Wac 246-945

Chapter 246-945 WAC
PHARMACY QUALITY ASSURANCE COMMISSION

Last Update: 6/1/20
WAC
PART 1 - GENERAL PROVISIONS

246-945-001 Definitions.
Subpart A - Commission Operations
246-945-002 Administrative proceedings and appeals.
246-945-005 Commission inspections and investigations.
Subpart B - Prescription Labeling, Records, and Advertising
246-945-010 Prescription and chart order—Minimum requirements.
246-945-011 Prescription validity.
246-945-012 Prescription refills.
246-945-013 Partial filling of prescriptions.
246-945-015 Minimum requirements for dispensing practitioners.
246-945-016 Prescriptions—Outpatient labels—Minimum requirements.
246-945-017 Prescriptions—Hospital inpatient labels—Minimum requirements.
246-945-018 Prescriptions—Labeling—Prepackage medications.
246-945-020 Records retention period and commission access to records.
246-945-025 Prescription drug price advertising.
Subpart C - Legend Drugs and Controlled Substances
246-945-030 Identification of legend drugs for purposes of chapter 69.41 RCW.
246-945-031 Ephedrine prescription restrictions.
246-945-032 Child-resistant containers.
246-945-033 Over-the-counter drugs.
246-945-035 Drug sample prohibitions.
246-945-037 Regulated steroids.
246-945-038 Availability and identity of amygdalin.
246-945-040 Uniform Controlled Substance Act.
246-945-043 Designation of nonnarcotic stimulant drugs for the purposes of RCW 69.50.402 (1)(c).
246-945-045 Prescribing, dispensing, or administering of Schedule II nonnarcotic stimulants.
246-945-047 Sodium pentobarbital registration disciplinary action.
246-945-050 Commission authority to control.
246-945-051 Schedule I.
246-945-052 Schedule II.
246-945-053 Schedule II immediate precursors.
246-945-054 Schedule III.
246-945-055 Schedule IV.
246-945-056 Schedule V.
246-945-060 Other controlled substance registrants—Requirements.
246-945-063 Precursor definitions.
246-945-065 Precursor substance control.
246-945-070 Reports of precursor receipt.
246-945-072 Precursor substance monthly reporting.
246-945-075 Suspicious transactions and reporting requirements.
246-945-077 Precursor substance requirements for the sale of a restricted product.
246-945-078 Record of sales—Electronic methamphetamine precursor tracking.
246-945-080 Acceptable forms of identification.
246-945-085 Maintenance of and access to retail sales records of restricted products.
246-945-087 Exemptions from electronic reporting.
246-945-088 Denial of a sale—Override.
Subpart D – Home Dialysis
246-945-090 Home dialysis program—Legend drugs.
246-945-091 Home dialysis program—Pharmacist consultant.
246-945-092 Home dialysis program—Records.
246-945-093 Home dialysis program—Quality assurance.
Subpart E - Compounding
246-945-100 Compounding minimum standards.
PART 2 – GENERAL LICENSING
246-945-145 License required.
246-945-150 Applicable forms.
Subpart A – Pharmacy Interns and Pharmacist
246-945-155 Pharmacy interns—Registration requirements.
246-945-156 Pharmacy intern—Temporary practice permit.
246-945-162 Pharmacist license qualifications.
246-945-163 Certification of internship hours.
246-945-165 Pharmacist licensure and jurisprudence examinations.
246-945-170 Pharmacist licensure by license transfer—Temporary practice permits.
246-945-173 Expired pharmacist license.
246-945-175 Inactive pharmacist license.
246-945-178 Pharmacist continuing education.
246-945-180 Nuclear pharmacist endorsement.
Certified on 7/9/2020 Page 1

Subpart B – Pharmacy Assistants and Technicians
246-945-200 Pharmacy assistants.
246-945-203 Pharmacy technician-in-training authority for experiential training.
246-945-205 Pharmacy technician certification.
246-945-210 Pharmacy technician—Temporary practice permit—Military spouse eligibility and issuance.
246-945-215 Pharmacy technician education and training programs.
246-945-217 Expired pharmacy technician certification.
246-945-220 Pharmacy technician—Continuing education.
Subpart C – Pharmaceutical Firm Licensing
246-945-230 General information, change of location, ownership or new construction.
246-945-232 Pharmacy licensing.
246-945-233 Hospital pharmacy associated clinics.
246-945-235 Nonresident pharmacy license.
246-945-245 Health care entity license.
246-945-246 Wholesaler.
246-945-247 Pharmaceutical manufacturer license.
Subpart D – Commission Registrations
246-945-250 Researcher and other controlled substance registration.
246-945-253 Shopkeeper registration.
246-945-254 Animal control and humane society registration.
246-945-255 Chemical capture—Department of fish and wildlife.
PART 3 – PROFESSIONAL STANDARDS
246-945-305 Pharmacist's professional responsibilities.
246-945-310 Responsible pharmacy manager.
246-945-315 Delegation of pharmacy functions to pharmacy ancillary personnel.
246-945-317 Tech check tech.
246-945-320 Nondelegable tasks.
246-945-325 Patient counseling.
246-945-330 Refilling prescriptions.
246-945-332 Continuity of care.
246-945-335 Prescription adaptation.
246-945-340 Prescriptions—Drug product substitutions.
246-945-345 Prescription transfers.
246-945-350 Collaborative drug therapy agreements.
246-945-355 Monitoring of drug therapy by pharmacist.
246-945-360 Patient rights.
246-945-365 Approval of impaired practitioner substance abuse monitoring program.
246-945-370 Sexual misconduct.
PART 4 – OPERATIONAL STANDARDS
Subpart A – Pharmacies, HCEs and HPACs

246-945-405 Applicability.
246-945-410 Facility standards.
246-945-415 Dispensing and delivery of prescription drugs.
246-945-417 Electronic systems for patient medication records, prescriptions, chart orders, and con-
trolled substance records.
246-945-418 Paper recordkeeping procedure.
246-945-420 Facility inventory requirements.
246-945-425 Shared pharmacy services.
246-945-430 Pharmacies storing, dispensing and delivering drugs to patients without a pharmacist on-
site.
246-945-435 Provision of emergency department discharge medication when pharmacy services are un-
available.
246-945-440 Administration of patient owned medications.
246-945-445 Investigational drugs.
246-945-450 Accessing technology used to dispense—Nursing students.
246-945-455 Drugs stored outside of the pharmacy.
246-945-460 Staffing and supervision of pharmacy staff.
246-945-480 Facility reporting requirements.
246-945-485 Destruction or return of drugs or devices—Restrictions.
246-945-490 Nuclear pharmacies.
246-945-492 Nuclear pharmacies—Equipment requirements.
Subpart B – Registrations
246-945-500 Humane societies, animal control agencies, and department of fish and wildlife chemical
capture programs—Designated person.
capture programs—Authorized personnel.
246-945-505 Humane societies and animal control agencies—Approved legend drugs and approved con-
trolled substances.
246-945-507 Department of fish and wildlife chemical capture programs—Approved legend drugs and ap-
proved controlled substances.
capture programs—Recordkeeping and reports.
capture programs—Drug storage and field use.
Subpart

Subpart C – Drug Distributors
246-945-550 Manufacturers—Minimum standards.
246-945-553 Teat dip containers.
246-945-555 Wholesaler—Minimum standards—Scope.
246-945-560 Wholesaler—Facility standards.
246-945-565 Wholesaler—Drug storage.
246-945-570 Wholesaler—Drug shipment inspection.
246-945-575 Wholesaler—Recordkeeping.
246-945-580 Wholesaler—Personnel.
246-945-585 Wholesaler—Suspicious orders and due diligence.
246-945-590 Wholesaler—Policies and procedures.
246-945-595 Wholesaler and manufacturer—Prohibited acts.
246-945-600 Salvaging and reprocessing.
PART 1 - GENERAL PROVISIONS
WAC 246-945-001 Definitions. The definitions in chapters 18.64

and 18.64A RCW and those in this section apply throughout this chapter
unless otherwise stated.
(1) "ACPE" means accreditation council for pharmacy education.
(2) "Active ingredient" means any component that is intended to
furnish pharmacological activity or other direct effect in the diagno-
sis, cure, mitigation, treatment, or prevention of disease, or to af-
fect the structure or any function of the body of humans or other ani-
mals. The term includes those components that may undergo chemical
change in the manufacture of the drug product and be present in that
drug product in a modified form intended to furnish the specified ac-
tivity or effect.
(3) "Adulterated" refers to a drug that was produced and the
methods used in, or the facilities or controls used for, its manufac-
ture, processing, packing, or holding do not conform to or are not op-
erated or administered in conformity with WAC 246-945-550 as to safety
and has the identity and strength, and meets the quality and purity
characteristics, which it purports or is represented to possess.
(4) "Animal control agency" means any agency authorized by law to
euthanize or destroy animals; to sedate animals prior to euthanasia or
to engage in chemical capture of animals.
(5) "Approved legend drugs" means any legend drug approved by the
commission for use by registered humane societies or animal control
agencies for the sole purpose of sedating animals prior to euthanasia,
when necessary, and for use in chemical capture programs.
(6) "Audit trail" means all materials and documents required for
the entire process of filling a prescription, which shall be suffi-
cient to document or reconstruct the origin of the prescription, and
authorization of subsequent modifications of that prescription.
(7) "Blood" means whole blood collected from a single donor and
processed either for transfusion or further manufacturing.
(8) "Blood component" means that part of the blood separated by
physical or mechanical means.
(9) "Central fill pharmacy" means a pharmacy contracting with an
originating pharmacy, or having the same owner as an originating phar-
macy, that provides centralized prescription filling on behalf of the
originating pharmacy pursuant to these rules.
(10) "Chemical capture program" means wildlife management pro-
grams registered under RCW 69.41.080 and 69.50.320 to use approved
legend drugs and controlled substance for chemical capture. Chemical
capture includes immobilization of individual animals in order for the

animals to be moved, treated, examined, or for other legitimate purpo-
ses.
(11) "Collaborative drug therapy agreement" or "CDTA" means a
written guideline or protocol previously established and approved by a
practitioner authorized to prescribe drugs that enables a pharmacist
to exercise prescriptive authority.
(12) "Controlled substances" has the same meaning as RCW
69.50.101.
(13) "Controlled substance wholesaler" means a wholesaler li-
censed under RCW 18.64.046 to possess and sell controlled substances
to a licensed pharmacy or other legally licensed or authorized person.
(14) "Commission" means the pharmacy quality assurance commis-
sion.
(15) "Counterfeit" means a drug which, or the container or label-
ing of which, without authorization, bears the trademark, trade name,
or other identifying mark, imprint, or device, or any likeness there-
of, of a drug manufacturer, processor, packer, or distributor other
than the person or persons who in fact manufactured, processed,
packed, or distributed such drug and which thereby falsely purports or
is represented to be the product of, or to have been packed or dis-
tributed by, such other drug manufacturer, processor, packer, or dis-
tributor.
(16) "CPE" means continuing pharmacy education accredited by the
ACPE.
(17) "Consultation" means:
(a) A communication or deliberation between a pharmacist and a
patient, a patient's agent, or a patient's health care provider in
which the pharmacist uses professional judgment to provide advice
about drug therapy.
(b) A method by which the pharmacist meets patient information
requirements as set forth in WAC 246-945-325.
(18) "Credential" means a license, certification, or registration
under the chapters specified in RCW 18.130.040 issued to a person to
practice a regulated health care profession. Whether the credential is
a license, certification, or registration is determined by the law
regulating the profession.
(19) "DEA" means the United States Drug Enforcement Administra-
tion.
(20) "Delegated tasks" means tasks that are performed pursuant to
a pharmacist's direction, without the exercise of the pharmacy ancil-
lary personnel's own judgment and discretion, and which do not require
the pharmacy ancillary personnel's to exercise the independent profes-
sional judgment that is the foundation of the practice of the profes-
sion of pharmacy.
(21) "Department" means the Washington state department of
health.
(22) "Dose" means the amount of drug to be administered at one
time.
(23) "Drug(s) of concern" are those drugs identified by the com-
mission as demonstrating a potential for abuse by all professionals
licensed to prescribe, dispense, or administer such substances in this
state.
(24) "Drug price advertising" means the dissemination of nonpro-
motional information pertaining to the prices of legend or prescrip-
tion drugs.
(25) "Drug product" means a finished dosage form (e.g., tablet,
capsule, solution) that contains an active drug ingredient generally,

but not necessarily, in association with inactive ingredients. The
term also includes a finished dosage form that does not contain an ac-
tive ingredient but is intended to be used as a placebo.
(26) "Drug sample" means a unit of prescription drug that is not
intended to be sold and is intended to promote the sale of the drug.
(27) "Drug standard and information sources" means industry rec-
ognized reference and resources.
(28) "Drug storage area" means an area where legend drugs, con-
trolled substances, or other restricted items are stored, compounded,
or dispensed.
(29) "Drug utilization review" includes, but is not limited to,
the following activities:
(a) Evaluation of prescriptions and patient records for known al-
lergies, rational therapy-contraindications, appropriate dose, and
route of administration and appropriate directions for use;
(b) Evaluation of prescriptions and patient records for duplica-
tion of therapy;
(c) Evaluation of prescriptions and patient records for interac-
tions between drug-drug, drug-food, drug-disease, and adverse drug re-
actions; and
(d) Evaluation of prescriptions and patient records for proper
utilization, including over- or under-utilization, and optimum thera-
peutic outcomes.
(30) "Electronic means" an electronic device used to send, re-
ceive, and/or store prescription information, including computers,
facsimile machines, etc.
(31) "Electronic signature" means an electronic sound, symbol, or
process attached to or logically associated with a contract or other
record and executed or adopted by a person with the intent to sign the
record.
(32) "Enrolled student" means a student who has accepted an offer
of admission in writing and the student has made the appropriate de-
posit securing admission to an accredited school or college of pharma-
cy.
(33) "Equivalent manager" means an individual authorized to act
on behalf of a pharmaceutical firm not licensed as a pharmacy to serve
as the primary contact for the department and is responsible for man-
aging the facility operations which includes, but is not limited to,
actively involved in and aware of the daily operations of the facili-
ty.
(34) "Export wholesaler" means any wholesaler authorized by the
commission to export legend drugs and nonprescription (OTC) drugs to
foreign countries.
(35) "FDA" – United States Food and Drug Administration.
(36) "Full-line wholesaler" means a drug wholesale distributor
that is licensed under RCW 18.64.046 to possess and sell legend drugs,
controlled substance and nonprescription drugs to a licensed pharmacy
or other legally licensed or authorized person.
(37) "FPGEC" means foreign pharmacy graduate examination commit-
tee.
(38) "FPGEE" means foreign pharmacy graduate equivalency examina-
tion.
(39) "Generic substitution" means the act of switching between a
branded drug and its therapeutically equivalent generic version.
(40) "HIPAA" means Health Insurance Portability and Accountabili-
ty Act.

(41) "Hospital" means any institution licensed under chapter
70.41 or 71.12 RCW or designated under RCW 72.23.020.
(42) "Hospital pharmacy" means that portion of a hospital li-
censed under RCW 18.64.043 which is engaged in the manufacture, pro-
duction, preparation, dispensing, sale, or distribution of drugs, com-
ponents, biologicals, chemicals, devices and other materials used in
the diagnosis and treatment of injury, illness and diseases.
(43) "Hospital pharmacy associated clinic" or "HPAC" means an in-
dividual practitioner's office or multipractitioner clinic owned, op-
erated, or under common control of a parent hospital or health system,
where the physical address of the office or clinic is identified on a
hospital pharmacy license.
(44) "Immediate supervision" means supervision by a pharmacist
who is immediately available at all times the delegated tasks are be-
ing performed; who is aware of delegated tasks being performed; and
who provides personal assistance, direction and approval throughout
the time the delegated tasks are being performed.
(a) "Immediately available" means the pharmacist and pharmacy an-
cillary personnel or interns are on the same physical premises, or if
not, technology is used to enable real time, two-way communications
between the pharmacist and technician(s).
(b) Use of technology: A pharmacist, as an adjunct to assist in
the immediate supervision of the pharmacy ancillary personnel or in-
tern, may employ technological means to communicate with or observe
the pharmacy ancillary personnel or intern. A pharmacist shall make
certain all applicable state and federal laws including, but not limi-
ted to, confidentiality, are fully observed when employing technologi-
cal means of communication and observation. If technology is being
used to provide immediate supervision of pharmacy ancillary personnel
or intern such technology shall be sufficient to provide the personal
assistance, direction and approval required to meet the standard of
practice for the delegated tasks.
(45) "Inoperable" means a credential status indicating that an
individual cannot practice because he or she is not actively partici-
pating or enrolled in a required training program when this condition
is a requirement of the credential. Inoperable status is not the re-
sult of enforcement action. The health care professional can resume
practice when appropriately enrolled in a required training program
and the credential is reactivated.
(46) "Internal test assessment" means, but is not limited to,
conducting those tests of quality assurance necessary to ensure the
integrity of the test.
(47) "Investigational drug" means any article drug that has an
investigational drug application (INDA) that has been approved by the
FDA.
(48) "Key party" means immediate family members and others who
would be reasonably expected to play a significant role in the health
care decisions of the patient or client and includes, but is not limi-
ted to, the spouse, domestic partner, sibling, parent, child, guardian
and person authorized to make health care decisions of the patient or
client.
(49) "Law enforcement" means any general or limited authority
Washington peace officer or federal law enforcement officer or tribal
officer.

(50) "License transfer" means the process used by licensed phar-
macists to transfer their existing pharmacist license to Washington
using NABP's Electronic Licensure Transfer Program® (e-LTPTM).
(51) "Lot" means a batch or a specific identified portion of a
batch having uniform character and quality within specified limits, or
in the case of a drug product produced by continuous process, it is a
specific identified amount produced in a unit of time or quantity in a
manner that assures it is having uniform character and quality within
specified limits.
(52) "Manual signature" means a printed or wet signature.
(53) "Misbranded" applies to all drugs the package or label of
which bears any statement, design or device regarding such article or
the ingredients or substances contained therein which is false or mis-
leading in any particular way, and drug product which is falsely bran-
ded as to the state, territory or country in which it is manufactured
or produced.
(54) "NABP" means the National Association of Boards of Pharmacy.
(55) "NDC" means National Drug Code.
(56) "Nuclear pharmacy" means a pharmacy providing radiopharma-
ceutical services.
(57) "Nuclear pharmacist" means a pharmacist licensed under RCW
18.64.080 who holds an endorsement that meets the requirements of WAC
246-945-180.
(58) "Originating pharmacy" means a pharmacy that receives a pre-
scription from a patient, the patient's agent, or a prescriber, out-
sources prescription filling or processing functions to another phar-
macy, and ultimately dispenses the prescription drug or device to the
patient or the patient's agent. This does not include pharmacies en-
gaged in shared pharmacy services in accordance with RCW 18.64.570.
(59) "Over-the-counter drugs" or "OTC" means "nonlegend" or "non-
prescription" drugs, and any drugs which may be lawfully sold without
a prescription.
(60) "Over-the-counter only wholesaler" means any wholesaler li-
censed under RCW 18.64.046 to possess and sell OTC drugs to any out-
lets credentialed for resale.
(61) "Pharmaceutical firm" means a business engaged in the dis-
pensing, delivering, distributing, manufacturing, or wholesaling of
prescription drugs or devices within or into Washington state.
(62) "Pharmacy intern" means a person who is registered with the
commission under RCW 18.64.080(3) as a pharmacy intern.
(63) "Pharmacy services" means any services provided that meet
the definition of the practice of pharmacy, RCW 18.64.011.
(64) "Plan of correction" is a proposal devised by the applicant
or credential holder that includes specific corrective actions that
must be taken to correct identified unresolved deficiencies with time
frames to complete them.
(65) "Precursor drugs" as defined in chapter 69.43 RCW.
(66) "Prescription drug" means any drug, including any biological
product required by federal statute or regulation to be dispensed only
by a prescription, including finished dosage forms and bulk drug sub-
stances subject to section 503(b) of the Federal Food, Drug, and Cos-
metic Act.
(67) "Protocol" means a written set of procedures, steps or guid-
ance.
(68) "Radiopharmaceutical service" means, but is not limited to:

(a) The preparing, compounding, dispensing, labeling, and deliv-
ery of radiopharmaceuticals;
(b) The participation in radiopharmaceutical selection and radio-
pharmaceutical utilization reviews;
(c) The proper and safe storage and distribution of radiopharma-
ceuticals;
(d) The maintenance of radiopharmaceutical quality assurance;
(e) The responsibility for advising, where necessary or where
regulated, of therapeutic values, hazards and use of radiopharmaceuti-
cals; or
(f) The offering or performing of those acts, services, opera-
tions or transactions necessary in the conduct, operation management
and control of a nuclear pharmacy.
(69) "Radiopharmaceutical" means any substance defined as a drug
in section 201(g)(1) of the Federal Food, Drug, and Cosmetic Act which
exhibits spontaneous disintegration of unstable nuclei with the emis-
sion of nuclear particles or photons and includes any nonradioactive
reagent kit or nuclide generator which is intended to be used in the
preparation of any such substance but does not include drugs such as
carbon-containing compounds or potassium-containing salts which con-
tain trace quantities of naturally occurring radionuclides. The term
"radioactive drug" includes a "radioactive biological product."
(70) "Radiopharmaceutical quality assurance" means, but is not
limited to, the performance of appropriate chemical, biological and
physical tests on radiopharmaceuticals and the interpretation of the
resulting data to determine their suitability for use in humans and
animals, including internal test assessment authentication of product
history and the keeping of proper records.
(71) "Readily retrievable" means a record that is kept by auto-
matic data processing systems or other electronic, mechanized, or
written recordkeeping systems in such a manner that it can be separa-
ted out from all other records in a reasonable time.
(72) "Reverse distributor" means a pharmaceutical wholesaler that
receives drugs for destruction, return credit, or otherwise disposes
of drugs received from a registrant that holds a credential to dis-
pense or possess drugs.
(73) "Secretary" means the secretary of the Washington state de-
partment of health.
(74) "Strength" means:
(a) The concentration of the drug product; and/or
(b) The potency, that is, the therapeutic activity of the drug
product as indicated by appropriate laboratory tests or by adequately
developed and controlled clinical data.
(75) "U.S. jurisdiction" means a state of the United States, the
District of Columbia, the Commonwealth of Puerto Rico, or a territory
or insular possession subject to the jurisdiction of the United
States.
(76) "USP" means the United States Pharmacopeia.
(77) "Therapeutic substitution" means the act of dispensing an
alternative drug that is believed to be therapeutically similar but
may be chemically different, in a different category, or with differ-
ent pharmacokinetic properties. This substitution is based on the
premise that the substituted drug will provide similar clinical effi-
cacy, desired outcome, and safety profile.
(78) "TOEFL iBT" means an internet based test which measures the
ability to use and understand English. It evaluates the combined use
of reading, listening, speaking and writing skills.

