, § 510.600(c) of this chapter.
2014; 81 FR 48702, July 26, 2016; 87 FR 17946,
Mar. 29, 2022] (c) Conditions of use in dogs and cats—
(1) Amounts and indications for use. Ad-
§ 522.1962 Promazine. minister 0.05 to 0.5 mg per pound of
body weight by intravenous or
intramuscular injection for
promazine hydrochloride. tranquilization. Administer 0.25 mg per
pound of body weight by intravenous
§ 510.600(c) of this chapter for use as in injection as a preanesthetic.
paragraph (c) of this section: (2) Limitations. Federal law restricts
(1) No. 054771 for use as in paragraphs this drug to use by or on the order of a
(c)(1)(i)(A), (c)(1)(ii)(A), (c)(1)(iii), and licensed veterinarian.
(c)(2) of this section. [79 FR 16195, Mar. 25, 2014]
(c)(1)(i)(B), (c)(1)(ii)(B), and (c)(1)(iii) of § 522.2005 Propofol.
this section. (a) Specifications. Each milliliter of
(c) Conditions of use—(1) Horses—(i) emulsion contains 10 milligrams (mg)
Amount. (A) 0.2 to 0.5 milligrams per propofol.
pounds (mg/lb) body weight
intramuscularly or intravenously
every 4 to 6 hours.
(B) 0.2 to 0.5 mg/lb body weight intra-
(c)(1), (c)(2)(i), and (c)(3) of this section.
venously as required.
(ii) Indications for use. (A) For use as (2) No. 054771 for use as in paragraph
a tranquilizer, preanesthetic, or for (c) of this section.
minor operative procedures in conjunc- (c) Conditions of use in dogs and cats—
tion with local anesthesia; and as ad- (1) Amount. Administer by intravenous
junctive therapy for tetanus. injection according to label directions.
(B) For use as a tranquilizer and The use of preanesthetic medication
preanesthetic. reduces propofol dose requirements.
(iii) Limitations. Do not use in horses (2) Indications for use. (i) As a single
intended for human consumption. Fed- injection to provide general anesthesia
eral law restricts this drug to use by or for short procedures; for induction and
on the order of a licensed veterinarian. maintenance of general anesthesia
(2) Dogs and cats—(i) Amount. 1 to 2 using incremental doses to effect; for
mg/lb body weight intramuscularly or induction of general anesthesia where
intravenously every 4 to 6 hours. maintenance is provided by inhalant
(ii) Indications for use. For use as a anesthetics.
tranquilizer, preanesthetic, for minor (ii) For the induction and mainte-
operative procedures in conjunction nance of anesthesia and for induction
with local anesthesia, as adjunctive of anesthesia followed by maintenance

therapy for tetanus, and as an with an inhalant anesthetic.
336
(3) Limitations. Federal law restricts eral law restricts this drug to use by or
this drug to use by or on the order of a on the order of a licensed veterinarian.
[75 FR 20269, Apr. 19, 2010, as amended at 75 FR 8974, Mar. 13, 2019]
FR 38700, July 6, 2010; 78 FR 17868, Mar. 25,
2013; 79 FR 16195, Mar. 25, 2014; 80 FR 18776, § 522.2065 Rabacfosadine.
Apr. 8, 2015; 81 FR 36789, June 8, 2016]
(a) Specifications. Each vial of powder
§ 522.2012 Prostalene. contains 16.4 milligrams (mg)
rabacfosadine. Each milliliter of con-
(a) Specifications. Each milliliter of stituted solution contains 8.2 mg
solution contains 1 milligram of rabacfosadine.
prostalene. (b) Sponsor. See No. 058198 in
(b) Sponsor. No. 054771 in § 510.600(c) of § 510.600(c) of this chapter.
this chapter. (c) Conditions of use in dogs—(1)
(c) Conditions of use in horses—(1) Amount. Administer rabacfosadine at 1
Amount. Administer 5 micrograms per mg/kilogram body weight as a 30-
kilogram of body weight as a single minute intravenous infusion, once
subcutaneous injection.
every 3 weeks, for up to 5 doses.
of estrus in mares.
ment of lymphoma in dogs.
[87 FR 10969, Feb. 28, 2022]
[79 FR 16195, Mar. 25, 2014]
§ 522.2075 Robenacoxib.
§ 522.2063 Pyrilamine.
solution contains 20 milligrams (mg) of
pyrilamine maleate. robenacoxib.
(b) Sponsors. See sponsor numbers in (b) Sponsor. See No. 058198 in
§ 510.600(c) of this chapter for uses in § 510.600(c) of this chapter.
paragraph (c) of this section. (c) Conditions of use—(1) Dogs—(i)
(1) No. 000061 for use as in paragraph Amount. Administer 0.91 mg per pound
(c)(1)(i), (2), and (3) of this section. (2 mg/kilogram (kg)) by subcutaneous
(2) No. 061133 for use as in paragraph injection, once daily, for a maximum of
(c)(1)(ii), (2), and (3) of this section. 3 days. After the initial subcutaneous
(c) Conditions of use—(1) Amount. (i) dose, subsequent doses can be given by
Horses, 40 to 60 mg per 100 pounds (lbs) subcutaneous injection or as the oral
body weight; foals, 20 mg/100 lbs body tablet in dogs weighing at least 5.5
weight. Administer by intramuscular, pounds (2.5 kg) and at least 4 months of
subcutaneous, or intravenous injection. age, for a maximum of 3 total doses
Dosage may be repeated every 6 to 12 over 3 days, not to exceed 1 dose per
hours whenever necessary. day. See § 520.2075(c)(1) of this chapter.
(ii) Horses, 40 to 60 mg/100 lbs body (ii) Indications for use. For the control
weight; foals, 20 mg/100 lbs body of postoperative pain and inflamma-
weight. Administer by slow intra- tion associated with soft tissue surgery
venous injection. Dosage may be rein dogs at least 4 months of age for a
peated every 6 to 12 hours if necessary. maximum of 3 days.
(2) Indications for use. It is intended (iii) Limitations. Federal law restricts
for treating horses in conditions in this drug to use by or on the order of a
which antihistaminic therapy may be licensed veterinarian.
expected to lead to alleviation of some (2) Cats—(i) Amount. Administer 0.91
signs of disease. mg per pound (2 mg/kg) by subcuta-
(3) Limitations. Do not use in horses neous injection, once daily, for a max-
intended for human consumption. Fed- imum of 3 days.
337
§ 522.2076 21 CFR Ch. I (4–1–23 Edition)
(ii) Indications for use. For the control (d) Conditions of use in dogs—(1)
of postoperative pain and inflamma- Amount. Administer 1 mL per 10 pounds
tion associated with orthopedic sur- of body weight as a single, bolus intra-
gery, ovariohysterectomy, and castra- venous injection.
tion in cats at least 4 months of age for (2) Indications for use. For humane,
a maximum of 3 days. painless, and rapid euthanasia.
(iii) Limitations. Federal law restricts (3) Limitations. Do not use in animals
this drug to use by or on the order of a intended for food. Federal law restricts
licensed veterinarian. this drug to use by or on the order of a
FR 12170, Mar. 1, 2017] [85 FR 18120, Apr. 1, 2020]
§ 522.2076 Romifidine. § 522.2100 Selenium and vitamin E.

(a) Specifications. Each milliliter of (a)(1) Specifications. Each milliliter of
solution contains 10 milligrams (mg) emulsion contains 5.48 milligrams (mg)
romifidine hydrochloride. sodium selenite (equivalent to 2.5 mg
(b) Sponsor. See No. 000010 in selenium) and 50 mg of vitamin E (68
§ 510.600(c) of this chapter. I.U.) (as d-alpha tocopheryl acetate).
(c) Conditions of use in horses—(1) (2) Sponsor. See No. 000061 in
Amount. 40 to 120 micrograms per kilo- § 510.600(c) of this chapter.
gram of body weight (mcg/kg BW) in- (3) Conditions of use in horses—(i)
travenously for sedation and analgesia; Amount. Administer 1 milliliter (mL)
100 mcg/kg BW intravenously as a per (/) 100 pounds (lbs) of body weight
preanesthetic. by intravenous injection or by deep
(2) Indications for use. For use as a intramuscular injection in divided
sedative and analgesic to facilitate doses in two or more sites in the glu-
handling, clinical examinations, clin- teal or cervical muscles. Administra-
ical procedures, and minor surgical tion may be repeated at 5 to 10 day in-
procedures in adult horses; and for use tervals.
as a preanesthetic prior to the induc- (ii) Indications for use. For the pre-
tion of general anesthesia in adult vention and treatment of selenium-to-
horses. copherol deficiency syndrome in
(3) Limitations. Do not use in horses horses.
intended for human consumption. Fed- (iii) Limitations. Do not use in horses
[69 FR 47363, Aug. 5, 2004, as amended at 79 (b)(1) Specifications. Each milliliter
FR 16195, Mar. 25, 2014] contains 2.19 mg of sodium selenite
(equivalent to 1 mg of selenium), 50 mg
§ 522.2092 Secobarbital and dibucaine. of vitamin E (68 I.U.) (as d-alpha
(a) Specifications. Each milliliter tocopheryl acetate).
(mL) of solution contains 400 milligram (2) Sponsor. See No. 000061 in
(mg) secobarbital sodium and 25 mg di- § 510.600(c) of this chapter.
bucaine hydrochloride. (3) Conditions of use in dogs—(i)
(b) Sponsor. See No. 054771 in Amount. Administer by subcutaneous
§ 510.600(c) of this chapter. or intramuscular injection in divided
(c) Special considerations. Product la- doses in two or more sites at 1 mL/20
beling shall bear the following warning lbs of body weight with a minimum
statements: ‘‘ENVIRONMENTAL HAZ- dosage of 1⁄4 mL and a maximum dosage
ARD: This product is toxic to wildlife. of 5 mL. The dose is repeated at 3-day
Birds and mammals feeding on treated intervals until a satisfactory thera-
animals may be killed. Euthanized ani- peutic response is observed. A mainte-
mals must be properly disposed of by nance regimen is then initiated which
deep burial, incineration, or other consists of 1 mL per 40 lbs of body
method in compliance with State and weight with a minimum dosage of 1⁄4
local laws, to prevent consumption of mL which is repeated every 3 days or 7
carcass material by scavenging wild- days, or longer, as required to main-

life.’’ tain continued improvement or an
338
asymptomatic condition; or the drug (ii) Indications for use. Weanling

may be used in capsule form for oral calves and breeding beef cows: For the
maintenance therapy. prevention and treatment of selenium-
(ii) Indications for use. As an aid in al- tocopherol deficiency syndrome.
leviating and controlling inflamma- (iii) Limitations. For subcutaneous or
tion, pain, and lameness associated intramuscular use. Discontinue use 30
with certain arthropathies in dogs. days before treated cattle are slaugh-
(iii) Limitations. Federal law restricts tered for human consumption. Federal
this drug to use by or on the order of a law restricts this drug to use by or on
licensed veterinarian. the order of a licensed veterinarian.
(c)(1) Specifications. Each milliliter (e)(1) Specifications. Each milliliter
contains 2.19 milligrams of selenite so- contains 0.55 milligram selenite sodium
dium (equivalent to 1 milligram sele- (equivalent to 0.25 milligram sele-
nium), 50 milligrams vitamin E (68 nium), 50 milligrams (68 U.S.P. units)
U.S.P. units). vitamin E.
(3) Conditions of use—(i) Dosage. New-
(3) Conditions of use—(i) Dosage. born lambs: 1 milliliter. Lambs 2 weeks
Calves: 2.5 to 3.75 milliliters per 100 of age or older: 4 milliliters. Baby pigs:
pounds of body weight. Lambs 2 weeks 1 milliliter (or treat the sow during the
of age or older: 1 milliliter per 40 last week of pregnancy).
pounds, minimum 1 milliliter. Ewes: 2.5 (ii) Indications for use. Lambs: for pre-
milliliters per 100 pounds. Sows: 1 mil- vention and treatment of white muscle
liliter per 40 pounds. Weanling pigs: 1 disease (selenium-tocopherol deficiency
milliliter per 40 pounds, minimum 1 syndrome). Baby pigs: an aid in the
milliliter. prevention and treatment of selenium-
(ii) Indications for use. Calves, lambs, tocopherol deficiency.
and ewes: prevention and treatment of (iii) Limitations. For subcutaneous or
white muscle disease (selenium-tocoph- intramuscular use only. Discontinue
erol deficiency syndrome). Sows and use 14 days before treated animals are
weanling pigs: an aid in the prevention slaughtered for human consumption.
and treatment of selenium-tocopherol Federal law restricts this drug to use
deficiency. by or on the order of a licensed veteri-
(iii) Limitations. For subcutaneous or narian.
intramuscular use. Not for use in new-
born pigs. Do not use in pregnant ewes. [40 FR 13858, Mar. 27, 1975, as amended at 52
FR 7832, Mar. 13, 1987; 57 FR 21209, May 19,
Calves: Discontinue use 30 days before
1992; 58 FR 57556, Oct. 26, 1993; 60 FR 57833,
treated calves are slaughtered for Nov. 22, 1995; 64 FR 27916, May 24, 1999; 79 FR
human consumption. Lambs, ewes, 16195, Mar. 25, 2014]
sows, or pigs: Discontinue use 14 days
before treated lambs, ewes, sows, or § 522.2112 Sometribove zinc suspen-
pigs are slaughtered for human con- sion.
sumption. Federal law restricts this (a) Specifications. Each single-dose sy-
drug to use by or on the order of a li- ringe contains 500 milligrams (mg)
censed veterinarian. sometribove zinc in a prolonged-release
(d)(1) Specifications. Each milliliter suspension.
contains 10.95 milligrams selenite so- (b) Sponsor. See No. 086106 in
dium (equivalent to 5 milligrams sele- § 510.600(c) of this chapter.
nium), 50 milligrams vitamin E (68 (c) Conditions of use—(1) Amount. In-
U.S.P. units). ject 500 mg every 14 days starting dur-
(2) Sponsors. See Nos. 000061 and 054771 ing the 9th or 10th week (57 to 70 days)
in § 510.600(c) of this chapter. after calving and continue until the
(3) Conditions of use—(i) Dosage. end of lactation.
Breeding beef cows: 1 milliliter per 200 (2) Indications for use. To increase
pounds of body weight during the mid- production of marketable milk in
dle third of gestation, and 30 days be- healthy lactating dairy cows.
fore calving. Weanling calves: 1 milli- (3) Limitations. Use in lactating dairy
liter per 200 pounds of body weight. cows only. Safety to replacement bulls
339
§ 522.2120 21 CFR Ch. I (4–1–23 Edition)
born to treated dairy cows has not been (C) Administer 2.5 to 5 mg per chick
established. Inject subcutaneously. as an aid in the control of mortality
Avoid injections within 2 weeks of ex- and to lessen severity of infections
pected slaughter to minimize injection caused by M. synoviae, Salmonella
site blemishes on carcass. There is no typhimurium, S. infantis, and E. coli.
milk discard or preslaughter with- (ii) Limitations. For use only in 1- to
drawal period. Use may reduce preg- 3-day-old turkey poults and newly
nancy rates and increase days open. hatched chicks.
Treated cows are at an increased risk
(2) Dogs—(i) Amount. Administer 2.5
for mastitis and higher milk somatic
to 5.0 mg per pound of body weight by
cell counts. Use care to differentiate
intramuscular injection twice daily.
increased body temperature due to use
of this product from an increased body Treatment may be continued for 4
temperature that may occur due to ill- days.
ness. Cows treated with this product (ii) Indications for use. For treatment
may have more enlarged hocks and dis- of infections caused by gram-negative
orders of the foot region. Use may re- and gram-positive organisms suscep-
duce hemoglobin and hematocrit val- tible to spectinomycin.
ues during treatment. Human warning: (iii) Limitations. Federal law restricts
Avoid prolonged or repeated contact this drug to use by or on the order of a
with eyes and skin. licensed veterinarian.
[58 FR 59947, Nov. 12, 1993, as amended at 67 [86 FR 14820, Mar. 19, 2021]
FR 18085, Apr. 15, 2002; 68 FR 62006, Oct. 31,
2003; 74 FR 53164, Oct. 16, 2009; 81 FR 48702, § 522.2121 Spectinomycin sulfate.
July 26, 2016; 85 FR 4208, Jan. 24, 2020]
§ 522.2120 Spectinomycin hydro- solution contains spectinomycin sul-
chloride. fate tetrahydrate equivalent to 100 mil-
(a) Specifications. Each milliliter of ligrams (mg) spectinomycin.
solution contains 100 milligrams (mg) (b) Sponsor. See Nos. 054771 and 061133
spectinomycin hydrochloride (as in § 510.600(c) of this chapter.
spectinomycin dihydrochloride (c) Related tolerances. See § 556.600 of
pentahydrate). this chapter.
(b) Sponsors. See sponsors in (d) Conditions of use in cattle—(1)
§ 510.600(c) of this chapter: Amount. 10 to 15 mg per kilogram of
(1) Nos. 016592 and 054771 for use as in body weight at 24-hour intervals for 3
paragraph (d)(1) of this section; and to 5 consecutive days.
(2) No. 058198 for use as in paragraph (2) Indications for use. For the treat-
(d)(2) of this section. ment of bovine respiratory disease
(c) Related tolerances. See § 556.600 of (pneumonia) associated with
this chapter. Mannheimia haemolytica, Pasteurella
(d) Conditions of use. It is adminis- multocida, and Histophilus somni.
tered as follows: (3) Limitations. Do not slaughter with-
(1) Turkeys (1- to 3-day-old poults) and in 11 days of last treatment. Do not use
chickens (newly hatched chicks)—(i) in female dairy cattle 20 months of age
Amounts and indications for use. (A) Ad- or older. Use in this class of cattle may
minister 5 mg per poult subcutaneously cause residues in milk. A withdrawal
as an aid in the control of chronic res- period has not been established for this
piratory disease (CRD) associated with product in preruminating calves. Do
Escherichia coli in 1- to 3-day-old turkey not use in calves to be processed for
poults. veal. Federal law restricts this drug to
(B) Administer 10 mg per poult as a use by or on the order of a licensed vet-
single subcutaneous injection in the erinarian.
nape of the neck as an aid in the con-
trol of airsacculitis associated with [72 FR 31178, June 6, 2007, as amended at 79
Mycoplasma meleagridis sensitive to FR 16195, Mar. 25, 2014; 88 FR 14899, Mar. 10,
spectinomycin in 1- to 3-day-old turkey 2023]

poults.
340
§ 522.2150 Stanozolol. (2) 400 mg of sulfadimethoxine so-

dium.
suspension contains 50 milligrams (mg) (b) Sponsors. See sponsor numbers in
of stanozolol. § 510.600(c) of this chapter for use as in
(b) Sponsor. No. 054771 in § 510.600(c) of paragraph (d) of this section.
this chapter. (1) No. 069043 for use of the product
(c) Conditions of use—(1) Amount—(i) described in paragraph (a)(1) as in para-
Dogs and cats. For cats and small graph (d)(1) of this section.
breeds of dogs: 25 mg. For larger dogs: (2) No. 054771 for use of the product
50 mg. Administer by deep described in paragraph (a)(2) as in para-
intramuscular injection in the thigh at graphs (d)(2), (3), and (4) of this section.
weekly intervals, for several weeks. (3) Nos. 016592 and 061133 for use of
(ii) Horses. Administer 25 mg per 100 the product described in paragraph
pounds of body weight by deep (a)(2) as in paragraph (d)(4) of this sec-
intramuscular injection in the gluteal tion.
region at weekly intervals, for not (c) Related tolerances. See § 556.640 of
more than 4 weeks. this chapter.
(2) Indications for use. For use as an (d) Conditions of use—(1) Dogs—(i)
anabolic steroid treatment. Amount. Administer by subcutaneous,
(3) Limitations. Do not use in horses intramuscular, or intravenous injec-
intended for human consumption. Fed- tion at an initial dose of 25 mg per
eral law restricts this drug to use by or pound of body weight followed by 12.5
on the order of a licensed veterinarian. mg per pound of body weight every 24
[79 FR 16195, Mar. 25, 2014] hours thereafter. Continue treatment
until the animal is free from symptoms
§ 522.2200 Sulfachlorpyridazine. for 48 hours.
(a) Specifications. Each milliliter of (ii) Indications for use. For use in the
solution contains sodium treatment of sulfadimethoxine-suscep-
sulfachlorpyridazine equivalent to 200 tible bacterial infections in dogs.
milligrams (mg) sulfachlorpyridazine. (iii) Limitations. Federal law restricts
(c) Related tolerances. See § 556.630 of (2) Dogs and cats—(i) Amount. Admin-
this chapter. ister by intravenous or subcutaneous
(d) Conditions of use in calves. It is injection at an initial dose of 55 mg per
used as follows: kilogram of body weight followed by
(1) Amount. Administer 30 to 45 mg 27.5 mg per kilogram of body weight
per pound (/lb) of body weight in di- every 24 hours.
vided doses by twice daily injection for (ii) Indications for use. For the treat-
1 to 5 days. ment of respiratory, genitourinary
(2) Indications for use. For the treat- tract, enteric, and soft tissue infec-
ment of diarrhea caused or complicated tions when caused by Streptococci,
by Escherichia coli (colibacillosis). Staphylococci, Escherichia, Salmonella,
(3) Limitations. Treated calves must Klebsiella, Proteus, or Shigella orga-
not be slaughtered for food during nisms sensitive to sulfadimethoxine,
treatment or for 5 days after the last and in the treatment of canine bac-
treatment. A withdrawal period has terial enteritis associated with coccidi-
not been established for this product in osis and canine Salmonellosis.
preruminating calves. Do not use in (iii) Limitations. Federal law restricts
calves to be processed for veal.
[75 FR 10167, Mar. 5, 2010] licensed veterinarian.
(3) Horses—(i) Amount. Administer by
§ 522.2220 Sulfadimethoxine. intravenous injection at an initial dose
(a) Specifications. Each milliliter of of 55 mg per kilogram of body weight
solution contains: followed by 27.5 mg per kilogram of
(1) 100 milligrams (mg) of body weight every 24 hours until the
sulfadimethoxine sodium. patient is asymptomatic for 48 hours.
341
§ 522.2240 21 CFR Ch. I (4–1–23 Edition)
(ii) Indications for use. For the treat- adjunctive therapy in septicemia ac-
ment of respiratory disease caused by companying mastitis and metritis.
Streptococcus equi (strangles). (3) Limitations. Do not treat within 16
(iii) Limitations. Do not use in horses days of slaughter. Milk that has been
intended for human consumption. Fed- taken from animals during treatment
eral law restricts this drug to use by or and for 72 hours (6 milkings) after the
on the order of a licensed veterinarian. latest treatment must not be used for
(4) Cattle—(i) Amount. Administer an food. Federal law restricts this drug to
initial dose of 25 mg per pound of body use by or on the order of a licensed vet-
weight by intravenous injection fol- erinarian.
lowed by 12.5 mg per pound of body
[79 FR 16196, Mar. 25, 2014]
weight every 24 hours until the animal
is asymptomatic for 48 hours. § 522.2260 Sulfamethazine.
ment of bovine respiratory disease (a) Specifications. Each milliliter
complex (shipping fever complex) and (mL) of solution contains 250 milli-
bacterial pneumonia associated with grams (mg) sulfamethazine sodium.
Pasteurella spp. sensitive to (b) Sponsor. See No. 016592 in
sulfadimethoxine; necrotic § 510.600(c) of this chapter.
pododermatitis (foot rot) and calf diph- (c) Related tolerances. See § 556.670 of
theria caused by Fusobacterium this chapter.
necrophorum sensitive to (d) Conditions of use in cattle—(1)
sulfadimethoxine. Amount. Initially administer 20 mL for
(iii) Limitations. Milk taken from ani- each 50 pounds (lb) of body weight (100
mals during treatment and for 60 hours mg/lb) by intravenous injection, fol-
(5 milkings) after the latest treatment lowed by 20 mL per 100 lb of body
must not be used for food. Do not ad- weight (50 mg/lb) by intravenous injec-
minister within 5 days of slaughter. A tion, daily thereafter. Treatment
withdrawal period has not been estab- should not exceed a total of 5 consecu-
lished for this product in tive days.
preruminating calves. Do not use in (2) Indications for use. For cattle for
calves to be processed for veal. Federal treatment of bacterial pneumonia and
law restricts this drug to use by or on bovine respiratory disease complex
the order of a licensed veterinarian. (shipping fever complex) (Pasteurella
spp.), colibacillosis (bacterial scours)
(Escherichia coli), necrotic
FR 22524, Apr. 18, 2016; 83 FR 48946, Sept. 28,
2018; 84 FR 8974, Mar. 13, 2019; 88 FR 14900, pododermatitis (foot rot)
Mar. 10, 2023] (Fusobacterium necrophorum), calf diph-
theria (Fusobacterium necrophorum),
§ 522.2240 Sulfaethoxypyridazine. acute mastitis and acute metritis
(a) Specifications. The drug is an aque- (Streptococcus spp.) when caused by one
ous solution of sulfaethoxypyridazine. or more pathogenic organisms sen-
(b) Sponsor. See No. 054771 in sitive to sulfamethazine.
§ 510.600(c) of this chapter. (3) Limitations. Withdraw medication
(c) Related tolerances. See § 556.650 of from cattle 10 days prior to slaughter.
this chapter. Do not use in female dairy cattle 20
(d) Conditions of use in cattle—(1) months of age or older. Federal law re-
Amount. Administer 2.5 grams per 100 stricts this drug to use by or on the
pounds of body weight per day by in- order of a licensed veterinarian.
travenous injection for not more than 4 [46 FR 62055, Dec. 22, 1981, as amended at 67
days; or first treatment may be fol- FR 78355, Dec. 24, 2002; 75 FR 10167, Mar. 5,
lowed by 3 days of treatment with 2010; 76 FR 53051, Aug. 25, 2011; 81 FR 17608,
sulfaethoxypyridazine in drinking Mar. 30, 2016]
water or tablets in accordance with
§§ 520.2240a(e) and 520.2240b(e) of this § 522.2340 Sulfomyxin.
chapter. (a) Specifications. Sulfomyxin for in-
(2) Indications for use. For treatment jection is sterile. It is derived from the
of respiratory infection (pneumonia, antibiotic substance produced by the

shipping fever), foot rot, calf scours; as growth of Bacillus polymyxa or is the
342
same substance produced by any other (ii) 20 mg estradiol benzoate and 200
means. mg testosterone propionate (one im-
(b) Sponsor. See No. 054771 in plant consisting of 9 pellets, each of 8
§ 510.600(c) of this chapter. pellets containing 2.5 mg estradiol ben-
(c) Special considerations. The quan- zoate and 25 mg testosterone propio-
tities of antibiotic in paragraph (e) of nate, and 1 pellet containing 29 mg
this section refer to the activity of the tylosin tartrate) per implant dose.
appropriate standard. (2) Indications for use. For increased
(d) Related tolerances. See § 556.700 of rate of weight gain and improved feed
this chapter. efficiency.
(e) Conditions of use. (1) It is used or (3) Limitations. For subcutaneous ear
intended for use in chickens and tur- implantation, one dose per animal. Not
keys as an aid in the treatment of dis- for use in dairy or beef replacement
ease caused or complicated by E. coli, heifers. Do not use in beef calves less
such as colibacillosis and complicated than 2 months of age, dairy calves, and
chronic respiratory disease. veal calves because safety and effec-
(2) It is administered by subcuta- tiveness have not been established. A
neous injection as follows: withdrawal period has not been estab-
Antibiotic activity
lished for this product in
Age of birds in days
preruminating calves. Do not use in
Chickens Turkeys calves to be processed for veal.
(units) (units)
1 to 14 ........................................... 12,500 12,500
15 to 28 ......................................... 25,000 25,000 FR 31723, May 30, 2012; 79 FR 16187, Mar. 25,
29 to 63 ......................................... 50,000 50,000 2014; 81 FR 48702, July 26, 2016. Redesignated
Over 63 .......................................... 50,000 100,000 and amended at 87 FR 10969, Feb. 28, 2022; 87
FR 17946, Mar. 29, 2022]
(3) A second injection may be given 3
days later if symptoms persist. § 522.2404 Thialbarbitone sodium for
(4) Not for use in laying hens; do not injection.
treat chickens within 5 days of slaugh- (a) Specifications. Thialbarbitone so-
ter. Do not treat turkeys within 7 days dium for injection when reconstituted
of slaughter. Federal law restricts this with sterile distilled water provides 94
drug to use by or on the order of a li- milligrams of thialbarbitone sodium
censed veterinarian. per milliliter of solution.
FR 16196, Mar. 25, 2014; 88 FR 14900, Mar. 10, § 510.600(c) of this chapter.
2023] (c) Conditions of use. (1) The drug is
administered as a general anesthetic in
§ 522.2343 Testosterone propionate surgical procedures on dogs, cats,
and estradiol benzoate. swine, sheep, cattle, and horses. The
(a) Sponsors. See sponsors in drug is used for procedures of rel-
§ 510.600(c) of this chapter for use as in atively short duration. However, the
paragraph (c) of this section. period of anesthesia can be lengthened
(1) No. 054771 for use as in paragraph by slower initial injection and supple-
(c)(1)(i), (c)(2), and (c)(3) of this section. mental administration during surgery.
(2) No. 058198 for use as in paragraph (2) It is administered intravenously.
(c) of this section. The drug is injected slowly to dogs,
(b) Related tolerances. See §§ 556.240 cats, cattle, sheep, and swine. For
and 556.710 of this chapter. horses, it is recommended that a pre-
(c) Conditions of use. For implanta- anesthetic sedation be administered to
tion in growing beef heifers weighing the horse 30 minutes before the drug is
400 lb or more as follows: administered. The drug is then injected
(1) Amount. (i) 20 milligrams (mg) es- rapidly and completely. The drug is
tradiol benzoate and 200 mg testos- used at the following dosage levels:
terone propionate (one implant con- Dosage in
sisting of 8 pellets, each pellet con- Weight of animal
Species milligrams
in pounds
taining 2.5 mg estradiol benzoate and per pound
25 mg testosterone propionate) per im- Dog ..................................... Over 50 ............... 14.1

plant dose. Do ................................ 30–50 .................. 18.8
343
§ 522.2424 21 CFR Ch. I (4–1–23 Edition)
Weight of animal Dosage in (b) Sponsor. See No. 054771 in

Species milligrams § 510.600(c) of this chapter.
in pounds per pound
Do ................................ 10–30 .................. 23.5 (1) Amount. Administer by intravenous
Do ................................ Under 10 ............. 28.2
Cat ...................................... ............................. 31.3–37.6
injection as follows:
Horse .................................. ............................. 6.3–7.8 (i) 6 to 9 milligrams (mg) per pound
Cattle and swine ................ ............................. 6.7–9.4 of body weight for brief anesthesia (6 to
Calves and sheep .............. ............................. 9.4–11.8
10 minutes).
(ii) 10 to 12 mg per pound of body
weight for anesthesia of 15 to 25 min-
utes duration.
erinarian.
(2) Indications for use. It is used as an
[40 FR 13858, Mar. 27, 1975, as amended at 79 anesthetic for intravenous administra-
FR 16196, Mar. 25, 2014] tion to dogs and cats during short to
moderately long surgical and other
§ 522.2424 Thiamylal. procedures. It is also used to induce an-
(a) Specifications. The drug is a sterile esthesia in dogs and cats which then
powder. It is reconstituted with sterile have surgical anesthesia maintained by
distilled water, water for injection, or use of a volatile anesthetic.
sodium chloride injection, to a desired (3) Limitations. Federal law restricts
concentration of 0.5 to 4 percent so- this drug to use by or on the order of a
dium thiamylal. licensed veterinarian.
[79 FR 16196, Mar. 25, 2014]
(c) Conditions of use—(1) Amount. Ad- § 522.2444b Thiopental and pento-
minister by intravenous injection to ef- barbital powder for injection.
fect. The average single dose is:
(i) Dogs and cats: 8 milligrams (mg) (a) Specifications. Each gram of pow-
per pound of body weight (when used der contains 750 milligrams (mg) of so-
with a preanesthetic, generally one- dium thiopental and 250 mg of sodium
half the normal dose). pentobarbital powder for dilution with
(ii) Swine: 40 mg per 5 pounds (lbs) of sterile water for injection.
body weight. (b) Sponsor. See No. 061133 in
(iii) Horses: Light anesthesia, 1 gram § 510.600(c) of this chapter.
per 500 lbs to 1,100 lbs of body weight; (c) Conditions of use—(1) Amount. For
deep anethesia, 1 gram per 300 lbs of total anesthesia, it is given at approxi-
body weight (40 mg/12 lbs of body mately 10 to 12 mg per pound of body
weight). weight over a period of 3.5 to 5 min-
(iv) Cattle: Short duration, 20 mg/5 lbs utes. When preanesthetic medication is
of body weight; longer duration, 40 mg/ used, wait at least an hour before ad-
7 lbs of body weight. ministering thiopental and sodium pen-
(2) Indications for use. It is used as an tobarbital for injection, and the dosage
ultra-short-acting anesthetic in dogs, necessary for anesthesia is reduced.
cats, swine, horses, and cattle. Usually 1⁄2 to 2⁄3 the normal amount is
(3) Limitations. Do not use in horses adequate.
intended for human consumption. Fed- (2) Indications for use. It is used as an
eral law restricts this drug to use by or anesthetic for intravenous administra-
on the order of a licensed veterinarian. tion to dogs and cats during short to
moderately long surgical procedures.
[79 FR 16196, Mar. 25, 2014, as amended at 83 (3) Limitations. Federal law restricts
FR 48946, Sept. 28, 2018] this drug to use by or on the order of a
§ 522.2444 Thiopental injectable dos-
age forms. [79 FR 16197, Mar. 25, 2014, as amended at 84
FR 8974, Mar. 13, 2019]
§ 522.2444a Thiopental powder for in-
jection. § 522.2450 Tigilanol.
(a) Specifications. The drug contains (a) Specifications. Each milliliter
sodium thiopental powder for constitu- (mL) of solution contains 1 milligram

tion with sterile water for injection. tigilanol tiglate.
344
(b) Sponsor. See No. 086132 in solution contains tiletamine hydro-

§ 510.600(c) of this chapter. chloride equivalent to 50 milligrams
(c) Conditions of use in dogs—(1) (mg) of tiletamine base and zolazepam
Amount. Administer as an intratumoral hydrochloride equivalent to 50 mg of
injection at a dose of 0.5 mL per cubic zolazepam base.
centimeter of tumor volume. (b) Sponsors. See sponsors in
(2) Indications for use. For the treat- § 510.600(c) of this chapter.
ment of non-metastatic cutaneous (1) Nos. 017033 and 054771 for use as in
mast cell tumors and non-metastatic paragraph (c) of this section.
subcutaneous mast cell tumors located (2) No. 051311 for use as in paragraphs
at or distal to the elbow or the hock in (c)(1)(i)(A), (c)(1)(ii)(A), (c)(1)(iii), and
dogs. (c)(2) of this section.
(3) Limitations. Federal law restricts (c) Conditions of use—(1) Dogs—(i)
this drug to use by or on the order of a Amount. Expressed as milligrams of the
licensed veterinarian. drug combination:
(A) An initial intramuscular dosage
[86 FR 17064, Apr. 1, 2021]
of 3 to 4.5 milligrams per pound (mg/lb)
§ 522.2460 Tildipirosin. of body weight for diagnostic purposes;
4.5 to 6 mg/lb of body weight for minor
(a) Specifications. Each milliliter of procedures of short duration such as
solution contains: repair of lacerations and wounds, cas-
(1) 180 milligrams (mg) tildipirosin. trations, and other procedures requir-
(2) [Reserved] ing mild to moderate analgesia. Sup-
(b) Sponsor. See No. 000061 in plemental doses when required should
§ 510.600(c) of this chapter. be less than the initial dose and the
(c) Related tolerances. See § 556.733 of total dose given should not exceed 12
this chapter. mg/lb of body weight. The maximum
(d) Conditions of use—(1) Cattle—(i) total safe dose is 13.6 mg/lb of body
Amount. Administer 4 mg/kg of bodyweight.
weight one time by subcutaneous injec- (B) Administer intravenously at 1 to
tion in the neck. 2 mg/lb (2.2 to 4.4 mg/kg) body weight
(ii) Indications for use. For the treat- to effect for induction of anesthesia
ment of bovine respiratory disease followed by maintenance with an inhal-
(BRD) associated with Mannheimia ant anesthetic.
haemolytica, Pasteurella multocida, and (ii) Indications for use. (A)
Histophilus somni in beef and non-lac- Intramuscular administration in dogs
tating dairy cattle; and for the control for restraint and minor procedures of
of respiratory disease in beef and non- short duration (30 minutes average) re-
lactating dairy cattle at high risk of quiring mild to moderate analgesia.
developing BRD associated with M. (B) Intravenous administration in
haemolytica, P. multocida, and H. somni. dogs for induction of anesthesia fol-
(iii) Limitations. Cattle intended for lowed by maintenance with an inhalant
human consumption must not be anesthetic.
slaughtered within 21 days from the (iii) Limitations. Federal law restricts
last treatment. Do not use in female this drug to use by or on the order of a
dairy cattle 20 months of age or older. licensed veterinarian.
A withdrawal period has not been es- (2) Cats—(i) Amount. An initial
tablished for this product in intramuscular dosage of 4.4 to 5.4 mg/lb
preruminating calves. Do not use in of body weight is recommended for
calves to be processed for veal. Federal such procedures as dentistry, treat-
law restricts this drug to use by or on ment of abscesses, foreign body re-
the order of a licensed veterinarian. moval, and related types of surgery; 4.8
(2) [Reserved] to 5.7 mg/lb of body weight for minor
[77 FR 39391, July 3, 2012] procedures requiring mild to moderate
analgesia, such as repair of lacerations,
§ 522.2470 Tiletamine and zolazepam castrations, and other procedures of
for injection. short duration. Initial dosages of 6.5 to
(a) Specifications. The drug is a sterile 7.2 mg/lb of body weight are rec-
powder. Each milliliter of constituted ommended for ovariohysterectomy and
345
§ 522.2471 21 CFR Ch. I (4–1–23 Edition)
onychectomy. When supplemental human consumption must not be

doses are required, such individual sup- slaughtered within 42 days of last
plemental doses should be given in in- treatment. Federal law restricts this
crements that are less than the initial drug to use by or on the order of a li-
dose and the total dose given (initial censed veterinarian.
dose plus supplemental doses) should
not exceed the maximum allowable [67 FR 72367, Dec. 5, 2002, as amended at 75
FR 9334, Mar. 2, 2010; 81 FR 48703, July 26,
safe dose of 32.7 mg/lb of body weight. 2016; 88 FR 16548, Mar. 20, 2023]
(ii) Indications for use. For restraint
or for anesthesia combined with muscle § 522.2473 Tiludronate.
relaxation.
(iii) Limitations. Federal law restricts (a) Specifications. Each vial of powder
this drug to use by or on the order of a contains 500 milligrams (mg)
licensed veterinarian. tiludronate disodium. Each milliliter
of constituted solution contains 20 mg
tiludronate disodium.
FR 14587, Apr. 5, 2018; 86 FR 17064, Apr. 1,
2021; 87 FR 10969, Feb. 28, 2022; 88 FR 16548, (b) Sponsor. See No. 061133 in
Mar. 20, 2023] § 510.600(c) of this chapter.
§ 522.2471 Tilmicosin. Amount. Administer a single dose of 1
(a) Specifications. Each milliliter of mg per kilogram (0.45 mg/pound) of
solution contains 300 milligrams (mg) body weight by intravenous infusion.
tilmicosin base as tilmicosin phos- (2) Indication for use. For the control
phate. of clinical signs associated with navic-
(b) Sponsor. See No. 058198 in ular syndrome.
§ 510.600(c) of this chapter. (3) Limitations. Do not use in horses
(c) Related tolerances. See § 556.735 of intended for human consumption. Fed-
this chapter. eral law restricts this drug to use by or
(d) Conditions of use—(1) Cattle—(i) on the order of a licensed veterinarian.
Amount. 10 to 20 milligrams per kilo-
grams (mg/kg) of body weight as a sin- [79 FR 18159, Apr. 1, 2014, as amended at 82
gle subcutaneous injection. FR 21691, May 10, 2017; 84 FR 8974, Mar. 13,
(ii) Indications for use. For the treat- 2019]
ment of bovine respiratory disease
§ 522.2474 Tolazoline.
(BRD) associated with Mannheimia
haemolytica, Pasteurella multocida, and (a) Specifications. Each milliliter of
Histophilus somni. For the control of solution contains tolazoline hydro-
respiratory disease in cattle at high chloride equivalent to 100 milligrams
risk of developing BRD associated with (mg) of base activity.
M. haemolytica. (b) Sponsor. See No. 059399 in
(iii) Limitations. Animals intended for § 510.600(c) of this chapter.
human consumption must not be (c) Conditions of use in horses—(1)
slaughtered within 42 days of last Amount. Administer slowly by intra-
treatment. Do not use in lactating venous injection 4 mg per kilogram of
dairy cattle 20 months of age or older. body weight or 1.8 mg per pound (4 mil-
Use of tilmicosin in this class of cattle liliters (mL) per 100 kilograms or 4 mL
may cause milk residues. Federal law per 220 pounds).
(2) Indications for use. For use in
horses when it is desirable to reverse
(2) Sheep—(i) Amount. 10 mg/kg body
the effects of sedation and analgesia
weight as a single subcutaneous injec-
caused by xylazine.
tion.
(ii) Indications for use. For the treat- (3) Limitations. Do not use in horses
ment of ovine respiratory disease intended for human consumption. Fed-
(ORD) associated with Mannheimia (P.) eral law restricts this drug to use by or
haemolytica. on the order of a licensed veterinarian.
(iii) Limitations. Not for use in lac- [79 FR 16197, Mar. 25, 2014, as amended at 79
tating ewes producing milk for human FR 74020, Dec. 15, 2014; 80 FR 13230, Mar. 13,
consumption. Animals intended for 2015]
346
§ 522.2476 Trenbolone acetate. lished in veal calves. A withdrawal pe-

(a) Sponsors. See sponsors in riod has not been established for this
§ 510.600(c) of this chapter for use as in product in preruminating calves. Do
paragraph (d) of this section. not use in calves to be processed for
(1) No. 058198 for use as in paragraph veal.
(c) of this section. [66 FR 47961, Sept. 17, 2001, as amended at 69
(2) No. 000061 for use as in paragraphs FR 70056, Dec. 2, 2004; 74 FR 61517, Nov. 25,
(c)(1)(i)(A), (c)(1)(ii), (c)(1)(iii), 2009; 81 FR 48703, July 26, 2016]
(c)(2)(i)(A), (c)(2)(ii), and (c)(2)(iii) of
this section. § 522.2477 Trenbolone acetate and es-
tradiol.
(b) Related tolerances. See § 556.739 of
this chapter. (a) [Reserved]
(c) Conditions of use—(1) Steers fed in (b) Sponsors. See sponsors in
confinement for slaughter—(i) Amount. § 510.600(c) of this chapter for uses as in
Use 126 days prior to slaughter; should paragraph (d) of this section.
be reimplanted once after 63 days. (1) No. 058198 for use as in paragraphs
(A) 140 milligrams (mg) trenbolone (d)(1)(i)(A), (d)(1)(i)(B), (d)(1)(i)(C),
acetate (one implant consisting of 7 (d)(1)(i)(D), (d)(1)(i)(E), (d)(1)(i)(F),
pellets, each pellet containing 20 mg (d)(1)(ii), (d)(1)(iii), (d)(2), and (d)(3) of
trenbolone acetate) per implant dose. this section.
(B) 140 mg trenbolone acetate (one (2) No. 000061 for use as in paragraphs
implant consisting of 8 pellets, each of (d)(1)(i)(A), (d)(1)(i)(C), (d)(1)(i)(D),
7 pellets containing 20 milligrams (d)(1)(ii), (d)(1)(iii), (d)(2)(i)(A),
trenbolone acetate, and 1 pellet con- (d)(2)(i)(C), (d)(2)(i)(D), (d)(2)(ii),
taining 29 mg tylosin tartrate) per im- (d)(2)(iii), (d)(3)(i)(A), (d)(3)(ii),
plant dose. (d)(3)(iii), (d)(4), (d)(5), and (d)(6) of this
(ii) Indications for use. For improved section.
feed efficiency. (3) No. 054771 for use as in paragraphs
(iii) Limitations. Implant (d)(1)(i)(A), (d)(1)(i)(D), (d)(1)(ii),
subcutaneously in ear only. Do not use (d)(1)(iii), (d)(3)(i)(A), (d)(3)(ii), and
in animals intended for subsequent (d)(3)(iii) of this section.
breeding or in dairy animals. Safety (c) Related tolerances. See §§ 556.240
and effectiveness have not been estab- and 556.739 of this chapter.
lished in veal calves. A withdrawal pe- (d) Conditions of use—(1) Steers fed in
riod has not been established for this confinement for slaughter—(i) Amount.
product in preruminating calves. Do (A) 120 milligrams (mg) trenbolone ace-
not use in calves to be processed for tate and 24 mg estradiol (one implant
veal. consisting of 6 pellets, each pellet con-
(2) Heifers fed in confinement for taining 20 mg trenbolone acetate and 4
slaughter—(i) Amount. Use last 63 days mg estradiol) per implant dose.
prior to slaughter. (B) 120 mg trenbolone acetate and 24
(A) 200 mg trenbolone acetate (one mg estradiol (one implant consisting of
implant consisting of 10 pellets, each 7 pellets, each of 6 pellets containing 20
pellet containing 20 mg trenbolone ace- mg trenbolone acetate and 4 mg estra-
tate) per implant dose. diol, and 1 pellet containing 29 mg
(B) 200 mg of trenbolone acetate (one tylosin tartrate) per implant dose.
implant consisting of 11 pellets, each of (C) 200 mg trenbolone acetate and 20
10 pellets containing 20 mg of mg estradiol (one implant consisting of
trenbolone acetate, and 1 pellet con- 10 pellets, each pellet containing 20 mg
taining 29 mg of tylosin tartrate) per trenbolone acetate and 2 mg estradiol)
implant dose. per implant dose.
(ii) Indications for use. For increased (D) 80 mg trenbolone acetate and 16
rate of weight gain and improved feed mg estradiol (one implant consisting of
efficiency. 4 pellets, each pellet containing 20 mg
(iii) Limitations. Implant trenbolone acetate and 4 mg estradiol)
subcutaneously in ear only. Do not use per implant dose.
in animals intended for subsequent (E) 200 mg trenbolone acetate and 20
breeding or in dairy animals. Safety mg estradiol (one implant consisting of

and effectiveness have not been estab- 11 pellets, each of 10 pellets containing
347
§ 522.2477 21 CFR Ch. I (4–1–23 Edition)
20 mg trenbolone acetate and 2 mg es- (F) 200 mg trenbolone acetate and 20

tradiol, and 1 pellet containing 29 mg mg estradiol (one implant consisting of
tylosin tartrate) per implant dose. 11 pellets, each of 10 pellets containing
(F) 80 mg trenbolone acetate and 16 20 mg trenbolone acetate and 2 mg es-
mg estradiol (one implant consisting of tradiol, and 1 pellet containing 29 mg
5 pellets, each of 4 pellets containing 20 tylosin tartrate) per implant dose.
mg trenbolone acetate and 4 mg estra- (ii) Indications for use. (A) For in-
diol, and 1 pellet containing 29 mg creased rate of weight gain and im-
tylosin tartrate) per implant dose. proved feed efficiency.
(ii) Indications for use. For increased (B) For increased rate of weight gain.
rate of weight gain and improved feed (iii) Limitations. Administer implant
efficiency. subcutaneously in the ear only. Do not
(iii) Limitations. Administer implant use in animals intended for subsequent
subcutaneously in the ear only. Do not breeding or in dairy animals. Safety
use in animals intended for subsequent and effectiveness have not been estab-
breeding or in dairy animals. Safety lished in veal calves. A withdrawal pe-
and effectiveness have not been estab- riod has not been established for this
lished in veal calves. A withdrawal pe- product in preruminating calves. Do
riod has not been established for this not use in calves to be processed for
product in preruminating calves. Do veal.
not use in calves to be processed for (3) Pasture cattle (slaughter, stocker,
veal. and feeder steers and heifers)—(i)
(2) Heifers fed in confinement for Amount. (A) 40 mg trenbolone acetate
slaughter—(i) Amount. (A) 140 mg and 8 mg estradiol (one implant con-
trenbolone acetate and 14 mg estradiol sisting of 2 pellets, each pellet con-
(one implant consisting of 7 pellets, taining 20 mg trenbolone acetate and 4
each pellet containing 20 mg mg estradiol) per implant dose.
trenbolone acetate and 2 mg estradiol) (B) 40 mg trenbolone acetate and 8
per implant dose for use as in para- mg estradiol (one implant consisting of
graph (d)(2)(ii)(A) of this section. 3 pellets, each of 2 pellets containing 20
mg trenbolone acetate and 4 mg estra-
(B) 140 mg trenbolone acetate and 14
diol, and 1 pellet containing 29 mg
mg estradiol (one implant consisting of
tylosin tartrate) per implant dose.
8 pellets, each of 7 pellets containing 20
(ii) Indications for use. For increased
mg trenbolone acetate and 2 mg estra-
rate of weight gain.
diol, and 1 pellet containing 29 mg
(iii) Limitations. Administer implant
tylosin tartrate) per implant dose for
subcutaneously in the ear only. Do not
use as in paragraphs (d)(2)(ii)(A) of this
use in animals intended for subsequent
section.
breeding or in dairy animals. Safety
(C) 80 mg trenbolone acetate and 8
and effectiveness have not been estab-
mg estradiol (one implant consisting of
lished in veal calves. A withdrawal pe-
4 pellets, each pellet containing 20 mg
riod has not been established for this
trenbolone acetate and 2 mg estradiol)
per implant dose for use as in para-
graph (d)(2)(ii)(B) of this section.
veal.
(D) 200 mg trenbolone acetate and 20 (4) Beef steers and heifers fed in con-
mg estradiol (one implant consisting of finement for slaughter—(i) Amount. Each
10 pellets, each pellet containing 20 mg extended- and delayed-release implant
trenbolone acetate and 2 mg estradiol) contains 200 mg trenbolone acetate and
per implant dose for use as in para- 20 mg estradiol (one implant consisting
graph (d)(2)(ii)(A) of this section. of 10 pellets, each pellet containing 20
(E) 80 mg trenbolone acetate and 8 mg trenbolone acetate and 2 mg estra-
mg estradiol (one implant consisting of diol) per implant dose.
5 pellets, each of 4 pellets containing 20 (ii) Indications for use. For increased
mg trenbolone acetate and 2 mg rate of weight gain and improved feed
estradiol, and 1 pellet containing 29 mg efficiency during 70 to 200 days after
tylosin tartrate) per implant dose for implantation.
use as in paragraph (d)(2)(ii)(B) of this (iii) Limitations. Administer implant

section. subcutaneously in the ear only. Do not
348
use in lactating dairy cows or in ani- (ii) Indications for use. For increased
mals intended for subsequent breeding. rate of weight gain and improved feed
Use in these cattle may cause drug res- efficiency for up to 200 days after im-
idues in milk and/or in calves born to plantation.
these cows. Do not use in calves to be (iii) Limitations. Administer implant
processed for veal. A withdrawal period subcutaneously in the ear only. Do not
has not been established for this prod- use in lactating dairy cows or in ani-
uct in pre-ruminating calves. Effective- mals intended for subsequent breeding.
ness and animal safety in veal calves Use in these cattle may cause drug res-
have not been established. Not ap- idues in milk and/or in calves born to
proved for repeated implantation (re- these cows. A withdrawal period has
implantation) with this or any other not been established for this product in
cattle ear implant during the produc- pre-ruminating calves. Do not use in
tion phase(s) identified on labeling calves to be processed for veal. Effec-
(beef steers and heifers fed in confine- tiveness and animal safety in veal
ment for slaughter) unless otherwise calves have not been established. Not
indicated on labeling because safety approved for repeated implantation (re-
and effectiveness have not been evalu- implantation) with this or any other
ated. cattle ear implant during the produc-
(5) Beef heifers fed in confinement for tion phase(s) identified on labeling
slaughter—(i) Amount. Each extended- (steers fed in confinement for slaugh-
release implant contains 200 mg ter) unless otherwise indicated on la-
trenbolone acetate and 20 mg estradiol beling because safety and effectiveness
(one implant consisting of 6 coated and have not been evaluated.
4 uncoated pellets, each pellet con- [60 FR 4376, Jan. 23, 1995]
taining 20 mg trenbolone acetate and 2
mg estradiol).
tations affecting § 522.2477, see the List of
(ii) Indications for use. For increased CFR Sections Affected, which appears in the
rate of weight gain and improved feed Finding Aids section of the printed volume
efficiency for up to 200 days after im- and at www.govinfo.gov.
plantation.
(iii) Limitations. Administer implant § 522.2478 Trenbolone acetate and es-
subcutaneously in the ear only. Do not tradiol benzoate.
use in lactating dairy cows or in ani- (a) Specifications. (1) Each implant
mals intended for subsequent breeding. consists of:
Use in these cattle may cause drug res- (i) 100 milligrams (mg) trenbolone ac-
idues in milk and/or in calves born to etate and 14 mg estradiol benzoate (one
these cows. Do not use in calves to be implant consisting of four pellets, each
processed for veal. A withdrawal period pellet containing 25 mg trenbolone ace-
has not been established for this prod- tate and 3.5 mg estradiol benzoate) per
uct in pre-ruminating calves. Effective- implant dose.
ness and animal safety in veal calves (ii) 200 mg trenbolone acetate and 28
have not been established. Not ap- mg estradiol benzoate (one implant
proved for repeated implantation (re- consisting of eight pellets, each pellet
implantation) with this or any other containing 25 mg trenbolone acetate
cattle ear implant during the produc- and 3.5 mg estradiol benzoate) per im-
tion phase(s) identified on labeling plant dose.
(beef heifers fed in confinement for (2) Each extended-release implant
slaughter) unless otherwise indicated consists of:
on labeling because safety and effec- (i) 150 mg trenbolone acetate and 21
tiveness have not been evaluated. mg estradiol benzoate (one implant
(6) Steers fed in confinement for slaugh- consisting of six pellets with a porous
ter—(i) Amount. Each extended-release polymer film coating, each pellet con-
implant contains 200 mg trenbolone ac- taining 25 mg trenbolone acetate and
etate and 40 mg estradiol (one implant 3.5 mg estradiol benzoate) per implant
consisting of 6 coated and 4 uncoated dose.
pellets, each containing 20 mg (ii) 200 mg trenbolone acetate and 28

trenbolone acetate and 4 mg estradiol). mg estradiol benzoate (one implant
349
§ 522.2478 21 CFR Ch. I (4–1–23 Edition)
consisting of eight pellets with a po- for up to 200 days in a reimplantation

rous polymer film coating, each pellet program where an implant as described
containing 25 mg trenbolone acetate in paragraph (a)(1)(i) of this section is
and 3.5 mg estradiol benzoate) per im- the first implant and an implant as de-
plant dose. scribed in paragraph (a)(2)(ii) of this
(b) Sponsor. See No. 054771 in section is administered 60 to 120 days
§ 510.600(c) of this chapter. later.
(c) Related tolerances. See §§ 556.240 (ii) Limitations. Implant pellets
and 556.739 of this chapter. subcutaneously in ear only. Other than
(d) Conditions of use—(1) Growing beef as described on the labeling, this im-
steers and heifers fed in confinement for
plant is not approved for repeated im-
slaughter—(i) Amounts and indications
plantation (reimplantation) with any
for use. (A) An implant containing 100
mg trenbolone acetate and 14 mg estra- other cattle ear implant in growing
diol benzoate as described in paragraph beef steers and heifers fed in confine-
(a)(1)(i) of this section for increased ment for slaughter as safety and effec-
rate of weight gain in growing beef tiveness have not been evaluated. Do
steers fed in confinement for slaughter not use in beef calves less than 2
and for increased rate of weight gain months of age, dairy calves, and veal
and improved feed efficiency in grow- calves because effectiveness and safety
ing beef heifers fed in confinement for have not been established. A with-
slaughter. For increased rate of weight drawal period has not been established
gain for up to 200 days in a reimplanta- for this product in pre-ruminating
tion program where an implant as de- calves. Do not use in dairy cows or in
scribed in paragraph (a)(1)(i) of this animals intended for subsequent breed-
section is the first implant and an im- ing. Use in these cattle may cause drug
plant as described in paragraph (a)(1)(i) residues in milk and/or in calves born
or (ii) or (a)(2)(ii) of this section is ad- to these cows. The extended-release
ministered 60 to 120 days later. implant described in paragraph (a)(2)(i)
(B) An implant containing 200 mg of this section, used as described in
trenbolone acetate and 28 mg estradiol paragraph (d)(1)(i)(C) of this section, is
benzoate as described in paragraph not approved for repeated implantation
(a)(1)(ii) of this section for increased (reimplantation) with this or any other
cattle ear implant.
efficiency in growing beef steers fed in
(2) Growing beef steers and heifers on
confinement for slaughter and for in-
creased rate of weight gain in growing pasture (stocker, feeder, and slaughter)—
beef heifers fed in confinement for (i) Amounts and indications for use. An
slaughter. For increased rate of weight extended-release implant containing
gain for up to 200 days in a reimplanta- 150 mg trenbolone acetate and 21 mg
tion program where an implant as de- estradiol benzoate as described in para-
scribed in paragraph (a)(1)(i) of this graph (a)(2)(i) of this section for in-
section is the first implant and an im- creased rate of weight gain for up to
plant as described in paragraph 200 days.
(a)(1)(ii) of this section is administered (ii) Limitations. Implant pellets
60 to 120 days later. subcutaneously in ear only. Not ap-
(C) An extended-release implant con- proved for repeated implantation (re-
taining 150 mg trenbolone acetate and implantation) with this or any other
21 mg estradiol benzoate as described cattle ear implant. Safety and effec-
in paragraph (a)(2)(i) of this section for tiveness following reimplantation have
increased rate of weight gain for up to not been evaluated. Do not use in beef
200 days. calves less than 2 months of age, dairy
(D) An extended-release implant con- calves, and veal calves because effec-
taining 200 mg trenbolone acetate and tiveness and safety have not been es-
28 mg estradiol benzoate as described tablished. A withdrawal period has not
in paragraph (a)(2)(ii) of this section
been established for this product in
for increased rate of weight gain and
pre-ruminating calves. Do not use in

improved feed efficiency for up to 200
days. For increased rate of weight gain dairy cows or in animals intended for
350
subsequent breeding. Use in these cat- tial results are inadequate or too tran-
tle may cause drug residues in milk sient, dosage may be increased, not to
and/or in calves born to these cows. exceed 18 mg.
[88 FR 14900, Mar. 10, 2023] (ii) Indications for use. For the treat-
ment of inflammation and related dis-
§ 522.2483 Triamcinolone. orders.
(a) Specifications. Each milliliter of (iii) Limitations. Do not use in horses
suspension contains 2 or 6 milligrams intended for human consumption. Fed-
(mg) triamcinolone acetonide. eral law restricts this drug to use by or
(b) Sponsors. See Nos. 000010 and on the order of a licensed veterinarian.
069043 in § 510.600(c) of this chapter. [75 FR 10167, Mar. 5, 2010, as amended at 78
(c) Conditions of use—(1) Dogs and FR 21060, Apr. 9, 2013; 80 FR 34279, June 16,
cats—(i) Amount—(A) Intramuscular or 2015; 83 FR 48946, Sept. 28, 2018]
subcutaneous. For inflammatory, ar-
thritic, or allergic disorders, admin- § 522.2582 Triflupromazine.
ister 0.05 to 0.1 mg per pound (/lb) of (a) Specifications. Each milliliter of
body weight as a single injection. For solution contains 20 milligrams (mg) of
dermatologic disorders, administer 0.1 triflupromazine hydrochloride.
mg per pound (/lb) of body weight as a (b) Sponsor. See No. 054771 in
single injection. If symptoms recur, the § 510.600(c) of this chapter.
dose may be repeated, or oral (c) Conditions of use—(1) Amount—(i)
corticosteroid therapy may be insti- Dogs. Administer by intravenous injec-
tuted. tion at a dosage of 0.5 to 1 mg per
(B) Intralesional. Administer 1.2 to 1.8 pound of body weight daily, or by
mg, divided in several injections intramuscular injection at a dosage of
around the lesion, spaced 0.5 to 2.5 cen- 1 to 2 mg per pound of body weight
timeters apart, depending on lesion daily.
size. At any one site, the dose injected (ii) Cats. Administer by
should not exceed 0.6 mg. and should be intramuscular injection at a dosage of
well into the cutis to prevent rupture 2 to 4 mg per pound of body weight
of the epidermis. When treating ani- daily.
mals with multiple lesions, do not ex- (iii) Horses. Administer by intra-
ceed a total dose of 6 mg. venous or intramuscular injection at a
(C) Intra-articular and intrasynovial. dosage of 10 to 15 mg per 100 pounds of
Administer 1 to 3 mg as a single injec- body weight daily to a maximum dose
tion, depending on the size of the joint of 100 mg.
and severity of symptoms. After 3 or 4 (2) Indications for use. For use in dogs,
days, repeat dosage if indicated. If ini- cats, and horses to relieve anxiety and
tial results are inadequate or too tran- to help control psychomotor over-
sient, dosage may be increased, not to activity as well as to increase the tol-
exceed 3 mg. erance of animals to pain and pruritus.
(ii) Indications for use. For the treat- The drug is indicated in various office
ment of inflammation and related dis- and clinical procedures which require
orders, and the management and treat- the aid of a tranquilizer, antiemetic, or
ment of acute arthritis and allergic preanesthetic.
and dermatologic disorders. (3) Limitations. Do not use in horses
(2) Horses—(i) Amount—(A)
Intramuscular or subcutaneous. Admin- [79 FR 16197, Mar. 25, 2014]
ister 0.01 to 0.02 mg/lb of body weight as
a single injection. Usual dose is 12 to 20 § 522.2610 Trimethoprim and sulfa-
mg. diazine.
(B) Intra-articular and intrasynovial. (a) Specifications. Each milliliter
Administer 6 to 18 mg as a single injec- (mL) contains:
tion, depending on the size of the joint (1) 40 milligrams (mg) trimethoprim
and severity of symptoms. After 3 or 4 suspended in a solution containing 200

days, repeat dosage if indicated. If ini- mg sulfadiazine; or
351
§ 522.2615 21 CFR Ch. I (4–1–23 Edition)
(2) 80 mg trimethoprim suspended in taminic therapy may be expected to

a solution containing 400 mg sulfa- lead to alleviation of some signs of dis-
diazine (as the sodium salt). ease.
(b) Sponsors. See Nos. 000061 and (iii) Limitations. Federal law restricts
054771 in § 510.600(c) of this chapter. this drug to use by or on the order of a
(c) Conditions of use—(1) Dogs—(i) licensed veterinarian.
Amount. 1 mL of the product described (2) Horses—(i) Amount. Administer 0.5
in paragraph (a)(1) of this section (40 mg per pound of body weight by
mg trimethoprim and 200 mg sulfa- intramuscular injection.
diazine) per 20 pounds (9 kilograms) of (ii) Indications for use. For use in
body weight per day by subcutaneous treating conditions in which antihis-
injection. taminic therapy may be expected to
(ii) Indications for use. For the treat- lead to alleviation of some signs of dis-
ment of acute urinary tract infections, ease.
acute bacterial complications of dis- (iii) Limitations. Do not use in horses
temper, acute respiratory tract infec- intended for human consumption. Fed-
tions, acute alimentary tract infec- eral law restricts this drug to use by or
tions, and acute septicemia due to on the order of a licensed veterinarian.
Streptococcus zooepidemicus. (3) Cattle—(i) Amount. Administer 0.5
(iii) Limitations. Federal law restricts mg per pound of body weight by intra-
this drug to use by or on the order of a venous or intramuscular injection.
licensed veterinarian. (ii) Indications for use. For use in
(2) Horses—(i) Amount. 2 mL of the treating conditions in which antihis-
product described in paragraph (a)(2) of taminic therapy may be expected to
this section (160 mg trimethoprim and lead to alleviation of some signs of dis-
800 mg sulfadiazine) per 100 pounds (45 ease.
kilograms) of body weight per day by (iii) Limitations. Milk taken during
intravenous injection as single, daily treatment and for 24 hours after the
dose for 5 to 7 days. The daily dose may last treatment must not be used for
also be halved and given morning and human consumption. Cattle must not
evening. be slaughtered for human consumption
(ii) Indications for use. For use where within 4 days following the last treat-
systemic antibacterial action against ment with this drug product. Not for
sensitive organisms is required during use in beef calves less than 2 months of
treatment of acute strangles, res- age, dairy calves, and veal calves. A
piratory tract infections, acute uro- withdrawal period has not been estab-
genital infections, and wound infec- lished for this product in pre-rumi-
tions and abscesses. nating calves. Federal law restricts
(iii) Limitations. Do not use in horses this drug to use by or on the order of a
intended for human consumption. Fed- licensed veterinarian.
on the order of a licensed veterinarian. [51 FR 44450, Dec. 10, 1986, as amended at 61
FR 29480, June 11, 1996; 62 FR 4164, Jan. 29,
[71 FR 30803, May 31, 2006, as amended at 79 1997; 78 FR 17597, Mar. 22, 2013; 79 FR 16198,
FR 16197, Mar. 25, 2014] Mar. 25, 2014; 81 FR 22524, Apr. 18, 2016; 82 FR
11508, Feb. 24, 2017; 87 FR 58962, Sept. 29, 2022]
§ 522.2615 Tripelennamine.
(a) Specifications. Each milliliter of § 522.2630 Tulathromycin.
solution contains 20 milligrams (mg) of (a) Specifications. Each milliliter of
tripelennamine hydrochloride. solution contains:
(b) Sponsors. See Nos. 016592 and (1) 100 milligrams (mg)
051031 in § 510.600(c) of this chapter. tulathromycin
(c) Related tolerances. See § 556.741 of (2) 25 mg tulathromycin
this chapter. (b) Sponsors. See sponsor numbers in
(d) Conditions of use—(1) Dogs and § 510.600(c) of this chapter.
cats—(i) Amount. Administer 0.5 mg per (1) Nos. 000061, 013744, 051311, 054771,
pound of body weight by intramuscular 055529, 058198, 061133, and 068504 for use
injection. of product described in paragraph (a)(1)
(ii) Indications for use. For use in as in paragraphs (d)(1)(i), (d)(1)(ii),

treating conditions in which antihis- (d)(1)(iii)(A), and (d)(2) of this section.
352
(2) Nos. 013744, 051311, 054771, and parasuis, and Mycoplasma

