H.R. 467, HALT Fentanyl Act
H.R. 467, HALT Fentanyl Act
H.R. 467, HALT Fentanyl Act
[Strike out all after the enacting clause and insert the part printed in italic]
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MAY 17, 2023
Committee on the Judiciary discharged; committed to the Committee of the
Whole House on the State of the Union and ordered to be printed
[For text of introduced bill, see copy of bill as introduced on January 24, 2023]
A BILL
To amend the Controlled Substances Act with respect to
the scheduling of fentanyl-related substances, and for
other purposes.
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1 Be it enacted by the Senate and House of Representa-
2 tives of the United States of America in Congress assembled,
3 SECTION 1. SHORT TITLE.
7 STANCES.
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1 ‘‘(B) By substitution in or on the phenethyl
2 group with alkyl, alkenyl, alkoxyl, hydroxyl, halo,
3 haloalkyl, amino, or nitro groups.
4 ‘‘(C) By substitution in or on the piperidine
5 ring with alkyl, alkenyl, alkoxyl, ester, ether,
6 hydroxyl, halo, haloalkyl, amino, or nitro groups.
7 ‘‘(D) By replacement of the aniline ring with
8 any aromatic monocycle whether or not further sub-
9 stituted in or on the aromatic monocycle.
10 ‘‘(E) By replacement of the N–propionyl group
11 with another acyl group.
12 ‘‘(3) A substance that satisfies the definition of the
13 term ‘fentanyl-related substance’ in paragraph (2) shall
14 nonetheless not be treated as a fentanyl-related substance
15 subject to this schedule if the substance—
16 ‘‘(A) is controlled by action of the Attorney Gen-
17 eral under section 201; or
18 ‘‘(B) is otherwise expressly listed in a schedule
19 other than this schedule.
20 ‘‘(4)(A) The Attorney General may by order publish
21 in the Federal Register a list of substances that satisfy the
22 definition of the term ‘fentanyl-related substance’ in para-
23 graph (2).
24 ‘‘(B) The absence of a substance from a list published
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1 of the substance under this schedule if the substance satisfies
2 the definition of the term ‘fentanyl-related substance’ in
3 paragraph (2).’’.
4 SEC. 3. REGISTRATION REQUIREMENTS RELATED TO RE-
5 SEARCH.
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1 section 505(i) of the Federal Food, Drug, and
2 Cosmetic Act; or
3 ‘‘(B) is—
4 ‘‘(i) conducted by the Department of
5 Health and Human Services or the Depart-
6 ment of Veterans Affairs; or
7 ‘‘(ii) funded partly or entirely by a
8 grant, contract, cooperative agreement, or
9 other transaction from the Department of
10 Health and Human Services or the Depart-
11 ment of Veterans Affairs.
12 ‘‘(3) EXPEDITED PROCEDURES.—
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1 ‘‘(I) The chemical name of the
2 substance.
3 ‘‘(II) The quantity of the sub-
4 stance to be used in the research.
5 ‘‘(III) Demonstration that the re-
6 search is in the category described in
7 paragraph (2), which demonstration
8 may be satisfied—
9 ‘‘(aa) in the case of a grant,
10 contract, cooperative agreement,
11 or other transaction, or intra-
12 mural research project, by identi-
13 fying the sponsoring agency and
14 supplying the number of the
15 grant, contract, cooperative agree-
16 ment, other transaction, or
17 project; or
18 ‘‘(bb) in the case of an appli-
19 cation under section 505(i) of the
20 Federal Food, Drug, and Cosmetic
21 Act, by supplying the application
22 number and the sponsor of record
23 on the application.
24 ‘‘(IV) Demonstration that the re-
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1 search with respect to the substance
2 under the laws of the State in which
3 the research will take place.
4 ‘‘(ii) VERIFICATION OF INFORMATION
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1 ‘‘(II) not later than 45 days of re-
2 ceiving such a notice that contains all
3 information required under subpara-
4 graph (A)(i)—
5 ‘‘(aa) register the applicant;
6 or
7 ‘‘(bb) serve an order to show
8 cause upon the applicant in ac-
9 cordance with section 304(c).
10 ‘‘(4) ELECTRONIC SUBMISSIONS.—The Attorney
11 General shall provide a means to permit a practi-
12 tioner to submit a notification under paragraph (3)
13 electronically.