(79) "Virtual manufacturer" means an individual or facility that
sells his or her own prescription drugs, but never physically possess-
es the drugs.
(80) "Virtual wholesaler" means an individual or facility that
sells a prescription drug and/or device, but never physically possess-
es the product.
(81) "Wholesale distribution" means distribution of prescription
drugs to persons other than a consumer or patient, but does not in-
clude:
(a) The sale, purchase, or trade of a drug, an offer to sell,
purchase or trade a drug, or the dispensing of a drug pursuant to a
prescription;
(b) The lawful distribution of drug samples by manufacturers'
representatives or distributors' representatives;
(c) The sale, purchase, or trade of blood and blood components
intended for transfusion;
(d) Intracompany sales, being defined as any transaction or
transfer between any division, subsidiary, parent and/or affiliated or
related company under the common ownership and control of a corporate
entity, unless such transfer occurs between a wholesale distributor
and a health care entity or practitioner; or
(e) The sale, purchase, or trade of a drug or an offer to sell,
purchase, or trade a drug for emergency medical reasons, for purposes
of this section, "emergency medical reasons" includes transfers of
prescription drugs by retail pharmacy to another retail pharmacy or
practitioner to alleviate a temporary shortage, except that the gross
dollar value of such transfers shall not exceed five percent of the
total prescription drug sale revenue of either the transferor or
transferee pharmacy during any twelve consecutive month period.
[Statutory Authority: RCW 18.64.005, 18.64.080, 18.130.075, 18.64.043,

18.64.044, 18.64.045, 18.64.046, 18.64.370, 18.64.460, 69.50.310,
18.64.011, 18.64.245, 18.64.470, 18.64.255, 18.64.205, 18.64.253,
18.64.410, 18.64.500, 18.64.590. WSR 20-12-072, § 246-945-001, filed
6/1/20, effective 7/1/20.]
Subpart A - Commission Operations
WAC 246-945-002 Administrative proceedings and appeals. (1) The

commission adopts the model procedural rules for boards as adopted by
the department, and contained in chapter 246-11 WAC, including subse-
quent amendments.
(2) The commission adopts the administrative procedures and re-
quirements for credentialed heath care providers as adopted by the de-
partment and contained in chapter 246-12 WAC, including subsequent
amendments under chapter 246-12 WAC.
(3) Where there is a conflict between the rules incorporated in
subsections (1) and (2) of this section, the commission's rule shall
supersede.
18.64.044, 18.64.045, 18.64.046, 18.64.370, 18.64.460, 69.50.310,
18.64.011, 18.64.245, 18.64.470, 18.64.255, 18.64.205, 18.64.253,
18.64.410, 18.64.500, 18.64.590. WSR 20-12-072, § 246-945-002, filed
6/1/20, effective 7/1/20.]

WAC 246-945-005 Commission inspections and investigations. (1)
Records subject to commission inspection. A pharmaceutical firm shall
make available for inspection upon request by the commission or desig-
nee records created, maintained, or retained in compliance with stat-
utes or rules enforced by the commission. It is unlawful to refuse to
permit or to obstruct a commission inspection.
(2) Initial inspections. Prior to starting a business, as appli-
cable, and upon presentation of appropriate identification, a pharma-
ceutical firm shall permit the commission, or its designee, to enter
and inspect the premises and to audit the records of each entity for
compliance with laws enforced by or under the commission's jurisdic-
tion.
(3) Periodic commission inspection. A pharmaceutical firm is sub-
ject to periodic inspections to determine compliance with the laws
regulating the practice of pharmacy.
(a) Statement of deficiency.
(i) At the end of the inspection, the commission, or its desig-
nee, will conduct an exit meeting with the responsible pharmacy manag-
er, or designee, or equivalent manager, addressing unresolved defi-
ciencies identified during the inspection.
(ii) The commission, or its designee, shall provide a written
statement of deficiency to the pharmaceutical firm within ten business
days of the exit meeting.
(iii) The statement of deficiency may include unresolved defi-
ciencies identified at the end of a periodic commission inspection,
describing the unresolved deficiencies in detail with a reference to
all applicable laws.
(b) Plan of correction. A pharmaceutical firm shall submit a plan
of correction to the commission, or its designee, addressing each
identified unresolved deficiency within ten business days of receipt
of a statement of deficiency.
(i) The commission, or its designee, shall notify the pharmacy
within ten business days, whether or not a submitted plan of correc-
tion adequately addresses the unresolved deficiencies identified in
the statement of deficiency.
(ii) Implementation of the corrective action is required within
the time frames set in the approved plan of correction, and are sub-
ject to verification by the commission, or its designee, which may re-
quire the pharmacy to submit a progress report(s) attesting to the
correction of deficiencies, or a follow-up inspection.
(c) Pharmaceutical firms with deficiencies that represent an im-
minent or immediate risk or threat to public health, safety, or wel-
fare may be subject to summary suspension of the pharmacy license, at
the discretion of the commission.
(4) Self-inspections. The responsible pharmacy manager, or equiv-
alent manager, is required to conduct an annual self-inspection of the
pharmaceutical firm on the self-inspection worksheet(s) provided by
the commission. The self-inspection must be completed within the month
of March each year.
(a) The responsible pharmacy manager, or equivalent manager,
shall sign and date the completed self-inspection worksheet(s), and
maintain completed worksheets for two years from the date of comple-
tion.
(b) When a change in responsible pharmacy manager, or equivalent
manager occurs, the new responsible pharmacy manager, or equivalent
manager, shall conduct a self-inspection as required under this sec-
tion. The new responsible pharmacy manager, or equivalent manager,

shall sign and date the self-inspection worksheet(s) within thirty
days of becoming responsible pharmacy manager, or equivalent manager,
and maintain completed worksheets for two years from the date of com-
pletion.
(5) Inspection informal dispute process.
(a) A pharmaceutical firm may dispute within ten business days:
(i) Any or all deficiencies included on a statement of deficiency
issued by the commission;
(ii) The rejection of the first submitted plan of correction;
(iii) The pharmaceutical firm may request a one-time extension.
(b) A pharmaceutical firm shall submit a dispute under this sub-
section to the commission in writing. The dispute must be in detail
and include any supporting documentation for commission consideration.
(c) The commission may review and consider a second rejection of
a plan of correction.
(d) The commission shall consider any dispute and notify the
pharmaceutical firm of its determination.
(6) Investigations. A pharmaceutical firm shall cooperate with
commission investigations conducted to confirm compliance with laws
enforced by the commission, to gather information pertinent to a com-
plaint received by the commission, or to enforce disciplinary actions.

18.64.044, 18.64.045, 18.64.046, 18.64.370, 18.64.460, 69.50.310,
18.64.011, 18.64.245, 18.64.470, 18.64.255, 18.64.205, 18.64.253,
18.64.410, 18.64.500, 18.64.590. WSR 20-12-072, § 246-945-005, filed
6/1/20, effective 7/1/20.]
Subpart B - Prescription Labeling, Records, and Advertising
WAC 246-945-010 Prescription and chart order—Minimum require-

ments. (1) For the purposes of this section, prescription does not
include chart orders as defined in RCW 18.64.011(3).
(2) For the purposes of WAC 246-945-010 through 246-945-013, pre-
scription includes written and electronic prescriptions.
(3) A prescription for a noncontrolled legend drug must include,
but is not limited to, the following:
(a) Prescriber's name;
(b) Name of patient, authorized entity, or animal name and spe-
cies;
(c) Date of issuance;
(d) Drug name, strength, and quantity;
(e) Directions for use;
(f) Number of refills (if any);
(g) Instruction on whether or not a therapeutically equivalent
generic drug or interchangeable biological product may be substituted,
unless substitution is permitted under a prior-consent authorization;
(h) Prescriber's manual or electronic signature, or prescriber's
authorized agent signature if allowed by law; and
(i) If the prescription is written, it must be written on tamper-
resistant prescription pad or paper approved by the commission pur-
suant to RCW 18.64.500;

(4) A prescription for a controlled substance must include all
the information listed in subsection (1) of this section and the fol-
lowing:
(a) Patient's address;
(b) Dosage form;
(c) Prescriber's address;
(d) Prescriber's DEA registration number; and
(e) Any other requirements listed in 21 C.F.R., Chapter II.
(5) A chart order must meet the requirements of RCW 18.64.550 and
any other applicable requirements listed in 21 C.F.R., Chapter II.
(6) A controlled substance listed in Schedule II can only be dis-
pensed pursuant to a valid prescription in accordance with WAC
246-945-011 unless there is an "emergency."
(a) For the purposes of this subsection, an "emergency" exists
when the immediate administration of the drug is necessary for proper
treatment and no alternative treatment is available, and further, it
is not possible for the practitioner to provide a written or electron-
ic prescription for the drug at that time.
(b) If a Schedule II drug is dispensed in an emergency, the prac-
titioner must deliver a signed prescription to the dispenser within
seven days after authorizing an emergency oral prescription or if de-
livered by mail it must be postmarked within the seven day period, and
further the pharmacist must note on the prescription that it was fil-
led on an emergency basis.
(7) A controlled substance listed in Schedule III, IV, or V, can
only be dispensed pursuant to a valid prescription in accordance with
WAC 246-945-011, or an oral prescription. An oral prescription for a
controlled substance listed in Schedule III, IV, or V must be promptly
reduced to a written or electronic prescription that complies with WAC
246-945-011.
(8) A noncontrolled legend drug can only be dispensed pursuant to
a valid prescription in accordance with WAC 246-945-011, or an oral
prescription. An oral prescription for a noncontrolled legend drug
must be promptly reduced to a written or electronic prescription that
complies with WAC 246-945-011.

18.64.044, 18.64.045, 18.64.046, 18.64.370, 18.64.460, 69.50.310,
18.64.011, 18.64.245, 18.64.470, 18.64.255, 18.64.205, 18.64.253,
18.64.410, 18.64.500, 18.64.590. WSR 20-12-072, § 246-945-010, filed
6/1/20, effective 7/1/20.]
WAC 246-945-011 Prescription validity. (1) Prior to dispensing

and delivering a prescription, a pharmacist shall verify its validity.
(2) A prescription shall be considered invalid if:
(a) At the time of presentation, the prescription shows evidence
of alteration, erasure, or addition by any person other than the per-
son who wrote it;
(b) The prescription does not contain the required information as
provided in WAC 246-945-010;
(c) The prescription is expired; or
(d) The prescription is for a controlled substance and does not
comply with the requirements in RCW 69.50.308.
(3) A prescription is considered expired when:

(a) The prescription is for a controlled substance listed in
Schedule II through V and the date of dispensing is more than six
months after the prescription's date of issue.
(b) The prescription is for a noncontrolled legend drug or OTC's
and the date of dispensing is more than twelve months after the pre-
scription's date of issue.

18.64.044, 18.64.045, 18.64.046, 18.64.370, 18.64.460, 69.50.310,
18.64.011, 18.64.245, 18.64.470, 18.64.255, 18.64.205, 18.64.253,
18.64.410, 18.64.500, 18.64.590. WSR 20-12-072, § 246-945-011, filed
6/1/20, effective 7/1/20.]
WAC 246-945-012 Prescription refills. (1) A prescription for a

controlled substance listed in Schedule II cannot be refilled.
(2) A prescription for a controlled substance listed in Schedule
III, IV, or V may be refilled a maximum of five times as indicated by
the prescriber. The prescription will expire six months after the date
of issue pursuant to WAC 246-945-011 even if there are refills remain-
ing.
(3) A prescription for a noncontrolled legend drug may be refil-
led as indicated by the prescriber in accordance with RCW 18.64.520.
There is no limit on the number of refills, but the prescription will
expire after twelve months from the date of issue pursuant to WAC
246-945-011.
18.64.044, 18.64.045, 18.64.046, 18.64.370, 18.64.460, 69.50.310,
18.64.011, 18.64.245, 18.64.470, 18.64.255, 18.64.205, 18.64.253,
18.64.410, 18.64.500, 18.64.590. WSR 20-12-072, § 246-945-012, filed
6/1/20, effective 7/1/20.]
WAC 246-945-013 Partial filling of prescriptions. (1) A pharma-

cist may partially fill a prescription for noncontrolled legend drugs
and controlled substances listed in Schedule III through V provided
that:
(a) The partial fill is requested by the patient or the prescrib-
er;
(b) The partial filling is recorded in the same manner as a re-
filling;
(c) The total quantity dispensed and delivered in all partial
fillings must not exceed the total quantity prescribed; and
(d) Partial fills for controlled substances listed in Schedule
III through V comply with 21 C.F.R. Sec. 1306.23.
(2) A pharmacist may partially fill a prescription for a control-
led substance listed in Schedule II within the limits of RCW
18.64.265, 21 U.S.C. Sec. 829, and 21 C.F.R. Sec. 1306.13, as applica-
ble.

18.64.044, 18.64.045, 18.64.046, 18.64.370, 18.64.460, 69.50.310,
18.64.011, 18.64.245, 18.64.470, 18.64.255, 18.64.205, 18.64.253,
18.64.410, 18.64.500, 18.64.590. WSR 20-12-072, § 246-945-013, filed
6/1/20, effective 7/1/20.]

WAC 246-945-015 Minimum requirements for dispensing practition-
ers. (1) A practitioner authorized to prescribe or administer a leg-
end drug including a controlled substance, other than a pharmacy, can
dispense a legend drug including a controlled substance directly to an
ultimate user without a prescription.
(2) All practitioners authorized to prescribe legend drugs and
who dispense legend drugs directly to the ultimate user shall affix a
label to the prescription container that meets the requirements of RCW
69.41.050.
18.64.044, 18.64.045, 18.64.046, 18.64.370, 18.64.460, 69.50.310,
18.64.011, 18.64.245, 18.64.470, 18.64.255, 18.64.205, 18.64.253,
18.64.410, 18.64.500, 18.64.590. WSR 20-12-072, § 246-945-015, filed
6/1/20, effective 7/1/20.]
WAC 246-945-016 Prescriptions—Outpatient labels—Minimum re-

quirements. (1) All licensees of the commission who dispense legend
drugs to outpatients shall affix a label to the prescription container
that meets the requirements of RCW 69.41.050 and 18.64.246, and shall
also include:
(a) Drug quantity;
(b) The number of refills remaining, if any;
(c) The following statement, "Warning: State or federal law pro-
hibits transfer of this drug to any person other than the person for
whom it was prescribed.", except when dispensing to an animal, when a
warning sufficient to convey "for veterinary use only" may be used;
(d) The name and species of the patient, if a veterinary pre-
scription; and
(e) The name of the facility or entity authorized by law to pos-
sess a legend drug, if patient is the facility or entity.
(2) In addition to the requirements in subsection (1) of this
section, a compounded product must meet the applicable labeling re-
quirements of USP chapters <795˃, <797˃, <800˃, and <825˃. For com-
pounded products, the BUD shall be equivalent to the expiration date
required by RCW 18.64.246.
(3) For the purposes of determining an expiration date as re-
quired in RCW 18.64.246, the dispenser shall take the following fac-
tors into account:
(a) The nature of the drug;
(b) The container in which it was packaged by the manufacturer
and the expiration date;
(c) The characteristics of the patient's container, if the drug
is repackaged for dispensing;
(d) The expected conditions to which the drug may be exposed;
(e) The expected length of time of the course of therapy; and
(f) Any other relevant factors.

18.64.044, 18.64.045, 18.64.046, 18.64.370, 18.64.460, 69.50.310,
18.64.011, 18.64.245, 18.64.470, 18.64.255, 18.64.205, 18.64.253,
18.64.410, 18.64.500, 18.64.590. WSR 20-12-072, § 246-945-016, filed
6/1/20, effective 7/1/20.]

WAC 246-945-017 Prescriptions—Hospital inpatient labels—Minimum
requirements. (1) All licensees of the commission who dispense legend
drugs to hospital inpatients shall ensure all drug containers are la-
beled clearly, legibly and adequately to show the drug's name (generic
and/or trade) and strength, when applicable.
section, a compounded product dispensed to a hospital inpatient must
meet the applicable labeling requirements of USP chapters <795˃,
<797˃, <800˃, and <825˃.

18.64.044, 18.64.045, 18.64.046, 18.64.370, 18.64.460, 69.50.310,
18.64.011, 18.64.245, 18.64.470, 18.64.255, 18.64.205, 18.64.253,
18.64.410, 18.64.500, 18.64.590. WSR 20-12-072, § 246-945-017, filed
6/1/20, effective 7/1/20.]
WAC 246-945-018 Prescriptions—Labeling—Prepackage medications.

Prepackage medications dispensed pursuant to RCW 70.41.480, medica-
tions dispensed in unit dose form, medications dispensed by a pharmacy
to a long-term care facility must include a label with the following
information:
(1) Drug name;
(2) Drug strength;
(3) Expiration date in accordance with WAC 246-945-016(3);
(4) The manufacturer's name and lot number, if not maintained in
a separate record; and
(5) The identity of the pharmacist or provider responsible for
the prepackaging, if not maintained in a separate record.

18.64.044, 18.64.045, 18.64.046, 18.64.370, 18.64.460, 69.50.310,
18.64.011, 18.64.245, 18.64.470, 18.64.255, 18.64.205, 18.64.253,
18.64.410, 18.64.500, 18.64.590. WSR 20-12-072, § 246-945-018, filed
6/1/20, effective 7/1/20.]
WAC 246-945-020 Records retention period and commission access

to records. (1) Unless an alternative standard for a specified record
type, form, or format is expressly stated a pharmaceutical firm must
maintain and retain records required as evidence of compliance with
statutes and rules enforced by the commission in a readily retrievable
form and location for at least two years from the date the record was
created or received, whichever date is later.
(2) A pharmaceutical firm must allow the commission, or its des-
ignee, access to the pharmaceutical firm's records upon request for
the purposes of monitoring compliance with statutes and rules enforced
by the commission.

18.64.044, 18.64.045, 18.64.046, 18.64.370, 18.64.460, 69.50.310,
18.64.011, 18.64.245, 18.64.470, 18.64.255, 18.64.205, 18.64.253,
18.64.410, 18.64.500, 18.64.590. WSR 20-12-072, § 246-945-020, filed
6/1/20, effective 7/1/20.]

WAC 246-945-025 Prescription drug price advertising. (1) A
pharmacy may advertise legend or prescription drug prices provided:
(a) The advertising complies with all state and federal laws, in-
cluding regulations of the FDA and the Washington State Consumer Pro-
tection Act, chapter 19.86 RCW.
(b) The advertising is solely directed towards providing consum-
ers with drug price information and does not promote the use of a pre-
scription drug or drugs to the public.
(c) The drug price advertising shall contain all the following
information for all drug products or brand names used in the adver-
tisement:
(i) The proprietary name of the drug product advertised, if any;
(ii) The generic name of the drug product advertised, if any;
(iii) The strength of the drug product advertised. If the drug
product advertised contains more than one active ingredient and a rel-
evant strength can be associated with it without indicating each ac-
tive ingredient, the generic name and quantity of each active ingredi-
ent is not required; and
(iv) The price charged for a specified quantity of the drug prod-
uct.
(2) Advertising of any generic drug that in any way compares a
generic drug to a brand name drug may not in any manner imply that the
brand name drug is the product offered for sale.
(3) A person, partnership, corporation, association, or agency
may not advertise controlled substances for sale to the general public
in any manner that promotes or tends to promote the use or abuse of
those drugs. Controlled substances may not be physically displayed to
the public.
(4) Upon request from the patient, no pharmacy shall refuse to
disclose the cost to the specific patient of a prescription drug with-
out third-party reimbursement or discounts.