058198 for use of product described in hyopneumoniae; and for the control of
paragraph (a)(2) as in paragraphs SRD associated with A.
(d)(1)(i), (d)(1)(ii)(B), (d)(1)(iii)(B), and pleuropneumoniae, P. multocida, and M.
(d)(2) of this section. hyopneumoniae in groups of pigs where
(c) Related tolerances. See § 556.745 of SRD has been diagnosed.
this chapter. (iii) Limitations. Swine intended for
(d) Conditions of use—(1) Cattle—(i) human consumption must not be
Amount. 2.5 mg per kilogram (/kg) body slaughtered within 5 days from the last
weight as a single subcutaneous injec- treatment. Federal law restricts this
tion in the neck. drug to use by or on the order of a li-
(ii) Indications for use—(A) Beef and censed veterinarian.
non-lactating dairy cattle. For the treat- [70 FR 39918, July 12, 2005, as amended at 71
ment of bovine respiratory disease FR 57416, Sept. 29, 2006; 72 FR 54540, Sept. 26,
(BRD) associated with Mannheimia 2007; 73 FR 6018, Feb. 1, 2008; 73 FR 58872, Oct.
haemolytica, Pasteurella multocida, 8, 2008; 74 FR 53165, Oct. 16, 2009; 78 FR 63872,
Histophilus somni, and Mycoplasma bovis. Oct. 25, 2013; 79 FR 74020, Dec. 15, 2014; 80 FR
For the control of respiratory disease 13230, Mar. 13, 2015; 81 FR 67151, Sept. 30, 2016;
86 FR 57997, Oct. 20, 2021; 87 FR 58962, Sept.
in cattle at high risk of developing 29, 2022; 88 FR 16548, Mar. 20, 2023]
BRD associated with M. haemolytica, P.
multocida, H. somni, and M. bovis. For § 522.2632 Tulathromycin and
the treatment of infectious bovine ketoprofen.
keratoconjunctivitis (IBK) associated (a) Specifications. Each milliliter of
with Moraxella bovis. For the treatment solution contains 100 milligrams (mg)
of bovine foot rot (interdigital tulathromycin and 120 milligrams (mg)
necrobacillosis) associated with ketoprofen.
Fusobacterium necrophorum and (b) Sponsor. See No. 054771 in
Porphyromonas levii. § 510.600(c) of this chapter.
(B) Suckling calves, dairy calves, and (c) Related tolerances. See §§ 556.345
veal calves. For the treatment of bovine and 556.745 of this chapter.
respiratory disease (BRD) associated (d) Conditions of use—(1) Cattle—(i)
with Mannheimia haemolytica, Amount. Administer as a single sub-
Pasteurella multocida, Histophilus somni, cutaneous injection 2.5 mg
and Mycoplasma bovis. tulathromycin and 3 mg ketoprofen per
(iii) Limitations. (A) Cattle intended kilogram (1.1 mL/100 lb) of body weight.
for human consumption must not be (ii) Indications for use. For the treat-
slaughtered within 18 days from the ment of bovine respiratory disease
last treatment. This drug is not ap- (BRD) associated with Mannheimia
proved for use in female dairy cattle 20 haemolytica, Pasteurella multocida,
months of age or older, including dry Histophilus somni, and Mycoplasma bovis,
dairy cows. Use in these cattle may and control of pyrexia associated with
cause drug residues in milk and/or in BRD in beef steers, beef heifers, beef
calves born to these cows. Federal law calves 2 months of age and older, beef
restricts this drug to use by or on the bulls, dairy bulls, and replacement
order of a licensed veterinarian. dairy heifers.
(B) Calves intended for human con- (iii) Limitations. Not for use in repro-
sumption must not be slaughtered ducing animals over 1 year of age. Cat-
within 22 days from the last treatment. tle must not be slaughtered for human
Not for use in ruminating cattle. Fed- consumption within 18 days following
eral law restricts this drug to use by or last treatment with this drug product.
on the order of a licensed veterinarian. Not for use in female dairy cattle 1
(2) Swine—(i) Amount. 2.5 mg/kg body year of age or older, including dry
weight as a single intramuscular injec- dairy cows; use in these cattle may
tion in the neck. cause drug residues in milk and/or in
(ii) Indications for use. For the treat- calves born to these cows or heifers.
ment of swine respiratory disease Not for use in beef calves less than 2
(SRD) associated with Actinobacillus months of age, dairy calves, and veal
pleuropneumoniae, P. multocida, calves. A withdrawal period has not

Bordetella bronchiseptica, Haemophilus been established for this product in
353
§ 522.2640 21 CFR Ch. I (4–1–23 Edition)
pre-ruminating calves. Federal law re- (2) Swine—(i) Amount. Administer 4

stricts this drug to use by or on the mg/lb of body weight by intramuscular
order of a licensed veterinarian. injection twice daily for not more than
(2) [Reserved] 3 consecutive days. Continue treatment
[86 FR 61685, Nov. 8, 2021] 24 hours after symptoms disappear. If
tylosin medicated drinking water is
§ 522.2640 Tylosin. used as a followup treatment for swine
(a) Specifications. Each milliliter dysentery, the animal should there-
(mL) of solution contains 50 or 200 mil- after receive feed containing 40 to 100
ligrams (mg) of tylosin activity (as grams of tylosin per ton for 2 weeks to
tylosin base). assure depletion of tissue residues.
(b) Sponsors. See sponsors in (ii) Indications for use. Treatment of
§ 510.600(c) of this chapter as follows: swine arthritis caused by Mycoplasma
(1) No. 058198 for use of 50- or 200-mg/ hyosynoviae; swine pneumonia caused
mL solutions as in paragraph (e) of this by Pasteurella spp.; swine erysipelas
section. caused by Erysipelothrix rhusiopathiae;
(2) Nos. 016592 and 061133 for use of a swine dysentery associated with
200-mg/mL solution as in paragraphs Treponema hyodysenteriae when fol-
(e)(1) and (2) of this section. lowed by appropriate medication in the
(c) Related tolerances. See § 556.746 of drinking water and/or feed.
this chapter. (iii) Limitations. Swine intended for
(d) Special considerations. Labeling human consumption must not be
must bear the warning statements: slaughtered within 14 days of the last
‘‘Do not administer to horses or other use of this drug product. Federal law
equines. Injection of tylosin in equines restricts this drug to use by or on the
has been fatal.’’ order of a licensed veterinarian.
(e) Conditions of use—(1) Beef cattle (3) Dogs and cats—(i) Amount. Admin-
and nonlactating dairy cattle—(i) ister 3 to 5 mg/lb of body weight by
Amount. Administer 8 mg per pound intramuscular injection at 12- to 24-
(mg/lb) of body weight by hour intervals.
intramuscular injection once daily for (ii) Indications for use—(A) Dogs.
not more than 5 consecutive days. Con- Treatment of upper respiratory infec-
tinue treatment 24 hours after symp- tions such as bronchitis,
toms disappear. tracheobronchitis, tracheitis, laryn-
(ii) Indications for use. Treatment of gitis, tonsillitis, and pneumonia caused
bovine respiratory complex (shipping by Staphylococci spp., hemolytic
fever, pneumonia) usually associated Streptococci spp., and Pasteurella
with Pasteurella multocida and multocida.
Arcanobacterium pyogenes; foot rot (ne- (B) Cats. Treatment of upper res-
crotic pododermatitis) and calf diph- piratory infections when caused by
theria caused by Fusobacterium Staphylococci spp. and hemolytic
necrophorum and metritis caused by A. Streptococci spp. and for feline pneumo-
pyogenes. nitis when caused by tylosin-suscep-
(iii) Limitations. Cattle intended for tible organisms.
human consumption must not be (iii) Limitations. Federal law restricts
slaughtered within 21 days of the last this drug to use by or on the order of a
use of this drug product. This drug licensed veterinarian.
product is not approved for use in fe- [81 FR 67151, Sept. 30, 2016, as amended at 84
male dairy cattle 20 months of age or FR 8974, Mar. 13, 2019; 84 FR 32992, July 11,
older, including dry dairy cows. Use in 2019; 88 FR 14900, Mar. 10, 2023; 88 FR 16549,
these cattle may cause drug residues in Mar. 20, 2023]
milk and/or in calves born to these
cows. This product is not approved for § 522.2662 Xylazine.
use in calves intended to be processed (a) Specifications. Each milliliter
for veal. A withdrawal period has not (mL) of solution contains xylazine hy-
been established in preruminating drochloride equivalent to:
calves. Federal law restricts this drug (1) 20 milligrams (mg) xylazine.
to use by or on the order of a licensed (2) 100 mg xylazine.

veterinarian. (3) 300 mg xylazine.
354
(b) Sponsors. See sponsors in (C) Fallow deer (Dama dama): 2 to 4

§ 510.600(c) of this chapter for uses as in mg/lb.
paragraph (d) of this section. (ii) Indications for use. (A) To produce
(1) No. 069043 for use of product de- sedation, as an analgesic, and as a
scribed in paragraph (a)(2) of this sec- preanesthetic to local anesthesia.
tion as in paragraph (d)(2) of this sec- (B) To produce sedation, accom-
tion. panied by a shorter period of analgesia.
(2) Nos. 000010 and 061133 for use of May be used to calm and facilitate han-
product described in paragraph (a)(2) of dling of fractious animals for diag-
this section as in paragraphs (d)(2),
nostic procedures, for minor surgical
(d)(3)(i), (d)(3)(ii)(A), and (d)(3)(iii) of
procedures, for therapeutic medication
this section.
(3) Nos. 043264 and 061651 for use of for sedation and relief of pain following
product described in paragraph (a)(1) of injury or surgery, and as a
this section as in paragraph (d)(1) of preanesthetic to local anesthetic. At
this section; and product described in the recommended dosages, can be used
paragraph (a)(2) of this section as in in conjunction with local anesthetics,
paragraphs (d)(2), (d)(3)(i), (d)(3)(ii)(A), such as procaine or lidocaine.
and (d)(3)(iii) of this section. (iii) Limitations. Do not use in domes-
(4) No. 059399 for use of product de- tic food-producing animals. Do not use
scribed in paragraph (a)(1) of this sec- in Cervidae less than 15 days before or
tion as in paragraph (d)(1) of this sec- during the hunting season.
tion; product described in paragraph
(a)(2) of this section as in paragraphs
FR 10167, Mar. 5, 2010, 78 FR 21060, Apr. 9,
(d)(2), (d)(3)(i), (d)(3)(ii)(A), and 2013; 79 FR 16198, Mar. 25, 2014; 79 FR 21127,
(d)(3)(iii) of this section; and product Apr. 15, 2014; 79 FR 74020, Dec. 15, 2014; 80 FR
described in paragraph (a)(3) of this 13230, Mar. 13, 2015; 83 FR 48946, Sept. 28, 2018;
section as in paragraphs (d)(3)(i), 84 FR 8974, Mar. 13, 2019; 87 FR 17946, Mar. 29,
(d)(3)(ii)(B), and (d)(3)(iii) of this sec- 2022]
tion.
(c) Special considerations. Federal law § 522.2670 Yohimbine.
restricts this drug to use by or on the (a) Specifications. Each milliliter
(mL) of solution contains 2 or 5 milli-
grams (mg) of yohimbine (as hydro-
cats—(i) Amount. 0.5 mg/pound (lb) in-
travenously or 1.0 mg/lb chloride).
subcutaneously. (b) Sponsors. See sponsors in
(ii) Indications for use. To produce se- § 510.600(c) of this chapter for use as in
dation, as an analgesic, and as a paragraph (c) of this section.
preanesthetic to local or general anes- (1) No. 059399 for use of in 2 mg/mL
thesia. solution as in paragraph (c)(1) of this
(2) Horses—(i) Amount. 0.5 mg/lb intra- section.
venously or 1.0 mg/lb intramuscularly. (2) No. 053923 for use of in 5 mg/mL
(ii) Indications for use. To produce se- solution as in paragraph (c)(2) of this
dation, as an analgesic, and as a section.
preanesthetic to local or general anes- (c) Conditions of use—(1) Dogs—(i)
thesia. Amount. Administer 0.05 mg per pound
(iii) Limitations. Do not use in horses (0.11 mg per kilogram) of body weight
intended for human consumption. by intravenous injection.
(3) Elk and deer—(i) Amount. Admin- (ii) Indications for use. To reverse the
ister intramuscularly, by hand syringe,
effects of xylazine in dogs.
or by syringe dart, in the heavy mus-
(iii) Limitations. Not for use in food-
cles of the croup or shoulder as follows:
(A) Elk (Cervus canadensis): 0.25 to 0.5 producing animals. Federal law re-
mg/lb. stricts this drug to use by or on the
(B) Mule deer (Odocoileus hemionus), order of a licensed veterinarian.
sika deer (Cervus nippon), and white- (2) Deer and elk—(i) Amount. Admin-
tailed deer (Odocoileus virginianus): 1 to ister 0.2 to 0.3 mg per kilogram of body
2 mg/lb. weight by intravenous injection.
355
§ 522.2680 21 CFR Ch. I (4–1–23 Edition)
(ii) Indications for use. A s an antago- for this product in preruminating

nist to xylazine sedation in free rang- calves. Do not use in calves to be proc-
ing or confined members of the family essed for veal.
Cervidae (deer and elk). (3) Steers fed in confinement for slaugh-
(iii) Limitations. Do not use in domes- ter—(i) Amount. 72 mg zeranol (one im-
tic food-producing animals. Do not use plant consisting of 6 pellets, each pel-
for 30 days before or during hunting let containing 12 mg zeranol) per im-
season. Federal law restricts this drug plant dose.
(ii) Indications for use. For increased
veterinarian.
[79 FR 74020, Dec. 15, 2014, as amended at 80 efficiency.
FR 13230, Mar. 13, 2015]
(iii) Limitations. Implant
§ 522.2680 Zeranol. subcutaneously in ear only. Safety and
effectiveness have not been established
(a) Specifications. Each pellet con-
in veal calves. A withdrawal period has
tains 12, 18, or 20 milligrams (mg)
zeranol. not been established for this product in
(b) Sponsor. See 000061 in § 510.600(c) of preruminating calves. Do not use in
this chapter. calves to be processed for veal.
(c) Related tolerances. See § 556.760 of (4) Pasture cattle (slaughter, stocker,
this chapter. feeder steers, and heifers)—(i) Amount.
(d) Conditions of use—(1) Beef cattle— 138 mg zeranol (one implant consisting
(i) Amount. 36 mg zeranol (one implant of 7 pellets, each of 6 pellets containing
consisting of 3 pellets, each pellet con- 20 mg zeranol and a seventh pellet con-
taining 12 mg zeranol) per implant taining 18 mg zeranol) per implant
dose. dose.
(ii) Indications for use. (A) For in- (ii) Indications for use. For increased
creased rate of weight gain and im- rate of weight gain.
proved feed conversion in weaned beef (iii) Limitations. Implant
calves, growing beef cattle, feedlot subcutaneously in ear only. Safety and
steers, and feedlot heifers.
effectiveness have not been established
(B) For increased rate of weight gain
in veal calves. A withdrawal period has
in suckling calves.
(iii) Limitations. Implant not been established for this product in
subcutaneously in ear only. Do not use preruminating calves. Do not use in
in bulls intended for reproduction or in calves to be processed for veal.
dairy animals. Do not use before 1 [59 FR 19639, Apr. 25, 1994; 60 FR 26360, May
month of age or after weaning in heif- 17, 1995, as amended at 62 FR 61625, Nov. 19,
ers intended for reproduction. Safety 1997; 64 FR 46840, Aug. 27, 1999; 67 FR 6867,
and effectiveness have not been estab- Feb. 14, 2002; 70 FR 6764, Feb. 9, 2005]
lished in veal calves. A withdrawal pe-
riod has not been established for this § 522.2690 Zinc gluconate.
product in preruminating calves. Do (a) Specifications. Each milliliter of
not use in calves to be processed for solution contains 13.1 milligrams zinc
veal. as zinc gluconate neutralized to pH 7.0
(2) Feedlot lambs—(i) Amount. 12 mg with L-arginine.
zeranol (one implant consisting of 1
pellet containing 12 mg zeranol) per
implant dose. § 510.600(c) of this chapter.
(ii) Indications for use. For increased (c) Conditions of use in dogs—(1)
rate of weight gain and improved feed Amount. The volume injected into each
conversion. testicle is based on testicular width as
(iii) Limitations. Implant determined by measuring each testicle
subcutaneously in ear only. Do not use at its widest point using a metric scale
in breeding animals. Do not implant (millimeter) caliper.
animals within 40 days of slaughter. (2) Indications for use. Intratesticular
Safety and effectiveness have not been injection for chemical sterilization of
established in veal calves. A with- 3- to 10-month-old male dogs.

drawal period has not been established
356
(3) Limitations. Federal law restricts 524.1044e Gentamicin spray.

this drug to use by or on the order of a 524.1044f Gentamicinand betamethasone
licensed veterinarian. spray.
524.1044g Gentamicin, betamethasone, and
[68 FR 26995, May 19, 2003, as amended at 76 clotrimazole ointment.
FR 79064, Dec. 21, 2011; 87 FR 76422, Dec. 14, 524.1044h Gentamicin, mometasone, and
2022] clotrimazole otic suspension.
524.1044i Gentamicin and betamethasone
PART 524—OPHTHALMIC AND TOP- ophthalmic solution.
524.1132 Hydrocortisone, miconazole, and
ICAL DOSAGE FORM NEW ANI- gentamicin otic suspension.
MAL DRUGS 524.1140 Imidacloprid and ivermectin.
524.1146 Imidacloprid and moxidectin.
Sec. 524.1193 Ivermectin topical solution.
524.86 Amitraz. 524.1195 Ivermectin otic suspension.
524.154 Bacitracin, neomycin, and poly- 524.1200 Kanamycin ophthalmic and topical
myxin B ophthalmic ointment. dosage forms.
524.155 Bacitracin, neomycin, polymyxin B, 524.1200a Kanamycin ophthalmic ointment.
and hydrocortisone ophthalmic oint- 524.1200b Kanamycin ophthalmic solution.
ment. 524.1204 Kanamycin, amphomycin, and hy-
524.230 Buprenorphine. drocortisone ointment.
524.390 Chloramphenicol ophthalmic oint- 524.1240 Levamisole.
ment. 524.1376 2-Mercaptobenzothiazole solution.
524.402 Chlorhexidine. 524.1443 Miconazole.
524.450 Clotrimazole. 524.1445 Miconazole, polymixin B, and pred-
524.463 Copper naphthenate. nisolone suspension.
524.575 Cyclosporine ophthalmic ointment. 524.1446 Milbemycin otic solution.
524.590 Diclofenac. 524.1448 Mirtazapine transdermal ointment.
524.660 Dimethyl sulfoxide. 524.1450 Moxidectin.
524.770 Doramectin. 524.1465 Mupirocin.
524.775 Emodepside and praziquantel. 524.1484 Neomycin ophthalmic and topical
524.802 Enrofloxacin and silver sulfadiazine dosage forms.
otic emulsion. 524.1484b Neomycin, isoflupredone, and tet-
524.814 Eprinomectin. racaine powder.
524.815 Eprinomectin and praziquantel. 524.1484c Neomycin, isoflupredone, and tet-
524.900 Famphur. racaine ointment.
524.920 Fenthion. 524.1484d Neomycin, hydrocortisone, and
524.955 Florfenicol, terbinafine, and tetracaine otic ointment.
betamethasone acetate otic gel. 524.1484e Neomycin and polymyxin B oph-
524.957 Florfenicol, terbinafine, and thalmic solution.
mometasone otic solution. 524.1484f Neomycin, prednisolone, and tetra-
524.960 Flumethasone, neomycin, and poly- caine otic suspension.
myxin B ophthalmic solution. 524.1484g Neomycin, thiabendazole, and
524.970 Flunixin. dexamethasone solution.
524.1484h Neomycin, penicillin, polymyxin
FLUOCINOLONE TOPICAL AND OTIC DOSAGE
B, and hydrocortisone suspension.
FORMS
524.1484i Neomycin and hydrocortisone oint-
524.981 [Reserved] ment.
524.981a Fluocinolone cream. 524.1484j Neomycin and prednisolone oph-
524.981b Fluocinolone solution. thalmic ointment.
524.981c Fluocinolone and neomycin cream. 524.1484k Neomycin and prednisolone sus-
524.981d Fluocinolone and dimethyl sulf- pension.
oxide solution. 524.1580 Nitrofurazone topical dosage forms.
524.981e Fluocinolone and dimethyl sulf- 524.1580a Nitrofurazone ointment.
oxide otic solution. 524.1580b Nitrofurazone soluble powder.
524.998 Fluralaner. 524.1580c Nitrofurazone and butacaine oint-
524.1001 Fluralaner and moxidectin. ment.
524.1005 Furazolidone powder. 524.1600 Nystatin ophthalmic and topical
524.1044 Gentamicin sophthalmic and top- dosage forms.
ical dosage forms. 524.1600a Nystatin, neomycin, thiostrepton,
524.1044a Gentamicin ophthalmic solution. and triamcinolone ointment.
524.1044b Gentamicin and betamethasone 524.1600b Nystatin, neomycin, thiostrepton,
otic solution. and triamcinolone ophthalmic ointment
524.1044c Gentamicin ophthalmic ointment. 524.1610 Orbifloxacin, mometasone furoate
524.1044d Gentamicin and betamethasone monohydrate, and posaconazole suspen-

ointment. sion.
357
§ 524.86 21 CFR Ch. I (4–1–23 Edition)
524.1662 Oxytetracycline ophthalmic and (2) Nos. 000061, 043264, and 059399 for
topical dosage forms. use of product described in paragraph
524.1662a Oxytetracycline and hydro- (a)(2) as in paragraph (c) of this sec-
cortisone spray.
tion.
524.1662b Oxytetracycline and polymyxin B
ophthalmic ointment. (c) Conditions of use in dogs and cats—
524.1742 Phosmet emulsifiable liquid. (1) Amount. Apply a thin film over the
524.1982 Proparacaine ophthalmic solution. cornea 3 or 4 times daily.
524.2080 Ropinirole. (2) Indications for use. Treatment of
524.2098 Selamectin. superficial bacterial infections of the
524.2099 Selamectin and sarolaner. eyelid and conjunctiva of dogs and cats
524.2101 Selenium disulfide suspension. when due to susceptible organisms.
524.2350 Tolnaftate cream. (3) Limitations. Federal law restricts
524.2482 Triamcinolone spray.
524.2483 Triamcinolone cream.
524.2620 Liquid crystalline trypsin, Peru
balsam, castor oil. [57 FR 37333, Aug. 18, 1992, as amended at 61
AUTHORITY: 21 U.S.C. 360b. FR 8873, Mar. 6, 1996; 62 FR 61625, Nov. 19,
1997; 77 FR 64717, Oct. 23, 2012; 79 FR 10967,
SOURCE: 40 FR 13873, Mar. 27, 1975, unless Feb. 27, 2014; 80 FR 61297, Oct. 13, 2015]
otherwise noted.
§ 524.155 Bacitracin, neomycin, poly-
§ 524.86 Amitraz. myxin B, and hydrocortisone oph-
(a) Specifications. Amitraz liquid con- thalmic ointment.
tains 19.9 percent amitraz in an organic (a) Specifications. Each gram of oint-
solvent. ment contains 400 units of bacitracin
(b) Sponsor. See No. 054771 in zinc, 5 milligrams (mg) of neomycin
§ 510.600(c) of this chapter. sulfate (equivalent to 3.5 mg of neomy-
(c) Conditions of use—(1) Indications cin sulfate), 10,000 units of polymyxin B
for use. For dogs for the treatment of sulfate, and10 mg of hydrocortisone.
generalized demodicosis (Demodex (b) Sponsors. See Nos. 000061 and
canis). 043264 in § 510.600(c) of this chapter.
(2) Amount. One 10.6 milliliter bottle (c) Conditions of use in dogs and cats—
per 2 gallons of warm water (250 parts (1) Amount. Apply a thin film over the
per million) for each treatment, for a cornea three or four times daily.
total of 3 to 6 treatments, 14 days (2) Indications for use. For treating
apart. acute or chronic conjunctivitis caused
(3) Limitations. Federal law restricts by susceptible organisms.
this drug to use by or on the order of a (3) Limitations. Federal law restricts
licensed veterinarian. this drug to use by or on the order of a
[47 FR 18589, Apr. 30, 1982, as amended at 79 licensed veterinarian.
FR 10967, Feb. 27, 2014] [57 FR 37333, Aug. 18, 1992, as amended at 61
FR 8873, Mar. 6, 1996; 62 FR 61626, Nov. 19,
§ 524.154 Bacitracin, neomycin, and 1997; 77 FR 64717, Oct. 23, 2012; 79 FR 10967,
polymyxin B ophthalmic ointment. Feb. 27, 2014]
(a) Specifications. Each gram of oint-
ment contains: § 524.230 Buprenorphine.
(1) 500 units bacitracin, 3.5 milli- (a) Specifications. Each milliliter
grams (mg) neomycin sulfate (equiva- (mL) of solution contains 20 milligrams
lent to 3.5 mg neomycin base), and (mg) buprenorphine. The drug is sup-
10,000 units polymyxin B sulfate; or plied in tubes containing 0.4 mL (8 mg)
(2) 400 units bacitracin zinc, 5 mg ne- or 1.0 mL (20 mg).
omycin sulfate (equivalent to 3.5 mg (b) Sponsor. See No. 058198 in
neomycin base), and 10,000 units poly- § 510.600(c) of this chapter.
myxin B sulfate. (c) Conditions of use in cats—(1)
(b) Sponsors. See sponsor numbers in Amount. Administer topically to the
§ 510.600(c) of this chapter as follows: dorsal cervical area at the base of the
(1) No. 054771 for use of product de- skull a single dose of 1.2 to 3.1 mg/lb
scribed in paragraph (a)(1) as in para- (2.7 to 6.7 mg/kg) approximately 1 to 2

graph (c) of this section. hours before surgery.
358
(2) Indications for use. For the control cats caused by Microsporum canis and
of postoperative pain associated with Trichophyton mentagrophytes.
surgical procedures in cats. (3) Limitations. Federal law restricts
licensed veterinarian. Buprenorphine is
a Schedule III controlled substance. FR 10967, Feb. 27, 2014; 86 FR 14820, Mar. 19,
[87 FR 58962, Sept. 29, 2022] 2021]
§ 524.390 Chloramphenicol ophthalmic § 524.463 Copper naphthenate.

ointment. (a) Amount. The drug is a 37.5 percent
(a) Specifications. Each gram contains solution of copper naphthenate.
10 milligrams chloramphenicol. (b) Sponsors. See Nos. 017135, 054771,
(b) Sponsors. See Nos. 043264 and and 058829 in § 510.600(c) of this chapter.
054771 in § 510.600(c) of this chapter. (c) Conditions of use in horses—(1)
(c) Conditions of use in dogs and cats— Amount. Apply daily to affected hooves
(1) Amount. Apply every 3 hours around until fully healed.
the clock for 48 hours, after which (2) Indications for use. As an aid in
night instillations may be omitted. treating horses and ponies for thrush
(2) Indications for use. For treatment caused by organisms susceptible to
of bacterial conjunctivitis caused by copper naphthenate.
pathogens susceptible to chloramphen- (3) Limitations. Use on horses and
icol. ponies only. Avoid contact around
(3) Limitations. Federal law restricts eyes. Do not contaminate feed. Do not
this drug to use by or on the order of a use in horses intended for human con-
licensed veterinarian. Federal law pro- sumption.
hibits the use of this drug in food-pro-
ducing animals. [47 FR 4250, Jan. 29, 1982, as amended at 68
FR 55825, Sept. 29, 2003; 71 FR 38074, July 5,
[77 FR 4897, Feb. 1, 2012, as amended at 77 FR 2006; 79 FR 10967, Feb. 27, 2014]
64717, Oct. 23, 2012; 79 FR 10967, Feb. 27, 2014]
§ 524.575 Cyclosporine ophthalmic
§ 524.402 Chlorhexidine. ointment.
(a) Specifications. Each gram of oint- (a) Specifications. Each gram of oint-
ment contains 10 milligrams ment contains 2 milligrams of
chlorhexidine acetate. cyclosporine.
(b) Sponsors. See Nos. 054771 and (b) Sponsor. See No. 000061 in
058829 in § 510.600(c) of this chapter. § 510.600(c) of this chapter.
(c) Conditions of use in dogs, cats, and (c) Conditions of use—(1) Amount.
horses—(1) Indications for use. For use Apply a 1⁄4-inch strip of ointment di-
as a topical antiseptic ointment for rectly on the cornea or into the con-
surface wounds. junctival sac of the affected eye(s)
(2) Limitations. Do not use in horses every 12 hours.
intended for human consumption. (2) Indications for use. For manage-
[72 FR 265, Jan. 4, 2007, as amended at 79 FR ment of chronic keratoconjunctivitis
10967, Feb. 27, 2014] sicca (KCS) and chronic superficial
keratitis (CSK) in dogs.
§ 524.450 Clotrimazole. (3) Limitations. Federal law restricts
(a) Specifications. Each gram of cream this drug to use by or on the order of a
contains 10 milligrams of clotrimazole. licensed veterinarian.
(b) Sponsor. See No. 058198 in [60 FR 48651, Sept. 20, 1995, as amended at 62
§ 510.600(c) of this chapter. FR 48940, Sept. 18, 1997; 79 FR 10967, Feb. 27,
(c) Conditions of use—(1) Amount. 2014]
Apply 1⁄4-inch ribbon of cream per
square inch of lesion once daily for 2 to § 524.590 Diclofenac.
4 weeks. (a) Specifications. Each gram of cream
(2) Indications of use. For the treat- contains 10 milligrams diclofenac so-
ment of fungal infections of dogs and dium.
359
§ 524.660 21 CFR Ch. I (4–1–23 Edition)
(b) Sponsor. See No. 000010 in (d) Special considerations. See § 500.25
§ 510.600(c) of this chapter. of this chapter.
(c) Conditions of use in horses—(1) (e) Conditions of use in cattle—(1)
Amount. Apply a 5-inch (5″) ribbon of Amount. Administer topically 1 mL (5
cream twice daily over the affected mg doramectin) per 22 lb (10 kg) of
joint for up to 10 days and rub thor- body weight.
oughly into the hair covering the joint (2) Indications for use. For treatment
until it disappears. and control of gastrointestinal
(2) Indications for use in horses. For roundworms: Ostertagia ostertagi (adults
the control of pain and inflammation and fourth-stage larvae), Ostertagia
associated with osteoarthritis in tar- ostertagi (inhibited fourth-stage lar-
sal, carpal, metacarpophalangeal, vae), Ostertagia lyrata (adults),
metatarsophalangeal, and proximal Haemonchus placei (adults and fourth-
interphalangeal (hock, knee, fetlock stage larvae), Trichostrongylus axei
and pastern) joints. (adults and fourth-stage larvae),
(3) Limitations. Do not use in horses Trichostrongylus colubriformis (adults
intended for human consumption. Fed- and fourth-stage larvae), Cooperia
eral law restricts this drug to use by or oncophora (adults and fourth-stage lar-
on the order of a licensed veterinarian. vae), Cooperia punctata (adults and
fourth-stage larvae), Cooperia pectinata
(adults), Cooperia surnabada (adults),
FR 26782, June 4, 2009; 74 FR 47436, Sept. 16,
2009] Bunostomum phlebotomum (adults),
Oesophagostomum radiatum (adults and
§ 524.660 Dimethyl sulfoxide. fourth-stage larvae), Trichuris spp.
(adults); lungworms: Dictyocaulus
(a) Specifications. (1) Each milliliter
viviparus (adults and fourth-stage lar-
(mL) of solution contains 90 percent di-
vae); eyeworms: Thelazia gulosa
methyl sulfoxide and 10 percent water.
(adults), Thelazia skrjabini (adults);
(2) Each milliliter (mL) of gel prod-
grubs: Hypoderma bovis and Hypoderma
uct contains 90 percent dimethyl sulf-
lineatum; sucking lice: Linognathus
oxide.
vituli, Haematopinus eurysternus, and
Solenopotes capillatus; biting lice:
Bovicola (Damalinia) bovis; mange
(c) Conditions of use in horses and
mites: Chorioptes bovis and Sarcoptes
dogs—(1) Amount—(i) Horses. Apply
scabiei; horn flies: Haematobia irritans;
topically two to three times daily in an
and to control infections and to protect
amount not to exceed 100 mL per day.
from reinfection with Cooperia
Total duration of therapy should not
oncophora, Dictyocaulus viviparus,
exceed 30 days.
Ostertagia ostertagi, and
(ii) Dogs. Apply topically three to
Oesophagostomum radiatum for 28 days;
four times daily in an amount not to
and with Cooperia punctata and
exceed 20 mL per day. Total duration of
Haemonchus placei for 35 days after
therapy should not exceed 14 days.
treatment; and to control infestations
(2) Indications for use. To reduce acute
and to protect from reinfestation with
swelling due to trauma.
Linognathus vituli for 42 days and with
Bovicola (Damalinia) bovis for 77 days
after treatment.
(3) Limitations. Cattle must not be
slaughtered for human consumption
[79 FR 10967, Feb. 27, 2014] within 45 days of treatment. Not for
use in female dairy cattle 20 months of
§ 524.770 Doramectin. age or older. A withdrawal period has
(a) Specifications. Each milliliter not been established for this product in
(mL) of solution contains 5 milligrams pre-ruminating calves. Do not use in
(mg) doramectin. calves to be processed for veal.
(b) Sponsor. See No. 054771 in [69 FR 48392, Aug. 10, 2004, as amended at 70
§ 510.600(c) of this chapter. FR 43046, July 26, 2005; 79 FR 10967, Feb. 27,
(c) Related tolerances. See § 556.222 of 2014; 84 FR 32993, July 11, 2019; 87 FR 10970,
this chapter. Feb. 28, 2022]
360
§ 524.775 Emodepside and (c) Related tolerances. See § 556.227 of

praziquantel. this chapter.
(a) Specifications. Each milliliter of (d) Special considerations. See § 500.25
solution contains 21.4 milligrams (mg) of this chapter.
emodepside and 85.7 mg praziquantel. (e) Conditions of use in cattle—(1)
(b) Sponsor. See No. 058198 in Amount. Apply 5 mg (1 mL) per 10 kilo-
§ 510.600(c) of this chapter. grams (kg) of body weight (500
(c) Conditions of use in cats—(1) micrograms/kg) applied topically along
Amount. The recommended minimum backbone from withers to tailhead.
dose is 1.36 mg/pound (lb) (3 mg/kilo- (2) Indications for use. For treatment
gram (kg)) emodepside and 5.45 mg/lb and control of gastrointestinal
(12 mg/kg) praziquantel applied as a roundworms (Haemonchus placei (adult
single topical dose. and L4), Ostertagia ostertagi (adult and
(2) Indications for use. For the treat- L4, including inhibited L4),
ment and control of hookworm infec- Trichostrongylus axei (adult and L4), T.
tions caused by Ancylostoma tubaeforme colubriformis (adult and L4), T.
(adults, immature adults, and fourth longispicularis (adult), Cooperia
stage larvae), roundworm infections oncophora (adult and L4), C. punctata
caused by Toxocara cati (adults and (adult and L4), C. surnabada (adult and
fourth stage larvae), and tapeworm in- L4), Nematodirus helvetianus (adult and
fections caused by Dipylidium caninum L4), Bunostomum phlebotomum (adult
(adults) and Taenia taeniaeformis and L4), Oesophagostomum radiatum
(adults). (adult and L4), Strongyloides papillosus
(3) Limitations. Federal law restricts (adults), Trichuris spp. (adults));
this drug to use by or on the order of a lungworms (Dictyocaulus viviparus,
licensed veterinarian. adult and L4); cattle grubs (all para-
sitic stages Hypoderma lineatum, H.
[72 FR 42291, Aug. 2, 2007, as amended at 86 bovis); lice (Damalinia bovis,
FR 14820, Mar. 19, 2021] Linognathus vituli, Haematopinus
eurysternus, Solenopotes capillatus);
§ 524.802 Enrofloxacin and silver sulfa-
diazine otic emulsion. mange mites (Chorioptes bovis, Sarcoptes
scabiei); and horn flies (Haematobia
(a) Specifications. Each milliliter con- irritans). Controls and protects from re-
tains 5 milligrams (mg) enrofloxacin infection of D. viviparus for 21 days
and 10 mg silver sulfadiazine. after treatment and H. irritans for 7
(b) Sponsor. See No. 058198 in days after treatment.
§ 510.600(c) of this chapter. (3) Limitations. A withdrawal period
(c) Conditions of use—Dogs—(1) has not been established for
Amount. 5 to 10 drops for dogs weighing preruminating calves. Do not use in
35 pounds (lb) or less and 10 to 15 drops calves to be processed for veal.
for dogs weighing more than 35 lb; ap-
plied twice daily for up to 14 days. [76 FR 72619, Nov. 25, 2011, as amended at 83
FR 48946, Sept. 28, 2018; 84 FR 39184, Aug. 9,
(2) Indications for use. For the treat- 2019]
ment of otitis externa in dogs.
(3) Limitations. Federal law restricts § 524.815 Eprinomectin and
this drug to use by or on the order of a praziquantel.
licensed veterinarian. Federal law pro- (a) Specifications. Each milliliter
hibits the extralabel use of this drug in (mL) of solution contains 4 milligrams
food-producing animals. (mg) eprinomectin and 83 mg
[65 FR 66620, Nov. 7, 2000, as amended at 79 praziquantel.
FR 10967, Feb. 27, 2014; 86 FR 14821, Mar. 19, (b) Sponsor. See No. 000010 in
2021] § 510.600(c) of this chapter.
(c) Conditions of use in cats—(1)
§ 524.814 Eprinomectin. Amount. Using the 0.3 mL and 0.9 mL
(a) Specifications. Each milliliter unit applicators, administer a min-
(mL) contains 5 milligrams (mg) of imum dose of 0.23 mg eprinomectin per
eprinomectin. pound body weight and 4.55 mg
(b) Sponsors. See Nos. 000010 and praziquantel per pound body weight by
055529 in § 510.600(c) of this chapter. topical application on the dorsal
361
§ 524.900 21 CFR Ch. I (4–1–23 Edition)
midline between the base of the skull man bulls. Swine should be eliminated
and the shoulder blades. from area where runoff occurs.
(2) Indications for use. For the preven- [40 FR 13873, Mar. 27, 1975, as amended at 49
tion of heartworm disease caused by FR 34352, Aug. 30, 1984; 57 FR 7652, Mar. 4,
Dirofilaria immitis, and for the treat- 1992; 59 FR 28769, June 3, 1994; 62 FR 55161,
ment and control of roundworms (adult Oct. 23, 1997; 62 FR 61626, Nov. 19, 1997; 69 FR
and fourth stage larval Toxocara cati), 41427, July 9, 2004; 79 FR 10968, Feb. 27, 2014;
hookworms (adult and fourth stage lar- 83 FR 48946, Sept. 28, 2018]
val Ancylostoma tubaeforme; adult § 524.920 Fenthion.
Ancylostoma braziliense), and tapeworms
(adult Dipylidium caninum and (a) Specifications. (1) The drug is a liq-
Echinococcus multilocularis), in cats and uid containing:
kittens 7 weeks of age and older and 1.8 (i) 3 percent of fenthion; or
lbs or greater. (ii) 20 percent fenthion.
(3) Limitations. Federal law restricts (2) The drug is a solution containing
this drug to use by or on the order of a either 5.6 or 13.8 percent fenthion. Each
licensed veterinarian. concentration is available in 2 volumes
which are contained in single-dose ap-
[83 FR 48946, Sept. 28, 2018, as amended at 84 plicators.
FR 39184, Aug. 9, 2019] (b) Sponsor. See sponsors in
§ 510.600(c) of this chapter:
§ 524.900 Famphur. (1) No. 058198 for use of product de-
(a) Specifications. The drug is in liquid scribed in paragraph (a)(1)(i) of this
form containing 13.2 percent famphur. section as in paragraph (d)(1) of this
(b) Sponsor. See No. 000061 in section.
§ 510.600(c) of this chapter. (2) No. 058198 for use of product de-
(c) Special considerations. Do not use scribed in paragraph (a)(1)(ii) of this
on animals simultaneously or within a section as in paragraph (d)(2) of this
few days before or after treatment with section.
or exposure to cholinesterase-inhib- (3) No. 058198 for use of products de-
iting drugs, pesticides, or chemicals. scribed in paragraph (a)(2) of this sec-
tion as in paragraph (d)(3) of this sec-
(d) Related tolerances. See § 556.273 of
tion.
this chapter.
(e) Conditions of use—(1) Amount. this chapter.
Apply 1 ounce per 200 pounds body (d) Conditions of use—(1) Beef cattle
weight, not to exceed a total dosage of and nonlactating dairy cattle—(i)
4 ounces, from the shoulder to the tail Amount. It is used at the rate of one-
head as a single treatment. Apply as half fluid ounce per 100 pounds of body
soon as possible after heel fly activity weight applied topically on the
ceases. backline of the animal. Only one appli-
(2) Indications for use in beef and non- cation per season should be made for
lactating dairy cattle. For control of cat- grub control and this will also provide
tle grubs and to reduce cattle lice in- initial control of lice. A second appli-
festations. cation for lice control may be made if
(3) Limitations. Do not slaughter with- animals become reinfested, but no
in 35 days after treatment. Do not use sooner than 35 days after the first
on lactating dairy cows or dry dairy treatment. Proper timing of treatment
cows within 21 days of freshening, is important for grub control; cattle
calves less than 3 months old, animals should be treated as soon as possible
stressed from castration, overexcite- after heel-fly activity ceases.
ment or dehorning, sick or convales- (ii) Indications for use. For the control
cent animals. Animals may become de- of grubs and lice in beef and nonlac-
hydrated and under stress following tating cattle.
shipment. Do not treat until they are (iii) Limitations. Do not use on ani-
in good condition. Brahman and Brah- mals simultaneously or within a few
man crossbreeds are less tolerant of days before or after treatment with or
cholinesterase-inhibiting insecticides exposure to cholinesterase-inhibiting

than other breeds. Do not treat Brah- drugs, pesticides, or chemicals. Cattle
362
should not be slaughtered within 35 from which the cattle came and/or
days following a single treatment. If a exact stage of the grubs, it is rec-
second application is made for lice con- ommended that the cattle receive only
trol, cattle should not be slaughtered a maintenance ration of low-energy
within 45 days of the second treatment. feed during the treatment period. This
The drug must not be used within 28 lessens the likelihood of severe bloat
days of freshening of dairy cattle. If which may occur in cattle on full feed
freshening should occur within 28 days when the common grub is killed while
after treatment, do not use milk as in the gullet. Do not treat dairy cattle
human food for the balance of the 28- of breeding age; calves less than 3
day interval. Do not treat lactating months old; sick, convalescent, or se-
dairy cattle; calves less than 3 months verely stressed livestock. Do not treat
old; or sick, convalescent, or stressed cattle for 10 days before or after ship-
livestock. Do not treat cattle for 10 ping, weaning, dehorning, or after ex-
days before or after shipping, weaning, posure to contagious or infectious dis-
or dehorning or after exposure to con- eases. Do not slaughter within 45 days
tagious infectious diseases. of treatment.
(2) Beef cattle and dairy cattle not of (3) Dogs—(i) Amount. Four to 8 milli-
breeding age—(i) Amount. It is adminis- grams per kilogram of body weight.
tered as a single, topical application Apply the contents of the proper size,
placed on the backline of animals as single-dose tube directly to one spot on
follows: For animals weighing 150 to the dog’s skin.
300 pounds, apply 4 milliliters (mL); for (ii) Indications for use. For flea con-
animals weighing 301 to 600 pounds, trol on dogs only.
apply 8 mL; for animals weighing 601 to (iii) Limitations. Federal law restricts
900 pounds, apply 12 mL; for animals this drug to use by or on the order of a
weighing 901 to 1,200 pounds, apply 16 licensed veterinarian.
mL; and for animal weighing over 1,200 [79 FR 10968, Feb. 27, 2014, as amended at 84
pounds, apply 20 mL. For most effec- FR 32993, July 11, 2019; 86 FR 14821, Mar. 19,
tive results, cattle should be treated as 2021]
soon as possible after heel-fly activity
ceases. A second application is required § 524.955 Florfenicol, terbinafine, and
betamethasone acetate otic gel.
for animals heavily infested with lice
or for those which become reinfested. A (a) Specifications. Each milliliter of
second application should be made no gel contains 10 milligrams (mg)
sooner than 35 days after the first florfenicol, 10 mg terbinafine, and 1 mg
treatment. betamethasone acetate.
(ii) Indications for use. For control of (b) Sponsor. See No. 043264 in
cattle grubs and as an aid in control- § 510.600(c) of this chapter.
ling lice on beef cattle and on dairy (c) Conditions of use in dogs—(1)
cattle not of breeding age. Amount. Administer one dose (1 tube)
(iii) Limitations. Do not use on ani- per affected ear(s) and repeat adminis-
mals simultaneously or within a few tration in 7 days.
days before or after treatment with or (2) Indications for use. For the treat-
exposure to cholinesterase-inhibiting ment of otitis externa in dogs associ-
drugs, pesticides, or chemicals. Host- ated with susceptible strains of bac-
parasite reactions such as bloat, saliva- teria (Staphylococcus pseudintermedius)
tion, staggering and paralysis may and yeast (Malassezia pachydermatis).
sometimes occur when cattle are treat- (3) Limitations. Federal law restricts
ed while the common cattle grub this drug to use by or on the order of a
(Hypoderma lineatum) is in the gullet, licensed veterinarian.
or while the northern cattle grub (H. [80 FR 13230, Mar. 13, 2015, as amended at 86
bovis) is in the area of the spinal cord. FR 14821, Mar. 19, 2021]
Cattle should be treated before these
stages of grub development. Consult § 524.957 Florfenicol, terbinafine, and
your veterinarian, extension livestock mometasone otic solution.
specialist, or extension entomologist (a) Specifications. Each single-dose,
regarding the timing of treatment. If it prefilled dropperette contains 1 milli-

is impossible to determine the area liter (mL) of a solution containing 16.6
363
§ 524.960 21 CFR Ch. I (4–1–23 Edition)
milligrams (mg) florfenicol, 14.8 mg flunixin (equivalent to 83 mg flunixin

terbinafine (equivalent to 16.6 mg meglumine).
terbinafine hydrochloride), and 2.2 mg (b) Sponsor. See No. 000061 in
mometasone furoate. § 510.600(c) of this chapter.
(b) Sponsor. See Nos. 017030 and 058198 (c) Related tolerances. See § 556.286 of
in § 510.600(c) of this chapter. this chapter.
(c) Conditions of use in dogs—(1) (d) Conditions of use—(1) Amount.
Amount. Administer one dropperette (1 Apply only once at a dose of 3.3 mg
mL) per affected ear(s). flunixin per kg body weight (1.5 mg/lb;
(2) Indications for use. For the treat- 3 mL per 100 lbs) topically in a narrow
ment of otitis externa in dogs associ- strip along the dorsal midline from the
ated with susceptible strains of yeast withers to the tailhead.
(Malassezia pachydermatis) and bacteria
(Staphylococcus pseudintermedius).
of pyrexia associated with bovine res-
piratory disease and acute bovine mas-
titis, and the control of pain associated
with foot rot in beef cattle 2 months of
[80 FR 76387, Dec. 9, 2015, as amended at 83 age and older and dairy cattle.
FR 64740, Dec. 18, 2018; 86 FR 14821, Mar. 19, (3) Limitations. Not for use in beef and
2021; 88 FR 14901, Mar. 10, 2023]
dairy bulls intended for breeding over 1
§ 524.960 Flumethasone, neomycin, year of age. Milk that has been taken
and polymyxin B ophthalmic solu- during treatment and for 48 hours after
tion. treatment must not be used for human
(a) Specifications. Each milliliter of consumption. Cattle must not be
ophthalmic preparation contains 0.10 slaughtered for human consumption
milligram flumethasone, 5.0 milligrams within 8 days of treatment. Not for use
neomycin sulfate (3.5 milligrams neo- in replacement dairy heifers 20 months
mycin base), and 10,000 units of poly- of age or older or dry dairy cows; use in
myxin B sulfate, with or without these cattle may cause drug residues in
hydroxypropyl methylcellulose. calves born to these cows or heifers.
(b) Sponsor. See No. 054771 in Not for use in beef calves less than 2
§ 510.600(c) of this chapter. months of age, dairy calves, and veal
(c) Conditions of use—(1) Amount—(i) calves. A withdrawal period has not
Preparation containing hydroxypropyl been established for this product in
methylcellulose. Dogs: 1 to 2 drops per pre-ruminating calves. Approved only
eye, every 6 hours. as a single topical dose in cattle. Re-
(ii) Preparation without hydroxyproply peated treatments may result in viola-
methylcellulose. Dogs and cats: 2 to 3 tive residues in milk or in edible tis-
drops per eye, every 4 hours. sues. Federal law restricts this drug to
(2) Indications for use. Treatment of use by or on the order of a licensed vet-
the inflammation, edema, and sec- erinarian.
ondary bacterial infections associated [83 FR 13635, Mar. 30, 2018, as amended at 88
with topical ophthalmological condi- FR 16549, Mar. 20, 2023]
tions of the eye such as corneal inju-
ries, incipient pannus, superficial kera- FLUOCINOLONE TOPICAL AND OTIC
titis, conjunctivitis, acute DOSAGE FORMS
nongranulomatous anterior uveitis,
keratoconjunctivitis, and blepharitis. § 524.981 [Reserved]
this drug to use by or on the order of a § 524.981a Fluocinolone cream.
licensed veterinarian. (a) Specifications. The drug contains
[44 FR 16012, Mar. 16, 1979, as amended at 61 0.025 percent fluocinolone acetonide.
FR 5507, Feb. 13, 1996; 79 FR 10968, Feb. 27, (b) Sponsor. See No. 099207 in
2013] § 510.600(c) of this chapter.
§ 524.970 Flunixin. Amount. A small amount is applied to
(a) Specifications. Each milliliter of the affected area two or three times
solution contains 50 milligrams (mg) daily.
364
(2) Indications for use. For the relief of (ii) Dogs and cats. Used in the treat-
pruritis and inflammation associated ment of wound infections.
with certain superficial acute and (3) Federal law restricts this drug to
chronic dermatoses. It is used in the use by or on the order of a licensed vet-
treatment of allergic and acute moist erinarian.
dermatitis and for the relief of super-
ficial inflammation caused by chemical [40 FR 13873, Mar. 27, 1975, as amended at 62
burns and physical abrasions. FR 40932, July 31, 1997; 79 FR 10969, Feb. 27,
2014]
§ 524.981d Fluocinolone and dimethyl
erinarian. sulfoxide solution.
[40 FR 13873, Mar. 27, 1975, as amended at 62 (a) Specifications. Each milliliter of
FR 40932, July 31, 1997; 79 FR 10968, Feb. 27,
2014]
solution contains 0.01 percent
fluocinolone acetonide and 20 percent
§ 524.981b Fluocinolone solution. dimethyl sulfoxide.
(a) Specifications. The drug contains (b) Sponsor. See No. 054771 in
0.01 percent fluocinolone acetonide. § 510.600(c) of this chapter.
(b) Sponsor. See No. 099207 in (c) Conditions of use in dogs—(1)
§ 510.600(c) of this chapter. Amount. Instill 1 to 2 milliliters into
(c) Conditions of use in dogs—(1) each anal sac following expression of
Amount. A small amount of solution is anal sac contents.
applied to the affected area two or (2) Indications for use. For the relief of
three times daily. impaction commonly present in appar-
(2) Indications for use—(i) Dogs. For ently normal anal sacs, for the reversal
the relief of pruritis and inflammation of inflammatory changes associated
associated with otitis externa and cer- with abnormal anal sacs, and to coun-
tain superficial acute and chronic teract the offensive odor of anal sac se-
dermatoses. cretions.
(ii) Cats. For the relief of pruritis and (3) Limitations. Federal law restricts
inflammation associated with acute this drug to use by or on the order of a
otitis externa and certain superficial licensed veterinarian.
acute and chronic dermatoses.
(3) Federal law restricts this drug to [79 FR 10969, Feb. 27, 2014]
erinarian. § 524.981e Fluocinolone and dimethyl
sulfoxide otic solution.
FR 40932, July 31, 1997; 79 FR 10969, Feb. 27, (a) Specifications. Each milliliter of
2014] solution contains 0.01 percent
fluocinolone acetonide and 60 percent
§ 524.981c Fluocinolone and neomycin dimethyl sulfoxide.
cream. (b) Sponsor. See No. 054771 in
(a) Specifications. The drug contains § 510.600(c) of this chapter.
0.025 percent fluocinolone acetonide (c) Conditions of use in dogs—(1)
and 0.5 percent neomycin sulfate (0.35 Amount. Instill 4 to 6 drops (0.2 milli-
percent neomycin base). liter) twice daily into the ear canal for
(b) Sponsor. See No. 099207 in a maximum period of 14 days. The total
§ 510.600(c) of this chapter. dosage used should not exceed 17 milli-
(c) Conditions of use in dogs—(1) liters.
Amount. A small amount is applied to (2) Indications for use. For the relief of
the affected area two or three times pruritis and inflammation associated
daily. with acute and chronic otitis.
(2) Indications for use—(i) Dogs. For
the relief of pruritis and inflammation
associated with superficial acute and
chronic dermatoses. It is used in the
treatment of allergic and acute moist [79 FR 10969, Feb. 27, 2014]
dermatitis and nonspecific dermatoses.
365
§ 524.998 21 CFR Ch. I (4–1–23 Edition)
§ 524.998 Fluralaner. § 524.1001 Fluralaner and moxidectin.

(a) Specifications. Each milliliter of (a) Specifications. Each milliliter of
solution contains 280 milligrams (mg) solution contains 280 milligram (mg)
fluralaner. fluralaner and 14 mg moxidectin. Each
(b) Sponsor. See No. 000061 in individually packaged tube contains ei-
§ 510.600(c) of this chapter. ther 112.5 mg fluralaner and 5.6 mg
(c) Conditions of use—(1) Dogs—(i) moxidectin; 250 mg fluralaner and 12.5
Amount. Administer topically as a sin- mg moxidectin; or 500 mg fluralaner
gle dose every 12 weeks according to and 25 mg moxidectin.
the label dosage schedule to provide a (b) Sponsor. See No. 000061 in
minimum dose of 11.4 mg/lb (25 mg/kg) § 510.600(c) of this chapter.
body weight. May be administered
every 8 weeks in case of potential expo-
minister topically as a single dose
sure to Amblyomma americanum ticks.
(ii) Indications for use. Kills adult every 2 months to provide a minimum
fleas; for the treatment and prevention dose of 18.2 mg/lb (40 mg/kg) fluralaner
of flea infestations (Ctenocephalides and 0.9 mg/lb (2 mg/kg) moxidectin.
felis) and the treatment and control of (2) Indications for use. For the preven-
tick infestations (Ixodes scapularis tion of heartworm disease caused by
(black-legged tick), Dermacentor Dirofilaria immitis and for the treatment
variabilis (American dog tick), and of infections with intestinal
Rhipicephalus sanguineus (brown dog roundworm (Toxocara cati, fourth-stage
tick)) for 12 weeks in dogs and puppies larvae, immature adults, and adults)
6 months of age and older, and weigh- and hookworm (Ancylostoma tubaeforme,
ing 4.4 lb or greater; for the treatment fourth-stage larvae, immature adults,
and control of A. americanum (lone star and adults); kills adult fleas and is in-
tick) infestations for 8 weeks in dogs dicated for the treatment and preven-
and puppies 6 months of age and older, tion of flea infestations
and weighing 4.4 lb or greater. (Ctenocephalides felis) and the treat-
(iii) Limitations. Federal law restricts ment and control of tick infestations
this drug to use by or on the order of a (Ixodes scapularis (black-legged tick),
licensed veterinarian. Dermacentor variabilis (American dog
(2) Cats—(i) Amount. Administer topi- tick), and Haemaphysalis longicornis
cally as a single dose every 12 weeks (Asian longhorned tick)) for 2 months
according to the label dosage schedule in cats and kittens 6 months of age and
to provide a minimum dose of 18.2 mg/ older and weighing 2.6 lb or greater.
lb (40 mg/kg) body weight. May be ad- (3) Limitations. Federal law restricts
ministered every 8 weeks in case of po- this drug to use by or on the order of a
tential exposure to D. variabilis ticks. licensed veterinarian.
(ii) Indications for use. Kills adult
fleas; for the treatment and prevention [85 FR 18120, Apr. 1, 2020, as amended at 87
of flea infestations (C. felis) and the FR 58963, Sept. 29, 2022; 88 FR 14901, Mar. 10,
2023]
treatment and control of I. scapularis
(black-legged tick) and Haemaphysalis § 524.1005 Furazolidone powder.
longicornis (Asian longhorned tick) in-
festations for 12 weeks in cats and kit- (a) Specifications. The product con-
tens 6 months of age and older, and tains either 4 or 10 percent furazolidone
weighing 2.6 lb or greater; for the in inert dispersing agent and propel-
treatment and control of D. variabilis lant.
(American dog tick) infestations for 8 (b) Sponsors. (1) See No. 051031 in
weeks in cats and kittens 6 months of § 510.600(c) of this chapter for use as in
age and older, and weighing 2.6 lb or paragraphs (c)(1), (c)(2)(i), (c)(2)(ii), and
greater. (c)(3) of this section.
(iii) Limitations. Federal law restricts (2) See No. 017135 for use of the 4 per-
this drug to use by or on the order of a cent product as in paragraph (c)(2)(iv)
licensed veterinarian. of this section.
[81 FR 67152, Sept. 30, 2016, as amended at 82 (c) Conditions of use—(1) Amount. Hold
FR 43485, Sept. 18, 2017; 88 FR 14901, Mar. 10, container about 6 to 12 inches from the
2023] eye or affected area and apply only
366
enough powder to impart a light yellow (3) Limitations. Federal law restricts
color. this drug to use by or on the order of a
(2) Indications of use—(i) Dogs. For licensed veterinarian.
treatment or prevention of bacterial
[80 FR 18776, Apr. 8, 2015]
infection of superficial wounds, abra-
sions, lacerations, and pyogenic derma-
§ 524.1044b Gentamicin and
titis. betamethasone otic solution.
(ii) Horses. For treatment or preven-
tion of bacterial infection of superficial (a) Specifications. Each milliliter of
wounds, abrasions, lacerations, and fol- solution contains gentamicin sulfate
lowing firing (heat or electrocautery). equivalent to 3 milligrams (mg)
(iii) [Reserved] gentamicin base and betamethasone
(iv) Horses and ponies. For treatment valerate equivalent to 1 mg
or prevention of bacterial infection of betamethasone alcohol.
superficial wounds, abrasions, and lac- (b) Sponsors. See Nos. 000061 and
erations caused by Staphylococcus 054925 in § 510.600(c) of this chapter.
aureus, Streptococcus spp. and Proteus (c) Conditions of use—(1) Amounts and
spp. sensitive to furazolidone. indications for use. (i) For the treat-
(3) Limitations. For topical applica- ment of acute and chronic otitis
tion in horses, ponies, and dogs: Clean externa caused by bacteria sensitive to
affected area thoroughly, apply drug gentamicin in dogs, instill three to
once or twice daily, and repeat treat- eight drops of solution into the ear
ment as required. Use only as rec- canal twice daily for 7 to 14 days.
ommended by a veterinarian in treat-
(ii) For the treatment of infected su-
ment of puncture wounds, wounds re-
perficial lesions caused by bacteria
quiring surgical debridement or sutur-
ing, those of a chronic nature involving sensitive to gentamicin in dogs and
proud flesh, generalized and chronic in- cats, apply a sufficient amount of the
fections of the skin, and those skin drug to cover the treatment area twice
conditions associated with intense daily for 7 to 14 days.
itching. If redness, irritation, or swell- (2) Limitations. Federal law restricts
ing persists or increases, discontinue this drug to use by or on the order of a
use and consult a veterinarian. Do not licensed veterinarian.
use in horses intended for human con- [71 FR 13542, Mar. 16, 2006]
sumption.
[45 FR 49543, July 25, 1980, as amended at 50 § 524.1044c Gentamicin ophthalmic
FR 30153, July 24, 1985; 56 FR 50653, Oct. 8, ointment.
1991; 57 FR 31314, July 15, 1992; 60 FR 55659, (a) Specifications. Each gram of oint-
Nov. 2, 1995; 65 FR 41588, July 6, 2000; 79 FR
10969, Feb. 27, 2014; 82 FR 11508, Feb. 24, 2017] ment contains gentamicin sulfate
equivalent to 3 milligrams of
§ 524.1044 Gentamicin ophthalmic and gentamicin.
topical dosage forms. (b) Sponsors. See Nos. 000061 and
§ 524.1044a Gentamicin ophthalmic so-
lution. (c) Conditions of use in dogs and cats—
(1) Amount. Apply approximately a 1/2-
(a) Specifications. Each milliliter of inch strip to the affected eye 2 to 4
solution contains gentamicin sulfate times a day.
equivalent to 3 milligrams of (2) Indications for use. For treatment
gentamicin.
of conjunctivitis caused by susceptible
bacteria.
(c) Conditions of use in dogs and cats— (3) Limitations. Federal law restricts
(1) Amount. Administer 1 or 2 drops into this drug to use by or on the order of a
the conjunctival sac 2 to 4 times a day. licensed veterinarian.
(2) Indications for use. For the topical [69 FR 47363, Aug. 5, 2004, as amended at 77
treatment of infections of the con- FR 64717, Oct. 23, 2012; 85 FR 4208, Jan. 24,
junctiva caused by susceptible bac- 2020; 88 FR 16549, Mar. 20, 2023]

teria.
367
§ 524.1044d 21 CFR Ch. I (4–1–23 Edition)
§ 524.1044d Gentamicin and § 524.1044f Gentamicin and

betamethasone ointment. betamethasone spray.
(a) Specifications. Each gram of oint- (a) Specifications. Each milliliter of
ment contains gentamicin sulfate spray contains gentamicin sulfate
equivalent to 3 milligrams of equivalent to 0.57 milligram (mg)
gentamicin base and betamethasone gentamicin base and betamethasone
valerate equivalent to 1 milligram of valerate equivalent to 0.284 mg
betamethasone. betamethasone.
(b) Sponsor. See No. 000061 in (b) Sponsors. See Nos. 000061, 017033,
§ 510.600(c) of this chapter. 054925, 058005, and 058829 in § 510.600(c) of
Amount—(i) Otitis externa. Instill 3 to 8 (c) Conditions of use in dogs—(1)
drops into the ear canal twice daily for Amount. Hold bottle upright 3 to 6
7 days. inches from the lesion and depress the
(ii) Infected superficial lesions. Apply sprayer head twice. Administer two
to cover the treatment area twice daily spray actuations two to four times
for 7 to 14 days. daily for 7 days.
(2) Indications for use. For the treat- (2) Indications for use. For the treat-
ment of acute and chronic otitis ment of infected superficial lesions
externa and infected superficial lesions caused by bacteria susceptible to
caused by bacteria sensitive to gentamicin.
gentamicin. (3) Limitations. Federal law restricts
[47 FR 26378, June 18, 1982, as amended at 52 FR 5929, Feb. 8, 2007; 74 FR 22822, May 15,
FR 7832, Mar. 13, 1987; 79 FR 10969, Feb. 27, 2009; 77 FR 3598, Jan. 25, 2012; 88 FR 16549,
2014] Mar. 20, 2023]
§ 524.1044e Gentamicin spray. § 524.1044g Gentamicin,

(a) Specification. Each milliliter of betamethasone, and clotrimazole
ointment.
sterile aqueous solution contains
gentamicin sulfate equivalent to 1.07 (a) Specifications. Each gram (g) of
milligrams of gentamicin. ointment contains gentamicin sulfate
(b) Sponsor. See No. 000061 in equivalent to 3 milligrams (mg)
§ 510.600(c) of this chapter. gentamicin base, betamethasone val-
(c) Related tolerances. See § 556.300 of erate equivalent to 1 mg
this chapter. betamethasone, and 10 mg
(d) Conditions of use in cattle—(1) clotrimazole.
Amount. Hold the sprayer upright 3 to 6 (b) Sponsors. See sponsors in
inches from the affected eye, with the § 510.600(c) of this chapter for uses as in
opening directed towards the eye, and paragraph (c) of this section.
pump once. Treat once daily for up to (1) No. 000061 for use of 7.5- or 15-gram
3 days. (g) tubes, 12.5-, 30-, or 215-g bottles.
(2) Indications for use. For the treat- (2) No. 054925 for use of 7.5- or 15-g
ment of pinkeye in cattle (infectious tubes; 10-, 15-, 25-, or 215-g bottles.
bovine keratoconjunctivitis) caused by (3) No. 069043 for use of 10-, 20-, 40-, or
Moraxella bovis. 215-g bottles.
(3) Limitations. Conditions other than (4) No. 025463 for use of 7.5- or 15-g
bacterial infections of the bovine eye tubes, or 215-g bottles.
and infectious keratoconjunctivitis (c) Conditions of use in dogs—(1)
caused by Moraxella bovis may produce Amount. Instill ointment twice daily
similar signs. If conditions persists or into the ear canal for 7 consecutive
increases, discontinue use and consult days.
a veterinarian. (i) From 7.5- or 15-g tubes; 10-, 12.5-,
[48 FR 41157, Sept. 14, 1983, as amended 52 FR 15-, 25-, or 30-g bottles: 4 drops for dogs
7833, Mar. 13, 1987; 79 FR 10969, Feb. 27, 2014; weighing less than 30 pounds (lb) or 8
84 FR 32993, July 11, 2019] drops for dogs weighing 30 lb or more.
368
(ii) From 20-, 40-, or 215-g bottles: 2 (3) Limitations. Federal law restricts
drops for dogs weighing less than 30 lb this drug to use by or on the order of a
or 4 drops for dogs weighing 30 lb or licensed veterinarian.
more. [66 FR 712, Jan. 4, 2001, as amended at 68 FR
(ii) From 20- or 215-g bottles: 2 drops 15370, Mar. 31, 2003; 70 FR 36338, June 23, 2005;
for dogs weighing less than 30 lb or 4 79 FR 10969, Feb. 27, 2014; 81 FR 59134, Aug. 29,
drops for dogs weighing 30 lb or more. 2016]
(2) Indications for use. For the treat- § 524.1044i Gentamicin and
ment of acute and chronic canine otitis betamethasone ophthalmic solution.
externa associated with yeast
(Malassezia pachydermatis, formerly (mL) of solution contains gentamicin
Pityrosporum canis) and/or bacteria sus- sulfate equivalent to 3 milligrams (mg)
ceptible to gentamicin. of gentamicin base and 1 mg
(3) Limitations. Federal law restricts betamethasone acetate equivalent to
this drug to use by or on the order of a 0.89 mg betamethasone alcohol.
FR 31932, June 11, 1998; 68 FR 42970, July 21,
2003; 70 FR 8291, Feb. 18, 2005; 71 FR 13542, Amount. Instill one or two drops of so-
Mar. 16, 2006; 71 FR 16481, Apr. 3, 2006; 71 FR lution in the conjunctival sac three or
38261, July 6, 2006; 71 FR 56867, Sept. 28, 2006; four times a day.
78 FR 17597, Mar. 22, 2013; 79 FR 10969, Feb. 27, (2) Indications for use. For treatment
2014; 81 FR 17608, Mar. 30, 2016] of external eye infections and inflam-
mation.
§ 524.1044h Gentamicin, mometasone, (3) Limitations. Federal law restricts
and clotrimazole otic suspension. this drug to use by or on the order of a
(a) Specifications. Each gram of sus- licensed veterinarian.
pension contains gentamicin sulfate, [75 FR 54492, Sept. 8, 2010, as amended at 80
United States Pharmacopeia (USP) FR 13230, Mar. 13, 2015]
equivalent to 3 milligram (mg)
§ 524.1132 Hydrocortisone, miconazole,
gentamicin base, mometasone furoate and gentamicin otic suspension.
monohydrate or mometasone furoate
anhydrous, USP, equivalent to 1 mg (a) Specifications. Each milliliter
(mL) of suspension contains 1.11 milli-
mometasone, and 10 mg clotrimazole,
grams (mg) hydrocortisone aceponate,
USP. 17.4 mg miconazole nitrate, and 1.5 mg
(b) Sponsors. See Nos. 000061 and gentamicin (as gentamicin sulfate).
054925 in § 510.600(c) of this chapter. (b) Sponsor. See No.051311 in
(c) Conditions of use in dogs—(1) § 510.600(c) of this chapter.
Amount. For dogs weighing less than 30 (c) Conditions of use in dogs—(1)
pounds (lb), instill 4 drops from the 7.5- Amount. Instill 1.0 mL in the affected
, 15-, or 30-gram (g) bottle into the ear ear once daily for 5 days.
canal (2 drops from the 215-g bottle) or, (2) Indications for use. For the treat-
for dogs weighing 30 lb or more, instill ment of otitis externa in dogs associ-
8 drops from the 7.5-, 15-, or 30-g bottle ated with susceptible strains of yeast
into the ear canal (4 drops from the 215- (Malassezia pachydermatis) and bacteria
g bottle), once or twice daily for 7 days. (Staphylococcus pseudintermedius).
(2) Indications for use. For the treat- (3) Limitations. Federal law restricts
ment of otitis externa caused by sus-
ceptible strains of yeast (Malassezia
pachydermatis) and bacteria [76 FR 78150, Dec. 16, 2011, as amended at 83
(Pseudomonas spp. [including P. FR 13635, Mar. 30, 2018]
aeruginosa], coagulase-positive § 524.1140 Imidacloprid and
staphylococci, Enterococcus faecalis, ivermectin.
Proteus mirabilis, and beta-hemolytic
(a) Specifications. The product is
streptococci).
available in unit applicator tubes con-
taining 0.4, 1.0, 2.5, or 4.0 milliliters
369
§ 524.1146 21 CFR Ch. I (4–1–23 Edition)
(mL). Each mL of solution contains 100 stenocephala), and whipworms (Trichuris

milligrams (mg) imidacloprid and 800 vulpis); kills adult fleas and treats flea
micrograms (μg) ivermectin. infestations (Ctenocephalides felis).
(b) Sponsor. See No. 058198 in (B) For treatment of Dirofilaria
§ 510.600(c) of this chapter. immitis circulating microfilariae in
(c) Conditions of Use in Dogs—(1) heartworm-positive dogs and the treat-
Amount. The recommended minimum ment and control of sarcoptic mange
dosage is 4.5 mg/pound (lb) (10 mg/kilo- caused by Sarcoptes scabiei var. canis.
gram (kg)) of imidacloprid and 36.4 μg/ (2) Cats—(i) Amount. Topically apply
lb (80 μg/kg) of ivermectin, topically 4.5 mg/lb body weight (10 mg/kg)
once a month. imidacloprid and 0.45 mg/lb (1.0 mg/kg)
(2) Indications for Use. For the preven- moxidectin, once a month.
tion of heartworm disease caused by (ii) Indications for use. For the pre-
Dirofilaria immitis; kills adult fleas and vention of heartworm disease caused
is indicated for the treatment of flea by Dirofilaria immitis; for the treatment
infestations (Ctenocephalides felis). and control of ear mite (Otodectes
(3) Limitations. Federal law restricts cynotis) infestations, intestinal
this drug to use by or on the order of a roundworms (Toxocara cati), and
licensed veterinarian. hookworms (Ancylostoma tubaeforme);
[67 FR 78685, Dec. 26, 2002, as amended at 86 kills adult fleas and treats flea infesta-
FR 14821, Mar. 19, 2021] tions (Ctenocephalides felis).
(3) Ferrets—(i) Amount. Topically
§ 524.1146 Imidacloprid and apply 9.0 mg/lb body weight (20 mg/kg)
moxidectin. imidacloprid and 0.9 mg/lb (2 mg/kg)
(a) Specifications. Each milliliter of moxidectin, once a month.
solution contains: (ii) Indications for use. For the pre-
(1) 100 milligrams (mg) imidacloprid vention of heartworm disease caused
and 25 mg moxidectin; or by Dirofilaria immitis; kills adult fleas
(2) 100 mg imidacloprid and 10 mg (Ctenocephalides felis) and is indicated
moxidectin. for the treatment of flea infestations
(b) Sponsors. See sponsor numbers in on ferrets.
§ 510.600(c) of this chapter as follows: [72 FR 10597, Mar. 9, 2007, as amended at 78
(1) Nos. 017030, 051072, 055529, 058198, FR 73698, Dec. 9, 2013; 85 FR 18120, Apr. 1,
and 061651 for use of product described 2020; 86 FR 13185, Mar. 8, 2021; 86 FR 14821,
in paragraph (a)(1) of this section as in Mar. 19, 2021; 87 FR 17946, Mar. 29, 2022; 87 FR
paragraph (d)(1) of this section. 58963, Sept. 29, 2022]
(2) Nos. 017030, 051072, 055529, 058198,
and 061651 for use of product described § 524.1193 Ivermectin topical solution.
in paragraph (a)(2) of this section as in (a) Specifications. Each milliliter
paragraph (d)(2) of this section. (mL) of solution contains 5 milligrams
(3) Nos. 051072 and 058198 for use of of ivermectin.
product described in paragraph (a)(2) of (b) Sponsors. See sponsors in
this section as in paragraph (d)(3) of § 510.600(c) of this chapter for use as in
this section. paragraph (e) of this section.
(c) Special considerations. Federal law (1) Nos. 000010, 055529, 058829, 061133
restricts this drug to use by or on the for use as in paragraphs (e)(1), (e)(2)(i),
order of a licensed veterinarian. (e)(2)(iii), and (e)(3) of this section.
(d) Conditions of use—(1) Dogs—(i) (2) Nos. 016592 and 054925, for use as in
Amount. Topically apply 4.5 mg/lb body paragraphs (e)(1), (e)(2)(i), (e)(2)(ii), and
weight (10 mg/kg) imidacloprid and 1.1 (e)(3) of this section.
mg/lb (2.5 mg/kg) moxidectin, once a (c) Related tolerances. See § 556.344 of
month. this chapter.
(ii) Indications for use. (A) For the (d) Special considerations. See § 500.25
prevention of heartworm disease of this chapter.
caused by Dirofilaria immitis; and the (e) Conditions of use in cattle—(1)
treatment and control of intestinal Amount. One mL per 22 pounds (0.5 mil-
roundworms (Toxocara canis and ligram per kilogram) of body weight
Toxascaris leonina), hookworms applied topically to the back of the