14 ‘‘(5) LIMITATION ON AMOUNTS.—A practitioner
15 conducting research with a schedule I substance under
16 this subsection may only possess the amounts of
17 schedule I substance identified in—
18 ‘‘(A) the notification to the Attorney Gen-
19 eral under paragraph (3); or
20 ‘‘(B) a supplemental notification that the
21 practitioner may send if the practitioner needs
22 additional amounts for the research, which sup-
23 plemental notification shall include—
24 ‘‘(i) the name of the practitioner;
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1 ‘‘(ii) the additional quantity needed of
2 the substance; and
3 ‘‘(iii) an attestation that the research
4 to be conducted with the substance is con-
5 sistent with the scope of the research that
6 was the subject of the notification under
7 paragraph (3).
8 ‘‘(6) IMPORTATION AND EXPORTATION REQUIRE-
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1 ‘‘(C) the researcher who is so registered—
2 ‘‘(i) informs the Attorney General of
3 the name, position title, and employing in-
4 stitution of the agent or employee who is
5 not separately registered;
6 ‘‘(ii) authorizes that agent or employee
7 to perform research under the registration of
8 the registered researcher; and
9 ‘‘(iii) affirms that any act taken by
10 that agent or employee involving a con-
11 trolled substance shall be attributable to the
12 registered researcher, as if the researcher
13 had directly committed the act, for purposes
14 of any proceeding under section 304(a) to
15 suspend or revoke the registration of the reg-
16 istered researcher; and
17 ‘‘(D) the Attorney General does not, within
18 30 days of receiving the information, authoriza-
19 tion, and affirmation described in subparagraph
20 (C), refuse, for a reason listed in section 304(a),
21 to allow the agent or employee to possess the sub-
22 stance without a separate registration.’’.
23 (c) SINGLE REGISTRATION FOR RELATED RESEARCH
24 SITES.—Section 302(e) of the Controlled Substances Act (21
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1 U.S.C. 822(e)) is amended by adding at the end the fol-
2 lowing:
3 ‘‘(4)(A) Notwithstanding paragraph (1), a person reg-
4 istered to conduct research with a controlled substance
5 under section 303(f) may conduct the research under a sin-
6 gle registration if—
7 ‘‘(i) the research occurs exclusively on sites all of
8 which are—
9 ‘‘(I) within the same city or county; and
10 ‘‘(II) under the control of the same institu-
11 tion, organization, or agency; and
12 ‘‘(ii) before commencing the research, the re-
13 searcher notifies the Attorney General of each site
14 where—
15 ‘‘(I) the research will be conducted; or
16 ‘‘(II) the controlled substance will be stored
17 or administered.
18 ‘‘(B) A site described in subparagraph (A) shall be in-
19 cluded in a registration described in that subparagraph
20 only if the researcher has notified the Attorney General of
21 the site—
22 ‘‘(i) in the application for the registration; or
23 ‘‘(ii) before the research is conducted, or before
24 the controlled substance is stored or administered, at
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25 the site.
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1 ‘‘(C) The Attorney General may, in consultation with
2 the Secretary, issue regulations addressing, with respect to
3 research sites described in subparagraph (A)—
4 ‘‘(i) the manner in which controlled substances
5 may be delivered to the research sites;
6 ‘‘(ii) the storage and security of controlled sub-
7 stances at the research sites;
8 ‘‘(iii) the maintenance of records for the research
9 sites; and
10 ‘‘(iv) any other matters necessary to ensure effec-
11 tive controls against diversion at the research sites.’’.
12 (d) NEW INSPECTION NOT REQUIRED IN CERTAIN SIT-
13 UATIONS.—Section 302(f) of the Controlled Substances Act
14 (21 U.S.C. 822(f)) is amended—
15 (1) by striking ‘‘(f) The’’ and inserting ‘‘(f)(1)
16 The’’; and
17 (2) by adding at the end the following:
18 ‘‘(2)(A) If a person is registered to conduct research
19 with a controlled substance and applies for a registration,
20 or for a modification of a registration, to conduct research
21 with a second controlled substance that is in the same sched-
22 ule as the first controlled substance, or is in a schedule with
23 a higher numerical designation than the schedule of the first
24 controlled substance, a new inspection by the Attorney Gen-
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1 ‘‘(B) Nothing in subparagraph (A) shall prohibit the
2 Attorney General from conducting an inspection that the
3 Attorney General determines necessary to ensure that a reg-
4 istrant maintains effective controls against diversion.’’.