18.64.044, 18.64.045, 18.64.046, 18.64.370, 18.64.460, 69.50.310,
18.64.011, 18.64.245, 18.64.470, 18.64.255, 18.64.205, 18.64.253,
18.64.410, 18.64.500, 18.64.590. WSR 20-12-072, § 246-945-025, filed
6/1/20, effective 7/1/20.]
Subpart C - Legend Drugs and Controlled Substances
WAC 246-945-030 Identification of legend drugs for purposes of

chapter 69.41 RCW. (1) Those drugs determined by the FDA to require a
prescription under federal law should be classified as legend drugs
under state law because their toxicity, potential for harmful effect,
methods of use, or collateral measures necessary to their use indicate
they are only safe for use under the supervision of a practitioner.
(2) The commission finds that under state law, legend drugs are
those drugs designated as legend drugs under federal law, as of the
date of adoption of this rule, and listed in at least one of the fol-
lowing publications:
(a) The 39th Edition, including supplements, of the Approved Drug
Products with Therapeutic Equivalence Evaluations "Orange Book"
(available at https://www.fda.gov/drugs/drug-approvals-and-databases/
approved-drug-products-therapeutic-equivalence-evaluations-orange-
book).

(b) The 2019 version, including monthly updates, of the Approved
Animal Drug Products "Green Book" (available at https://www.fda.gov/
animal-veterinary/products/approved-animal-drug-products-green-book).
(c) The 2019 List of Licensed Biological Products with Reference
Product Exclusivity and Biosimilarity or Interchangeability Evalua
tions "Purple Book" (available at https://www.fda.gov/drugs/
therapeutic-biologics-applications-bla/purple-book-lists-licensed-
biological-products-reference-product-exclusivity-and-biosimilarity-
or).
(3) Copies of the reference material listed in subsection (2) of
this section are available for public inspection at the commission's
office at Department of Health, Town Center 2, 111 Israel Road S.E.,
Tumwater, WA 98501.
(4) The commission also identifies those ephedrine products
specified in WAC 246-945-031 as legend drugs under state law.
(5) There may be changes in the marketing status of drugs after
the publication of the above references. Upon application of a manu-
facturer or distributor, the commission may grant authority for the
over-the-counter distribution of certain drugs designated as legend
drugs in these references. These determinations will be made after
public hearing and will be published as an amendment to this chapter.

18.64.044, 18.64.045, 18.64.046, 18.64.370, 18.64.460, 69.50.310,
18.64.011, 18.64.245, 18.64.470, 18.64.255, 18.64.205, 18.64.253,
18.64.410, 18.64.500, 18.64.590. WSR 20-12-072, § 246-945-030, filed
6/1/20, effective 7/1/20.]
WAC 246-945-031 Ephedrine prescription restrictions. (1) The

commission, under RCW 69.41.075, identifies ephedrine, or any of its
salts in a solid or aqueous form normally intended for oral adminis-
tration, in any quantity, as a legend drug subject to the restrictions
of RCW 69.41.030.
(2) The following products containing ephedrine or its salts in
the amount of 25 mg. or less per solid dosage unit or per 5 ml. of
liquid forms in combination with other ingredients in therapeutic
amounts are exempt from subsection (1) of this section:
TRADE NAME EPHEDRINE CONTENT
1. AMESAC capsule 25 mg. ephedrine HCL
(Russ)
2. AZMA AID tablet 24 mg. ephedrine HCL
(Various, e.g., Purepac)
3. BRONC-EASE PLUS 25 mg. ephedrine HCL
(Natur-Pharma)
4. BRONCHODILATOR 25 mg. ephedrine HCL
AND EXPECTORANT
(PDK Labs)
5. BRONITIN tablet 24 mg. ephedrine HCL
(Whitehall)
6. BRONKAID tablet 24 mg. ephedrine sulfate
(Breon)
7. BRONKOLIXER 12 mg. ephedrine
(Sterling Winthrop)
8. BRONKOTABS tablet 24 mg. ephedrine sulfate
(Breon)
9. EFEDRON nasal jelly 0.6% ephedrine HCL in 20 g.
(Hyrex)
10. MINI THINS asthma relief 25 mg. ephedrine
(BDI Pharmaceuticals)

TRADE NAME EPHEDRINE CONTENT
11. PAZO HEMORRHOID 3.86 mg. ephedrine sulfate
suppository
(Bristol-Meyers)
12. PAZO HEMORRHOID 0.2% ephedrine sulfate
ointment
(Bristol-Meyers)
13. PRIMATENE tablet 24 mg. ephedrine HCL
(Whitehall)
14. PRIMATENE M tablet 24 mg. ephedrine HCL
(Whitehall)
15. PRIMATENE P tablet 24 mg. ephedrine HCL
(Whitehall)
16. QUELIDRINE 5 mg. ephedrine HCL
(Abbott)
17. TEDRAL tablet 24 mg. ephedrine HCL
(Parke-Davis)
18. THEODRINE tablet 25 mg. ephedrine HCL
(Rugby)
19. VATRONOL nose drops 0.5% ephedrine sulfate
(Vicks Health Care)
(3) Ma Huang or other botanical products of genus ephedra used in

their natural state and containing 25 mg. or less of ephedrine per
recommended dosage as a preparation for human consumption are not leg-
end drugs for the purposes of this section.
(4) Any reformulation of listed products which increases the
ephedrine content to more than 25 mg. of ephedrine per solid dosage
unit or per 5 ml. of liquid forms shall negate the exemption. The man-
ufacturers of listed products shall notify the commission of any re-
formulation which increases the ephedrine content to more than 25 mg.
of ephedrine per solid dosage unit or per 5 ml. of liquid forms prior
to distributing that product in the state of Washington.
(5) Manufacturers of products containing 25 mg. or less of ephe-
drine per solid dosage unit or per 5 ml. of liquid forms in combina-
tion with other ingredients in therapeutic amounts may gain exemption
from subsection (1) of this section if, prior to the distributing of
any such product in the state of Washington, the manufacturer:
(a) Provides the commission with the formulation of any such
product;
(b) Provides the commission samples of all dosage forms in which
the product is to be marketed in the packaging in which the product is
to be marketed; and
(c) Receives the commission's approval to market such product.

18.64.044, 18.64.045, 18.64.046, 18.64.370, 18.64.460, 69.50.310,
18.64.011, 18.64.245, 18.64.470, 18.64.255, 18.64.205, 18.64.253,
18.64.410, 18.64.500, 18.64.590. WSR 20-12-072, § 246-945-031, filed
6/1/20, effective 7/1/20.]
WAC 246-945-032 Child-resistant containers. (1) All legend

drugs shall be dispensed in a child-resistant container as required by
federal law or regulation, including 16 C.F.R., Part 1700, unless:
(a) Authorization is received from the prescriber to dispense in
a container that is not child-resistant.
(b) Authorization is obtained from the patient or a representa-
tive of the patient to dispense in a container that is not child-re-
sistant.

(2) No pharmacist or pharmacy employee may designate themselves
as the patient's agent.

18.64.044, 18.64.045, 18.64.046, 18.64.370, 18.64.460, 69.50.310,
18.64.011, 18.64.245, 18.64.470, 18.64.255, 18.64.205, 18.64.253,
18.64.410, 18.64.500, 18.64.590. WSR 20-12-072, § 246-945-032, filed
6/1/20, effective 7/1/20.]
WAC 246-945-033 Over-the-counter drugs. Except as provided in

21 C.F.R. 206.1 et seq., no nonimprinted solid dosage form drug that
is intended for OTC sale may be distributed into or sold in the state
of Washington unless it has been found by the commission to be exempt
from the provisions of this chapter or has received an exemption from
the FDA pursuant to 21 C.F.R. 206.7.

18.64.044, 18.64.045, 18.64.046, 18.64.370, 18.64.460, 69.50.310,
18.64.011, 18.64.245, 18.64.470, 18.64.255, 18.64.205, 18.64.253,
18.64.410, 18.64.500, 18.64.590. WSR 20-12-072, § 246-945-033, filed
6/1/20, effective 7/1/20.]
WAC 246-945-035 Drug sample prohibitions. (1) Except as provi-

ded in subsection (2) of this section, a pharmacy shall not possess,
distribute or dispense legend drug samples.
(2) A pharmacy of a licensed hospital or health care entity which
receives and distributes drug samples at the request of an authorized
practitioner pursuant to RCW 69.45.050 may possess, distribute or dis-
pense legend drug samples.

18.64.044, 18.64.045, 18.64.046, 18.64.370, 18.64.460, 69.50.310,
18.64.011, 18.64.245, 18.64.470, 18.64.255, 18.64.205, 18.64.253,
18.64.410, 18.64.500, 18.64.590. WSR 20-12-072, § 246-945-035, filed
6/1/20, effective 7/1/20.]
WAC 246-945-037 Regulated steroids. The following drugs are

classified as steroids for the purposes of RCW 69.41.310. The drugs
designated shall include the following and any synthetic derivatives
or any isomer, ester, salt, or derivative of the following that act in
the same manner on the human body:
(1) Anabolicum;
(2) Anadrol;
(3) Anatrofin;
(4) Anavar;
(5) Androxon;
(6) Andriol;
(7) Android;
(8) Bolandiol;
(9) Bolasterone;
(10) Boldenone;
(11) Boldenone undecylenate;
(12) Bolenol;
(13) Bolfortan;

(14) Bolmantalate;
(15) Cheque;
(16) Chlorotestosterone;
(17) Clostebol;
(18) Deca Durabolin;
(19) Dehydrochlormethyl-testosterone;
(20) Delatestyl;
(21) Dianabol; and
(22) Dihydrolone.
18.64.044, 18.64.045, 18.64.046, 18.64.370, 18.64.460, 69.50.310,
18.64.011, 18.64.245, 18.64.470, 18.64.255, 18.64.205, 18.64.253,
18.64.410, 18.64.500, 18.64.590. WSR 20-12-072, § 246-945-037, filed
6/1/20, effective 7/1/20.]
WAC 246-945-038 Availability and identity of amygdalin. (1)

Amygdalin (laetrile) may be manufactured and distributed through in-
trastate commerce in Washington in accordance with all applicable
state laws and regulations.
(2) Amygdalin (laetrile) imported into the state of Washington
shall be imported in conformity with federal regulations or court de-
cisions.
(3) Under the direction of the commission batches of amygdalin
(laetrile) must be made with the costs for required testing, including
purity and potency, to be borne by the manufacturer and wholesale dis-
tributor. The manufacturer and wholesale distributor is responsible
for the quality of the drug product, in accordance with RCW 18.64.270.
18.64.044, 18.64.045, 18.64.046, 18.64.370, 18.64.460, 69.50.310,
18.64.011, 18.64.245, 18.64.470, 18.64.255, 18.64.205, 18.64.253,
18.64.410, 18.64.500, 18.64.590. WSR 20-12-072, § 246-945-038, filed
6/1/20, effective 7/1/20.]
WAC 246-945-040 Uniform Controlled Substance Act. (1) The com-

mission adopts 21 C.F.R. as its own. The following sections do not ap-
ply: Sec. 1301.13, Sec. 1301.33, Sec. 1301.35-.46, Sec. 1303, Sec.
1308.41-.45, and Sec. 1316.31-.67. Any inconsistencies between 21
C.F.R. Sec. 1300 through 1321 and this chapter should be resolved in
favor of this chapter. Nothing in this chapter applies to the produc-
tion, processing, distribution, or possession of marijuana as author-
ized and regulated by the Washington state liquor and cannabis board.
(2) Registration. A separate registration is required for each
place of business, as defined in 21 C.F.R. Sec. 1301.12, where con-
trolled substances are manufactured, distributed, or dispensed. Appli-
cation for registration must be made on forms supplied by the commis-
sion, and all requested information must be supplied unless the infor-
mation is not applicable, which must be indicated by the applicant. An
applicant for registration must hold the appropriate license provided
for in chapter 18.64 RCW.
(3) Recordkeeping and Inventory. Every registrant shall keep and
maintain inventory records required by 21 C.F.R. Sec. 1304.04. Regis-
trants are also required to keep a record of receipt and distribution
of controlled substances. Records shall include:

(a) Invoices, orders, receipts, or any other document regardless
of how titled, establishing the date, supplier, and quantity of drug
received, and the name of the drug;
(b) Distribution records, including invoices, or any other docu-
ment regardless of how titled from wholesalers, manufacturers, or any
other entity to which the substances were distributed and prescrip-
tions records for dispensers;
(c) In the event of a significant loss or theft, two copies of
DEA 106 (report of theft or loss of controlled substances) must be
transmitted to the federal authorities and a copy must be sent to the
commission;
(d) For transfers of controlled substances from one dispenser to
another, a record of the transfer must be made at the time of transfer
indicating the drug, quantity, date of transfer, who it was transfer-
red to, and from whom. Records must be retained by both the transferee
and the transferor. These transfers can only be made in emergencies
pursuant to 21 C.F.R. Sec. 1307.11.
(4) Credential holders and pharmaceutical firms shall maintain
records for Schedule II drugs separately from all other records.
(5) Credential holders and pharmaceutical firms may maintain re-
cords for Schedule III, IV, and V drugs either separately or in a form
that is readily retrievable from the business records of the regis-
trant.
(6) A federal order form is required for each distribution of a
Schedule I or II controlled substance. Credential holders and pharma-
ceutical firms must keep and make readily available these forms and
other records to the commission or its designee.

18.64.044, 18.64.045, 18.64.046, 18.64.370, 18.64.460, 69.50.310,
18.64.011, 18.64.245, 18.64.470, 18.64.255, 18.64.205, 18.64.253,
18.64.410, 18.64.500, 18.64.590. WSR 20-12-072, § 246-945-040, filed
6/1/20, effective 7/1/20.]
WAC 246-945-043 Designation of nonnarcotic stimulant drugs for

the purposes of RCW 69.50.402 (1)(c). The commission hereby designa-
tes, the following Schedule II controlled substances as nonnarcotic
stimulants for purposes of RCW 69.50.402 (1)(c):
(1) Amphetamine sulfate in any of its generic forms.
(2) Dextroamphetamine sulfate in any of its generic forms and un-
der the following brand names:
(a) Dexedrine (SKF);
(b) Dexedrine spansules (SKF).
(3) Dextroamphetamine HCL in any of its generic forms.
(4) Dextroamphetamine tannate in any of its generic forms.
(5) Methamphetamine HCL (Desoxyephedrine HCL) in any of its ge-
neric forms and under the following brand name: Desoxyn (Abbott).
(6) Amphetamine complex in any of its generic forms and under the
following brand names:
(a) Biphetamine 12 1/2 (Pennwalt);
(b) Biphetamine 20 (Pennwalt).
(7) Combined amphetamines sold under the following brand names:
Obetrol-10 and 20 (Obetrol).
(8) Phenmetrazine HCL in any of its generic forms and under the
following brand name: Preludin (Boehringer-Ingelheim).

(9) Methylphenidate HCL in any of its generic forms and under the
following brand name: Ritalin (Ciba).
(10) Lisdexamfetamine in any of its generic forms and under the
following brand name: Vyvanse.

18.64.044, 18.64.045, 18.64.046, 18.64.370, 18.64.460, 69.50.310,
18.64.011, 18.64.245, 18.64.470, 18.64.255, 18.64.205, 18.64.253,
18.64.410, 18.64.500, 18.64.590. WSR 20-12-072, § 246-945-043, filed
6/1/20, effective 7/1/20.]
WAC 246-945-045 Prescribing, dispensing, or administering of

Schedule II nonnarcotic stimulants. The Schedule II stimulants listed
in WAC 246-945-043 may be prescribed, dispensed, or administered to
patients for the following disease states or conditions:
(1) Disease states or conditions listed in RCW 69.50.402
(1)(c)(ii); and
(2) Moderate to severe binge eating disorder in adults.

18.64.044, 18.64.045, 18.64.046, 18.64.370, 18.64.460, 69.50.310,
18.64.011, 18.64.245, 18.64.470, 18.64.255, 18.64.205, 18.64.253,
18.64.410, 18.64.500, 18.64.590. WSR 20-12-072, § 246-945-045, filed
6/1/20, effective 7/1/20.]
WAC 246-945-047 Sodium pentobarbital registration disciplinary

action. In addition to any criminal or civil liabilities that may oc-
cur, the commission may deny, suspend, or revoke registration upon de-
termination that:
(1) The registration was procured through fraud or misrepresenta-
tion;
(2) The registrant or any agent or employee of the registrant has
violated any of the federal or state laws related to drugs, or has
violated any of the rules or regulations of the commission.
18.64.044, 18.64.045, 18.64.046, 18.64.370, 18.64.460, 69.50.310,
18.64.011, 18.64.245, 18.64.470, 18.64.255, 18.64.205, 18.64.253,
18.64.410, 18.64.500, 18.64.590. WSR 20-12-072, § 246-945-047, filed
6/1/20, effective 7/1/20.]
WAC 246-945-050 Commission authority to control. Pursuant to

the authority granted to the commission in RCW 69.50.201, the commis-
sion has considered the following factors with regards to each of the
substances listed in this chapter and in chapter 69.50 RCW:
(1) The actual or relative potential for abuse;
(2) The scientific evidence of its pharmacological effect, if
known;
(3) The state of current scientific knowledge regarding the sub-
stance;
(4) The history and current pattern of abuse;
(5) The scope, duration, and significance of abuse;
(6) The risk to the public health;

(7) The potential of the substance to produce psychic or psycho-
logical dependence liability; and
(8) Whether the substance is an immediate precursor of a sub-
stance already controlled under the Uniform Controlled Substances Act
(chapter 69.50 RCW).

18.64.044, 18.64.045, 18.64.046, 18.64.370, 18.64.460, 69.50.310,
18.64.011, 18.64.245, 18.64.470, 18.64.255, 18.64.205, 18.64.253,
18.64.410, 18.64.500, 18.64.590. WSR 20-12-072, § 246-945-050, filed
6/1/20, effective 7/1/20.]
WAC 246-945-051 Schedule I. The commission finds that the fol-

lowing substances have high potential for abuse and have no accepted
medical use in treatment in the United States or that they lack accep-
ted safety for use in treatment under medical supervision. In addition
to the substances scheduled in RCW 69.50.204 the commission places
each of the following controlled substances by whatever official name,
common or usual name, chemical name, or brand name in Schedule I.
(1) Opiates. Unless specifically exempted or unless listed in an-
other schedule, any of the following opiates, including their isomers,
esters, ethers, salts, and salts of isomers, esters, and ethers, when-
ever the existence of these isomers, esters, ethers, and salts is pos-
sible within the specific chemical designation:
(a) (N-(1-phenethylpiperidin-4-yl)-N-phenylacetamide); some other
names: Acetyl fentanyl;
(b) 3,4-Dichloro-N-[2-(dimethylamino)cyclohexyl]-N-methylbenza-
mide, its isomers, esters, ethers, salts, and salts of isomers, es-
ters, and ethers; some other names: U-47700;
(c) 3,4-dichloro-N-[(1-dimethylamino) cyclohexylmethyl]benzamide;
some other names: AH-7921;
(d) Dextrorphan;
(e) N-(1-phenethylpiperidin-4-yl)-N-phenylacrylamide, its iso-
mers, esters, ethers, salts, and salts of isomers, esters, and ethers;
some other names: Acryl fentanyl and acryloylfentanyl;
(f) N-(1-phenethylpiperidin-4-yl)-N-phenylbutyramide, its iso-
mers, esters, ethers, salts, and salts of isomers, esters, and ethers;
some other names: Butyryl fentanyl;
(g) N-(1-phenethylpiperidin-4-yl)-N-phenylfuran-2-carboxamide,
its isomers, esters, ethers, salts, and salts of isomers, esters, and
ethers; some other names: Furanyl fentanyl;
(h) N-(4-fluorophenyl)-N-(1-phenethylpiperidin-4-yl)isobutyra-
mide, its isomers, esters, ethers, salts, and salts of isomers, es-
ters, and ethers; some other names: 4-fluoroisobutyryl fentanyl and
para-fluoroisobutyryl fentanyl;
(i) N-[1-[2-hydroxy-2-(thiophen-2-yl)ethyl]piperidin-4-yl]-N-phe-
nylpropionamide, its isomers, esters, ethers, salts, and salts of iso-
mers, esters, and ethers; some other names: Beta-hydroxythiofentanyl;
and
(j) Propheptazine.
(2) Opium derivatives. Unless specifically exempted or unless
listed in another schedule, any of the following opium derivatives,
its salts, isomers, and salts of isomers, whenever the existence of
these salts, isomers, and salts of isomers is possible within the spe-
cific chemical designation: Methylhydromorphine.