(Ancylostoma caninum and Uncinaria animal.
370
(2) Indications for use. (i) It is used for (c) Conditions of use—(1) Amount. Ad-
the treatment and control of: Gastro- minister the contents of one 0.5-mL
intestinal roundworms (adults and tube topically into each external ear
fourth-stage larvae) Ostertagia ostertagi canal.
(including inhibited stage), Haemonchus (2) Indications for use. For the treat-
placei, Trichostrongylus axei, T. ment of adult ear mite (Otodectes
colubriformis, Cooperia oncophora, C. cynotis) infestations in cats and kittens
punctata, C. surnabada, 4 weeks of age and older. Effectiveness
Oesophagostomum radiatum; (adults)
against eggs and immature stages has
Strongyloides papillosus, Trichuris spp.;
not been proven.
lungworms (adults and fourth-stage
larvae) Dictyocaulus viviparus; cattle (3) Limitations. Federal law restricts
grubs (parasitic stages) Hypoderma this drug to use by or on the order of a
bovis, H. lineatum; mites Sarcoptes licensed veterinarian.
scabiei var. bovis; lice Linognathus vituli, [66 FR 7578, Jan. 24, 2001, as amended at 74
Haematopinus eurysternus, Damalinia FR 26782, June 4, 2009]
bovis, Solenoptes capillatus; and horn
flies Haematobia irritans. § 524.1200 Kanamycin ophthalmic and
(ii) It controls infections and pre- topical dosage forms.
vents reinfection with O. ostertagi, O.
radiatum, H. placei, T. axei, C. punctata, § 524.1200a Kanamycin ophthalmic
and C. oncophora for 14 days after ointment.
treatment. (a) Specifications. Each gram of oint-
(iii) It controls infections and pre- ment contains 3.5 milligrams
vents reinfection with O. radiatum and kanamycin activity as kanamycin sul-
D. viviparus for 28 days after treatment, fate.
C. punctata and T. axei for 21 days after (b) Sponsor. See No. 054771 in
treatment, O. ostertagi, H. placei, C.
oncophora, and C. surnabada for 14 days
after treatment, and D. bovis for 56 (c) Conditions of use in dogs—(1)
days after treatment. Amount. Apply a thin film to the af-
(3) Limitations. Do not treat cattle fected eye three or four times daily or
within 48 days of slaughter. Because a more frequently if deemed advisable.
withdrawal time in milk has not been Treatment should be continued for at
established, do not use in female dairy least 48 hours after the eye appears
cattle of breeding age. A withdrawal normal.
period has not been established for this (2) Indications for use. For the treat-
product on preruminating calves. Do ment of various eye infections (con-
not use on calves to be processed for junctivitis, blepharitis, dacryocystitis,
veal. keratitis, and corneal ulcerations) due
[55 FR 50551, Dec. 7, 1990, as amended at 62 to bacteria sensitive to kanamycin.
FR 38908, July 21, 1997; 62 FR 63271, Nov. 28, For prophylaxis in traumatic condi-
1997; 63 FR 44385, Aug. 19, 1998; 66 FR 13236, tions, removal of foreign bodies, and
Mar. 5, 2001; 66 FR 63165, Dec. 5, 2001; 68 FR intraocular surgery.
3817, Jan. 27, 2003; 68 FR 4713, Jan. 30, 2003; 69 (3) Limitations. Federal law restricts
FR 501, Jan. 6, 2004; 69 FR 62181, Oct. 25, 2004;
71 FR 13542, Mar. 16, 2006; 72 FR 6464, Feb. 12, this drug to use by or on the order of a
2007; 74 FR 36112, July 22, 2009; 75 FR 26648, licensed veterinarian.
May 12, 2010; 76 FR 81807, Dec. 29, 2011; 78 FR
[79 FR 10969, Feb. 27, 2014]
17597, Mar. 22, 2013; 78 FR 63872, Oct. 25, 2013;
81 FR 25328, Apr. 28, 2016; 83 FR 13635, Mar. 30,
2018; 84 FR 8974, Mar. 13, 2019; 84 FR 39184, § 524.1200b Kanamycin ophthalmic so-
Aug. 9, 2019; 86 FR 13185, Mar. 8, 2021] lution.
§ 524.1195 Ivermectin otic suspension. solution contains 10 milligrams
(a) Specifications. Each tube contains kanamycin activity as kanamycin sul-
0.5 milliliter (mL) of a 0.01 percent sus- fate.
pension of ivermectin. (b) Sponsor. See No. 054771 in

371
§ 524.1204 21 CFR Ch. I (4–1–23 Edition)
(c) Conditions of use in dogs—(1) liter of diethylene glycol monobutyl

Amount. Instill a few drops into the af- ether (DGME) solution.
fected eye every 3 hours or more fre- (b) Sponsors. See Nos. 000061 and
quently if deemed advisable. Admin- 054771 in § 510.600(c) of this chapter.
ister as frequently as possible for the (c) Related tolerances. See § 556.350 of
first 48 hours, after which the fre- this chapter.
quency of applications may be de- (d) Conditions of use. Cattle—(1)
creased. Treatment should be contin- Amount. 2.5 milliliters per 110 pounds
ued for at least 48 hours after the eye (10 milligrams of levamisole per kilo-
appears normal. gram) of body weight as a single dose
(2) Indications for use. For the treat- topically to the back of the animal.
ment of various eye infections (con- (2) Indications for use. Anthelmintic
junctivitis, blepharitis, dacryocystitis, effective against stomach worms
keratitis, and corneal ulcerations) due (Haemonchus, Trichostrongylus,
to bacteria sensitive to kanamycin. Ostertagia), intestinal worms
For prophylaxis in traumatic condi- (Trichostrongylus, Cooperia,
tions, removal of foreign bodies, and
Nematodirus, Bunostomum,
intraocular surgery.
Oesophagostomum, Chabertia), and
(3) Limitations. Federal law restricts lungworms (Dictyocaulus).
(3) Limitations. Conditions of constant
helminth exposure may require re-
[79 FR 10970, Feb. 27, 2014] treatment within 2 to 4 weeks after the
first treatment. Cattle must not be
§ 524.1204 Kanamycin, amphomycin, slaughtered within 9 days following
and hydrocortisone ointment. last treatment. Do not administer to
(a) Specifications. Each gram of oint- dairy animals of breeding age. Do not
ment contains 5 milligrams kanamycin treat animals before dipping or prior to
activity as kanamycin sulfate, 5 milli- exposure to heavy rain. Consult your
grams of amphomycin activity as the veterinarian for assistance in the diag-
calcium salt, and 10 milligrams of hy- nosis, treatment, and control of para-
drocortisone acetate. sitism, and before using in severely de-
(b) Sponsor. See No. 054771 in bilitated animals.
§ 510.600(c) of this chapter. [52 FR 10887, Apr. 6, 1987, as amended at 53
(c) Conditions of use in dogs—(1) FR 7504, Mar. 9, 1988; 62 FR 61626, Nov. 19,
Amount. Apply to the affected areas of 1997; 67 FR 78355, Dec. 24, 2002; 79 FR 10970,
the skin at least twice daily. In severe Feb. 27, 2014]
or widespread lesions it may be desir-
able to apply the ointment more than § 524.1376 2-Mercaptobenzothiazole so-
twice daily. After some improvement is lution.
observed, treatment can usually be re- (a) Specifications. The drug contains
duced to once daily. 1.3 percent 2-mercaptobenzothiazole in
(2) Indications for use. For the treat- a suitable solvent.
ment of acute otitis externa, furuncu- (b) Sponsor. See 017135 in § 510.600(c) of
losis, folliculitis, pruritus, anal gland this chapter.
infections, erythema, decubital ulcers, (c) Conditions of use—(1) Amount.
superficial wounds, and superficial ab- Apply twice daily to affected area.
scesses associated with bacterial infec- (2) Indications for use. For dogs as an
tions caused by organisms susceptible aid in the treatment of hot spots
to one or both antibiotics. (moist dermatitis) and as first aid for
(3) Limitations. Federal law restricts scrapes and abrasions.
this drug to use by or on the order of a (3) Limitations. Clip hair from affected
licensed veterinarian. area before applying. If no improve-
[79 FR 10970, Feb. 27, 2014] ment is seen within 1 week, consult a
veterinarian.
§ 524.1240 Levamisole.
(a) Specifications. The drug contains FR 50913, Aug. 22, 2000; 68 FR 33381, June 4,
200 milligrams of levamisole per milli- 2003]
372
§ 524.1443 Miconazole. § 524.1446 Milbemycin otic solution.

(a) Specifications. (1) Each gram of (a) Specifications. Each tube contains
cream contains miconazole nitrate 0.25 milliliter of a 0.1 percent solution
equivalent to 20 milligrams miconazole of milbemycin oxime.
base. (b) Sponsor. See No. 058198 in
(2) Each gram of lotion or spray con- § 510.600(c) of this chapter.
tains miconazole nitrate equivalent to (c) Conditions of use—(1) Amount. One
1 percent miconazole base.
tube administered topically into each
(b) Sponsors. See § 510.600(c) of this
external ear canal.
chapter for use as in paragraph (c) of
this section: (2) Indications for use. For the treat-
(1) No. 000061 for use of cream, lotion, ment of ear mite (Otodectes cynotis) in-
and spray; festations in cats and kittens 4 weeks
(2) Nos. 054925 and 058829 for use of lo- of age and older. Effectiveness is main-
tion and spray. tained throughout the life cycle of the
(c) Conditions of use in dogs and cats— ear mite.
(1) Amount. Apply once daily by rub- (3) Limitations. Federal law restricts
bing into or spraying a light covering this drug to use by or on the order of a
on the infected site and the immediate licensed veterinarian.
surrounding vicinity. Continue treat-
ment for 2 to 4 weeks until infection is
FR 13849, Mar. 8, 2001]
completely eradicated as determined
by appropriate laboratory examina- § 524.1448 Mirtazapine transdermal
tion. ointment.
(2) Indications for use. For topical
treatment of infections caused by (a) Specifications. Each gram of oint-
Microsporum canis, Microsporum ment contains 20 milligrams (mg)
gypseum, and Trichophyton mirtazapine.
mentagrophytes. (b) Sponsor. See No. 043264 in
(3) Limitations. Federal law restricts § 510.600(c) of this chapter.
this drug to use by or on the order of a (c) Conditions of use—(1) Amount. Ad-
licensed veterinarian. minister topically by applying a 1.5
[71 FR 13542, Mar. 16, 2006] inch ribbon of ointment (approxi-
mately 2 mg) on the inner pinna of the
§ 524.1445 Miconazole, polymixin B, cat’s ear once daily for 14 days. Alter-
and prednisolone suspension. nate the daily application of ointment
(a) Specifications. Each milliliter of between the left and right inner pinna
suspension contains 23 milligrams (mg) of the ears.
miconazole nitrate, 0.5293 mg (2) Indications for use. For body
polymixin B sulfate, and 5 mg prednis- weight gain in cats with a history of
olone acetate. weight loss.
(c) Conditions of use in dogs—(1) licensed veterinarian.
Amount. Instill five drops in the ear
canal twice daily for 7 consecutive [83 FR 64740, Dec. 18, 2018, as amended at 85
FR 45308, July 28, 2020; 88 FR 16549, Mar. 20,
days.
2023]
ment of canine otitis externa associ- § 524.1450 Moxidectin.
ated with susceptible strains of yeast
(Malassezia pachydermatis) and bacteria (a) Specifications. Each milliliter of
(Staphylococcus pseudintermedius). solution contains:
(3) Limitations. Federal law restricts (1) 5 milligrams (mg) moxidectin (0.5
this drug to use by or on the order of a percent solution).
licensed veterinarian. (2) 25 mg moxidectin (2.5 percent so-
[ 75 FR 4693, Jan. 29, 2010, as amended at 77 lution).
FR 46613, Aug. 6, 2012; 81 FR 48703, July 26, (b) Sponsors. See sponsor numbers in
2016] § 510.600 of this chapter:
373
§ 524.1465 21 CFR Ch. I (4–1–23 Edition)
(1) No. 058198 for use of product de- roundworm (Toxocara canis (adult and
scribed in paragraph (a)(1) of this sec- L4 larvae) and Toxascaris leonina
tion as in paragraph (d)(1) of this sec- (adult)), and whipworm (Trichuris vulpis
tion; and (adult)) infections in dogs and puppies
(2) No. 058198 for use of product de- that are at least 7 weeks of age and
scribed in paragraph (a)(2) of this sec- that weigh at least 3 lbs.
tion as in paragraph (d)(2) of this sec- (iii) Limitations. Federal law restricts
tion. this drug to use by or on the order of a
(c) Related tolerances. See § 556.426 of licensed veterinarian.
this chapter. [63 FR 14036, Mar. 24, 1998, as amended at 65
(d) Conditions of use—(1) Cattle—(i) FR 36617, June 9, 2000; 66 FR 46370, Sept. 5,
Amount. Administer topically 0.5 mg 2001. Redesignated at 76 FR 48715, Aug. 9,
per kilogram (kg) of body weight. 2011, as amended at 80 FR 53460, Sept. 4, 2015;
(ii) Indications for use. Beef and dairy 82 FR 21691, May 10, 2017; 86 FR 14821, Mar. 19,
cattle: For treatment and control of in- 2021]
ternal and external parasites: gastro-
§ 524.1465 Mupirocin.
intestinal roundworms (Ostertagia
ostertagi (adult and L4, including inhib- (a) Specifications. Each gram of oint-
ited larvae), Haemonchus placei (adult ment contains 20 milligrams
and L4), Trichostrongylus axei (adult mupirocin.
and L4), T. colubriformis (adult and L4), (b) Sponsors. See Nos. 025463, 051672,
Cooperia oncophora (adult and L4), C. and 054771 in § 510.600(c) of this chapter.
pectinata (adult), C. punctata (adult and (c) Conditions of use in dogs—(1)
L4), C. spatulata (adult), C. surnabada Amount. Apply twice daily. Treatment
(adult and L4), Bunostomum should not exceed 30 days.
phlebotomum (adult), Oesophagostomum (2) Indications for use. For the topical
radiatum (adult and L4), Nematodirus treatment of bacterial infections of the
helvetianus (adult and L4)); lungworms skin, including superficial pyoderma,
(Dictyocaulus viviparus (adult and L4)); caused by susceptible strains of Staphy-
cattle grubs (Hypoderma bovis, H. lococcus aureus and S. intermedius.
lineatum); mites (Chorioptes bovis, (3) Limitations. Federal law restricts
Psoroptes ovis (P. communis var. bovis)); this drug to use by or on the order of a
lice (Linognathus vituli, Haematopinus licensed veterinarian.
eurysternus, Solenopotes capillatus, [72 FR 18119, Apr. 11, 2007, as amended at 75
Bovicola (Damalinia) bovis); and horn FR 79296, Dec. 20, 2010; 78 FR 52854, Aug. 27,
flies (Haematobia irritans). To control 2013; 79 FR 10970, Feb. 27, 2014; 82 FR 11508,
infections and to protect from reinfec- Feb. 24, 2017]
tion with H. placei for 14 days after § 524.1484 Neomycin ophthalmic and
treatment, O. radiatum and O. ostertagi topical dosage forms.
for 28 days after treatment, and D.
viviparus for 42 days after treatment. § 524.1484b Neomycin, isoflupredone,
(iii) Limitations. A withdrawal period and tetracaine powder.
has not been established for this prod- (a) Specifications. Each 15-gram
uct on preruminating calves. Do not insufflator bottle contains 5 milli-
use on calves to be processed for veal. grams (mg) neomycin sulfate (equiva-
See § 500.25 of this chapter. lent to 3.5 mg neomycin base), 1 mg
(2) Dogs—(i) Amount. Administer topi- isoflupredone acetate, and 5 mg tetra-
cally a minimum of 1.1 mg per pound caine hydrochloride in a powder base.
(lb) (2.5 mg/kg) of body weight, once (b) Sponsor. See No. 054771 in
monthly using the appropriate pre- § 510.600(c) of this chapter.
loaded applicator tube. (c) Conditions of use in horses, dogs,
(ii) Indications for use. For the pre- and cats—(1) Amount. Apply to affected
vention of heartworm disease caused areas as a dusting powder.
by Dirofilaria immitis, as well as the (2) Indications for use. For the treat-
treatment and control of intestinal ment or as adjunctive therapy of cer-
hookworm (Ancylostoma caninum tain ear and skin conditions caused by
(adult, immature adult, and L4 larvae) or associated with neomycin-suscep-
and Uncinaria stenocephala (adult, im- tible organisms and/or allergy; as a su-
mature adult, and L4 larvae)), perficial dressing applied to minor
374
cuts, wounds, lacerations, abrasions, (3) Limitations. Federal law restricts

and for postsurgical application where this drug to use by or on the order of a
reduction of pain and inflammatory re- licensed veterinarian.
sponse is deemed desirable; as a dust- [40 FR 13873, Mar. 27, 1975, as amended at 43
ing powder following amputation of FR 18172, Apr. 28, 1978; 79 FR 10970, Feb. 27,
tails, claws, and dewclaws and fol- 2014]
lowing ear trimming, castrating, and
such surgical procedures as § 524.1484d Neomycin, hydrocortisone,
and tetracaine otic ointment.
ovariohysterectomies. For the treat-
ment of acute otitis externa, acute (a) Specifications. The product con-
moist dermatitis, and interdigital der- tains 5 milligrams of neomycin sulfate,
matitis in dogs. equivalent to 3.5 milligrams of neomy-
(3) Limitations. Federal law restricts cin base, 5 milligrams of hydro-
this drug to use by or on the order of a cortisone acetate, and 5 milligrams of
licensed veterinarian. tetracaine hydrochloride in each gram
of ointment.
[40 FR 13873, Mar. 27, 1975, as amended at 43 (b) Sponsor. See No. 054771 in
FR 18172, Apr. 28, 1978; 79 FR 10970, Feb. 27, § 510.600(c) of this chapter.
2014; 85 FR 45308, July 28, 2020] (c) Conditions of use in dogs and cats—
(1) Amount. Instill a quantity of oint-
§ 524.1484c Neomycin, isoflupredone, ment sufficient to fill the external ear
and tetracaine ointment. canal; may be applied one to three
(a) Specifications. The drug contains 5 times daily.
milligrams of neomycin sulfate (equiv- (2) Indications for use. For the treat-
alent to 3.5 milligrams of neomycin ment of ear canker and other inflam-
base), 1 milligram of isoflupredone ace- matory conditions of the external ear
tate, and 5 milligrams of tetracaine hy- canal, acute otitis externa and, to a
drochloride in each gram of ointment. lesser degree, chronic otitis externa.
Amount. In treatment of otitis externa [40 FR 13873, Mar. 27, 1975, as amended at 49
and other inflammatory conditions of FR 21922, May 24, 1984; 79 FR 10970, Feb. 27,
2014]
the external ear canal, a quantity of
ointment sufficient to fill the external § 524.1484e Neomycin and polymyxin B
ear canal; may be applied one to three ophthalmic solution.
times daily. When used on the skin or
mucous membranes, the affected area the ophthalmic preparation contains
should be cleansed, and a small amount 5.0 milligrams neomycin sulfate (3.5
of the ointment applied and spread or milligrams neomycin base), and 10,000
rubbed in gently. The involved area Units of polymyxin B sulfate.
may be treated one to three times a (b) Sponsor. See No. 054771 in
day and these daily applications con- § 510.600(c) of this chapter.
tinued in accordance with the clinical (c) Conditions of use in dogs—(1)
response. Amount. Instill 1 to 2 drops per eye
(2) Indications for use. For the treat- every 6 hours.
ment of acute otitis externa in dogs (2) Indications for use. For the treat-
and to a lesser degree, chronic otitis ment of bacterial infections associated
externa in dogs. It also is effective in with topical ophthalmological condi-
treating anal gland infections and tions such as corneal injuries, super-
moist dermatitis in the dog and is a ficial keratitis, conjunctivitis,
useful dressing for minor cuts, lacera- keratoconjunctivitis, and blepharitis.
tions, abrasions, and post-surgical (3) Limitations. Federal law restricts
therapy in the horse, cat, and dog. It this drug to use by or on the order of a
may also be used following amputation licensed veterinarian.
of dewclaws, tails and claws, following [40 FR 13873, Mar. 27, 1975, as amended at 61
ear trimming and castrating oper- FR 5507, Feb. 13, 1996; 79 FR 10970, Feb. 27,
ations. 2014]
375
§ 524.1484f 21 CFR Ch. I (4–1–23 Edition)
§ 524.1484f Neomycin, prednisolone, § 524.1484h Neomycin, penicillin, poly-

and tetracaine otic suspension. myxin B, and hydrocortisone sus-
pension.
(a) Specifications. The product con-
tains 5 milligrams of neomycin sulfate (a) Specifications. Each milliliter of
equivalent to 3.5 milligrams of neomy- suspension contains 25 milligrams of
neomycin sulfate equivalent to 17.5
cin base, 2.5 milligrams of prednisolone
milligrams of neomycin, 10,000 inter-
acetate, and 5 milligrams of tetracaine
national units of penicillin G procaine,
hydrochloride in each milliliter of ster- 5,000 international units of polymyxin
ile suspension. B sulfate, 2 milligrams of hydro-
(b) Sponsor. See No. 054771 in cortisone acetate, and 1.25 milligrams
§ 510.600(c) of this chapter. of hydrocortisone sodium succinate.
(c) Conditions of use in dogs and cats— (b) Sponsor. See No. 054771 in
(1) Amount. Instill 2 to 6 drops in the § 510.600(c) of this chapter.
external ear canal 2 or 3 times daily. (c) Conditions of use in dogs—(1)
(2) Indications for use. For the treat- Amount. Rub a small amount into the
ment of acute otitis externa and, to a affected area 1 to 3 times a day. After
lesser degree, chronic otitis externa; as definite improvement, apply once daily
treatment or adjunctive therapy of cer- or every other day.
tain ear conditions caused by or associ- (2) Indications for use. For the treat-
ated with neomycin-susceptible orga- ment of summer eczema, atopic derma-
titis, interdigital eczema, and otitis
nisms and/or allergy.
externa caused by bacteria susceptible
(3) Limitations. Federal law restricts to neomycin, penicillin, and polymyxin
this drug to use by or on the order of a B.
licensed veterinarian. (3) Limitations. Federal law restricts
[40 FR 13873, Mar. 27, 1975, as amended at 79 this drug to use by or on the order of a
FR 10971, Feb. 27, 2014] licensed veterinarian.
(d) Conditions of use—dogs—(1)
§ 524.1484g Neomycin, thiabendazole, Amount. Rub a small amount into the
and dexamethasone solution. involved area 1 to 3 times a day. After
definite improvement, it may be ap-
plied once a day or every other day.
thiabendazole, 3.2 mg neomycin (from summer eczema, atopic dermatitis,
neomycin sulfate), and 1 mg dexa- interdigital eczema, and otitis externa
methasone. caused by bacteria susceptible to neo-
(b) Sponsors. See Nos. 000010 and mycin, penicillin, and polymyxin B.
017033 in § 510.600(c) of this chapter. (3) Limitations. For use in dogs only.
(c) Conditions of use in dogs and cats— Shake drug thoroughly and clean le-
(1) Amount. In treating dermatoses af- sion before using. If redness, irritation,
fecting areas other than the ear, the or swelling persists or increases, dis-
surface of the lesions should be well continue use and reevaluate diagnosis.
moistened (2 to 4 drops per square inch) Federal law restricts this drug to use
twice daily. In treating otitis externa, by or on the order of a licensed veteri-
instill 5 to 15 drops in the ear twice narian.
daily. Treat for up to 7 days. [59 FR 5105, Feb. 3, 1994, as amended at 79 FR
(2) Indications for use. As an aid in the 10971, Feb. 27, 2014]
treatment of bacterial, mycotic, and
inflammatory dermatoses and otitis § 524.1484i Neomycin and hydro-
cortisone ointment.
externa.
(3) Limitations. Federal law restricts (a) Specifications. The drug contains 5
this drug to use by or on the order of a milligrams of neomycin sulfate, equiv-
licensed veterinarian. alent to 3.5 milligrams of neomycin
base, and 5 milligrams of hydro-
[40 FR 13873, Mar. 27, 1975, as amended at 62 cortisone acetate in each gram of oint-
FR 63271, Nov. 28, 1997; 79 FR 10971, Feb. 27, ment.1
2014; 80 FR 61297, Oct. 13, 2015; 84 FR 39184, (b) Sponsor. See No. 054771 in
Aug. 9, 2019; 88 FR 16549, Mar. 20, 2023] § 510.600(c) of this chapter.
376
(c) Conditions of use in dogs and cats— of neomycin sulfate equivalent to 3.5
(1) Amount. Apply 3 or 4 times daily milligrams of neomycin base.
into the conjunctival sac. With im- (b) Sponsor. See No. 054771 in
provement, frequency may be reduced § 510.600(c) of this chapter.
to 2 or 3 times daily. For treatment of (c) Conditions of use in dogs and cats—
ear canker and other inflammatory (1) Amount. For beginning treatment of
conditions of the external ear canal, acute ocular inflammations place 1 or 2
fill external ear canal 1 to 3 times drops in the conjunctival sac 3 to 6
daily. times during a 24 hour period. When
(2) Indications for use. For the treat- improvement occurs, reduce the dosage
ment of infections, allergic and trau- to 1 drop 2 to 4 times daily. For otitis
matic keratitis, conjunctivitis, acute externa, place 2 to 6 drops in the exter-
otitis externa and, to a lesser degree, nal ear canal 2 or 3 times daily.
chronic otitis externa. (2) Indications for use. For the treat-
(3) Limitations. Federal law restricts ment of treating infectious, allergic
this drug to use by or on the order of a and traumatic keratitis and conjunc-
licensed veterinarian. tivitis, acute otitis externa, and chron-
[43 FR 40456, Sept. 12, 1978, as amended at 79 ic otitis externa.
FR 10971, Feb. 27, 2014] (3) Limitations. Federal law restricts
§ 524.1484j Neomycin and prednisolone licensed veterinarian.
ophthalmic ointment.
[79 FR 10971, Feb. 27, 2014]
(a) Specifications. Each gram of oint-
ment contains prednisolone sodium § 524.1580 Nitrofurazone topical dos-
phosphate equivalent to 2.5 milligrams age forms.
prednisolone 21-phosphate and 5 milli-
grams neomycin sulfate equivalent to § 524.1580a Nitrofurazone ointment.
3.5 milligrams neomycin base. (a) Specifications. The drug contains
(b) Sponsor. See No. 000010 in 0.2 percent nitrofurazone in a water-
§ 510.600(c) of this chapter. soluble base.
(c) Conditions of use in dogs and cats— (b) Sponsors. See sponsors in
(1) Amount. A small quantity of the § 510.600(c) of this chapter.
ointment should be expressed into the (1) See Nos. 054925, 058005, 059051,
conjunctival sac 4 times a day (at in- 061133, and 069043 for use on dogs, cats,
tervals of 1 to 8 hours) for a few days or horses.
until there is a favorable response, (2) See No. 017135 for use on dogs and
then the frequency of application may horses.
be reduced to twice daily as long as the (3) See Nos. 017153 and 058829 for use
condition remains under control. on horses.
Treatment may require from a few (c) [Reserved]
days to several weeks. (d) Conditions of use—(1) Amount.
(2) Indications for use. For use in su- Apply directly on the lesion with a
perficial ocular inflammations or infec- spatula or first place on a piece of
tions limited to the conjunctiva or the gauze. The preparation should remain
anterior segment of the eye, such as on the lesion for at least 24 hours. Use
those associated with allergic reactions of a bandage is optional.
or gross irritants. (2) Indications for use. For prevention
(3) Limitations. Federal law restricts or treatment of surface bacterial infec-
this drug to use by or on the order of a tions of wounds, burns, and cutaneous
licensed veterinarian. ulcers of dogs, cats, or horses.
[79 FR 10971, Feb. 27, 2014, as amended at 84 (3) Limitations. For use only on dogs,
FR 39184, Aug. 9, 2019] cats, and horses. Do not use on horses
§ 524.1484k Neomycin and prednis- eral law prohibits the use of this prod-
olone suspension. uct in food-producing animals. In case
(a) Specifications. Each milliliter of of deep or puncture wounds or serious
suspension contains 2.5 milligrams of burns, use only as recommended by

prednisolone acetate and 5 milligrams veterinarian. If redness, irritation, or
377
§ 524.1580b 21 CFR Ch. I (4–1–23 Edition)
swelling persists or increases, dis- on the lesion for at least 24 hours. The
continue use; consult veterinarian. dressing may be changed several times
[46 FR 43402, June 27, 1980. Redesignated at 79
daily or left on the lesion for a longer
FR 10971, Feb. 27, 2014] period. For use only on dogs, cats, and
horses (not for food use). In case of
tations affecting § 524.1580a, see the List of
deep or puncture wounds or serious
CFR Sections Affected, which appears in the burns, use only as recommended by a
Finding Aids section of the printed volume veterinarian. If redness, irritation, or
and at www.govinfo.gov. swelling persists or increases, dis-
continue use; consult veterinarian.
§ 524.1580b Nitrofurazone soluble pow-
der. [49 FR 9417, Mar. 13, 1984, as amended at 71
FR 13542, Mar. 16, 2006. Redesignated at 79 FR
(a) Specifications. The drug contains 10971, Feb. 27, 2014; 79 FR 10971, Feb. 27, 2014]
0.2 percent nitrofurazone in a water-
soluble base. § 524.1600 Nystatin ophthalmic and
(b) Sponsor. See Nos. 059051 and 069043 topical dosage forms.
in § 510.600(c) of this chapter.
(c) Conditions of use—(1) Amount. § 524.1600a Nystatin, neomycin,
Apply several times daily to the lesion thiostrepton, and triamcinolone
or affected area from the plastic ointment.
squeeze bottle. (a) Specifications. Each milliliter of
(2) Indications for use. For prevention petrolatum base or each gram of van-
or treatment of surface bacterial infec- ishing cream base ointment contains:
tions of wounds, burns, skin ulcers, and 100,000 units of nystatin; neomycin sul-
abscesses after incision. fate equivalent to 2.5 milligrams of ne-
(3) Limitations. In case of deep or
omycin base; 2,500 units of
puncture wounds or serious burns, use
thiostrepton; and 1.0 milligram of
only as recommended by veterinarian.
triamcinolone acetonide.
If redness, irritation, or swelling per-
sists or increases, discontinue use; con- (b) Sponsors. For petrolatum base
sult veterinarian. For use only on dogs, ointments see Nos. 000856, 025463, 054771,
cats, and horses (not for food use). and 054925 in § 510.600(c) of this chapter.
For vanishing cream base ointments
[45 FR 43402, June 27, 1980, as amended at 47 see Nos. 025463, 054771, and 054925.
FR 43368, Oct. 1, 1982; 48 FR 28984, June 24,
1983; 53 FR 40728, Oct. 18, 1988; 54 FR 30542,
(c) Conditions of use—(1) Amount. (i)
July 21, 1989; 56 FR 50653, Oct. 8, 1991; 59 FR For topical dermatological use: Clean
33197, June 28, 1994; 60 FR 55659, Nov. 2, 1995; affected areas and remove any en-
62 FR 35077, June 30, 1997; 76 FR 17778, Mar. crusted discharge or exudate, and apply
31, 2011; 78 FR 21060, Apr. 9, 2013. Redesig- sparingly either ointment in a thin
nated at 79 FR 10971, Feb. 27, 2014, as amend- film.
ed at 79 FR 64117, Oct. 28, 2014; 83 FR 48947,
Sept. 28, 2018]
(ii) For otic use: Clean ear canal of
impacted cerumen, remove any foreign
§ 524.1580c Nitrofurazone and buta- bodies such as grass awns and ticks,
caine ointment. and instill three to five drops of petro-
(a) Specifications. The drug contains latum base ointment. Preliminary use
0.2 percent nitrofurazone and 0.5 per- of a local anesthetic may be advisable.
cent butacaine sulfate in a water-solu- (iii) For infected anal glands and cys-
ble base. tic areas: Drain gland or cyst and fill
(b) Sponsor. See No. 054925 in with petrolatum base ointment.
§ 510.600(c) of this chapter. (2) Indications for use. (i) Topically:
(c) Conditions of use—(1) Indications Use either ointment in dogs and cats
for use. For prevention or treatment of for anti-inflammatory, antipruritic,
surface bacterial infections of ears, antifungal, and antibacterial treat-
wounds, burns, and cutaneous ulcers of ment of superficial bacterial infec-
dogs, cats, and horses. tions, and for dermatologic disorders
(2) Limitations. Apply directly on the characterized by inflammation and dry
lesion with a spatula or first place on a or exudative dermatitis, particularly
piece of gauze. Use of a bandage is op- associated with bacterial or candidal

tional. The preparation should remain (Candida albicans) infections.
378
(ii) Otitis, cysts, and anal gland in- § 524.1610 Orbifloxacin, mometasone
fections: Use petrolatum base ointment furoate monohydrate, and
in dogs and cats for the treatment of posaconazole suspension.
acute and chronic otitis and interdig- (a) Specifications. Each gram of sus-
ital cysts, and in dogs for anal gland pension contains 10 milligrams (mg)
infections. orbifloxacin, mometasone furoate
(3) Limitations. Federal law restricts monohydrate equivalent to 1 mg
this drug to use by or on the order of a mometasone furoate, and 1 mg
licensed veterinarian. posaconazole.
[40 FR 13873, Mar. 27, 1975, as amended at 43 § 510.600(c) of this chapter.
FR 29770, July 11, 1978; 50 FR 41490, Oct. 11,
1985; 53 FR 39257, Oct. 6, 1988; 54 FR 5431, Feb.
3, 1989; 54 FR 48090, Nov. 21, 1989; 56 FR 50653, Amount. For dogs weighing less than 30
Oct. 8, 1991; 60 FR 55660, Nov. 2, 1995; 61 FR lbs. instill 4 drops once daily into the
63712, Dec. 2, 1996; 64 FR 42831, Aug. 6, 1999; 67 ear canal. For dogs weighing 30 lbs. or
FR 67521, Nov. 6, 2002; 68 FR 55201, Sept. 23, more, instill 8 drops into the ear canal.
2003; 70 FR 50183, Aug. 26, 2005; 71 FR 13542, Therapy should continue for 7 consecu-
Mar. 16, 2006; 79 FR 10972, Feb. 27, 2014] tive days.
§ 524.1600b Nystatin, neomycin, ment of otitis externa associated with
thiostrepton, and triamcinolone susceptible strains of yeast (Malassezia
ophthalmic ointment.
pachydermatis) and bacteria (coagulase-
(a) Specifications. Each cubic centi- positive staphylococci, Pseudomonas
meter of ointment contains: 100,000 aeruginosa, and Enterococcus faecalis).
units of nystatin, neomycin sulfate (3) Limitations. Federal law restricts
equivalent to 2.5 milligrams of neomy- this drug to use by or on the order of a
cin base, 2,500 units of thiostrepton, licensed veterinarian.
and 1.0 milligram of triamcinolone
[75 FR 16346, Apr. 1, 2010]
acetonide.
(b) Sponsor. See No. 053501 in § 524.1662 Oxytetracycline ophthalmic
§ 510.600(c) of this chapter. and topical dosage forms.
(c) Related tolerances. See §§ 556.430
and 556.470 of this chapter. § 524.1662a Oxytetracycline and hydro-
cortisone spray.
cats—(i) Amount. Apply 1 drop of oint- (a) Specifications. Each 3-ounce unit
ment to the affected eye(s) 2 or 3 times of oxytetracycline hydrochloride and
daily. Treatment may be continued for hydrocortisone spray contains 300 mil-
up to 2 weeks if necessary. ligrams of oxytetracycline hydro-
(ii) Indications for use. For use as an chloride and 100 milligrams of hydro-
anti-inflammatory, antipruritic, cortisone with an inert freon propel-
antifungal (Candida albicans), and anti- lant such that a 1-second spray treat-
bacterial ointment for local therapy in ment will deliver approximately 2.5
keratitis and conjunctivitis. milligrams of oxytetracycline hydro-
(iii) Limitations. Federal law restricts chloride and 0.8 milligram of hydro-
this drug to use by or on the order of a cortisone.
(2) Cattle—(i) Amount. Apply small
line of ointment to the affected eye(s)
(1) Amount. A small quantity should be
once daily. Treatment may be contin-
sprayed on the affected surface by
ued for up to 2 weeks if necessary.
holding the container about 6 inches
(ii) Indications for use. For infectious from the area to be treated and press-
kerato-conjunctivitis (pinkeye). ing the nozzle for 1 or 2 seconds. Only
(iii) Limitations. Federal law restricts sufficient spray to coat the skin thinly
this drug to use by or on the order of a is necessary. The application of small
licensed veterinarian. amounts at frequent intervals will give
[40 FR 13873, Mar. 27, 1975, as amended at 50 best results. Before treating animals
FR 41490, Oct. 11, 1985; 79 FR 10972, Feb. 27, with long or matted hair, it may be
2014; 84 FR 32993, July 11, 2019] necessary to clip the affected area or
379
§ 524.1662b 21 CFR Ch. I (4–1–23 Edition)
spread the hairs to allow the medica- (3) Limitations. Federal law restricts
tion to contact the skin surface. Relief this drug to use by or on the order of a
may be noted following the first or sec- licensed veterinarian.
ond treatment; however, treatment [40 FR 13873, Mar. 27, 1975, as amended at 79
should not be discontinued too soon FR 10972, Feb. 27, 2014; 88 FR 14901, Mar. 10,
after the initial favorable response has 2023]
been obtained.
(2) Indications for use. For the relief of § 524.1742 Phosmet emulsifiable liquid.
discomfort and continued treatment of (a) Specifications. The emulsifiable
many allergic, infectious, and trau- liquid contains 11.6 percent N-
matic skin conditions; for the preven- (mercaptomethyl) phthalimide S-(O,O-
tion of bacterial infections in super- dimethyl phosphorodithioate).
ficial wounds, cuts, and abrasions, (b) Sponsor. See No. 000061 in
treatment of allergic dermatoses, in- § 510.600(c) of this chapter.
cluding urticaria, eczemas, insect (c) Related tolerances. See 40 CFR
bites, and cutaneous drug reactions, in- 180.261.
fections associated with minor burns (d) Conditions of use—(1) Methods of
and wounds, and nonspecific pruritus. application. Methods of application to
control the following conditions on
(3) Limitations. Keep away from eyes
beef cattle:
or other mucous membranes; avoid in-
haling; use with adequate ventilation; TABLE 1 TO PARAGRAPH (d)(1)
in case of deep or puncture wounds or
serious burns, consult a veterinarian. Dilution rate
To control/method of use (gal. drug: gal.
of water)
FR 10972, Feb. 27, 2014] Grubs:
Dip ......................................................... 1:60
§ 524.1662b Oxytetracycline and poly- Pour-on .................................................. 1:2
Spray ..................................................... 1:49
myxin B ophthalmic ointment. Lice:
(a) Specifications. Each gram of the Dip ......................................................... 1:60
Pour-on .................................................. 1:2 or 1:5
ointment contains oxytetracycline hy- Spray ..................................................... 1:49 or 1:100
drochloride equivalent to 5 milligrams Hornflies:
of oxytetracycline and 10,000 units of Dip ......................................................... 1:60
Spray ..................................................... 1:49 or 1:100
polymyxin B sulfate. Cattle Ticks:
(b) Sponsor. See No. 054771 in Dip ......................................................... 1:60 or 1:240
§ 510.600(c) of this chapter. Spray ..................................................... 1:49
Southern cattle ticks:
(c) Conditions of use in dogs and cats— Dip ......................................................... 1:60 or 1:240
(1) Amount. Administer topically to the Spray ..................................................... 1:49
eye two to four times daily. Scabies mites:.
Dip ......................................................... 1:60
(2) Indications for use. For the prophy- Lone Star Ticks:
laxis and local treatment of superficial Dip ......................................................... 1:60
Spray ..................................................... 1:49 or 1:100
ocular infections due to
oxytetracycline- and polymyxin-sen-
(i) Dip vat procedure. (A) Prior to
sitive organisms including ocular in-
charging vat, empty old contents and
fections due to streptococci, thoroughly clean the vat. Dip vats
rickettsiae, E. coli, and A. aerogenes should be calibrated to maintain an ac-
(such as conjunctivitis, keratitis, pink- curate dilution. Add water, then drug
eye, corneal ulcer, and blepharitis in to the vat according to the dilution
dogs, cats, cattle, sheep, and horses); rate indicated in the table. Add super
ocular infections due to secondary bac- phosphate at a rate of 100 pounds per
terial complications associated with 1,000 gallons of vat solution. Super
distemper in dogs; and ocular infec- phosphate is added to control the pH of
tions due to bacterial inflammatory the solution and ensure vat stability.
conditions which may occur secondary Super phosphate is usually available at
to other infectious diseases in dogs, most fertilizer dealers as 0–45–0 or 0–46–
cats, cattle, sheep, and horses. 0. Stir the dip thoroughly, preferably
with a compressed air device; however,
380
any form of thorough mixing is ade- soon as possible after the heel fly sea-
quate. Re-stir vat contents prior to son, before the grub larvae reach the
each use. During the dipping operation, gullet or spinal canal, as the rapid kill
each time the dip’s volume is reduced of large numbers of larvae in these tis-
by 1⁄8 to 1⁄4 of its initial volume, replen- sues may cause toxic side effects, such
ish with water and add the drug at a as bloat, salivation, staggering, and pa-
rate of 1 gallon for each 50 or 200 gal- ralysis.
lons water added—depending on dilu- (3) Treatment regimens. (i) Control of
tion rate 1:60 or 1:240. Also add super scabies mites requires two treatments,
phosphate as necessary to maintain pH 10 to 14 days apart.
between 4.5 and 6.5. Stir well and re- (ii) Control of Lone Star Ticks and
sume dipping. Repeat replenishment hornflies requires two treatments, 7
process as necessary. For evaportion, days apart.
add additional water accordingly. For (4) Warnings. The drug is a cholin-
added water due to rainfall, merely re- esterase inhibitor. Do not use this drug
plenish dip with the product according on animals simultaneously or within a
to directions. If overflow occurs, either few days before or after treatment with
analyze for drug concentration and ad- or exposure to cholinesterase-inhib-
just accordingly or dispose of vat con- iting drugs, pesticides, or chemicals.
tents and recharge. Check pH after Do not apply within 21 days of slaugh-
each addition of water or super phos- ter. For use on beef cattle only. Do not
phate to assure proper pH controls. treat sick, convalescent, or stressed
(B) Dip maintenance. (1) With use of cattle, or calves less than 3 months old
dip vat tester, dipping may continue as except in Federal or State eradication
long as the drug concentration is main- programs where immediate treatment
tained between 0.15 and 0.25 percent, of all animals in an infested herd is
and the dip is not too foul for satisfac- mandatory. Be sure free access to
tory use as indicated by foul odor or drinking water is available to cattle
excessive darkening (i.e., color changes prior to dipping. Do not dip excessively
from beige to very dark brown). thirsty animals. Do not dip animals
(2) Without use of dip vat tester, vat when overheated. Repeat treatment as
should be emptied, cleaned, and re- necessary but not more often than
charged each time one of the following every 7 to 10 days. Treatment for lice,
occurs: When the dip has been charged ticks, hornflies, and scabies mites may
for 120 days; when the dip becomes too be made any time of the year except
foul for satisfactory use, within the when cattle grub larvae are in the gul-
120-day limit; if the number of animals let or spinal canal. Treatment for lice,
dipped equals twice the number of gal- ticks, and scabies mites may be made
lons of the initial dip volume, within any time 7 to 10 days following treat-
the 120-day limit. ment for grubs. Do not treat grubs
(ii) Spray method. To prepare the when the grub larvae are in the gullet
spray, mix drug with water according or spinal canal. Do not get in eyes, on
to table and stir thoroughly. Apply the skin, or on clothing. Do not breathe
fresh mixture as a high-pressure spray, spray mist. Wear rubber gloves, gog-
taking care to wet the skin, not just gles, and protective clothing. In case of
the hair. Apply to the point of ‘‘run- skin contact, wash immediately with
off,’’ about 1 gallon of diluted spray per soap and water; for eyes, flush with
adult animal. Lesser amounts will per- water. Wash all contaminated clothing
mit runoff for younger animals. with soap and hot water before re-use.
(iii) Pour-on method. Dilute the drug [40 FR 13873, Mar. 27, 1975, as amended at 46
with water according to table by slow- FR 27914, May 22, 1981; 48 FR 39607, Sept. 1,
ly adding water to the product while 1983; 54 FR 51021, Dec. 12, 1989; 61 FR 8873,
stirring. Apply 1 ounce of the diluted Mar. 6, 1996; 62 FR 61626, Nov. 19, 1997; 63 FR
mixture per 100 pounds of body weight 5255, Feb. 2, 1998; 85 FR 18120, Apr. 1, 2020]
(to a maximum of 8 ounces per head)
down the center line of the back. § 524.1982 Proparacaine ophthalmic
(2) Timing of applications for cattle solution.
grub control. For optimum cattle grub (a) Specifications. The drug is an aque-
control, it is important to treat as ous solution containing 0.5 percent
381
§ 524.2080 21 CFR Ch. I (4–1–23 Edition)
proparacaine hydrochloride, 2.45 per- suspected. Local applications may also

cent glycerin as a stabilizer, and 0.2 be used as an aid in the removal of for-
percent chlorobutanol (choral deriva- eign bodies from the nose and ear
tive) and 1:10,000 benzalkonium chlo- canal, as an accessory in the examina-
ride as preservatives. tion and treatment of painful otitis, in
(b) Sponsor. See No. 054771 in minor surgery, and prior to catheter-
§ 510.600(c) of this chapter. ization.
(c) Conditions of use in dogs and cats— (2) It is administered as follows:
(1) Amount. It is administered as fol- (i) For removal of sutures: Instill one
lows:
to two drops 2 or 3 minutes before re-
(i) For removal of sutures: Instill one
moval of stitches.
to two drops 2 or 3 minutes before re-
moval of stitches. (ii) For removal of foreign bodies
(ii) For removal of foreign bodies from eye, ear, and nose: For oph-
from eye, ear, and nose: For ophthalmic use, instill three to five drops
thalmic use, instill three to five drops in the eye prior to examination; for
in the eye prior to examination; for otic use, instill five to 10 drops in the
otic use, instill five to ten drops in the ear; for nasal use, instill five to 10
ear; for nasal use, instill five to ten drops in each nostril every 3 minutes
drops in each nostril every 3 minutes for three doses.
for three doses. (iii) For tonometry: Instill one to
(iii) For tonometry: Instill one to two drops immediately before measure-
two drops immediately before measurement.
ment. (iv) As an aid in treatment of otitis:
(iv) As an aid in treatment of otitis: Instill two drops into the ear every 5
Instill two drops into the ear every 5 minutes for three doses.
minutes for three doses. (v) For minor surgery: Instill one or
(v) For minor surgery: Instill one or more drops as required.
more drops as required. (vi) For catheterization: Instill two
(vi) For catheterization: Instill two to three drops with a blunt 20-gauge
to three drops with a blunt 20-gauge
needle immediately before inserting
needle immediately before inserting
catheter.
catheter.
(2) Indications for use. For use as a (3) For use only by or on the order of
topical ophthalmic anesthetic. It is a licensed veterinarian.
used as an anesthetic in cauterization [40 FR 13873, Mar. 27, 1975, as amended at 50
of corneal ulcers, removal of foreign FR 41490, Oct. 11, 1985; 79 FR 10972, Feb. 27,
bodies and sutures from the cornea, 2014]
and measurement of intraocular pres-
sure (tonometry) when glaucoma is § 524.2080 Ropinirole.
suspected; as an aid in the removal of (a) Specifications. Each milliliter of
foreign bodies from the nose and ear solution contains 30 milligrams (mg)
canal; as an accessory in the examina- ropinirole (equivalent to 34.2 mg
tion and treatment of painful otitis, in ropinirole hydrochloride).
minor surgery, and prior to catheter-
ization.
(3) Limitations. Keep away from eyes
or other mucous membranes; avoid in- (c) Conditions of use—(1) Amount.
haling; use with adequate ventilation; Using the table provided in labeling,
in case of deep or puncture wounds or administer the number of eye drops
serious burns, consult a veterinarian. topically, corresponding to body
(d) Conditions of use. (1) The drug is weight, that results in a target dose of
indicated for use as a topical oph- 3.75 mg per square meter (mg/m2) (dose
thalmic anesthetic in animals. It is band 2.7 to 5.4 mg/m2). If the dog does
used as an anesthetic in cauterization not vomit within 20 minutes of the
of corneal ulcers, removal of foreign first dose, then a second dose may be
bodies and sutures from the cornea, administered.
and measurement of intraocular pres- (2) Indications for use. For the induc-
sure (tonometry) when glaucoma is tion of vomiting in dogs.
382
(3) Limitations. Federal law restricts animal at the base of the neck in front
this drug to use by or on the order of a of the shoulder blades.
licensed veterinarian. (2) Indications for use. For the preven-
[86 FR 13185, Mar. 8, 2021]
tion of heartworm disease caused by
Dirofilaria immitis. Kills adult fleas
§ 524.2098 Selamectin. (Ctenocephalides felis) and is indicated
for the treatment and prevention of
(a) Specifications. Each milliliter con- flea infestations; the treatment and
tains 60 or 120 milligrams (mg) of control of tick infestations with Ixodes
selamectin. scapularis (black-legged or deer tick),
(b) Sponsors. See Nos. 051072, 054771, Amblyomma maculatum (Gulf Coast
055529, 061133, and 061651 in § 510.600(c) of tick), and Dermacentor variabilis (Amer-
this chapter. ican dog tick); the treatment and con-
(c) Conditions of use—(1) Amount. Ad- trol of ear mite (Otodectes cynotis) in-
minister topically 2.7 mg of selamectin festations; and the treatment and con-
per pound (6 mg per kilogram) of body trol of roundworm (Toxocara cati) and
weight. intestinal hookworm (Ancylostoma
(2) Indications for use. Kills adult fleas tubaeforme) infections in cats and kit-
and prevents flea eggs from hatching tens 8 weeks of age and older, and
for 1 month, and it is indicated for the weighing 2.8 pounds or greater.
prevention and control of flea infesta- (3) Limitations. Federal law restricts
tions (Ctenocephalides felis), prevention this drug to use by or on the order of a
of heartworm disease caused by licensed veterinarian.
Dirofilaria immitis, and treatment and
control of ear mite (Otodectes cynotis) [84 FR 12494, Apr. 2, 2019]
infestations in dogs and cats. Treat-
ment and control of sarcoptic mange § 524.2101 Selenium disulfide suspen-
sion.
(Sarcoptes scabiei) and control of tick
(Dermacentor variabilis) infestations in (a) Specifications. The product con-
dogs. Treatment and control of intes- tains 0.9-percent weight in weight (w/w)
tinal hookworm (Ancylostoma selenium disulfide (1-percent weight in
tubaeforme) and roundworm (Toxocara volume (w/v)).
cati) infections in cats. For dogs 6 (b) Sponsors. See Nos. 000010, 000061,
weeks of age and older, and cats 8 and 017135 in § 510.600(c) of this chapter.
weeks of age and older. (c) Conditions of use on dogs—(1) Indi-
(3) Limitations. Federal law restricts cations for use. For use as a cleansing
this drug to use by or on the order of a shampoo and as an agent for removing
licensed veterinarian. skin debris associated with dry eczema,
seborrhea, and nonspecific dermatoses.
FR 48707, Sept. 8, 1999; 65 FR 45282, July 21, (2) Amount. One to 2 ounces per appli-
2000; 74 FR 19878, Apr. 30, 2009; 79 FR 10972, cation.
Feb. 27, 2014; 86 FR 17064, Apr. 1, 2021; 87 FR (3) Limitations. Use carefully around
58963, Sept. 29, 2022] scrotum and eyes, covering scrotum
with petrolatum. Allow the shampoo to
§ 524.2099 Selamectin and sarolaner. remain for 5 to 15 minutes before thor-
(a) Specifications. Each milliliter ough rinsing. Repeat treatment once or
(mL) of solution contains 60 milligrams twice a week. If conditions persist or if
(mg) selamectin and 10 mg sarolaner. rash or irritation develops, discontinue
The drug is provided in single dose use and consult a veterinarian.
tubes containing 0.25, 0.5, or 1 mL of so- [47 FR 53351, Nov. 26, 1982, as amended at 48
lution. FR 32762, July 19, 1983; 54 FR 36962, Sept. 6,
(b) Sponsor. See No. 054771 in 1989; 56 FR 9623, Mar. 7, 1991; 58 FR 41025,
§ 510.600(c) of this chapter. Aug. 2, 1993; 63 FR 26981, May 15, 1998; 70 FR
(c) Conditions of use in cats—(1) 50183, Aug. 26, 2005; 84 FR 39184, Aug. 9, 2019]
Amount. Administer 2.7 mg selamectin
per pound (/lb) (6 mg per kilogram (/ § 524.2350 Tolnaftate cream.
kg)) of body weight and 0.45 mg/lb (a) Specifications. The drug contains 1
sarolaner (1 mg/kg) by emptying the percent tolnaftate in an anhydrous

contents of the tube on the back of the cream base.
383
§ 524.2482 21 CFR Ch. I (4–1–23 Edition)
(b) Sponsor. See No. 000061 in § 524.2620 Liquid crystalline trypsin,

§ 510.600(c) of this chapter. Peru balsam, castor oil.
(c) Conditions of use—(1) Amount. (a) Specifications. (1) Each gram of liq-
Apply a small amount of the cream to uid or aerosol contains 0.12 milligram
the affected areas once or twice a day of crystalline trypsin, 87.0 milligrams
for 2 to 4 weeks. of Peru balsam, and 788.0 milligrams of
(2) Indications for use. For the treat- castor oil.
ment of ringworm lesions due to (2) Each gram of liquid or aerosol
Microsporum canis and Microsporum contains 0.1 milligram of crystalline
gypseum. trypsin, 72.5 milligrams of Peru bal-
(3) Limitations. Federal law restricts sam, and 800 milligrams of castor oil.
this drug to use by or on the order of a (b) Sponsors. See sponsor numbers in
licensed veterinarian. § 510.600(c) of this chapter for use as in
[79 FR 10972, Feb. 27, 2014] paragraph (c) in this section:
§ 524.2482 Triamcinolone spray. scribed in paragraph (a)(1).
scribed in paragraph (a)(2).
solution contains 0.15 milligrams
(c) Conditions of use—(1) Amount.
triamcinolone acetonide.
Apply directly to the wound site.
(2) Indications for use. As an aid in the
treatment of external wounds and as-
(c) Conditions of use in dogs—(1) sists healing by facilitating the re-
Amount. Apply sufficient pump sprays moval of necrotic tissue, exudate, and
to uniformly and thoroughly wet the organic debris.
affected areas while avoiding run off of
excess product. Administer twice daily [79 FR 10973, Feb. 27, 2014, as amended at 88
for 7 days, then once daily for 7 days, FR 14901, Mar. 10, 2023]
then every other day for an additional
14 days (28 days total). PART 526—INTRAMAMMARY DOS-
(2) Indications for use. For the control AGE FORM NEW ANIMAL
of pruritus associated with allergic der- DRUGS
matitis.
(3) Limitations. Federal law restricts Sec.
this drug to use by or on the order of a 526.88 Amoxicillin.
licensed veterinarian. 526.313 Ceftiofur.
526.363 Cephapirin benzathine.
[68 FR 4916, Jan. 31, 2003, as amended at 78 526.365 Cephapirin sodium.
FR 17868, Mar. 25, 2013] 526.464 Cloxacillin benzathine.
526.465 Cloxacillin sodium.
§ 524.2483 Triamcinolone cream. 526.820 Erythromycin.
(a) Specifications. The vanishing 526.1130 Hetacillin.
526.1590 Novobiocin.
cream contains 0.1 percent
526.1696 Penicillin G procaine.
triamcinolone acetonide. 526.1697 Penicillin G procaine and dihydro-
(b) Sponsor. See Nos. 000010 and 054925 streptomycin.
in § 510.600(c) of this chapter. 526.1698 Penicillin G procaine and
(c) Conditions of use in dogs—(1) novobiocin.
Amount. Rub into affected areas two to 526.1810 Pirlimycin.
four times daily for 4 to 10 days. AUTHORITY: 21 U.S.C. 360b.
(2) Indications for use. For topical
treatment of allergic dermatitis and § 526.88 Amoxicillin.
summer eczema. (a) Specifications. Each single-dose,
(3) Limitations. Federal law restricts 10-milliliter syringe contains
this drug to use by or on the order of a amoxicillin trihydrate equivalent to
licensed veterinarian. 62.5 milligrams (mg) amoxicillin.
FR 79318, Dec. 29, 2008. Redesignated and § 510.600(c) of this chapter.
amended at 75 FR 10168, Mar. 5, 2010; 77 FR (c) Related tolerances. See § 556.38 of