5 (e) CONTINUATION OF RESEARCH ON SUBSTANCES
6 NEWLY ADDED TO SCHEDULE I.—Section 302 of the Con-
7 trolled Substances Act (21 U.S.C. 822) is amended by add-
8 ing at the end the following:
9 ‘‘(h) CONTINUATION OF RESEARCH ON SUBSTANCES
10 NEWLY ADDED TO SCHEDULE I.—If a person is conducting
11 research on a substance when the substance is added to
12 schedule I, and the person is already registered to conduct
13 research with a controlled substance in schedule I—
14 ‘‘(1) not later than 90 days after the scheduling
15 of the newly scheduled substance, the person shall sub-
16 mit a completed application for registration or modi-
17 fication of existing registration, to conduct research
18 on the substance, in accordance with regulations
19 issued by the Attorney General for purposes of this
20 paragraph;
21 ‘‘(2) the person may, notwithstanding sub-
22 sections (a) and (b), continue to conduct the research
23 on the substance until—
24 ‘‘(A) the person withdraws the application
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1 ‘‘(B) the Attorney General serves on the per-
2 son an order to show cause proposing the denial
3 of the application under section 304(c);
4 ‘‘(3) if the Attorney General serves an order to
5 show cause as described in paragraph (2)(B) and the
6 person requests a hearing, the hearing shall be held on
7 an expedited basis and not later than 45 days after
8 the request is made, except that the hearing may be
9 held at a later time if so requested by the person; and
10 ‘‘(4) if the person sends a copy of the application
11 described in paragraph (1) to a manufacturer or dis-
12 tributor of the substance, receipt of the copy by the
13 manufacturer or distributor shall constitute sufficient
14 evidence that the person is authorized to receive the
15 substance.’’.
16 (f) TREATMENT OF CERTAIN MANUFACTURING ACTIVI-
17 TIES AS COINCIDENT TO RESEARCH.—Section 302 of the
18 Controlled Substances Act (21 U.S.C. 822), as amended by
19 subsection (e), is amended by adding at the end the fol-
20 lowing:
21 ‘‘(i) TREATMENT OF CERTAIN MANUFACTURING AC-
22 TIVITIES AS COINCIDENT TO RESEARCH.—
23 ‘‘(1) IN GENERAL.—Except as provided in para-
24 graph (3), a person who is registered to perform re-
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1 facturing activities with small quantities of that sub-
2 stance, including activities described in paragraph
3 (2), without being required to obtain a manufac-
4 turing registration, if—
5 ‘‘(A) the activities are performed for the
6 purpose of the research; and
7 ‘‘(B) the activities and the quantities of the
8 substance involved in the activities are stated
9 in—
10 ‘‘(i) a notification submitted to the At-
11 torney General under section 303(l);
12 ‘‘(ii) a research protocol filed with an
13 application for registration approval under
14 section 303(f); or
15 ‘‘(iii) a notification to the Attorney
16 General that includes—
17 ‘‘(I) the name of the registrant;
18 and
19 ‘‘(II) an attestation that the re-
20 search to be conducted with the small
21 quantities of manufactured substance
22 is consistent with the scope of the re-
23 search that is the basis for the registra-
24 tion.
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1 ‘‘(2) ACTIVITIES INCLUDED.—Activities per-
2 mitted under paragraph (1) include—
3 ‘‘(A) processing the substance to create ex-
4 tracts, tinctures, oils, solutions, derivatives, or
5 other forms of the substance consistent with—
6 ‘‘(i) the information provided as part
7 of a notification submitted to the Attorney
8 General under section 303(l); or
9 ‘‘(ii) a research protocol filed with an
10 application for registration approval under
11 section 303(f); and
12 ‘‘(B) dosage form development studies per-
13 formed for the purpose of requesting an inves-
14 tigational new drug exemption under section
15 505(i) of the Federal Food, Drug, and Cosmetic
16 Act (21 U.S.C. 355(i)).
17 ‘‘(3) EXCEPTION REGARDING MARIHUANA.—The
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1 ‘‘(o) TRANSPARENCY REGARDING SPECIAL PROCE-
2 DURES.—
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1 that paragraph, regardless of whether a practitioner
2 has submitted such an application at that time.’’.
3 SEC. 4. RULEMAKING.
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1 by this Act in accordance with section 553 of title 5,
2 United States Code.
3 SEC. 5. PENALTIES.
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1 SEC. 6. APPLICABILITY; OTHER MATTERS.
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Union Calendar No. 47
118TH CONGRESS
1ST SESSION H. R. 467
[Report No. 118–67, Part I]
H467
A BILL
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To amend the Controlled Substances Act with re-
spect to the scheduling of fentanyl-related sub-
stances, and for other purposes.
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MAY 17, 2023
Reported from the Committee on Energy and Commerce
with an amendment
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MAY 17, 2023
Committee on the Judiciary discharged; committed to the
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Committee of the Whole House on the State of the
Union and ordered to be printed
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