(3) Hallucinogenic substances. Unless specifically exempted or
unless listed in another schedule, any material, compound, mixture, or
preparation which contains any quantity of the following hallucinogen-
ic substances, or which contains any of its salts, isomers, and salts
of isomers, whenever the existence of such salts, isomers, and salts
of isomers is possible within the specific chemical designation. For
purposes of this subsection only, the term "isomer" includes the opti-
cal, position, and geometric isomers:
(a) 1-(1,3-benzodioxol-5-yl)-2-(methylamino)butan-1-one; some
other names: Butylone and bk-MBDB;
(b) 1-(1,3-benzodioxol-5-yl)-2-(methylamino)pentan-1-one; some
other names: Pentylone and bk-MBDP;
(c) 2-(2,5-Dimethoxy-4-(n)-propylphenyl)ethanamine; some other
names: 2C-P;
(d) 2-(2,5-Dimethoxy-4-ethylphenyl)ethanamine; some other names:
2C-E;
(e) 2-(2,5-Dimethoxy-4-methylphenyl)ethanamine; some other names:
2C-D;
(f) 2-(2,5-Dimethoxy-4-nitrophenyl)ethanamine; some other names:
2C-N;
(g) 2-(2,5-Dimethoxyphenyl)ethanamine; some other names: 2C-H;
(h) 2-(4-bromo-2,5-dimethoxyphenyl)-N-(2-methoxybenzyl)ethana-
mine; some other names: 25B-NBOMe and 2C-B-NBOMe;
(i) 2-(4-Chloro-2,5-dimethoxyphenyl)ethanamine; some other names:
2C-C;
(j) 2-(4-chloro-2,5-dimethoxyphenyl)-N-(2-methoxybenzyl)ethana-
mine; some other names: 25C-NBOMe and 2C-C-NBOMe;
(k) 2-(4-Iodo-2,5-dimethoxyphenyl)ethanamine; some other names:
2C-I;
(l) 2-(4-Iodo-2,5-dimethoxyphenyl)-N-(2-methoxybenzyl)ethanamine;
some other names: 25I-NBOMe and 2C-I-NBOMe;
(m) 2,5-dimethoxyamphetamine; some other names: 2,5-dimethoxy-al-
pha-methylphenethylamine and 2,5-DMA;
(n) 2-[4-(Ethylthio)-2,5-dimethoxyphenyl]ethanamine; some other
names: 2C-T-2;
(o) 2-[4-(Isopropylthio)-2,5-dimethoxyphenyl]ethanamine; some
other names: 2C-T-4;
(p) 3,4-Methylenedioxymethcathinone; some other names: Methylone;
(q) 3,4-methylenedioxy-N-ethylamphetamine; some other names: N-
ethyl-alpha-methyl-3,4(methylenedioxy)-phenethylamine, N-ethyl MDA,
MDE, and MDEA;
(r) 3,4-Methylenedioxypyrovalerone; some other names: MDPV;
(s) 4-bromo-2,5-dimethoxy-amphetamine: Some trade or other names:
4-bromo-2,5-dimethoxy-alpha-methylphenethylamine; some other names: 4-
bromo-2,5-DMA;
(t) 4-methoxyamphetamine; some other names: 4-methoxy-alpha-meth-
ylphenethylamine; paramethoxyamphetamine, PMA;
(u) 4-methyl-2,5-diamethoxyamphetamine;
(v) 4-methyl-2,5-dimethoxy-amphetamine; some other names: 4-meth-
yl-2,5-dimethoxy-alpha-methylphenethylamine; "DOM"; and "STP";
(w) 4-Methylmethcathinone; some other names: Mephedrone;
(x) 5-methoxy-N,N-dimethyltryptamine; some other names: 5-me-
thoxy-3-[2-(dimethylamino)ethyl]indole and 5-MeO-DMT;
(y) Alpha-ethyltryptamine; some other names: Etryptamine; monase;
a-ethyl-1H-indole-3-ethanamine; 3-(2-aminobutyl) indole; a-ET; and
AET;

(z) Beta-keto-N-Methylbenzodioxolylpropylamine; some other names:
bk-MBDB and Butylone;
(aa) Ethylamine analog of phencyclidine; some other names: N-eth-
yl-1phenylcyclohexalymine, (1-phenylcyclohexyl) ethylamine; N-(1-phe-
nylcyclohexyl)ethylamine; cyclohexamine; and PCE;
(bb) Ibogaine; some other names: 7-Ethyl-6,6 beta,7,8,9,10,12,13-
octahydro-2-methoxy-6,9-methano-5H-pyrido [1',2':1,2] azepino [5,4-b]
indole; and Tabernanthe iboga;
(cc) Marijuana Extract - Meaning an extract containing one or
more cannabinoids that has been derived from any plant of the genus
Cannabis, other than the separated resin (whether crude or purified)
obtained from the plant;
(dd) N-hydroxy-3,4-methylenedioxyamphetamine; some other names:
N-hydroxy-alpha-methyl-3,4(methylenedioxy)-phenethylamine; and N-hy-
droxy MDA;
(ee) Pyrrolidine analog of phencyclidine; some other names: 1-(1-
phenylcyclohexyl)pyrrolidine; PCPy; and PHP;
(ff) Thiophene analog of phencyclidine; some other names:
1-[1-(2-thienyl)-cyclohexyl]-pipendine; 2-thienylanalog of phencycli-
dine; TPCP; TCP.
(4) Stimulants. Unless specifically exempted or unless listed in
another schedule, any material, compound, mixture, or preparation
which contains any quantity of the following substances having a
stimulant effect on the central nervous system, including its salts,
isomers, and salts of isomers:
(a) Cathinone; also known as 2-amino-1-phenyl-1-propanone, alpha-
aminopropiophenone; 2-aminopropiophenone; and norephedrone;
(b) N,N-dimethylamphetamine; some other names: N,N-alpha-trimeth-
yl-benzeneethanamine; and N,N-alpha-trimethylphenethylene.
(5) Cannabimimetic agents and synthetic cannabinoids. Any of the
following synthetic cannabimimetics and cannabinoids, commonly known
as spice, their salts, isomers, and salts of isomers, unless specifi-
cally exempted or unless listed in another schedule, any material,
compound, mixture, or preparation which contains any quality of the
following substances, or which contains their salts, isomers, and
salts of isomers whenever the existence of such salts, isomers, and
salts of isomers is possible within the specific chemical designation:
(a) (1-pentyl-1H-indol-3-yl) (2,2,3,3-tetramethylcycloprop-
yl)methanone; some other names: UR-144;
(b) [1-(5-fluoropentyl)-1H-indazol-3-yl](naphthalen-1-yl)metha-
none, its optical, positional, and geometric isomers, salts, and salts
of isomers; some other names: THJ-2201;
(c) [1-(5-fluoro-pentyl)-1H-indol-3-yl](2,2,3,3-tetramethylcyclo-
propyl)methanone; some other names: 5-fluoro-UR-144 and XLR11;
(d) 1-(5-fluoropentyl)-3-(1-naphthoyl)indole; some other names:
AM2201;
(e) 1-(5-fluoropentyl)-3-(2-iodobenzoyl)indole; some other names:
AM694;
(f) 1-[2-(4-morpholinyl)ethyl]-3-(1-naphthoyl)indole; some other
names: JWH-200;
(g) 1-butyl-3-(1-naphthoyl)indole; some other names: JWH-073;
(h) 1-cyclohexylethyl-3-(2-methoxyphenylacetyl)indole; some other
names: SR-18 and RCS-8;
(i) 1-hexyl-3-(1-naphthoyl)indole; some other names: JWH-019;
(j) 1-pentyl-3-(1-naphthoyl)indole; some other names: JWH-018 and
AM678;

(k) 1-pentyl-3-(2-chlorophenylacetyl)indole; some other names:
JWH-203;
(l) 1-pentyl-3-(2-methoxyphenylacetyl)indole; some other names:
JWH-250;
(m) 1-pentyl-3-(4-chloro-1-naphthoyl)indole; some other names:
JWH-398;
(n) 1-pentyl-3-(4-methyl-1-naphthoyl)indole; some other names:
JWH-122;
(o) 1-pentyl-3-[(4-methoxy)-benzoyl]indole; some other names:
SR-19 and RCS-4;
(p) 1-pentyl-3-[1-(4-methoxynaphthoyl)]indole; some other names:
JWH-081;
(q) 5-(1,1-dimethylheptyl)-2-[(1R,3S)-3-hydroxycyclohexyl]-phe-
nol; some other names: CP-47,497;
(r) 5-(1,1-dimethyloctyl)-2-[(1R,3S)-3-hydroxycyclohexyl]-phenol;
some other names: Cannabicyclohexanol or CP-47,497 C8-homolog;
(s) Methyl 2-(1-(4-fluorobenzyl)-1H-indazole-3-carboxamido)-3,3-
dimethylbutanoate, its optical, positional, and geometric isomers,
salts, and salts of isomers; some other names: MDMB-FUBINACA;
(t) Methyl 2-(1-(5-fluoropentyl)-1H-indazole-3-carboxamido)-3,3-
salts, and salts of isomers; some other names: 5F-ADB; and 5F-MDMB-PI-
NACA;
(u) Methyl 2-(1-(5-fluoropentyl)-1H-indazole-3-carboxamido)-3-
methylbutanoate, its optical, positional, and geometric isomers,
salts, and salts of isomers; some other names: 5F-AMB;
(v) Methyl 2-(1-(cyclohexylmethyl)-1H-indole-3-carboxamido)-3,3-
salts, and salts of isomers; some other names: MDMB-CHMICA; and MMB-
CHMINACA;
(w) N-(1-adamantyl)-1-pentyl-1H-indazole-3-carboxamide; some oth-
er names: APINACA and AKB48;
(x) N-(1-amino-3,3-dimethyl-1-oxobutan-2-yl)-1-(4-fluoroben-
zyl)-1H-indazole-3-carboxamide, its optical, positional, and geometric
isomers, salts, and salts of isomers; some other names: ADB-FUBINACA;
(y) N-(1-amino-3,3-dimethyl-1-oxobutan-2-yl)-1-
(cyclohexylmethyl)-1H-indazole-3-carboxamide, its optical, positional,
and geometric isomers, salts, and salts of isomers; some other names:
MAB-CHMINACA; and ADB-CHMINACA;
(z) N-(1-amino-3,3-dimethyl-1-oxobutan-2-yl)-1-pentyl-1H-inda-
zole-3-carboxamide; some other names: ADB-PINACA;
(aa) N-(1-amino-3-methyl-1-oxobutan-2-yl)-1-(4-fluorobenzyl)-1H-
indazole-3-carboxamide; some other names: AB-FUBINACA;
(bb) N-(1-amino-3-methyl-1-oxobutan-2-yl)-1-
(cyclohexylmethyl)-1H-indazole-3-carboxamide, its optical, positional,
and geometric isomers, salts, and salts of isomers; some other names:
AB-CHMINACA;
(cc) N-(1-amino-3-methyl-1-oxobutan-2-yl)-1-pentyl-1H-indazole-3-
carboxamide, its optical, positional, and geometric isomers, salts,
and salts of isomers; some other names: AB-PINACA;
(dd) N-(adamantan-1-yl)-1-(5-fluoropentyl)-1H-indazole-3-carboxa-
mide, its optical, positional, and geometric isomers, salts, and salts
of isomers; some other names: 5F-APINACA; and 5F-AKB48;
(ee) Quinolin-8-yl 1-(5-fluoropentyl)-1H-indole-3-carboxylate;
some other names: 5-fluoro-PB-22; and 5F-PB-22;
(ff) Quinolin-8-yl 1-pentyl-1H-indole-3-carboxylate; some other
names: PB-22; and QUPIC.

(6) Synthetic cathinones, commonly known as bath salts, and its
derivatives. Unless specifically exempted or listed in another sched-
ule, any of the following synthetic cathinone and derivatives, their
salts, isomers, and salts of isomers, whenever the existence of these
salts, isomers, and salts of isomers is possible within the specific
designation:
(a) 1-(naphthalen-2-yl)-2-(pyrrolidin-1-yl)pentan-1-one; some
other names: Naphyrone;
(b) 2-(methylamino)-1-phenylpentan-1-one; some other names: Pen-
tedrone;
(c) 3-fluoro-N-methylcathinone; some other names: 3-FMC;
(d) 4-fluoro-N-methylcathinone; some other names: 4-FMC and fle-
phedrone;
(e) 4-methyl-alpha-pyrrolidinopropiophenone; some other names: 4-
MePPP;
(f) 4-methyl-N-ethylcathinone; some other names: 4-MEC;
(g) Alpha-pyrrolidinobutiophenone; some other names: Alpha-PBP;
(h) Alpha-pyrrolidinopentiophenone; some other names: Alpha-PVP;
(i) N-Ethylpentylone, its optical, positional, and geometric iso-
mers, salts, and salts of isomers; some other names: 1-(1,3-benzodiox-
ol-5-yl)-2-(ethylamino)-pentan-1-one).

18.64.044, 18.64.045, 18.64.046, 18.64.370, 18.64.460, 69.50.310,
18.64.011, 18.64.245, 18.64.470, 18.64.255, 18.64.205, 18.64.253,
18.64.410, 18.64.500, 18.64.590. WSR 20-12-072, § 246-945-051, filed
6/1/20, effective 7/1/20.]
Reviser's note: The brackets and enclosed material in the text of the above section occurred in
the copy filed by the agency.
WAC 246-945-052 Schedule II. The commission finds that the fol-
lowing substances have a high potential for abuse and have currently
accepted medical use in treatment in the United States, or currently
accepted medical use with severe restrictions and that the abuse of
the following substances may lead to severe psychic or psychological
dependence. In addition to the substances listed in RCW 69.50.206, the
commission places each of the following drugs and other substances by
whatever official name, common or usual name, chemical name, or brand
name in Schedule II.
(1) Coca leaves and any salt, compound, derivative, or prepara-
tion of coca leaves (including cocaine and ecgonine and their salts,
isomers, derivatives and salts of isomers and derivatives), and any
salt, compound, derivative, or preparation thereof which is chemically
equivalent or identical with any of these substances, but not includ-
ing:
(a) Decocainized coca leaves or extractions which do not contain
cocaine or ecgonine; or
(b)[123I]ioflupane.
(2) Opiates. Unless specifically exempted or unless in another
schedule any of the following opiates, including its isomers, esters,
ethers, salts, and salts of isomers, esters and ethers whenever the
existence of such isomers, esters, ethers, and salts is possible with-
in the specific chemical designation, dextrorphan and levopropoxyphene
exempted: Thiafentanil.
(3) Hallucinogenic substances.

(a) Dronabinol[(-)-delta-9-trans tetrahydrocannabinol] in an oral
solution in a drug product approved for marketing by the U.S. Food and
Drug Administration;
(b) Nabilone; some other names: (±)-trans-3-(1,1-dimethlhep-
tyl)-6,6a,7,8,10,10a-hexahydro-1-hydroxy-6,6-dimethyl-9H-diben-
zol[b,d]pyran-9-one.
(4) Immediate precursors. Unless specifically exempted or unless
listed in another schedule, any material, compound, mixture, or prepa-
ration which contains any quantity of the following substances: Imme-
diate precursor to fentanyl: 4-anilino-N-phenethyl-4-piperidine
(ANPP).

18.64.044, 18.64.045, 18.64.046, 18.64.370, 18.64.460, 69.50.310,
18.64.011, 18.64.245, 18.64.470, 18.64.255, 18.64.205, 18.64.253,
18.64.410, 18.64.500, 18.64.590. WSR 20-12-072, § 246-945-052, filed
6/1/20, effective 7/1/20.]
WAC 246-945-053 Schedule II immediate precursors. The commis-

sion finds and designates the following substances as being the prin-
cipal compound used or produced primarily for use and which are an im-
mediate chemical intermediary used or likely to be used, in the manu-
facture of a Schedule II controlled substance, the control of which is
necessary to prevent, curtail or limit manufacture.
(1) Unless specifically exempted or listed in another schedule,
any material, compound, mixture or preparation which contains any
quantity of the following substances or their salts or isomers having
potential for abuse associated with the preparation of controlled sub-
stances shall be a Schedule II controlled substance.
(a) Anthranilic acid;
(b) Ephedrine;
(c) Hydriodic acid;
(d) Methylamine;
(e) Phenylacetic acid;
(f) Pseudoephedrine;
(g) Methephedrine;
(h) Lead acetate; and
(i) Methyl formamide.
(2) Any drug or compound containing ephedrine, or any of its
salts or isomers, or pseudoephedrine, or any of its salts or isomers
that are prepared for dispensing or over-the-counter distribution and
are in compliance with the Federal Food, Drug and Cosmetic Act and ap-
plicable regulations are not controlled substances for the purpose of
this section.
(3) Any cosmetic containing lead acetate that is distributed in
compliance with the Federal Food, Drug and Cosmetic Act and applicable
regulations are not controlled substances.

18.64.044, 18.64.045, 18.64.046, 18.64.370, 18.64.460, 69.50.310,
18.64.011, 18.64.245, 18.64.470, 18.64.255, 18.64.205, 18.64.253,
18.64.410, 18.64.500, 18.64.590. WSR 20-12-072, § 246-945-053, filed
6/1/20, effective 7/1/20.]

WAC 246-945-054 Schedule III. The commission finds that the
following substances have a potential for abuse less than the substan-
ces listed in Schedule I under RCW 69.50.204 and WAC 246-945-051 and
Schedule II under RCW 69.50.206 and WAC 246-945-052, and have current-
ly accepted medical use in treatment in the United States and that the
abuse of the substances may lead to moderate or low physical dependen-
cy or high psychological dependency. In addition to substances listed
in RCW 69.50.208, the commission places each of the following drugs
and other substances by whatever official name, common or usual name,
chemical name, or brand name in Schedule III.
(1) Depressants. Unless specifically exempted or unless listed in
which contains any quantity of the following substances having a de-
pressant effect on the central nervous system: Perampanel, and its
salts, isomers, and salts of isomers.
(2) Anabolic steroids. The term "anabolic steroid" means any drug
or hormonal substance, chemically and pharmacologically related to
testosterone, other than estrogens, progestins, and corticosteroids
that promotes muscle growth, and includes:
(a) 17alpha-methyl-3alpha,17beta-dihydroxy-5alpha-androstane;
(b) 17alpha-methyl-3beta,17beta-dihydroxy-5alpha-androstane;
(c) 17alpha-methyl-delta1-dihydrotestosterone (17beta-hy-
droxy-17alpha-methyl-5alpha-androst-1-en-3-one) some other names: '17-
alpha-methyl-1-testosterone';
(d) 19-nor-4,9(10)-androstadienedione (estra-4,9(10)-dine-3,17-
dione);
(e) Norandrostenediol:
(i) 19-nor-4-androstenediol (3alpha, 17beta-dihydroxyestr-4-ene);
(ii) 19-nor-4-androstenediol (3beta, 17beta-dihydroxyestr-4-ene);
(iii) 19-nor-5-androstenediol (3beta, 17beta-dihydroxyestr-5-
ene);
(iv) 19-nor-5-androstenediol (3alpha, 17beta-dihydroxyestr-5-
ene).
(f) Norandrostenedione:
(i) 19-nor-4-androstenedione (estr-4-en-3,17-dione);
(ii) 9-nor-5-androstenedione (estr-5-en-3,17-dione).
(g) Androstanediol:
(i) 3alpha,17beta-dihydroxy-5alpha-androstane;
(ii) 3beta,17beta-dihydroxy-5alpha-androstane.
(h) Boldione (androsta-1,4-dine-3,17-dione);
(i) Desoxymethyltestosterone (17alpha-methyl-5alpha-androst-2-
en-17beta-ol); some other names: 'madol'.
(j) Mestanolone (17alpha-methyl-17beta-hydroxy-5alpha-andro-
stan-3-one);
(k) Methasterone (2alpha,17alpha-dimethyl-5alpha-androstan-17be-
ta-ol-3-one);
(l) Prostanozol (17beta-hydroxy-5alpha-androstano[3,2-c]pyra-
zole).
(m) Any salt, ester, or isomer of a drug or substance described
or listed in this paragraph, if that salt, ester, or isomer promotes
muscle growth. Except such term does not include an anabolic steroid
which is expressly intended for administration through implants to
cattle or other nonhuman species and which has been approved by the
secretary of health and human services for such administration. If any
person prescribes, dispenses, or distributes such steroid for human
use such person shall be considered to have prescribed, dispensed, or
distributed an anabolic steroid within the meaning of this subsection.