60302, Oct. 3, 2012] this chapter.
384
(d) Conditions of use in lactating required. Federal law restricts this

cows—(1) Amount. Infuse the contents drug to use by or on the order of a li-
of one syringe (equivalent to 62.5 mg censed veterinarian.
amoxicillin) into each infected quarter (4) Special considerations. Federal law
every 12 hours for a maximum of 3 prohibits extralabel use of this drug in
doses. lactating dairy cattle for disease pre-
(2) Indications for use. For the treat- vention purposes; at unapproved doses;
ment of subclinical infectious bovine frequencies, durations, or routes of ad-
mastitis due to Streptococcus agalactiae ministration; and in unapproved major
and Straphylococcus aureus (penicillin food-producing species/production
sensitive). classes.
(3) Limitations. Milk taken from ani- (e) Conditions of use for syringe de-
mals during treatment and for 60 hours scribed in paragraph (a)(2) of this section
(5 milkings) after the last treatment in dry cows—(1) Amount. Infuse the con-
must not be used for food. Treated ani- tents of one syringe (500 mg ceftiofur
mals must not be slaughtered for food equivalents) into each affected quarter
purposes within 12 days after the last at the time of dry off.
treatment. Federal law restricts this
ment of subclinical mastitis in dairy
cattle at the time of dry off associated
[57 FR 37334, Aug. 18, 1992, as amended at 60 with Staphylococcus aureus, Strepto-
FR 55660, Nov. 2, 1995; 68 FR 44878, July 31, coccus dysgalactiae, and Streptococcus
2003; 86 FR 13185, Mar. 8, 2021] uberis.
§ 526.313 Ceftiofur. (3) Limitations. Milk taken from cows
completing a 30-day dry-off period may
(a) Specifications. Each single-dose, be used for food with no milk discard
10-milliliter syringe contains: due to ceftiofur residues. Following
(1) 125 milligrams (mg) ceftiofur intramammary infusion, a 16-day
equivalents as the hydrochloride salt; preslaughter withdrawal period is re-
or quired for treated cows. No
(2) 500 mg ceftiofur equivalents as the preslaughter withdrawal period is re-
hydrochloride salt. quired for neonatal calves from treated
cows regardless of colostrum consump-
this chapter.
erinarian.
(d) Conditions of use for syringe de-
scribed in paragraph (a)(1) of this section (4) Special considerations. Federal law
in lactating cows—(1) Amount. Infuse the prohibits extralabel use of this drug in
contents of one syringe (125 mg dry dairy cattle for disease prevention
ceftiofur equivalents) into each af- purposes; at unapproved doses; fre-
fected quarter. Repeat treatment in 24 quencies, durations, or routes of ad-
hours. Once daily treatment may be re- ministration; and in unapproved major
peated for up to 8 consecutive days. food-producing species/production
(2) Indications for use. For the treat- classes.
ment of clinical mastitis associated [70 FR 9516, Feb. 28, 2005, as amended at 70
with coagulase-negative staphylococci, FR 20048, Apr. 18, 2005. Redesignated and
Streptococcus dysgalactiae, and Esch- amended at 71 FR 39545, July 13, 2006; 79 FR
erichia coli; and the treatment of diag- 10973, Feb. 27, 2013; 79 FR 18159, Apr. 1, 2014;
nosed subclinical mastitis associated 80 FR 34279, June 16, 2015; 86 FR 13185, Mar.
8, 2021]
with coagulase-negative staphylococci
and S. dysgalactiae.
§ 526.363 Cephapirin benzathine.
(3) Limitations. Milk taken from cows
during treatment (a maximum of 8 (a) Specifications. Each single-dose,
daily infusions) and for 72 hours after 10-milliliter syringe contains 300 milli-
the last treatment must not be used for grams cephapirin activity (as
human consumption. Following label cephapirin benzathine).
use for up to 8 consecutive days, a 2- (b) Sponsor. See No. 000010 in

day preslaughter withdrawal period is § 510.600(c) of this chapter.
385
§ 526.365 21 CFR Ch. I (4–1–23 Edition)
(c) Related tolerances. See § 556.115 of to use by or on the order of a licensed

this chapter. veterinarian.
(d) Conditions of use in dry cows—(1) [40 FR 57455, Dec. 10, 1975, as amended at 53
Amount. Infuse the contents of one sy- FR 27852, July 25, 1988. Redesignated at 63 FR
ringe (300 mg cephapirin activity) into 8349, Feb. 19, 1998; 65 FR 20733, Apr. 18, 2000;
each quarter following last milking, 73 FR 3181, Jan. 17, 2008; 75 FR 10168, Mar. 5,
but no later than 30 days before 2010; 86 FR 13186, Mar. 8, 2021; 88 FR 16549,
calving. Mar. 20, 2023]
(2) Indications for use. For the treat- § 526.464 Cloxacillin benzathine.
ment of mastitis caused by susceptible
strains of Streptococcus agalactiae and (a) Specifications. Each single-dose,
Staphylococcus aureus, including peni- 7.5- or 10-milliliter syringe contains
cillin-resistant strains. cloxacillin benzathine equivalent to 500
(3) Limitations. For use in dry cows milligrams (mg) cloxacillin.
only. Not to be used within 30 days of (b) Sponsor. See No. 000010 in
calving. Milk from treated cows must § 510.600(c) of this chapter.
not be used for food during the first 72 (c) Related tolerances. See § 556.165 of
hours after calving. Animals infused this chapter.
with this product must not be slaugh- (d) Conditions of use in dry cows—(1)
tered for food until 42 days after the Amount. Infuse the contents of one sy-
latest infusion. Federal law restricts ringe (equivalent to 500 mg cloxacillin)
into each quarter immediately after
last milking, but no later than 30 days
before calving.
[43 FR 37174, Aug. 22, 1978, as amended at 53 (2) Indications for use. For the treat-
FR 27851, July 25, 1988; 73 FR 12262, Mar. 7, ment of mastitis caused by Staphy-
2008; 75 FR 10168, Mar. 5, 2010; 76 FR 17338, lococcus aureus and Streptococcus
Mar. 29, 2011; 86 FR 13186, Mar. 8, 2021; 88 FR agalactiae including penicillin resistant
16549, Mar. 20, 2023] strains in dairy cows during the dry pe-
riod.
§ 526.365 Cephapirin sodium.
(3) Limitations. Animals infused with
(a) Specifications. Each single-dose, this product must not be slaughtered
10-milliliter syringe contains 200 milli- for food until 30 days after the latest
grams (mg) cephapirin sodium activity. infusion. Federal law restricts this
(b) Sponsor. See No. 000010 in drug to use by or on the order of a li-
§ 510.600(c) of this chapter. censed veterinarian.
(c) Related tolerances. See § 556.115 of [86 FR 13186, Mar. 8, 2021]
this chapter.
(d) Conditions of use in lactating § 526.465 Cloxacillin sodium.
cows—(1) Amount. Infuse the contents (a) Specifications. Each single-dose,
of one syringe (200 mg cephapirin activ- 10-milliliter syringe contains
ity) into each infected quarter imme- cloxacillin sodium equivalent to 200
diately after the quarter has been com- milligrams (mg) cloxacillin.
pletely milked out. Do not milk out for (b) Sponsor. See No. 000061 in
12 hours. Repeat once only in 12 hours. § 510.600(c) of this chapter.
(2) Indications for use. For the treat- (c) Related tolerances. See § 556.165 of
ment of mastitis in lactating cows this chapter.
caused by susceptible strains of Strepto- (d) Conditions of use in lactating
coccus agalactiae and Staphylococcus cows—(1) Amount. Infuse the contents
aureus including strains resistant to of one syringe (equivalent to 200 mg
penicillin. cloxacillin) into each infected quarter.
(3) Limitations. Milk that has been Treatment should be repeated at 12-
taken from animals during treatment hour intervals for a total of 3 doses.
and for 96 hours after the last treat- (2) Indications for use. For the treat-
ment must not be used for food. Treat- ment of mastitis in lactating cows due
ed animals must not be slaughtered for to Streptococcus agalactiae and Staphy-
food until 4 days after the last treat- lococcus aureus, nonpenicillinase-pro-
ment. Federal law restricts this drug ducing strains.
386
(3) Limitations. Milk taken from use by or on the order of a licensed vet-
treated animals within 48 hours (4 erinarian.
milkings) after the latest treatment [86 FR 13186, Mar. 8, 2021, as amended at 88
should not be used for food. Treated FR 14901, Mar. 10, 2023]
animals should not be slaughtered for
food within 10 days after the latest § 526.1130 Hetacillin.
treatment. Federal law restricts this (a) Specifications. Each single-dose,
drug to use by or on the order of a li- 10-milliliter syringe contains hetacillin
censed veterinarian. potassium equivalent of 62.5 milli-
[57 FR 37335, Aug. 18, 1992, as amended at 60 grams (mg) ampicillin.
FR 55660, Nov. 2, 1995; 68 FR 44878, July 31, (b) Sponsor. See No. 000010 in
2003. Redesignated at 85 FR 18120, Apr. 1, § 510.600(c) of this chapter.
2020. Redesignated and amended at 86 FR (c) Related tolerances. See § 556.316 of
(d) Conditions of use in lactating
§ 526.820 Erythromycin. cows—(1) Amount. Infuse the contents
(a) Specifications. (1) Each single-dose, of one syringe (equivalent to 62.5 mg
6-milliliter (mL) syringe contains 300 ampicillin) into each infected quarter.
milligrams (mg) erythromycin (as the Repeat at 24-hour intervals for a max-
base). imum of 3 treatments.
(2) Each single-dose, 12-mL syringe (2) Indications for use. For the treat-
contains 600 mg erythromycin (as the ment of acute, chronic, or subclinical
base). mastitis in lactating cows caused by
(b) Sponsors. See Nos. 054771 and susceptible strains of Streptococcus
061133 in § 510.600(c) of this chapter. agalactiae, Streptococcus dysgalactiae,
Staphylococcus aureus, and Escherichia
coli.
this chapter.
(3) Limitations. Milk that has been
(d) Conditions of use for syringe de- taken from animals during treatment
scribed in paragraph (a)(1) of this section and for 72 hours (6 milkings) after the
in lactating cows—(1) Amount. Infuse the latest treatment must not be used for
contents of one 6-mL syringe (300 mg food. Treated animals must not be
erythromycin base) into each infected slaughtered for food until 10 days after
quarter. Repeat infusion at 12-hour in- the latest treatment. Federal law re-
tervals for a maximum of 3 infusions. stricts this drug to use by or on the
(2) Indications for use. For the treat- order of a licensed veterinarian.
ment of mastitis due to Staphylococcus
aureus, Streptococcus agalactiae, Strepto- [57 FR 37335, Aug. 18, 1992, as amended at 75
FR 10168, Mar. 5, 2010; 84 FR 53311, Oct. 7,
coccus dysgalactiae, and Streptococcus 2019; 86 FR 13186, Mar. 8, 2021]
uberis in lactating cows.
(3) Limitations. Milk taken from ani- § 526.1590 Novobiocin.
mals during treatment and for 36 hours (a) Specifications. Each single-dose,
(3 milkings) after the latest treatment 10-milliliter syringe contains:
must not be used for food. Federal law (1) 150 milligrams (mg) of novobiocin
restricts this drug to use by or on the equivalents as sodium novobiocin, or
order of a licensed veterinarian. (2) 400 mg of novobiocin equivalents
(e) Conditions of use for syringe de- as sodium novobiocin.
scribed in paragraph (a)(2) of this section (b) Sponsor. See No. 054771 in
in dry cows—(1) Amount. Infuse the con- § 510.600(c) of this chapter.
tents of one 12-mL syringe (600 mg (c) Related tolerances. See § 556.460 of
erythromycin base) into each infected this chapter.
quarter at the time of drying off. (d) Conditions of use for syringe de-
(2) Indications for use. For the treat- scribed in paragraph (a)(1) of this section
ment of mastitis due to Staphylococcus in lactating cows—(1) Amount. Infuse the
aureus, Streptococcus agalactiae, Strepto- contents of one syringe (equivalent to
coccus dysgalactiae, and Streptococcus 150 mg novobiocin) into each infected
uberis in dry cows. quarter after milking. Repeat treat-
(3) Limitations. For use in dry cows ment once after 24 hours. Do not milk
only. Federal law restricts this drug to for at least 6 hours after treatment.
387
§ 526.1696 21 CFR Ch. I (4–1–23 Edition)
(2) Indications for use. For the treat- (e) Conditions of use in dry cows—(1)
ment of mastitis caused by susceptible Amount. Infuse the contents of one 10-
strains of Staphylococcus aureus in lac- milliliter syringe (equivalent to 100,000
tating cows. units penicillin G) into each infected
(3) Limitations. Milk taken from quarter at time of drying-off.
treated animals within 72 hours (6 (2) Indications for use. For the treat-
milkings) after latest treatment should ment of mastitis caused by Strepto-
not be used for food. Do not slaughter coccus agalactiae in dry cows.
treated animals for food for 15 days fol- (3) Limitations. For intramammary
lowing latest treatment. Federal law infusion in dry cows only. Animals in-
restricts this drug to use by or on the tended for human consumption must
order of a licensed veterinarian. not be slaughtered within 14 days of
(e) Conditions of use for syringe de- last treatment. Discard all milk for 72
scribed in paragraph (a)(2) of this section hours (6 milkings) following calving, or
in dry cows—(1) Amount. Infuse the con- later as indicated by the marketable
tents of one syringe (equivalent to 400 quality of the milk.
mg novobiocin) into each quarter at
the time of drying off. FR 57998, Oct. 20, 2021]
ment of mastitis caused by susceptible § 526.1697 Penicillin G procaine and
strains of Staphylococcus aureus and dihydrostreptomycin.
Streptococcus agalactiae in dry cows. (a) Specifications. Each single-use, 10-
(3) Limitations. For udder installation milliliter syringe contains a suspen-
for the treatment of mastitis in dry
sion of:
cows only. Infuse each quarter at the (1) Penicillin G procaine equivalent
time of drying off, but not less than 30
to 200,000 units penicillin G and dihy-
days prior to calving. Do not slaughter
drostreptomycin sulfate equivalent to
treated animals for food for 30 days fol-
300 milligrams dihydrostreptomycin; or
lowing udder infusion.
(2) Penicillin G procaine equivalent
[86 FR 13187, Mar. 8, 2021] to 1 million units penicillin G and di-
hydrostreptomycin sulfate equivalent
§ 526.1696 Penicillin G procaine. to 1 gram dihydrostreptomycin.
(a) Specifications. Each single-dose, (b) Sponsor. See No. 042791 in
10-milliliter syringe contains penicillin § 510.600(c) of this chapter.
G procaine equivalent to 100,000 units (c) Related tolerances. See §§ 556.200
of penicillin G. and 556.510 of this chapter.
(b) See Nos. 042791 and 061133 in (d) Conditions of use for syringe de-
§ 510.600(c) of this chapter. scribed in paragraph (a)(1) of this section
(c) Related tolerances. See § 556.510 of in dry cows—(1) Amount. Infuse the con-
this chapter. tents of one syringe (equivalent to
(d) Conditions of use in lactating 200,000 units penicillin G and 300 milli-
cows—(1) Amount. Infuse the contents grams dihydrostreptomycin) into each
of one 10-milliliter syringe (equivalent quarter at the last milking prior to
to 100,000 units penicillin G) into each drying off.
infected quarter. Treatment may be re- (2) Indications for use. For the treat-
peated at 12-hour intervals for not ment of subclinical mastitis in dairy
more than 3 doses, as indicated by clin- cows at the time of drying off, specifi-
ical response. cally against infections caused by
(2) Indications for use. For the treat- Staphylococcus aureus and Streptococcus
ment of mastitis caused by Strepto- agalactiae.
coccus agalactiae, S. dysgalactiae, and S. (3) Limitations. For use in dry cows
uberus in lactating cows. only. Not to be used within 6 weeks of
(3) Limitations. For intramammary calving. Milk taken from cows within
infusion in lactating cows only. Dis- 24 hours (2 milkings) after calving
card all milk for 60 hours (5 milkings) must not be used for food. Animals in-
after the latest treatment. Animals infused with this drug must not be
tended for human consumption must slaughtered for food within 60 days of
not be slaughtered within 3 days of lat- treatment or within 24 hours after

est treatment. calving.
388
(e) Conditions of use for syringe de- (3) Limitations. For udder instillation
scribed in paragraph (a)(2) of this section in lactating cows only. Do not milk for
in dry cows—(1) Amount. Infuse the con- at least 6 hours after treatment; there-
tents of one syringe (equivalent to 1 after, milk at regular intervals. Milk
million units penicillin G and 1 gram taken from treated animals within 72
dihydrostreptomycin) into each quar- hours (6 milkings) after the latest
ter at the last milking prior to drying treatment must not be used for food.
off. Treated animals must not be slaugh-
(2) Indications for use. To reduce the tered for food for 15 days following the
frequency of existing infection and to latest treatment. Federal law restricts
prevent new infections with Staphy- this drug to use by or on the order of a
lococcus aureus in dry cows. licensed veterinarian.
(3) Limitations. Not for use in lac- (e) Conditions of use for syringe de-
tating cows. Not to be used within 6 scribed in paragraph (a)(2) of this section
weeks of calving. Milk taken from in lactating cows—(1) Amount. Infuse the
cows within 96 hours (8 milkings) after contents of one syringe (equivalent to
calving must not be used for food. Ani- 200,000 units penicillin G and 400 mg
mals infused with this drug must not novobiocin) into each quarter at dry
be slaughtered for food within 60 days off.
from the time of infusion or within 96 (2) Indications for use. For the treat-
hours after calving. Federal law re- ment of subclinical mastitis caused by
stricts this drug to use by or on the susceptible strains of Staphylococcus
order of a licensed veterinarian. aureus and Streptococcus agalactiae in
dry cows.
[57 FR 37336, Aug. 18, 1992, as amended at 78 (3) Limitations. For udder instillation
FR 21060, Apr. 9, 2013; 83 FR 14587, Apr. 5, in dry cows only. Do not use less than
2018. Redesignated and amended at 86 FR
13187, Mar. 8, 2021]
30 days prior to calving. Milk from
treated cows must not be used for food
§ 526.1698 Penicillin G procaine and during the first 72 hours after calving.
novobiocin. Treated animals must not be slaugh-
tered for food for 30 days following
(a) Specifications. Each single-use, 10- udder infusion. Federal law restricts
milliliter syringe contains a suspen- this drug to use by or on the order of a
sion of: licensed veterinarian.
(1) Penicillin G procaine equivalent
to 100,000 units penicillin G and 150 mil- [57 FR 37336, Aug. 18, 1992; 57 FR 42623, Sept.
ligrams (mg) novobiocin as novobiocin 15, 1992; 79 FR 10973, Feb. 27, 2014; 84 FR 32993,
July 11, 2019. Redesignated and amended at
sodium; or
86 FR 13187, Mar. 8, 2021; 88 FR 14901, Mar. 10,
(2) Penicillin G procaine equivalent 2023]
to 200,000 units penicillin G and 400 mg
novobiocin as novobiocin sodium. § 526.1810 Pirlimycin.
(b) Sponsor. See No. 054771 in (a) Specifications. Each single-dose,
§ 510.600(c) of this chapter. 10-milliliter syringe contains 50 milli-
(c) Related tolerances. See §§ 556.460 grams (mg) of pirlimycin (as
and 556.510 of this chapter. pirlimycin hydrochloride).
(d) Conditions of use for syringe de- (b) Sponsor. See No. 054771 in
scribed in paragraph (a)(1) of this section § 510.600(c) of this chapter.
in lactating cows—(1) Amount. Infuse the (c) Related tolerances. See § 556.515 of
contents of one syringe (equivalent to this chapter.
100,000 units penicillin G and 150 mg (d) Conditions of use in lactating
novobiocin) into each infected quarter cows—(1) Amount. Infuse the contents
after milking. Repeat once after 24 of one syringe (50 mg pirlimycin) into
hours. each infected quarter. Daily treatment
(2) Indications for use. For the treat- may be repeated at 24-hour intervals
ment of mastitis caused by susceptible for up to 8 consecutive days.
strains of Staphylococcus aureus, Strep- (2) Indications for use. For the treat-
tococcus agalactiae, Streptococcus ment of clinical and subclinical mas-
dysgalactiae, and Streptococcus uberis in titis in lactating dairy cattle associ-

lactating cows. ated with Staphylococcus species such
389
as Staphylococcus aureus and Strepto- binant hFVIIa intended for the treat-
coccus species such as Streptococcus ment of hemophilia A or B in humans
agalactiae, Streptococcus dysgalactiae, with inhibitors to Factors VIII and IX.
and Streptococcus uberis. (2) Limitations. Food or feed from R69
(3) Limitations. Milk taken from ani- rabbits is not permitted in the food or
mals during treatment and for 36 hours feed supply.
following the last treatment must not
[84 FR 12494, Apr. 2, 2019]
be used for food regardless of treat-
ment duration. Following infusion § 528.1092 opAFP-GHc2 recombinant
twice at a 24-hour interval, treated ani- deoxyribonucleic acid construct.
mals must not be slaughtered for 9
(a) Specifications. A single copy of the
days. Following any extended duration
a-form of the opAFP–GHc2 recombinant
of therapy (infusion longer than twice
deoxyribonucleic acid (rDNA) con-
at a 24-hour interval, up to 8 consecu-
struct at the a-locus in the EO–1 a lin-
tive days), animals must not be slaugh-
eage of triploid, hemizygous, all-female
tered for 21 days. Federal law restricts
Atlantic salmon (Salmo salar).
of this chapter.
[58 FR 58486, Nov. 2, 1993, as amended at 65 (c) Indications for use. Significantly
FR 61091, Oct. 16, 2000; 73 FR 811, Jan. 4, 2008; more of these Atlantic salmon grow to
79 FR 10973, Feb. 27, 2014; 86 FR 13188, Mar. 8, at least 100 grams within 2,700 Celsius
2021]
degree-days than their comparators.
(d) Limitations. These Atlantic salm-
PART 528—INTENTIONAL GENOMIC on are produced as eyed-eggs and
ALTERATIONS IN ANIMALS grown-out only in physically-con-
tained, freshwater culture facilities
Sec. specified in an FDA-approved applica-
528.1080 Bc2371 recombinant tion.
deoxyribonucleic acid construct.
528.1092 opAFP-GHc2 recombinant [80 FR 73104, Nov. 24, 2015]
deoxyribonucleic acid construct.
528.2001 pPL657 recombinant § 528.2001 pPL657 recombinant
deoxyribonucleic acid construct. deoxyribonucleic acid construct.
528.2010 Human lysosomal acid lipase re- (a) Specifications. pPL657 in the
combinant deoxyribonucleic acid con-
glycoprotein galactosyltransferase alpha-
struct.
1,3 (GGTA1) gene in domestic pigs.
AUTHORITY: 21 U.S.C. 360b. (b) Sponsor. See No. 086134 in
SOURCE: 74 FR 6823, Feb. 11, 2009, unless § 510.600(c) of this chapter.
otherwise noted. (c) Conditions of use—(1) Intended use.
pPL657 rDNA construct in the
§ 528.1080 Bc2371 recombinant glycoprotein galactosyltransferase alpha-
deoxyribonucleic acid construct. 1,3 gene (GGTA1) in the lineage of do-
(a) Specifications and intended use. A mestic pigs (Sus scrofa domesticus)
single copy of Bc2371, a human Factor hemizygous and homozygous for the in-
VII recombinant deoxyribonucleic acid tentional genomic alteration resulting
(rDNA) gene construct, located on in undetectable endogenous galactose
chromosome 3p1.1–2 in a diploid line alpha-1,3-galactose sugar residues on
(R69) of hemizygous and homozygous biological derivatives of domestic pigs
New Zealand white rabbits (Oryctolagus homozygous for the intentional
cuniculus). genomic alteration lineage that are in-
(b) Sponsor. See No. 086047 in § 510.600 tended to be used as sources of food or
of this chapter. human therapeutics including
(c) Conditions of use—(1) Intended use. excipients, devices, drugs, or biological
The construct directs gene expression products.
of recombinant human Factor VII (2) Limitations. Pigs of this lineage
(hFVII) in the mammary gland such (possessing the intentional genomic al-
that recombinant hFVII zymogen is teration (pPL657 rDNA construct))
present in the rabbit milk, enabling pu- should not be treated with
rification and activation of recom- aminoglycoside drugs and must only be
390
housed in physically contained facili- AUTHORITY: 21 U.S.C. 360b.

ties specified in the approved applica- SOURCE: 40 FR 13881, Mar. 27, 1975, unless
tion. otherwise noted.
[86 FR 17064, Apr. 1, 2021]
§ 529.40 Albuterol.
§ 528.2010 Human lysosomal acid (a) Specifications. A net weight of 6.7
lipase recombinant
deoxyribonucleic acid construct. grams of formulated albuterol sulfate
is supplied in a pressurized aluminum
(a) Specifications. A single copy of a canister within an actuator system
human lysosomal acid lipase (hLAL) equipped with a detachable nasal deliv-
recombinant deoxyribonucleic acid
ery bulb.
(rDNA) gene construct located at the
SYN LAL–C site in chromosome 6 in a (b) Approvals. See No. 000010 in
specific, diploid line (SBC LAL–C) of § 510.600(c) of this chapter for uses as in
hemizygous and homozygous domestic paragraph (d) of this section.
chickens (Gallus gallus), derived from (c) Conditions of use—(1) Amount.
the lineage progenitor XLL 109. Each valve actuation (puff) of the de-
(b) Sponsor. See No. 069334 in § 510.600 vice delivers 120 micrograms (mcg) of
of this chapter. albuterol sulfate. One dose is three (3)
(c) Conditions of use—(1) Intended use. puffs, totaling 360 mcg.
The gene construct directs the expres- (2) Indications for use. For the imme-
sion of that encoding gene such that diate relief of bronchospasm and
recombinant, human lysosomal acid bronchoconstriction associated with
lipase (rhLAL) protein intended for the reversible airway obstruction in
treatment of human disease is present horses.
in SBC LAL–C chicken egg whites. (3) Not for use in horses intended for
(2) Limitations. Food or feed from food. Federal law restricts this drug to
XLL 109 chickens is not permitted in
the food or feed supply.
erinarian.
[81 FR 17608, Mar. 30, 2016]
FR 10973, Feb. 27 , 2014]
PART 529—CERTAIN OTHER DOS-
AGE FORM NEW ANIMAL § 529.56 Amikacin.
DRUGS (a) Specifications. Each milliliter
Sec.
529.40 Albuterol. grams of amikacin as amikacin sulfate.
529.56 Amikacin. (b) Sponsors. See Nos. 054771 and
529.382 Chloramine-T. 058198 in § 510.600(c) of this chapter.
529.400 Chlorhexidine tablets and suspen- (c) Conditions of use in horses—(1)
sion. Amount. Administer 2 grams (8 mL) di-
529.443 Ciclesonide.
529.536 Detomidine. luted with 200 mL of sterile physio-
529.539 Dexmedetomidine. logical saline by intrauterine infusion
529.778 Doxycycline. daily for 3 consecutive days.
529.1004 Formalin. (2) Indications for use. For treating
529.1044 Gentamicin in certain other dosage genital tract infections (endometritis,
forms.
529.1044a Gentamicin solution for infusion. metritis, and pyometra) in mares
529.1044b Gentamicin solution for dipping caused by susceptible organisms in-
eggs. cluding Escherichia coli, Pseudomonas
529.1115 Halothane. spp., and Klebsiella spp.
529.1150 Hydrogen peroxide. (3) Limitations. Do not use in horses
529.1186 Isoflurane.
529.1350 Meloxicam. intended for human consumption. Fed-
529.1660 Oxytetracycline. eral law restricts this drug to use by or
529.1940 Progesterone intravaginal inserts. on the order of a licensed veterinarian.
529.2110 Sevoflurane.
529.2464 Ticarcillin. [76 FR 17339, Mar. 29, 2011, as amended at 78
529.2503 Tricaine methanesulfonate. FR 17597, Mar. 22, 2013; 79 FR 10973, Feb. 27,
529.2620 Triptorelin. 2014; 86 FR 14821, Mar. 19, 2021]
391
§ 529.382 21 CFR Ch. I (4–1–23 Edition)
§ 529.382 Chloramine-T. in cows and mares when caused by

pathogens sensitive to chlorhexidine
(a) Specifications. Chloramine-T tri-
dihydrochloride.
hydrate powder for solution.
(3) Limitations. Prior to administra-
tion, remove any unattached placental
membranes, any excess uterine fluid or
(c) Related tolerances. See § 556.118 of debris, and carefully clean external
this chapter. genitalia. Use a clean, sterile insemi-
(d) Conditions of use—(1) Freshwater- nating pipette for administrating solu-
reared salmonids—(i) Amount. 12 to 20 tions and suspensions. Treatment may
milligrams per liter (mg/L) water in a be repeated in 48 to 72 hours.
continuous flow water supply or as a
static bath once per day for 60 minutes [43 FR 10705, Feb. 23, 1979, as amended at 79
on consecutive or alternative days for FR 10973, Feb. 27, 2014; 81 FR 67152, Sept. 30,
2016; 84 FR 32993, July 11, 2019]
three treatments.
(ii) Indications for use. For the control EDITORIAL NOTE: At 79 FR 10973, Feb. 27,
of mortality in freshwater-reared 2014, § 529.400 was amended by revising the
salmonids due to bacterial gill disease section heading, however, the section head-
ing was not provided, therefore, the amend-
associated with Flavobacterium spp. ment could not be incorporated because of an
(2) Walleye—(i) Amount. 10 to 20 mg/L inaccurate amendatory instruction.
water in a continuous flow water sup-
ply or as a static bath once per day for § 529.443 Ciclesonide.
60 minutes on consecutive or alter- (a) Specifications. A non-pressurized
native days for three treatments. metered dose inhaler and drug car-
(ii) Indications for use. For the control tridge combination containing a solu-
of mortality in walleye due to external tion of 30 milligrams/milliliter of the
columnaris disease associated with prodrug ciclesonide. Each actuation re-
Flavobacterium columnare. leases 343 micrograms (mcg) of
(3) Freshwater-reared warmwater ciclesonide.
finfish—(i) Amount. 20 mg/L water in a (b) Sponsor. See No. 000010 in
continuous flow water supply or as a § 510.600(c) of this chapter.
static bath once per day for 60 minutes (c) Conditions of use—(1) Amount. Ad-
on consecutive or alternative days for minister an initial dose of 8 actuations
three treatments. (2,744 mcg ciclesonide) twice daily for 5
(ii) Indications for use. For the control days, followed by 12 actuations (4,116
of mortality in freshwater-reared mcg ciclesonide) once daily for 5 days.
warmwater finfish due to external (2) Indications for use. For the man-
columnaris disease associated with F. agement of clinical signs associated
columnare. with severe equine asthma.
[79 FR 37621, July 2, 2014]
§ 529.400 Chlorhexidine tablets and eral law restricts this drug to use by or
suspension. on the order of a licensed veterinarian.
(a) Specification. Each tablet and each [86 FR 13188, Mar. 8, 2021]
28-milliliter syringe of suspension con-
tain 1 gram of chlorhexidine § 529.536 Detomidine.
dihydrochloride. (a) Specifications. Each milliliter of
(b) Sponsor. See No. 054771 in gel contains 7.6 milligrams (mg) of
§ 510.600(c) of this chapter. detomidine hydrochloride.
(c) Related tolerances. See § 556.120 of (b) Sponsor. See No. 052483 in
(d) Conditions of use—(1) Amount. (c) Conditions of use in horses—(1)
Place 1 or 2 tablets deep in each uter- Amount. Administer 0.018 mg per pound
ine horn; or infuse a solution of 1 tab- (mg/lb) (0.040 mg/kilogram (kg) sublin-
let disolved in an appropriate amount gually.
of clean boiled water; or infuse one sy- (2) Indications for use. For sedation
ringe of suspension into the uterus. and restraint.
(2) Indications for use. For prevention (3) Limitations. Federal law restricts
or treatment of metritis and vaginitis this drug to use by or on the order of a
392
licensed veterinarian. Do not use in (c) [Reserved]

horses intended for human consump- (d) Conditions of use. It is added to en-
tion. vironmental water as follows:
[75 FR 21163, Apr. 23, 2010, as amended at 76 (1) Indications for use—(i) Penaeid
FR 16533, Mar. 24, 2011] shrimp. For control of external proto-
zoan parasites Bodo spp., Epistylis spp.,
§ 529.539 Dexmedetomidine. and Zoothamnium spp.
(a) Specifications. Each milliliter of (ii) All finfish. For control of external
gel contains 0.09 milligrams (mg) protozoa Ichthyophthirius spp.,
dexmedetomidine (equivalent to 0.1 mg Chilodonella spp., Ichthyobodo spp.,
dexmedetomidine hydrochloride). Ambiphrya spp., Epistylis spp., and
(b) Sponsor. See No. 052483 in Trichodina spp., and the monogeneans
§ 510.600(c) of this chapter. Cleidodiscus spp., Gyrodactylus spp., and
(c) Conditions of use—(1) Amount. Ad- Dactylogyrus spp.
minister onto the oral mucosa between (iii) All finfish eggs: For control of
the dog’s cheek and gum at a dose of fungi of the family Saprolegniaceae.
125 micrograms per square meter. (iv) Freshwater-reared finfish. For the
(2) Indications for use. For the treat- control of mortality due to
ment of noise aversion in dogs. saprolegniasis associated with fungi in
(3) Limitations. Federal law restricts the family Saprolegniaceae.
this drug to use by or on the order of a (2) Amount. The drug concentrations
licensed veterinarian. required are as follows:
(i) For control of external protozoan
[81 FR 17608, Mar. 30, 2016]
parasites on shrimp:
§ 529.778 Doxycycline. Concentration of formalin (microliters
per liter)
(a) Specifications. Doxycycline
Shrimp
hyclate solution contains 8.5 percent Tanks and race- Earthen ponds
ways (up to 4
doxycycline activity. A syringe of N- hours daily) (single treatment)
methyl-2-pyrrolidone and poly (DL-
lactide) mixed with a syringe of Penaeid Shrimp ... 50 to 100 1 ............ 25 2
doxycycline produces 0.5 milliliter of 1 Treat for up to 4 hours daily. Treatment may be repeated
solution. daily until parasite control is achieved. Use the lower con-
centration when tanks or raceways are heavily loaded with
(b) Sponsor. See 054771 in § 510.600(c) of phytoplankton or shrimp, to avoid oxygen depletion due to the
this chapter. biological oxygen demand created by decay of dead
phytoplankton. Alternatively, a higher concentration might be
(c) Conditions of use in dogs—(1) used if dissolved oxygen is strictly monitored.
2 Single treatment. Treatment may be repeated in 5 to 10
Amount. Apply subgingivally to peri-
days if needed.
odontal pocket(s) of affected teeth.
(2) Indications for use. For treatment (ii) For control of external parasites
and control of periodontal disease. on finfish:
Administer in tanks
this drug to use by or on the order of a and raceways for Administer in
licensed veterinarian. Aquatic species up to 1 hour earthen ponds sin-
(microliter/liter or gle treatment (μL/L
[79 FR 10973, Feb. 27, 2014] part per million or ppm)
(μL/L or ppm))
§ 529.1004 Formalin. Salmon and trout:
Above 50 °F Up to 170 15 to 25 1 2
(a) Specifications. Formalin is an Below 50 °F Up to 250 15 to 25 1 2
aqueous solution containing approxi- All other finfish Up to 250 15 to 25 1 2
mately 37 percent by weight of form- 1 Use the lower concentration when ponds, tanks, or race-
aldehyde gas, U.S.P. ways are heavily loaded with phytoplankton or fish to avoid
(b) Sponsors. See sponsors in oxygen depletion due to the biological oxygen demand by
decay of dead phytoplankton. Alternatively, a higher con-
§ 510.600(c) of this chapter for uses as in centration may be used if dissolved oxygen is strictly mon-
paragraph (d) of this section. itored.
2 Although the indicated concentrations are considered safe
(1) No. 050378 for use as in paragraph for cold and warm water finfish, a small number of each lot or
(d) of this section. pond to be treated should always be used to check for any
unusual sensitivity to formalin before proceeding.
(2) Nos. 049968 and 067188 for use as in
paragraphs (d)(1)(i), (ii), and (iii), (iii) For control of fungi of the fam-
(d)(2)(i), (ii), and (iii), and (d)(3) of this ily Saprolegniaceae on finfish eggs:
section. Eggs of all finfish except
393
§ 529.1044 21 CFR Ch. I (4–1–23 Edition)
Acipenseriformes, 1,000 to 2,000 μL/L (c) Conditions of use in horses—(1)

(ppm) for 15 minutes; eggs of Amount. Infuse 2 to 2.5 grams per day
Acipenseriformes, up to 1,500 μL/L for 3 to 5 days during estrus.
(ppm) for 15 minutes. A preliminary (2) Indications for use. For control of
bioassay should be conducted on a bacterial infections of the uterus (me-
small subsample of fish eggs to deter- tritis) and as an aid in improving con-
mine sensitivity before treating an en- ception in mares with uterine infec-
tire group. This is necessary for all spe- tions caused by bacteria sensitive to
cies because egg sensitivity can vary gentamicin.
with species or strain and the unique
conditions at each facility.
(iv) For the control of mortality in intended for human consumption. Fed-
freshwater-reared finfish due to eral law restricts this drug to use by or
saprolegniasis associated with fungi in on the order of a licensed veterinarian.
the family Saprolegniaceae: In tanks [71 FR 51727, Aug. 31, 2006, as amended at 78
and raceways, administer 150 μL/L FR 17597, Mar. 22, 2013; 78 FR 21060, Apr. 9,
(ppm) for 60 minutes per day on alter- 2013; 79 FR 10973, Feb. 27, 2014; 83 FR 48947,
nate days for three treatments. Sept. 28, 2018; 84 FR 8974, Mar. 13, 2019; 86 FR
(3) Limitations. Fish tanks and race- 14821, Mar. 19, 2021]
ways may be treated daily until para-
site control is achieved. Pond treat- § 529.1044b Gentamicin solution for
ment may be repeated in 5 to 10 days if dipping eggs.
needed. However, pond treatments for (a) Specifications. Each milliliter of
Ichthyophthirius spp. should be made at solution contains gentamicin sulfate
2-day intervals until control is equivalent to 50 milligrams of
achieved. Egg tanks may be treated as gentamicin base.
often as necessary to prevent growth of (b) Sponsors. See Nos. 000061 and
fungi. Do not use formalin which has 054925 in § 510.600(c) of this chapter.
been subjected to temperatures below (c) Conditions of use in turkeys—(1)
40 °F, or allowed to freeze. Treatments
Amount. The drug is added to clean
in tanks and raceways should never ex-
water to provide a dip solution with a
ceed 1 hour for fish or 4 hours for
gentamicin concentration of 250 to
penaeid shrimp (even if they show no
1,000 parts per million. A concentration
sign of distress), nor should it exceed 15
of 500 parts per million is rec-
minutes for fish eggs. Do not apply for-
malin to ponds with water warmer ommended. Clean eggs should be held
than 27 °C (80 °F), when a heavy bloom submerged in the gentamicin solution
of phytoplankton is present, or when under a vacuum of about 27.5 to 38 cen-
the concentration of dissolved oxygen timeters of mercury for 5 minutes fol-
is less than 5 milligrams per liter. lowed by additional soaking in
gentamicin solution for approximately
[51 FR 11441, Apr. 3, 1986, as amended at 58 10 minutes at atmospheric pressure.
FR 59169, Nov. 8, 1993; 59 FR 60076, Nov. 22,
Eggs can also be treated by warming
1994; 63 FR 38304, July 16, 1998; 68 FR 5563;
Feb. 4, 2003; 72 FR 45158, Aug. 13, 2007; 76 FR them for 3 to 6 hours at approximately
17339, Mar. 29, 2011; 79 FR 2786, Jan. 16, 2014; 100 °F then immediately submerging
82 FR 58556, Dec. 13, 2017; 84 FR 53311, Oct. 7, them in gentamicin solution main-
2019. Redesignated at 87 FR 10970, Feb. 28, tained at about 40 °F, keeping the eggs
2022] submerged for 10 to 15 minutes.
(2) Indications for use. As an aid in the
§ 529.1044 Gentamicin in certain other
dosage forms. reduction or elimination of the fol-
lowing microorganisms from turkey-
§ 529.1044a Gentamicin solution for in- hatching eggs: Arizona hinshawii
fusion. (paracolon), Salmonella Saintpaul, and
(a) Specifications. Each milliliter of Mycoplasma meleagridis.
solution contains 50 or 100 milligrams (3) Limitations. For use in the dipping
gentamicin sulfate. treatment of turkey-hatching eggs
(b) Sponsors. See Nos. 000061, 016592, only. Eggs which have been dipped in
054628, 054771, 058005, 058198, and 061133 the drug shall not be used for food. For
in § 510.600(c) of this chapter. No. 000061: Federal law restricts this
394
drug to use by or on the order of a li- including salmonids (all life stages),
censed veterinarian. freshwater-reared coolwater finfish
[40 FR 13881, Mar. 27, 1975, as amended at 52 fingerlings and adults, and freshwater-
FR 7833, Mar. 13, 1987; 62 FR 22889, Apr. 28, reared warmwater finfish fingerlings
1997; 71 FR 13543, Mar. 16, 2006; 79 FR 10973, and adults: 75 mg/L for 60 minutes in
Feb. 27, 2014; 88 FR 16549, Mar. 20, 2023] continuous flow water supply or as a
static bath once per day on alternate
§ 529.1115 Halothane.
days for three treatments.
(a) Specifications. The drug is a color- (iii) Freshwater-reared salmonids for
less, odorless, nonflammable, nonexplo- the control of mortality due to bac-
sive, heavy liquid containing 0.01 per- terial gill disease associated with
cent thymol as a preservative.
Flavobacterium branchiophilum: 100 mg/L
for 30 minutes, or 50 to 100 mg/L for 60
(c) Conditions of use—(1) Amount. Two minutes, in a continuous flow water
to 5 percent of inhaled atmosphere for supply or as a static bath once per day
induction of anesthesia; 0.5 to 2 percent on alternate days for three treatments.
for maintenance of anesthesia. (iv) Freshwater-reared salmonids for
(2) Indications for use. For nonfood the treatment and control of
animals for the induction and mainte- Gyrodactylus spp: 100 mg/L for 30 min-
nance of anesthesia. utes, or 50 to 100 mg/L for 60 minutes,
(3) Limitations. Not for use in animals in a continuous flow water supply or as
intended for food. Federal law restricts a static bath once per day on alternate
this drug to use by or on the order of a days for three treatments.
licensed veterinarian. (v) Freshwater-reared coolwater and
[46 FR 27915, May 22, 1981, as amended at 62 warmwater finfish fingerlings and
FR 29014, May 29, 1997; 79 FR 10973, Feb. 27, adults for the control of mortality due
2014; 85 FR 4208, Jan. 24, 2020] to external columnaris disease associ-
ated with Flavobacterium columnare: 50
§ 529.1150 Hydrogen peroxide.
to 75 mg/L for 60 minutes in continuous
(a) Specifications. Each milliliter of flow water supply or as a static bath
solution contains 396.1 milligrams (mg) once per day on alternate days for
hydrogen peroxide (a 35% w/w solu- three treatments.
tion).
(vi) Freshwater-reared coolwater
§ 510.600(c) of this chapter. finfish fry and warmwater finfish fry
(c) Conditions of use—(1) Indications for the control of mortality due to ex-
and amount. (i) Freshwater-reared ternal columnaris disease associated
finfish eggs for the control of mortality with Flavobacterium columnare: 50 mg/L
in due to saprolegniasis associated for 60 minutes in continuous flow water
with fungi in the family supply or as a static bath once per day
Saprolegniaceae: on alternate days for three treatments.
(A) For all coldwater and coolwater (2) Limitations. (i) Initial bioassay on
species of freshwater-reared finfish a small number is recommended before
eggs: 500 to 1,000 mg per liter (/L) of treating the entire group.
culture water for 15 minutes in a con- (ii) Eggs: Some strains of rainbow
tinuous flow system once per day on trout eggs are sensitive to hydrogen
consecutive or alternate days until peroxide treatment at a time during in-
hatch, or cubation concurrent with blastopore
(B) For all freshwater-reared formation through closure, about 70 to
warmwater finfish eggs: 750 to 1,000 mg/ 140 Daily Temperature Units, °C. Con-
L for 15 minutes in a continuous flow sider withholding treatment or using
system once per day on consecutive or
an alternate therapeutant during that
alternate days until hatch.
sensitive time to reduce egg mortali-
(ii) Freshwater-reared finfish for the
control of mortality due to ties due to drug toxicity.
saprolegniasis associated with the (iii) Finfish: Because finfish sensi-
fungi in the family Saprolegniaceae: tivity to 35% PEROX–AID® increases

For freshwater-reared coldwater finfish with increasing water temperature,
395
§ 529.1186 21 CFR Ch. I (4–1–23 Edition)
consider administering initial treat- gram of body weight once daily using
ments at the lower end of the treat- the metered dose pump.
ment regimen or reducing water tem- (2) Indications for use. For the control
perature before treatment. Do not use of pain and inflammation associated
this product to treat northern pike with osteoarthritis in dogs.
(Esox lucius) or paddlefish (Polyodon (3) Limitations. Federal law restricts
spathula) of any age. Do not use this this drug to use by or on the order of a
product to treat pallid sturgeon fry. licensed veterinarian.
Use with caution on walleye (Sander [77 FR 76863, Dec. 31, 2012, as amended at 80
vitreus) and ornamental finfish. FR 18776, Apr. 8, 2015]
(iv) Preharvest withdrawal time:
Zero days. § 529.1660 Oxytetracycline.
[72 FR 5330, Feb. 6, 2007, as amended at 78 FR (a) Specifications. (1) Each gram of
73698, Dec. 9, 2013; 85 FR 4208, Jan. 24, 2020] powder contains 366 milligrams (mg)
oxytetracycline hydrochloride.
§ 529.1186 Isoflurane. (2) Each gram of powder contains 753
(a) Specifications. The drug is a clear, mg oxytetracycline hydrochloride.
colorless, stable liquid. (b) Sponsors. See sponsors in
(b) Sponsors. See Nos. 017033, 054771, § 510.600(c) of this chapter for use of
065085, and 066794 in § 510.600(c) of this products described in paragraph (a) of
chapter. this section as in paragraph (d) of this
(c) Conditions of use. Administer by section.
inhalation: (1) Nos. 054771 and 061133 for use of
(1) Amount—(i) Horses: For induction product in paragraph (a)(1) of this sec-
of surgical anesthesia: 3 to 5 percent tion.
isoflurane (with oxygen) for 5 to 10 (2) Nos. 054771, 061133, and 069254 for
minutes. For maintenance of surgical use of product described in paragraph
anesthesia: 1.5 to 1.8 percent isoflurane (a)(2) of this section.
(with oxygen). (c) Related tolerances. See § 556.500 of
(ii) Dogs: For induction of surgical this chapter.
anesthesia: 2 to 2.5 percent isoflurane (d) Conditions of use in finfish—(1)
(with oxygen) for 5 to 10 minutes. For Amount. Immerse fish in a solution
maintenance of surgical anesthesia: 1.5 containing 200 to 700 mg oxytetra-
to 1.8 percent isoflurane (with oxygen). cycline hydrochloride (buffered) per
(2) Indications for use. For induction liter of water for 2 to 6 hours.
and maintenance of general anesthesia (2) Indications for use. For skeletal
in horses and dogs. marking of finfish fry and fingerlings.
on the order of a licensed veterinarian. [69 FR 6557, Feb. 11, 2004, as amended at 69
[51 FR 594, Jan. 7, 1986, as amended at 54 FR FR 61999, Oct. 22, 2004; 70 FR 41140, July 18,
23472, June 1, 1989; 58 FR 17346, Apr. 2, 1993; 59 2005; 72 FR 26289, May 9, 2007; 76 FR 17026,
FR 44315, Aug. 29, 1994; 60 FR 40456, Aug. 9, Mar. 28, 2011; 79 FR 10973, Feb. 27, 2014; 81 FR
1995; 63 FR 8122, Feb. 18, 1998; 63 FR 24106, 22524, Apr. 18, 2016; 81 FR 94991, Dec. 27, 2016;
May 1, 1998; 66 FR 17510, Apr. 2, 2001; 71 FR 84 FR 8974, Mar. 13, 2019]
43967, Aug. 3, 2006; 74 FR 68530, Dec. 28, 2009;
76 FR 16533, Mar. 24, 2011; 78 FR 14669, Mar. 7, § 529.1940 Progesterone intravaginal
2013; 78 FR 17868, Mar. 25, 2013; 80 FR 18776, inserts.
Apr. 8, 2015; 87 FR 58963, Sept. 29, 2022] (a) Specifications. Each insert con-
tains:
§ 529.1350 Meloxicam. (1) 1.38 grams (g) progesterone in
(a) Specifications. Each milliliter of molded silicone over a nylon spine.
solution contains 5 milligrams (mg) (2) 0.3 g progesterone in molded sili-
meloxicam. cone over a flexible nylon spine.
(b) Sponsor. See No. 054771 in (b) Sponsor. See No. 054771 in
§ 510.600(c) of this chapter. § 510.600(c) of this chapter for use of the
(c) Conditions of use in dogs—(1) product described in paragraph (a)(1) of

Amount. Administer 0.1 mg per kilo- this section as in paragraph (e)(1) of
396
this section; and the product described duced fertility. Dinoprost injection for
in paragraph (a)(2) of this section as in use as in paragraphs (e)(1)(ii)(A) and
paragraph (e)(2) of this section. (B) of this section as in § 522.690 of this
(c) Related tolerances. See § 556.540 of chapter, provided by Nos. 054771 and
this chapter. 061133 in § 510.600(c) of this chapter.
(d) Special considerations. Product la- (2) Ewes—(i) Amount. Administer one
beling shall bear the following warn- intravaginal insert per animal for 5
ing: ‘‘Avoid contact with skin by wear- days.
ing protective gloves when handling in- (ii) Indications for use. For induction
serts. Store removed inserts in a seal- of estrus in ewes (sheep) during sea-
able container until they can be dis- sonal anestrus.
posed of in accordance with applicable (iii) Limitations. Do not use in ani-
local, state, and Federal regulations.’’ mals with abnormal, immature, or in-
(e) Conditions of use—(1) Cows—(i) fected genital tracts; or in ewes that
Amount. Administer one intravaginal have never lambed. Do not use an in-
insert per animal for 7 days. When used sert more than once. To prevent the
for indications listed in paragraph potential transmission of venereal and
(e)(1)(ii)(A) of this section, administer bloodborne diseases, the inserts should
25 mg dinoprost as a single be disposed after a single use.
intramuscular injection 1 day prior to
insert removal (Day 6). When used for [74 FR 59074, Nov. 17, 2009, as amended at 75
FR 63085, Oct. 14, 2010; 79 FR 10965, 10974, Feb.
indications listed in paragraph
27, 2014; 79 FR 44278, July 31, 2014; 87 FR 10970,
(e)(1)(ii)(B) of this section, administer Feb. 28, 2022; 87 FR 17947, Mar. 29, 2022]
25 mg dinoprost as a single
intramuscular injection on the day of § 529.2110 Sevoflurane.
insert removal (Day 7).
(ii) Indications for use. (A) For syn- (a) Specifications. Sevoflurane liquid.
chronization of estrus in suckled beef (b) Sponsors. See Nos. 017033, 054771,
cows and replacement beef and dairy and 066794 in § 510.600(c) of this chapter.
heifers; for advancement of first (c) Conditions of use—(1) Amount. For
postpartum estrus in suckled beef induction of surgical anesthesia: up to
cows; and for advancement of first pu- 7 percent sevoflurane. For maintenance
bertal estrus in replacement beef heif- of surgical anesthesia: 3.7 to 4 percent
ers. sevoflurane with oxygen in the absence
(B) For synchronization of estrus in of premedication and 3.3 to 3.6 percent
lactating dairy cows. in the presence of premedication.
(C) For synchronization of the return (2) Indications for use. For induction
to estrus in lactating dairy cows in- and maintenance of general anesthesia
seminated at the immediately pre- in dogs.
ceding estrus. (3) Limitations. Federal law restricts
(D) For induction of estrous cycles in this drug to use by or on the order of a
anestrous lactating dairy cows. licensed veterinarian.
(iii) Limitations. Do not use in beef or [64 FR 71640, Dec. 22, 1999, as amended at 73
dairy heifers of insufficient size or age FR 25508, May 7, 2008; 74 FR 10484, Mar. 11,
for breeding or in animals with abnor- 2009, 75 FR 1021, Jan. 8, 2010; 76 FR 16533, Mar.
mal, immature, or infected genital 24, 2011; 78 FR 17868, Mar. 25, 2013; 80 FR 18776,
tracts. Do not use in anestrous lac- Apr. 8, 2015. Redesignated at 86 FR 13188,
tating dairy cows less than 42 days or Mar. 8, 2021, as amended at 87 FR 58963, Sept.
greater than 78 days postpartum. Do 29, 2022]
not use in lactating dairy cows less
§ 529.2464 Ticarcillin.
than 40 days postpartum. Do not use in
beef cows that are less than 20 days (a) Specifications. Each vial contains
postpartum. Do not use an insert more ticarcillin disodium powder equivalent
than once. To prevent the potential to 6 grams of ticarcillin for reconstitu-
transmission of venereal and tion with 25 milliliters of sterile water
bloodborne diseases, the inserts should for injection or sterile physiological
be disposed after a single use. Adminis- saline.
tration of vaginal inserts for periods (b) Sponsor. See No. 054771 in
greater than 7 days may result in re- § 510.600(c) of this chapter.
397
§ 529.2503 21 CFR Ch. I (4–1–23 Edition)
(c) Conditions of use in horses—(1) § 529.2620 Triptorelin.

Amount. Administer 6 grams daily by
intrauterine infusion for 3 consecutive
gel contains 100 micrograms (mcg)
days during estrus.
triptorelin as triptorelin acetate.
ment of endometritis caused by beta-
hemolytic streptococci.
(c) Conditions of use in swine—(1)
Amount. Administer 200 mcg
intravaginally approximately 96 hours
after weaning.
(2) Indications for use. For the syn-
[79 FR 10974, Feb. 27, 2014] chronization of time of insemination in
weaned sows to facilitate a single
§ 529.2503 Tricaine methanesulfonate. fixed-time artificial insemination.
(a) Specifications. The drug is ethyl-m- (3) Limitations. Not approved for use
amino-benzoate methanesulfonate. in gilts. Safety and effectiveness have
(b) Sponsor. See Nos. 050378 and 051212 not been evaluated in these animals.
in § 510.600(c) of this chapter. Should not be used in sows with obvi-
(c) Conditions of use—(1) Amount. It is ous reproductive tract abnormalities.
used as follows: [77 FR 64717, Oct. 23, 2012]
(i) Fish. The drug is added to ambient
water at a concentration of from 15 to
330 milligrams per liter depending upon PART 530—EXTRALABEL DRUG USE
the degree of anesthetization or seda- IN ANIMALS
tion desired, the species and size of the
fish, and the temperature and softness Subpart A—General Provisions
of the water. Preliminary tests of solu- Sec.
tions must be made with small num- 530.1 Scope.
bers of fish to determine the desired 530.2 Purpose.
rates of sedation or anesthesia and the 530.3 Definitions.
appropriate exposure times for the spe- 530.4 Advertising and promotion.
cific lots of fish under prevailing condi- 530.5 Veterinary records.
tions.
(ii) Amphibians and other aquatic cold- Subpart B—Rules and Provisions for
blooded animals. The drug is added to Extralabel Uses of Drugs in Animals
ambient water in concentrations of
530.10 Provision permitting extralabel use
from 1:1000 to 1:20,000 depending upon of animal drugs.
species and stage of development. 530.11 Limitations.
(2) Indications for use. For the tem- 530.12 Labeling.
porary immobilization of fish, amphib- 530.13 Extralabel use from compounding of
ians, and other aquatic coldblooded approved new animal and approved
animals (poikilotherms) as an aid in human drugs.
handling during manual spawning (fish
stripping), weighing, measuring, mark- Subpart C—Specific Provisions Relating to
ing, surgical operations, transport, Extralabel Use of Animal and Human
photography, and research. Drugs in Food-Producing Animals
(3) Limitations. Do not use within 21 530.20 Conditions for permitted extralabel
days of harvesting fish for food. Use in animal and human drug use in food-pro-
fish intended for food should be reducing animals.
stricted to Ictaluridae, Salmonidae, 530.21 Prohibitions for food-producing ani-
Esocidae, and Percidae, and water tem- mals.
perature exceeding 10 °C (50 °F). In 530.22 Safe levels and analytical methods
other fish and in coldblooded animals, for food-producing animals.
the drug should be limited to hatchery 530.23 Procedure for setting and announcing
or laboratory use. safe levels.
530.24 Procedure for announcing analytical

[79 FR 10974, Feb. 27, 2014] methods for drug residue quantification.
398
530.25 Orders prohibiting extralabel uses for dosage levels, frequencies, or routes of
drugs in food-producing animals. administration other than those stated
in the labeling, and deviation from the
Subpart D—Extralabel Use of Human and labeled withdrawal time based on these
Animal Drugs in Animals Not Intended different uses.
for Human Consumption (b) FDA means the U.S. Food and
530.30 Extralabel drug use in nonfood ani- Drug Administration.
mals. (c) The phrase a reasonable probability
that a drug’s use may present a risk to the
Subpart E—Safe Levels for Extralabel Use of public health means that FDA has rea-
Drugs in Animals and Drugs Prohibited son to believe that use of a drug may
From Extralabel Use in Animals be likely to cause a potential adverse
530.40 Safe levels and availability of analyt- event.
ical methods. (d) The phrase use of a drug may
530.41 Drugs prohibited for extralabel use in present a risk to the public health means
animals. that FDA has information that indi-
AUTHORITY: 15 U.S.C. 1453, 1454, 1455; 21
cates that use of a drug may cause an
U.S.C. 321, 331, 351, 352, 353, 355, 357, 360b, 371, adverse event.
379e. (e) The phrase use of a drug presents a
risk to the public health means that FDA
SOURCE: 61 FR 57743, Nov. 7, 1996, unless
otherwise noted.
has evidence that demonstrates that
the use of a drug has caused or likely
will cause an adverse event.
Subpart A—General Provisions (f) A residue means any compound
§ 530.1 Scope. present in edible tissues that results
from the use of a drug, and includes the
This part applies to the extralabel drug, its metabolites, and any other
use in an animal of any approved new substance formed in or on food because
animal drug or approved new human of the drug’s use.
drug by or on the lawful order of a li- (g) A safe level is a conservative esti-
censed veterinarian within the context mate of a drug residue level in edible
of a valid veterinary-client-patient re- animal tissue derived from food safety
lationship. data or other scientific information.
Concentrations of residues in tissue
§ 530.2 Purpose. below the safe level will not raise
The purpose of this part is to estab- human food safety concerns. A safe
lish conditions for extralabel use or in- level is not a safe concentration or a
tended extralabel use in animals by or tolerance and does not indicate that an
on the lawful order of licensed veteri- approval exists for the drug in that
narians of Food and Drug Administra- species or category of animal from
tion approved new animal drugs and which the food is derived.
approved new human drugs. Such use is (h) Veterinarian means a person li-
limited to treatment modalities when censed by a State or Territory to prac-
the health of an animal is threatened tice veterinary medicine.
or suffering or death may result from (i) A valid veterinarian-client-patient
failure to treat. This section imple- relationship is one in which:
ments the Animal Medicinal Drug Use (1) A veterinarian has assumed the
Clarification Act of 1994 (the AMDUCA) responsibility for making medical
(Pub. L. 103–396). judgments regarding the health of (an)
animal(s) and the need for medical
§ 530.3 Definitions. treatment, and the client (the owner of
(a) Extralabel use means actual use or the animal or animals or other care-
intended use of a drug in an animal in taker) has agreed to follow the instruc-
a manner that is not in accordance tions of the veterinarian;
with the approved labeling. This in- (2) There is sufficient knowledge of
cludes, but is not limited to, use in spe- the animal(s) by the veterinarian to
cies not listed in the labeling, use for initiate at least a general or prelimi-
indications (disease or other condi- nary diagnosis of the medical condition

tions) not listed in the labeling, use at of the animal(s); and
399
§ 530.4 21 CFR Ch. I (4–1–23 Edition)
(3) The practicing veterinarian is wise required by Federal or State law,

readily available for followup in case of whichever is greater.
adverse reactions or failure of the regi- (c) Any person who is in charge, con-
men of therapy. Such a relationship trol, or custody of such records shall,
can exist only when the veterinarian upon request of a person designated by
has recently seen and is personally ac- FDA, permit such person designated by
quainted with the keeping and care of FDA to, at all reasonable times, have
the animal(s) by virtue of examination access to, permit copying, and verify
of the animal(s), and/or by medically such records.
appropriate and timely visits to the
premises where the animal(s) are kept. Subpart B—Rules and Provisions
§ 530.4 Advertising and promotion. for Extralabel Uses of Drugs in
Animals
Nothing in this part shall be con-
strued as permitting the advertising or § 530.10 Provision permitting
promotion of extralabel uses in ani- extralabel use of animal drugs.
mals of approved new animal drugs or An approved new animal drug or
approved human drugs. human drug intended to be used for an
extralabel purpose in an animal is not
§ 530.5 Veterinary records.
unsafe under section 512 of the act and
(a) As a condition of extralabel use is exempt from the labeling require-
permitted under this part, to permit ments of section 502(f) of the act if such
FDA to ascertain any extralabel use or use is:
intended extralabel use of drugs that (a) By or on the lawful written or
the agency has determined may oral order of a licensed veterinarian
present a risk to the public health, vet- within the context of a valid veteri-
erinarians shall maintain the following narian-client-patient relationship; and
records of extralabel uses. Such records (b) In compliance with this part.
shall be legible, documented in an ac-
curate and timely manner, and be read- § 530.11 Limitations.
ily accessible to permit prompt re- In addition to uses which do not com-
trieval of information. Such records ply with the provision set forth in
shall be adequate to substantiate the § 530.10, the following specific
identification of the animals and shall extralabel uses are not permitted and
be maintained either as individual result in the drug being deemed unsafe
records or, in food animal practices, on within the meaning of section 512 of
a group, herd, flock, or per-client basis. the act:
Records shall be adequate to provide (a) Extralabel use in an animal of an
the following information: approved new animal drug or human
(1) The established name of the drug drug by a lay person (except when
and its active ingredient, or if formu- under the supervision of a licensed vet-
lated from more than one ingredient, erinarian);
the established name of each ingre- (b) Extralabel use of an approved new
dient; animal drug or human drug in or on an
(2) The condition treated; animal feed;
(3) The species of the treated ani- (c) Extralabel use resulting in any
mal(s); residue which may present a risk to
(4) The dosage administered; the public health; and
(5) The duration of treatment; (d) Extralabel use resulting in any
(6) The numbers of animals treated; residue above an established safe level,
and safe concentration or tolerance.
(7) The specified withdrawal, with-
holding, or discard time(s), if applica- § 530.12 Labeling.
ble, for meat, milk, eggs, or any food Any human or animal drug pre-
which might be derived from any food scribed and dispensed for extralabel use
animals treated. by a veterinarian or dispensed by a
(b) A veterinarian shall keep all re- pharmacist on the order of a veteri-
quired records for 2 years or as other- narian shall bear or be accompanied by
400
labeling information adequate to as- (3) The compounding is performed by

sure the safe and proper use of the a licensed pharmacist or veterinarian
product. Such information shall in- within the scope of a professional prac-
clude the following: tice;
(a) The name and address of the pre- (4) Adequate procedures and proc-
scribing veterinarian. If the drug is dis- esses are followed that ensure the safe-
pensed by a pharmacy on the order of a ty and effectiveness of the compounded
veterinarian, the labeling shall include product;
the name of the prescribing veteri- (5) The scale of the compounding op-
narian and the name and address of the eration is commensurate with the es-
dispensing pharmacy, and may include tablished need for compounded prod-
the address of the prescribing veteri- ucts (e.g., similar to that of com-
narian; parable practices); and
(b) The established name of the drug (6) All relevant State laws relating to
or, if formulated from more than one the compounding of drugs for use in
active ingredient, the established name animals are followed.
of each ingredient;
(c) Guidance on the subject of
(c) Any directions for use specified by
compounding may be found in guidance
the veterinarian, including the class/
documents issued by FDA.
species or identification of the animal
or herd, flock, pen, lot, or other group
of animals being treated, in which the Subpart C—Specific Provisions Re-
drug is intended to be used; the dosage, lating to Extralabel Use of Ani-
frequency, and route of administration; mal and Human Drugs in
and the duration of therapy; Food-Producing Animals
(d) Any cautionary statements; and
(e) The veterinarian’s specified with- § 530.20 Conditions for permitted
drawal, withholding, or discard time extralabel animal and human drug
for meat, milk, eggs, or any other food use in food-producing animals.
which might be derived from the treat- (a) The following conditions must be
ed animal or animals. met for a permitted extralabel use in
food-producing animals of approved
§ 530.13 Extralabel use from
compounding of approved new ani- new animal and human drugs:
mal and approved human drugs. (1) There is no approved new animal
drug that is labeled for such use and
(a) This part applies to compounding
that contains the same active ingre-
of a product from approved animal or
dient which is in the required dosage
human drugs by a veterinarian or a
form and concentration, except where a
pharmacist on the order of a veteri-
veterinarian finds, within the context
narian within the practice of veteri-
of a valid veterinarian-client-patient
nary medicine. Nothing in this part
relationship, that the approved new
shall be construed as permitting
animal drug is clinically ineffective for
compounding from bulk drugs.
its intended use.
(b) Extralabel use from compounding
of approved new animal or human (2) Prior to prescribing or dispensing
drugs is permitted if: an approved new animal or human drug
(1) All relevant portions of this part for an extralabel use in food animals,
have been complied with; the veterinarian must:
(2) There is no approved new animal (i) Make a careful diagnosis and eval-
or approved new human drug that, uation of the conditions for which the
when used as labeled or in conformity drug is to be used;
with criteria established in this part, (ii) Establish a substantially ex-
will, in the available dosage form and tended withdrawal period prior to mar-
concentration, appropriately treat the keting of milk, meat, eggs, or other ed-
condition diagnosed. Compounding ible products supported by appropriate
from a human drug for use in food-pro- scientific information, if applicable;
ducing animals will not be permitted if (iii) Institute procedures to assure
an approved animal drug can be used that the identity of the treated animal
for the compounding; or animals is carefully maintained; and
401
§ 530.21 21 CFR Ch. I (4–1–23 Edition)
(iv) Take appropriate measures to as- extralabel use may present a risk to
sure that assigned timeframes for with- the public health. FDA may:
drawal are met and no illegal drug resi- (1) Establish a finite safe level based
dues occur in any food-producing ani- on residue and metabolism information
mal subjected to extralabel treatment. from available sources;
(b) The following additional condi- (2) Establish a safe level based on the
tions must be met for a permitted lowest level that can be measured by a
extralabel use of in food-producing ani- practical analytical method; or
mals an approved human drug, or of an (3) Establish a safe level based on
animal drug approved only for use in other appropriate scientific, technical,
animals not intended for human con- or regulatory criteria.
sumption: (b) FDA may require the develop-
(1) Such use must be accomplished in ment of an acceptable analytical meth-
accordance with an appropriate med- od for the quantification of residues
ical rationale; and above any safe level established under
(2) If scientific information on the this part. If FDA requires the develop-
human food safety aspect of the use of ment of such an acceptable analytical
the drug in food-producing animals is method, the agency will publish notice
not available, the veterinarian must of that requirement in the FEDERAL
take appropriate measures to assure REGISTER.
that the animal and its food products (c) The extralabel use of an animal
will not enter the human food supply. drug or human drug that results in res-
(c) Extralabel use of an approved idues exceeding a safe level established
human drug in a food-producing animal under this part is an unsafe use of such
is not permitted under this part if an drug.
animal drug approved for use in food- (d) If the agency establishes a safe
producing animals can be used in an level for a particular species or cat-
extralabel manner for the particular egory of animals and a tolerance or
use. safe concentration is later established
through an approval for that particular
§ 530.21 Prohibitions for food-pro- species or category of animals, for that
ducing animals. species or category of animals, the safe
(a) FDA may prohibit the extralabel level is superseded by the tolerance or
use of an approved new animal or safe concentration for that species or
human drug or class of drugs in food- category of animals.
producing animals if FDA determines
that: § 530.23 Procedure for setting and an-
(1) An acceptable analytical method nouncing safe levels.
needs to be established and such meth- (a) FDA may issue an order estab-
od has not been established or cannot lishing a safe level for a residue of an
be established; or extralabel use of an approved human
(2) The extralabel use of the drug or drug or an approved animal drug. The
class of drugs presents a risk to the agency will publish in the FEDERAL
public health. REGISTER a notice of the order. The no-
(b) A prohibition may be a general tice will include:
ban on the extralabel use of the drug or (1) A statement setting forth the
class of drugs or may be limited to a agency’s finding that there is a reason-
specific species, indication, dosage able probability that extralabel use in
form, route of administration, or com- animals of the human drug or animal
bination of factors. drug may present a risk to the public
health;
§ 530.22 Safe levels and analytical (2) A statement of the basis for that
methods for food-producing ani- finding; and
mals. (3) A request for public comments.
(a) FDA may establish a safe level for (b) A current listing of those drugs
extralabel use of an approved human for which a safe level for extralabel
drug or an approved new animal drug drug use in food-producing animals has
when the agency finds that there is a been established, the specific safe lev-
reasonable probability that an els, and the availability, if any, of a
402
specific analytical method or methods ticular human drug or animal drug pre-
for drug residue detection will be codi- sents a risk to the public health, FDA
fied in § 530.40. will publish in the FEDERAL REGISTER,
with a 90-day delayed effective date, an
§ 530.24 Procedure for announcing an- order of prohibition for an extralabel
alytical methods for drug residue use of a drug in food-producing ani-
quantification. mals. Such order shall state that an ac-
(a) FDA may issue an order announc- ceptable analytical method required
ing a specific analytical method or under § 530.22 has not been developed,
methods for the quantification of submitted, and found to be acceptable
extralabel use drug residues above the by FDA; that such method cannot be
safe levels established under § 530.22 for established; or that the extralabel use
extralabel use of an approved human in animals presents a risk to the public
drug or an approved animal drug. The health; and shall:
agency will publish in the FEDERAL (1) Specify the nature and extent of
REGISTER a notice of the order, includ- the order of prohibition and the rea-
ing the name of the specific analytical sons for the prohibition;
method or methods and the drug or (2) Request public comments; and
drugs for which the method is applica- (3) Provide a period of not less than
ble. 60 days for comments.
(b) Copies of analytical methods for (c) The order of prohibition will be-
the quantification of extralabel use come effective 90 days after date of
drug residues above the safe levels es- publication of the order unless FDA
tablished under § 530.22 will be available publishes a notice in the FEDERAL REG-
upon request from the Communications ISTER prior to that date, that revokes
and Education Branch (HFV–12), Divi- the order of prohibition, modifies it, or
sion of Program Communication and extends the period of public comment.
Administrative Management, Center (d) The agency may publish an order
for Veterinary Medicine, 7500 Standish of prohibition with a shorter comment
Pl., Rockville, MD 20855. When an ana- period and/or delayed effective date
lytical method for the detection of than specified in paragraph (b) of this
extralabel use drug residues above the section in exceptional circumstances
safe levels established under § 530.22 is (e.g., where there is immediate risk to
developed, and that method is accept- the public health), provided that the
able to the agency, FDA will incor- order of prohibition states that the
porate that method by reference. comment period and/or effective date
have been abbreviated because there
§ 530.25 Orders prohibiting extralabel are exceptional circumstances, and the
uses for drugs in food-producing order of prohibition sets forth the
animals. agency’s rationale for taking such ac-
(a) FDA may issue an order prohib- tion.
iting extralabel use of an approved new (e) If FDA publishes a notice in the
animal or human drug in food-pro- FEDERAL REGISTER modifying an order
ducing animals if the agency finds, of prohibition, the agency will specify
after providing an opportunity for pub- in the modified order of prohibition the
lic comment, that: nature and extent of the modified pro-
(1) An acceptable analytical method hibition, the reasons for it, and the
required under § 530.22 has not been de- agency’s response to any comments on
veloped, submitted, and found to be ac- the original order of prohibition.
ceptable by FDA or that such method (f) A current listing of drugs prohib-
cannot be established; or ited for extralabel use in animals will
(2) The extralabel use in animals pre- be codified in § 530.41.
sents a risk to the public health. (g) After the submission of appro-
(b) After making a determination priate information (i.e., adequate data,
that the analytical method required an acceptable method, approval of a
under § 530.22 has not been developed new animal drug application for the
and submitted, or that such method prohibited extralabel use, or informa-
cannot be established, or that an tion demonstrating that the prohibi-

extralabel use in animals of a par- tion was based on incorrect data), FDA
403
§ 530.30 21 CFR Ch. I (4–1–23 Edition)
may, by publication of an appropriate for extralabel animal and human drug

notice in the FEDERAL REGISTER, re- uses in food-producing animals.
move a drug from the list of human (1) Chloramphenicol;
and animal drugs prohibited for (2) Clenbuterol;
extralabel use in animals, or may mod- (3) Diethylstilbestrol (DES);
ify a prohibition. (4) Dimetridazole;
(h) FDA may prohibit extralabel use (5) Ipronidazole;
of a drug in food-producing animals
(6) Other nitroimidazoles;
without establishing a safe level.
(7) Furazolidone.
(8) Nitrofurazone.
Subpart D—Extralabel Use of (9) Sulfonamide drugs in lactating
Human and Animal Drugs in dairy cattle (except approved use of
Animals Not Intended for sulfadimethoxine,
Human Consumption sulfabromomethazine, and
sulfaethoxypyridazine);
§ 530.30 Extralabel drug use in
nonfood animals. (10) Fluoroquinolones; and
(11) Glycopeptides.
(a) Because extralabel use of animal (12) Phenylbutazone in female dairy
and human drugs in nonfood-producing
cattle 20 months of age or older.
animals does not ordinarily pose a
(13) Cephalosporins (not including
threat to the public health, extralabel
use of animal and human drugs is per- cephapirin) in cattle, swine, chickens,
mitted in nonfood-producing animal or turkeys:
practice except when the public health (i) For disease prevention purposes;
is threatened. In addition, the provi- (ii) At unapproved doses, frequencies,
sions of § 530.20(a)(1) will apply to the durations, or routes of administration;
use of an approved animal drug. or
(b) If FDA determines that an (iii) If the drug is not approved for
extralabel drug use in animals not in- that species and production class.
tended for human consumption pre- (b) The following drugs, families of
sents a risk to the public health, the drugs, and substances are prohibited
agency may publish in the FEDERAL for extralabel animal and human drug
REGISTER a notice prohibiting such use uses in nonfood-producing animals:
following the procedures in § 530.25. The [Reserved]
prohibited extralabel drug use will be (c) [Reserved]
codified in § 530.41. (d) The following drugs, or classes of
drugs, that are approved for treating or
Subpart E—Safe Levels for preventing influenza A, are prohibited
Extralabel Use of Drugs in Ani- from extralabel use in chickens, tur-
mals and Drugs Prohibited keys, and ducks:
From Extralabel Use in Ani- (1) Adamantanes.
mals (2) Neuraminidase inhibitors.
§ 530.40 Safe levels and availability of [62 FR 27947, May 22, 1997, as amended at 67
analytical methods. FR 5471, Feb. 6, 2002; 68 FR 9530, Feb. 28, 2003;
68 FR 14134, Mar. 24, 2003; 71 FR 14377, Mar.
(a) In accordance with § 530.22, the 22, 2006; 77 FR 745, Jan. 6, 2012]
following safe levels for extralabel use
of an approved animal drug or human
drug have been established: [Reserved]
PART 556—TOLERANCES FOR RESI-
(b) In accordance with § 530.22, the DUES OF NEW ANIMAL DRUGS IN
following analytical methods have FOOD
been accepted by FDA: [Reserved]
§ 530.41 Drugs prohibited for
extralabel use in animals. Sec.
556.1 Scope.
(a) The following drugs, families of 556.3 Definitions.