(3) Exempt anabolic steroid products. The following anabolic ste-
roid products in Table A of this subsection containing compounds, mix-
tures, or preparations are exempt from the recordkeeping, refill re-
strictions, and other Controlled Substances Act requirements:
Table A
Trade Name Company Form Ingredients Quantity
Andro-Estro 90-4 Rugby Laboratories, Vial Testosterone enanthate; 90 mg/mL;
Rockville Centre, NY Estradiol valerate 4 mg/mL
Androgyn L.A. Forest Pharmaceuticals, Vial Testosterone enanthate; 90 mg/mL;
St. Louis, MO Estradiol valerate 4 mg/mL
Component E-H in Ivy Laboratories, Inc., Pail or drum Testosterone propionate; 10 parts;
process granulation Overland Park, KS Estradiol benzoate 1 part
Component E-H in Ivy Laboratories, Inc., Pail Testosterone propionate; 25 mg/2.5 mg/
process pellets Overland Park, KS Estradiol benzoate pellet
Component TE-S in Ivy Laboratories, Inc., Pail or drum Trenbolone acetate; 5 parts;
process granulation Overland Park, KS Estradiol USP 1 part
Component TE-S in Ivy Laboratories, Inc., Pail Trenbolone acetate; 120 mg/24
process pellets Overland Park, KS Estradiol USP mg/pellet
depANDROGYN Forest Pharmaceuticals, Vial Testosterone cypionate; 50 mg/mL;
St. Louis, MO Estradiol cypionate 2 mg/mL
Depo-Testadiol The Upjohn Company, Vial Testosterone cypionate; 50 mg/mL;
Kalamazoo, MI Estradiol cypionate 2 mg/mL
depTESTROGEN Martica Pharmaceuticals, Vial Testosterone cypionate; 50 mg/mL;
Phoenix, AZ Estradiol cypionate 2 mg/mL
DEPTO-T.E. Quality Research Pharm., Vial Testosterone cypionate; 50 mg/mL;
Carmel, IN Estradiol cypionate 2 mg/mL
Duomone Wintec Pharmaceutical, Vial Testosterone enanthate; 90 mg/mL;
Pacific, MO Estradiol valerate 4 mg/mL
DUO-SPAN II Primedics Laboratories, Vial Testosterone cypionate; 50 mg/mL;
Gardena, CA Estradiol cypionate 2 mg/mL
DURATESTRIN W. E. Hauck, Vial Testosterone cypionate; 50 mg/mL;
Alpharetta, GA Estradiol cypionate 2 mg/mL
Essian Pharmaceutics International TB Esterified estrogens; 1.25 mg;
Inc., Methyltestosterone 2.5 mg
Hunt Valley, MD
Essian H.S. Pharmaceutics International TB Esterified estrogens; 0.625 mg;
Inc., Methyltestosterone 1.25 mg
Hunt Valley, MD
Esterified Estrogens and Interpharm, Inc. TB Esterified estrogens; 0.625 mg;
Methyltestosterone, USP Methyltestosterone 1.25 mg
(0.625 mg/1.25 mg)
Esterified Estrogens and Interpharm, Inc. TB Esterified estrogens; 1.25 mg;
Methyltestosterone, USP Methyltestosterone 2.5 mg
(1.25 mg/2.5 mg)
Esterified Estrogens/ ANDAPharm, LLC TB Esterified estrogens; 0.625 mg;
Methyltestosterone, (0.625 Methyltestosterone 1.25 mg
mg/1.25 mg) Tablet
Esterified Estrogens/ ANDAPharm, LLC TB Esterified estrogens; 1.25 mg;
Methyltestosterone, (1.25 Methyltestosterone 2.5 mg
mg/2.5 mg) Tablet
Estratest Solvay Pharmaceuticals, TB Esterified estrogens; 1.25 mg;
Marietta, GA Methyltestosterone 2.5 mg
Estratest H.S. Solvay Pharmaceuticals, TB Esterified estrogens; 0.625 mg;
Marietta, GA Methyltestosterone 1.25 mg

Masculinizing Feed for Rangen, Inc., Plastic Bags Methyltestosterone 60 mg/kg fish
Fish (Investigational) Buhl, ID feed
Menogen Sage Pharmaceuticals, TB Esterified estrogens; 1.25 mg;
Shreveport, LA Methyltestosterone 2.5 mg
Menogen H.S. Sage Pharmaceuticals, TB Esterified estrogens; 0.625 mg;
Shreveport, LA Methyltestosterone 1.25 mg
Methyltestosterone and Lannett Company, Inc. TB Esterified estrogens; 1.25 mg;
Esterified Estrogens (2.5 Methyltestosterone 2.5 mg
mg/1.25 mg)
Methyltestosterone and Lannett Company, Inc. TB Esterified estrogens; 0.625 mg;
Esterified Estrogens (Half Methyltestosterone 1.25 mg
Strength) (1.25 mg/0.625
mg)
PAN ESTRA TEST Pan American Labs; Vial Testosterone cypionate; 50 mg/mL;
Covington, LA Estradiol cypionate 2 mg/mL
Premarin with Ayerst Labs Inc., TB Conjugated estrogens; 0.625 mg;
Methyltestosterone New York, NY Methyltestosterone 5.0 mg
Premarin with Ayerst Labs Inc., TB Conjugated estrogens; 1.25 mg;
Methyltestosterone New York, NY Methyltestosterone 10.0 mg
Synovex H in-process Syntex Animal Health, Drum Testosterone propionate; 25 mg;
bulk pellets Palo Alto, CA Estradiol benzoate 2.5 mg/pellet
Synovex H in-process Syntex Animal Health, Drum Testosterone propionate; 10 parts;
granulation Palo Alto, CA Estradiol benzoate 1 part
Synovex Plus in-process Fort Dodge Animal Health, Drum Trenbolone acetate; 25 mg;
bulk pellets Fort Dodge, IA Estradiol benzoate 3.5 mg/pellet
Synovex Plus in-process Fort Dodge Animal Health, Drum Trenbolone acetate; 25 parts;
granulation Fort Dodge, IA Estradiol benzoate 3.5 parts
Syntest D.S. Syntho Pharmaceuticals, TB Esterified estrogens; 1.25 mg;
Inc. Methyltestosterone 2.5 mg
Syntest H.S. Syntho Pharmaceuticals, TB Esterified estrogens; 0.625 mg;
Inc. Methyltestosterone 1.25 mg
TEST-ESTRO Cypionates Rugby Laboratories, Vial Testosterone cypionate; 50 mg/mL;
Rockville Centre, NY Estradiol cypionate 2 mg/mL
Testoderm 4 mg/d Alza Corp., Patch Testosterone 10 mg
Palo Alto, CA
Testoderm 6 mg/d Alza Corp., Patch Testosterone 15 mg
Palo Alto, CA
Testoderm in-process film Alza Corp., Sheet Testosterone 0.25 mg/cm2
Palo Alto, CA
Testoderm with Adhesive Alza Corp., Patch Testosterone 10 mg
4 mg/d Palo Alto, CA
Testoderm with Adhesive Alza Corp., Patch Testosterone 15 mg
6 mg/d Palo Alto, CA
Testoderm with Adhesive Alza Corp., Sheet Testosterone 0.25 mg/cm2
in-process film Palo Alto, CA
Testosterone Cyp 50 I.D.E.-Interstate, Vial Testosterone cypionate; 50 mg/mL;
Estradiol Cyp 2 Amityville, NY Estradiol cypionate 2 mg/mL
Testosterone Cypionate/ Best Generics, Vial Testosterone cypionate; 50 mg/mL;
Estradiol Cypionate North Miami Beach, FL Estradiol cypionate 2 mg/mL
Injection
Testosterone Cypionate/ Goldline Labs, Vial Testosterone cypionate; 50 mg/mL;
Estradiol Cypionate Ft. Lauderdale, FL Estradiol cypionate 2 mg/mL
Injection

Testosterone Cypionate/ Schein Pharmaceuticals, Vial Testosterone cypionate; 50 mg/mL;
Estradiol Cypionate Port Washington, NY Estradiol cypionate 2 mg/mL
Injection
Testosterone Cypionate/ Steris Labs Inc., Vial Testosterone cypionate; 50 mg/mL;
Estradiol Cypionate Phoenix, AZ Estradiol cypionate 2 mg/mL
Injection

18.64.044, 18.64.045, 18.64.046, 18.64.370, 18.64.460, 69.50.310,
18.64.011, 18.64.245, 18.64.470, 18.64.255, 18.64.205, 18.64.253,
18.64.410, 18.64.500, 18.64.590. WSR 20-12-072, § 246-945-054, filed
6/1/20, effective 7/1/20.]
WAC 246-945-055 Schedule IV. The commission finds that the fol-
lowing substances have a low potential for abuse relative to substan-
ces in Schedule III under RCW 69.50.208 and WAC 246-945-054, and have
currently accepted medical use in treatment in the United States and
that the abuse of the substances may lead to limited physical depend-
ence or psychological dependence relative to the substances in Sched-
ule III. In addition to substances listed in RCW 69.50.210, the com-
mission places each of the following drugs and substances by whatever
official name, common or usual name, chemical name, or brand name in
Schedule IV.
(1) Narcotic drugs. Unless specifically exempted or unless listed
in another schedule, any material, compound, mixture, or preparation
containing any of the following narcotic drugs, or their salts calcu-
lated as the free anhydrous base or alkaloid, in limited quantities as
set in this subsection: 2-[(dimethylamino)methyl]-1-(3-methoxyphen-
yl)cyclohexanol, its salts, optical and geometric isomers, and salts
of these isomers (including tramadol).
(2) Depressants. Unless specifically exempted or unless listed in
which contains any quantity of the following substances, including its
salts, isomers, and salts of isomers whenever the existence of such
salts, isomers, and salts of isomers is possible within the specific
chemical designation:
(a) Alfaxalone;
(b) Fospropofol;
(c) Suvorexant.
(3) Any material, compound, mixture, or preparation which con-
tains any quantity of Lorcaserin, including its salts, isomers, and
salts of such isomers, wherever the existence of such salts, isomers,
and salts of isomers is possible.
(4) Stimulants. Unless specifically exempted or unless listed in
which contains any quantity of the following substances having a
stimulant effect on the central nervous system, including its salts,
isomers (whether optical, position, or geometric), and salts of such
isomers whenever the existence of such salts, isomers, and salts of
isomers is possible within the specific chemical designation:
(a) Cathine ((+) - norpseudoephedrine);
(b) SPA ((-)-1-dimethylamino-1,2-diphenylethane).

(5) Other substances. Unless specifically exempted or unless lis-
ted in another schedule, any material, compound, mixture, or prepara-
tion which contains any quantity of the following substances, includ-
ing its salts: Eluxadoline
(5-[[[
(2S)-2-amino-3-[4-aminocarbonyl)-2,6-dimethylphenyl]-1-oxopropyl][(1S)
-1-(4-phenyl-1H-imidazol-2-yl)ethyl]amino]methyl]-2-methoxybenzoic
acid) (including its optical isomers) and its salts, isomers, and
salts of isomers.
18.64.044, 18.64.045, 18.64.046, 18.64.370, 18.64.460, 69.50.310,
18.64.011, 18.64.245, 18.64.470, 18.64.255, 18.64.205, 18.64.253,
18.64.410, 18.64.500, 18.64.590. WSR 20-12-072, § 246-945-055, filed
6/1/20, effective 7/1/20.]
WAC 246-945-056 Schedule V. The commission finds that the fol-

lowing substances have low potential for abuse relative to substances
in Schedule IV under RCW 69.50.210 and WAC 246-945-055 and have cur-
rently accepted medical use in treatment in the United States and that
the substances have limited physical dependence or psychological de-
pendence liability relative to the substance in Schedule IV. In addi-
tion to the substances listed in RCW 69.50.212, the commission places
each of the following drugs and substances by whatever official name,
common or usual name, chemical name, or brand name in Schedule V.
Depressants. Unless specifically exempted or excluded or unless
listed in another schedule, any material, compound, mixture, or prepa-
ration which contains any quantity of the following substances having
a depressant effect on the central nervous system, including its
salts:
(1) Brivaracetam ((2S)-2-[(4R)-2-oxo-4-propylpyrrolidin-1-yl] bu-
tanamide); also referred to as BRV; UCB-34714; Briviact;
(2) Ezogabine [N-[2-amino-4-(4-fluorobenzylamino)-phenyl]-carba-
mic acid ethyl ester].
(3) Approved cannabidiol drugs. A drug product in finished dosage
formulation that has been approved by the U.S. Food and Drug Adminis-
tration that contains cannabidiol (2-[1R-3-methyl-6R-(1-methylethen-
yl)-2-cyclohexen-1-yl]-5-pentyl-1,3-benzenediol) derived from cannabis
and no more than 0.1 percent (w/w) residual tetrahydrocannabinols, al-
so known as Epidiolex.

18.64.044, 18.64.045, 18.64.046, 18.64.370, 18.64.460, 69.50.310,
18.64.011, 18.64.245, 18.64.470, 18.64.255, 18.64.205, 18.64.253,
18.64.410, 18.64.500, 18.64.590. WSR 20-12-072, § 246-945-056, filed
6/1/20, effective 7/1/20.]
WAC 246-945-060 Other controlled substance registrants—Require-

ments. (1) All persons and firms, except persons exempt from regis-
tration, must register with the commission in order to legally possess
or use controlled substances.

(2) Persons or firms which are not classified as pharmacies,
wholesalers, manufacturers, or researchers will be classified as other
controlled substance registrants. Examples of persons or firms in this
classification include analytical laboratories, dog handlers/trainers
who use dogs for drug detection purposes, school laboratories and oth-
er agencies which have a legitimate need to use precursor chemicals as
defined in WAC 246-945-053.
(3) The applicant for a controlled substance registration must
complete and return an application form supplied by the commission. A
list of the controlled substances to be used, the purpose for such
use, and the names of the persons authorized to access the controlled
substances must be listed on the application or on an addendum.
(4) All controlled substances must be stored in a substantially
constructed locked cabinet. The registrant shall maintain records in
sufficient detail in order to account for the receipt, use, and dispo-
sition of all controlled substances. The registrant shall inventory
all controlled substances in the possession of the registrant every
two years on the anniversary of the issuances of the registration and
shall maintain the inventory list for two years. The registrant shall
return unwanted, outdated, or unusable controlled substances to the
source from which it was obtained or surrendered to the DEA.

18.64.044, 18.64.045, 18.64.046, 18.64.370, 18.64.460, 69.50.310,
18.64.011, 18.64.245, 18.64.470, 18.64.255, 18.64.205, 18.64.253,
18.64.410, 18.64.500, 18.64.590. WSR 20-12-072, § 246-945-060, filed
6/1/20, effective 7/1/20.]
WAC 246-945-063 Precursor definitions. The definitions in this

section apply to WAC 246-945-065 through 246-945-088.
(1) "Registered product" means any nonprescription product con-
taining any detectable quantity of ephedrine, pseudoephedrine, and
phenylpropanolamine or their salts or isomers, or salts of isomers.
(2) "Retailer" means a pharmacy licensed by, or shopkeeper or
itinerant vendor registered with, the department of health under chap-
ter 18.64 RCW that sells, dispenses, or otherwise provides restricted
products to purchasers.
(3) "Sale" means the transfer, selling, or otherwise furnishing
of any restricted product to any person.
18.64.044, 18.64.045, 18.64.046, 18.64.370, 18.64.460, 69.50.310,
18.64.011, 18.64.245, 18.64.470, 18.64.255, 18.64.205, 18.64.253,
18.64.410, 18.64.500, 18.64.590. WSR 20-12-072, § 246-945-063, filed
6/1/20, effective 7/1/20.]
WAC 246-945-065 Precursor substance control. (1) For the pur-

pose of this chapter, in addition to the substances in RCW 69.43.010,
a precursor substance is any of the following substances or their
salts or isomers:
(a) Gamma-butyrolactone (GBL); and
(b) Hydriodic acid.
(2) A precursor substance defined in subsection (1) of this sec-
tion does not include any drug that contains ephedrine, phenylpropa-
nolamine, or pseudoephedrine or any cosmetic if that drug or cosmetic

can be lawfully sold, transferred, or furnished over-the-counter with-
out a prescription or by a prescription under chapter 69.04 or 69.41
RCW.

18.64.044, 18.64.045, 18.64.046, 18.64.370, 18.64.460, 69.50.310,
18.64.011, 18.64.245, 18.64.470, 18.64.255, 18.64.205, 18.64.253,
18.64.410, 18.64.500, 18.64.590. WSR 20-12-072, § 246-945-065, filed
6/1/20, effective 7/1/20.]
WAC 246-945-070 Reports of precursor receipt. (1) Any manufac-

turer, wholesaler, retailer, or any other person who receives from any
source outside the state of Washington any precursor substance listed
in WAC 246-945-065 or RCW 69.43.010 shall submit a report of such
transaction within fourteen days of the receipt of that substance.
(2) The report shall contain the following information:
(a) Name of substance;
(b) Quantity received;
(c) Date received;
(d) Name and address of firm or person receiving substance; and
(e) Name and address of the source selling, transferring, or fur-
nishing the substance.
(3) The report shall be on a form approved by the commission. In
lieu of an approved form the commission will accept a copy of an in-
voice, packing list, or other shipping document which contains the in-
formation in subsection (2) of this section. Under this option pur-
chase price information appearing on the document can be deleted.

18.64.044, 18.64.045, 18.64.046, 18.64.370, 18.64.460, 69.50.310,
18.64.011, 18.64.245, 18.64.470, 18.64.255, 18.64.205, 18.64.253,
18.64.410, 18.64.500, 18.64.590. WSR 20-12-072, § 246-945-070, filed
6/1/20, effective 7/1/20.]
WAC 246-945-072 Precursor substance monthly reporting. (1) A

permit holder who regularly transfers the same precursor substance to
the same recipient may apply to the commission for authorization to
submit the report of said transactions on a monthly basis. Requests
for monthly reporting authorization must be received at the commission
office at least thirty days prior to the commission meeting at which
the request will be considered. The commission will review each re-
quest to determine if the requirements of RCW 69.43.010(4), are met
and will notify the permit holder of its decision and the reporting
format that will be authorized.
(2) A permit holder may also petition the commission to accept
the monthly report on a computer-generated basis. The report may be
furnished in hard copy, on commission-approved data storage methods or
by computer interface with a commission-operated computer. The permit
holder is responsible for the accuracy of the report and the prompt
correction of any data entry or transmission errors.
(3) The authorization to use monthly reports or computer-gener-
ated monthly reports may be rescinded at the commission's discretion
and with thirty days' notice.

18.64.044, 18.64.045, 18.64.046, 18.64.370, 18.64.460, 69.50.310,
18.64.011, 18.64.245, 18.64.470, 18.64.255, 18.64.205, 18.64.253,
18.64.410, 18.64.500, 18.64.590. WSR 20-12-072, § 246-945-072, filed
6/1/20, effective 7/1/20.]
WAC 246-945-075 Suspicious transactions and reporting require-

ments. (1) A manufacturer, wholesaler or distributor who sells,
transfers, or furnishes a regulated product to any licensee shall re-
port any suspicious transaction in writing to the commission.
(2) For the purpose of this rule, a regulated product is defined
as a product specified in RCW 69.43.010(1) or WAC 246-945-065.
(3) For the purposes of this rule, a "suspicious transaction" is
defined as any sale or transfer that meets any of the following crite-
ria:
(a) Any sale or transfer that would lead a reasonable person to
believe that the substance is likely to be used for the purpose of un-
lawfully manufacturing a controlled substance under chapter 69.50 RCW,
based on such factors as:
(i) The amount of the substance involved;
(ii) The method of payment;
(iii) The method of delivery; or
(iv) Any past dealings with any participant in the transaction.
(b) Any sale or transfer involving payment for a regulated prod-
uct in cash or money orders in a total amount of more than two hundred
dollars.
(c) Any sale or transfer of a regulated product that meets the
criteria identifying suspicious orders in the U.S. Department of Jus-
tice, Drug Enforcement Administration, Diversion Control Program Re-
port of the Suspicious Orders Task Force. Copies of the publication
are available upon request from the commission.
(d) Any individual sale or transfer of a regulated product that
exceeds ten percent of the nonprescription drugs contained in the or-
der.
(e) Any order which contains regulated products and has no addi-
tional nonprescription drugs is considered a suspicious transaction.
(4) The written report of a suspicious transaction shall contain,
at a minimum, the following information:
(a) Name, address, and phone number of the manufacturer and/or
wholesaler making the report;
(b) Washington state license number of the wholesaler;
(c) Washington state unified business identifier (UBI) number of
the recipient of the suspicious transaction;
(d) Trade/brand name of regulated product;
(e) Generic name of regulated product's active ingredients;
(f) Name, address and phone number of the recipient of the suspi-
cious transaction;
(g) Quantity of substance purchased, transferred, or furnished,
by number of units and doses per unit;
(h) Date of purchase or transfer;
(i) Method of payment of the substance;
(j) Lot number if available; and
(k) National Drug Code number if available.

18.64.044, 18.64.045, 18.64.046, 18.64.370, 18.64.460, 69.50.310,
18.64.011, 18.64.245, 18.64.470, 18.64.255, 18.64.205, 18.64.253,
18.64.410, 18.64.500, 18.64.590. WSR 20-12-072, § 246-945-075, filed
6/1/20, effective 7/1/20.]
WAC 246-945-077 Precursor substance requirements for the sale of

a restricted product. Unless exempted in RCW 69.43.110, a retailer
must:
(1) Verify the purchaser's identity by means of acceptable iden-
tification as defined in this chapter;
(2) Ensure that the purchaser is at least eighteen years of age;
and
(3) Record all of the information required in WAC 246-945-078 in
the record of transaction before completing the sale.
18.64.044, 18.64.045, 18.64.046, 18.64.370, 18.64.460, 69.50.310,
18.64.011, 18.64.245, 18.64.470, 18.64.255, 18.64.205, 18.64.253,
18.64.410, 18.64.500, 18.64.590. WSR 20-12-072, § 246-945-077, filed
6/1/20, effective 7/1/20.]
WAC 246-945-078 Record of sales—Electronic methamphetamine pre-

cursor tracking. (1) Unless granted an exemption under RCW 69.43.110
upon the sale or attempted sale of a restricted product, each retailer
shall enter and electronically transmit the following information to
the methamphetamine precursor tracking system prior to completion of
the transaction:
(a) Sale transaction information including:
(i) Date and time of the intended purchase;
(ii) Product description;
(iii) Quantity of product to be sold including:
(A) Total grams of restricted product per box;
(B) Number of boxes per transaction.
(b) Purchaser's information including:
(i) Full name as it appears on the acceptable identification;
(ii) Date of birth;
(iii) The address as it appears on the photo identification or
the current address if the form of photo identification used does not
contain the purchaser's address. The address information must include
the house number, street, city, state, and zip code;
(iv) Form of photo identification presented by the purchaser, in-
cluding the issuing agency of the acceptable identification, and the
identification number appearing on the identification; and
(v) Purchaser's signature. If the retailer is not able to secure
an electronic signature, the retailer shall maintain a hard copy of a
signature logbook consisting of each purchaser's signature and the
transaction number provided by the methamphetamine precursor tracking
system.
(c) The full name or initials of the individual conducting the
transaction; and
(d) Other information as required by the methamphetamine precur-
sor tracking system database.

(2) If a transaction occurs during a time when the methampheta-
mine precursor tracking system is temporarily unavailable due to power
outage or other technical difficulties, the retailer shall record the
information required in this section in a written logbook for entry
into the methamphetamine precursor tracking system within seventy-two
hours of the system becoming operational.

18.64.044, 18.64.045, 18.64.046, 18.64.370, 18.64.460, 69.50.310,
18.64.011, 18.64.245, 18.64.470, 18.64.255, 18.64.205, 18.64.253,
18.64.410, 18.64.500, 18.64.590. WSR 20-12-072, § 246-945-078, filed
6/1/20, effective 7/1/20.]
WAC 246-945-080 Acceptable forms of identification. Acceptable

forms of identification are defined as current foreign, federal,
state, or tribal government-issued identification which include the
person's photograph, name, date of birth, signature, and physical de-
scription. Acceptable forms of identification include, but are not
limited to:
(1) A valid driver's license or instruction permit issued by any
U.S. state or foreign government. If the purchaser's driver's license
has expired, he or she must also show a valid temporary driver's li-
cense with the expired card.
(2) A United States Armed Forces identification card issued to
active duty, reserve, and retired personnel and the personnel's de-
pendents.
(3) A merchant marine identification card issued by the United
States Coast Guard.
(4) An identification card issued by any foreign, federal, or
state government.
(5) An official U.S. passport or an unexpired foreign passport
that contains a temporary I-551 stamp.
(6) An enrollment card issued by the governing authority of a
federally recognized Indian tribe located in Washington state, if the
enrollment card incorporates security features comparable to those im-
plemented by the department of licensing for Washington state drivers'
licenses.

18.64.044, 18.64.045, 18.64.046, 18.64.370, 18.64.460, 69.50.310,
18.64.011, 18.64.245, 18.64.470, 18.64.255, 18.64.205, 18.64.253,
18.64.410, 18.64.500, 18.64.590. WSR 20-12-072, § 246-945-080, filed
6/1/20, effective 7/1/20.]
WAC 246-945-085 Maintenance of and access to retail sales re-

cords of restricted products. (1) The retail sales records required
under WAC 246-945-078 are confidential and accessible by the commis-
sion and law enforcement agencies. Law enforcement may access the re-
tail sales records for criminal investigations when, at a minimum,
there is an articulated individualized suspicion of criminal activity.
(2) Each law enforcement agency's administrator, chief, sheriff,
or other chief executive officer shall ensure:
(a) Only authorized employees have access to the databases;
(b) Each employee use his or her unique password or access code
to access the databases;

(c) Each employee adheres to all state and federal laws regarding
confidentiality; and
(d) As employees change, new passwords or access codes are as-
signed to new employees and passwords of ex-employees or transferred
employees are removed.
(3) Retail sales records of restricted products, electronic or
written, must be kept for a minimum of two years.
(4) Retail sales records must be destroyed in a manner that
leaves the record unidentifiable and nonretrievable.
18.64.044, 18.64.045, 18.64.046, 18.64.370, 18.64.460, 69.50.310,
18.64.011, 18.64.245, 18.64.470, 18.64.255, 18.64.205, 18.64.253,
18.64.410, 18.64.500, 18.64.590. WSR 20-12-072, § 246-945-085, filed
6/1/20, effective 7/1/20.]
WAC 246-945-087 Exemptions from electronic reporting. (1) Phar-

macies are exempt from entering purchase information into the metham-
phetamine precursor tracking system when the sale of products contain-
ing ephedrine, pseudoephedrine, or phenylpropanolamine or their salts
or isomers, or salts of isomers is sold pursuant to a prescription
written by an authorized practitioner.
(2) A retailer must demonstrate "good cause" to qualify for an
exemption from electronic reporting requirements. "Good cause" in-
cludes, but is not limited to, situations where the installation of
the necessary equipment to access the methamphetamine precursor track-
ing system is unavailable or cost prohibitive to the retailer.
(a) A retailer must submit a written request on a form provided
by the commission, which shall include the following information:
(i) The reason for the exemption; and
(ii) The anticipated duration needed for the exemption.
(b) An exemption from electronic reporting may not exceed one
hundred eighty days.
(c) A retailer may request additional exemptions by submitting a
form defined in this subsection at least thirty days before the cur-
rent exemption expires. The retailer must show that compliance will
cause the business significant hardship.
(d) For all sales transactions involving the sale or attempted
sale of a restricted product occurring during the period of an exemp-
tion, the retailer shall record into a written logbook, at the time of
the sale or attempted sale, the information required under WAC
246-945-078(1).
(e) The written logbook of each sale or attempted sale shall be
available for inspection by any law enforcement officer or commission
inspector during normal business hours.

18.64.044, 18.64.045, 18.64.046, 18.64.370, 18.64.460, 69.50.310,
18.64.011, 18.64.245, 18.64.470, 18.64.255, 18.64.205, 18.64.253,
18.64.410, 18.64.500, 18.64.590. WSR 20-12-072, § 246-945-087, filed
6/1/20, effective 7/1/20.]
WAC 246-945-088 Denial of a sale—Override. (1) The retailer

must deny the sale of restricted product to purchasers who are not

able to produce acceptable identification or if the sale would violate
RCW 69.43.110 or federal law.
(2) In the event that the retailer perceives that refusal of the
purchase may place them in imminent physical harm, the retailer may
use the database safety override function to proceed with the sale,
provided that when the threat is no longer perceived, the retailer
must immediately contact local law enforcement to report the incident.

18.64.044, 18.64.045, 18.64.046, 18.64.370, 18.64.460, 69.50.310,
18.64.011, 18.64.245, 18.64.470, 18.64.255, 18.64.205, 18.64.253,
18.64.410, 18.64.500, 18.64.590. WSR 20-12-072, § 246-945-088, filed
6/1/20, effective 7/1/20.]
Subpart D – Home Dialysis
WAC 246-945-090 Home dialysis program—Legend drugs. Pursuant

to RCW 18.64.257 and 69.41.032, a medicare-approved dialysis center or
facility operating a medicare-approved home dialysis program may sell,
deliver, possess or dispense directly to its home dialysis patients in
cases or full shelf package lots, if prescribed by a physician, the
following legend drugs:
(1) Sterile heparin, 1000 u/mL, in vials;
(2) Sterile potassium chloride, 2 mEq/mL, for injection;
(3) Commercially available dialysate; and
(4) Sterile sodium chloride, 0.9%, for injection in containers of
not less than 150 mL.

18.64.044, 18.64.045, 18.64.046, 18.64.370, 18.64.460, 69.50.310,
18.64.011, 18.64.245, 18.64.470, 18.64.255, 18.64.205, 18.64.253,
18.64.410, 18.64.500, 18.64.590. WSR 20-12-072, § 246-945-090, filed
6/1/20, effective 7/1/20.]
WAC 246-945-091 Home dialysis program—Pharmacist consultant.

Home dialysis programs involved in the distribution of legend drugs as
permitted by RCW 18.64.257 and 69.41.032, shall have an agreement with
a pharmacist which provides for consultation as necessary. This shall
include advice on the drug distribution process to home dialysis pa-
tients and on the location used for storage and distribution of the
authorized drugs, which shall be reasonably separated from other ac-
tivities and shall be secure.

18.64.044, 18.64.045, 18.64.046, 18.64.370, 18.64.460, 69.50.310,
18.64.011, 18.64.245, 18.64.470, 18.64.255, 18.64.205, 18.64.253,
18.64.410, 18.64.500, 18.64.590. WSR 20-12-072, § 246-945-091, filed
6/1/20, effective 7/1/20.]
WAC 246-945-092 Home dialysis program—Records. (1) A record of

shipment shall be attached to the prescriber's order and shall in-
clude:

(a) The name of the patient;
(b) Strengths and quantities of drugs;
(c) The manufacturers' names;
(d) Date of shipment;
(e) Names of persons who selected, assembled and packaged for
shipment; and
(f) The name of the pharmacist or designated individual responsi-
ble for the distribution.
(2) Prescription and drug distribution records shall be main-
tained in accordance with WAC 246-945-020.
18.64.044, 18.64.045, 18.64.046, 18.64.370, 18.64.460, 69.50.310,
18.64.011, 18.64.245, 18.64.470, 18.64.255, 18.64.205, 18.64.253,
18.64.410, 18.64.500, 18.64.590. WSR 20-12-072, § 246-945-092, filed
6/1/20, effective 7/1/20.]
WAC 246-945-093 Home dialysis program—Quality assurance. Home

dialysis programs involved in the distribution of legend drugs as per-
mitted by RCW 18.64.257 and 69.41.032, shall develop a quality assur-
ance program for drug distribution and shall maintain records of drug
distribution errors and other problems, including loss due to damage
or theft.

18.64.044, 18.64.045, 18.64.046, 18.64.370, 18.64.460, 69.50.310,
18.64.011, 18.64.245, 18.64.470, 18.64.255, 18.64.205, 18.64.253,
18.64.410, 18.64.500, 18.64.590. WSR 20-12-072, § 246-945-093, filed
6/1/20, effective 7/1/20.]
Subpart E - Compounding
WAC 246-945-100 Compounding minimum standards. (1) All licen-

sees of the commission must comply, at a minimum, with the following
chapters of the United States Pharmacopeia (USP) when engaged in com-
pounding nonsterile and sterile products for patient administration or
distribution to a licensed practitioner for patient use or administra-
tion:
(a) USP General Chapter <795˃ Pharmaceutical Compounding - Non-
sterile Preparations;
(b) USP General Chapter <797˃ Pharmaceutical Compounding - Ster-
ile Preparations;
(c) USP General Chapter <800˃ Hazardous Drugs - Handling in
Healthcare Settings; and
(d) USP General Chapter <825˃ Radiopharmaceuticals - Preparation,
Compounding, Dispensing, and Repackaging.
(2) Copies of the USP General Chapters listed in subsection (1)
of this section are available for public inspection at the commis-
sion's office at Department of Health, Town Center 2, 111 Israel Road
S.E., Tumwater, WA 98501. Requestors may also contact USP directly to
obtain copies.

18.64.044, 18.64.045, 18.64.046, 18.64.370, 18.64.460, 69.50.310,
18.64.011, 18.64.245, 18.64.470, 18.64.255, 18.64.205, 18.64.253,
18.64.410, 18.64.500, 18.64.590. WSR 20-12-072, § 246-945-100, filed
6/1/20, effective 7/1/20.]
PART 2 – GENERAL LICENSING
WAC 246-945-145 License required. An individual providing phar-

macy services to individuals located in Washington is required to be
credentialed by the commission, unless the individual is providing
pharmacy services within the scope of their employment, or affilia-
tion, with a Washington licensed nonresident pharmacy or the law oth-
erwise permits the practice.

18.64.044, 18.64.045, 18.64.046, 18.64.370, 18.64.460, 69.50.310,
18.64.011, 18.64.245, 18.64.470, 18.64.255, 18.64.205, 18.64.253,
18.64.410, 18.64.500, 18.64.590. WSR 20-12-072, § 246-945-145, filed
6/1/20, effective 7/1/20.]
WAC 246-945-150 Applicable forms. All applications for initial

licensure and renewals must be submitted on forms provided by the com-
mission as well as any other required documentation.

18.64.044, 18.64.045, 18.64.046, 18.64.370, 18.64.460, 69.50.310,
18.64.011, 18.64.245, 18.64.470, 18.64.255, 18.64.205, 18.64.253,
18.64.410, 18.64.500, 18.64.590. WSR 20-12-072, § 246-945-150, filed
6/1/20, effective 7/1/20.]
Subpart A – Pharmacy Interns and Pharmacist
WAC 246-945-155 Pharmacy interns—Registration requirements.

(1) Unless otherwise stated, each individual shall register with the
commission, as a pharmacy intern before beginning pharmacy practice
experiences in Washington state. The commission shall grant a regis-
tration to practice pharmacy as a pharmacy intern to an individual who
is:
(a) Currently enrolled in a professional degree program of a com-
mission accredited school or college of pharmacy and making satisfac-
tory progress towards meeting the requirements for licensure as a
pharmacist;
(b) A graduate of a commission accredited school or college of
pharmacy;
(c) A graduate of a school or college of pharmacy located outside
the United States who has established educational equivalency by ob-
taining certification by FPGEC;
(d) Required by the commission to be an intern because the com-
mission has determined the individual needs to complete additional

practical experience before a pharmacist license is issued or reis-
sued; or
(e) An out-of-state pharmacist enrolled in or participating in an
established residency program.
(2) A pharmacy intern shall practice under the immediate supervi-
sion of a licensed pharmacist except in accordance with RCW 18.64.253.
(3) A pharmacy intern registration can only be renewed twice.
(4) The commission may consider a pharmacy intern registration
inoperable or superseded if one of the following occurs:
(a) A pharmacy intern has not graduated from and is no longer en-
rolled or in good standing with a commission accredited school or col-
lege of pharmacy.
(b) A pharmacy intern is issued a license to practice as a phar-
macist in Washington state or another U.S. jurisdiction.

18.64.044, 18.64.045, 18.64.046, 18.64.370, 18.64.460, 69.50.310,
18.64.011, 18.64.245, 18.64.470, 18.64.255, 18.64.205, 18.64.253,
18.64.410, 18.64.500, 18.64.590. WSR 20-12-072, § 246-945-155, filed
6/1/20, effective 7/1/20.]
WAC 246-945-156 Pharmacy intern—Temporary practice permit. (1)

An individual that holds a pharmacy intern registration in another U.S
jurisdiction, that has registration standards substantially equivalent
to Washington, may request a temporary practice permit if:
(a) The applicant is not subject to denial of a credential or is-
suance of a conditional or restricted credential in any state;
(b) Does not have a criminal record in Washington state;
(c) The applicant's fingerprint-based national background check
results are pending; and
(d) The applicant meets WAC 246-945-155 (1)(a) or (b).
(2) To request a temporary practice permit, the pharmacy intern
applicant shall submit a written request for a temporary practice per-
mit, and any applicable fees in accordance with chapter 246-907 WAC.
(3) A temporary practice permit expires:
(a) When the pharmacy intern registration is issued;
(b) When a notice of decision on the pharmacy intern registration
application is mailed to the applicant; or
(c) Ninety days after the temporary practice permit is issued.
The applicant may obtain a one-time extension of up to ninety days
with approval of the commission.
18.64.044, 18.64.045, 18.64.046, 18.64.370, 18.64.460, 69.50.310,
18.64.011, 18.64.245, 18.64.470, 18.64.255, 18.64.205, 18.64.253,
18.64.410, 18.64.500, 18.64.590. WSR 20-12-072, § 246-945-156, filed
6/1/20, effective 7/1/20.]
WAC 246-945-162 Pharmacist license qualifications. (1) In addi-

tion to the requirements in RCW 18.64.080, an applicant for a pharma-
cist license who holds a baccalaureate degree in pharmacy or a doctor
of pharmacy degree from a commission accredited school or college of
pharmacy shall submit documentation of education and practice experi-
ence as follows:

(a) An applicant who graduated before July 1, 2020, whose offi-
cial transcripts confer or award a baccalaureate of pharmacy or doc-
torate of pharmacy degree shall provide certification of at least fif-
teen hundred pharmacy internship hours in accordance with WAC
246-945-163.
(b) An applicant who graduates after July 1, 2020, whose official
transcripts confer or award a doctorate of pharmacy is deemed to have
satisfied the pharmacy practice experience and education requirements
for licensure without documentation of internship hours.
(2) An applicant for a pharmacist license whose academic training
in pharmacy is from institutions in foreign countries shall:
(a) Achieve certification by FPGEC including:
(i) Passing FPGEE;
(ii) Passing required TOEFL iBT;
(b) Provide official transcripts or diploma that shows a bacca-
laureate of pharmacy or doctorate of pharmacy degree is awarded or
conferred; and
(c) Certification of a minimum of fifteen hundred pharmacy in-
ternship hours in accordance with WAC 246-945-163.
(3) An applicant for a pharmacist license shall take and pass
pharmacist licensure examinations as defined in WAC 246-945-165.
(4) An applicant for a pharmacist license shall provide proof of
completion of seven hours of AIDS education as required in chapter
246-12 WAC, Part 8. The applicant is exempt from this requirement if
they are a graduate of a commission accredited school or college of
pharmacy because the curriculum satisfies this requirement.

18.64.044, 18.64.045, 18.64.046, 18.64.370, 18.64.460, 69.50.310,
18.64.011, 18.64.245, 18.64.470, 18.64.255, 18.64.205, 18.64.253,
18.64.410, 18.64.500, 18.64.590. WSR 20-12-072, § 246-945-162, filed
6/1/20, effective 7/1/20.]
WAC 246-945-163 Certification of internship hours. Hours repor-

ted to the commission under WAC 246-945-162, 246-945-173, and
246-945-175, shall occur as follows:
(1) Hours must be completed within eighteen months from the date
of graduation;
(2) From a commission accredited school or college of pharmacy,
U.S. jurisdiction board or commission or the supervising pharmacist at
the internship site;
(3) Hours shall be reported thirty days after the completion of
any internship experience;
(4) The documentation must include the supervising pharmacist's
evaluation and certification of internship hours, and an intern site
evaluation;
(5) If the report of hours submitted to the commission indicates
that the intern has not adequately performed the practice of pharmacy,
the commission may reject all or part of the hours reported.

18.64.044, 18.64.045, 18.64.046, 18.64.370, 18.64.460, 69.50.310,
18.64.011, 18.64.245, 18.64.470, 18.64.255, 18.64.205, 18.64.253,
18.64.410, 18.64.500, 18.64.590. WSR 20-12-072, § 246-945-163, filed
6/1/20, effective 7/1/20.]

WAC 246-945-165 Pharmacist licensure and jurisprudence examina-
tions. (1) Upon authorization by the commission or its designee, an
individual applying for a pharmacist license shall take and pass a
pharmacy licensure examination and jurisprudence examination approved
by the commission.
(2) A score of seventy-five or higher is required to pass each of
the examinations.
(3) An individual who fails the licensure examination or juris-
prudence examination three times shall not be authorized for further
examination until they have satisfactorily completed a study or tuto-
rial program approved by the commission.
(4) An applicant for a pharmacist license who has passed an ap-
proved licensure examination in another state may transfer their score
to Washington to meet the commission's requirement to take and pass a
commission approved pharmacy licensure examination if:
(a) The applicant meets the requirements in WAC 246-945-162; and
(b) The applicant completes the application process to receive a
pharmacist license before the score transfer expires. The score trans-
fer application will expire one year from the date the department re-
ceives the score transfer application.

18.64.044, 18.64.045, 18.64.046, 18.64.370, 18.64.460, 69.50.310,
18.64.011, 18.64.245, 18.64.470, 18.64.255, 18.64.205, 18.64.253,
18.64.410, 18.64.500, 18.64.590. WSR 20-12-072, § 246-945-165, filed
6/1/20, effective 7/1/20.]
WAC 246-945-170 Pharmacist licensure by license transfer—Tempo-

rary practice permits. (1) An individual who holds an active pharma-
cist license, in good standing, issued by another U.S. jurisdiction
may apply for a pharmacist license in Washington by license transfer.
In addition to the completion of the commission's application, the ap-
plicant must:
(a) File for license transfer using the NABP eLTP process; and
(b) Take and pass the approved jurisprudence examination.
(2) A temporary practice permit to practice pharmacy may be is-
sued to an applicant for a pharmacist license by license transfer if
the applicant meets all of the requirements and qualifications in sub-
section (1) of this section, and the following criteria are met:
(a) The applicant is not subject to denial of a credential or is-
suance of a conditional or restricted credential in any U.S. jurisdic-
tion;
(b) Does not have a criminal record in Washington state;
(c) The applicant's fingerprint-based national background check
results are pending; and
(d) To request a temporary practice permit, the applicant shall
submit a written request for a temporary practice permit, and pay the
applicable fees in accordance with chapter 246-907 WAC.
(3) A temporary practice permit expires:
(a) When the pharmacist license is issued;
(b) When a notice of decision on the pharmacist license applica-
tion is mailed to the applicant; or
(c) One hundred eighty days after the temporary practice permit
is issued. The applicant may obtain a one-time extension of one hun-
dred eighty days with approval of the commission.

(4) A temporary practice permit holder cannot qualify as a re-
sponsible pharmacy manager.