drugs, and substances are prohibited
404
556.5 General considerations. 556.430 Neomycin.
556.445 Nicarbazin.
Subpart B—Specific Tolerances for Resi- 556.460 Novobiocin.
dues of Approved and Conditionally 556.470 Nystatin.
Approved New Animal Drugs 556.490 Ormetoprim.
556.495 Oxfendazole.
556.34 Albendazole. 556.500 Oxytetracycline.
556.36 Altrenogest. 556.510 Penicillin.
556.38 Amoxicillin. 556.515 Pirlimycin.
556.40 Ampicillin. 556.517 Poloxalene.
556.50 Amprolium. 556.540 Progesterone.
556.52 Apramycin. 556.560 Pyrantel.
556.60 Avilamycin. 556.570 Ractopamine.
556.68 Azaperone. 556.580 Robenidine.
556.70 Bacitracin. 556.592 Salinomycin.
556.75 Bambermycins. 556.597 Semduramicin.
556.100 Carbadox. 556.600 Spectinomycin.
556.110 Carbomycin. 556.610 Streptomycin.
556.113 Ceftiofur. 556.620 Sulfabromomethazine.
556.115 Cephapirin. 556.625 Sulfachloropyrazine.
556.118 Chloramine-T. 556.630 Sulfachlorpyridazine.
556.120 Chlorhexidine. 556.640 Sulfadimethoxine.
556.150 Chlortetracycline. 556.650 Sulfaethoxypyridazine.
556.160 Clopidol. 556.660 Sulfamerazine.
556.163 Clorsulon. 556.670 Sulfamethazine.
556.165 Cloxacillin. 556.685 Sulfaquinoxaline.
556.167 Colistimethate. 556.700 Sulfomyxin.
556.168 Coumaphos. 556.710 Testosterone.
556.169 Danofloxacin. 556.720 Tetracycline.
556.170 Decoquinate. 556.730 Thiabendazole.
556.180 Dichlorvos. 556.732 Tiamulin.
556.185 Diclazuril. 556.733 Tildipirosin.
556.200 Dihydrostreptomycin. 556.735 Tilmicosin.
556.222 Doramectin. 556.739 Trenbolone.
556.224 Efrotomycin. 556.741 Tripelennamine.
556.226 Enrofloxacin. 556.745 Tulathromycin.
556.227 Eprinomectin. 556.746 Tylosin.
556.230 Erythromycin. 556.748 Tylvalosin.
556.240 Estradiol and related esters. 556.750 Virginiamycin.
556.260 Ethopabate. 556.760 Zeranol.
556.273 Famphur. 556.765 Zilpaterol.
556.275 Fenbendazole. 556.770 Zoalene.
556.277 Fenprostalene.
556.280 Fenthion. AUTHORITY: 21 U.S.C. 342, 360b, 371.
556.283 Florfenicol. SOURCE: 84 FR 32993, July 11, 2019, unless
556.286 Flunixin. otherwise noted.
556.292 Gamithromycin.
556.300 Gentamicin.
556.304 Gonadotropin. Subpart A—General Provisions
556.308 Halofuginone.
556.310 Haloxon. § 556.1 Scope.
556.316 Hetacillin. (a) The Federal Food, Drug, and Cos-
556.330 Hygromycin B.
metic Act requires an applicant seek-
556.344 Ivermectin.
556.345 Ketoprofen. ing approval or conditional approval of
556.346 Laidlomycin. a new animal drug to submit a pro-
556.347 Lasalocid. posed tolerance as part of its new ani-
556.350 Levamisole. mal drug application when such a tol-
556.360 Lincomycin. erance is needed to assure that the pro-
556.370 Lubabegron. posed use of the new animal drug will
556.375 Maduramicin. be safe (see sections 512(b)(1)(H) and
556.380 Melengestrol.
571(a)(2)(A) of the Federal Food, Drug,
556.410 Metoserpate.
556.420 Monensin. and Cosmetic Act). FDA assigns toler-
556.425 Morantel. ances for animal drugs used in food-
556.426 Moxidectin. producing animals as part of the appli-

556.428 Narasin. cation approval process. Tolerances for
405
§ 556.3 21 CFR Ch. I (4–1–23 Edition)
approved and conditionally approved ppt means parts per trillion (equiva-
new animal drugs are codified in sub- lent to picograms per gram (pg/g) or
part B of this part. nanograms per kilogram (ng/kg)).
(b) Compounds that have been found Residue means any compound present
to be carcinogenic are regulated under in edible tissues that results from the
subpart E of part 500 of this chapter. use of a drug, and includes the drug, its
metabolites, and any other substance
§ 556.3 Definitions. formed in or on food because of the
As used in this part: drug’s use.
Acceptable daily intake (ADI) means Target tissue means the edible tissue
the daily intake which, during up to an selected to monitor for residues in the
entire life of a human, appears to be target animals.
without adverse effects or harm to the Tolerance means the maximum con-
health of the consumer. The ADI most centration of a marker residue, or
often will be set on the basis of the other residue indicated for monitoring,
drug’s toxicological, microbiological, that can legally remain in a specific
or pharmacological properties. It is edible tissue of a treated animal.
usually expressed in micrograms or Total residue means the aggregate of
milligrams of the chemical per kilo- all compounds that results from the
gram of body weight per day. use of an animal drug, including the
Acute reference dose (ARfD) means an drug, its metabolites, and any other
estimate of the amount of residues ex- substances formed in or on food be-
pressed on a body weight basis that can cause of such drug use.
be ingested in a period of 24 hours or μg/kg means microgram per kilogram.
less without adverse effects or harm to
Zero, in reference to tolerances in
the health of the human consumer.
this part, means any residues detected
Edible tissues means muscle, liver,
in the edible tissue renders it unsafe.
kidney, fat, skin with fat in natural
proportions, whole eggs, whole milk, § 556.5 General considerations.
and honey.
Marker residue means the residue (a) The tolerances listed in subpart B
whose concentration is in a known re- of this part pertain only to the species
lationship to the concentration of total and production classes of the animal
residue in an edible tissue. for which the drug use has been ap-
mg/kg means milligrams per kilo- proved or conditionally approved. Ap-
gram. proved and conditionally approved con-
Not required, in reference to toler- ditions of use in parts 516, 520, 522, 524,
ances in this part, means that at the 526, 529, and 558 of this chapter, includ-
time of approval: ing the species and production classes
(1) No withdrawal period was nec- of animals, are referenced in each tol-
essary for residues of the drug to de- erance section in subpart B of this
plete to or below the concentrations part.
considered to be safe, or an adequate (b) All tolerances refer to the con-
withdrawal period was inherent in the centrations of a marker residue, or
proposed drug use, and there was a other residue indicated for monitoring,
rapid depletion of residues, so there permitted in uncooked tissues.
was no concern about residues result- (c) After a tolerance is listed, the
ing from misuse or overdosing; or finding that the concentration of the
(2) No withdrawal period was nec- marker residue in the target tissue
essary because the drug was poorly ab- from a tested animal is at or below the
sorbed or metabolized rapidly so as to tolerance indicates that all edible tis-
make selection of an analyte imprac- sues (excluding milk and eggs unless
tical or impossible. otherwise indicated) from that tested
ppb means parts per billion (equiva- animal are safe for human consump-
lent to nanograms per gram (ng/g) or tion. If a listed tolerance is not ex-
μg/kg). pressly linked to a target tissue, then
ppm means parts per million (equiva- the tolerance is specific only for the
lent to micrograms per gram (μg/g) or named edible tissue and inferences can-
mg/kg). not be made about the safety of the
406
other edible tissues from the tested (c) Related conditions of use. See
animal. §§ 520.88d, 520.88e, 522.88, and 526.88 of
(d) FDA requires that a drug sponsor this chapter.
submit a practicable method as part of [84 FR 32993, July 11, 2019, as amended at 86
their new animal drug application. FR 13188, Mar. 8, 2021]
FDA uses the practicable method to de-
termine the quantity of the drug resi- § 556.40 Ampicillin.
dues that can safely remain in edible
(a) [Reserved]
tissues (i.e., the tolerance), the with-
(b) Tolerances. The tolerances for am-
drawal period, and any other use re-
picillin are:
strictions necessary to ensure that the
(1) Cattle. Edible tissues: 0.01 ppm.
proposed use of the drug will be safe.
(2) Swine. Edible tissues: 0.01 ppm.
(c) Related conditions of use. See
Subpart B—Specific Tolerances for §§ 520.90c, 522.90a, and 522.90b of this
Residues of Approved and chapter.
Conditionally Approved New [84 FR 32993, July 11, 2019, as amended at 85
Animal Drugs FR 18120, Apr. 1, 2020]
§ 556.34 Albendazole. § 556.50 Amprolium.
(a) Acceptable daily intake (ADI). The (a) [Reserved]
ADI for total residue of albendazole is (b) Tolerances. The tolerances for
5 μg/kg of body weight per day. amprolium are:
(b) Tolerances. The tolerances for (1) Cattle. (i) Liver, kidney, and mus-
albendazole 2-aminosulfone (marker cle: 0.5 ppm.
residue) are: (ii) Fat: 2.0 ppm.
(1) Cattle. (i) Liver (target tissue): 0.2 (2) Chickens and turkeys. (i) Liver and
ppm. kidney: 1 ppm.
(ii) Muscle: 0.05 ppm. (ii) Muscle: 0.5 ppm.
(2) Sheep. (i) Liver (target tissue): 0.25 (iii) Eggs:
ppm. (A) Egg yolks: 8 ppm.
(ii) Muscle: 0.05 ppm. (B) Whole eggs: 4 ppm.
(3) Goat. (i) Liver (target tissue): 0.25 (3) Pheasants. (i) Liver: 1 ppm.
ppm. (ii) Muscle: 0.5 ppm.
(ii) [Reserved] (c) Related conditions of use. See
(c) Related conditions of use. See §§ 520.100, 558.55, and 558.58 of this chap-
§§ 520.38a and 520.38b of this chapter. ter.
§ 556.36 Altrenogest. § 556.52 Apramycin.

(a) Acceptable daily intake (ADI). The (a) Acceptable daily intake (ADI). The
ADI for total residue of altrenogest is ADI for total residue of apramycin is 25
0.04 μg/kg of body weight per day. μg/kg of body weight per day.
(b) Tolerances. The tolerances for (b) Tolerances. The tolerance for
altrenogest (marker residue) are: apramycin (marker residue) is:
(1) Swine. Kidney (target tissue): 0.1
(1) Swine. (i) Liver (target tissue): 4
ppm.
ppb.
(2) [Reserved]
(ii) Muscle: 1 ppb.
(2) [Reserved] §§ 520.110 and 558.59 of this chapter.
§ 520.48 of this chapter. § 556.60 Avilamycin.
§ 556.38 Amoxicillin. (a) Acceptable daily intake (ADI). The
ADI for total residue of avilamycin is
(a) [Reserved] 1.1 mg/kg of body weight per day.
(b) Tolerances. The tolerance for (b) Tolerances. The tolerances for
amoxicillin is: avilamycin are:
(1) Cattle. Edible tissues: 0.01 ppm. (1) Chickens. Edible tissues (excluding
(2) [Reserved] eggs): Not required.
407
§ 556.68 21 CFR Ch. I (4–1–23 Edition)
(2) Swine. Edible tissues: Not re- (1) Chickens. Edible tissues (excluding
quired. eggs): Zero.
(c) Related conditions of use. See (2) [Reserved]
§ 558.68 of this chapter. (c) Related conditions of use. See
§ 520.1660a of this chapter.
§ 556.68 Azaperone.
(a) Acceptable daily intake (ADI). The § 556.113 Ceftiofur.
ADI for total residue of azaperone is (a) Acceptable daily intake and acute
0.63 μg/kg of body weight per day. reference dose—(1) Acceptable daily in-
(b) Tolerances. The tolerance for take (ADI). The ADI for total residue of
azaperone is: ceftiofur is 30 μg/kg of body weight per
(1) Swine. Edible tissues: Not re- day.
quired. (2) Acute reference dose (ARfD). The
(2) [Reserved] ARfD for total residue of ceftiofur is
(c) Related conditions of use. See 0.830 mg/kg of body weight.
§ 522.150 of this chapter. (b) Tolerances. The tolerances for
desfuroylceftiofur (marker residue)
§ 556.70 Bacitracin.
are:
(a) Acceptable daily intake (ADI). The (1) Cattle. (i) Kidney (target tissue):
ADI for total residue of bacitracin is 0.4 ppm.
0.05 mg/kg of body weight per day. (ii) Liver: 2 ppm.
(b) Tolerances. The tolerances for bac- (iii) Muscle: 1 ppm.
itracin are: (iv) Milk: 0.1 ppm.
(1) Cattle. Edible tissues: 0.5 ppm. (2) Chickens and turkeys. Edible tis-
(2) Chickens, turkeys, pheasants, quail. sues (excluding eggs): Not required.
Edible tissues: 0.5 ppm. (3) Goats. (i) Kidney (target tissue): 8
(3) Swine. Edible tissues: 0.5 ppm. ppm.
(ii) Liver: 2 ppm.
§§ 520.154a, 520.154c, 558.76, and 558.78 of
(iii) Muscle: 1 ppm.
this chapter.
(iv) Milk: 0.1 ppm.
§ 556.75 Bambermycins. (4) Sheep. Edible tissues (excluding
milk): Not required.
(a) [Reserved]
(5) Swine. (i) Kidney (target tissue):
(b) Tolerances. The tolerances for
0.25 ppm.
bambermycins are:
(1) Cattle. Edible tissues (excluding (ii) Liver: 3 ppm.
milk): Not required. (iii) Muscle: 2 ppm.
(2) Chickens and turkeys. Edible tis- (c) Related conditions of use. See
sues (excluding eggs): Not required. §§ 522.313a, 522.313b, 522.313c, and 526.313
(3) Swine. Edible tissues: Not re- of this chapter.
quired.
§ 556.115 Cephapirin.
§ 558.95 of this chapter. (a) [Reserved]
§ 556.100 Carbadox. cephapirin are:
(a) [Reserved] (1) Cattle. (i) Edible tissues (excluding
(b) Tolerances. The tolerance for milk): 0.1 ppm.
quinoxaline-2-carboxylic acid (marker (ii) Milk: 0.02 ppm.
residue) is: (2) [Reserved]
(1) Swine. Liver (target tissue): 30 (c) Related conditions of use. See
ppb. §§ 526.363 and 526.365 of this chapter.
(2) [Reserved]
(c) Related conditions of use. See § 556.118 Chloramine-T.
§ 558.115 of this chapter. (a) Acceptable daily intake (ADI). The
ADI for total residue of chloramine-T
§ 556.110 Carbomycin. is 5 μg/kg of body weight per day.
(a) [Reserved] (b) Tolerances. The tolerance for para-
(b) Tolerances. The tolerance for toluenesulfonamide (marker residue)

carbomycin is: is:
408
(1) Fish. Muscle/skin (target tissue): (b) Tolerances. The tolerances for
0.9 ppm. clorsulon (marker residue) are:
(2) [Reserved] (1) Cattle. (i) Kidney (target tissue):
(c) Related conditions of use. See 1.0 ppm.
§ 529.382 of this chapter. (ii) Muscle: 0.1 ppm.
(2) [Reserved]
§ 556.120 Chlorhexidine. (c) Related conditions of use. See
(a) [Reserved] §§ 520.462 and 522.1193 of this chapter.
(b) Tolerances. The tolerance for
§ 556.165 Cloxacillin.
chlorhexidine is:
(1) Cattle. Edible tissues (excluding (a) [Reserved]
milk): Zero. (b) Tolerances. The tolerance for
(2) [Reserved] cloxacillin is:
(c) Related conditions of use. See (1) Cattle. Edible tissues: 0.01 ppm.
§ 529.400 of this chapter. (2) [Reserved]
§ 556.150 Chlortetracycline. §§ 526.464 and 526.465 of this chapter.
(a) Acceptable daily intake (ADI). The [84 FR 32993, July 11, 2019, as amended at 85
ADI for total residue of tetracyclines FR 18121, Apr. 1, 2020; 86 FR 13188, Mar. 8,
including chlortetracycline, oxytetra- 2021]
cycline, and tetracycline is 25 μg/kg of
§ 556.167 Colistimethate.
body weight per day.
(b) Tolerances. The tolerances for the (a) [Reserved]
sum of tetracycline residues are: (b) Tolerances. The tolerance for
(1) Cattle. (i) Liver: 6 ppm. colistimethate is:
(ii) Kidney and fat: 12 ppm. (1) Chickens. Edible tissues (excluding
(iii) Muscle: 2 ppm. eggs): Not required.
(2) Chickens, turkeys, and ducks. (i) (2) [Reserved]
Liver: 6 ppm. (c) Related conditions of use. See
(ii) Kidney and fat: 12 ppm. § 522.468 of this chapter.
(iii) Muscle: 2 ppm.
§ 556.168 Coumaphos.
(iv) Eggs: 0.4 ppm for chlortetra-
cycline only. (a) [Reserved]
(3) Sheep. (i) Liver: 6 ppm. (b) Tolerances. The tolerances for
(ii) Kidney and fat: 12 ppm. coumaphos (measured as coumaphos
(iii) Muscle: 2 ppm. and its oxygen analog, O,O-diethyl O-3-
(4) Swine. (i) Liver: 6 ppm. chloro-4-methyl-2-oxo-2 H-1-
(ii) Kidney and fat: 12 ppm. benzopyran-7-yl phosphate) are:
(iii) Muscle: 2 ppm. (1) Chickens. (i) Edible tissues (ex-
(c) Related conditions of use. See cluding eggs): 1 ppm.
§§ 520.441, 520.443, 520.445, 558.128, and (ii) Eggs: 0.1 ppm.
558.140 of this chapter. (2) [Reserved]
§ 556.160 Clopidol. § 558.185 of this chapter.
(a) [Reserved] [86 FR 14821, Mar. 19, 2021]
clopidol are: § 556.169 Danofloxacin.
(1) Chickens and turkeys. (i) Liver and (a) Acceptable daily intake (ADI). The
kidney: 15 ppm. ADI for total residue of danofloxacin is
(ii) Muscle: 5 ppm. 2.4 μg/kg of body weight per day.
(2) [Reserved] (b) Tolerances. The tolerances for
(c) Related conditions of use. See danofloxacin (marker residue) are:
§ 558.175 of this chapter. (1) Cattle. (i) Liver (target tissue): 0.2
ppm.
§ 556.163 Clorsulon. (ii) Muscle: 0.2 ppm.
(a) Acceptable daily intake (ADI). The (2) [Reserved]
ADI for total residue of clorsulon is 8 (c) Related conditions of use. See
μg/kg of body weight per day. § 522.522 of this chapter.
409
§ 556.170 21 CFR Ch. I (4–1–23 Edition)
§ 556.170 Decoquinate. (c) Related conditions of use. See

§§ 522.650, 526.1696b, and 526.1696c of this
(a) Acceptable daily intake (ADI). The
chapter.
ADI for total residue of decoquinate is
75 μg/kg of body weight per day. § 556.222 Doramectin.
decoquinate are: (a) Acceptable daily intake (ADI). The
(1) Cattle. (i) Muscle: 1 ppm. ADI for total residue of doramectin is
(ii) Other edible tissues (excluding 0.75 μg/kg of body weight per day.
milk): 2 ppm. (b) Tolerances. The tolerances for
(2) Chickens. (i) Muscle: 1 ppm. doramectin (marker residue) are:
(1) Cattle. (i) Liver (target tissue): 300
(ii) Other edible tissues (excluding
ppb.
eggs): 2 ppm.
(ii) Muscle: 30 ppb.
(3) Goats. (i) Muscle: 1 ppm.
(2) Swine. Liver (target tissue): 160
(ii) Other edible tissues (excluding
ppb.
milk): 2 ppm.
§§ 522.770, 522.772, and 524.770 of this
§§ 520.534 and 558.195 of this chapter.
chapter.
FR 13188, Mar. 8, 2021]
FR 16549, Mar. 20, 2023]
§ 556.180 Dichlorvos. § 556.224 Efrotomycin.
(a) [Reserved] (a) Acceptable daily intake (ADI). The
(b) Tolerances. The tolerance for ADI for total residue of efrotomycin is
dichlorvos is: 10 μg/kg of body weight per day.
(1) Swine. Edible tissues: 0.1 ppm. (b) Tolerances. The tolerance for
(2) [Reserved] efrotomycin is:
(c) Related conditions of use. See (1) Swine. Edible tissues: Not re-
§§ 520.596 and 558.198 of this chapter. quired.
[84 FR 32993, July 11, 2019, as amended at 86 (2) [Reserved]
FR 13188, Mar. 8, 2021] (c) Related conditions of use. See
§ 556.185 Diclazuril.
(a) Acceptable daily intake (ADI). The § 556.226 Enrofloxacin.
ADI for total residue of diclazuril is 25 (a) Acceptable daily intake (ADI). The
μg/kg of body weight per day. ADI for total residue of enrofloxacin is
(b) Tolerances. The tolerances for 3 μg/kg of body weight per day.
diclazuril are: (b) Tolerances. The tolerances for
(1) Chickens and turkeys. (i) Liver: 3 enrofloxacin are:
ppm. (1) Cattle. Liver (target tissue): 0.1
(ii) Muscle: 0.5 ppm. ppm desethylene ciprofloxacin (marker
(iii) Skin/fat: 1 ppm. residue).
(2) [Reserved] (2) Swine. Liver (target tissue): 0.5
(c) Related conditions of use. See ppm enrofloxacin (marker residue).
§ 558.205 of this chapter. (c) Related conditions of use. See
FR 13188, Mar. 8, 2021] [84 FR 32993, July 11, 2019, as amended at 86
FR 13188, Mar. 8, 2021]
§ 556.200 Dihydrostreptomycin.
(a) [Reserved] § 556.227 Eprinomectin.
(b) Tolerances. The tolerances for di- (a) Acceptable daily intake (ADI). The
hydrostreptomycin are: ADI for total residue of eprinomectin is
(1) Cattle. (i) Kidney: 2.0 ppm. 10 μg/kg of body weight per day.
(ii) Other edible tissues (excluding (b) Tolerances. The tolerances for
milk): 0.5 ppm. eprinomectin B1a (marker residue) are:
(iii) Milk: 0.125 ppm. (1) Cattle. (i) Liver (target tissue): 1.5
(2) Swine. (i) Kidney: 2.0 ppm. ppm.

(ii) Other edible tissues: 0.5 ppm. (ii) Muscle: 100 ppb.
410
(iii) Milk: 12 ppb. (c) Related conditions of use. See

(2) [Reserved] §§ 520.1242g, 524.900, and 558.254 of this
(c) Related conditions of use. See chapter.
§ 556.275 Fenbendazole.
§ 556.230 Erythromycin. (a) Acceptable daily intake (ADI). The
(a) [Reserved] ADI for total residue of fenbendazole is
(b) Tolerances. The tolerances for 40 μg/kg of body weight per day.
erythromycin are: (b) Tolerances. The tolerances for
(1) Cattle. (i) Edible tissues (excluding fenbendazole are:
milk): 0.1 ppm. (1) Cattle. (i) Liver (target tissue): 0.8
(ii) Milk: Zero. ppm fenbendazole (marker residue).
(2) Chickens and turkeys. (i) Edible tis- (ii) Milk: 0.22 ppm fenbendazole sulf-
sues (excluding eggs): 0.125 ppm. oxide (marker residue).
(ii) Eggs: 0.025 ppm. (2) Chickens. (i) Liver (target tissue):
(c) Related conditions of use. See 5.2 ppm fenbendazole sulfone (marker
§§ 520.823, 522.820, 526.820, and 558.248 of residue).
this chapter. (ii) Eggs: 1.8 ppm fenbendazole
[84 FR 32993, July 11, 2019, as amended at 85 sulfone (marker residue).
FR 18121, Apr. 1, 2020] (3) Goats. (i) Liver (target tissue): 0.8
ppm fenbendazole (marker residue).
§ 556.240 Estradiol and related esters. (ii) [Reserved]
(a) [Reserved] (4) Swine. (i) Liver (target tissue): 3.2
(b) Residues. Residues of estradiol are ppm fenbendazole (marker residue).
not permitted in excess of the fol- (ii) [Reserved]
lowing increments above the con- (5) Turkeys. (i) Liver (target tissue): 6
centrations of estradiol naturally ppm fenbendazole sulfone (marker res-
present in untreated animals: idue).
(1) Cattle. (i) Muscle: 0.2 ppb. (ii) [Reserved]
(ii) Liver: 0.6 ppb. (c) Related conditions of use. See
(iii) Kidney: 1.2 ppb. §§ 520.905a, 520.905b, 520.905c, 520.905d,
(iv) Fat: 1.2 ppb. and 558.258 of this chapter.
(2) [Reserved] [84 FR 32993, July 11, 2019, as amended at 86
(c) Related conditions of use. See FR 57998, Oct. 20, 2021; 86 FR 61686, Nov. 8,
§§ 522.840, 522.850, 522.1940, 522.2343, 2021]
522.2477, and 522.2478 of this chapter.
§ 556.277 Fenprostalene.
FR 17947, Mar. 29, 2022] (a) Acceptable daily intake (ADI). The
ADI for total residue of fenprostalene
§ 556.260 Ethopabate. is 0.08 μg/kg of body weight per day.
(a) [Reserved] (b) Tolerances. The tolerances for
(b) Tolerances. The tolerances for fenprostalene are:
ethopabate, measured as (1) Cattle. Edible tissues (excluding
metaphenetidine, are: milk): Not required.
(1) Chickens. (i) Liver: 1.5 ppm. (2) Swine. Edible tissues: Not re-
(ii) Kidney: 1.5 ppm. quired.
(iii) Muscle: 0.5 ppm. (c) Related conditions of use. See
(2) [Reserved] § 522.914 of this chapter.
§ 558.58 of this chapter. § 556.280 Fenthion.
(a) [Reserved]
§ 556.273 Famphur. (b) Tolerances. The tolerance for
(a) [Reserved] fenthion is:
(b) Tolerances. The tolerance for (1) Cattle. Edible tissues (excluding
famphur including its oxygen analog is: milk): 0.1 ppm.
(1) Cattle. Edible tissues (excluding (2) [Reserved]
milk): 0.1 ppm. (c) Related conditions of use. See

(2) [Reserved] § 524.920 of this chapter.
411
§ 556.283 21 CFR Ch. I (4–1–23 Edition)
§ 556.283 Florfenicol. (1) Chickens and turkeys. Edible tis-

(a) Acceptable daily intake (ADI). The sues (excluding eggs): 0.1 ppm.
ADI for total residue of florfenicol is 10 (2) Swine. (i) Liver: 0.3 ppm.
μg/kg of body weight per day. (ii) Kidney (target tissue): 0.4 ppm
(b) Tolerances. The tolerances for gentamicin (marker residue).
florfenicol amine (marker residue) are: (iii) Fat: 0.4 ppm.
(1) Cattle. (i) Liver (target tissue): 3.7 (iv) Muscle: 0.1 ppm.
ppm. (c) Related conditions of use. See
(ii) Muscle: 0.3 ppm. §§ 520.1044a, 520.1044b, 520.1044c, 522.1044,
(2) Swine. (i) Liver (target tissue): 2.5 524.1044e, and 529.1044b of this chapter.
ppm. [84 FR 32993, July 11, 2019, as amended at 86
(ii) Muscle: 0.2 ppm. FR 13188, Mar. 8, 2021]
(3) Catfish. Muscle (target tissue): 1
ppm. § 556.304 Gonadotropin.
(4) Freshwater-reared warmwater (a) Acceptable daily intake (ADI). The
finfish (other than catfish) and ADI for residues of total gonadotropins
salmonids. Muscle/skin (target tissue): 1 (human chorionic gonadotropin and
ppm. pregnant mare serum gonadotropin) is
(c) Related conditions of use. See 42.25 International Units per kilogram
§§ 520.955, 522.955, 522.956, and 558.261 of of body weight per day.
this chapter. (b) Tolerances. The tolerances for
gonadotropin are:
§ 556.286 Flunixin.
(1) Cattle. Edible tissues (excluding
(a) Acceptable daily intake (ADI). The milk): Not required.
ADI for total residue of flunixin is 0.72 (2) Fish. Edible tissues: Not required.
μg/kg of body weight per day. (3) Swine. Edible tissues: Not re-
(b) Tolerances. The tolerances for quired.
flunixin are: (c) Related conditions of use. See
(1) Cattle. (i) Liver (target tissue): 125 §§ 522.1079 and 522.1081 of this chapter.
ppb flunixin free acid (marker residue).
(ii) Muscle: 25 ppb flunixin free acid. [84 FR 32993, July 11, 2019, as amended at 85
FR 18121, Apr. 1, 2020]
(iii) Milk: 2 ppb 5-hydroxy flunixin
(marker residue). § 556.308 Halofuginone.
(2) Swine. (i) Liver (target tissue): 30
ppb flunixin free acid (marker residue). (a) Acceptable daily intake (ADI). The
(ii) Muscle: 25 ppb flunixin free acid. ADI for total residue of halofuginone
(c) Related conditions of use. See hydrobromide is 0.7 μg/kg of body
§§ 522.956, 522.970, 522.1664, and 524.970 of weight per day.
this chapter. (b) Tolerances. The tolerances for
halofuginone (marker residue) are:
§ 556.292 Gamithromycin. (1) Chickens. Liver (target tissue): 0.16
(a) Acceptable daily intake (ADI). The ppm.
ADI for total residue of gamithromycin (2) Turkeys. Liver (target tissue): 0.13
is 10 μg/kg of body weight per day. ppm.
(b) Tolerances. The tolerances for (c) Related conditions of use. See
gamithromycin (marker residue) are: § 558.265 of this chapter.
(1) Cattle. (i) Liver (target tissue): 500
§ 556.310 Haloxon.
ppb.
(ii) Muscle: 150 ppb. (a) [Reserved]
(2) [Reserved] (b) Tolerances. The tolerance for
(c) Related conditions of use. See haloxon is:
§ 522.1014 of this chapter. (1) Cattle. Edible tissues (excluding
milk): 0.1 ppm.
§ 556.300 Gentamicin. (2) [Reserved]
(a) Acceptable daily intake (ADI). The (c) Related conditions of use. See
ADI for total residue of gentamicin is §§ 520.1120a and 520.1120b of this chapter.
60 μg/kg of body weight per day.
(b) Tolerances. The tolerances for § 556.316 Hetacillin.

gentamicin are: (a) [Reserved]
412
(b) Tolerances. The tolerances for am- § 556.346 Laidlomycin.

picillin (marker residue for hetacillin)
are:
ADI for total residue of laidlomycin is
(1) Cattle. Edible tissues: 0.01 ppm. 7.5 μg/kg of body weight per day.
(2) [Reserved] (b) Tolerances. The tolerance for
(c) Related conditions of use. See laidlomycin (marker residue) is:
§ 526.1130 of this chapter. (1) Cattle. Liver (target tissue): 0.2
[84 FR 53311, Oct. 7, 2019] ppm.
(2) [Reserved]
§ 556.330 Hygromycin B. (c) Related conditions of use. See
(a) [Reserved] § 558.305 of this chapter.
(b) Tolerances. The tolerances for § 556.347 Lasalocid.
hygromycin B are:
(1) Chickens. Edible tissues: Zero. (a) Acceptable daily intake (ADI). The
(2) Swine. Edible tissues: Zero. ADI for total residue of lasalocid is 10
μg/kg of body weight per day.
lasalocid (marker residue) are:
§ 556.344 Ivermectin. (1) Cattle. Liver (target tissue): 0.7
ppm.
(a) Acceptable daily intake (ADI). The (2) Chickens. (i) Skin with adhering
ADI for total residue of ivermectin is 5 fat (target tissue): 1.2 ppm.
μg/kg of body weight per day. (ii) Liver: 0.4 ppm.
(b) Tolerances. The tolerances for (3) Rabbits. Liver (target tissue): 0.7
22,23-dihydroavermectin B1a (marker ppm.
residue) are: (4) Sheep. Liver (target tissue): 1.0
(1) American bison. Liver (target tis- ppm.
sue): 15 ppb. (5) Turkeys. (i) Liver (target tissue):
(2) Cattle. (i) Liver (target tissue): 1.6 0.4 ppm.
ppm. (ii) Skin with adhering fat: 0.4 ppm.
(ii) Muscle: 650 ppb. (c) Related conditions of use. See
(3) Reindeer. Liver (target tissue): 15 § 558.311 of this chapter.
ppb.
(4) Sheep. Liver (target tissue): 30 § 556.350 Levamisole.
ppb. (a) [Reserved]
(5) Swine. (i) Liver (target tissue): 20 (b) Tolerances. The tolerances for
ppb. levamisole are:
(ii) Muscle: 20 ppb. (1) Cattle. Edible tissues (excluding
(c) Related conditions of use. See milk): 0.1 ppm.
§§ 520.1192, 520.1195, 520.1197, 522.1192, (2) Sheep. Edible tissues (excluding
522.1193, 524.1193, and 558.300 of this milk): 0.1 ppm.
chapter. (3) Swine. Edible tissues: 0.1 ppm.
[84 FR 32993, July 11, 2019, as amended at 85 (c) Related conditions of use. See
FR 18121, Apr. 1, 2020] §§ 520.1242a, 520.1242b, 520.1242d,
520.1242e, 520.1242f, 520.1242g, 522.1242,
§ 556.345 Ketoprofen. and 524.1240 of this chapter.
(a) Acceptable daily intake (ADI). The § 556.360 Lincomycin.
ADI for total residue of ketoprofen is 5
μg/kg of body weight per day. (a) Acceptable daily intake (ADI). The
(b) Tolerances. The tolerances for ADI for total residue of lincomycin is
ketoprofen (marker residue) are: 25 μg/kg of body weight per day.
(1) Cattle. (i) Kidney (target tissue): (b) Tolerances. The tolerances for lin-
0.36 ppm. comycin are:
(1) Chickens. Edible tissues (excluding
(ii) [Reserved]
eggs): Not required.
(2) Swine. (i) Liver: 0.6 ppm.
(ii) Muscle: 0.1 ppm.

[86 FR 61686, Nov. 8, 2021] (3) Honey. 750 ppb.
413
§ 556.370 21 CFR Ch. I (4–1–23 Edition)
(c) Related conditions of use. See § 556.420 Monensin.

§§ 520.1263b, 522.1260, and 558.325 of this (a) Acceptable daily intake (ADI). The
chapter. ADI for total residue of monensin is
[84 FR 32993, July 11, 2019, as amended at 85 12.5 μg/kg of body weight per day.
FR 18121, Apr. 1, 2020] (b) Tolerances. The tolerances for
monensin are:
EDITORIAL NOTE: At 86 FR 13188, Mar. 8,
2021, in § 556.360, paragraph (c) was amended; (1) Cattle. (i) Liver: 0.10 ppm.
however, the amendment could not be incor- (ii) Muscle, kidney, and fat: 0.05 ppm.
porated due to inaccurate amendatory in- (iii) Milk: Not required.
struction. (2) Chickens and turkeys. Edible tis-
sues (excluding eggs): Not required.
§ 556.370 Lubabegron. (3) Goats. Edible tissues (excluding
(a) Acceptable daily intake (ADI). The milk): 0.05 ppm.
ADI for total residues of lubabegron is (4) Quail. Edible tissues (excluding
3 micrograms per kilogram of body eggs): Not required.
weight per day.
lubabegron (marker residue) are: § 556.425 Morantel.
(1) Cattle. (i) Liver (target tissue): 10 (a) Acceptable daily intake (ADI). The
ppb. ADI for total residue of morantel tar-
(ii) Muscle: 3 ppb. trate is 10 μg/kg of body weight per
(iii) Kidney: 20 ppb. day.
(2) [Reserved] (b) Tolerances. The tolerances for N-
(c) Related conditions of use. See methyl-1,3-propanediamine (marker
§ 558.330 of this chapter. residue) are:
(1) Cattle. (i) Liver (target tissue): 0.7
FR 17947, Mar. 29, 2022] ppm.
(ii) Milk: Not required.
§ 556.375 Maduramicin. (2) Goats. (i) Liver (target tissue): 0.7
ppm.
(a) [Reserved] (ii) Milk: Not required.
(b) Tolerances. The tolerance for (c) Related conditions of use. See
maduramicin (marker residue) is: §§ 520.1450a, 520.1450b, 520.1450c, and
(1) Chickens. Fat (target tissue): 0.38 558.360 of this chapter.
ppm.
(2) [Reserved] § 556.426 Moxidectin.
(c) Related conditions of use. See (a) Acceptable daily intake (ADI). The
§ 558.340 of this chapter. ADI for total residue of moxidectin is 4
μg/kg of body weight per day.
§ 556.380 Melengestrol. (b) Tolerances. The tolerances for
(a) [Reserved] moxidectin (marker residue) are:
(b) Tolerances. The tolerance for (1) Cattle. (i) Fat (target tissue): 900
melengestrol is: ppb.
(1) Cattle. Fat: 25 ppb. (ii) Liver: 200 ppb.
(2) [Reserved] (iii) Muscle: 50 ppb.
(iv) Milk: 40 ppb.
(2) Sheep. (i) Fat (target tissue): 900
ppb.
§ 556.410 Metoserpate. (ii) Liver: 200 ppb.
(iii) Muscle: 50 ppb.
(a) [Reserved] (c) Related conditions of use. See
(b) Tolerances. The tolerance for §§ 520.1454, 522.1450, and 524.1450 of this
metoserpate is: chapter.
(1) Chickens. Edible tissues (excluding
eggs): 0.02 ppm. § 556.428 Narasin.
(2) [Reserved] (a) Acceptable daily intake (ADI). The
(c) Related conditions of use. See ADI for total residue of narasin is 5 μg/
§ 520.1422 of this chapter. kg of body weight per day.
414
(b) Tolerances. The tolerance for (ii) Milk: 0.1 ppm.

narasin (marker residue) is: (2) Chickens, turkeys, and ducks. Edi-
(1) Chickens. Abdominal fat (target ble tissues (excluding eggs): 1 ppm.
tissue): 480 ppb. (c) Related conditions of use. See
(2) [Reserved] §§ 526.1590, 526.1696d, and 558.415 of this
(c) Related conditions of use. See chapter.
§ 556.470 Nystatin.
§ 556.430 Neomycin.
(a) [Reserved]
(a) Acceptable daily intake (ADI). The (b) Tolerances. The tolerances for nys-
ADI for total residue of neomycin is 6 tatin are:
μg/kg of body weight per day. (1) Cattle. Edible tissues (excluding
(b) Tolerances. The tolerances for neo- milk): Zero.
mycin are: (2) Chickens and turkeys. Edible tis-
(1) Cattle. (i) Kidney (target tissue): sues: Zero.
7.2 ppm. (c) Related conditions of use. See
(ii) Liver: 3.6 ppm. §§ 524.1600b and 558.430 of this chapter.
(iii) Muscle: 1.2 ppm.
(iv) Fat: 7.2 ppm. § 556.490 Ormetoprim.
(v) Milk: 0.15 ppm.
(a) [Reserved]
(2) Sheep and goats. (i) Kidney (target
tissue): 7.2 ppm.
ormetoprim are:
(ii) Liver: 3.6 ppm.
(1) Chickens, turkeys, ducks, and
(iii) Muscle: 1.2 ppm.
chukar partridges. Edible tissues (ex-
(iv) Fat: 7.2 ppm.
cluding eggs): 0.1 ppm.
(v) Milk: 0.15 ppm.
(3) Swine. (i) Kidney (target tissue): (2) Salmonids and catfish. Edible tis-
7.2 ppm. sues: 0.1 ppm.
(ii) Liver: 3.6 ppm. (c) Related conditions of use. See
(iii) Muscle: 1.2 ppm. § 558.575 of this chapter.
(iv) Fat: 7.2 ppm. § 556.495 Oxfendazole.
(4) Turkeys. (i) Skin with adhering
fat: 7.2 ppm. (a) Acceptable daily intake (ADI). The
(ii) Liver: 3.6 ppm. ADI for total residue of oxfendazole is
(iii) Muscle: 1.2 ppm. 7 μg/kg of body weight per day.
(c) Related conditions of use. See (b) Tolerances. The tolerance for
§§ 520.1484, 524.1600b, 558.365, and 558.455 fenbendazole (marker residue) is:
of this chapter. (1) Cattle. Liver (target tissue): 0.8
ppm.
§ 556.445 Nicarbazin. (2) [Reserved]
(a) Acceptable daily intake (ADI). The (c) Related conditions of use. See
ADI for total residues of nicarbazin §§ 520.1629 and 520.1630 of this chapter.
(4,4′-dinitrocarbanilide and 2-hydroxy-
4,6-dimethylpyrimidine) is 200 μg/kg of § 556.500 Oxytetracycline.
body weight per day. (a) Acceptable daily intake (ADI). The
(b) Tolerances. The tolerance for 4,4′- ADI for total tetracycline residues
dinitrocarbanilide (marker residue) is: (chlortetracycline, oxytetracycline,
(1) Chickens. Liver (target tissue): 52 and tetracycline) is 25 μg/kg of body
ppm. weight per day.
(2) [Reserved] (b) Tolerances. The tolerances for the
(c) Related conditions of use. See sum of tetracycline residues are:
§§ 558.364 and 558.366 of this chapter. (1) Cattle. (i) Muscle: 2 ppm.
(ii) Liver: 6 ppm.
§ 556.460 Novobiocin. (iii) Fat and kidney: 12 ppm.
(a) [Reserved] (iv) Milk: 0.3 ppm.
(b) Tolerances. The tolerances for (2) Chickens and turkeys. (i) Muscle: 2
novobiocin are: ppm.
(1) Cattle. (i) Edible tissues (excluding (ii) Liver: 6 ppm.

milk): 1 ppm. (iii) Fat and kidney: 12 ppm.
415
§ 556.510 21 CFR Ch. I (4–1–23 Edition)
(3) Finfish. Muscle (with adhering (c) Related conditions of use. See
skin when edible): 2 ppm. §§ 520.1840 and 558.464 of this chapter.
(4) Lobster. Muscle: 2 ppm. [84 FR 32993, July 11, 2019, as amended at 86
(5) Swine and sheep. (i) Muscle: 2 ppm. FR 14821, Mar. 19, 2021]
(ii) Liver: 6 ppm.
(iii) Fat and kidney: 12 ppm. § 556.540 Progesterone.
(6) Honey. 750 ppb. (a) [Reserved]
(c) Related conditions of use. See (b) Residues. Residues of progesterone
§§ 520.1660a, 520.1660c, 520.1660d, are not permitted in excess of the fol-
522.1660a, 522.1660b, 522.1662, 522.1664, lowing increments above the con-
529.1660, 558.450, and 558.455 of this chap- centrations of progesterone naturally
ter. present in untreated animals:
[84 FR 32993, July 11, 2019, as amended at 85 (1) Cattle and sheep. (i) Muscle: 5 ppb.
FR 18121, Apr. 1, 2020; 88 FR 16549, Mar. 20, (ii) Liver: 15 ppb.
2023] (iii) Kidney: 30 ppb.
(iv) Fat: 30 ppb.
§ 556.510 Penicillin.
(2) [Reserved]
(a) [Reserved] (c) Related conditions of use. See
(b) Tolerances. The tolerances for pen- §§ 522.1940 and 529.1940 of this chapter.
icillin are:
(1) Cattle. (i) Edible tissues (excluding § 556.560 Pyrantel.
milk): 0.05 ppm. (a) [Reserved]
(ii) Milk: Zero. (b) Tolerances. The tolerances for
(2) Chickens. Edible tissues: Zero. pyrantel are:
(3) Pheasants and quail. Edible tis- (1) Swine. (i) Liver and kidney: 10
sues: Zero. ppm.
(4) Sheep and swine. Edible tissues: (ii) Muscle: 1 ppm.
Zero. (2) [Reserved]
(5) Turkeys. Edible tissues (excluding (c) Related conditions of use. See
eggs): 0.01 ppm. §§ 520.2045 and 558.485 of this chapter.
§§ 520.1696a, 522.1696a, 522.1696b, 526.1696, § 556.570 Ractopamine.
526.1697, and 526.1698 of this chapter. (a) Acceptable daily intake (ADI). The
[84 FR 32993, July 11, 2019, as amended at 85 ADI for total residue of ractopamine
FR 18121, Apr. 1, 2020; 86 FR 13188, Mar. 8, hydrochloride is 1.25 μg/kg of body
2021] weight per day.
§ 556.515 Pirlimycin. ractopamine (marker residue) are:
(a) Acceptable daily intake (ADI). The (1) Cattle. (i) Liver (target tissue): 0.09
ADI for total residue of pirlimycin is ppm.
0.01 mg/kg of body weight per day. (ii) Muscle: 0.03 ppm.
(b) Tolerances. The tolerances for (2) Swine. (i) Liver (target tissue): 0.15
pirlimycin (marker residue) are: ppm.
(1) Cattle. (i) Liver (target tissue): 0.5 (ii) Muscle: 0.05 ppm.
ppm. (3) Turkeys. (i) Liver (target tissue):
(ii) Muscle: 0.3 ppm. 0.45 ppm.
(iii) Milk: 0.4 ppm. (ii) Muscle: 0.1 ppm.
(2) [Reserved] (c) Related conditions of use. See
(c) Related conditions of use. See § 558.500 of this chapter.
§ 556.580 Robenidine.
§ 556.517 Poloxalene. (a) [Reserved]
(a) [Reserved] (b) Tolerances. The tolerances for
(b) Tolerances. The tolerance for robenidine are:
poloxalene is: (1) Chickens. (i) Skin and fat: 0.2 ppm.
(1) Cattle. Edible tissues (excluding (ii) Other edible tissues (excluding
milk): Not required. eggs): 0.1 ppm.

(2) [Reserved] (2) [Reserved]
416
(c) Related conditions of use. See § 556.620 Sulfabromomethazine.

(a) [Reserved]
§ 556.592 Salinomycin. (b) Tolerances. The tolerances for
sulfabromomethazine are:
(a) Acceptable daily intake (ADI). The (1) Cattle. (i) Edible tissues (excluding
ADI for total residue of salinomycin is milk): 0.1 ppm.
5 μg/kg of body weight per day. (ii) Milk: 0.01 ppm.
(b) Tolerances. The tolerances for (2) [Reserved]
salinomycin are: (c) Related conditions of use. See
(1) Chickens. Edible tissues (excluding § 520.2170 of this chapter.
eggs): Not required.
(2) Quail. Edible tissues (excluding § 556.625 Sulfachloropyrazine.
eggs): Not required. (a) [Reserved]
(c) Related conditions of use. See (b) Tolerances. The tolerance for
§ 558.550 of this chapter. sulfachloropyrazine is:
§ 556.597 Semduramicin. (1) Chickens. Edible tissues (excluding
eggs): Zero.
(a) Acceptable daily intake (ADI). The (2) [Reserved]
ADI for total residue of semduramicin (c) Related conditions of use. See
is 3 μg/kg of body weight per day. § 520.2184 of this chapter.
semduramicin are: § 556.630 Sulfachlorpyridazine.
(1) Chickens. (i) Liver: 400 ppb. (a) [Reserved]
(ii) Muscle: 130 ppb. (b) Tolerances. The tolerances for
(2) [Reserved] sulfachlorpyridazine are:
(c) Related conditions of use. See (1) Cattle and swine. Edible tissues
§ 558.555 of this chapter. (excluding milk): 0.1 ppm.
(2) [Reserved]
§ 556.600 Spectinomycin.
(a) Acceptable daily intake (ADI). The §§ 520.2200 and 522.2200 of this chapter.
ADI for total residue of spectinomycin
is 25 μg/kg of body weight per day. § 556.640 Sulfadimethoxine.
(b) Tolerances. The tolerances for (a) [Reserved]
spectinomycin are: (b) Tolerances. The tolerances for
(1) Cattle. (i) Kidney (target tissue): 4 sulfadimethoxine are:
ppm spectinomycin (marker residue). (1) Catfish and salmonids. Edible tis-
(ii) Muscle: 0.25 ppm. sues: 0.1 ppm.
(2) Chickens and turkeys. Edible tis- (2) Cattle. (i) Edible tissues (excluding
sues (excluding eggs): 0.1 ppm. milk): 0.1 ppm.
(3) Swine. Edible tissues: Not re- (ii) Milk: 0.01 ppm.
quired. (3) Chickens, turkeys, ducks, and
(c) Related conditions of use. See chukar partridges. Edible tissues (ex-
§§ 520.1265, 520.2123b, 520.2123c, 522.2120, cluding eggs): 0.1 ppm.
and 522.2121 of this chapter. (c) Related conditions of use. See
§§ 520.2220a, 520.2220d, 520.2220e, 522.2220,
§ 556.610 Streptomycin. and 558.575 of this chapter.
(a) [Reserved]
(b) Tolerances. The tolerances for § 556.650 Sulfaethoxypyridazine.
streptomycin are: (a) [Reserved]
(1) Cattle and swine. (i) Kidney: 2.0 (b) Tolerances. The tolerances for
ppm. sulfaethoxypyridazine are:
(ii) Other edible tissues (excluding (1) Cattle. (i) Edible tissues (excluding
milk): 0.5 ppm. milk): 0.1 ppm.
(2) Chickens. (i) Kidney: 2.0 ppm. (ii) Milk: Zero.
(ii) Other edible tissues (excluding (2) Swine. Edible tissues: Zero.
eggs): 0.5 ppm. (c) Related conditions of use. See
(c) Related conditions of use. See §§ 520.2240a, 520.2240b, and 522.2240 of

§ 520.2158 of this chapter. this chapter.
417
§ 556.660 21 CFR Ch. I (4–1–23 Edition)
§ 556.660 Sulfamerazine. centrations of testosterone naturally

present in untreated animals:
(a) [Reserved]
(1) Cattle. (i) Fat: 2.6 ppb.
(b) Tolerances. The tolerance for sul-
(ii) Kidney: 1.9 ppb.
famerazine is:
(iii) Liver: 1.3 ppb.
(1) Trout. Edible tissues: Zero.
(iv) Muscle: 0.64 ppb.
(2) [Reserved]
(2) [Reserved]
§§ 520.2218 and 558.582 of this chapter. (c) Related conditions of use. See
FR 18121, Apr. 1, 2020] [84 FR 32993, July 11, 2019, as amended at 87
FR 10970, Feb. 28, 2022]
§ 556.670 Sulfamethazine.
§ 556.720 Tetracycline.
(a) [Reserved]
(b) Tolerances. The tolerances for (a) Acceptable daily intake (ADI). The
sulfamethazine are: ADI for total tetracycline residues
(chlortetracycline, oxytetracycline,
and tetracycline) is 25 μg/kg of body
milk): 0.1 ppm.
weight per day.
(2) Chickens and turkeys. Edible tis-
(b) Tolerances. The tolerances for the
sues (excluding eggs): 0.1 ppm.
sum of tetracycline residues are:
(3) Swine. Edible tissues: 0.1 ppm.
(1) Cattle and sheep. (i) Kidney and
fat: 12 ppm.
§§ 520.445, 520.2218, 520.2260a, 520.2260b,
(ii) Liver: 6 ppm.
520.2260c, 520.2261a, 520.2261b, 522.2260,
558.140, and 558.630 of this chapter. (iii) Muscle: 2 ppm.
(2) Chickens and turkeys. (i) Kidney
[84 FR 32993, July 11, 2019, as amended at 85 and fat: 12 ppm.
FR 18121, Apr. 1, 2020; 86 FR 13188, Mar. 8, (ii) Liver: 6 ppm.
2021] (iii) Muscle: 2 ppm.
§ 556.685 Sulfaquinoxaline. (3) Swine. (i) Kidney and fat: 12 ppm.
(ii) Liver: 6 ppm.
(a) [Reserved] (iii) Muscle: 2 ppm.
(b) Tolerances. The tolerances for (c) Related conditions of use. See
sulfaquinoxaline are: §§ 520.2345c and 520.2345d of this chapter.
milk): 0.1 ppm. § 556.730 Thiabendazole.
(2) Chickens and turkeys. Edible tis- (a) [Reserved]
sues (excluding eggs): 0.1 ppm. (b) Tolerances. The tolerances for
(c) Related conditions of use. See thiabendazole are:
§§ 520.2218, 520.2325a, 520.2325b, and (1) Cattle. (i) Edible tissues (excluding
558.586 of this chapter. milk): 0.1 ppm.
[84 FR 32993, July 11, 2019, as amended at 85 (ii) Milk: 0.05 ppm.
FR 18121, Apr. 1, 2020] (2) Swine. Edible tissues: 0.1 ppm.
(3) Sheep and goats. (i) Edible tissues
§ 556.700 Sulfomyxin. (excluding milk): 0.1 ppm.
(a) [Reserved] (ii) Milk: 0.05 ppm.
(b) Tolerances. The tolerances for (4) Pheasants. Edible tissues (exclud-
sulfomyxin are: ing eggs): 0.1 ppm.
(1) Chickens and turkeys. Edible tis- (c) Related conditions of use. See
sues (excluding eggs): Zero. §§ 520.2380a, 520.2380b, 520.2380c, and
(2) [Reserved] 558.600 of this chapter.
§ 522.2340 of this chapter. § 556.732 Tiamulin.
§ 556.710 Testosterone. ADI for total residue of tiamulin is 25
(a) [Reserved] μg/kg of body weight per day.
(b) Residues. Residues of testosterone (b) Tolerances. The tolerance for 8-
are not permitted in excess of the fol- alpha-hydroxymutilin (marker residue)

lowing increments above the con- is:
418
(1) Swine. Liver (target tissue): 0.6 (ii) Milk: 20 ppb.

ppm. (2) [Reserved]
(c) Related conditions of use. See § 522.2615 of this chapter.
§ 556.745 Tulathromycin.
§ 556.733 Tildipirosin.
(a) Acceptable daily intake (ADI). The ADI for total residue of tulathromycin
ADI for total residue of tildipirosin is is 15 μg/kg of body weight per day.
50 μg/kg of body weight per day. (b) Tolerances. The tolerances for CP–
(b) Tolerances. The tolerance for 60,300 (marker residue) are:
tildipirosin (the marker residue) is: (1) Cattle. Liver (target tissue): 5.5
(1) Cattle. (i) Liver (the target tissue): ppm.
10 ppm. (2) Swine. Kidney (target tissue): 15
(ii) [Reserved]
ppm.
(2) [Reserved]
FR 18121, Apr. 1, 2020] FR 61686, Nov. 8, 2021]
§ 556.735 Tilmicosin. § 556.746 Tylosin.

(a) Acceptable daily intake (ADI). The (a) [Reserved]
ADI for total residue of tilmicosin is 25 (b) Tolerances. The tolerances for
μg/kg of body weight per day. tylosin are:
(b) Tolerances. The tolerances for (1) Cattle. (i) Liver, kidney, fat, and
tilmicosin (marker residue) are: muscle: 0.2 ppm.
(1) Cattle. (i) Liver (target tissue): 1.2 (ii) Milk: 0.05 ppm.
ppm. (2) Chickens and turkeys. (i) Liver,
(ii) Muscle: 0.1 ppm. kidney, fat, and muscle: 0.2 ppm.
(2) Sheep. (i) Liver (target tissue): 1.2 (ii) Eggs: 0.2 ppm.
ppm. (3) Swine. Liver, kidney, fat, and
(ii) Muscle: 0.1 ppm. muscle: 0.2 ppm.
(3) Swine. (i) Liver (target tissue): 7.5 (4) Honey. 500 ppb.
ppm. (c) Related conditions of use. See
(ii) Muscle: 0.1 ppm. §§ 520.2640, 522.2640, 558.625, and 558.630 of
(c) Related conditions of use. See this chapter.
§§ 520.2471, 522.2471, and 558.618 of this
chapter. [84 FR 32993, July 11, 2019, as amended at 85
FR 18121, Apr. 1, 2020]
§ 556.739 Trenbolone.
§ 556.748 Tylvalosin.
ADI for total residue of trenbolone is (a) Acceptable daily intake (ADI). The
0.4 μg/kg of body weight per day. ADI for total residues of tylvalosin is
(b) Tolerances. The tolerance for 47.7 μg/kg of body weight per day.
trenbolone is: (b) Tolerances. A tolerance for
(1) Cattle. Edible tissues (excluding tylvalosin in edible tissues of swine is
milk): Not required. not required.
(c) Related conditions of use. See §§ 520.2645 and 558.633 of this chapter.
§§ 522.2476, 522.2477, and 522.2478 of this
chapter. § 556.750 Virginiamycin.
§ 556.741 Tripelennamine. ADI for total residue of virginiamycin
(a) [Reserved] is 250 μg/kg of body weight per day.
(b) Tolerances. The tolerances for (b) Tolerances. The tolerances for
tripelennamine are: virginiamycin are:
(1) Cattle. (i) Edible tissues (excluding (1) Cattle. Edible tissues (excluding
milk): 200 ppb. milk): Not required.
419
§ 556.760 21 CFR Ch. I (4–1–23 Edition)
(2) Chickens. Edible tissues (excluding PART 558—NEW ANIMAL DRUGS

eggs): Not required. FOR USE IN ANIMAL FEEDS
(3) Swine. (i) Kidney, skin, and fat: 0.4
ppm. Subpart A—General Provisions
(ii) Liver: 0.3 ppm.
Sec.
(iii) Muscle: 0.1 ppm. 558.3 Definitions and general considerations
(c) Related conditions of use. See applicable to this part.
§ 558.635 of this chapter. 558.4 Requirement of a medicated feed mill
license.
[84 FR 32993, July 11, 2019, as amended at 85 558.5 Requirements for liquid medicated
FR 18121, Apr. 1, 2020] feed.
558.6 Veterinary feed directive drugs.
§ 556.760 Zeranol.
(a) Acceptable daily intake (ADI). The Subpart B—Specific New Animal Drugs For
Use in Animal Feeds
ADI for total residue of zeranol is 1.25
μg/kg of body weight per day. 558.55 Amprolium.
(b) Tolerances. The tolerances for 558.58 Amprolium and ethopabate.
zeranol are: 558.59 Apramycin.
558.68 Avilamycin.
(1) Cattle. Edible tissues (excluding 558.76 Bacitracin methylenedisalicylate.
milk): Not required. 558.78 Bacitracin zinc.
(2) Sheep. Edible tissues (excluding 558.95 Bambermycins.
milk): 20 ppb. 558.115 Carbadox.
(c) Related conditions of use. See 558.128 Chlortetracycline.
558.140 Chlortetracycline and
§ 522.2680 of this chapter. sulfamethazine.
558.175 Clopidol.
§ 556.765 Zilpaterol. 558.185 Coumaphos.
(a) Acceptable daily intake (ADI). The 558.195 Decoquinate.
558.198 Dichlorvos.
ADI for total residue of zilpaterol is
558.205 Diclazuril.
0.083 μg/kg of body weight per day. 558.235 Efrotomycin.
(b) Tolerances. The tolerance for 558.248 Erythromycin.
zilpaterol freebase (marker residue) is: 558.254 Famphur.
(1) Cattle. (i) Liver (target tissue): 12 558.258 Fenbendazole.
558.261 Florfenicol.
ppb.
558.265 Halofuginone hydrobromide.
(ii) Muscle: 10 ppb. 558.274 Hygromycin B.
(2) [Reserved] 558.295 Iodinated casein.
(c) Related conditions of use. See 558.300 Ivermectin.
§ 558.665 of this chapter. 558.305 Laidlomycin.
558.311 Lasalocid.
[84 FR 32993, July 11, 2019, as amended at 85 558.325 Lincomycin.
FR 18121, Apr. 1, 2020] 558.330 Lubabegron.
558.340 Maduramicin.
§ 556.770 Zoalene. 558.342 Melengestrol.
558.348 Mibolerone.
(a) [Reserved] 558.355 Monensin.
(b) Tolerances. The tolerances for 558.360 Morantel.
zoalene and its metabolite 3-amino-5- 558.363 Narasin.
nitro-o-toluamide are: 558.364 Narasin and nicarbazin.
558.365 Neomycin sulfate.
(1) Chickens. (i) Liver and kidney: 6 558.366 Nicarbazin.
ppm. 558.415 Novobiocin.
(ii) Muscle: 3 ppm. 558.430 Nystatin.
(iii) Fat: 2 ppm. 558.450 Oxytetracycline.
(2) Turkeys. Liver and muscle: 3 ppm. 558.455 Oxytetracycline and neomycin.
558.464 Poloxalene.
(c) Related conditions of use. See 558.470 Polyoxyethylene.
§ 558.680 of this chapter. 558.485 Pyrantel.
558.500 Ractopamine.
558.515 Robenidine.
558.550 Salinomycin.
558.555 Semduramicin.
420
558.575 Sulfadimethoxine and ormetoprim. chapter or an index listing granted
558.582 Sulfamerazine. under § 516.151 of this chapter.
558.586 Sulfaquinoxaline. (3) A ‘‘Type B medicated feed’’ is in-
558.600 Thiabendazole.
558.612 Tiamulin. tended solely for the manufacture of
558.618 Tilmicosin. other medicated feeds (Type B or Type
558.625 Tylosin. C). It contains a substantial quantity
558.630 Tylosin and sulfamethazine. of nutrients including vitamins and/or
558.633 Tylvalosin. minerals and/or other nutritional in-
558.635 Virginiamycin. gredients in an amount not less than 25
558.665 Zilpaterol.
percent of the weight. It is manufac-
558.680 Zoalene.
tured by diluting a Type A medicated
AUTHORITY: 21 U.S.C. 354, 360b, 360ccc, article or another Type B medicated
360ccc–1, 371. feed. The maximum concentration of
SOURCE: 40 FR 13959, Mar. 27, 1975, unless animal drug(s) in a Type B medicated
otherwise noted. feed is 200 times the highest continuous
use level for Category I drugs and 100
Subpart A—General Provisions times the highest continuous use level
for Category II drugs. The term ‘‘high-
§ 558.3 Definitions and general consid- est continuous use level’’ means the
erations applicable to this part. highest dosage at which the drug is ap-
(a) Regulations in this part provide proved for continuous use (14 days or
for approved uses of drugs and com- more), or, if the drug is not approved
binations of drugs in animal feeds. Ap- for continuous use, it means the high-
proved combinations of such drugs are est level used for disease prevention or
specifically identified or incorporated control. If the drug is approved for
by cross-reference. Unless specifically multiple species at different use levels,
provided for by the regulations, a com- the highest approved level of use would
bination of two or more drugs is not govern under this definition. The man-
approved. ufacture of a Type B medicated feed
(b) The following definitions apply to from a Category II, Type A medicated
terms used in this part: article requires a medicated feed mill
(1) New animal drugs approved for license application approved under
use in animal feed are placed in two § 515.20 of this chapter.
categories as follows: (4) A ‘‘Type C medicated feed’’ is in-
(i) Category I—These drugs require tended as the complete feed for the ani-
no withdrawal period at the lowest use mal or may be fed ‘‘top dressed’’ (added
level in each major species for which on top of usual ration) on or offered
they are approved or are approved for ‘‘free-choice’’ (e.g., supplement) in con-
use only in minor species. junction with other animal feed. It
(ii) Category II—These drugs require contains a substantial quantity of nu-
a withdrawal period at the lowest use trients including vitamins, minerals,
level for at least one major species for and/or other nutritional ingredients. It
which they are approved, or are regu- is manufactured by diluting a Type A
lated on a ‘‘no-residue’’ basis or with a medicated article or a Type B medi-
zero tolerance because of carcinogenic cated feed. A Type C medicated feed
concern regardless of whether a with- may be further diluted to produce an-
drawal period is required in any spe- other Type C medicated feed. The man-
cies. ufacture of a Type C medicated feed
(2) A ‘‘Type A medicated article’’ is from a Category II, Type A medicated
intended solely for use in the manufac- article requires a medicated feed mill
ture of another Type A medicated arti- license application approved under
cle or a Type B or Type C medicated § 515.20 of this chapter.
feed. It consists of a new animal (5) A Type B or Type C medicated
drug(s), with or without carrier (e.g., feed manufactured from a drug compo-
calcium carbonate, rice hull, corn, glu- nent (bulk or ‘‘drum-run’’ (dried crude
ten) with or without inactive ingredi- fermentation product)) requires an ap-
ents. The manufacture of a Type A plication approved under § 514.105 of
medicated article requires an applica- this chapter or an index listing granted

tion approved under § 514.105 of this under § 516.151 of this chapter.
421
§ 558.4 21 CFR Ch. I (4–1–23 Edition)
(6) A ‘‘veterinary feed directive (ii) That the distributor will not ship
(VFD) drug’’ is a drug intended for use such VFD feed to another distributor
in or on animal feed which is limited without receiving a similar written ac-
by an approved application filed pursu- knowledgment letter, and
ant to section 512(b) of the Federal (iii) That the distributor has com-
Food, Drug, and Cosmetic Act, a condi- plied with the distributor notification
tionally approved application filed pur- requirements of § 558.6(c)(5).
suant to section 571 of the Federal (12) A ‘‘combination veterinary feed
Food, Drug, and Cosmetic Act, or an directive (VFD) drug’’ is a combination
index listing under section 572 of the new animal drug (as defined in
Federal Food, Drug, and Cosmetic Act § 514.4(c)(1)(i) of this chapter) intended
to use under the professional super- for use in or on animal feed which is
vision of a licensed veterinarian. Use of limited by an approved application
animal feed bearing or containing a filed under section 512(b) of the Federal
VFD drug must be authorized by a law- Food, Drug, and Cosmetic Act, a condi-
ful veterinary feed directive. tionally approved application filed
(7) A ‘‘veterinary feed directive’’ is a under section 571 of the Federal Food,
written (nonverbal) statement issued Drug, and Cosmetic Act, or an index
by a licensed veterinarian in the course listing under section 572 of the Federal
of the veterinarian’s professional prac- Food, Drug, and Cosmetic Act to use
tice that orders the use of a VFD drug under the professional supervision of a
or combination VFD drug in or on an licensed veterinarian, and at least one
animal feed. This written statement of the new animal drugs in the com-
authorizes the client (the owner of the bination is a VFD drug. Use of animal
animal or animals or other caretaker) feed bearing or containing a combina-
to obtain and use animal feed bearing tion VFD drug must be authorized by a
or containing a VFD drug or combina- lawful VFD.
tion VFD drug to treat the client’s ani-
(13) ‘‘Major species’’ means cattle,
mals only in accordance with the con-
horses, swine, chickens, turkeys, dogs,
ditions for use approved, conditionally
and cats.
approved, or indexed by the Food and
Drug Administration. (14) ‘‘Minor species’’ means animals,
(8) A ‘‘medicated feed’’ means a Type other than humans, that are not major
B medicated feed as defined in para- species.
graph (b)(3) of this section or a Type C [51 FR 7392, Mar. 3, 1986, as amended at 52 FR
medicated feed as defined in paragraph 2682, Jan. 26, 1987; 54 FR 51386, Dec. 15, 1989;
(b)(4) of this section. 56 FR 19268, Apr. 26, 1991; 64 FR 63206, Nov. 19,
(9) For the purposes of this part, a 1999; 65 FR 76929, Dec. 8, 2000; 72 FR 69130,
‘‘distributor’’ means any person who Dec. 6, 2007; 80 FR 31733, June 3, 2015; 81 FR
57800, Aug. 24, 2016]
distributes a medicated feed containing
a VFD drug to another person. Such § 558.4 Requirement of a medicated
other person may be another dis- feed mill license.
tributor or the client-recipient of a
VFD. (a) A feed manufacturing facility
(10) An ‘‘animal production facility’’ must possess a medicated feed mill li-
is a location where animals are raised cense in order to manufacture a Type B
for any purpose, but does not include or Type C medicated feed from a Cat-
the specific location where medicated egory II, Type A medicated article.
feed is made. (b) The manufacture of the following
(11) An ‘‘acknowledgment letter’’ is a types of feed are exempt from the re-
written (nonverbal) communication quired license, unless otherwise speci-
provided to a distributor (consignor) fied:
from another distributor (consignee). (1) Type B or Type C medicated feed
An acknowledgment letter must be using Category I, Type A medicated ar-
provided either in hardcopy or through ticles or Category I, Type B or Type C
electronic media and must affirm: medicated feeds; and
(i) That the distributor will not ship (2) Type B or Type C medicated feed
such VFD feed to an animal production using Category II, Type B or Type C
facility that does not have a VFD, medicated feeds.
422
(c) The use of Type B and Type C of drug in Type B medicated feeds, and
medicated feeds shall also conform to the assay limits for the drug in Type A
the conditions of use provided for in medicated articles and Type B and
subpart B of this part. Type C medicated feeds, as follows:
(d) This paragraph identifies each
drug by category, the maximum level
CATEGORY I
Assay limits
Drug percent 1 Type B maximum (200x) Assay limits percent 1 Type B/C 2
Type A
Amprolium with Ethopabate ......... 94–114 22.75 g/lb (5.0%) ........................ 80–120.
Avilamycin .................................... 90–110 7.3 g/lb (1.6%) ............................ 80–110.
Bacitracin methylenedisalicylate .. 85–115 25.0 g/lb (5.5%) ........................... 70–130.
Bacitracin zinc .............................. 84–115 5.0 g/lb (1.1%) ............................ 70–130.
Bambermycins .............................. 90–110 800 g/ton (0.09%) ....................... 80–120/70–130.
Chlortetracycline ........................... 85–115 40.0 g/lb (8.8%) .......................... 80–115/70–130.
Coumaphos .................................. 95–115 6.0 g/lb (1.3%) ............................ 80–120.
Decoquinate ................................. 90–105 2.72 g/lb (0.6%) ........................... 80–120.
Dichlorvos ..................................... 100–115 33.0 g/lb (7.3%) .......................... 90–120/80–130.
Diclazuril ....................................... 90–110 182 g/t (0.02%) ........................... 85–115/70–120.
Efrotomycin ................................... 94–113 1.45 g/lb (0.32%) ........................ 80–120.
Iodinated casein ........................... 85–115 20.0 g/lb (4.4%) .......................... 75–125.
Laidlomycin propionate potassium 90–110 1 g/lb (0.22%) ............................. 90–115/85–115.
Lasalocid ...................................... 95–115 40.0 g/lb (8.8%) ........................... Type B (cattle and sheep): 80–120; Type
C (all): 75–125.
Lincomycin .................................... 90–115 20.0 g/lb (4.4%) ........................... 80–130.
Lubabegron .................................. 87–107 908 g/ton ..................................... 85–115/80–120.
Melengestrol acetate .................... 90–110 10.0 g/ton (0.0011%) .................. 70–120.
Monensin ...................................... 85–115 40.0 g/lb (8.8%) .......................... Chickens, turkeys, and quail: 75–125;
Cattle: 5–10 g/ton 80–120; Cattle: 10–
30 g/ton 85–115; Goats: 20 g/ton 85–
115; Liq. feed: 80–120.
Narasin ......................................... 90–110 9.0 g/lb (1.98%) .......................... 85–115/75–125.
Nicarbazin (granular) ............. 90–110 9.0 g/lb (1.98%) .......................... 85–115/75–125.
Narasin ......................................... 90–110 9.0 g/lb (1.98%) .......................... 85–115/75–125.
Nystatin ......................................... 85–125 5.0 g/lb (1.1%) ............................ 75–125.
Oxytetracycline ............................. 90–120 20.0 g/lb (4.4%) .......................... 75–125/65–135.
Poloxalene .................................... 90–110 54.48 g/lb (12.0%) ...................... Liq. feed: 85–115.
Ractopamine ................................ 85–105 2.46 g/lb (0.54%) ......................... 80–110/75–125.
Salinomycin .................................. 90–110 6.0 g/lb (1.3%) ............................ 80–120.
Semduramicin (as semduramicin 90–110 2.27 g/lb (0.50%) ......................... 80–110
sodium).
Semduramicin (as semduramicin 90–110 2.27 g/lb (0.50%) ......................... 80–120
sodium biomass).
Tylosin .......................................... 80–120 10.0 g/lb (2.2%) .......................... 75–125.
Tylvalosin ...................................... 90–110 3.86 g/lb ...................................... 85–115.
Virginiamycin ................................ 85–115 10.0 g/lb (2.2%) .......................... 70–130.
Zoalene ......................................... 92–104 11.35 g/lb (2.5%) ........................ 85–115.
1 Percent of labeled amount.
2 Values given represent ranges for either Type B or Type C medicated feeds. For those drugs that have two range limits, the
first set is for a Type B medicated feed and the second set is for a Type C medicated feed. These values (ranges) have been
assigned in order to provide for the possibility of dilution of a Type B medicated feed with lower assay limits to make Type C
medicated feed.
CATEGORY II
Assay limits
Type A
Amprolium .................................... 94–114 11.35 g/lb (2.5%) ......................... 80–120.