18.64.044, 18.64.045, 18.64.046, 18.64.370, 18.64.460, 69.50.310,
18.64.011, 18.64.245, 18.64.470, 18.64.255, 18.64.205, 18.64.253,
18.64.410, 18.64.500, 18.64.590. WSR 20-12-072, § 246-945-170, filed
6/1/20, effective 7/1/20.]
WAC 246-945-173 Expired pharmacist license. To return to active

status a pharmacist with an expired license shall pay the applicable
fees in accordance with chapter 246-907 WAC and:
(1) If the pharmacist license has been expired for less than
three years the pharmacist shall meet the requirements of chapter
246-12 WAC, Part 2 and fifteen CPE hours per year the license has been
expired.
(2) If the pharmacist license has been expired for three years or
more, and the pharmacist holds an active credential in another U.S.
jurisdiction, and is in good standing, the pharmacist shall:
(a) Meet the requirements in chapter 246-12 WAC, Part 2;
(b) Provide certification of an active pharmacist license which
includes:
(i) Name and license number;
(ii) Issue and expiration date; and
(iii) Verification that the license has not been the subject of
final or pending disciplinary action.
(c) Submit verification of current active pharmacy practice from
another U.S. jurisdiction; and
(d) Take and pass the commission approved jurisprudence examina-
tion.
(3) If a pharmacist license has been expired for three years or
more, and the pharmacist has not been in active practice in another
U.S. jurisdiction, the pharmacist shall:
(a) Meet the requirements of chapter 246-12 WAC, Part 2;
(b) Serve an internship of three hundred hours in compliance with
WAC 246-945-163; and
(c) Take and pass the commission approved jurisprudence and li-
censure examinations.

18.64.044, 18.64.045, 18.64.046, 18.64.370, 18.64.460, 69.50.310,
18.64.011, 18.64.245, 18.64.470, 18.64.255, 18.64.205, 18.64.253,
18.64.410, 18.64.500, 18.64.590. WSR 20-12-072, § 246-945-173, filed
6/1/20, effective 7/1/20.]
WAC 246-945-175 Inactive pharmacist license. (1) A pharmacist

may obtain an inactive license by meeting the requirements of WAC
246-12-090 and RCW 18.64.140.
(2) An inactive license can be renewed in accordance with chapter
246-907 WAC.
(3) If a license is inactive for three years or less, to return
to active status a pharmacist shall meet the requirements of chapter
246-12 WAC, Part 4.

(4) If a license is inactive for more than three years, and the
pharmacist has been in active practice in another U.S. jurisdiction,
to return to active status the pharmacist must:
(a) Provide certification of an active pharmacist license which
includes:
(i) Name and license number;
(ii) Issue and expiration date; and
(iii) Verification that the license has not been the subject of
final or pending disciplinary action.
(b) Submit verification of current active pharmacy from another
U.S. jurisdiction;
(c) Meet the requirements of chapter 246-12 WAC, Part 4; and
(d) Take and pass the commission approved jurisprudence examina-
tion.
(5) If a pharmacist license has been inactive for more than three
years, and the pharmacist has not been in active practice in another
U.S. jurisdiction, to return to active status, the pharmacist shall
comply with the requirements of WAC 246-945-173(3).

18.64.044, 18.64.045, 18.64.046, 18.64.370, 18.64.460, 69.50.310,
18.64.011, 18.64.245, 18.64.470, 18.64.255, 18.64.205, 18.64.253,
18.64.410, 18.64.500, 18.64.590. WSR 20-12-072, § 246-945-175, filed
6/1/20, effective 7/1/20.]
(Effective March 1, 2021)
WAC 246-945-178 Pharmacist continuing education. (1) As part of

the process to renew a pharmacist license, a pharmacist shall complete
CPE in compliance with this section.
(2) A pharmacist shall complete the equivalent of 3.0 of CPE
hours (equal to thirty contact hours) administered by an ACPE accredi-
ted provider each license renewal cycle.
(3) A pharmacist shall register with a program designated by the
commission for tracking completed CPE hours.
(4) A pharmacist shall complete a one-time training in suicide
screening and referral by the end of the first full renewal cycle af-
ter initial licensure. The training must meet the following require-
ments:
(a) Be at least three hours long;
(b) Be from the department of health's model list of approved
suicide prevention training programs, and include content related to
imminent harm via lethal means; and
(c) The hours spent completing the training in this subsection
may count toward meeting CPE requirements.
(5) CPE hours cannot be carried over to the next renewal cycle.

18.64.044, 18.64.045, 18.64.046, 18.64.370, 18.64.460, 69.50.310,
18.64.011, 18.64.245, 18.64.470, 18.64.255, 18.64.205, 18.64.253,
18.64.410, 18.64.500, 18.64.590. WSR 20-12-072, § 246-945-178, filed
6/1/20, effective 3/1/21.]
WAC 246-945-180 Nuclear pharmacist endorsement. To receive a

nuclear pharmacist endorsement, a pharmacist must:

(1) Be licensed to practice in Washington;
(2) Meet minimal standards of training and experience in the han-
dling of radioactive materials in accordance with WAC 246-240-075 and
submit to the commission proof of compliance; and
(3) Receive a letter of recognition as a nuclear pharmacist from
the commission.

18.64.044, 18.64.045, 18.64.046, 18.64.370, 18.64.460, 69.50.310,
18.64.011, 18.64.245, 18.64.470, 18.64.255, 18.64.205, 18.64.253,
18.64.410, 18.64.500, 18.64.590. WSR 20-12-072, § 246-945-180, filed
6/1/20, effective 7/1/20.]
Subpart B – Pharmacy Assistants and Technicians
WAC 246-945-200 Pharmacy assistants. (1) To become registered

as a pharmacy assistant an applicant shall submit an application to
the commission that meets the requirements of chapter 246-12 WAC, Part
2.
(2) An initial applicant shall complete four hours of AIDS educa-
tion as required in chapter 246-12 WAC, Part 8.
(3) The supervising pharmacist, shall instruct the pharmacy as-
sistant regarding their scope of practice.
(4) To renew a registration a pharmacy assistant shall submit an
application to the commission with the applicable fees in accordance
with chapter 246-907 WAC.
18.64.044, 18.64.045, 18.64.046, 18.64.370, 18.64.460, 69.50.310,
18.64.011, 18.64.245, 18.64.470, 18.64.255, 18.64.205, 18.64.253,
18.64.410, 18.64.500, 18.64.590. WSR 20-12-072, § 246-945-200, filed
6/1/20, effective 7/1/20.]
WAC 246-945-203 Pharmacy technician-in-training authority for

experiential training. (1) An individual who is enrolled in a commis-
sion-approved pharmacy-technician training program shall obtain an en-
dorsement for experiential training in a pharmacy for:
(a) Initial certification; or
(b) As required by the commission to complete additional practice
experience before a pharmacy technician certification is issued, re-
newed, or reactivated.
(2) An individual with a technician in training endorsement may
only work in that capacity at those sites identified on the applica-
tion.
(3) Before beginning the pharmacy-technician training program the
individual shall submit an application to the commission to become
certified as a pharmacy assistant. The application must include veri-
fication of enrollment in a commission-approved pharmacy-technician
education and training program.
(4) The commission may consider the pharmacy technician-in-train-
ing authority inoperable or superseded if one of the following occurs:
(a) A pharmacy technician certification is issued;
(b) A pharmacy technician-in-training is no longer enrolled or in
good standing with a commission-approved training program; or

(c) A pharmacy technician-in-training does not complete a train-
ing program within two years of entering a technician-in-training pro-
gram, unless otherwise authorized by the commission.

18.64.044, 18.64.045, 18.64.046, 18.64.370, 18.64.460, 69.50.310,
18.64.011, 18.64.245, 18.64.470, 18.64.255, 18.64.205, 18.64.253,
18.64.410, 18.64.500, 18.64.590. WSR 20-12-072, § 246-945-203, filed
6/1/20, effective 7/1/20.]
WAC 246-945-205 Pharmacy technician certification. (1) An ap-

plicant for a pharmacy technician certification shall be eighteen
years of age and hold a high school diploma or GED.
(2) To be issued a certification as a pharmacy technician an ap-
plicant shall meet the qualifications in RCW 18.64A.020, and:
(a) Provide proof of completion of eight hours of guided study of
Washington state and federal pharmacy law. The law study shall be done
in coordination and oversight of a Washington licensed pharmacist.
(b) Provide proof of four hours of AIDS education as required in
chapter 246-12 WAC, Part 8, the applicant is exempt if they have com-
pleted a commission-approved training program whose program materials
on file with the commission office document four hours of AIDS educa-
tion.
(c) Provide proof of successful completion of a commission-ap-
proved pharmacy-technician training program WAC 246-945-215. Accepta-
ble documentation includes:
(i) On-the-job training program. Successful completion of didac-
tic and practice experience signed by the program director on a form
provided by the commission; or
(ii) Formal academic or college programs. Official transcripts of
completion of a diploma or certificate program at a pharmacy techni-
cian school or a two-year associate degree program, which shall in-
clude evidence of practice training hours; or
(iii) Certificate of Release or Discharge from Active Duty, DD214
documenting evidence of pharmacy technician training provided by a
branch of the federal armed services.
(d) Pass a national certification examination approved by the
commission within one year of completing a commission-approved train-
ing program and applying for certification, unless otherwise author-
ized by the commission.
(3) An applicant who is a graduate of a foreign school, universi-
ty or college of pharmacy or medicine, whose professional degree pro-
gram is approved by the commission shall complete the following:
(a) If English is not the primary language, the applicant shall
take and pass TOEFL iBT;
(b) Complete five hundred twenty hours of supervised experience
under the supervision of a licensed pharmacist with training hours re-
ported using forms provided by the commission; and
(c) Pass a national certification examination approved by the
commission.
(4) An out-of-state pharmacy technician applicant must meet the
same requirements as a pharmacy technician trained in Washington
state.
18.64.044, 18.64.045, 18.64.046, 18.64.370, 18.64.460, 69.50.310,

18.64.011, 18.64.245, 18.64.470, 18.64.255, 18.64.205, 18.64.253,
18.64.410, 18.64.500, 18.64.590. WSR 20-12-072, § 246-945-205, filed
6/1/20, effective 7/1/20.]
WAC 246-945-210 Pharmacy technician—Temporary practice permit—

Military spouse eligibility and issuance. A military spouse or state
registered domestic partner of a member of the military may receive a
temporary practice permit while completing any specific additional re-
quirements that are not related to training or practice standards for
a pharmacy technician certification. The commission adopts the proce-
dural rules as adopted by the department of health in WAC 246-12-051.

18.64.044, 18.64.045, 18.64.046, 18.64.370, 18.64.460, 69.50.310,
18.64.011, 18.64.245, 18.64.470, 18.64.255, 18.64.205, 18.64.253,
18.64.410, 18.64.500, 18.64.590. WSR 20-12-072, § 246-945-210, filed
6/1/20, effective 7/1/20.]
WAC 246-945-215 Pharmacy technician education and training pro-

grams. A pharmacy technician-training program must meet the minimum
requirements of this section and be approved by the commission.
(1) A pharmacy technician-training program shall be considered
approved by the commission if it is accredited, approved, or adminis-
tered by:
(a) The American Society of Health-System Pharmacists (ASHP);
(b) The Accreditation Council for Pharmacy Education;
(c) Pharmacy Technician Certification Board; or
(d) The United States Armed Forces.
(2) A pharmacy technician education and training program not cov-
ered by subsection (1) of this section shall be considered meeting the
requirements of RCW 18.64A.020 and approved by the commission if it
meets the following minimum requirements:
(a) Prepare students for entry-level practice in a variety of
settings including, but not limited to, community, hospital, and long-
term care, this shall include:
(i) Orientation to pharmacy practice. Health care delivery sys-
tems, broad definitions of pharmacy practice and practice settings,
communication techniques, confidentiality of information and safety
considerations;
(ii) Basic pharmaceutics. Medical and pharmaceutical terminology
and abbreviations, components of a prescription and patient medication
record, drug dosage forms, routes of administration and drug product
packaging, weighing and measuring, labeling, drug nomenclature, asep-
tic techniques, drug storage and handling, and drug standard and in-
formation sources;
(iii) Federal and state regulations. A minimum of eight hours in
principles of applicable state and federal pharmacy laws, rules, regu-
lations, guidelines, and interpretive statements; and
(iv) Pharmaceutical calculations. Basic mathematics including:
Fractions, decimals, percentages, proportions, and weights and meas-
ures.
(b) Include a multicultural health curriculum as required by RCW
43.70.615.

(c) Have a pharmacist program director that is accountable for
the overall quality of the program.
(d) Include minimum hours of education and training that extends
over a period of fifteen weeks but under twenty-four months, and in-
cludes at a minimum:
(i) For vocational or technical training eight hundred hours
which includes one hundred sixty hours supervised practice experience.
(ii) For formal or academic training programs two academic quar-
ters with thirty credit hours each and includes one hundred sixty su-
pervised practice experience.
(iii) On-the-job training of at least five hundred twenty hours
with twelve hours of instructive education.
(3) To be approved by the commission a program must provide to
the commission:
(a) A complete application;
(b) The name of a designated licensed pharmacist as program di-
rector;
(c) A list or copies of training manuals and reference;
(d) Content of instruction;
(e) Methods for evaluating trainees; and
(f) Verification of eight hours of pharmacy law study.
(4) Except for programs listed in subsection (1) of this section,
a pharmacy technician-training program must renew every five years.
(5) Any substantive changes to the program or change in program
director must be reported to the commission within thirty calendar
days.

18.64.044, 18.64.045, 18.64.046, 18.64.370, 18.64.460, 69.50.310,
18.64.011, 18.64.245, 18.64.470, 18.64.255, 18.64.205, 18.64.253,
18.64.410, 18.64.500, 18.64.590. WSR 20-12-072, § 246-945-215, filed
6/1/20, effective 7/1/20.]
WAC 246-945-217 Expired pharmacy technician certification. To

return to active status a pharmacy technician with an expired certifi-
cation shall pay the applicable fees in accordance with chapter
246-907 WAC, and:
(1) If a pharmacy technician's certification has expired for five
years or less, the pharmacy technician shall meet the requirements of
chapter 246-12 WAC, Part 2.
(2) If the pharmacy technician's certification has expired for
over five years and they have not been in active practice in another
U.S. jurisdiction, the pharmacy technician shall:
(a) Complete the requirements for certification under WAC
246-945-205; and
(b) Meet the requirements of chapter 246-12 WAC, Part 2.
(3) If the pharmacy technician's certification has expired for
over five years and they have been in an active practice in another
U.S. jurisdiction with duties that are substantially equivalent to a
pharmacy technician in Washington state, the pharmacy technician
shall:
(a) Submit verification of current active pharmacy practice in
another U.S. jurisdiction; and
(b) Meet the requirements of chapter 246-12 WAC, Part 2.

18.64.044, 18.64.045, 18.64.046, 18.64.370, 18.64.460, 69.50.310,
18.64.011, 18.64.245, 18.64.470, 18.64.255, 18.64.205, 18.64.253,
18.64.410, 18.64.500, 18.64.590. WSR 20-12-072, § 246-945-217, filed
6/1/20, effective 7/1/20.]
(Effective March 1, 2021)
WAC 246-945-220 Pharmacy technician—Continuing education. (1)

As part of the process to renew a pharmacy technician license, a phar-
macy technician shall complete continuing pharmacy education (CPE) in
compliance with this section.
(2) A pharmacy technician shall complete 2.0 CPE hours (equal to
twenty contact hours) administered by an ACPE accredited program each
certification renewal period.
(3) A pharmacy technician shall register with a program designa-
ted by the commission for tracking completed CPE hours.
(4) CPE hours cannot be carried over to the next renewal cycle.

18.64.044, 18.64.045, 18.64.046, 18.64.370, 18.64.460, 69.50.310,
18.64.011, 18.64.245, 18.64.470, 18.64.255, 18.64.205, 18.64.253,
18.64.410, 18.64.500, 18.64.590. WSR 20-12-072, § 246-945-220, filed
6/1/20, effective 3/1/21.]
Subpart C – Pharmaceutical Firm Licensing
WAC 246-945-230 General information, change of location, owner-

ship or new construction. (1) The definitions in this subsection ap-
ply throughout WAC 246-945-230 through 246-945-247 unless otherwise
specified:
(a) "License" includes "licensing," "licensure," "certificate,"
"certification," and "registration."
(b) "Facility" includes pharmacies, nonresident pharmacies,
health care entities, hospital pharmacy associated clinics, wholesal-
ers, and manufacturers.
(2) The commission shall license a facility that:
(a) Submits a completed application for the license applied for
on forms provided by the commission;
(b) Pays the applicable fees in accordance with chapter 246-907
WAC. This fee will not be prorated under any circumstances;
(c) Undergoes an inspection by the commission if the facility is
located in Washington pursuant to WAC 246-945-005 that results in ei-
ther no deficiencies or an approved plan of correction; and
(d) Obtains a controlled substances registration from the commis-
sion and is registered with the DEA if the facility intends to possess
or distribute controlled substances.
(3) Once an initial license is issued, a licensed facility must:
(a) Notify the commission and pay a facility inspection fee in
lieu of paying an original license fee for modifications or remodels.
A modification or remodel of a pharmacy location includes changes to a
previously approved area, room or pharmacy building which result in

changes in the pharmacy that affects security, square footage, access
to drugs, compounding or necessitates temporary relocation of pharmacy
services.
(b) Submit a new application on forms provided by the commission
and pay the original license fee as established in chapter 246-907 WAC
if the facility changes location to a different address. If located in
Washington, a facility may not relocate prior to the inspection of the
new premises.
(c) Notify the commission and pay the original license fee in ac-
cordance with chapter 246-907 WAC whenever there is a change of owner-
ship. Change in ownership includes changes in business or organiza-
tional structure such as a change from sole proprietorship to a corpo-
ration, or a change of more than fifty percent ownership in a corpora-
tion.
(i) Upon receipt of a change of ownership application and fees,
the purchaser may begin operations prior to the issuance of a new
pharmacy license only when the purchaser and seller have a written
power of attorney agreement. This agreement shall delineate that vio-
lations during the pending application process shall be the sole re-
sponsibility of the seller.
(ii) This agreement shall be provided to the commission upon re-
quest.
(d) Notify the commission within thirty days of any changes to
the information provided on their application.
(e) Notify the commission of any changes in their responsible
pharmacy manager in accordance with WAC 246-945-480, if a responsible
pharmacy manager is required for initial licensure.
(f) Renew their license in accordance with chapter 246-907 WAC.
(4) A license is issued to a location and is not transferable.

18.64.044, 18.64.045, 18.64.046, 18.64.370, 18.64.460, 69.50.310,
18.64.011, 18.64.245, 18.64.470, 18.64.255, 18.64.205, 18.64.253,
18.64.410, 18.64.500, 18.64.590. WSR 20-12-072, § 246-945-230, filed
6/1/20, effective 7/1/20.]
WAC 246-945-232 Pharmacy licensing. The commission shall issue

a pharmacy license to an applicant that:
(1) Is in compliance with WAC 246-945-230;
(2) Has a designated responsible pharmacy manager; and
(3) If a pharmacy is new or remodeled, the applicant has provided
the commission evidence of being built or remodeled in accordance with
all building, health, and fire codes required for the particular area.

18.64.044, 18.64.045, 18.64.046, 18.64.370, 18.64.460, 69.50.310,
18.64.011, 18.64.245, 18.64.470, 18.64.255, 18.64.205, 18.64.253,
18.64.410, 18.64.500, 18.64.590. WSR 20-12-072, § 246-945-232, filed
6/1/20, effective 7/1/20.]
WAC 246-945-233 Hospital pharmacy associated clinics. (1) A pa-

rent hospital pharmacy may add or delete a hospital pharmacy associ-
ated clinic (HPAC) to a hospital pharmacy license at any time in com-
pliance with WAC 246-945-230 (2)(a), (b), and (d).

(2) The HPAC must designate a responsible pharmacy manager and
notify the commission of changes.
(3) HPAC locations are identified as follows:
(a) Category 1 HPAC: Receives drugs transferred from the parent
hospital pharmacy to the HPAC and does not perform sterile or nonster-
ile compounding of drugs.
(b) Category 2 HPAC: Receives drugs transferred from the parent
hospital pharmacy to the HPAC and performs sterile or nonsterile com-
pounding of drugs.
(4) A HPAC licensed under the parent hospital pharmacy license
must obtain a separate DEA registration in order to possess controlled
substances.
18.64.044, 18.64.045, 18.64.046, 18.64.370, 18.64.460, 69.50.310,
18.64.011, 18.64.245, 18.64.470, 18.64.255, 18.64.205, 18.64.253,
18.64.410, 18.64.500, 18.64.590. WSR 20-12-072, § 246-945-233, filed
6/1/20, effective 7/1/20.]
WAC 246-945-235 Nonresident pharmacy license. The commission

shall issue a nonresident pharmacy license to an applicant that:
(1) Provides all information required by RCW 18.64.360;
(2) Is in compliance with WAC 246-945-230;
(3) Has identified a responsible pharmacy manager, whose license
is in good standing in the U.S. jurisdiction in which they are loca-
ted; and
(4) Has provided to the commission proof that its resident li-
cense is in good standing.
18.64.044, 18.64.045, 18.64.046, 18.64.370, 18.64.460, 69.50.310,
18.64.011, 18.64.245, 18.64.470, 18.64.255, 18.64.205, 18.64.253,
18.64.410, 18.64.500, 18.64.590. WSR 20-12-072, § 246-945-235, filed
6/1/20, effective 7/1/20.]
WAC 246-945-245 Health care entity license. (1) The commission

shall issue a health care entity license to an applicant that:
(a) Is in compliance with WAC 246-945-230; and
(b) Has designated a responsible pharmacy manager.
(2) An organization (e.g., a clinic) must obtain a separate li-
cense for each of its locations. One organization occupying multiple
suites in one facility is deemed to be occupying one location requir-
ing one license. Separate organizations occupying the same location
must obtain separate licenses.