Apramycin ..................................... 88–112 7.5 g/lb (1.65%) .......................... 80–120.
Carbadox ...................................... 90–110 2.5 g/lb (0.55%) .......................... 75–125.
Clopidol ......................................... 94–106 11.4 g/lb (2.5%) .......................... 90–115/80–120.
Erythromycin ................................. 85–115 4.625 g/lb (1.02%) ....................... 75–125.
Famphur ....................................... 100–110 5.5 g/lb (1.21%) .......................... 90–115/80–120.
Fenbendazole ............................... 93–113 8.87 g/lb (1.96%) ........................ 75–125.
Florfenicol ..................................... 90–110 9.1 g/lb (2.0%) ............................ Swine feed: 85–115
Catfish feed: 80–110.
Salmonid feed: 80–110.

Halofuginone hydrobromide ......... 90–115 272.0 g/ton (.03%) ...................... 75–125.
Hygromycin B ............................... 90–110 1,200 g/ton (0.13%) .................... 75–125.
423
§ 558.5 21 CFR Ch. I (4–1–23 Edition)
CATEGORY II—Continued
Assay limits
Type A
Ivermectin ..................................... 95–105 1,180 g/ton (0.13%) .................... 80–110.

Maduramicin ammonium .............. 90–110 545 g/ton (.06%) ......................... 80–120.
Morantel tartrate ........................... 90–110 66.0 g/lb (14.52%) ....................... 85–115.
Neomycin ...................................... 80–120 20 g/lb (4.4%) .............................. 70–125.
Oxytetracycline ............................. 80–120 20 g/lb (4.4%) .............................. 65–135.
Neomycin sulfate ................... 80–120 100 g/lb (22.0%) .......................... 70–125.
Nicarbazin (granular) .................... 90–110 5.675 g/lb (1.25%) ....................... 85–115/75–125.
Nicarbazin (powder) ..................... 96–104 9.08 g/lb (2.00%) ........................ 85–115/80–120.
Novobiocin .................................... 85–115 17.5 g/lb (3.85%) ........................ 80–120.
Pyrantel tartrate ............................ 90–110 36 g/lb (7.9%) .............................. 75–125.
Robenidine ................................... 95–115 1.5 g/lb (0.33%) ........................... 80–120.
Sulfadimethoxine .......................... 90–110 Poultry: 5.675 g/lb ....................... 80–115/75–125.
Fish: 85.1 g/lb .............................
Ormetoprim ........................... 90–110 Poultry: 3.405 g/lb ....................... 80–115.
Fish: 17.0 g/lb .............................
Sulfamerazine ............................... 85–115 18.6 g/lb (4.0%) ........................... 85–115.
Sulfamethazine ............................. 85–115 10.0 g/lb (2.2%) .......................... 80–120.
Chlortetracycline .................... 85–115 10.0 g/lb (2.2%) .......................... 85–125/70–130.
Sulfamethazine ............................. 85–115 10.0 g/lb (2.2%) .......................... 80–120.
Tylosin ................................... 80–120 10.0 g/lb (2.2%) .......................... 75–125.
Sulfaquinoxaline ........................... 98–106 11.2 g/lb (2.5%) .......................... 85–115.
Thiabendazole .............................. 94–106 45.4 g/lb (10.0%) ........................ >7% 85–115; <7% 90–110.
Tiamulin hydrogen fumarate ........ 90–115 10 g/lb ......................................... 90–115/70–130.
Tilmicosin ...................................... 90–110 37.9 g/lb (8.35%) ......................... Swine Type B/C feed: 85–115.
Cattle Type B feed: 85–115.
Cattle Type C feed: 80–110.
Zilpaterol ....................................... 90–110 680 g/t (0.075%) ......................... 80–110/75–115.
1 Percent of labeled amount.
2 Values given represent ranges for either Type B or Type C medicated feeds. For those drugs that have two range limit, the
first set is for a Type B medicated feed and the second set is for a Type C medicated feed. These values (ranges) have been
assigned in order to provide for the possibility of dilution of a Type B medicated feed with lower assay limits to make a Type C
medicated feed.
(e) When drugs from both categories (b) How is liquid free-choice medicated
are in combination, the Category II re- feed regulated? Liquid free-choice medi-
quirements will apply to the combina- cated feed is covered by this section
tion drug product. and by § 510.455.
(c) What is required for new animal
[51 FR 7392, Mar. 3, 1986]
drugs intended for use in liquid feed? Any
EDITORIAL NOTE: For FEDERAL REGISTER ci- new animal drug intended for use in
tations affecting § 558.4, see the List of CFR liquid feed must be approved for such
Sections Affected, which appears in the use under section 512 of the Federal
Finding Aids section of the printed volume Food, Drug, and Cosmetic Act (the act)
or index listed under section 572 of the
act. Such approvals under section 512
§ 558.5 Requirements for liquid medi-
cated feed. of the act must be:
(1) An original NADA,
(a) What types of liquid medicated feeds (2) A supplemental NADA, or
are covered by this section? This section (3) An abbreviated NADA.
covers the following types of liquid
(d) What are the approval requirements
medicated feed: under section 512 of the act for new ani-
(1) Type B feed that is intended for mal drugs intended for use in liquid feed?
further manufacture of other medi- An approval under section 512 of the
cated feeds (§ 558.3(b)(3)) or: act for a new animal drug intended for
(2) Type C feed that is intended for use in liquid feed must contain the fol-
the following: lowing information:
(i) Further manufacture of another (1) Data, or a reference to data in a
Type C feed, or master file (MF), that shows the rel-
(ii) Top-dressing (adding on top of the evant ranges of conditions under which
usual ration) (§ 558.3(b)(4)). the drug will be chemically stable in
424
liquid feed under field use conditions; animal feed or drinking water but not in
and liquid medicated feed, from being diverted
(2) Data, or a reference to data in an to use in liquid feeds? Any product con-
MF, that shows that the drug is phys- taining any form of bacitracin, oxytet-
ically stable in liquid feed under field racycline, or chlortetracycline, in-
conditions; or tended for oral administration via ani-
(3) Feed labeling with recirculation mal feed and/or drinking water, and
or agitation directions as follows: not approved for use in a liquid medi-
(i) For liquid feeds stored in recircu- cated feed must include in its labeling
lating tank systems: Recirculate im- the following statement: ‘‘FOR USE IN
mediately prior to use for not less than ___ ONLY. NOT FOR USE IN LIQUID
10 minutes, moving not less than 1 per- MEDICATED FEEDS.’’ The blank may
cent of the tank contents per minute be filled in with the words: ‘‘DRY
from the bottom of the tank to the top. FEEDS’’, ‘‘DRINKING WATER’’, or
Recirculate daily as described even ‘‘DRY FEEDS AND DRINKING
when not used. WATER’’.
(ii) For liquid feeds stored in me- (i) Can the labeling provisions of para-
chanical, air, or other agitation-type graph (h) of this section be waived, and
tank systems: Agitate immediately how can I apply for a waiver? (1) The la-
prior to use for not less than 10 min- beling provisions of paragraph (h) of
utes, creating a turbulence at the bot- this section may be waived if there is
tom of the tank that is visible at the evidence to indicate that it is unlikely
top. Agitate daily as described even a new animal drug would be used in the
when not used. manufacture of a liquid medicated
(e) How are chemical and physical sta- feed.
bility data to be submitted? The data (2) To obtain a waiver, you must sub-
must be submitted as follows: mit a letter requesting a waiver to the
(1) Directly in the NADA, Office of New Animal Drug Evaluation
(2) By a sponsor, or (HFV–100), Center for Veterinary Medi-
(3) To an MF that a sponsor may then cine, Food and Drug Administration,
reference in its NADA with written 7500 Standish Pl., Rockville, MD 20855.
consent of the MF holder. (3) The letter must include a copy of
(f) What will be stated in the published the product label; a description of the
approval for a new animal drug intended formulation; and information to estab-
for use in liquid feed? The approval of a lish that the physical, chemical, or
new animal drug intended for use in other properties of the new animal
liquid feed as published in this sub- drug are such that diversion to use in
chapter will include the following re- liquid medicated feed is unlikely.
quirements: (j) What else do I need to know about
(1) The formula and/or specifications the labeling provisions of paragraph (h) of
of the liquid medicated feed, where the this section? The labeling provisions of
owner of this information requests paragraph (h) of this section may be
such publication; and/or implemented without prior approval as
(2) A statement that the approval has provided for in § 514.8(c)(3) of this chap-
been granted for a proprietary formula ter.
and/or specifications. [69 FR 30197, May 27, 2004, as amended at 71
(g) When is a medicated feed mill license FR 74785, Dec. 13, 2006; 72 FR 69131, Dec. 6,
required for the manufacture of a liquid 2007]
medicated feed? An approved medicated
feed mill license is required for the § 558.6 Veterinary feed directive
manufacture of the following types of drugs.
feeds: (a) General requirements related to vet-
(1) All liquid medicated feeds that erinary feed directive (VFD) drugs. (1)
contain a Category II drug, and Animal feed bearing or containing a
(2) Liquid medicated feeds that con- VFD drug or a combination VFD drug
tain a Category I drug and use a propri- (a VFD feed or combination VFD feed)
etary formula and/or specifications. may be fed to animals only by or upon
(h) What measures are in place to pre- a lawful VFD issued by a licensed vet-
vent certain drugs, approved for use in erinarian.
425
§ 558.6 21 CFR Ch. I (4–1–23 Edition)
(2) A VFD feed or combination VFD (3) The veterinarian must ensure that
feed must not be fed to animals after the following information is fully and
the expiration date on the VFD. accurately included on the VFD:
(3) Use and labeling of a VFD drug or (i) The veterinarian’s name, address,
a combination VFD drug in feed is lim- and telephone number;
ited to the approved, conditionally ap- (ii) The client’s name, business or
proved, or indexed conditions of use. home address, and telephone number;
Use of feed containing this veterinary (iii) The premises at which the ani-
feed directive (VFD) drug in a manner mals specified in the VFD are located;
other than as directed on the labeling (iv) The date of VFD issuance;
(extralabel use) is not permitted. (v) The expiration date of the VFD.
(4) All involved parties (the veteri- This date must not extend beyond the
narian, the distributor, and the client) expiration date specified in the ap-
must retain a copy of the VFD for 2 proval, conditional approval, or index
years. The veterinarian must retain listing, if such date is specified. In
the original VFD in its original form cases where the expiration date is not
(electronic or hardcopy). The dis- specified in the approval, conditional
tributor and client copies may be kept approval, or index listing, the expira-
as an electronic copy or hardcopy. tion date of the VFD must not exceed
(5) All involved parties must make 6 months after the date of issuance;
the VFD and any other records speci- (vi) The name of the VFD drug(s);
fied in this section available for inspec- (vii) The species and production class
tion and copying by FDA upon request. of animals to be fed the VFD feed;
(6) All labeling and advertising for (viii) The approximate number of
VFD drugs, combination VFD drugs, animals to be fed the VFD feed by the
and feeds containing VFD drugs or expiration date of the VFD. The ap-
combination VFD drugs must promi- proximate number of animals is the po-
nently and conspicuously display the tential number of animals of the spe-
following cautionary statement: ‘‘Cau- cies and production class identified on
tion: Federal law restricts medicated the VFD that will be fed the VFD feed
feed containing this veterinary feed di- or combination VFD feed at the speci-
rective (VFD) drug to use by or on the fied premises by the expiration date of
order of a licensed veterinarian.’’ the VFD;
(b) Responsibilities of the veterinarian (ix) The indication for which the
issuing the VFD. (1) In order for a VFD VFD is issued;
to be lawful, the veterinarian issuing (x) The level of VFD drug in the VFD
the VFD must: feed and duration of use;
(i) Be licensed to practice veterinary (xi) The withdrawal time, special in-
medicine; and structions, and cautionary statements
(ii) Be operating in the course of the necessary for use of the drug in con-
veterinarian’s professional practice formance with the approval;
and in compliance with all applicable (xii) The number of reorders (refills)
veterinary licensing and practice re- authorized, if permitted by the drug
quirements, including issuing the VFD approval, conditional approval, or
in the context of a veterinarian-client- index listing. In cases where reorders
patient relationship (VCPR) as defined (refills) are not specified on the label-
by the State. If applicable VCPR re- ing for an approved, conditionally ap-
quirements as defined by such State do proved, or index listed VFD drug, reor-
not include the key elements of a valid ders (refills) are not permitted;
VCPR as defined in § 530.3(i) of this (xiii) The statement: ‘‘Use of feed
chapter, the veterinarian must issue containing this veterinary feed direc-
the VFD in the context of a valid tive (VFD) drug in a manner other
VCPR as defined in § 530.3(i) of this than as directed on the labeling
chapter. (extralabel use) is not permitted.’’;
(2) The veterinarian must only issue (xiv) An affirmation of intent for
a VFD that is in compliance with the combination VFD drugs as described in
conditions for use approved, condi- paragraph (6) of this section; and
tionally approved, or indexed for the (xv) The veterinarian’s electronic or

VFD drug or combination VFD drug. written signature.
426
(4) The veterinarian may, at his or (7) The veterinarian must issue a
her discretion, enter the following in- written (nonverbal) VFD.
formation on the VFD to more specifi- (8) The veterinarian must send a copy
cally identify the animals authorized of the VFD to the distributor via
to be treated/fed the VFD feed: hardcopy, facsimile (fax), or electroni-
(i) A more specific description of the cally. If in hardcopy, the veterinarian
location of animals (e.g., by site, pen, must send the copy of the VFD to the
barn, stall, tank, or other descriptor distributor either directly or through
that the veterinarian deems appro- the client.
priate); (9) The veterinarian must provide a
(ii) The approximate age range of the copy of the VFD to the client.
animals; (c) Responsibilities of any person who
(iii) The approximate weight range of distributes an animal feed containing a
the animals; and VFD drug or a combination VFD drug. (1)
The distributor is permitted to fill a
(iv) Any other information the vet-
VFD only if the VFD contains all the
erinarian deems appropriate to identify
information required in paragraph
the animals specified in the VFD.
(b)(3) of this section.
(5) For VFDs intended to authorize (2) The distributor is permitted to
the use of an approved, conditionally distribute an animal feed containing a
approved, or indexed combination VFD VFD drug or combination VFD drug
drug that includes more than one VFD only if it complies with the terms of
drug, the veterinarian must include the the VFD and is manufactured and la-
drug-specific information required in beled in conformity with the approved,
paragraphs (b)(3)(vi), (ix), (x), and (xi) conditionally approved, or indexed con-
of this section for each VFD drug in ditions of use for such drug.
the combination. (3) The distributor must keep records
(6) The veterinarian may restrict of the receipt and distribution of all
VFD authorization to only include the medicated animal feed containing a
VFD drug(s) cited on the VFD or may VFD drug for 2 years.
expand such authorization to allow the (4) In addition to other applicable
use of the cited VFD drug(s) along with recordkeeping requirements found in
one or more over-the-counter (OTC) this section, if the distributor manu-
animal drugs in an approved, condi- factures the animal feed bearing or
tionally approved, or indexed combina- containing the VFD drug, the dis-
tion VFD drug. The veterinarian must tributor must also keep VFD feed man-
affirm his or her intent regarding com- ufacturing records for 1 year in accord-
bination VFD drugs by including one of ance with part 225 of this chapter. Such
the following statements on the VFD: records must be made available for in-
(i) ‘‘This VFD only authorizes the use spection and copying by FDA upon re-
of the VFD drug(s) cited in this order quest.
and is not intended to authorize the (5) A distributor of animal feed con-
use of such drug(s) in combination with taining a VFD drug must notify FDA
any other animal drugs.’’ prior to the first time it distributes
(ii) ‘‘This VFD authorizes the use of animal feed containing a VFD drug.
the VFD drug(s) cited in this order in The notification is required one time
the following FDA-approved, condi- per distributor and must include the
tionally approved, or indexed combina- following information:
tion(s) in medicated feed that contains (i) The distributor’s complete name
the VFD drug(s) as a component.’’ [List and business address;
specific approved, conditionally ap- (ii) The distributor’s signature or the
proved, or indexed combination medi- signature of the distributor’s author-
cated feeds following this statement.] ized agent; and
(iii) ‘‘This VFD authorizes the use of (iii) The date the notification was
the VFD drug(s) cited in this order in signed.
any FDA-approved, conditionally ap- (6) A distributor must also notify
proved, or indexed combination(s) in FDA within 30 days of any change in
medicated feed that contains the VFD ownership, business name, or business
drug(s) as a component.’’ address.
427
§ 558.55 21 CFR Ch. I (4–1–23 Edition)
(7) The notifications cited in para- consignee distributor’s acknowledg-

graphs (c)(5) and (6) of this section ment letter for 2 years.
must be submitted to the Food and [80 FR 31733, June 3, 2015; 80 FR 35841, June
Drug Administration, Center for Vet- 23, 2015, as amended at 85 FR 50784, Aug. 18,
erinary Medicine, Division of Animal 2020]
Feeds (HFV–220), 12225 Wilkins Ave.,
Rockville, MD 20852, Fax: 240–453–6882, Subpart B—Specific New Animal
or email (via attachment): Drugs for Use in Animal Feeds
MedicatedFeedsTeamMail@fda.hhs.gov.
(8) A distributor is permitted to dis- § 558.55 Amprolium.
tribute a VFD feed to another dis- (a) Specifications. Type A medicated
tributor only if the originating dis- article containing 25 percent
tributor (consignor) first obtains a amprolium.
written (nonverbal) acknowledgment (b) Sponsor. No. 016592 in § 510.600(c) of
letter, as defined in § 558.3(b)(11), from this chapter.
the receiving distributor (consignee) (c) Related tolerances. See § 556.50 of
before the feed is shipped. Consignor this chapter.
distributors must retain a copy of each (d) Special considerations. Do not use
in Type B or Type C medicated feeds
containing bentonite.
(e) Conditions of use—(1) Cattle. It is
used as follows:
Amprolium in grams Indications for use Limitations Sponsor
per ton
(i) 113.5 to 11, 350; to Calves: As an aid in the prevention of coc- Top-dress on or mix in the daily ration. Feed 016592
provide 5 milligrams cidiosis caused by Eimeria bovis and E. for 21 days when experience indicates
per kilogram of zuernii. that coccidiosis is likely to be a hazard, as
body weight per the sole source of amprolium. Withdraw
day. 24 hours before slaughter. A withdrawal
period has not been established for this
product in preruminating calves. Do not
use in calves to be processed for veal.
(ii) 113.5 to 11, 350; Calves: As an aid in the treatment of coc- Top-dress on or mix in the daily ration. Feed 016592
to provide 10 milli- cidiosis caused by Eimeria bovis and E. for 5 days as the sole source of
grams per kilogram zuernii. amprolium. Withdraw 24 hours before
of body weight per slaughter. A withdrawal period has not
day. been established for this product in
preruminating calves. Do not use in
(2) Chickens. It is used as follows:

Amprolium in grams Combination in Indications for use Limitations Sponsor
per ton grams per ton
(i) 36.3 to 113.5 ...... ................................. Replacement chickens: For devel- Feed continuously until onset of 016592
opment of active immunity to production as follows:
coccidiosis.
Up to 5 weeks of age From 5 to 8 weeks of Over 8 weeks of age

age
Growing conditions Amprolium in grams Amprolium in grams
Amprolium in grams
per ton per ton
per ton
Severe exposure to coccidiosis .................................... 113.5 72.6–113.5 36.3–113.5

(0.0125%) (0.008%–0.0125%) (0.004%–0.0125%)
Moderate exposure to coccidiosis ................................. 72.6–113.5 54.5–113.5 36.3–113.5
(0.008%–0.0125%) (0.006%–0.0125%) (0.004%–0.0125%)
Slight exposure to coccidiosis ....................................... 36.3–113.5 36.3–113.5 36.3–113.5
(0.004%–0.0125%) (0.004%–0.0125%) (0.004%–0.0125%)
428

(ii) 36.3 to 113.5 ..... Bacitracin Replacement chickens: For devel- Feed according to subtable in 054771
methylenedisalicy- opment of active immunity to item (i). Bacitracin
late 4 to 50. coccidiosis; and for increased methylenedisalicylate as pro-
rate of weight gain and im- vided by No. 054771 in
proved feed efficiency. § 510.600(c) of this chapter.
(iii) 72.6 to 113.5 .... ................................. Broiler chickens: For prevention Feed continuously as the sole ra- 016592
of coccidiosis caused by tion; as sole source of
Eimeria tenella only. amprolium.
(iv) 72.6 to 113.5 .... Bambermycins 1 to Broiler chickens: For prevention Feed continuously as the sole ra- 016592
2. of coccidiosis caused by tion; as sole source of
Eimeria tenella only; and for in- amprolium. Bambermycins as
creased rate of weight gain and provided by No. 016592 in
improved feed efficiency. § 510.600(c) of this chapter.
(v) 113.5 ................. ................................. 1. Laying chickens: For preven- Feed continuously as the sole ra- 016592
tion of coccidiosis. tion; as the sole source of
amprolium.
2. Laying chickens: For treatment Feed for 2 weeks.
of coccidiosis in moderate out-
breaks.
(vi) 113.5 to 227 ..... ................................. 1. Replacement chickens: For Feed continuously from day-old 016592
prevention of coccidiosis where until onset of production; as the
immunity to coccidiosis is not sole source of amprolium.
desired.
2. Broiler chickens: For preven- Feed continuously as the sole ra-
tion of coccidiosis where immu- tion; as sole source of
nity to coccidiosis is not desired. amprolium.
(vii) 113.5 to 227 .... Bambermycins 1 to Broiler chickens: For prevention Feed continuously as the sole ra- 016592
2. of coccidiosis where immunity tion; as sole source of
to coccidiosis is not desired; amprolium. Bambermycins as
and for increased rate of weight provided by No. 016592 in
gain and improved feed effi- § 510.600(c) of this chapter.
ciency.
(viii) 227 .................. ................................. Laying chickens: For treatment of Feed for 2 weeks ......................... 016592
coccidiosis in severe outbreaks..
(3) Turkeys. It is used as follows:

(i) 113.5 .................. Bambermycins 1 to Growing turkeys: For prevention Feed continuously as the sole 016592
4. of coccidiosis; and for in- source of amprolium;
creased rate of weight gain and bambermycins as provided by
improved feed efficiency. No. 016592 in § 510.600(c) of
this chapter.
(ii) 113.5 to 227 ...... ................................. Turkeys: For prevention of coc- Feed continuously as the sole ra- 016592
cidiosis. tion; as sole source of
amprolium.
(4) Pheasants. It is used as follows:

(i) 159 ..................... ................................. Growing pheasants: For the pre- Feed continuously as sole ration. 016592
vention of coccidiosis caused Use as sole source of
by Eimeria colchici, E. amprolium.
duodenalis, and E. phasiani.
(ii) [Reserved]
(5) Permitted combinations. Amprolium (ii) [Reserved]

may also be used in combination with:
[41 FR 10985, Mar. 15, 1976]
(i) Virginiamycin as in § 558.635.

429
§ 558.58 21 CFR Ch. I (4–1–23 Edition)
Sections Affected, which appears in the amprolium and 0.16 percent
Finding Aids section of the printed volume ethopabate.
§ 558.58 Amprolium and ethopabate. § 510.600(c) of this chapter.
(c) Related tolerances. See §§ 556.50 and
(a) Specifications. Type A medicated
articles containing: 556.260 of this chapter.
(1) 25 percent amprolium and 8 per- (d) Special considerations. Do not use
cent ethopabate or 5 percent in Type B or Type C medicated feeds
amprolium and 1.6 percent ethopabate; containing bentonite.
(2) 25 percent amprolium and 0.8 per- (e) Conditions of use. It is used in
cent ethopabate or 5 percent chicken feed as follows:
Amprolium and Combination in
ethopabate in grams Indications for use Limitations Sponsor
grams per ton
per ton
(1) Amprolium 113.5 ................................. Broiler chickens: As an aid in the Feed continuously as sole ration; 016592
and ethopabate prevention of coccidiosis. as sole source of amprolium.
3.6. Not for laying chickens.
(2) Amprolium 113.5 ................................. Broiler chickens and replacement Feed continuously as sole ration; 016592
and ethopabate chickens: where immunity to as sole source of amprolium.
36.3. coccidiosis is not desired: As Not for chickens over 16 weeks
an aid in the prevention of coc- of age.
cidiosis where severe exposure
to coccidiosis from Eimeria
acervulina, E. maxima, and E.
brunetti is likely to occur.
(3) Amprolium 113.5 Bacitracin 4 to 50 ... 1. Broiler chickens and replace- Feed as the sole ration from the 016592
and ethopabate ment chickens: where immunity time chickens are placed on lit-
36.3. to coccidiosis is not desired; to ter until past the time when
aid in prevention of coccidiosis coccidiosis is ordinarily a haz-
where severe exposure to coc- ard. Not for chickens over 16
cidiosis from Eimeria weeks of age; do not feed to
acervulina, E. maxima, and E. laying chickens; as sole source
brunetti is likely to occur; for in- of amprolium; not for use as a
creased rate of weight gain in treatment for outbreaks of coc-
broiler chickens raised in floor cidiosis. Bacitracin as bacitracin
pens. methylenedisalicylate as pro-
vided by No. 054771 in
(4) Amprolium 113.5 Bacitracin 4 to 50 ... 2. Broiler chickens: As an aid in Feed as the sole ration from the 054771
and ethopabate prevention of coccidiosis where time chickens are placed on lit-
36.3. severe exposure to coccidiosis ter until market weight. Not for
from Eimeria acervulina, E. chickens over 16 weeks of age;
maxima, and E. brunetti is likely do not feed to laying chickens;
to occur; for improved feed effi- as sole source of amprolium;
ciency. not for use as a treatment for
coccidiosis. Bacitracin zinc as
provided by No. 054771 in
(5) Amprolium 113.5 Bambermycins 1 to Broiler chickens: As an aid in the Feed continuously as the sole ra- 016592
and ethopabate 3. prevention of coccidiosis where tion; as sole source of
36.6. severe exposure to coccidiosis amprolium.
from Eimeria acervulina, E. Bambermycins as provided by
maxima, and E. brunetti is likely No. 016592 in § 510.600(c) of
to occur; for increased rate of this chapter.
weight gain, improved feed effi-
ciency.
(6) Amprolium 227 ................................. For broiler chickens and replace- Not for laying chickens ................. 016592
and ethopabate ment chickens where immunity
3.6. to coccidiosis is not desired;
prevention of coccidiosis.
(f) Amprolium and ethopabate may EDITORIAL NOTE: For FEDERAL REGISTER ci-
also be used in combination with: tations affecting § 558.58, see the List of CFR
(1)–(2) [Reserved] Sections Affected, which appears in the
(3) Chlortetracycline as in § 558.128.
[41 FR 10990, Mar. 15, 1976]
430
§ 558.59 Apramycin. this veterinary feed directive (VFD)

(a) Specifications. Type A articles con- drug to use by or on the order of a li-
taining 75 grams apramycin (as censed veterinarian. See § 558.6 for addi-
apramycin sulfate) per pound. tional requirements.
(b) Sponsor. See No. 058198 in (2) The expiration date of VFDs for
§ 510.600(c) of this chapter. apramycin medicated feeds must not
(c) Related tolerances. See § 556.52 of exceed 6 months from the date of
this chapter. issuance. VFDs for apramycin shall not
(d) Special considerations. (1) Federal be refilled.
law restricts medicated feed containing (e) Conditions of use in swine—
Apramycin Combination in Indications for use Limitations Sponsor
grams/ton grams/ton
(1) 150 ............................... ........................ For control of porcine colibacillosis Feed as the sole ration for 058198
(weanling pig scours) caused by sus- 14 consecutive days.
ceptible strains of Escherichia coli. Withdraw 28 days be-
fore slaughter.
(2) [Reserved].
[81 FR 94995, Dec. 27, 2016, as amended at 87 FR 10970, Feb. 28, 2022]
§ 558.68 Avilamycin. drug to use by or on the order of a li-

(a) Specifications. Each pound of Type censed veterinarian. See § 558.6 for addi-
A medicated article contains 45.4 or tional requirements.
90.7 grams of avilamycin. (2) The expiration date of VFDs for
(b) Sponsor. See No. 058198 in avilamycin medicated feeds must not
§ 510.600(c) of this chapter. exceed 90 days from the date of
(c) Related tolerances. See § 556.60 of issuance. VFDs for avilamycin shall
this chapter. not be refilled.
(d) Special considerations. (1) Federal (e) Conditions of use. Administer in
law restricts medicated feed containing feed as follows:
this veterinary feed directive (VFD) (1) Chickens—
Avilamycin in Combination in Indications for use Limitations Sponsor
grams/ton grams/ton
(i) 13.6 to 40.9 ...... ........................ Broiler chickens: For the preven- Feed as the sole ration for 21 con- 058198
tion of mortality caused by ne- secutive days. To assure re-
crotic enteritis associated with sponsible antimicrobial drug use
Clostridium perfringens in broiler in broiler chickens, treatment ad-
chickens. ministration must begin on or
before 18 days of age.
(ii) 13.6 to 40.9 ..... Monensin, 90 Broiler chickens: For the preven- Feed as the sole ration for 21 con- 058198
to 110 tion of mortality caused by ne- secutive days. To assure re-
crotic enteritis associated with sponsible antimicrobial drug use
Clostridium perfringens; and as in broiler chickens, treatment ad-
an aid in the prevention of coc- ministration must begin on or
cidiosis caused by Eimeria before 18 days of age. See
necatrix, E. tenella, E. § 558.355(d) of this chapter.
acervulina, E. brunetti, E. mivati, Monensin as provided by No.
and E. maxima.. 058198 in § 510.600(c) of this
chapter..
431
§ 558.68 21 CFR Ch. I (4–1–23 Edition)
Avilamycin in Combination in Indications for use Limitations Sponsor

grams/ton grams/ton
(iii) 13.6 to 40.9 .... Narasin, 54 to Broiler chickens: For the preven- Feed as the sole ration for 21 con- 058198
90 tion of mortality caused by ne- secutive days to chickens that
crotic enteritis associated with are at risk of developing, but not
Clostridium perfringens; and for yet showing clinical signs of, ne-
the prevention of coccidiosis crotic enteritis associated with
caused by Eimeria necatrix, E. Clostridium perfringens. To as-
tenella, E. acervulina, E. sure responsible antimicrobial
brunetti, E. mivati, and E. maxi- drug use in broiler chickens,
ma.. treatment administration must
begin on or before 18 days of
age. Do not allow adult turkeys,
horses, or other equines access
to narasin formulations. Inges-
tion of narasin by these species
has been fatal. Narasin as pro-
§ 510.600(c) of this chapter..
(iv) 13.6 to 40.9 .... Narasin, 27 to Broiler chickens: For the preven- Feed as the sole ration for 21 con- 058198
45 plus tion of mortality caused by ne- secutive days to chickens that
nicarbazin, 27 crotic enteritis associated with are at risk of developing, but not
to 45 Clostridium perfringens; and for yet showing clinical signs of, ne-
the prevention of coccidiosis crotic enteritis associated with
caused by Eimeria necatrix, E. Clostridium perfringens.
tenella, E. acervulina, E. Avilamycin has not been dem-
brunetti, E. mivati, and E. maxi- onstrated to be effective in broil-
ma. er chickens showing clinical
signs of necrotic enteritis prior to
the start of medication. To as-
sure responsible antimicrobial
drug use in broiler chickens,
treatment administration must
age. The safety of avilamycin
has not been established in
chickens intended for breeding
purposes. Do not allow adult tur-
keys, horses, or other equines
access to narasin formulations.
Ingestion of narasin by these
species has been fatal. Do not
feed to chickens producing eggs
for human consumption. Narasin
and nicarbazin as provided by
No. 058198 in § 510.600(c) of
this chapter.
(v) 13.6 to 40.9 ..... Salinomycin Broiler chickens: For the preven- Feed as the sole ration for 21 con- 058198
sodium, 40 to tion of mortality caused by ne- secutive days. Feed to chickens
60 crotic enteritis associated with that are at risk of developing,
Clostridium perfringens; and for but not yet showing clinical
the prevention of coccidiosis signs of, necrotic enteritis asso-
caused by Eimeria tenella, E. ciated with Clostridium
necatrix, E. acervulina, E. maxi- perfringens. Not approved for
ma, E. brunetti, and E. mivati.. use with pellet binders. To as-
sure responsible antimicrobial
drug use in broiler chickens,
treatment administration must
age. The safety of avilamycin
has not been established in
chickens intended for breeding
purposes. Avilamycin has not
been demonstrated to be effec-
tive in broiler chickens showing
clinical signs of necrotic enteritis
prior to the start of medication.
Do not feed to laying hens pro-
ducing eggs for human con-
sumption. May be fatal if fed to
adult turkeys or to horses.
Salinomycin as provided by No.
016592 in § 510.600(c) of this

chapter..
432
(2) Swine—
Avilamycin in Combinationin Indications for use Limitations Sponsor
grams/ton grams/ton
(i) 73 ..................... ........................ Weaned pigs less than 14 weeks Feed as the sole ration for 21 con- 058198
of age: For the reduction in inci- secutive days. To assure re-
dence and overall severity of di- sponsible antimicrobial drug use
arrhea in the presence of patho- in pigs, do not administer to pigs
genic Escherichia coli in groups 14 weeks of age or older.
of weaned pigs.
(ii) [Reserved].
[80 FR 61297, Oct. 13, 2015, as amended at 80 (2) Type A medicated article con-
FR 76387, Dec. 9, 2015; 81 FR 17609, Mar. 30, taining feed grade bacitracin
2016; 81 FR 48703, July 26, 2016; 81 FR 59134,
Aug. 29, 2016; 81 FR 67152, Sept. 30, 2016; 82 FR
methylenedisalicylate equivalent to 50
11509, Feb. 24, 2017; 83 FR 14587, Apr. 5, 2018; grams bacitracin per pound.
83 FR 64741, Dec. 18, 2018; 84 FR 8974, Mar. 13, (b) Sponsors. See sponsors in
2019; 84 FR 33001, July 11, 2019; 85 FR 4209, § 510.600(c) of this chapter as follows:
Jan. 24, 2020; 85 FR 45308, July 28, 2020; 86 FR (1) No. 054771 for use of products in
13188, Mar. 8, 2021; 86 FR 14821, Mar. 19, 2021]
paragraph (a)(1) of this section as in
§ 558.76 Bacitracin paragraph (d) of this section.
methylenedisalicylate. (2) No. 069254 for use of product in
(a) Specifications. (1) Type A medi- paragraph (a)(2) of this section as in
cated articles containing feed grade paragraph (d) of this section.
bacitracin methylenedisalicylate (c) Related tolerances. See § 556.70 of
equivalent to 10, 25, 30, 40, 50, 60, or 75 this chapter.
grams bacitracin per pound. (d) Conditions of use—(1) Chickens—
Bacitracin in Indications for use Limitations Sponsor
grams per ton
(i) 4 to 50 ....................... Broiler and replacement chickens: For in- Feed continuously as sole ration .............. 054771
creased rate of weight gain and im- 069254
proved feed efficiency.
(ii) 10 to 25 .................... Laying hens: For increased egg produc- Feed continuously as sole ration for the 054771
tion and improved feed efficiency. first 7 months of egg production.
(iii) 50 ............................. Broiler and replacement chickens: As an Feed continuously as sole ration .............. 054771
aid in the prevention of necrotic enter-
itis caused or complicated by Clos-
tridium spp. or other organisms suscep-
tible to bacitracin.
(iv) 50 ............................. Broiler and replacement chickens: For the Feed as the sole ration for 28 to 35 days, 069254
prevention of mortality caused by ne- starting from the time chicks are placed
crotic enteritis associated with Clos- for brooding.
tridium perfringens.
(v) 100 to 200 ................ Broiler and replacement chickens: As an Feed continuously as sole ration. Start at 054771
aid in the control of necrotic enteritis first clinical signs of disease. Vary dos-
caused or complicated by Clostridium age based on severity of infection. Ad-
spp. or other organisms susceptible to minister continuously for 5 to 7 days or
bacitracin. as long as clinical signs persist, then
reduce medication to prevention level
(50 grams/ton).
(2) Turkeys—
grams per ton
(i) 4 to 50 ....................... Growing turkeys: For increased rate of Feed continuously as sole ration .............. 054771
weight gain and improved feed effi- 069254
ciency.
433
§ 558.76 21 CFR Ch. I (4–1–23 Edition)

grams per ton
(ii) 200 ............................ Growing turkeys: As an aid in the control Feed continuously as the sole ration ........ 054771
of transmissible enteritis complicated by
organisms susceptible to bacitracin
(3) Swine—
grams per ton
(i) 10 to 30 ..................... Growing and finishing swine: For in- .................................................................... 054771
creased rate of weight gain and im-
(ii) 250 ............................ Growing and finishing swine: For control Feed as the sole ration. Feed 250 grams 054771
of swine dysentery (bloody scours) as- per ton of complete feed on premises
sociated with Brachyspira with a history of swine dysentery, but
hyodysenteriae in pigs up to 250 lbs where signs of the disease have not
body weight. yet occurred or following an approved
treatment of the disease condition. Di-
agnosis should be confirmed by a vet-
erinarian a when results are not satis-
factory.
(iii) 250 ........................... Pregnant sows: For control of clostridial As the sole ration. Feed to sows from 14 054771
enteritis caused by Clostridium days before through 21 days after
perfringens in suckling piglets. farrowing on premises with a history of
clostridial scours. Diagnosis should be
confirmed by a veterinarian when re-
sults are not satisfactory.
(4) Cattle—
Bacitracin Indications for use Limitations Sponsor
amount
(i) 70 mg per head per Beef steers and heifers fed in confine- Administer continuously throughout the 054771
day. ment for slaughter: For reduction in the feeding period. 069254
number of liver condemnations due to
abscesses.
(ii) 250 mg per head per Beef steers and heifers fed in confine- Administer continuously for 5 days then 054771
day. ment for slaughter: For reduction in the discontinue for subsequent 25 days, re- 069254
number of liver condemnations due to peat the pattern during the feeding pe-
abscesses. riod.
(5) Game birds—

grams per ton
(i) 4 to 50 ....................... Growing pheasants: For increased rate of Feed continuously as sole ration .............. 054771
weight gain and improved feed effi- 069254
ciency.
(ii) 5 to 20 ...................... Growing quail: For increased rate of Feed continuously as sole ration to quail 054771
weight gain and improved feed effi- not over 5 weeks of age. 069254
ciency in quail not over 5 weeks of age.
(iii) 200 ........................... Growing quail: For the prevention of ul- Feed continuously as the sole ration ........ 054771
cerative enteritis in growing quail due to
Clostridium colinum susceptible to baci-
tracin methylenedisalicylate.
(6) Bacitracin methylenedisalicylate (ii) Amprolium and ethopabate as in

may also be used in combination with: § 558.58.
(i) Amprolium as in § 558.55. (iii) Chlortetracycline as in § 558.128.

(iv) Clopidol as in § 558.175.
434
(v) Decoquinate as in § 558.195. EDITORIAL NOTE: For FEDERAL REGISTER ci-

(vi) Diclazuril as in § 558.198. tations affecting § 558.76, see the List of CFR
(vii) Fenbendazole as in § 558.258. Sections Affected, which appears in the
(viii) Halofuginone as in § 558.265. and at www.govinfo.gov.
(ix) Ivermectin as in § 558.300.
(x) Lasalocid as in § 558.311. § 558.78 Bacitracin zinc.
(xi) Monensin as in § 558.355.
(xii) Narasin as in § 558.363.
articles containing bacitracin zinc
(xiii) Narasin and nicarbazin as in
equivalent to 10, 25, 40, or 50 grams per
§ 558.364.
pound bacitracin.
(xiv) Nicarbazin as in § 558.366.
(xv) Robenidine as in § 558.515. § 510.600(c) of this chapter.
(xvi) Salinomycin as in § 558.550. (c) Related tolerances. See § 556.70 of
(xvii) Semduramicin as in § 558.555. this chapter.
(xviii) Zoalene as in § 558.680. (d) Conditions of use. (1) It is used as
[41 FR 10993, Mar. 15, 1976] follows:
Bacitracin zinc in Combinations in Indications for use Limitations Sponsor
grams per ton grams per ton
(i) 4 to 50 ................... ............................. Chickens: for increased rate of Growing chickens ....................... 054771
weight gain and improved
feed efficiency.
(ii) 4 to 50 .................. ............................. Turkeys and pheasants: for in- Growing turkeys and pheasants 054771
creased rate of weight gain
and improved feed efficiency.
(iii) 5 to 20 ................. .................................. Quail; for increased rate of Growing quail; feed as the Type 054771
weight gain and improved C feed to starting quail
feed efficiency. through 5 weeks of age.
(iv) 10 to 25 ............... .................................. Laying chickens; improved feed ..................................................... 054771
efficiency and increased egg
production.
(v) 10 to 50 ................ .................................. Swine; increased rate of weight Growing and finishing swine ...... 054771
gain and improved feed effi-
ciency.
(vi) 20 ........................ .................................. Growing-finishing swine; in- In Type C feed ........................... 054771
creased rate of weight gain.
(vii) 20 to 40 .............. .................................. Growing-finishing swine; im- ......do ......................................... 054771
(2) It is used in feed for growing cat- EDITORIAL NOTE: For FEDERAL REGISTER ci-
tle at 35 to 70 milligrams per head per tations affecting § 558.78, see the List of CFR
day as follows: Sections Affected, which appears in the
(i) To aid in stimulating growth and and at www.govinfo.gov.
improving feed efficiency.
(ii) For increased rate of weight gain § 558.95 Bambermycins.
and improved feed efficiency; see spon- (a) Specifications. Type A medicated
sor 054771. articles containing 2, 4, or 10 grams
(3) Bacitracin zinc may also be used bambermycins per pound.
in combination with: (b) Sponsors. See sponsors in
(i) Amprolium and ethopabate as in § 510.600(c) of this chapter as follows:
§ 558.58. (1) No. 016592: 2, 4, and 10 grams per
(ii) Clopidol as in § 558.175. pound for use as in paragraphs (e)(1)
(iii) Decoquinate as in § 558.195. through (4) of this section.
(iv) Lasalocid as in § 558.311. (2) No. 012286: 2 grams for use as in
(v) Monensin as in § 558.355. paragraph (e)(2) of this section and 0.4
(vi) Naracin as in § 558.363. and 2 grams per pound for use as in
(vii) Nicarbazin as in § 558.366. paragraph (e)(3) of this section.
(viii) Robenidine as in § 558.515. (c) Related tolerances. See § 556.75 of
this chapter.
(ix) Salinomycin as in § 558.550.
(d) Special considerations. (1)

[41 FR 10994, Mar. 15, 1976] Bambermycins liquid Type B feeds may
435
§ 558.95 21 CFR Ch. I (4–1–23 Edition)
be manufactured from dry manufacture. The expiration date for

bambermycins Type A articles. The the dry Type C feed made from the liq-
liquid Type B feeds must have a pH of uid Type B feed is 1 week after date of
3.8 to 7.5, moisture content of 30 to 45 manufacture.
percent. (e) Conditions of use—(1) Chickens. Use
(2) The expiration date for the liquid in medicated feed as follows:
Type B feed is 8 weeks after date of
Bambermycins in grams/ton Indications for use Limitations Sponsor
(i) 1 to 2 ................................. Broiler chickens: For increased Feed continuously as the sole 016592.
rate of weight gain and im- ration.
(ii) [Reserved].
(2) Turkeys. Use in medicated feed as follows:

(i) 1 to 2 ................................. Growing turkeys: For improved Feed continuously as the sole 012286, 016592.
feed efficiency. ration.
(ii) 2 ........................................ Growing turkeys: For in- Feed continuously as the sole 012286, 016592.
creased rate of weight gain ration.
and improved feed efficiency.
(3) Swine. Use in medicated feed as follows:

(i) 2 ......................................... Growing-finishing swine: For Feed continuously as the sole 012286, 016592.
increased rate of weight ration.
gain and improved feed effi-
ciency.
(ii) 2 to 4 ................................ Growing-finishing swine: For Feed continuously as the sole 012286, 016592.
increased rate of weight. ration.
(4) Cattle.
(i) 1 to 4 ................................. Growing beef steers and heif- Feed continuously at a rate of 016592.
ers fed in confinement for 10 to 20 milligrams per head
slaughter: For increased per day.
rate of weight gain and im-
(ii) 2 to 80 .............................. Growing beef steers and heif- Feed continuously on a hand- 016592.
ers on pasture (stocker, fed basis at a rate of 10 to
feeder, and slaughter), and 40 milligrams per head per
replacement beef and dairy day in 1 to 10 pounds of
heifers on pasture: For in- supplemental Type C medi-
creased rate of weight gain. cated feed.
(iii) Used as a free-choice Type C feeder cattle; and beef replacement

medicated loose-mineral feed for pas- heifers) as follows:
ture cattle (slaughter, stocker, and (a) Specifications.
Ingredient International Feed No. Percent
Deflorinated phosphate (20.5% calcium, 18.5% phosphorus) ...................... 6–01–080 ...................... 42.50
Sodium chloride (salt) .................................................................................... 6–04–152 ...................... 20.10
Calcium carbonate (38% calcium) ................................................................. 6–01–069 ...................... 15.24
Corn distillers dried grains w/solubles ........................................................... 5–28–236 ...................... 9.57
Magnesium oxide ........................................................................................... 6–02–756 ...................... 5.15
Vitamin and trace mineral premix * ............................................................... ......... ............................. 3.72
Mineral oil ...................................................................................................... ......... ............................. 1.00
Yeast (primary dehydrated yeast) ................................................................. 7–05–533 ...................... 0.75

Bambermycins Type A article (10 g/lb) ......................................................... ......... ............................. 0.60
Iron oxide ....................................................................................................... 6–02–431 ...................... 0.50
436
Magnesium sulfate (67%) .............................................................................. 6–02–758 ...................... 0.32

Selenium premix (270 mg/lb) * ...................................................................... ......... ............................. 0.21
Copper sulfate ............................................................................................... 6–01–720 ...................... 0.18
Potassium sulfate (0.33%) ............................................................................. 6–06–098 ...................... 0.16
*Content of vitamin/trace mineral premix may be varied. However, they should be comparable to those used for other free-
choice feeds. Formulation modifications require FDA approval prior to marketing. Selenium must comply with 21 CFR 573.920.
Ethylenediamine dihydroiodide (EDDI) should comply with FDA Compliance Policy Guides Sec. 651.100 (CPG 7125.18).
(b) Amount per ton. 120 grams. (a) Amount. Feed continuously to pro-
(c)Indications for use. For increased vide 10 to 40 milligrams of
rate of weight gain. bambermycins per head per day.
(d) Limitations. For free-choice feed- (b) Indications for use. For increased
ing to pasture cattle (slaughter, stock- rate of weight gain.
er, and feeder cattle; and beef replace- (c) Limitations. Each use in a free-
ment heifers). Feed a nonmedicated choice Type C medicated feed must be
commercial mineral product for 6 the subject of an approved new animal
weeks to stabilize consumption be- drug application (NADA) or supple-
tween 2.66 and 10.66 ounces per head per mental NADA as required by 21 CFR
day. Feed continuously to provide 10 to 510.455. Daily bambermycins intakes in
40 milligrams bambermycins per head excess of 20 mg/head/day have not been
per day. Daily bambermycins intakes shown to be more effective than 20 mg/
in excess of 20 mg/head/day have not head/day.
been shown to be more effective than 20 (v) Used as a free-choice Type C
mg/head/day. medicated loose mineral feed for pas-
(iv) Use free-choice Type C medicated ture cattle (slaughter, stocker, and
feeds for pasture cattle (slaughter, feeder cattle; and dairy and beef re-
stocker, and feeder cattle; and beef replacement heifers) as follows:
placement heifers) as follows: (A) Specifications.
Deflorinated phosphate (20.5% calcium, 18.5% phosphorus) ...................... 6–01–080 ...................... 42.50
Sodium chloride (salt) .................................................................................... 6–04–152 ...................... 20.10
Calcium carbonate (38% calcium) ................................................................. 6–01–069 ...................... 15.45
Corn distillers dried grains w/solubles ........................................................... 5–28–236 ...................... 9.57
Magnesium oxide ........................................................................................... 6–02–756 ...................... 5.15
Vitamin and trace mineral premix * ................................................................ ........................................ 3.72
Mineral oil ...................................................................................................... ........................................ 1.00
Yeast (primary dehydrated yeast) ................................................................. 7–05–533 ...................... 0.75
Bambermycins Type A article (10 g/lb) ......................................................... ........................................ 0.60
Iron oxide ....................................................................................................... 6–02–431 ...................... 0.50
Magnesium sulfate (67%) .............................................................................. 6–02–758 ...................... 0.32
Copper sulfate ............................................................................................... 6–01–720 ...................... 0.18
Potassium sulfate (0.33%) ............................................................................. 6–06–098 ...................... 0.16
* Content of vitamin/trace mineral premix may be varied. However, they should be comparable to those used for other free-
choice feeds. Formulation modifications require FDA approval prior to marketing. Ethylenediamine dihydroiodide (EDDI) should
comply with FDA Compliance Policy Guides Sec. 651.100 (CPG 7125.18).
(B) Amount per ton. 120 grams. per day. Daily bambermycins intakes
(C) Indications for use. For increased in excess of 20 mg/head/day have not
rate of weight gain. been shown to be more effective than 20
(D) Limitations. For free-choice feed- mg/head/day.
ing to pasture cattle (slaughter, stock- (5) Combinations. Bambermycins may
er, and feeder cattle; and dairy and beef also be used in combination with:
replacement heifers). Feed a non-medi- (i) Amprolium as in § 558.55.
(ii) Amprolium and ethopabate as in
cated commercial mineral product for 6
§ 558.58.
weeks to stabilize consumption be- (iii) Clopidol as in § 558.175.
tween 2.66 and 10.66 ounces per head per (iv) Diclazuril as in § 558.198.
day. Feed continuously to provide 10 to (v) Halofuginone as in § 558.265.

40 milligrams bambermycins per head (vi) Lasalocid as in § 558.311.
437
§ 558.115 21 CFR Ch. I (4–1–23 Edition)
(vii) Monensin as in § 558.355. (Ascaris suum) infections; aid in the

(viii) Narasin as in § 558.363. prevention of establishment of nodular
(ix) Narasin and nicarbazin as in worm (Oesophagostomum) infections.
§ 558.364. (ii) Limitations. Do not feed to swine
(x) Nicarbazin as in § 558.366. over 75 pounds; do not feed within 10
(xi) Salinomycin as in § 558.550. weeks of slaughter; consult a veteri-
(xii) Zoalene as in § 558.680. narian before feeding to severely de-
[40 FR 13959, Mar. 27, 1975] bilitated animals; feed continuously as
sole ration. Do not use in complete
EDITORIAL NOTE: For FEDERAL REGISTER ci- feeds containing less than 15 percent
crude protein.
Finding Aids section of the printed volume (4) Carbadox may also be used in
and at www.govinfo.gov. combination with oxytetracycline as in
§ 558.450.
§ 558.115 Carbadox.
(a) Approvals. Type A medicated arti- FR 45164, Oct. 1, 1975; 40 FR 57798, Dec. 12,
cles: 2.2. percent (10 grams per pound) 1975; 42 FR 761, Jan. 4, 1977; 51 FR 7396, Mar.
to 066104 in § 510.600(c) of this chapter. 3, 1986; 63 FR 59216, Nov. 3, 1998; 66 FR 47963,
(b) Related tolerances. See § 556.100 of Sept. 17, 2001; 69 FR 51173, Aug. 18, 2004; 82 FR
this chapter. 21691, May 10, 2017]
(c) Special considerations. Do not use
§ 558.128 Chlortetracycline.
in Type B or Type C medicated feeds
containing bentonite. (a) Specifications. Type A medicated
(d) Conditions of use. It is used for articles containing either chlortetra-
swine as follows: cycline calcium complex equivalent to
(1) Amount per ton. 10–25 grams chlortetracycline hydrochloride, or for
(0.0011–0.00275 percent). products intended for use in milk re-
(i) Indications for use. For increase in placer, chlortetracycline hydro-
rate of weight gain and improvement of chloride.
feed efficiency. (b) Sponsors. See sponsors in
(ii) Limitations. Not for use in preg- § 510.600(c) of this chapter as follows:
nant swine or swine intended for breed- (1) No. 054771: 50, 70, 80, 90, or 100
ing purposes. Do not feed to swine grams per pound (g/lb) Type A medi-
within 42 days of slaughter. cated article.
(2) Amount per ton. 50 grams (0.0055 (2) No. 066104: 10, 20, 30, 50, 70, or 100
percent). g/lb of Type A medicated article.
(i) Indications for use. For control of (3) No. 069254: 50, 90, or 100 g/lb of
swine dysentery (vibrionic dysentery, Type A medicated article.
bloody scours, or hemorrhagic dys- (c) Related tolerances. See § 556.150 of
entery); control of bacterial swine en- this chapter.
teritis (salmonellosis or necrotic enter- (d) Special considerations. (1) Federal
itis caused by Salmonella choleraesuis); law restricts medicated feed containing
increased rate of weight gain and im- this veterinary feed directive (VFD)
proved feed efficiency. drug to use by or on the order of a li-
(ii) Limitations. Not for use in preg- censed veterinarian. See § 558.6 for addi-
nant swine or swine intended for breed- tional requirements.
ing purposes. Do not feed to swine (2) The expiration date of VFDs for
within 42 days of slaughter. chlortetracycline medicated feeds must
(3) Amount per ton. Carbadox 50 grams not exceed 6 months from the date of
(0.0055 percent) plus pyrantel tartrate, issuance. VFDs for chlortetracycline
96 grams (0.0106 percent). shall not be refilled.
(i) Indications for use. For control of (3) In milk replacers or starter feed;
swine dysentery (vibrionic dysentery, include on labeling the warning: ‘‘A
bloody scours, or hemorrhagic dys- withdrawal period has not been estab-
entery); control of bacterial swine en- lished for this product in
teritis (salmonellosis or necrotic enter- preruminating calves. Do not use in
itis caused by Salmonella choleraesuis); calves to be processed for veal.’’
aid in the prevention of migration and (4) Manufacture for use in free-choice
establishment of large roundworm feeds as in paragraph (e)(4)(vi) of this
438
section must conform to § 510.455 of this disease, transmissible between wild and
chapter. domestic birds, other animals, and
(5) When manufactured for use as in man. Contact appropriate public health
paragraph (e)(5)(iii) of this section, in- and regulatory officials.’’
clude on labeling the warning: ‘‘Psit- (e) Conditions of use—(1) Chickens. It
tacosis, avian chlamydiosis, or orni- is used as follows:
thosis is a reportable communicable
Chlortetracycline Combination in Indications for use Limitations Sponsor
amount grams/ton
(i) 100 to 200 g/ton .... .................................. Chickens: For control of infec- Feed continuously for 7 to 14 054771
tious synovitis caused by days. For No. 066104: Do not 066104
Mycoplasma synoviae suscep- feed to chickens producing 069254
tible to chlortetracycline. eggs for human consumption.
(ii) 100 to 200 g/ton ... Clopidol, 113.5 ........ Broiler and replacement chick- Feed continuously as the sole 016592
ens: As an aid in the preven- ration from the time chicks are
tion of coccidiosis caused by placed in floor pens for 7 to
Eimeria tenella, E. necatrix, E. 14 days. Do not feed to chick-
acervulina, E. maxima, E. ens over 16 weeks of age. Do
mivati, and E. brunetti; and for not feed to chickens producing
control of infectious synovitis eggs for human consumption.
caused by M. synoviae sus- Chlortetracycline as provided
ceptible to chlortetracycline. by No. 054771; clopidol as
(iii) 100 to 200 g/ton .. Decoquinate, 27.2 ... Chickens: For prevention of coc- Feed continuously for 7 to 14 054771
cidiosis caused by Eimeria days. Bentonite should not be
tenella, E. necatrix, E. mivati, used in decoquinate feeds. Do
E. acervulina, E. maxima, and not feed to chickens producing
E. brunetti; and for control of eggs for human consumption.
infectious synovitis caused by Chlortetracycline and
M, synoviae susceptible to decoquinate as provided by
chlortetracycline. No. 054771 in § 510.600(c) of
this chapter.
(iv) 100 g/ton ............. Robenidine, 30 ........ Broiler and fryer chickens: As an Feed continuously as sole ra- 054771
aid in the prevention of coc- tion. Do not use this product
cidiosis caused by E. mivati, in feeds conta.
E. brunetti, E. tenella, E. Chlortetracycline and robenidine
acervulina, E. maxima, and E. as provided by No. 054771 in
necatrix; as an aid in the con- § 510.600(c) of this chapter.
trol of chronic respiratory dis-
ease (CRD) caused by Myco-
plasma gallisepticum suscep-
tible to chlortetracycline; and
as an aid in the control of in-
fectious synovitis caused by
M. synoviae susceptible to
chlortetracycline.
(v) 200 to 400 g/ton ... .................................. Chickens: For the control of Feed continuously for 7 to 14 054771
chronic respiratory disease days. For No. 066104: Do not 066104
(CRD) and air sac infection feed to chickens producing 069254
caused by M. gallisepticum eggs for human consumption.
and Escherichia coli suscep-
tible to chlortetracycline.
(vi) 200 g/ton ............. Amprolium, 227 and For chickens where immunity to Use in low calcium feed con- 054771
ethopabate, 3.6. coccidiosis is not desired: For taining 0.8% dietary calcium
prevention of coccidiosis; and and 1.5% sodium sulfate; feed
for treatment of chronic res- continuously as sole ration for
piratory disease (CRD) 7 to 14 days; do not feed to
caused by M. gallisepticum chickens producing eggs for
susceptible to chlortetracycline. human consumption. Chlor-
tetracycline as provided by
No. 054771; amprolium and
ethopabate as provided by
No. 016592 in § 510.600(c) of
this chapter.
439
§ 558.128 21 CFR Ch. I (4–1–23 Edition)

amount grams/ton
(vii) 200 g/ton ............ Decoquinate, 27.2 ... Broilers: As an aid in the pre- Feed continuously as the sole 054771
vention of coccidiosis caused ration for no more than 8
by Eimeria tenella, E. necatrix, weeks. Use in low calcium
E. acervulina, E. mivati, E. feed containing 0.8% dietary
maxima, and E. brunetti; and calcium. Bentonite should not
for the treatment of chronic be used in decoquinate feeds.
respiratory disease (air sac in- Do not feed to chickens pro-
fection) and the prevention of ducing eggs for human con-
synovitis. sumption.
Chlortetracycline and
decoquinate as provided by
No. 054771 in § 510.600(c) of
this chapter.
(viii) 200 g/ton ............ Robenidine 30 ......... Broiler and fryer chickens: As an Feed continuously as sole ra- 054771
aid in the prevention of coc- tion. Do not use this product
cidiosis caused by E. mivati, in feeds containing bentonite.
E. brunetti, E. tenella, E. Do not feed to chickens pro-
acervulina, E. maxima, and E. ducing eggs for human con-
necatrix; as an aid in the consumption. Withdraw 5 days
trol of chronic respiratory dis- prior to slaughter.
ease (CRD) caused by M. Chlortetracycline and robenidine
gallisepticum susceptible to as provided by No. 054771 in
chlortetracycline; and as an § 510.600(c) of this chapter.
aid in the control of infectious
synovitis caused by M.
synoviae susceptible to chlor-
tetracycline.
(ix) 500 g/ton ............. .................................. Chickens: For the reduction of 1. Feed for 5 days. To sponsor 054771
mortality due to E. coli infec- No. 054771 under NADA 048– 069254
tions susceptible to chlortetra- 761 and No. 069254 under
cycline. ANADA 200–510: zero with-
drawal time.
2. Feed for 5 days; withdraw 24 054771
hours prior to slaughter. Do 066104
not feed to chickens producing 069254
eggs for human consumption.
(x) 500 g/ton .............. Monensin, 90 to 110 Chickens: As an aid in the re- Feed for 5 days as the sole ra- 054771
duction of mortality due to E. tion. Do not feed to laying 069254
coli infections susceptible to chickens. Not to be fed con-
chlortetracycline; and as an tinuously for more than 5
aid in the prevention of coc- days. Do not feed to chickens
cidiosis caused by Eimeria over 16 weeks of age. With-
tenella, E. necatrix, E. draw 24 hours before slaugh-
acervulina, E. maxima, E. ter. See § 558.355(d) of this
brunetti, and E. mivati. chapter. Chlortetracycline as
provided by No. 054771;
monensin as provided by No.
058198 in § 510.600(c) of this
chapter.
(xi) 500 g/ton ............. Robenidine, 30 ........ Broiler and fryer chickens: As an Feed continuously as sole ration 054771
aid in the prevention of coc- for up to 5 days. Do not use
cidiosis caused by Eimeria this product in feeds con-
mivati, E. brunetti, E. tenella, taining bentonite. Do not feed
E. acervulina, E. maxima, and to chickens producing eggs for
E. necatrix; as an aid in the human consumption. With-
reduction of mortality due to draw 5 days prior to slaughter.
E. coli susceptible to chlor- Chlortetracycline and robenidine
tetracycline. as provided by No. 054771 in
440

amount grams/ton
(xii) 500 g/ton ............ Salinomycin, 40 to Broiler chickens: As an aid in For use in low calcium feeds 016592
60. the prevention of coccidiosis containing 0.8% calcium. Not 054771
caused by Eimeria tenella, E. approved for use with pellet 069254
necatrix, E. acervulina, E. binders. Not to be fed continu-
maxima, E. brunetti, and E. ously for more than 5 days.
mivati; and as an aid in the re- Do not feed to laying chickens
duction of mortality due to E. producing eggs for human
coli susceptible to chlortetra- consumption. Withdraw 24
cycline. hours before slaughter. May
be fatal if accidentally fed to
adult turkeys or horses. Chlor-
tetracycline as provided by
Nos. 054771 or 069254;
salinomycin as provided by
Nos. 054771 or 016592 in
(2) Turkeys. It is used as follows:

amount grams/ton
(i) 200 g/ton ............... .................................. Turkeys: For control of infectious Feed continuously for 7 to 14 054771
synovitis caused by M. days. Do not feed to turkeys 066104
synoviae susceptible to chlor- producing eggs for human 069254
tetracycline. consumption.
(ii) 400 g/ton .............. .................................. 1. Turkeys: For control of Feed continuously for 7 to 14 054771
hexamitiasis caused by days. Do not feed to turkeys 066104
Hexamita meleagridis suscep- producing eggs for human 069254
tible to chlortetracycline. consumption.
............................... .................................. 2. Turkey poults not over 4 ..................................................... 054771
weeks of age: For reduction of 066104
mortality due to paratyphoid 069254
caused by Salmonella
typhimurium susceptible to
chlortetracycline.
(iii) 25 mg/lb of body .................................. Turkeys: For control of compli- Feed continuously for 7 to 14 054771
weight. cating bacterial organisms as- days. Do not feed to turkeys 066104
sociated with bluecomb (trans- producing eggs for human 069254
missible enteritis; coronaviral consumption.
enteritis) susceptible to chlor-
tetracycline.
(3) Swine. It is used as follows:

amount grams/ton
(i) 50 to 100 g/ton ...... .................................. Swine: For reducing the inci- ..................................................... 054771
dence of cervical lymphade- 066104
nitis (jowl abscesses) caused 069254
by Group E Streptococci sus-
ceptible to chlortetracycline.
(ii) 400 g/ton .............. .................................. Breeding swine: For the control Feed continuously for not more 054771
of leptospirosis (reducing the than 14 days. 066104
incidence of abortion and 069254
shedding of leptospirae)
caused by Leptospira pomona
susceptible to chlortetracycline.
441
§ 558.128 21 CFR Ch. I (4–1–23 Edition)

amount grams/ton
(iii) 10 mg/lb of body .................................. Swine: For treatment of bacterial Feed approximately 400 g/ton, 054771
weight. enteritis caused by Esch- varying with body weight and 066104
erichia coli and S. feed consumption to provide 069254
choleraesuis and bacterial 10 mg/lb per day. Feed for not
pneumonia caused by more than 14 days. Withdraw
Pasteurella multocida suscep- 5 d prior to slaughter for spon-
tible to chlortetracycline; for sor No. 069254 in
the control of porcine prolif- § 510.600(c) of this chapter.
erative enteropathies (ileitis)
caused by Lawsonia
intracellularis susceptible to
chlortetracycline.
(iv) 10 mg/lb of body Bacitracin Swine: For treatment of bacterial Feed approximately 400 g/ton, 054771
weight. methylenedisalicyl- enteritis caused by E. coli and varying with body weight and
ate, 10 to 30. S. choleraesuis and bacterial feed consumption to provide
pneumonia caused by P. 10 mg/lb per day. Feed for not
multocida susceptible to chlor- more than 14 days. Chlortetra-
tetracycline; for the control of cycline and bacitracin
porcine proliferative methylenedisalicylate as pro-
enteropathies (ileitis) caused vided by No. 054771 in
by Lawsonia intracellularis § 510.600(c) of this chapter.
susceptible to chlortetra-
cycline; and for increased rate
of weight gain and improved
feed efficiency.
(v) 10 mg/lb of body Bacitracin Swine: For treatment of bacterial Feed chlortetracycline at ap- 054771
weight. methylenedisalicyl- enteritis caused by E. coli and proximately 400 g/ton of feed, 069254
ate, 10 to 30. S. choleraesuis and bacterial varying with body weight and
pneumonia caused by P. food consumption, to provide
multocida susceptible to chlor- 10 mg/lb of body weight. Feed
tetracycline; and for increased for not more than 14 days.
rate of weight gain and im- Withdraw 5 d prior to slaugh-
proved feed efficiency. ter for sponsor No. 069254.
Bacitracin
methylenedisalicylate provided
by No. 054771; chlortetra-
cycline provided by Nos.
054771 and 069254 in
(vi) 10 mg/lb of body Tiamulin hydrogen For control of swine dysentery Feed chlortetracycline at ap- 058198
weight. fumarate, 35. associated with Brachyspira proximately 400 g/ton of feed, 069254
(formerly Serpulina or varying with body weight and
Treponema) hyodysenteriae food consumption, to provide
susceptible to tiamulin and for 10 mg/lb of body weight. Feed
treatment of swine bacterial continuously as the sole ration
enteritis caused by E. coli and for 14 days. Withdraw medi-
Salmonella choleraesuis sen- cated feed 2 days before
sitive to chlortetracycline and slaughter. Tiamulin as pro-
treatment of bacterial pneu- vided by Nos. 058198 or
monia caused by P. multocida 069254 in § 510.600(c) of this
sensitive to chlortetracycline. chapter.
(4) Cattle. It is used as follows:

Combination in
Chlortetracycline amount Indications for use Limitations Sponsor
grams/ton
(i) to provide 70 mg/head/ ................................ Growing cattle (over 400 lb): Feed to provide chlortetra- 054771
day. For reduction of liver con- cycline at the rate of 70 mg 066104
demnation due to liver ab- per animal daily. A with- 069254
scesses. drawal period has not been
established in pre-rumi-
nating calves. Do not use in
calves to be processed for
veal.
442
Combination in
grams/ton
(ii) 5.83 to 14 g/ton to pro- Melengestrol ace- Growing beef heifers fed in Melengestrol acetate Type C 054771
vide 70 mg/head/day. tate, 0.25 to 2 g/ confinement for slaughter top-dress medicated feed
ton to provide (over 400 lb): For reduction must be top dressed onto or
0.25 to 0.5 mg of the incidence of liver ab- mixed at feeding with the
melengestrol ac- scesses, increased rate of Type C medicated feed con-
etate per head weight gain, improved feed taining 5.83 to 14 g/ton
per day. efficiency, and suppression chlortetracycline. Chlortetra-
of estrus (heat). cycline and melengestrol as
(iii) 7 to 17.5 g/ton .............. Monensin, 5 to 40 Growing beef steers and heif- Feed as the sole ration to pro- 069254
ers fed in confinement for vide 70 mg chlortetracycline
slaughter over 400 lb: For per head per day and 50 to
reduction of the incidence of 480 mg monensin per head
liver abscesses and for im- per day. No additional im-
proved feed efficiency. provement in feed efficiency
has been shown from feed-
ing monensin at levels
greater than 30 grams per
ton (360 mg monensin per
head per day). For use in
dry feeds only. Not for use
in liquid feed supplements.
Do not allow horses or other
equines access to feed con-
taining monensin. Ingestion
of monensin by horses has
been fatal. Monensin medi-
cated cattle and goat feeds
are safe for use in cattle
and goats only. Consump-
tion by unapproved species
may result in toxic reactions.
Do not exceed the levels of
monensin recommended in
the feeding directions, as re-
duced average daily gains
may result. If feed refusals
containing monensin are fed
to other groups of cattle, the
concentration of monensin
in the refusals and amount
of refusals fed should be
taken into consideration to
prevent monensin over-
dosing. A withdrawal period
has not been established for
this product in pre-rumi-
veal. Monensin as provided
by No. 058198, chlortetra-
cycline by No. 069254 in
443
§ 558.128 21 CFR Ch. I (4–1–23 Edition)
Combination in
grams/ton
(iv) 7 to 17.5 g/ton .............. Monensin, 10 to 40 Growing beef steers and heif- Feed as the sole ration to pro- 069254
slaughter over 400 lb: For per head per day and 0.14
reduction of the incidence of to 0.42 mg monensin per lb.
liver abscesses and for pre- body weight per day to pro-
vention and control of coc- vide, depending upon sever-
cidiosis due to Eimeria bovis ity of coccidiosis challenge,
and Eimeria zuernii. up to 480 mg monensin per
head per day. For use in dry
feeds only. Not for use in
liquid feed supplements. Do
not allow horses or other
(v) to provide 0.5 mg/lb of ................................ Beef cattle (over 700 lb): For Feed to provide chlortetra- 054771
body weight daily. control of active infection of cycline at the rate of 0.5 mg 066104
anaplasmosis caused by per pound of body weight 069254
Anaplasma marginale sus- daily. Withdraw 48 hours
ceptible to chlortetracycline. prior to slaughter. To spon-
sor Nos. 054771 and
069254: Zero withdrawal
time.
(vi) 33.33 to 50 g/ton to Melengestrol ace- Replacement beef heifers over Melengestrol acetate Type C 054771
provide 0.5 mg/lb of body tate, 0.5 to 2 g/ 700 lb: For control of active top-dress medicated feed
weight per day. ton to provide 0.5 infection of anaplasmosis must be top dressed onto or
mg melengestrol caused by Anaplasma mixed at feeding with a
acetate per head marginale susceptible to Type C medicated feed con-
per day. chlortetracycline and for taining 33.33 to 50 g/ton
suppression of estrus (heat). chlortetracycline. Feeding a
Type C top-dress medicated
feed containing
melengestrol acetate shall
not exceed 24 days. Chlor-
tetracycline and
melengestrol as provided by
No. 054771 in § 510.600(c)
of this chapter.
444
Combination in
grams/ton
(vii) 25 to 1,100 g/ton to Lasalocid, 30 to Pasture cattle (slaughter, Feed continuously on a hand- 054771
provide 0.5 mg/lb of body 600. stocker, feeder cattle, beef fed basis 0.5 mg chlortetra- 069254
weight daily. replacement heifers) over cycline per lb. body weight
700 pounds: For control of per day and not less than
active infection of 60 mg or more than 300 mg
anaplasmosis caused by lasalocid per head daily in
Anaplasma marginale sus- at least 1 pound of feed.
ceptible to chlortetracycline; Daily lasalocid intakes in ex-
and for increased rate of cess of 200 mg/head/day in
weight gain. pasture cattle have not been
shown to be more effective
than 200 mg lasalocid/head/
day. Do not allow horses or
other equines access to
feeds containing lasalocid.
No withdrawal period is re-
quired. A withdrawal period
veal. See § 558.311(d) of
this chapter. Lasalocid as
(viii) 25 to 1,100 g/ton to Lasalocid, 30 to Replacement beef heifers on The melengestrol acetate 054771
provide 0.5 mg/lb of body 600; pasture over 700 pounds: Type C top-dress medicated
weight daily. melengestrol ac- For control of active infec- feed must be top dressed
etate, 0.5 to 2 g/ tion of anaplasmosis caused onto or mixed at feeding
ton to provide 0.5 by Anaplasma marginale with a Type C medicated
mg/head/day susceptible to chlortetra- feed containing 25 to 1,100
melengestrol ac- cycline, increased rate of g/ton of chlortetracycline
etate. weight gain, and suppres- and 30 to 600 g/ton
sion of estrus (heat). lasalocid to provide 0.5 mg
chlortetracycline per lb body
weight per day and not less
than 60 mg or more than
300 mg lasalocid per head
per day in at least 1 pound
of feed. Do not exceed 24
days of feeding. See
§ 558.311(d) of this chapter.
Chlortetracycline, lasalocid,
and melengestrol as pro-
445
§ 558.128 21 CFR Ch. I (4–1–23 Edition)
Combination in
grams/ton
(ix) 33.33 to 66.67 g/ton ..... Monensin, 5 to 40 Growing beef steers and heif- Feed as the sole ration to pro- 069254
ers fed in confinement for vide 0.5 mg chlortetracycline
slaughter over 700 lb: For per lb. body weight per day
control of active infection of and 50 to 480 mg monensin
anaplasmosis caused by per head per day. No addi-
Anaplasma marginale sus- tional improvement in feed
ceptible to chlortetracycline efficiency has been shown
and for improved feed effi- from feeding monensin at
ciency. levels greater than 30
grams per ton (360 mg
monensin per head per
day). For use in dry feeds
only. Not for use in liquid
feed supplements. Do not
allow horses or other
446
Combination in
grams/ton
(x) 33.33 to 66.67 g/ton ...... Monensin, 10 to 40 Growing beef steers and heif- Feed as the sole ration to pro- 069254
ers fed in confinement for vide 0.5 mg chlortetracycline
slaughter over 700 lb: For per lb. body weight per day
control of active infection of and 0.14 to 0.42 mg
anaplasmosis caused by monensin per lb. body
Anaplasma marginale sus- weight per day to provide,
ceptible to chlortetracycline depending upon severity of
and for the prevention and coccidiosis challenge, up to
control of coccidiosis due to 480 mg monensin per head
Eimeria bovis and Eimeria per day. For use in dry
zuernii. feeds only. Not for use in
447
§ 558.128 21 CFR Ch. I (4–1–23 Edition)
Combination in
grams/ton
(xi) 50 to 117 g/ton ............. Monensin, 7.14 to Growing beef steers and heif- Feed as the sole ration to pro- 069254
40. ers fed in confinement for vide 350 mg chlortetra-
slaughter under 700 lb: For cycline per head per day
control of active infection of and 50 to 480 mg monensin
anaplasmosis caused by per head per day. No addi-
Anaplasma marginale sus- tional improvement in feed
ceptible to chlortetracycline efficiency has been shown
and for improved feed effi- from feeding monensin at
ciency. levels greater than 30
448
Combination in
grams/ton
(xii) 50 to 117 g/ton ............ Monensin, 10 to 40 Growing beef steers and heif- Feed as the sole ration to pro- 069254
ers fed in confinement for vide 350 mg chlortetra-
slaughter under 700 lb: For cycline per head per day
control of active infection of and 0.14 to 0.42 mg
anaplasmosis caused by monensin per lb. body
Anaplasma marginale sus- weight per day to provide,
ceptible to chlortetracycline depending upon severity of
control of coccidiosis due to 480 mg monensin per head
Eimeria bovis and Eimeria per day. For use in dry
zuernii. feeds only. Not for use in
449
§ 558.128 21 CFR Ch. I (4–1–23 Edition)
Combination in
grams/ton
(xiii) 50 to 117 g/ton ........... Monensin, 7.14 to Growing beef steers and heif- Feed as the sole ration to pro- 069254
40. ers fed in confinement for vide 350 mg chlortetra-
slaughter: For the control of cycline per head per day
bacterial pneumonia associ- and 50 to 480 mg monensin
ated with shipping fever per head per day. No addi-
complex caused by tional improvement in feed
Pasteurella spp. susceptible efficiency has been shown
to chlortetracycline and for from feeding monensin at
improved feed efficiency. levels greater than 30
450
Combination in
grams/ton
(xiv) 50 to 117 g/ton ........... Monensin, 10 to 40 Growing beef steers and heif- Feed as the sole ration to pro- 069254
ers fed in confinement for vide 350 mg chlortetra-
slaughter: For the control of cycline per head per day
bacterial pneumonia associ- and 0.14 to 0.42 mg
ated with shipping fever monensin per lb. body
complex caused by weight per day to provide,
Pasteurella spp. susceptible depending upon severity of
to chlortetracycline and for coccidiosis challenge, up to
the prevention and control 480 mg monensin per head
of coccidiosis due to per day. For use in dry
Eimeria bovis and Eimeria feeds only. Not for use in
zuernii. liquid feed supplements. Do
(xv) to provide 0.5 to 2.0 ................................ Beef cattle and nonlactating In Type C free-choice cattle 054771
mg/lb of body weight dairy cattle: As an aid in the feeds such as feed blocks
daily. control of active infection of or salt-mineral mixes manu-
anaplasmosis caused by factured from approved
Anaplasma marginale sus- Type A articles. See para-
ceptible to chlortetracycline. graph (d)(4) of this section.
(xvi) to provide 10 mg/lb of ................................ Calves, beef and nonlactating Feed approximately 400 g/ton, 054771
body weight daily. dairy cattle: For treatment of varying with body weight 066104
bacterial enteritis caused by and feed consumption to 069254
Escherichia coli and bac- provide 10 mg/lb per day.
terial pneumonia caused by Treat for not more than 5
Pasteurella multocida orga- days. To sponsor No.
nisms susceptible to chlor- 054771 (NADAs 048–761
tetracycline. and 046–699) and to spon-
sor No. 069254 (ANADA
200–510): May be mixed in
the cattle’s daily ration or
administered as a top-dress.
In feed including milk re-
placers withdraw 10 days
prior to slaughter. To spon-
sor Nos. 054771 and
069254: Zero withdrawal
time. See paragraph (d)(3)
of this section.
451
§ 558.128 21 CFR Ch. I (4–1–23 Edition)
Combination in
grams/ton
(xvii) to provide 10 mg/lb of ................................ Calves (up to 250 lb): For the A withdrawal period has not 054771
body weight daily. treatment of bacterial enter- been established for this 066104
itis caused by Escherichia product in pre-ruminating 069254
coli susceptible to chlortetra- calves. Do not use in calves
cycline. to be processed for veal.
(xviii) 400 to 2,000 g/ton .... Monensin, 5 to 40 Growing beef steers and heif- Feed as the sole ration to pro- 069254
slaughter: For treatment of per lb. body weight per day.
bacterial enteritis caused by Treat for not more than 5
Escherichia coli and bac- days, then continue feeding
terial pneumonia caused by monensin Type C medi-
Pasteurella multocida sus- cated feed alone. No addi-
ceptible to chlortetracycline; tional improvement in feed
for improved feed efficiency. efficiency has been shown
from feeding monensin at
levels greater than 30
452
Combination in
grams/ton
(xix) 400 to 2,000 g/ton ...... Monensin, 5 to 40 Growing beef steers and heif- Feed as the sole ration to pro- 069254
ers: For treatment of bac- vide 10 mg chlortetracycline
terial enteritis caused by per lb. body weight per day
Escherichia coli and bac- and 0.14 to 0.42 mg
terial pneumonia caused by monensin per lb. body
Pasteurella multocida sus- weight per day to provide,
ceptible to chlortetracycline; depending upon severity of
and for the prevention and the coccidiosis challenge,
control of coccidiosis due to up to 480 mg monensin per
Eimeria bovis and Eimeria head per day. Treat for not
zuernii. more than 5 days, then con-
tinue feeding monensin
Type C medicated feed
alone. For use in dry feeds
453
§ 558.128 21 CFR Ch. I (4–1–23 Edition)
Combination in
grams/ton
(xx) 400 to 2,000 g/ton ....... Monensin, 10 to Beef calves 2 months of age Feed as the sole ration to pro- 069254
200. and older: For treatment of vide 10 mg chlortetracycline
bacterial enteritis caused by per lb. body weight per day
Escherichia coli and bac- and 0.14 to 1.00 mg
terial pneumonia caused by monensin per lb. body
Pasteurella multocida sus- weight per day to provide,
ceptible to chlortetracycline; depending upon severity of
control of coccidiosis due to 200 mg of monensin per
Eimeria bovis and Eimeria head per day. Feed for not
zuernii. more than 5 days, then con-
tinue to feed monensin Type
C medicated feed alone. For
use in dry feeds only. Not
for use in liquid feed supple-
ments. Do not allow horses
or other equines access to
feed containing monensin.
Ingestion of monensin by
horses has been fatal.
Monensin medicated cattle
and goat feeds are safe for
use in cattle and goats only.
Consumption by unap-
proved species may result
in toxic reactions. Do not
exceed the levels of
(xxi) 500 to 2,000 g/ton to Laidlomycin, 5 ....... Cattle fed in confinement for Feed continuously at a rate of 054771
provide 10 mg/lb of body slaughter: For treatment of 30 to 75 mg laidlomycin pro-
weight daily. bacterial enteritis caused by pionate potassium per head
Escherichia coli and bac- per day for not more than 5
terial pneumonia caused by days. A withdrawal period
Pasteurella multocida orga- has not been established for
nisms susceptible to chlor- this product in pre-rumi-
tetracycline; and for in- nating calves. Do not use in
creased rate of weight gain calves to be processed for
and improved feed effi- veal. See § 558.305(d) of
ciency. this chapter. Laidlomycin as
454
Combination in
grams/ton
(xxii) 500 to 4,000 g/ton to Laidlomycin, 5 to Cattle fed in confinement for Feed continuously at a rate of 054771
provide 10 mg/lb of body 10. slaughter: For treatment of 30 to 75 mg laidlomycin pro-
weight daily. bacterial enteritis caused by pionate potassium per head
Escherichia coli and bac- per day for not more than 5
terial pneumonia caused by days. A withdrawal period
Pasteurella multocida orga- has not been established for
nisms susceptible to chlor- this product in pre-rumi-
tetracycline; and for im- nating calves. Do not use in
proved feed efficiency. calves to be processed for
this chapter. Laidlomycin as
(xxiii) 500 to 2,000 to pro- Lasalocid, 10 to 30 Cattle fed in confinement for Feed continuously in complete 054771
vide 10 mg/lb of body slaughter: For treatment of feed for not more than 5 069254
weight daily. bacterial enteritis caused by days to provide 10 mg
Escherichia coli and bac- chlortetracycline per lb.
terial pneumonia caused by body weight per day and not
Pasteurella multocida orga- less than 100 mg or more
nisms susceptible to chlor- than 360 mg lasalocid per
tetracycline; and for im- head per day. Do not allow
proved feed efficiency. horses or other equines ac-
cess to feeds containing
lasalocid. No withdrawal pe-
riod is required. A with-
drawal period has not been
established for this product
in pre-ruminating calves. Do
not use in calves to be proc-
essed for veal. See
Lasalocid as provided by
No. 054771 in § 510.600(c)
of this chapter.
(xxiv) 500 to 1,200 g/ton to Lasalocid, 25 to 30 Cattle fed in confinement for Feed continuously in complete 054771
provide 10 mg/lb of body slaughter: For treatment of feed to provide 10 mg chlor-
weight daily. bacterial enteritis caused by tetracycline per lb body
Escherichia coli and bac- weight and not less than
terial pneumonia caused by 250 mg or more than 360
Pasteurella multocida orga- mg lasalocid per head per
nisms susceptible to chlor- day. Do not allow horses or
tetracycline; and for in- other equines access to
creased rate of weight gain feeds containing lasalocid. A
and improved feed effi- withdrawal period has not
ciency. been established for this
product in pre-ruminating
calves. Do not use in calves
to be processed for veal.
See § 558.311(d) of this
chapter. Lasalocid as pro-
455
§ 558.128 21 CFR Ch. I (4–1–23 Edition)
Combination in
grams/ton
(xxv) 500 to 4,000 to pro- Lasalocid, 30 to Pasture cattle (slaughter, Feed continuously on a hand- 054771
vide 10 mg/lb of body 600. stocker, feeder cattle, dairy fed basis for not more than 069254
weight daily. and beef replacement heif- 5 days to provide 10 mg
ers): For treatment of bac- chlortetracycline per lb.
terial enteritis caused by body weight per day and not
Escherichia coli and bac- less than 60 mg or more
terial pneumonia caused by than 300 mg lasalocid per
Pasteurella multocida orga- head per day in at least 1
nisms susceptible to chlor- pound of feed. Daily
tetracycline; and for in- lasalocid intakes in excess
creased rate of weight gain. of 200 mg/head/day in pas-
ture cattle have not been
(xxvi) 500 to 4,000 g/ton to Lasalocid, 30 to Replacement dairy heifers on The melengestrol acetate 054771
provide 10 mg/lb of body 600: pasture less than 20 months Type C top-dress medicated
weight daily. Melengestrol ac- of age and replacement feed must be top dressed
etate, 0.5 to 2 g/ beef heifers on pasture: For onto or mixed at feeding
ton to provide 0.5 treatment of bacterial enter- with a Type C medicated
mg/head/day itis caused by Escherichia feed containing 500 to 4,000
melengestrol ac- coli and bacterial pneu- g/ton of chlortetracycline
etate. monia caused by and 30 to 600 g/ton
Pasteurella multocida orga- lasalocid to provide 10 mg
nisms susceptible to chlor- chlortetracycline per lb body
tetracycline, increased rate weight per day and not less
of weight gain, and suppres- than 60 mg or more than
sion of estrus (heat). 300 mg lasalocid per head
per day in at least 1 pound
of feed for not more than 5
days. After completing feed-
ing of this combination, con-
tinue feeding a Type C top-
dress medicated feed con-
taining melengestrol acetate
alone for a total time not ex-
ceeding 24 days of feeding.
chapter. Chlortetracycline,
lasalocid, and melengestrol
as provided by No. 054771
in § 510.600(c) of this chap-
ter.
(xxvii) 500 to 4,000 g/ton ... ................................ Calves, beef and nonlactating Hand feed continuously for not 054771
dairy cattle: For the treat- more than 5 days to provide 069254
ment of bacterial enteritis 10 mg/lb body weight per
caused by Escherichia coli day. A withdrawal period
and bacterial pneumonia has not been established for
caused by Pasteurella this product in pre-rumi-
multocida susceptible to nating calves. Do not use in
chlortetracycline. calves to be processed for
veal. To sponsor No.
054771 under NADA 046–
699: 24-hour withdrawal pe-
riod. To sponsor No.
761 and No. 069254 under
ANADA 200–510: Zero with-
drawal period.
456
Combination in
grams/ton
(xxviii) 500 to 4,000 g/ton ... Decoquinate, 12.9 Calves, beef and non-lactating Feed at a rate of 1g chlortetra- 054771
to 90.8. dairy cattle: For the treat- cycline per 100 lb body 069254
ment of bacterial enteritis weight/day and 22.7 mg
caused by Escherichia coli decoquinate per 100 lb of
and bacterial pneumonia body weight/day for not
caused by Pasteurella more than 5 days. When it
multocida organisms sus- is fully consumed, resume
ceptible to chlortetracycline; feeding 22.7 mg
and for the prevention of decoquinate per 100 lb of
coccidiosis caused by body weight/day for a total
Eimeria bovis and E. zuernii. of 28 days to prevent coc-
cidiosis. A withdrawal period
veal. Do not feed to animals
producing milk for food.
Decoquinate as provided by
No. 054771 in § 510.600(c)
of this chapter.
(xxiv) 500 to 4,000 to pro- Melengestrol ace- Growing beef heifers fed in Melengestrol acetate Type C 054771
vide 10 mg per pound of tate, 0.25 to 2 g/ confinement for slaughter: top-dress medicated feed
body weight. ton to provide For the treatment of bac- must be top dressed onto or
0.25 to 0.5 mg terial enteritis caused by mixed at feeding with a
melengestrol ac- Escherichia coli and bac- Type C medicated feed con-
etate per head terial pneumonia caused by taining 500 to 4,000 g/ton
per day. Pasteurella multocida orga- chlortetracycline for not
nisms susceptible to chlor- more than 5 days. After
tetracycline, increased rate completing feeding of this
of weight gain, improved combination, continue feed-
feed efficiency, and sup- ing a Type C top-dress
pression of estrus (heat). medicated feed containing
melengestrol acetate alone.
No. 054771 in § 510.600(c)
of this chapter.
(xxx) 500 to 4,000 to pro- Melengestrol ace- Replacement dairy heifers less Melengestrol acetate Type C 054771
vide 10 mg per pound of tate, 0.5 to 2 g/ than 20 months of age and top-dress medicated feed
body weight. ton to provide 0.5 replacement beef heifers: must be top dressed onto or
mg melengestrol For the treatment of bac- mixed at feeding with a
acetate per head terial enteritis caused by Type C medicated feed con-
per day. Escherichia coli and bac- taining 500 to 4,000 g/ton
terial pneumonia caused by chlortetracycline for not
Pasteurella multocida orga- more than 5 days. After
nisms susceptible to chlor- completing feeding of this
tetracycline, and for sup- combination, continue feed-
pression of estrus (heat). ing a Type C top-dress
medicated feed containing
melengestrol acetate alone
for a total time not exceed-
ing 24 days. Use in dairy
heifers less than 20 months
of age may cause drug resi-
dues in milk and/or in calves
born to these cows. A with-
essed for veal. Chlortetra-
cycline and melengestrol as
457
§ 558.128 21 CFR Ch. I (4–1–23 Edition)
Combination in
grams/ton
(xxxi) 4,000 to 20,000 g/ton ................................ Calves, beef and nonlactating Administer as a top dress, 054771
dairy cattle: For the treat- varying with body weight 069254
ment of bacterial enteritis and feed consumption, to
caused by Escherichia coli provide 10 mg/lb per day.
and bacterial pneumonia Treat for not more than 5
caused by Pasteurella days. A withdrawal period
multocida organisms sus- has not been established for
ceptible to chlortetracycline. this product in pre-rumi-
veal.
(xxxii) 4,000 to 20,000 g/ton Decoquinate, 90.8 Calves, beef and non-lactating Feed at a rate of 1g chlortetra- 054771
to 535.7. dairy cattle: For the treat- cycline per 100 lb body 069254
ment of bacterial enteritis weight/day and 22.7 mg
caused by Escherichia coli decoquinate per 100 lb of
and bacterial pneumonia body weight/day for not
caused by Pasteurella more than 5 days. When it
multocida organisms sus- is fully consumed, resume
ceptible to chlortetracycline; feeding 22.7 mg
and for the prevention of decoquinate per 100 lb of
coccidiosis caused by body weight/day for a total
Eimeria bovis and E. zuernii. of 28 days to prevent coc-
cidiosis. A withdrawal period
veal. Do not feed to animals
producing milk for food.
Decoquinate as provided by
No. 054771 in § 510.600(c)
of this chapter.
(xxxiii) 4,000 to 20,000 g/ Melengestrol ace- Growing beef heifers fed in Top dress 0.5 to 2 pounds of 054771
ton to provide 10 mg/lb of tate, 0.25 to 2 g/ confinement for slaughter: this medicated feed con-
body weight per day. ton to provide For the treatment of bac- taining both drugs onto or
0.25 to 0.5 mg terial enteritis caused by mix at feeding with a non-
melengestrol ac- Escherichia coli and bac- medicated feed for not more
etate per head terial pneumonia caused by than 5 days. After com-
per day. Pasteurella multocida orga- pleting feeding of this com-
nisms susceptible to chlor- bination, continue feeding a
tetracycline, and for in- Type C top-dress medicated
creased rate of weight gain, feed containing
improved feed efficiency, melengestrol acetate alone.
and suppression of estrus A withdrawal period has not
(heat). been established for this
product in pre-ruminating
calves. Do not use in calves
to be processed for veal.
No. 054771 in § 510.600(c)
of this chapter.
458
Combination in
grams/ton
(xxxiv) 4,000 to 20,000 g/ Melengestrol ace- Replacement dairy heifers less Top dress 0.5 to 2 pounds of 054771
ton to provide 10 mg/lb of tate, 0.5 to 2 g/ than 20 months of age and this medicated feed con-
body weight per day. ton to provide 0.5 replacement beef heifers: taining both drugs onto or
mg melengestrol For the treatment of bac- mix at feeding with a non-
acetate per head terial enteritis caused by medicated feed for not more
per day. Escherichia coli and bac- than 5 days. After com-
terial pneumonia caused by pleting feeding of this com-
Pasteurella multocida orga- bination, continue feeding a
nisms susceptible to chlor- Type C top-dress medicated
tetracycline, and for sup- feed containing
pression of estrus (heat). melengestrol acetate alone
for a total time not exceed-
ing 24 days. Use in dairy
heifers less than 20 months
of age may cause drug resi-
dues in milk and/or in calves
born to these cows. A with-
essed for veal. Chlortetra-
cycline and melengestrol as
(xxxv) to provide 350 mg/ ................................ Beef cattle: For control of bac- Feed to provide chlortetra- 054771
head/day. terial pneumonia associated cycline at the rate of 350 066104
with shipping fever complex mg per animal daily. A with- 069254
caused by Pasteurella spp. drawal period has not been
susceptible to chlortetra- established for this product
cycline. in pre-ruminating calves. Do
essed for veal. Withdrawal
periods: To sponsor No.
054771 under NADAs 046–
699 and 049–287, No.
286, and No. 069254 under
NADA 048–480: Withdraw
48 hours prior to slaughter.
To sponsor No. 054771
under NADA 048–761 and
No. 069254 under NADA
138–935 and ANADA 200–
510: Zero withdrawal period.
(xxxvi) to provide 350 mg/ ................................ Beef cattle (under 700 lb): For Feed to provide chlortetra- 054771
head/day. control of active infection of cycline at the rate of 350 066104
anaplasmosis caused by mg per animal daily. A with- 069254
Anaplasma marginale sus- drawal period has not been
ceptible to chlortetracycline. established for this product
essed for veal. Withdrawal
periods: To sponsor No.
054771 under NADAs 046–
699 and 049–287, No.
286, and No. 069254 under
NADA 048–480: Withdraw
48 hours prior to slaughter.
To sponsor No. 054771
under NADA 048–761 and
No. 069254 under NADA
138–935 and ANADA 200–
510: Zero withdrawal period.
459
§ 558.128 21 CFR Ch. I (4–1–23 Edition)
Combination in
grams/ton
(xxxvii) 50 to 350 g/ton to Melengestrol ace- Replacement beef heifers Melengestrol acetate Type C 054771
provide 350 mg/head/day. tate, 0.5 to 2 g/ under 700 lb: For control of top-dress medicated feed
ton to provide 0.5 active infection of must be top dressed or
mg melengestrol anaplasmosis caused by mixed at feeding with the
acetate per head Anaplasma marginale sus- Type C medicated feed con-
per day. ceptible to chlortetracycline taining 50 to 350 g/ton
and for suppression of chlortetracycline for up to 24
estrus (heat). days of feeding. Do not ex-
ceed 24 days of feeding.
No. 054771 in § 510.600(c)
of this chapter.
(xxxviii) 20 to 350 g/ton ...... ................................ Beef cattle and replacement Feed to provide chlortetra- 054771
dairy heifers: For control of cycline at the rate of 350 069254
bacterial pneumonia associ- mg per head per day. This
ated with shipping fever drug is not approved for use
complex caused by in female dairy cattle 20
Pasteurella spp. susceptible months of age or older, in-
to chlortetracycline. cluding dry dairy cows. Use
in these cattle may cause
drug residues in milk and/or
in calves born to these
cows. A withdrawal period
veal. To sponsor No.
761 and No. 069254 under
ANADA 200–510: Zero with-
drawal period.
(xxxix) 20 to 350 g/ton to Melengestrol ace- Growing beef heifers fed in Melengestrol acetate Type C 054771
provide 350 mg/head/day. tate, 0.25 to 2 g/ confinement for slaughter: top-dress medicated feed
ton to provide For control of bacterial must be top dressed onto or
0.25 to 0.5 mg pneumonia associated with mixed at feeding with the
melengestrol ac- shipping fever complex Type C medicated feed con-
etate per head caused by Pasteurella spp. taining 20 to 350 g/ton
per day. susceptible to chlortetra- chlortetracycline. Chlortetra-
cycline, increased rate of cycline and melengestrol as
weight gain, improved feed provided by No. 054771 in
efficiency, and suppression § 510.600(c) of this chapter.
of estrus (heat).
(xl) 20 to 350 g/ton to pro- Melengestrol ace- Replacement dairy heifers less Melengestrol acetate Type C 054771
vide 350 mg/head/day. tate, 0.5 to 2 g/ than 20 months of age and top-dress medicated feed
ton to provide 0.5 replacement beef heifers: must be top dressed or
mg melengestrol For control of bacterial mixed at feeding with the
acetate per head pneumonia associated with Type C medicated feed con-
per day. shipping fever complex taining 20 to 350 g/ton
caused by Pasteurella spp. chlortetracycline. Use in
susceptible to chlortetra- dairy heifers less than 20
cycline and suppression of months of age may cause
estrus (heat). drug residues in milk and/or
in calves born to these
cows. A withdrawal period
veal. Chlortetracycline and
No. 054771 in § 510.600(c)
of this chapter.
460
Combination in
grams/ton
(xli) 23.3 to 58.3 g/ton to Laidlomycin, 5 ....... Cattle fed in confinement for Feed continuously at a rate of 054771
provide 350 mg/head/day. slaughter: For control of 30 to 75 mg laidlomycin pro-
bacterial pneumonia associ- pionate potassium per head
ated with shipping fever per day. A withdrawal period
complex caused by has not been established for
Pasteurella spp. susceptible this product in pre-rumi-
to chlortetracycline; and for nating calves. Do not use in
increased rate of weight calves to be processed for
gain and improved feed effi- veal. See § 558.305(d) of
ciency. this chapter. Laidlomycin as
(xlii) 14.6 to 116.7 g/ton to Laidlomycin, 5 to Cattle fed in confinement for Feed continuously at a rate of 054771
provide 350 mg/head/day. 10. slaughter: For control of 30 to 75 mg laidlomycin pro-
bacterial pneumonia associ- pionate potassium per head
ated with shipping fever per day. A withdrawal period
complex caused by has not been established for
Pasteurella spp. susceptible this product in pre-rumi-
to chlortetracycline; and for nating calves. Do not use in
improved feed efficiency. calves to be processed for
this chapter. Laidlomycin as
(xliii) 25 to 42.2 g/ton to Lasalocid, 25 to 30 Cattle under 700 pounds fed Feed continuously in complete 054771
provide 350 mg/head/day. in confinement for slaughter: feed at a rate of 350 mg 069254
For control of active infec- chlortetracycline and not
tion of anaplasmosis caused less than 250 mg nor more
by Anaplasma marginale than 360 mg lasalocid per
susceptible to chlortetra- head daily. Do not allow
cycline; and for increased horses or other equines ac-
rate of weight gain and im- cess to feeds containing
proved feed efficiency. lasalocid. No withdrawal pe-
essed for veal. See
No. 054771 in § 510.600(c)
of this chapter.
(xliv) 25 to 42.2 g/ton to Lasalocid, 25 to 30 Cattle fed in confinement for Feed continuously in complete 054771
provide 350 mg/head/day. slaughter: For control of feed at a rate of 350 mg 069254
bacterial pneumonia associ- chlortetracycline and not
ated with shipping fever less than 250 mg nor more
complex caused by than 360 mg lasalocid per
Pasteurella multocida orga- head daily. Do not allow
nisms susceptible to chlor- horses or other equines ac-
tetracycline; and for in- cess to feeds containing
creased rate of weight gain lasalocid. No withdrawal pe-
and improved feed effi- riod is required. A with-
ciency. drawal period has not been
essed for veal. See
No. 054771 in § 510.600(c)
of this chapter.
461
§ 558.128 21 CFR Ch. I (4–1–23 Edition)
Combination in
grams/ton
(xlv) 25 to 100 g/ton to pro- Lasalocid, 10 to 30 Cattle under 700 pounds fed Feed continuously in complete 054771
vide 350 mg/head/day. in confinement for slaughter: feed at a rate of 350 mg 069254
For control of active infec- chlortetracycline and not
tion of anaplasmosis caused less than 100 mg nor more
by Anaplasma marginale than 360 mg lasalocid per
susceptible to chlortetra- head daily. Do not allow
cycline; and for improved horses or other equines ac-
feed efficiency. cess to feeds containing
essed for veal. See
No. 054771 in § 510.600(c)
of this chapter.
(xlvi) 25 to 100 g/ton to pro- Lasalocid, 10 to 30 Cattle fed in confinement for Feed continuously in complete 054771
vide 350 mg/head/day. slaughter: For control of feed at a rate of 350 mg 069254
bacterial pneumonia associ- chlortetracycline and not
ated with shipping fever less than 100 mg nor more
complex caused by than 360 mg lasalocid per
Pasteurella multocida orga- head daily. Do not allow
nisms susceptible to chlor- horses or other equines ac-
tetracycline; and for im- cess to feeds containing
proved feed efficiency. lasalocid. No withdrawal pe-
essed for veal. See
No. 054771 in § 510.600(c)
of this chapter.
(xlvii) 25 to 700 to provide Lasalocid, 30 to Pasture cattle (slaughter, Feed continuously on a hand- 054771
350 g/head/day. 600. stocker, feeder cattle, dairy fed basis at a rate of 350 069254
and beef replacement heif- mg chlortetracycline and not
ers): For control of bacterial less than 60 mg nor more
pneumonia associated with than 300 mg lasalocid per
shipping fever complex head per day in at least 1
caused by Pasteurella pound of feed. Daily
multocida organisms sus- lasalocid intakes in excess
ceptible to chlortetracycline; of 200 mg/head/day in pas-
and for increased rate of ture cattle have not been
weight gain. shown to be more effective
462
Combination in
grams/ton
(xlviii) 25 to 700 g/ton to Lasalocid, 30 to Replacement beef heifers on The melengestrol acetate 054771
provide 350 mg/head/day. 600; pasture: For control of bac- Type C top-dress medicated
melengestrol ac- terial pneumonia associated feed must be top dressed
etate, 0.5 to 2 g/ with shipping fever complex onto or mixed at feeding
ton to provide 0.5 caused by Pasteurella spp. with a Type C medicated
mg/head/day susceptible to chlortetra- feed containing 25 to 700 g/
melengestrol ac- cycline, increased rate of ton of chlortetracycline and
etate. weight gain, and suppres- 30 to 600 g/ton lasalocid to
sion of estrus (heat). provide 350 mg chlortetra-
cycline per head daily and
not less than 60 mg or more
than 300 mg lasalocid per
head daily in at least 1
pound of feed. Do not ex-
ter.
(xliv) 25 to 700 to provide Lasalocid, 30 to Pasture cattle (slaughter, Feed continuously on a hand- 054771
350 mg/head/day. 600. stocker, feeder cattle, beef fed basis at a rate of 350 069254
replacement heifers) under mg chlortetracycline and not
700 pounds: For control of less than 60 mg nor more
active infection of than 300 mg lasalocid per
anaplasmosis caused by head per day in at least 1
Anaplasma marginale sus- pound of feed. Daily
ceptible to chlortetracycline; lasalocid intakes in excess
and for increased rate of of 200 mg/head/day in pas-
weight gain. ture cattle have not been
(l) 25 to 700 g/ton to pro- Lasalocid, 30 to Replacement beef heifers on The melengestrol acetate 054771
vide 350 mg/head/day. 600; pasture under 700 pounds: Type C top-dress medicated
melengestrol ac- For control of active infec- feed must be top dressed
etate, 0.5 to 2 g/ tion of anaplasmosis caused onto or mixed at feeding
ton to provide 0.5 by Anaplasma marginale with a Type C medicated
mg/head/day susceptible to chlortetra- feed containing 25 to 700 g/
melengestrol ac- cycline, increased rate of ton of chlortetracycline and
etate. weight gain, and suppres- 30 to 600 g/ton lasalocid to
sion of estrus (heat). provide 350 mg chlortetra-
cycline per head daily and
not less than 60 mg or more
than 300 mg lasalocid per
head daily in at least 1
pound of feed. Do not ex-
ter.
463
§ 558.128 21 CFR Ch. I (4–1–23 Edition)
Combination in
grams/ton
(li) 25 to 2,800 to provide Lasalocid, 30 to Beef cattle weighing under Hand feed continuously at a 054771
350 mg/head/day. 181.8. 700 pounds: For control of rate of 350 mg chlortetra- 069254
active infection of cycline and 1 mg lasalocid
anaplasmosis caused by per 2.2 lb. body weight daily
Anaplasma marginale sus- to cattle with a maximum of
ceptible to chlortetracycline; 360 mg of lasalocid per
and for the control of coc- head per day. Do not allow
cidiosis caused by Eimeria horses or other equines ac-
bovis and E. zuernii. cess to feeds containing
essed for veal. See
lasalocid as provided by No.
054771 in § 510.600(c) of
this chapter.
(lii) 25 to 2,800 g/ton to Lasalocid, 30 to Growing beef heifers fed in The melengestrol acetate 054771
provide 350 mg/head/day. 181.8; confinement for slaughter Type C top-dress medicated
melengestrol ac- under 700 pounds: For con- feed must be top dressed
etate, 0.25 to 2 trol of active infection of onto or mixed at feeding
g/ton to provide anaplasmosis caused by with a Type C medicated
0.25 to 0.5 mg/ Anaplasma marginale sus- feed containing 25 to 2,800
head/day ceptible to chlortetracycline, g/ton of chlortetracycline
melengestrol ac- control of coccidiosis and 30 to 181.8 g/ton
etate. caused by Eimeria bovis lasalocid to provide 350 mg
and E. zuernii, increased chlortetracycline per head
rate of weight gain, im- per day and 1 mg lasalocid
proved feed efficiency, and per 2.2 lb. of body weight
suppression of estrus (heat). daily with a maximum of
360 mg lasalocid per head
per day. See § 558.311(d) of
this chapter. Chlortetra-
cycline, lasalocid, and
No. 054771 in § 510.600(c)
of this chapter.
(liii) 25 to 2,800 to provide Lasalocid, 30 to Beef cattle weighing up to 800 Hand feed continuously at a 054771
350 mg/head/day. 181.8. pounds: For control of bac- rate of 350 mg chlortetra- 069254
terial pneumonia associated cycline and 1 mg lasalocid
with shipping fever complex per 2.2 lb. body weight daily
caused by Pasteurella spp. to cattle with a maximum of
susceptible to chlortetra- 360 mg of lasalocid per
cycline; and for the control head per day. Do not allow
of coccidiosis caused by horses or other equines ac-
Eimeria bovis and E. zuernii. cess to feeds containing
essed for veal. See
No. 054771 in § 510.600(c)
of this chapter.
464
Combination in
grams/ton
(liv) 25 to 2,800 g/ton to Lasalocid, 30 to Growing beef heifers fed in The melengestrol acetate 054771
provide 350 mg/head/day. 181.8; confinement for slaughter up Type C top-dress medicated
melengestrol ac- to 800 pounds: For control feed must be top dressed
etate, 0.25 to 2 of bacterial pneumonia as- onto or mixed at feeding
g/ton to provide sociated with shipping fever with a Type C medicated
0.25 to 0.5 mg/ complex caused by feed containing 25 to 2,800
head/day Pasteurella spp. susceptible g/ton of chlortetracycline
melengestrol ac- to chlortetracycline, control and 30 to 181.8 g/ton
etate. of coccidiosis caused by lasalocid to provide 350 mg
Eimeria bovis and E. chlortetracycline per head
zuernii, increased rate of daily and 1 mg lasalocid per
weight gain, improved feed 2.2 lb. of body weight daily
efficiency, and suppression with a maximum of 360 mg
of estrus (heat). lasalocid per head per day.
ter.
(lv) 25 to 2,800 g/ton to Lasalocid, 30 to Replacement beef heifers up The melengestrol acetate 054771
provide 350 mg/head/day. 181.8; to 800 pounds: For control Type C top-dress medicated
melengestrol ac- of bacterial pneumonia as- feed must be top dressed
etate, 0.5 to 2 g/ sociated with shipping fever onto or mixed at feeding
ton to provide 0.5 complex caused by with a Type C medicated
mg/head/day Pasteurella spp. susceptible feed containing 25 to 2,800
melengestrol ac- to chlortetracycline, control g/ton of chlortetracycline
etate. of coccidiosis caused by and 30 to 181.8 g/ton
Eimeria bovis and E. lasalocid to provide 350 mg
zuernii, and suppression of chlortetracycline per head
estrus (heat). daily and 1 mg lasalocid per
2.2 lb. of body weight daily
with a maximum of 360 mg
lasalocid per head per day.
Do not exceed 24 days of
feeding. See § 558.311(d) of
this chapter. Chlortetra-
cycline, lasalocid, and
No. 054771 in § 510.600(c)
of this chapter.
(lvi) 500 to 4,000 to provide Lasalocid, 30 to Cattle weighing up to 800 Hand feed continuously for not 054771
10 mg/head/day. 181.8. pounds: For the treatment of more than 5 days at a rate 069254
bacterial enteritis caused by of 10 mg chlortetracycline
Escherichia coli and bac- and 1 mg lasalocid per 2.2
terial pneumonia caused by lb. body weight daily to cat-
Pasteurella multocida sus- tle with a maximum of 360
ceptible to chlortetracycline; mg of lasalocid per head
and for the control of coc- per day. Do not allow
cidiosis caused by Eimeria horses or other equines ac-
bovis and E. zuernii. cess to feeds containing
essed for veal. See
No. 054771 in § 510.600(c)
of this chapter.
465
§ 558.128 21 CFR Ch. I (4–1–23 Edition)
Combination in
grams/ton
(lvii) 500 to 4,000 g/ton to Lasalocid, 30 to Growing beef heifers fed in The melengestrol acetate 054771
provide 10 mg/lb of body 181.8; confinement for slaughter up Type C top-dress medicated
weight daily. melengestrol ac- to 800 pounds: For the feed must be top dressed
etate, 0.25 to 2 treatment of bacterial enter- onto or mixed at feeding
g/ton to provide itis caused by Escherichia with a Type C medicated
0.25 to 0.5 mg/ coli and bacterial pneu- feed containing 500 to 4,000
head/day monia caused by g/ton of chlortetracycline
melengestrol ac- Pasteurella multocida orga- and 30 to 181.8 g/ton
etate. nisms susceptible to chlor- lasalocid to provide 10 mg
tetracycline, control of coc- chlortetracycline per lb of
cidiosis caused by Eimeria body weight per day and 1
bovis and E. zuernii, in- mg lasalocid per 2.2 lb of
creased rate of weight gain, body weight per day with a
improved feed efficiency, maximum of 360 mg
and suppression of estrus lasalocid per head per day
(heat). for not more than 5 days of
feeding. After completing
feeding of this combination,
continue feeding a Type C
top-dress medicated feed
containing melengestrol ac-
etate alone. See
Chlortetracycline, lasalocid,
and melengestrol as pro-
(lviii) 500 to 4,000 g/ton to Lasalocid, 30 to Replacement dairy heifers up The melengestrol acetate 054771
provide 10 mg/lb of body 181.8; to 800 pounds and less than Type C top-dress medicated
weight daily. melengestrol ac- 20 months of age and re- feed must be top dressed
etate, 0.5 to 2 g/ placement beef heifers up to onto or mixed at feeding
ton to provide 0.5 800 pounds: For the treat- with a Type C medicated
mg/head/day ment of bacterial enteritis feed containing 500 to 4,000
melengestrol ac- caused by Escherichia coli g/ton of chlortetracycline
etate. and bacterial pneumonia and 30 to 181.8 g/ton
caused by Pasteurella lasalocid to provide 10 mg
multocida organisms sus- chlortetracycline per lb of
ceptible to chlortetracycline, body weight per day and 1
control of coccidiosis mg lasalocid per 2.2 lb of
caused by Eimeria bovis body weight per day with a
and E. zuernii, and suppres- maximum of 360 mg
sion of estrus (heat). lasalocid per head per day
for not more than 5 days.
After completing feeding of
this combination, continue
feeding a Type C top-dress
medicated feed containing
melengestrol acetate alone.
ter.
(5) Minor species. It is used as follows:

(i) 80 mg/head/day ............. Breeding sheep; reducing the inci- ............................................................... 054771
dence of (vibrionic) abortion caused 066104
by Campylobacter fetus infection 069254
susceptible to chlortetracycline.
(ii) 200 to 400 g/ton ............ Ducks: For the control and treatment of Feed in complete ration to provide from 054771
fowl cholera caused by Pasteurella 8 to 28 mg/lb of body weight per 069254
multocida susceptible to chlortetra- day, depending upon age and sever-
cycline. ity of disease, for not more than 21
days. Do not feed to ducks pro-
ducing eggs for human consumption.
466
(iii) 10 mg/g of finished feed Psittacine birds (cockatoos, macaws, Feed continuously for 45 days. Each 054771
daily. and parrots) suspected or known to bird should consume daily an 069254
be infected with psittacosis caused amount of medicated feed equal to
by Chlamydia psittaci sensitive to one fifth of its body weight. See
chlortetracycline. paragraph (d)(5) of this section.
(6) It is used as a free-choice, loose (v) Sponsors. See Nos. 054771 and
mineral Type C feed as follows: 069254 in § 510.600(c) of this chapter.
(i) Specifications. [81 FR 94995, Dec. 27, 2016, as amended at 82
FR 21691, May 10, 2017; 82 FR 43485, Sept. 18,
International feed
Ingredient Percent 2017; 83 FR 13636, Mar. 30, 2018; 83 FR 14588,
No.
Apr. 5, 2018; 83 FR 48947, Sept. 28, 2018; 83 FR
Dicalcium Phos- 64741, Dec. 18, 2018; 84 FR 8975, Mar. 13, 2019;
phate .................. 46.20 6–26–335 84 FR 39185, Aug. 9, 2019; 86 FR 13189, Mar. 8,
Sodium Chloride 2021; 86 FR 14822, Mar. 19, 2021; 86 FR 17064,
(Salt) .................. 15.00 6–04–152 Apr. 1, 2021; 86 FR 57999, Oct. 20, 2021; 86 FR
Magnesium Oxide 10.67 6–02–756 61686, Nov. 8, 2021; 87 FR 58963, Sept. 29, 2022;
Cottonseed Meal ... 10.00 5–01–625 87 FR 76422, Dec. 14, 2022; 88 FR 14901, Mar. 10,
Trace Mineral/Vita- 2023]
min Premix 1 ....... 3.80
Calcium Carbonate 3.50 6–01–069
§ 558.140 Chlortetracycline and
Dried Cane Molas-
ses ..................... 3.00 4–04–695
sulfamethazine.
Potassium Chloride 2.00 6–03–755 (a) Specifications. Type A medicated
Mineral Oil ............. 2.00 8–03–123 articles containing:
Iron Oxide .............. 0.50 6–02–431
(1) 35 grams (g) per pound (/lb) each,
Chlortetracycline
Type A medi- chlortetracycline and sulfamethazine.
cated article (90 (2) 40 g/lb each, chlortetracycline and
gram/lb) .............. 3.33 sulfamethazine.
1 Contentof vitamin and trace mineral premixes may be (b) Sponsors. See sponsors in
varied. However, they should be comparable to those used for § 510.600(c) of this chapter as follows:
other free-choice feeds. Formulation modifications require
FDA approval prior to marketing. Selenium must comply with (1) No. 054771 for use of product de-
21 CFR 573.920. Ethylenediamine dihydroiodide (EDDI) scribed in paragraph (a)(1) as in para-
should comply with FDA Compliance Policy Guides Sec.
651.100 (CPG 7125.18). graph (e)(1) of this section.
(ii) Amount. 6,000 grams per ton.
scribed in paragraph (a)(1) as in para-
(iii) Indications for use. Beef and graph (e)(1)(i) of this section.
nonlactating dairy cattle: As an aid in (3) Nos. 054771 and 069254 for use of
the control of active infection of product described in paragraph (a)(2) as
anaplasmosis caused by Anaplasma in paragraph (e)(2) of this section.
marginale susceptible to chlortetra- (c) Related tolerances. See §§ 556.150
cycline. and 556.670 of this chapter.
(iv) Limitations. Feed continuously on (d) Special considerations. (1) Federal
a free-choice basis at a rate of 0.5 to 2.0 law restricts medicated feed containing
mg chlortetracycline per pound of body this veterinary feed directive (VFD)
weight per day. drug to use by or on the order of a li-
censed veterinarian. See § 558.6 for addi-
tional requirements.
(2) The expiration date of VFDs for
chlortetracycline and sulfamethazine
medicated feeds must not exceed 6
months from the date of issuance.
VFDs for chlortetracycline and
sulfamethazine shall not be refilled.
(e) Conditions of use—(1) Cattle—
467
§ 558.140 21 CFR Ch. I (4–1–23 Edition)
Chlortetra-
cycline Combina-
and tion in Indications for use Limitations Sponsors
sulfamethazine grams/ton
amount each
(i) To provide ................ Beef cattle: As an aid in Feed for 28 days. Withdraw 7 054771
350 milli- the maintenance of days prior to slaughter. A with- 069254
grams per weight gains in the pres- drawal period has not been es-
head per day. ence of respiratory dis- tablished for this product in pre-
ease such as shipping ruminating calves. Do not use in
fever. calves to be processed for veal.
(ii) 35 to 105 g/ Lasalocid, Beef steers and heifers fed Feed continuously for 28 days to 054771
ton, each. 10 to in confinement for provide 350 mg chlortetra-
30. slaughter: As an aid in cycline, 350 mg sulfamethazine,
the maintenance of and 100 to 300 mg lasalocid
weight gains in the pres- per head per day. Do not allow
ence of respiratory dis- horses or other equines access
ease such as shipping to Type C feeds containing
fever, and for improved lasalocid as ingestion may be
feed efficiency. fatal. Safety of lasalocid for use
in unapproved species has not
been established. Withdraw 7
days prior to slaughter. A with-
drawal period has not been es-
tablished for this product in pre-
ruminating calves. Do not use in
Lasalocid as provided by No.
054771 in § 510.600(c) of this
chapter.
(iii) 35 to 42.2 Lasalocid, Beef steers and heifers fed Feed continuously for 28 days to 054771
g/ton, each. 25 to in confinement for provide 350 mg chlortetra-
30. slaughter: As an aid in cycline, 350 mg sulfamethazine,
the maintenance of and 250 to 300 mg lasalocid
weight gains in the pres- per head per day. Do not allow
ence of respiratory dis- horses or other equines access
ease such as shipping to Type C feeds containing
fever, and for improved lasalocid as ingestion may be
feed efficiency and in- fatal. Safety of lasalocid for use
creased rate of weight in unapproved species has not
gain. been established. Withdraw 7
days prior to slaughter. A with-
drawal period has not been es-
tablished for this product in pre-
ruminating calves. Do not use in
054771 in § 510.600(c) of this
chapter.
468
Chlortetra-
cycline Combina-
and tion in Indications for use Limitations Sponsors
sulfamethazine grams/ton
amount each
(iv) 35 to 700 g/ Lasalocid, Beef cattle up to 800 lb: As Hand feed continuously for 28 054771
ton, each. 30 to an aid in the mainte- days to provide 350 mg chlor-
181.8. nance of weight gains in tetracycline, 350 mg
the presence of res- sulfamethazine, and 1 mg
piratory disease such as lasalocid per 2.2 lb body weight
shipping fever, and for per day up to a maximum of
control of coccidiosis 360 mg lasalocid per head per
caused by Eimeria bovis day. Do not allow horses or
and E. zuernii. other equines access to Type C
feeds containing lasalocid as in-
gestion may be fatal. Safety of
lasalocid for use in unapproved
species has not been estab-
lished. Withdraw 7 days prior to
slaughter. A withdrawal period
this product in pre-ruminating
calves. Do not use in calves to
be processed for veal.
054771 in § 510.600(c) of this
chapter.
(2) Swine—
Chlortetracycline and Indications for use Limitations Sponsors

sulfamethazine amount
(i) 100 g/ton of feed each, Swine: For reduction of the Feed as the sole ration. With- 054771
chlortetracycline and incidence of cervical ab- draw 15 days prior to 069254
sulfamethazine. scesses; treatment of bac- slaughter.
terial swine enteritis (sal-
monellosis or necrotic en-
teritis caused by Sal-
monella choleraesuis and
vibrionic dysentery); pre-
vention of these diseases
during times of stress; and
maintenance of weight
gains in the presence of
atrophic rhinitis.
(ii) [Reserved]
[79 FR 37622, July 2, 2014, as amended at 80 (b) Sponsor. See No. 016592 in
FR 13231, Mar. 13, 2015; 81 FR 63054, Sept. 14, § 510.600(c) of this chapter.
2016; 81 FR 95004, Dec. 27, 2016; 82 FR 21691,
May 10, 2017; 84 FR 12495, Apr. 2, 2019; 86 FR
13189, Mar. 8, 2021; 86 FR 14822, Mar. 19, 2021] this chapter.
(d) Conditions of use—(1) Chickens—
§ 558.175 Clopidol.
article containing 25 percent clopidol.
469
§ 558.175 21 CFR Ch. I (4–1–23 Edition)
Clopidol in Combination in Indications for use Limitations Sponsors

(i) 113.5 ............. ................................. Broiler chickens and re-placement Do not feed to chickens over 016592
chickens intended for use as 16 weeks of age.
caged layers: As an aid in the pre-
vention of coccidiosis caused by
Eimeria tenella, E. necatrix, E.
acervulina, E. maxima, E. brunetti,
and E. mivati..
(ii) 113.5 ............ Bacitracin Broiler chickens: As an aid in the Feed continuously as the sole 016592
methylenedisalicy- prevention of coccidiosis caused ration from the time chicks
late, 4 to 50. by Eimeria tenella, E. necatrix, E. are placed in floor pens until
acervulina, E. maxima, E. brunetti, slaughter. Do not feed to
and E. mivati, and for increased chickens over 16 weeks of
rate of weight gain.. age; bacitracin
methylenedisalicylate as pro-
(iii) 113.5 ........... Bacitracin zinc, 5 to Broiler chickens: As an aid in the Feed continuously as sole ra- 054771
25. prevention of coccidiosis caused tion; bacitracin zinc as pro- 016592
by Eimeria tenella, E. necatrix, E. vided by No. 054771 in
acervulina, E. maxima, E. brunetti, § 510.600(c) of this chapter.
and E. mivati, and for increased
rate of weight gain and improved
feed efficiency..
(iv) 113.5 ........... Bambermycins, 1 to Broiler chickens: As an aid in preven- Feed continuously as the sole 016592
2. tion of coccidiosis caused by ration. Do not feed to chick-
Eimeria tenella, E. necatrix, E. ens over 16 weeks of age.
acervulina, E. maxima, E. brunetti,
and E. mivati; and for increased
feed efficiency..
(v) 227 ............... ................................. Broiler and replacement chickens in- Feed continuously as the sole 016592
tended for use as caged layers: As ration; feed up to 16 weeks
an aid in the prevention of coccidi- of age if intended for use as
osis caused by Eimeria tenella, E. caged layers; withdraw 5
necatrix, E. acervulina, E. maxima, days before slaughter if
E. brunetti, and E. mivati.. given at the level of 0.025
percent in feed or reduce
level to 0.0125 percent 5
days before slaughter.
(vi) 227 .............. Bambermycins, 1 to Broiler chickens: As an aid in preven- Feed continuously as sole ra- 016592
2. tion of coccidiosis caused by tion until 5 days before
Eimeria tenella, E. necatrix, E. slaughter. Withdraw 5 days
acervulina, E. maxima, E. brunetti, before slaughter or feed
and E. mivati; and for increased 113.5 g/ton clopidol and 1 to
rate of weight gain and improved 2 g/ton bambermycins during
feed efficiency.. those 5 days before slaugh-
ter. Do not feed to chickens
over 16 weeks of age.
(2) Turkeys—
Clopidol in Combination in Indications for use Limitations Sponsors
(i) 113.5 or 227 ................................. Turkeys: As an aid in the prevention For turkeys grown for meat 016592
of leucocytozoonosis caused by purposes only; feed continu-
Leucocytozoon smithi.. ously as the sole ration at
0.0125 or 0.025 percent
clopidol depending on man-
agement practices, degree
of exposure, and amount of
feed eaten; withdraw 5 days
before slaughter.
(ii) [Reserved]
(3) Combinations. Clopidol may also be (i) Chlortetracycline as in § 558.128.

used in combination with:
470
(ii) Lincomycin as in § 558.325. (c) Related tolerances. See § 556.168 of

[68 FR 17882, Apr. 14, 2003, as amended at 72 this chapter.
FR 60551, Oct. 25, 2007; 74 FR 61028, Nov. 23, (d) Special considerations. (1) Labeling
2009; 79 FR 10965, 10982, Feb. 27, 2014; 79 FR shall bear the following warning: The
13545, Mar. 11, 2014; 81 FR 17609, Mar. 30, 2016; active ingredient coumaphos is a cho-
81 FR 95004, Dec. 27, 2016; 84 FR 12495, Apr. 2, linesterase inhibitor. Do not use this
2019; 86 FR 14822, Mar. 19, 2021]
product on animals simultaneously or
§ 558.185 Coumaphos. within a few days before or after treat-
ment with, or exposure to, cholin-
esterase-inhibiting drugs, pesticides, or
articles containing 1.12, 2.0, 11.2, or 50
percent coumaphos. chemicals.
(b) Sponsor. See No. 058198 in (2) See § 500.25 of this chapter.
§ 510.600(c) of this chapter. (e) Conditions of use in laying chickens.
Coumaphos in Indications for use Limitations Sponsor

grams per ton
(1) 27.2 (0.003 percent) .................... Laying chickens: For control of cap- Feed continuously as the sole ra- 058198
illary worm (Capillaria obsignata) tion for 14 days. If reinfection oc-
and as an aid in control of com- curs, treatment may be repeated,
mon round worm (Ascaridia galli) but not sooner than 3 weeks after
and cecal worm (Heterakis the end of the previous treatment.
gallinae). Do not feed to chickens within 10
days of vaccination or other con-
ditions of stress..
(2) 36.3 (0.004 percent) .................... Replacement pullets: For control of Feed continuously as the sole ra- 058198
capillary worm (Capillaria tion for from 10 to 14 days. Do
obsignata) and as an aid in con- not feed to chickens under 8
trol of common round worm weeks of age or within 10 days of
(Ascaridia galli) and cecal worm vaccination or other conditions of
(Heterakis gallinae). stress. If birds are maintained on
contaminated litter or exposed to
infected birds, a second 10- to
14-day treatment is rec-
ommended, but not sooner than
3 weeks after the end of the pre-
vious treatment. If reinfection oc-
curs after production begins, re-
peat treatment as recommended
for laying flocks..
[86 FR 14822, Mar. 19, 2021] (2) Type A medicated articles may be
used to manufacture dry or liquid Type
§ 558.195 Decoquinate. B cattle (including veal calf), sheep,
(a) Specifications. Type A medicated and goat feeds as in paragraphs (e)(2)
article containing 6 percent and (e)(3) of this section.
decoquinate. (3) Type C cattle feeds may be manu-
(b) Sponsor. See No. 054771 in factured from decoquinate liquid Type
§ 510.600(c) of this chapter. B feeds having a pH between 5.0 to 6.5
and containing a suspending agent to
maintain a viscosity of not less than
this chapter.
500 centipoises.
(d) Special considerations. (1) Ben- (e) Conditions of use. It is used as fol-
tonite should not be used in lows:
decoquinate feeds. (1) Chickens—
Decoquinate in Combination in Indications for use Limitations Sponsor
grams/ton grams/ton
(i) 27.2 ............... Broiler chickens: For prevention of Do not feed to laying hens pro- 054771
coccidiosis caused by Eimeria ducing eggs for human con-
tenella, E. necatrix, E. mivati, E. sumption.
acervulina, E. maxima, and E.
brunetti.
471
§ 558.195 21 CFR Ch. I (4–1–23 Edition)

grams/ton grams/ton
(ii) 27.2 .............. Bacitracin Broiler chickens: For prevention of Feed continuously as sole ra- 054771
methylenedisalicy- coccidiosis caused by Eimeria tion; do not feed to laying
late, 4 to 50. tenella, E. necatrix, E. mivati, E. chickens. Bacitracin
acervulina, E. maxima, and E. methylenedisalicylate as pro-
brunetti; and for increased rate of vided by No. 054771 in
weight gain and improved feed effi- § 510.600(c) of this chapter.
ciency.
(iii) 27.2 ............. Bacitracin zinc, 10 to Broiler chickens: For prevention of Feed continuously as sole ra- 054771
50. coccidiosis caused by Eimeria tion; do not feed to laying
tenella, E. necatrix, E. mivati, E. chickens. Bacitracin zinc as
acervulina, E. maxima, and E. provided by No. 054771 in
brunetti. § 510.600(c) of this chapter.
(2) Cattle—
grams/ton grams/ton
(i) 12.9 to 90.8 .. Cattle (including ruminating and non- Feed Type C feed or milk re- 054771
ruminating calves and veal calves): placer to provide 22.7 milli-
For prevention of coccidiosis grams (mg) per 100 pounds
caused by Eimeria bovis and E. (lb) of body weight (0.5 mg/
zuernii. kg) per day. Feed at least 28
days during periods of expo-
sure to coccidiosis or when it
is likely to be a hazard. Do
not feed to cows producing
milk for human consumption.
See paragraph (d)(3) of this
section.
(ii) 12.9 to 90.8 Monensin, 5 to 30 ... Cattle fed in confinement for slaugh- Feed continuously as the sole 016592,
ter: For prevention of coccidiosis ration to provide 22.7 mg of 054771
caused by Eimeria bovis and E. decoquinate per 100 lb of
zuernii; and for improved feed effi- body weight per day and 50
ciency. to 360 mg of monensin per
head per day. Feed at least
28 days during period of ex-
posure to coccidiosis or
when it is likely to be a haz-
ard. Do not feed to animals
producing milk for food. Do
not feed to lactating dairy
cattle. Also see paragraph
(d)(1) of this section and
§ 558.355(d)(9)(i). Monensin
or 058198 in § 510.600(c) of
this chapter.
(iii) 90.9 to 535.7 Cattle (including ruminating and non- Feed Type C medicated feed 054771
ruminating calves and veal calves): supplements as a top dress
For prevention of coccidiosis or mix into the daily ration to
caused by Eimeria bovis and E. provide 22.7 mg per 100 lb
zuernii. of body weight (0.5 mg/kg)
per day. Feed at least 28
not feed to cows producing
milk for food. See paragraph
(3) Minor species—

472

grams/ton grams/ton
(i) 12.9 to 90.8 .. ................................. 1. Young sheep: For the prevention Feed Type C feed or milk re- 054771
of coccidiosis caused by Eimeria placer at a rate to provide
ovinoidalis, E. crandallis, E. parva, 22.7 mg per 100 lb of body
and E. bakuensis. weight (0.5 mg per kg) per
day; feed for at least 28
not feed to sheep producing
...................... ............................. 2. Young goats: For the prevention of Feed Type C feed or milk re-
coccidiosis caused by Eimeria placer at a rate to provide
christenseni and E. 22.7 mg per 100 lb of body
ninakohlyakimovae. weight (0.5 mg per kg) per
day; feed for at least 28
not feed to goats producing
(ii) 90.9 to 535.7 ................................. 1. Young sheep: For the prevention Feed Type C medicated feed 054771
of coccidiosis caused by Eimeria supplements as a top dress
ovinoidalis, E. crandallis, E. parva, or mix into the daily ration to
and E. bakuensis. provide 22.7 mg per 100 lb
of body weight (0.5 mg per
kg) per day; feed for at least
28 days during periods of
exposure to coccidiosis or
ard. Do not feed to sheep
producing milk for human
consumption.
...................... ............................. 2. Young goats: For the prevention of Feed Type C medicated feed ....................
coccidiosis caused by Eimeria supplements as a top dress
christenseni and E. or mix into the daily ration to
ninakohlyakimovae. provide 22.7 mg per 100 lb
of body weight (0.5 mg per
kg) per day; feed for at least
28 days during periods of
exposure to coccidiosis or
ard. Do not feed to goats
producing milk for human
consumption.
(4) Decoquinate may also be used in § 558.198 Dichlorvos.

combination with:
(a) Specifications. Each pound of Type
(i)–(ii) [Reserved] A medicated article containing 3.1 or
(iii) Chlortetracycline as in § 558.128. 9.6 percent dichlorvos.
(iv) Lincomycin as in § 558.325. (b) Sponsor. See No. 054628 in
[67 FR 72370, Dec. 5, 2002; 68 FR 15372, Mar. 31, § 510.600(c) of this chapter.
2003; 69 FR 26499, May 13, 2004; 69 FR 52816, (c) Related tolerances. See § 556.180 of
Aug. 30, 2004; 69 FR 62407, Oct. 26, 2004; 69 FR this chapter.
67264, Nov. 17, 2004; 70 FR 2567, Jan. 14, 2005; (d) Special considerations. (1)
78 FR 25183, Apr. 30, 2013; 79 FR 10982, Feb. 27, Dichlorvos is to be included in meal or
2014; 79 FR 13545, Mar. 11, 2014; 79 FR 17860,
mash or mixed with feed in crumble
Mar. 31, 2014; 80 FR 13231, Mar. 13, 2015; 81 FR
form only after the crumble feed has
17609, Mar. 30, 2016; 81 FR 22525, Apr. 18, 2016;
81 FR 67152, Sept. 30, 2016; 81 FR 95004, Dec. been manufactured. Do not mix in
27, 2016; 83 FR 48947, Sept. 28, 2018; 84 FR feeds to be pelleted nor with pelleted
12496, Apr. 2, 2019; 85 FR 18121, Apr. 1, 2020; 86 feed. Do not soak the feed or admin-
FR 14822, Mar. 19, 2021] ister as wet mash. Feed must be dry
when administered. Do not use in ani-
mals other than swine. Do not allow

fowl access to feed containing this
473
§ 558.205 21 CFR Ch. I (4–1–23 Edition)
preparation or to feces from treated (3) Labeling for Type A articles and
animals. Type B feeds must include a statement
(2) Dichlorvos is a cholinesterase in- that containers or materials used in
hibitor. Do not use this product in ani- packaging such Type A articles and
mals simultaneously or within a few Type B feeds are not to be reused and
days before or after treatment with or all such packaging materials must be
exposure to cholinesterase-inhibiting destroyed after the product has been
drugs, pesticides, or chemicals. If used.
human or animal poisoning should
(e) Conditions of use. It is used in
occur, immediately consult a physician
swine feed as follows:
or a veterinarian. Atropine is anti-
dotal.
Dichlorvos Combination in Indications for use Limitations Sponsor
grams/ton grams/ton
(i) 348 ................ Swine up to 70 pounds body weight: Feed as sole ration for 2 con- 054628
For the removal and control of ma- secutive days. For swine
ture, immature, and/or fourth-stage from 70 pounds to market
larvae of the whipworm (Trichuris weight, feed as sole ration at
suis), nodular worm the rate of 8.4 pounds of
(Oesophagostomum sp.), large feed per head until the medi-
roundworm (Ascaris suum) and the cated feed has been con-
thick stomach worm (Ascarops sumed. For boars, open or
strongylina) of the gastrointestinal bred gilts, and sows, feed as
tract.. sole ration at the rate of 4.2
pounds per head per day for
2 consecutive days..
(ii) 479 ............... Boars, open or bred gilts, and sows: Feed as sole ration at the rate 054628
For the removal and control of ma- of 6 pounds per head for
ture, immature, and/or fourth-stage one feeding..
larvae of the whipworm (Trichuris
suis), nodular worm
(Oesophagostomum sp.), large
roundworm (Ascaris suum) and the
thick stomach worm (Ascarops
strongylina) of the gastrointestinal
tract..
(iii) 334 to 500 ... Pregnant swine: An aid in improving Mix into a gestation feed to 054628
litter production efficiency by in- provide 1,000 milligrams per
creasing pigs born alive, birth head daily during last 30
weights, survival to market, and days of gestation..
rate of weight gain. Treatment also
removes and controls mature, im-
mature and/or fourth stage larvae
of whipworm (Trichuris suis), nod-
ular worm (Oesophagostomum
spp.) large roundworm (Ascaris
suum), and the thick stomach
worm (Ascarops strongylina) occur-
ring in the gastrointestinal tract of
the sow or gilt..
[84 FR 12497, Apr. 2, 2019] (b) Sponsor. See No. 058198 in

§ 558.205 Diclazuril. (c) Related tolerances. See § 556.185 of
(a) Specifications. Type A medicated this chapter.
article containing 0.2 percent (d) Conditions of use—(1) Chickens. For
diclazuril. chickens it is used as follows:
474
Diclazuril Combination Indications for use Limitations Sponsor

grams/ton grams/ton
(i) 0.91 ..................... .............................. Broiler chickens: For the prevention Feed continuously as the 058198
of coccidiosis caused by Eimeria sole ration. Do not feed to
tenella, E. necatrix, E. acervulina, birds producing eggs for
E. brunetti, E. mitis (mivati), and E. human consumption.
maxima. Because diclazuril is ef-
fective against E. maxima later in
its life cycle, subclinical intestinal
lesions may be present for a short
time after infection. Diclazuril was
shown in studies to reduce lesion
scores and improve performance
and health of birds challenged with
E. maxima.
(ii) 0.91 ..................... Bacitracin Broiler chickens: For the prevention Feed continuously as the 058198
methylenedisali- of coccidiosis caused by Eimeria sole ration. Do not feed to
cylate, 4 to 50. tenella, E. necatrix, E. acervulina, birds producing eggs for
E. brunetti, E. mitis (mivati), and E. human consumption. Bac-
maxima, and for increased rate of itracin
weight gain and improved feed effi- methylenedisalicylate pro-
ciency. Because diclazuril is effec- vided by No. 054771 in
tive against E. maxima later in its § 510.600(c) of this chap-
life cycle, subclinical intestinal le- ter.
sions may be present for a short
E. maxima.
(iii) 0.91 .................... Bambermycins, 1 Broiler chickens: For the prevention Feed continuously as the 058198
to 2. of coccidiosis caused by Eimeria sole ration. Do not feed to
tenella, E. necatrix, E. acervulina, birds producing eggs for
E. brunetti, E. mitis (mivati), and E. human consumption.
maxima, and for increased rate of Bambermycins provided
weight gain and improved feed effi- by No. 016592 in
ciency. Because diclazuril is effec- § 510.600(c) of this chap-
tive against E. maxima later in its ter.
life cycle, subclinical intestinal le-
sions may be present for a short
E. maxima.
(2) Turkeys. For turkeys it is used as follows:

grams/ton grams/ton
(i) 0.91 ..................... .............................. Growing turkeys: For the prevention Feed continuously as the 058198
adenoeides, E. gallopavonis, and breeding turkeys. Do not
E. meleagrimitis. feed to birds producing
eggs for human consump-
tion.
(ii) 0.91 ..................... Bacitracin Growing turkeys: For the prevention Feed continuously as the 058198
methylenedisali- of coccidiosis caused by Eimeria sole ration. Do not feed to
cylate, 4 to 50. adenoeides, E. gallopavonis, and breeding turkeys. Do not
E. meleagrimitis, and for increased feed to birds producing
rate of weight gain and improved eggs for human consump-
feed efficiency. tion. Bacitracin
methylenedisalicylate as
provided by No. 054771
in § 510.600(c) of this
chapter.
475
§ 558.235 21 CFR Ch. I (4–1–23 Edition)

grams/ton grams/ton
(iii) 0.91 .................... Bambermycins 1 Growing turkeys: For the prevention Feed continuously as the 058198
to 2. of coccidiosis caused by Eimeria sole ration. Do not feed to
E. meleagrimitis, and for improved feed to birds producing
feed efficiency. eggs for human consump-
tion. Bambermycins as
in § 510.600(c) of this
chapter.
(iv) 0.91 .................... Bambermycins 2 .. Growing turkeys: For the prevention Feed continuously as the 058198
E. meleagrimitis, and for increased feed to birds producing
rate of weight gain and improved eggs for human consump-
feed efficiency. tion. Bambermycins as
in § 510.600(c) of this
chapter.
(3) Diclazuril may also be used in § 558.235 Efrotomycin.

combination with virginiamycin as in
§ 558.635.
articles containing 14.5 grams
[64 FR 35923, July 2, 1999, as amended at 65 efrotomycin per pound.
FR 50134, Aug. 17, 2000; 66 FR 47962, 47963,
Sept. 17, 2001; 66 FR 62917, Dec. 4, 2001; 67 FR
34830, May 16, 2002; 67 FR 47257, July 18, 2002; § 510.600(c) of this chapter.
67 FR 48549, July 25, 2002; 69 FR 9947, Mar. 3, (c) Related tolerances. See § 556.224 of
2004; 72 FR 60552, Oct. 25, 2007; 79 FR 10982, this chapter.
Feb. 27, 2014; 79 FR 13545, Mar. 11, 2014; 81 FR (d) Conditions of use in swine—
17609, Mar. 30, 2016; 81 FR 95004, Dec. 27, 2016.
Redesignated and amended at 84 FR 12497,
12498, Apr. 2, 2019; 87 FR 10970, Feb. 28, 2022]
Efrotomycin Indications for use Limitations Sponsor

in grams/ton
(1) 3.6 ................................ Swine: For improved feed efficiency ........ Feed continuously as sole ration. Not to 000010
be used in swine weighing more than
250 pounds.
(2) 3.6 to 14.5 ................... Swine: For increased rate of weight gain Feed continuously as sole ration. Not to 000010
be used in swine weighing more than
250 pounds.
[57 FR 38442, Aug. 25, 1992, as amended at 62 FR 63271, Nov. 28, 1997; 84 FR 33001, July 11, 2019;
84 FR 39185, Aug. 9, 2019; 85 FR 45309, July 28, 2020]
§ 558.248 Erythromycin. this veterinary feed directive (VFD)

(a) Specifications. Type A medicated drug to use by or on the order of a li-
articles containing 92.5 grams per censed veterinarian. See § 558.6 for addi-
pound erythromycin (as the tional requirements.
thiocyanate salt). (2) The expiration date of VFDs for
(b) Sponsor. See No. 061133 in erythromycin medicated feeds must
§ 510.600(c) of this chapter. not exceed 6 months from the date of
(c) Related tolerances. See § 556.230 of issuance. VFDs for erythromycin shall
this chapter. not be refilled.
(d) Special considerations. (1) Federal (e) Conditions of use—(1) Chickens—
law restricts medicated feed containing
476
Erythromycin in Combination in Indications for use Limitations Sponsor

grams/ton grams/ton
(i) 92.5 ................ ................................ Chickens: As an aid in the preven- Feed for 2 days before stress 061623
tion of chronic respiratory disease and 3 to 6 days after
during periods of stress. stress. Withdraw 24 hours
before slaughter.
(ii) 92.5 ............... ................................ Chickens: As an aid in the preven- Feed for 7 to 14 days. With- 061623
tion of infectious coryza. draw 24 hours before
slaughter.
(iii) 185 ............... ................................ Chickens: As an aid in the preven- Feed for 5 to 8 days. With- 061623
tion and reduction of lesions and draw 48 hours before
in lowering severity of chronic slaughter. Do not use in
respiratory disease (CRD). birds producing eggs for
food.
(2) Turkeys—
Erythromycin Combination in
thiocyanate in Indications for use Limitations Sponsor
grams/ton
grams/ton
(i) 92.5 ................ ................................ Turkeys: As an aid in the prevention Feed for 2 days before stress 061623
of chronic respiratory disease and 3 to 6 days after stress.
during periods of stress.
(ii) 185 ................ ................................ Turkeys: As an aid in the prevention Feed for 5 to 8 days. Do not 061623
and reduction of lesions and in use in birds producing eggs
lowering severity of chronic res- for food.
piratory disease (CRD).
FR 56799, Aug. 26, 1980; 49 FR 31281, Aug. 6, § 510.600(c) of this chapter.
1984; 51 FR 7397, Mar. 3, 1986; 52 FR 2684, Jan. (c) Related tolerances. See § 556.273 of
26, 1987; 54 FR 12189, Mar. 24, 1989; 66 FR 14074, this chapter.
Mar. 9, 2001; 68 FR 4915, Jan. 31, 2003; 79 FR (d) Special considerations. Famphur is
10982, Feb. 27, 2014; 81 FR 36790, June 8, 2016;
a cholinesterase inhibitor. Do not use
81 FR 95004, Dec. 27, 2016; 84 FR 8975, Mar. 13,
2019]
this product in animals simultaneously
or within a few days before or after
§ 558.254 Famphur. treatment with or exposure to cholin-
esterase-inhibiting drugs, pesticides, or
(a) Specifications. Type A medicated chemicals.
articles containing 13.2 or 33.3 percent (e) Conditions of use. It is used in cat-
famphur. tle feed as follows:
Famphur amount Indications for use Limitations Sponsor
(1) To provide 1.1 milligrams Beef cattle and nonlactating dairy cattle: Feed for 30 days. Withdraw from dry 000061
per pound (mg/lb) body For control of grubs and as an aid in dairy cows and heifers 21 days prior to
weight per day. control of sucking lice. freshening. Withdraw 4 days prior to
slaughter.
(2) To provide 2.3 mg/lb Beef cattle and nonlactating dairy cattle: Feed for 10 days. Withdraw from dry 000061
body weight per day. For control of grubs. dairy cows and heifers 21 days prior to
freshening. Withdraw 4 days prior to
slaughter.
[84 FR 39185, Aug. 9, 2019, as amended at 87 (b) Sponsor. See No. 000061 in
FR 17947, Mar. 29, 2022] § 510.600(c) of this chapter.
§ 558.258 Fenbendazole.
this chapter.
(a) Specifications. Type A medicated (d) Special considerations. See § 500.25
articles: 4 percent (18.1 grams per of this chapter.
pound (g/lb)), 8 percent (36.2 g/lb), and (e) Conditions of use—(1)

20 percent (90.7 g/lb) fenbendazole.
477
§ 558.258 21 CFR Ch. I (4–1–23 Edition)
Amount Combination in
fenbendazole in Indications for use Limitations Sponsor
grams per ton
grams per ton
(i) 14.5 ................ .................................. Growing turkeys: For the treatment Feed continuously as the sole 000061
and control of gastrointestinal ration for 6 days. For growing
worms: roundworms, adults and lar- turkeys only.
vae (Ascaridia dissimilis); cecal
worms, adults and larvae (Heterakis
gallinarum), an important vector of
Histomonas meleagridis (Black-
head).
(ii) [Reserved] ..... .................................. ............................................................. ................................................... ................
(2) Swine.
Fenbendazole Combination Indications for use Limitations Sponsor
(i) 10 to 300 ...... ................................. Swine: For the treatment and control Feed as the sole ration to pro- 000061
of Lungworms: adult vide 9 mg/kg of body weight
(Metastrongylus apri and M. (4.08 mg/lb) over a period of
pudendotectus); Gastrointestinal 3 to 12 consecutive days.
worms: adult and larvae (L3, 4 Swine must not be slaugh-
stages—liver, lung, intestinal tered for human consump-
forms) large roundworms (Ascaris tion within 4 days following
suum); adult nodular worms last treatment with this drug
(Oesophagostomum dentatum, O. product.
quadrispinulatum); adult small
stomach worms (Hyostrongylus
rubidus); adult and larvae (L2, 3, 4
stages—intestinal mucosal forms)
whipworms (Trichuris suis); and
Kidney worms: adult and larvae
(Stephanurus dentatus).
(ii) 10 to 300 (to Bacitracin Growing/finishing swine: For the re- Feed as the sole ration. Under 054771
provide 9 mg/ methylenedisalicy- moval and control of adult stage conditions of continued ex-
kg of body late, 10 to 30. lungworms (Metastrongylus apri posure to parasites, retreat-
weight). and M. pudendotectus); adult and ment may be needed after 4
larvae (L3, 4 stages—liver, lung, to 6 weeks. Bacitracin
intestinal forms) large roundworms methylenedisalicylate as pro-
(Ascaris suum); adult stage nod- vided by No. 054771 in
ular worms (Oesophagostomum § 510.600(c) of this chapter.
dentatum, O. quadrispinulatum);
adult stage small stomach worms
(Hyostrongylus rubidus); adult and
larvae (L2, 3, 4 stages—intestinal
mucosal forms) whipworms
(Trichuris suis); adult and larvae
kidney worms (Stephanurus
dentatus); and for increased rate of
weight gain and improved feed effi-
ciency.
478
Fenbendazole Combination Indications for use Limitations Sponsor

(iii) 10 to 300 (to Bacitracin 1. Growing/finishing swine: For the 1. Growing/finishing swine: 054771
provide 9 mg/ methylenedisalicy- removal and control of adult stage Feed as sole ration. Not for
kg of body late, 250. lungworms (Metastrongylus apri use in growing and finishing
weight). and M. pudendotectus); adult and swine that weigh more than
larvae (L3, 4 stages—liver, lung, 250 lbs. Diagnosis of swine
intestinal forms) large roundworms dysentery should be con-
(Ascaris suum); adult stage nod- firmed by a veterinarian
ular worms (Oesophagostomum when results are not satis-
dentatum, O. quadrispinulatum); factory. Under conditions of
adult stage small stomach worms continued exposure to
(Hyostrongylus rubidus); adult and parasites, retreatment may
larvae (L2, 3, 4 stages—intestinal be needed after 4 to 6
mucosal forms) whipworms weeks. Bacitracin
(Trichuris suis); adult and larvae methylenedisalicylate as pro-
kidney worms (Stephanurus vided by No. 054771 in
dentatus); and for control of swine § 510.600(c) of this chapter.
dysentery associated with
Treponema hyodysenteriae on
premises with a history of swine
dysentery, but where signs of dis-
ease have not yet occurred; or fol-
lowing an approved treatment of
the disease condition.
2. Pregnant sows: For the removal 2. Pregnant sows: Feed as
and control of adult stage sole ration. Diagnosis of
lungworms (Metastrongylus apri clostridial enteritis should be
and M. pudendotectus); adult and confirmed by a veterinarian
larvae (L3, 4 stages—liver, lung, when results are not satis-
intestinal forms) large roundworms factory. Under conditions of
(Ascaris suum); adult stage nod- continued exposure to
ular worms (Oesophagostomum parasites, retreatment may
dentatum, O. quadrispinulatum); be needed after 4 to 6
adult stage small stomach worms weeks. Bacitracin
(Hyostrongylus rubidus); adult and methylenedisalicylate as pro-
larvae (L2, 3, 4 stages—intestinal vided by No. 054771 in
mucosal forms) whipworms § 510.600(c) of this chapter.
(Trichuris suis); adult and larvae
kidney worms (Stephanurus
dentatus); for control of clostridial
enteritis in suckling pigs caused by
Clostridium perfringens.
(3) Cattle.
Fenbendazole Indications for use Limitations Sponsor
grams per ton
(i) 200 to 1,000 ............. Dairy and beef cattle: For the treat- Feed as the sole ration for 1 day to provide 000061
ment and control of: Lungworms: 5 mg/kg body weight (2.27 mg/lb). Milk
adult (Dictyocaulus viviparus); Stom- taken during treatment and for 60 hours
ach worms: adult brown stomach after the last treatment must not be used
worms (Ostertagia ostertagi), adult for human consumption. Cattle must not
and fourth-stage larvae barberpole be slaughtered for human consumption
worms (Haemonchus contortus), within 13 days following last treatment
fourth-stage larvae barberpole with this drug product. Not for use in
worms (H. placei), and adult and beef calves less than 2 months of age,
fourth-stage larvae small stomach dairy calves, and veal calves. A with-
worms (Trichostrongylus axei); In- drawal period has not been established
testinal worms (adult and fourth- for this product in pre-ruminating calves.
stage larvae): hookworms
(Bunostomum phlebotomum),
thread-necked intestinal worms
(Nematodirus helvetianus), small in-
testinal worms (Cooperia punctata
and C. oncophora), bankrupt worms
(Trichostrongylus colubriformis), and
nodular worms (Oesophagostomum
radiatum).
(ii) [Reserved] ............... .............................................................. ...................................................................... ........................
479
§ 558.258 21 CFR Ch. I (4–1–23 Edition)
(iii) Top dress medicated feed—(A) Proprietary formulas. The following feed can be
manufactured only per an approved proprietary formula and specifications:
concentration
(1) 2.27 g/lb ............. Beef and dairy cattle: For the treatment Feed as a top dress for 1 day to provide 000061
and control of: Lungworms: adult 5 mg/kg body weight (2.27 mg/lb). Milk
(Dictyocaulus viviparus); Stomach taken during treatment and for 60
worms: adult brown stomach worms hours after the last treatment must not
(Ostertagia ostertagi), adult and fourth- be used for human consumption. Cat-
stage larvae barberpole worms tle must not be slaughtered for human
(Haemonchus contortus), fourth-stage consumption within 13 days following
larvae barberpole worms (H. placei), last treatment with this drug product.
and adult and fourth-stage larvae Not for use in beef calves less than 2
small stomach worms months of age, dairy calves, and veal
(Trichostrongylus axei); Intestinal calves. A withdrawal period has not
worms (adult and fourth-stage larvae): been established for this product in
hookworms (Bunostomum pre-ruminating calves.
phlebotomum), thread-necked intes-
tinal worms (Nematodirus helvetianus),
small intestinal worms (Cooperia
punctata and C. oncophora), bankrupt
worms (Trichostrongylus
colubriformis), and nodular worms
(Oesophagostomum radiatum).
(2) [Reserved] ......... .................................................................. .................................................................. ..............................
(B) [Reserved]
(iv) Free-choice medicated feeds—(A) Proprietary formulas (21 CFR 510.455(e)(2)).
The following feeds can be manufactured only per an approved proprietary for-
mula and specifications:
concentration
(1) 12,100 g/ton Beef cattle on pasture: For the treatment Feed free-choice at the rate of 0.0375 lb 000061
mineral. and control of: Lungworms: adult per 100 pounds of body weight over a
(Dictyocaulus viviparus); Stomach 3- to 6-day period to provide a total of
worms: adult brown stomach worms 2.27 mg fenbendazole per pound of
(Ostertagia ostertagi), adult and fourth- body weight. Not for use in dairy cat-
stage larvae barberpole worms tle. Beef cattle must not be slaugh-
(Haemonchus contortus), fourth-stage tered for human consumption within
larvae barberpole worms (H. placei), 13 days following last treatment with
and adult and fourth-stage larvae this drug product. Not for use in beef
small stomach worms calves less than 2 months of age,
(Trichostrongylus axei); Intestinal dairy calves, and veal calves. A with-
worms (adult and fourth-stage larvae): drawal period has not been estab-
hookworms (Bunostomum lished for this product in pre-rumi-
phlebotomum), thread-necked intes- nating calves.
480

concentration
(2) 2.27 g/lb mineral Beef cattle on pasture: For the treatment Feed free-choice at the rate of 0.10 lb 000061
and control of: Lungworms: adult (1.6 oz) per 100 pounds of body
(Dictyocaulus viviparus); Stomach weight over a 3- to 6-day period, to
worms: adult brown stomach worms deliver a total of 2.27 mg
(Ostertagia ostertagi), adult and fourth- fenbendazole per pound of body
stage larvae barberpole worms weight. Not for use in dairy cattle.
(Haemonchus contortus), fourth-stage Beef cattle must not be slaughtered
larvae barberpole worms (H. placei), for human consumption within 13 days
and adult and fourth-stage larvae following last treatment with this drug
small stomach worms product. Not for use in beef calves
(Trichostrongylus axei); Intestinal less than 2 months of age, dairy
worms (adult and fourth-stage larvae): calves, and veal calves. A withdrawal
hookworms (Bunostomum period has not been established for
phlebotomum), thread-necked intes- this product in pre-ruminating calves.
(3) 750 mg/lb of pro- Beef cattle: For the treatment and con- Feed free choice at a rate of 0.1 pound 000061
tein block (to pro- trol of: Lungworms: adult (Dictyocaulus of block per 100 pounds of body
vide 5 mg/kg body viviparus); Stomach worms: adult weight per day for 3 days to deliver a
weight (2.27 mg/ brown stomach worms (Ostertagia total of 2.27 mg fenbendazole per
lb)). ostertagi), adult and fourth-stage lar- pound of body weight. Cattle must not
vae barberpole worms (Haemonchus be slaughtered for human consump-
contortus), fourth-stage larvae tion within 16 days following last treat-
barberpole worms (H. placei), and ment with this drug product. Not for
adult and fourth-stage larvae small use in female dairy cattle 20 months
stomach worms (Trichostrongylus of age or older, including dry dairy
axei); Intestinal worms (adult and cows. Use in these cattle may cause
fourth-stage larvae): hookworms drug residues in milk and/or in calves
(Bunostomum phlebotomum), thread- born to these cows or heifers. Not for
necked intestinal worms (Nematodirus use in beef calves less than 2 months
helvetianus), small intestinal worms of age, dairy calves, and veal calves.
(Cooperia punctata and C. A withdrawal period has not been es-
oncophora), bankrupt worms tablished for this product in pre-rumi-
(Trichostrongylus colubriformis), and nating calves.
radiatum).
(4) 750 mg/lb of mo- Beef cattle: For the treatment and con- Feed free choice at a rate of 0.1 pound 000061
lasses block (to trol of: Lungworms: adult (Dictyocaulus of block per 100 pounds of body
provide 5 mg/kg viviparus); Stomach worms: adult weight per day for 3 days to deliver a
body weight (2.27 brown stomach worms (Ostertagia total of 2.27 mg fenbendazole per
mg/lb)). ostertagi), adult and fourth-stage lar- pound of body weight. Cattle must not
vae barberpole worms (Haemonchus be slaughtered for human consump-
contortus), fourth-stage larvae tion within 11 days following last treat-
barberpole worms (H. placei), and ment with this drug product. Not for
adult and fourth-stage larvae small use in female dairy cattle 20 months
stomach worms (Trichostrongylus of age or older, including dry dairy
axei); Intestinal worms (adult and cows. Use in these cattle may cause
fourth-stage larvae): hookworms drug residues in milk and/or in calves
(Bunostomum phlebotomum), thread- born to these cows or heifers. Not for
necked intestinal worms (Nematodirus use in beef calves less than 2 months
helvetianus), small intestinal worms of age, dairy calves, and veal calves.
(Cooperia punctata and C. A withdrawal period has not been es-
oncophora), bankrupt worms tablished for this product in pre-rumi-
(Trichostrongylus colubriformis), and nating calves.
radiatum).
(B) Published formulas (§ 510.455(e)(1) of (1) Amount. 5 mg/kg body weight (2.27
this chapter). The following feeds can be mg/lb), including the following formu-
manufactured only per one of the for- lations:
mulas and specifications published
International Feed
below: Ingredient 1 Percent No.
(i) Free-choice, dry

Type C feed:
481
§ 558.258 21 CFR Ch. I (4–1–23 Edition)
International Feed International Feed

Ingredient 1 Percent Ingredient 1 Percent
No. No.
Salt (sodium Xantham gum 0.20 8–15–818

chloride) ...... 59.00 6–04–152 Trace min-
Monosodium erals 4 .......... 0.20 n/a
phosphate ... 31.16 6–04–288 Vitamin pre-
Dried cane mo- mix 4 ............ 0.01 n/a
lasses .......... 3.12 4–04–695 Fenbendazole
Zinc sulfate ..... 0.76 6–05–556 20% Type A
Copper sulfate 0.45 6–01–720 article .......... 0.278 n/a
Fenbendazole
20% Type A 1 Formulation modifications require FDA approval prior to
article .......... 5.51 n/a marketing. Selenium is not approved for use in the liquid,
(ii) Free-choice, dry free-choice formulations described in paragraph (e)(3)(iv)(B)
of this section. Free-choice cattle feeds containing selenium
Type C feed: must comply with published regulations (see 21 CFR
Salt (sodium 573.920).
chloride) ...... 35.93 6–04–152 2 The labeling for the liquid free-choice Type C medicated
Dicalcium feed must bear an expiration date of 12 weeks after the date
phosphate of manufacture.
3 The percentage of cane molasses and water in the formu-
(18.5% P) .... 32.44 6–00–080
Calcium car- lation may be adjusted as needed to bring the brix value of
the molasses to the industry standard of 79.5 brix.
bonate (38% 4 The contents of any added vitamin and trace mineral may
Ca) .............. 15.93 6–01–069 be varied; however, they should be comparable to those used
Magnesium by the manufacturer for other free-choice cattle feeds.
oxide (56%
Mg) .............. 10.14 6–02–756 (2) Indications for use. As in paragraph
Zinc sulfate ..... 1.47 6–05–556
(e)(3)(i) of this section.
Mineral oil ....... 1.00 8–03–123
Dried cane mo- (3) Limitations. Feed a total of 5 mg of
lasses (46% fenbendazole per kg (2.27 mg/lb) of body
sugars) ........ 0.98 4–04–695 weight to cattle over a 3- to 6-day pe-
Potassium io-
dide ............. 0.01 6–03–759 riod. Milk taken during treatment and
Fenbendazole for 60 hours after the last treatment
20% Type A must not be used for human consump-
article .......... 2.10 n/a
(iii) Free-choice, liq- tion. Cattle must not be slaughtered
uid Type C for human consumption within 13 days
feed 2: following last treatment with this drug
Cane molas-
ses 3 ............ 80.902 4–13–251
product. Not for use in beef calves less
Water .............. 9.36 n/a than 2 months of age, dairy calves, and
Urea solution, veal calves. A withdrawal period has
55% ............. 7.05 5–05–707 not been established for this product in
Phosphoric
acid 75% pre-ruminating calves.
(feed grade) 2.00 6–03–707 (4) Horses.
grams per ton
(i) 4,540 ................ 5 mg/kg body weight (2.27 mg/lb) for the Feed at the rate of 0.1 lb of feed per 100 lb 000061
control of large strongyles (Strongylus of body weight to provide 2.27 mg
edentatus, S. equinus, S. vulgaris, fenbendazole/lb of body weight in a 1-
Triodontophorus spp.), small strongyles day treatment or 0.2 lb of feed per 100 lb
(Cyathostomum spp., Cylicocyclus spp., of body weight to provide 4.54 mg
Cylicostephanus spp.), and pinworms fenbendazole/lb of body weight in a 1-
(Oxyuris equi); 10 mg/kg body weight day treatment. All horses must be eating
(4.54 mg/lb) for the control of ascarids normally to ensure that each animal con-
(Parascaris equorum). sumes an adequate amount of the medi-
cated feed. Do not use in horses in-
tended for human consumption.
(ii) [Reserved] ...... ....................................................................... ....................................................................... ........................
(5) Zoo and wildlife animals.

482
Fenbendazole
Species/Class Indications for use Limitations Sponsor
grams per ton
(i) Feral swine 90 to 325 ................ For the treatment and control of kid- Use as a complete feed at a 000061
(Sus scrofa):. ney worm (Stephanurus rate to provide 3 mg/kg/day
dentatus), roundworm (Ascaris for 3 consecutive days.
suum), nodular worm Prior withdrawal of feed or
(Oesophagostomum dentatum). water is not necessary. Re-
treatment may be required
in 6 weeks. Do not use 14
days before or during the
hunting season.
(ii) Ruminants 50 to 300 ................ For the treatment and control of Use as a complete feed at a 000061
(subfamily small stomach worm rate to provide 2.5 mg/kg/
Antilopinae, (Trichostrongylus spp.), thread day for 3 consecutive days.
Hippotraginae, necked intestinal worm Prior withdrawal of feed or
Caprinae). (Nematodirus spp.), barberpole water is not necessary. Re-
worm (Haemonchus spp.), treatment may be required
whipworm (Trichuris spp.). in 6 weeks. Do not use 14
hunting season.
(iii) Rocky moun- 375 to 1,000 ........... For the treatment and control of Use as a complete feed at a 000061
tain bighorn Protostrongylus spp.. rate to provide 10 mg/kg/
sheep (Ovis c. day for 3 consecutive days.
canadensis). Prior withdrawal of feed or
water is not necessary. Re-
treatment may be required
in 6 weeks. Do not use 14
hunting season.
(6) Fenbendazole may also be used in (d) Special considerations. (1) Federal
combination with: law restricts medicated feed containing
(i) [Reserved] this veterinary feed directive (VFD)
(ii) Lincomycin as in § 558.325. drug to use by or on the order of a li-
censed veterinarian. See § 558.6 for addi-
FR 34534, June 10, 2003; 72 FR 66046, Nov. 27,
tional requirements.
2007; 73 FR 58873, Oct. 8, 2008; 74 FR 61517, (2) The expiration date of VFDs for
Nov. 25, 2009; 79 FR 13545, Mar. 11, 2014; 81 FR florfenicol medicated feeds:
17609, Mar. 30, 2016; 81 FR 95005, Dec. 27, 2016; (i) For swine must not exceed 90 days
84 FR 12499, Apr. 2, 2019; 86 FR 14822, Mar. 19, from the date of issuance.
2021; 87 FR 58964, Sept. 29, 2022; 88 FR 14904, (ii) For fish must not exceed 6
Mar. 10, 2023] months from the date of issuance.
(3) VFDs for florfenicol shall not be
§ 558.261 Florfenicol. refilled.
(a) Specifications. Type A medicated (4) Type A medicated articles and
articles containing florfenicol in the medicated feeds intended for use in fish
following concentrations: shall bear the following: ‘‘Not for use
(1) 40 grams per kilogram for use as in animals intended for breeding pur-
in paragraph (e)(1) of this section. poses. The effects of florfenicol on re-
(2) 500 grams per kilogram for use as productive performance have not been
in paragraph (e)(2) of this section. determined. Toxicity studies in dogs,
(b) Sponsor. See No. 000061 in rats, and mice have associated the use
§ 510.600(c) of this chapter. of florfenicol with testicular degenera-
(c) Related tolerances. See § 556.283 of tion and atrophy.’’
this chapter. (e) Conditions of use—(1) Swine—
Florfenicol in grams/ton of Indications for use Limitations
feed
182 .................................. For the control of swine respiratory disease Feed continuously as a sole ration for 5 con-
(SRD) associated with Actinobacillus secutive days. The safety of florfenicol on
pleuropneumoniae, Pasteurella multocida, swine reproductive performance, pregnancy,
Streptococcus suis, and Bordetella and lactation have not been determined.
bronchiseptica in groups of swine in buildings Feeds containing florfenicol must be withdrawn

experiencing an outbreak of SRD.. 13 days prior to slaughter.
483
§ 558.261 21 CFR Ch. I (4–1–23 Edition)
(2) Fish—
Florfenicol in grams/ton of Indications for use Limitations
feed
(i) 182 to 2,724 ................ Catfish: For the control of mortality due to enteric Feed as a sole ration for 10 consecutive days to
septicemia of catfish associated with deliver 10 to 15 milligrams (mg) florfenicol per
Edwardsiella ictaluri. kilogram (kg) of fish. Feed containing
florfenicol shall not be fed for more than 10
days. Following administration, fish should be
reevaluated by a licensed veterinarian before
initiating a further course of therapy. A dose-
related decrease in hematopoietic/
lymphopoietic tissue may occur. The time re-
quired for hematopoietic/lymphopoietic tissues
to regenerate was not evaluated. The effects
of florfenicol on reproductive performance
have not been determined. Feeds containing
florfenicol must be withdrawn 15 days prior to
slaughter.
(ii) 182 to 1,816 ............... Freshwater-reared salmonids: For the control of Feed as a sole ration for 10 consecutive days to
mortality due to coldwater disease associated deliver 10 to 15 mg florfenicol per kg of fish.
with Flavobacterium psychrophilum and furun- Feed containing florfenicol shall not be fed for
culosis associated with Aeromonas more than 10 days. Following administration,
salmonicida. fish should be reevaluated by a licensed vet-
erinarian before initiating a further course of
therapy. The effects of florfenicol on reproduc-
tive performance have not been determined.
Feeds containing florfenicol must be withdrawn
15 days prior to slaughter.
(iii) 182 to 2,724 .............. Freshwater-reared finfish: For the control of mor- Feed as a sole ration for 10 consecutive days to
tality due to columnaris disease associated deliver 10 to 15 mg florfenicol per kg of fish for
with Flavobacterium columnare. freshwater-reared warmwater finfish and other
freshwater-reared finfish. Feed containing
florfenicol shall not be fed for more than 10
days. Following administration, fish should be
reevaluated by a licensed veterinarian before
initiating a further course of therapy. For cat-
fish, a dose-related decrease in hematopoietic/
lymphopoietic tissue may occur. The time re-
quired for hematopoietic/lymphopoietic tissues
to regenerate was not evaluated. The effects
of florfenicol on reproductive performance
have not been determined. Feeds containing
florfenicol must be withdrawn 15 days prior to
slaughter.
(iv) 273 to 2,724 .............. Freshwater-reared warmwater finfish: For the Feed as a sole ration for 10 consecutive days to
control of mortality due to streptococcal septi- deliver 15 mg florfenicol per kg of fish. Feed
cemia associated with Streptococcus iniae. containing florfenicol shall not be fed for more
than 10 days. Following administration, fish
should be reevaluated by a licensed veteri-
narian before initiating a further course of ther-
apy. For catfish, a dose-related decrease in
hematopoietic/lymphopoietic tissue may occur.
The time required for hematopoietic/
lymphopoietic tissues to regenerate was not
evaluated. The effects of florfenicol on repro-
ductive performance have not been deter-
mined. Feeds containing florfenicol must be
withdrawn 15 days prior to slaughter.
[70 FR 70047, Nov. 21, 2005, as amended at 71 FR 70304, Dec. 4, 2006; 72 FR 19798, Apr. 20, 2007;
72 FR 65885, Nov. 26, 2007; 77 FR 32012, May 31, 2012; 79 FR 18159, Apr. 1, 2014; 80 FR 76387, Dec.
9, 2015; 81 FR 17609, Mar. 30, 2016; 81 FR 67152, Sept. 30, 2016; 86 FR 14822, Mar. 19, 2021; 87 FR
10971, Feb. 28, 2022]
484
§ 558.265 Halofuginone. (b) Sponsor. See No. 016592 in

articles containing 6 grams of this chapter.
halofuginone hydrobromide per kilo- (d) Conditions of use. It is used in feed
gram. as follows:
(1) Chickens—
Halofuginone in Combination in Indications for use Limitations Sponsor
grams/ton grams/ton
(i) 2.72 ................ .................................. Broiler chickens: For the prevention of Feed continuously as sole ra- 016592
coccidiosis caused by Eimeria tion. Do not feed to layers.
tenella, E. necatrix, E. acervulina, Withdraw 4 days before
E. brunetti, E. mivati, and E. maxi- slaughter.
ma.
(ii) 2.72 ............... Bacitracin Broiler chickens: For the prevention of Feed continuously as sole ra- 016592
methylenedisalicyl- coccidiosis caused by Eimeria tion. Do not feed to layers.
ate, 10 to 50. tenella, E. necatrix, E. acervulina, Withdraw 5 days before
ma; for improved feed efficiency.
(iii) 2.72 ............... Bambermycins, 1 to Broiler chickens: For the prevention of Feed continuously as sole ra- 016592
2. coccidiosis caused by Eimeria tion. Do not feed to layers.
tenella, E. necatrix, E, acervulina, Withdraw 5 days before
ma; for increased rate of weight
gain and improved feed efficiency.
(iv) 2.72 .............. .................................. Replacement broiler breeder chickens Feed continuously as sole ra- 016592
and replacement cage laying chick- tion to replacement cage lay-
ens: For the prevention of coccidi- ing chickens until 20 weeks
osis caused by Eimeria tenella, E. of age. Feed continuously as
necatrix, E. acervulina, E. maxima, sole ration to replacement
E. mivati/E. mitis, and E. brunetti. broiler breeder chickens until
16 weeks of age. Do not feed
to laying chickens or water
fowl. Withdraw 4 days before
slaughter.
(2) Turkeys—
Halofuginone in Combination in Indications for use Limitations Sponsor
grams/ton grams/ton
(i) 1.36 to 2.72 .... .................................. Growing turkeys: For the prevention Feed continuously as sole ra- 016592
of coccidiosis caused by Eimeria tion. Withdraw 7 days before
adenoeides, E. meleagrimitis, and slaughter. Do not feed to lay-
E. gallopavonis. ers or water fowl.
(ii) 1.36 to 2.72 ... Bacitracin Growing turkeys: For the prevention Feed continuously as sole ra- 016592
methylenedisalicyl- of coccidiosis caused by Eimeria tion. Withdraw 7 days before
ate, 10 to 50. adenoeides, E. meleagrimitis, and slaughter. Do not feed to lay-
E. gallopavonis, and for increased ing chickens or water fowl.
(iii) 1.36 to 2.72 .. Bambermycins, 2 ..... Growing turkeys: For the prevention Feed continuously as sole ra- 016592
of coccidiosis caused by Eimeria tion. Withdraw 7 days before
adenoeides, E. meleagrimitis, and slaughter. Do not feed to lay-
E. gallopavonis, and for increased ing chickens or waterfowl.
485
§ 558.274 21 CFR Ch. I (4–1–23 Edition)
(3) Halofuginone may also be used in (b) Sponsor. See No. 058198 in
combination with: § 510.600(c) of this chapter for as fol-
(i) Lincomycin as in § 558.325. lows:
(ii) [Reserved] (c) Related tolerances. See § 556.330 of
[50 FR 33719, Aug. 21, 1985, as amended at 50 this chapter.
FR 42518, Oct. 21, 1985; 51 FR 7397, Mar. 3, (d) Special considerations. (1) Federal
1986; 51 FR 11439, Apr. 3, 1986; 51 FR 14989, law restricts medicated feed containing
Apr. 22, 1986; 51 FR 23737, July 1, 1986; 53 FR this veterinary feed directive (VFD)
1018, Jan. 15, 1988; 53 FR 11065, Apr. 5, 1988; 54
FR 11519, Mar. 21, 1989; 54 FR 28052, July 5, drug to use by or on the order of a li-
1989; 59 FR 51498, Oct. 12, 1994; 61 FR 21076, censed veterinarian. See § 558.6 for addi-
May 9, 1996; 61 FR 24694, May 16, 1996; 64 FR tional requirements.
42597, Aug. 5, 1999; 65 FR 45712, July 25, 2000; (2) The expiration date of VFDs for
66 FR 47962, Sept. 17, 2001; 71 FR 27956, May hygromycin B medicated feeds must
15, 2006; 79 FR 10982, Feb. 27, 2014; 84 FR 8975,
Mar. 13, 2019] not exceed 6 months from the date of
issuance. VFDs for hygromycin B shall
§ 558.274 Hygromycin B. not be refilled.
(a) Specifications. Type A medicated (e) Conditions of use. It is used in feed
articles containing 2.4 or 8 grams as follows:
hygromycin B per pound (g/lb). (1) Chickens—
Hygromycin B grams/ Combination in Indications for use Limitations Sponsor
ton grams/ton
(i) 8 to 12 ................... .................................. Chickens: For control of infec- Use in complete feed. Withdraw 058198
tions of large roundworms 3 days before slaughter.
(Ascaris galli), cecal worms
(Heterakis gallinae), and cap-
illary worms (Capillaria
obsignata).
(ii) [Reserved]
(2) Swine—
Hygromycin B grams/ Combination in Indications for use Limitations Sponsor
ton grams/ton
(i) 12 .......................... .................................. Swine: For control of infections In market hogs, use in complete 058198
of large roundworms (A. suis), feed for 8 weeks during the
nodular worms (O. dentatum), growing period. Withdraw 15
and whipworms (Trichuris days before slaughter.
suis).
(ii) [Reserved]
[81 FR 95005, Dec. 27, 2016] (b) Sponsor. See No. 017762 in
§ 558.295 Iodinated casein.
(c) Conditions of use—(1) Ducks—
article containing iodinated casein.
Amount in grams/ton Indications for use Limitations Sponsor
(i) 100 to 200 .................... Growing ducks: For increased rate of ................................................................... 017762
weight gain.
(ii) [Reserved]
(2) Dairy cows—

486
Amount in grams/pound Indications for use Limitations Sponsor
(1) 0.5 to 1.5 per 100 lb of Dairy cows: For increased milk produc- This drug is effective for limited periods 017762
body weight. tion. of time, and the effectiveness is limited
to the declining phase of lactation. Ad-
ministration must be accompanied with
increased feed intake. Administration
may increase heat sensitivity of the
animal.
(2) [Reserved]
[85 FR 45309, July 28, 2020, as amended at 86 FR 14823, Mar. 19, 2021]
§ 558.300 Ivermectin. (c) Related tolerances. See § 556.344 of

(a) Specifications. Type A medicated this chapter.
article containing 2.72 grams (d) Special considerations. See § 500.25
ivermectin per pound (g/lb). of this chapter.
(b) Sponsor. See No. 000010 in (e) Conditions of use in swine. It is
§ 510.600(c) of this chapter. used in feed as follows:
Ivermectin in Combination in Indications for use Limitations Sponsor
grams/ton grams/ton
(1) 1.8 ................. Weaned, growing-finishing swine: For Feed as the only feed for 7 000010
treatment and control of gastro- consecutive days to provide
intestinal roundworms (Ascaris 0.1 milligrams per kilograms
suum, adults and fourth-stage lar- (mg/kg) of body weight per
vae; Ascarops strongylina, adults; day. Withdraw 5 days before
Hyostrongylus rubidus, adults and slaughter.
fourth-stage larvae;
Oesophagostomum spp., adults
and fourth-stage larvae);
kidneyworms (Stephanurus
dentatus, adults and fourth-stage
larvae); lungworms (Metastrongylus
spp., adults); threadworms
(Strongyloides ransomi, adults and
somatic larvae); lice (Haematopinus
suis); and mange mites (Sarcoptes
scabiei var. suis).
(2) 1.8 ................. Bacitracin Weaned, growing-finishing swine: For Feed as the only feed for 7 000010
methylenedisalicyl- treatment and control of gastro- consecutive days to provide
ate, 10 to 30. intestinal roundworms (Ascaris 0.1 mg/kg of body weight per
suum, adults and fourth-stage lar- day. Withdraw 5 days before
vae; Ascarops strongylina, adults; slaughter.
Hyostrongylus rubidus, adults and
scabieivar. suis); and for increased
feed efficiency.
487
§ 558.300 21 CFR Ch. I (4–1–23 Edition)

grams/ton grams/ton
(3) 1.8 ................. Bacitracin Weaned, growing-finishing swine: For Feed as the only feed for 7 000010
methylenedisalicyl- treatment and control of gastro- consecutive days to provide
ate, 250. intestinal roundworms (Ascaris 0.1 mg/kg of body weight per
suum, adults and fourth-stage lar- day. Withdraw 5 days before
vae; Ascarops strongylina, adults; slaughter.
Hyostrongylus rubidus, adults and
scabiei var. suis); and for control of
swine dysentery associated with
Treponema hyodysenteriae on
premises with a history of swine
dysentery, but where symptoms
have not yet occurred, or following
an approved treatment of disease
condition.
(4) 1.8 to 11.8 .... Adult and breeding swine: For treat- Feed as the only feed for 7 000010
ment and control of gastrointestinal consecutive days to provide
roundworms (Ascaris suum, adults 0.1 mg/kg of body weight per
and fourth-stage larvae; Ascarops day. Withdraw 5 days before
strongylina, adults; Hyostrongylus slaughter.
rubidus, adults and fourth-stage lar-
vae; Oesophagostomum spp.,
adults and fourth-stage larvae);
somatic larvae, and prevention of
transmission of infective larvae to
piglets, via the colostrum or milk,
when fed during gestation); lice
(Haematopinus suis); and mange
mites (Sarcoptes scabiei var. suis).
(5) 1.8 to 11.8 .... Bacitracin Pregnant sows: For treatment and Feed as the only feed for 7 000010
methylenedisalicyl- control of gastrointestinal consecutive days to provide
ate, 250. roundworms (Ascaris suum, adults 0.1 mg/kg of body weight per
and fourth-stage larvae; Ascarops day. Withdraw 5 days before
strongylina, adults; Hyostrongylus slaughter. Feed bacitracin
rubidus, adults and fourth-stage lar- methylenedisalicylate Type C
vae; Oesophagostomum spp., medicated feed to sows from
adults and fourth-stage larvae); 14 days before through 21
kidneyworms (Stephanurus days after farrowing on prem-
dentatus, adults and fourth-stage ises with a history of
larvae); lungworms (Metastrongylus clostridial scours.
mites (Sarcoptes scabiei var. suis);
and for control of clostridial enteritis
caused by Clostridium perfringens
in suckling piglets.
488

grams/ton grams/ton
(6) 18.2 to 120 ... Adult and breeding swine: For treat- Top dress on daily ration for in- 000010
ment and control of gastrointestinal dividual treatment for 7 con-
roundworms (Ascaris suum, adults secutive days to provide 0.1
and fourth-stage larvae; Ascarops mg/kg of body weight per
strongylina, adults; Hyostrongylus day. Withdraw 5 days before
rubidus, adults and fourth-stage lar- slaughter.
vae; Oesophagostomum spp.,
adults and fourth-stage larvae);
mites (Sarcoptes scabiei var. suis).
[72 FR 37437, July 10, 2007, as amended at 81 (ii) For liquid feeds stored in me-
FR 17609, Mar. 30, 2016; 81 FR 95005, Dec. 27, chanical, air, or other agitation type
2016; 84 FR 12499, Apr. 2, 2019; 84 FR 39185, tank systems: Agitate immediately
Aug. 9, 2019]
prior to use for not less than 10 min-
§ 558.305 Laidlomycin. utes, creating a turbulence at the bot-
tom of the tank that is visible at the
(a) Specifications. Type A medicated top. Agitate daily as described even
articles containing 50 grams when not used.
laidlomycin propionate potassium per (2) The expiration date for the liquid
pound. Type B feed is 21 days after date of
(b) Sponsor. See No. 054771 in manufacture. The expiration date for
§ 510.600(c) of this chapter. the dry Type C feed made from the liq-
(c) Tolerances. See § 556.346 of this uid Type B feed is 7 days after date of
chapter. manufacture.
(d) Special considerations. (1) (3) Labeling for all Type B feeds (liq-
Laidlomycin liquid Type B feeds may uid and dry) and Type C feeds con-
be manufactured from dry laidlomycin taining laidlomycin shall bear the fol-
Type A articles. The liquid Type B lowing statements:
feeds must have a pH of 6.0 to 8.0, dry (i) Do not allow horses or other
matter of 62 to 75 percent, and bear ap- equines access to feeds containing
propriate mixing directions as follows: laidlomycin propionate potassium.
(i) For liquid feeds stored in recircu- (ii) The safety of laidlomycin propio-
lating tank systems: Recirculate im- nate potassium in unapproved species
mediately prior to use for no less than has not been established.
10 minutes, moving not less than 1 per- (iii) Not for use in animals intended
cent of the tank contents per minute for breeding.
from the bottom of the tank to the top. (e) Conditions of use. It is used in cat-
Recirculate daily as described even tle being fed in confinement for slaugh-
when not used. ter as follows:
Laidlomycin in Combination in Indications for use Limitations Sponsor
(1) 5 .................... ............................. For improved feed efficiency and in- Feed continuously in a Type C 054771
creased rate of weight gain.. feed at a rate of 30 to 75 mg/
head/day..
(2) 5 to 10 .......... ............................. For improved feed efficiency. ............. Feed continuously in a Type C 054771
feed at a rate of 30 to 150
milligrams/head/day..
489
§ 558.311 21 CFR Ch. I (4–1–23 Edition)
(f) Laidlomycin may also be used in (i) Either filing a new animal drug
combination with chlortetracycline as application for the product or estab-
in § 558.128. lishing a master file containing data to
support the stability of its product;
FR 53509, Oct. 16, 1995; 62 FR 9929, Mar. 5, (ii) Authorizing the agency to ref-
1997; 63 FR 27845, May 21, 1998; 66 FR 46706, erence and rely upon the data in the
Sept. 7, 2001; 68 FR 13839, Mar. 21, 2003; 68 FR master file to support approval of a
42590, July 18, 2003; 69 FR 30198, May 27, 2004; supplemental new animal drug applica-
79 FR 13545, Mar. 11, 2014; 81 FR 95005, Dec. 27, tion to establish physical stability; and
2016; 86 FR 14823, Mar. 19, 2021] (iii) Requesting the sponsor of an ap-
proved new animal drug application to
§ 558.311 Lasalocid. file a supplement to provide for use of
(a) Specifications. Each pound of Type its lasalocid Type A article in the man-
A medicated article contains 68 grams ufacture of the liquid feed specified in
(15 percent), 90.7 grams (20 percent), or the appropriate master file. If the data
150 grams (33.1 percent) lasalocid as demonstrate the stability of the liquid
lasalocid sodium activity. A minimum feed described in the master file, the
of 90 percent of lasalocid activity is de- supplemental new animal drug applica-
rived from lasalocid A. tion will be approved. The approval
(b) Sponsor. See No. 054771 in will provide a basis for the individual
§ 510.600(c) of this chapter. liquid feed manufacturer to manufac-
(c) Related tolerance. See § 556.347 of ture under a medicated feed license the
this chapter. liquid mediated feed described in the
(d) Special considerations. (1) Type C master file. A manufacturer who seeks
cattle and sheep feeds may be manufac- to market a physically unstable
tured from lasalocid liquid Type B lasalocid liquid feed with mixing direc-
feeds which have a pH of 4.0 to 8.0 and tions different from the standard direc-
bear appropriate mixing directions as tions established in paragraph (d)(1) of
follows: this section may also follow this proce-
(i) For liquid feeds stored in recircu- dure.
lating tank systems: Recirculate im- (4) If adequate information is sub-
mediately prior to use for no less than mitted to show that a particular liquid
10 minutes, moving not less than 1 per- feed containing lasalocid is stable out-
cent of the tank contents per minute side the pH of 4.0 to 8.0, the pH restric-
from the bottom of the tank to the top. tion described in paragraphs (d)(1) and
Recirculate daily as described even (d)(2) of this section may be waived.
when not used. (5) Required label statements:
(ii) For liquid feeds stored in me- (i) For liquid Type B feed (cattle and
chanical, air, or other agitation-type sheep): Mix thoroughly with grain and/
tank systems: Agitate immediately or roughage prior to feeding. Feeding
prior to use for not less than 10 min- undiluted, mixing errors, or inadequate
utes, creating a turbulence at the bot- mixing (recirculation or agitation)
tom of the tank that is visible at the may result in an excess lasalocid con-
top. Agitate daily as described even centration which could be fatal to cat-
when not used. tle and sheep. Do not allow horses or
(2) A physically stable lasalocid liq- other equines access to Type A articles
uid feed will not be subject to the re- or Type B feeds containing lasalocid as
quirements for mixing directions pre- ingestion may be fatal. Safety of
scribed in paragraph (d)(1) of this sec- lasalocid for use in unapproved species
tion provided it has a pH of 4.0 to 8.0 has not been established.
and contains a suspending agent(s) suf- (ii) For Type A articles or Type B
ficient to maintain a viscosity of not feeds (cattle and sheep): Feeding undi-
less than 300 centipoises per second for luted or mixing errors may result in an
3 months. excess lasalocid concentration which
(3) If a manufacturer is unable to could be fatal to cattle and sheep. Do
meet the requirements of paragraph not allow horses or other equines ac-
(d)(1) or (d)(2) of this section, the man- cess to Type A articles or Type B feeds
ufacturer may secure approval of a containing lasalocid as ingestion may

positionally stable liquid feed by: be fatal. Safety of lasalocid for use in
490
unapproved species has not been estab- (7) Each use in a free-choice Type C
lished. cattle feed as in paragraphs (e)(3)(vi)
(iii) For Type A articles, Type B or through (e)(3)(viii) of this section must
Type C feeds (cattle): A withdrawal pe- be the subject of an approved NADA or
riod has not been established for this supplemental NADA as provided in
product in preruminating calves. Do § 510.455 of this chapter.
not use in calves to be processed for (e) Conditions of use. It is used as fol-
veal. lows:
(6) Lasalocid Type A medicated arti-
(1) The conditions of use for chickens
cles containing lasalocid dried fer-
are:
mentation residue are for use in cattle
and sheep feed only.
Lasalocid in Combination in Indications for use Limitations Sponsor
grams/ton grams/ton
(i) 68 to 113 ...... ................................. Broiler or fryer chickens: For preven- Feed continuously as the sole 054771
tion of coccidiosis caused by ration..
Eimeria tenella, E. necatrix, E.
acervulina, E. brunetti, E. mivati,
and E. maxima..
(ii) 68 ................. Bacitracin Broiler chickens: For prevention of Feed continuously as the sole 054771
methylenedisalicy- coccidiosis caused by Eimeria ration. Bacitracin
late, 10 to 50. tenella, E. necatrix, E. acervulina, methylenedisalicylate pro-
E. brunetti, E. mivati, and E. maxi- vided by No. 054771 in
ma; and for increased rate of § 510.600(c) of this chapter..
ciency..
(iii) 68 to 113 ..... Bacitracin Broiler chickens: For prevention of Feed continuously as the sole 054771
methylenedisalicy- coccidiosis caused by Eimeria ration. Bacitracin
late, 4 to 50. tenella, E. necatrix, E. acervulina, methylenedisalicylate pro-
E. brunetti, E. mivati, and E. maxi- vided by No. 054771 in
ma; and for improved feed effi- § 510.600(c) of this chapter..
ciency..
(iv) 68 to 113 .... Bacitracin zinc, 4 to Broiler chickens. For prevention of Feed continuously as the sole 054771
50. coccidiosis caused by Eimeria ration. Bacitracin zinc pro-
tenella, E. necatrix, E. acervulina, vided by No. 054771 in
E. brunetti, E. mivati, and E. maxi- § 510.600(c) of this chapter..
ma; and for increased rate of
ciency..
(v) 68 to 113 ..... Bambermycins, 1 to Broiler chickens: For prevention of Feed continuously as sole ra- 016592
2. coccidiosis caused by Eimeria tion. Bambermycins provided
tenella, E. necatrix, E. acervulina, by No. 016592 in
E. brunetti, E. mivati, and E. maxi- § 510.600(c) of this chapter..
ma; and for increased rate of
ciency..
(2) The conditions of use for turkeys are:

Lasalocid in Combination in Indications for use Limitations Sponsor
grams/ton grams/ton
(i) 68 to 113 ...... ................................. Growing turkeys; For prevention of Feed continuously as sole ra- 054771
coccidiosis caused by Eimeria tion..
meleagrimitis, E. gallopavonis, and
E. adenoeides..
(ii) 68 to 113 ..... Bacitracin Growing turkeys: For prevention of Feed continuously as the sole 054771
methylenedisalicy- coccidiosis caused by E. ration. Bacitracin
late, 4 to 50. meleagrimitis, E. gallopavonis, and methylenedisalicylate as pro-
E. adenoeides; and for increased vided by No. 054771 in
rate of weight gain and improved § 510.600(c) in this chapter..
feed efficiency..
(iii) 68 to 113 ..... Bacitracin zinc, 4 to Growing turkeys: For prevention of Feed continuously as the sole 054771
50. coccidiosis caused by E. ration. Bacitracin zinc as
meleagrimitis, E. gallopavonis, and provided by No. 054771 in
E. adenoeides; and for increased § 510.600(c) in this chapter..
feed efficiency..
(3) The conditions of use for cattle are—
491
§ 558.311 21 CFR Ch. I (4–1–23 Edition)
Lasalocid amount Indications for use Limitations Sponsor
(i) 10 to 30 grams/ton of Cattle fed in confinement for Feed continuously in complete feed to provide 054771
feed. slaughter: For improved feed ef- not less than 100 milligrams (mg) nor more
ficiency.. than 360 mg of lasalocid sodium activity
per head per day..
(ii) 25 to 30 grams/ton of Cattle fed in confinement for Feed continuously in complete feed to provide 054771
feed. slaughter: For improved feed ef- not less than 250 mg nor more than 360
ficiency and increased rate of mg of lasalocid sodium activity per head
weight gain.. per day..
(iii) Not less than 60 mg or Pasture cattle (slaughter, stocker, Feed continuously at a rate of not less than 054771
more than 300 mg of feeder cattle, and dairy and 60 mg or more than 300 mg of lasalocid
lasalocid per head per beef replacement heifers): For per head per day when on pasture. The
day. increased rate of weight gain.. drug must be contained in at least 1 pound
of feed. Daily intakes of lasalocid in excess
of 200 mg/head/day have not been shown
to be more effective than 200 mg/head/day..
(iv) 1 mg lasalocid per 2.2 Cattle up to 800 lb: For control of Hand feed continuously at a rate of 1 mg of 054771
pounds (lb) body weight coccidiosis caused by Eimeria lasalocid per 2.2 lb body weight per day to
per day. bovis and E. zuernii.. provide not more than 360 mg of lasalocid
per head per day..
(v) 1 mg lasalocid per 2.2 lb Replacement calves: For control In milk replacer powder, hand feed at a rate 054771
body weight per day. of coccidiosis caused by E. of 1 mg of lasalocid per 2.2 lb body weight
bovis and E. zuernii.. per day. A withdrawal period has not been
established for lasalocid in pre-ruminating
calves. Do not use in calves to be proc-
essed for veal..
(vi) 1,440 grams/ton ............ Pasture cattle (slaughter, stocker, As a free-choice Type C medicated loose 012286
feeder cattle, and dairy and mineral, feed continuously at a rate of not
beef replacement heifers): For less than 60 mg nor more than 200 mg of
increased rate of weight gain.. lasalocid per head per day..
(vii) 1,440 grams/ton ........... Pasture cattle (slaughter, stocker, As a free-choice Type C medicated mineral 017800
feeder cattle, and dairy and block, feed continuously at a rate of not
beef replacement heifers): For less than 60 mg nor more than 200 mg of
(viii) 300 grams/ton ............. Pasture cattle (slaughter, stocker, As a free-choice Type C medicated protein 067949
feeder cattle, and dairy and block, feed continuously at a rate of not
beef replacement heifers): for less than 60 mg nor more than 200 mg of
(ix) 60 to 300 mg of Growing beef steers and heifers Feed continuously as a Type C free-choice 054771
lasalocid per head per on pasture (stocker, feeder, and medicated feed at a rate of 60 to 300 mg of
day. slaughter) and replacement beef lasalocid per head per day. Daily intakes of
and dairy heifers on pasture: lasalocid in excess of 200 mg/head/day
For increased rate of weight have not been shown to be more effective
gain. than 200 mg/head/day.
(4) The conditions of use for minor species are:

Lasalocid in Indications for use Limitations Sponsor
grams/ton
(i) 20 to 30 ........................... Sheep maintained in confinement: Feed continuously in complete feed to provide 054771
For prevention of coccidiosis not less than 15 milligrams (mg) nor more
caused by Eimeria ovina, E. than 70 mg of lasalocid sodium activity per
crandallis, E. ovinoidalis (E. head per day depending on body weight..
ninakohlyakimovae), E. parva,
and E. intricata..
(ii) 113 ................................. Chukar partridges: For prevention Feed continuously as sole ration up to 8 054771
of coccidiosis caused by E. weeks of age..
legionensis..
(iii) 113 ................................ Rabbits: For prevention of coccidi- Feed continuously as sole ration up to 6 1/2 054771
osis caused by E. stiedae.. weeks of age.
(5) It is used as a free-choice mineral Type C feed as follows:

(i) Specifications.
Ingredient Percent International feed No.
Defluorinated phosphate (20.5% Ca, 18.5% P) .......................................................................... 35.9 6–01–080

Sodium chloride (salt) ................................................................................................................. 20.0 6–04–152
Calcium carbonate (38% Ca) ...................................................................................................... 18.0 6–01–069
Cottonseed meal ......................................................................................................................... 10.0 5–01–621
Potassium chloride ...................................................................................................................... 3.0 6–03–755
Selenium premix (0.02 percent Se)1 ........................................................................................... 3.0

Dried cane molasses (46% sugars) ............................................................................................ 2.5 4–04–695
492
Ingredient Percent International feed No.
Magnesium sulfate ...................................................................................................................... 1.7 6–02–758

Vitamin premix1 ........................................................................................................................... 1.4
Magnesium oxide (58% Mg) ....................................................................................................... 1.2 6–02–756
Potassium sulfate ........................................................................................................................ 1.2 6–06–098
Trace mineral premix1 ................................................................................................................. 1.04
Lasalocid Type A medicated article (68 g/lb)2 ............................................................................ 1.06
1 Content of the vitamin and trace mineral premixes may be varied; however, they should be comparable to those used by the
firm for other free-choice feeds. Formulation modifications require FDA approval prior to marketing. Selenium must comply with
21 CFR 573.920. Ethylenediamine dihydroiodide (EDDI) should comply with FDA Compliance Policy Guides Sec. 651.100 (CPG

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Title 21

Food and Drugs

Revised as of April 1, 2023

Containing a codification of documents

Published by the Office of the Federal Register

Legal Status and Use of Seals and Logos

Use of ISBN Prefix

U.S. GOVERNMENT PUBLISHING OFFICE

U.S. Superintendent of Documents • Washington, DC 20402–0001

Phone: toll-free (866) 512-1800; DC area (202) 512-1800

Chapter I—Food and Drug Administration, Department of Health

Table of CFR Titles and Chapters ....................................................... 643

Alphabetical List of Agencies Appearing in the CFR ......................... 663

List of CFR Sections Affected ............................................................. 673

To cite the regulations in

lishing in the CFR are also included in this volume.

CHAPTER I—Food and Drug Administration, Department of

SUBCHAPTER E—ANIMAL DRUGS, FEEDS, AND RELATED PRODUCTS

570 Food additives ......................................................... 564

PART 500—GENERAL 500.92 Implementation.

Subpart F—Methods for Detection of Resi-

500.90 Waiver of requirements. required information, a statement that

assistance in the diagnosis, treatment, mal drug application, or listed in the

around an establishment producing trical transformers and condensers

§ 201.105(c) of this chapter, provided agents. In connection with this prob-

under conditions of use reasonably cer- § 500.82 Definitions.

whether chronic bioassays in test ani- no residue of the compound is detect-

REGISTER the complete regulatory following manner to compounds al-

§ 500.1410 N-methyl-2-pyrrolidone. Subpart A—General Provisions

(a) Standard for residues. No residues Sec.

(i) ‘‘Method of Analysis: N-methyl-2- 501.110 Animal feed labeling; collective

information panel and/or an alternate (d) All information required to ap-

(3) An appropriately descriptive is not false or misleading. The label

of an existing common or usual name, be a specific name and not a collective

known as concentrated milkfat) may stitute the ingredient to single

strength shall be declared as water in number of servings contained in such

is not generally understood by the con- drolysate, distillate, or any product of

which contains the flavoring constitu- tablishment, is displayed to the pur-

or usual name of the characterizing fla- seen under customary conditions of

any other employee acting on behalf of those certifications which are to be

names of the individual feed ingredi- 502.19 Petitions.

§ 502.5 General principles. of the common or usual name of the

food. order to withdraw a qualified facility ex-

§ 507.3 Definitions. Facility means a domestic facility or

spores of pathogenic sporeforming bac- harvesting include cutting (or other-

Monitor means to conduct a planned diting function. Examples of potential

or experience (or the combination propriate to the individual’s assigned

(f) For a farm mixed-type facility rived products, vitamins, minerals,

products, molasses, animal protein cates, permits, credentials, certifi-

as a State department of agriculture), ‘‘not a qualified facility’’ based on the

(4) Treating and disposing of waste so

contamination in areas where animal (b) Animal food-contact and non-con-

(e) Effective measures must be taken flooding-type cleaning or where normal

(4) Provide adequate floor drainage in agents;

be held in a way to protect against con- § 507.33 Hazard analysis.

90 calendar days after production of the propriate indicator organism, if con-

environmental pathogen is a hazard re- (vi) Identify the laboratory con-

to the requirements of subpart F of pertise obtained through education,

(2) To be a qualified auditor, a quali- that is directly linked to the qualified