18.64.044, 18.64.045, 18.64.046, 18.64.370, 18.64.460, 69.50.310,
18.64.011, 18.64.245, 18.64.470, 18.64.255, 18.64.205, 18.64.253,
18.64.410, 18.64.500, 18.64.590. WSR 20-12-072, § 246-945-245, filed
6/1/20, effective 7/1/20.]
WAC 246-945-246 Wholesaler. (1) Every wholesaler who engages in

wholesale distribution into, out of, or within Washington state must
be licensed by the commission before engaging in wholesale distribu-

tion of drugs. Entities required to be licensed as a wholesaler in-
cludes:
(a) In-state and out-of-state pharmaceutical wholesalers;
(b) Out-of-state manufacturer that distribute or sell drugs into
Washington;
(c) Virtual wholesalers;
(d) Out-of-state virtual manufacturers that distribute or sell
drugs into Washington;
(e) Outsourcing facilities required to be registered with the FDA
as an outsourcing facility as defined in 21 U.S.C. Sec. 353b(d)(4)(A)
that are located in Washington, or distribute or sell drugs into Wash-
ington; and
(f) Reverse distributors.
(2) The commission may issue a wholesaler license to an applicant
that is in compliance with the requirements in WAC 246-945-230 and
this section.
section if the applicant is located outside of Washington, the appli-
cant must provide:
(a) A copy of a site inspection conducted by the regulatory au-
thority in the resident U.S. jurisdiction or third-party inspection
program recognized by the commission within the last two years and ev-
ery two years with the distributor's renewal;
(b) A copy of the resident state license; and
(c) A list of licenses, registrations, permits or certificates
held in other U.S. jurisdictions.
section if the applicant plans to export noncontrolled drugs to per-
sons in a foreign jurisdiction, the applicant must provide letters
from the consulate of the country to which the drugs are exported and
should verify consignee receiving such drugs is legally entitled in
that country to receive them, if applicable. These letters shall be
made available to the commission upon its request. The issuance of an
export wholesaler license does not authorize delivery of drugs in the
United States.
(5) Minimum qualifications. The commission shall consider, at a
minimum, the following factors in reviewing the qualifications of in-
dividuals who engage in wholesale distribution of prescription drugs
within the state:
(a) Any convictions of the applicant under any federal, state, or
local laws relating to drug samples, wholesale, or retail drug distri-
bution, or distribution of controlled substances;
(b) Any felony convictions of the applicant under federal, state,
or local laws;
(c) The applicant's past experience in the manufacture or distri-
bution of prescription drugs, including controlled substances;
(d) Any false or fraudulent material furnished by the applicant
on any application made in connection with drug manufacturing or dis-
tribution;
(e) Suspension or revocation by federal, state, or local govern-
ment of any license currently or previously held by the applicant for
the manufacture or distribution of any drugs, including controlled
substances;
(f) Compliance with licensing requirements under any previously
granted licenses;
(g) Compliance with requirements to maintain and make available
to the commission, federal, state, or local enforcement officials

those records required to be maintained by wholesale drug distribu-
tors; and
(h) Any other factors or qualifications the commission considers
relevant to and consistent with public health and safety.
(6) When operations are conducted at more than one location by a
single wholesale distributor, each location shall be licensed by the
commission.

18.64.044, 18.64.045, 18.64.046, 18.64.370, 18.64.460, 69.50.310,
18.64.011, 18.64.245, 18.64.470, 18.64.255, 18.64.205, 18.64.253,
18.64.410, 18.64.500, 18.64.590. WSR 20-12-072, § 246-945-246, filed
6/1/20, effective 7/1/20.]
WAC 246-945-247 Pharmaceutical manufacturer license. (1) An en-

tity located in Washington state that manufactures drugs must be li-
censed by the commission in accordance with the laws and regulations
of Washington state before engaging in manufacturing.
(2) The commission shall issue a manufacturer license to an ap-
plicant that is in compliance with the requirements in WAC
246-945-230.
(3) When operations are conducted at more than one location by a
single manufacturer, each location shall be licensed by the commis-
sion.
18.64.044, 18.64.045, 18.64.046, 18.64.370, 18.64.460, 69.50.310,
18.64.011, 18.64.245, 18.64.470, 18.64.255, 18.64.205, 18.64.253,
18.64.410, 18.64.500, 18.64.590. WSR 20-12-072, § 246-945-247, filed
6/1/20, effective 7/1/20.]
Subpart D – Commission Registrations
WAC 246-945-250 Researcher and other controlled substance regis-

tration. (1) Applicants for initial registration and renewal for re-
searcher or other controlled substance registrations shall submit to
the commission a complete application with fees relevant to the regis-
tration type.
(a) Researcher:
(i) Noncontrolled legend drugs; or
(ii) Researchers requiring to purchase, possess, administer or
dispense controlled substances shall apply for a controlled substance
authority on its license with the commission and register with the
DEA.
(b) Other controlled substance registrations:
(i) Opioid treatment programs;
(ii) Analytical laboratories;
(iii) Dog handler; and
(iv) Other agencies who have demonstrated a legitimate need to
use precursor chemicals.
(2) The application shall:
(a) List all legend drugs and controlled substances to be used
and the purpose for its use;
(b) Name the primary registrant; and

(c) List the names of the individuals authorized to access the
controlled substances.
(3) Applicants shall undergo an initial inspection and periodic
inspections as deemed appropriate by the commission.

18.64.044, 18.64.045, 18.64.046, 18.64.370, 18.64.460, 69.50.310,
18.64.011, 18.64.245, 18.64.470, 18.64.255, 18.64.205, 18.64.253,
18.64.410, 18.64.500, 18.64.590. WSR 20-12-072, § 246-945-250, filed
6/1/20, effective 7/1/20.]
WAC 246-945-253 Shopkeeper registration. (1) A shopkeeper reg-

istration is issued to a business license authorizing the holder to
purchase, possess, and sell over-the-counter medications as defined in
RCW 18.64.044 and chapter 69.43 RCW, if applicable.
(2) A business entity with a licensed pharmacy with different op-
erating hours shall hold a shopkeeper registration to acquire, pos-
sess, and sell over-the-counter medications when the pharmacy is
closed.

18.64.044, 18.64.045, 18.64.046, 18.64.370, 18.64.460, 69.50.310,
18.64.011, 18.64.245, 18.64.470, 18.64.255, 18.64.205, 18.64.253,
18.64.410, 18.64.500, 18.64.590. WSR 20-12-072, § 246-945-253, filed
6/1/20, effective 7/1/20.]
WAC 246-945-254 Animal control and humane society registration.

(1) Humane societies and animal control agencies registered with the
commission under RCW 69.50.310 may purchase, possess, and administer
sodium pentobarbital and approved legend drugs as provided in RCW
69.41.080.
(2) To apply for registration, a humane society or animal control
agency shall submit to the commission a completed application for reg-
istration on forms provided by the commission and undergo an initial
inspection.
(3) The registered agency shall designate an individual responsi-
ble for maintaining all records and submitting all reports required by
applicable federal or state law or rule.
(4) The registered agency shall provide to the commission a list
of staff trained and authorized to administer approved drugs.

18.64.044, 18.64.045, 18.64.046, 18.64.370, 18.64.460, 69.50.310,
18.64.011, 18.64.245, 18.64.470, 18.64.255, 18.64.205, 18.64.253,
18.64.410, 18.64.500, 18.64.590. WSR 20-12-072, § 246-945-254, filed
6/1/20, effective 7/1/20.]
WAC 246-945-255 Chemical capture—Department of fish and wild-

life. (1) The department of fish and wildlife may apply to the com-
mission for a limited registration under chapters 69.50 and 69.41 RCW
to purchase, possess, and administer controlled substances and legend
drugs for use in chemical capture programs.

(2) Each department of fish and wildlife field office that stores
controlled substances or legend drugs must register with the commis-
sion. The department of fish and wildlife must notify the commission
of the names of individuals who are authorized to possess and adminis-
ter controlled substances and legend drugs.
(3) The department of fish and wildlife shall designate one indi-
vidual at each field office who shall be responsible for the ordering,
possession, safe storage, and utilization of controlled substances and
legend drugs. The department of fish and wildlife shall notify the
commission of the name of the designated individual.
18.64.044, 18.64.045, 18.64.046, 18.64.370, 18.64.460, 69.50.310,
18.64.011, 18.64.245, 18.64.470, 18.64.255, 18.64.205, 18.64.253,
18.64.410, 18.64.500, 18.64.590. WSR 20-12-072, § 246-945-255, filed
6/1/20, effective 7/1/20.]
PART 3 – PROFESSIONAL STANDARDS
WAC 246-945-305 Pharmacist's professional responsibilities. (1)

A pharmacist shall be knowledgeable of, and comply with, all applica-
ble rules and laws.
(2) A pharmacist is responsible for providing patients with safe
and appropriate medication therapy.
(3) A pharmacist shall be responsible for any delegated act per-
formed by pharmacy interns, pharmacy technicians, and pharmacy assis-
tants under their supervision.
(4) A pharmacist shall delegate pharmacy functions in accordance
with WAC 246-945-315.
18.64.044, 18.64.045, 18.64.046, 18.64.370, 18.64.460, 69.50.310,
18.64.011, 18.64.245, 18.64.470, 18.64.255, 18.64.205, 18.64.253,
18.64.410, 18.64.500, 18.64.590. WSR 20-12-072, § 246-945-305, filed
6/1/20, effective 7/1/20.]
WAC 246-945-310 Responsible pharmacy manager. The responsible

pharmacy manager must be licensed to practice pharmacy in the state of
Washington. The responsible pharmacy manager designated by a facility
as required under WAC 246-945-410 shall have the authority and respon-
sibility to assure that the area(s) within the facility where drugs
are stored, compounded, delivered, or dispensed are operated in com-
pliance with all applicable state and federal statutes and regula-
tions.

18.64.044, 18.64.045, 18.64.046, 18.64.370, 18.64.460, 69.50.310,
18.64.011, 18.64.245, 18.64.470, 18.64.255, 18.64.205, 18.64.253,
18.64.410, 18.64.500, 18.64.590. WSR 20-12-072, § 246-945-310, filed
6/1/20, effective 7/1/20.]
WAC 246-945-315 Delegation of pharmacy functions to pharmacy an-

cillary personnel. (1) All delegated pharmacy functions shall be per-

formed under a pharmacist's immediate supervision. A pharmacist, as an
adjunct to assist in the immediate supervision of the pharmacy ancil-
lary personnel or intern, may employ technological means to communi-
cate with or observe the pharmacy ancillary personnel or intern. A
pharmacist shall make certain all applicable state and federal laws
including, but not limited to, confidentiality, are fully observed
when employing technological means of communication and observation.
If technology is being used to provide immediate supervision of phar-
macy ancillary personnel or intern such technology shall be sufficient
to provide the personal assistance, direction and approval required to
meet the standard of practice for the delegated tasks.
(2) When delegating a pharmacy function to a pharmacy technician:
(a) A pharmacist shall consider the pharmacy technician's scope
of practice, education, skill, and experience and take them into ac-
count; and
(b) A pharmacist will not delegate a pharmacy function that is
listed in WAC 246-945-320.
(3) A pharmacist may delegate to a pharmacy assistant those func-
tions defined in RCW 18.64A.030 and the following:
(a) Prepackage and label drugs for subsequent use in prescription
dispensing operations; and
(b) Count, pour, and label for individual prescriptions.

18.64.044, 18.64.045, 18.64.046, 18.64.370, 18.64.460, 69.50.310,
18.64.011, 18.64.245, 18.64.470, 18.64.255, 18.64.205, 18.64.253,
18.64.410, 18.64.500, 18.64.590. WSR 20-12-072, § 246-945-315, filed
6/1/20, effective 7/1/20.]
WAC 246-945-317 Tech check tech. (1) "Verification" as used in

this section means the pharmacist has reviewed a patient prescription
initiated by an authorized prescriber, has examined the patient's drug
profile, and has approved the prescription after taking into account
pertinent drug and disease information to ensure the correctness of
the prescription for a specific patient. The verification process must
generate an audit trail that identifies the pharmacist. The pharmacist
who performs the verification of a prescription is responsible for all
reports generated by the approval of that prescription. The unit-dose
medication fill and check reports are an example.
(2) A pharmacist may allow for unit-dose medication checking.
Following verification of a prescription by the pharmacist, a techni-
cian may check unit-dose medication cassettes filled by another phar-
macy technician or pharmacy intern in pharmacies serving facilities
licensed under chapter 70.41, 71.12, 71A.20, or 74.42 RCW. No more
than a forty-eight hour supply of drugs may be included in the patient
medication cassettes and a licensed health professional must check the
drug before administering it to the patient.

18.64.044, 18.64.045, 18.64.046, 18.64.370, 18.64.460, 69.50.310,
18.64.011, 18.64.245, 18.64.470, 18.64.255, 18.64.205, 18.64.253,
18.64.410, 18.64.500, 18.64.590. WSR 20-12-072, § 246-945-317, filed
6/1/20, effective 7/1/20.]

WAC 246-945-320 Nondelegable tasks. (1) A pharmacist shall not
delegate the following to ancillary personnel:
(a) Receipt or transfer of a verbal prescription other than re-
fill authorization from a prescriber.
(b) Consultation with the patient regarding the prescription,
both prior to and after the prescription filling regarding any infor-
mation contained in a patient medication record system; however, this
shall not prohibit pharmacy ancillary personnel from providing to or
receiving from the patient or the patient's agent certain information
where no professional judgment is required.
(c) Consultation with the prescriber regarding the patient and
the patient's prescription.
(d) Interpretation of data in a patient medication record system.
(e) Ultimate responsibility for all aspects of the completed pre-
scription and assumption of the responsibility for the filled pre-
scription, such as: Accuracy of drug, strength, labeling, proper con-
tainer and other requirements.
(f) Patient counseling in accordance with WAC 246-945-325.
(g) Substitution of a biological or drug product in accordance
with WAC 246-945-340.
(h) Decision to not dispense lawfully prescribed drugs or devices
or to not distribute drugs and devices approved by the FDA for re-
stricted distribution by pharmacies.
(i) Prescription adaptation in accordance with WAC 246-945-335.
(2) A pharmacy intern can perform any pharmacy function based on
their education, skill and experience, except supervising other phar-
macy personnel.

18.64.044, 18.64.045, 18.64.046, 18.64.370, 18.64.460, 69.50.310,
18.64.011, 18.64.245, 18.64.470, 18.64.255, 18.64.205, 18.64.253,
18.64.410, 18.64.500, 18.64.590. WSR 20-12-072, § 246-945-320, filed
6/1/20, effective 7/1/20.]
WAC 246-945-325 Patient counseling. (1) The pharmacist shall

offer to counsel:
(a) Upon the initial fill of a prescription for a new or change
of therapy.
(b) When the pharmacist using their professional judgment deter-
mines counseling is necessary to promote safe and effective use and to
facilitate an appropriate therapeutic outcome for that patient.
(2) This does not apply to medications that are administered by a
licensed health professional acting within their scope of practice.

18.64.044, 18.64.045, 18.64.046, 18.64.370, 18.64.460, 69.50.310,
18.64.011, 18.64.245, 18.64.470, 18.64.255, 18.64.205, 18.64.253,
18.64.410, 18.64.500, 18.64.590. WSR 20-12-072, § 246-945-325, filed
6/1/20, effective 7/1/20.]
WAC 246-945-330 Refilling prescriptions. (1) A prescription may

be refilled when permitted by state and federal law and only as au-
thorized by the prescriber.
(2) Except as provided in subsection (1) of this section, a phar-
macist may renew a prescription for a noncontrolled legend drug one

time in a six-month period when an effort has been made to contact the
prescriber and they are not available for authorization under the fol-
lowing conditions:
(a) The amount dispensed is the quantity on the most recent fill
or a thirty-day supply, whichever is less;
(b) The refill is requested by the patient or the patients agent;
(c) The patient has a chronic medical condition;
(d) No changes have been made to the prescription; and
(e) The pharmacist communicates the renewal to the prescriber
within one business day.
18.64.044, 18.64.045, 18.64.046, 18.64.370, 18.64.460, 69.50.310,
18.64.011, 18.64.245, 18.64.470, 18.64.255, 18.64.205, 18.64.253,
18.64.410, 18.64.500, 18.64.590. WSR 20-12-072, § 246-945-330, filed
6/1/20, effective 7/1/20.]
WAC 246-945-332 Continuity of care. When the governor issues an

emergency proclamation for an event which prevents continuity of
health care for persons and animals because their prescribed medica-
tions are no longer available to them due to the emergency event,
pharmacists and pharmacies may provide emergency prescription supplies
for medications during the period of the proclaimed emergency as pro-
vided below:
(1) An initial supply of up to thirty days of current prescrip-
tions for legend drug (noncontrolled) medications or seven-day supply
of current prescriptions for controlled substance medications in
Schedules III, IV, and V may be provided to patients under the follow-
ing conditions:
(a) Presentation of a valid prescription container complete with
legible label indicating there are remaining refills, or confirmation
of the prescribed medication and available refills by review of the
patient's current medical records or pharmacy records or in the pro-
fessional judgment of the pharmacist; or
(b) If the prescription is expired or has no refills and the
pharmacist is unable to readily obtain refill authorization from the
prescriber, the pharmacist may dispense a one-time emergency refill of
the last dispensed quantity or up to a thirty-day supply of a mainte-
nance medication.
(c) If the patient is unable to provide either a valid prescrip-
tion or prescription container the pharmacist may use their professio-
nal judgment when accepting a provider reconciled medication list.
(2) For each medication dispensed under this section, a pharma-
cist shall:
(a) Document the dispensing as a prescription, noting where the
information from subsection (1)(a) of this section was obtained;
(b) Inform the patient's provider and the pharmacy at which the
patient obtains his or her medications of the dispensing as soon as
possible following the emergency dispensing;
(c) Record the prescription or patient record as an "emergency"
prescription.
(3) Nothing in this rule modifies insurers' requirements for cov-
erage and payment for prescribed medications.

18.64.044, 18.64.045, 18.64.046, 18.64.370, 18.64.460, 69.50.310,

18.64.011, 18.64.245, 18.64.470, 18.64.255, 18.64.205, 18.64.253,
18.64.410, 18.64.500, 18.64.590. WSR 20-12-072, § 246-945-332, filed
6/1/20, effective 7/1/20.]
WAC 246-945-335 Prescription adaptation. Upon patient consent,

a pharmacist may adapt drugs as specified in this rule, provided that
the prescriber has not indicated that adaptation is not permitted.
(1) Change quantity. A pharmacist may change the quantity of med-
ication prescribed if:
(a) The prescribed quantity or package size is not commercially
available;
(b) The change in quantity is related to a change in dosage form;
(c) The change is intended to dispense up to the total amount au-
thorized by the prescriber including refills in accordance with RCW
18.64.520; or
(d) The change extends a maintenance drug for the limited quanti-
ty necessary to coordinate a patient's refills in a medication syn-
chronization program in accordance with RCW 48.43.096.
(2) Change dosage form. A pharmacist may change the dosage form
of the prescription if it is in the best interest of patient care, so
long as the prescriber's directions are also modified to equate to an
equivalent amount of drug dispensed as prescribed.
(3) Complete missing information. A pharmacist may complete miss-
ing information on a prescription if there is evidence to support the
change.
(4) Documentation. A pharmacist who adapts a prescription in ac-
cordance with these rules must document the adaptation in the pa-
tient's record.

18.64.044, 18.64.045, 18.64.046, 18.64.370, 18.64.460, 69.50.310,
18.64.011, 18.64.245, 18.64.470, 18.64.255, 18.64.205, 18.64.253,
18.64.410, 18.64.500, 18.64.590. WSR 20-12-072, § 246-945-335, filed
6/1/20, effective 7/1/20.]
WAC 246-945-340 Prescriptions—Drug product substitutions. (1)

A pharmacist may substitute a drug or biologic product dispensed pur-
suant to a prescription if in compliance with applicable laws and
rules.
(2) A pharmacist may substitute a drug product or a biologic
product when any of the following applies:
(a) The substitution is permitted by RCW 69.41.120;
(b) The substitution is permitted by a formulary developed by an
interdisciplinary team of an institutional facility; or
(c) The substitution is otherwise permitted by law.
(3) In addition to any other applicable requirements, a pharma-
cist shall only substitute a drug or a biologic product pursuant to
subsection (2)(b) of this section if:
(a) An employee or contractor of the institutional facility pre-
scribed the drug or biologic product to be substituted;
(b) The interdisciplinary team was composed of a nonpharmacist
prescriber listed in RCW 69.41.030 and a pharmacist; and
(c) The formulary is readily retrievable by the pharmacist.

18.64.044, 18.64.045, 18.64.046, 18.64.370, 18.64.460, 69.50.310,
18.64.011, 18.64.245, 18.64.470, 18.64.255, 18.64.205, 18.64.253,
18.64.410, 18.64.500, 18.64.590. WSR 20-12-072, § 246-945-340, filed
6/1/20, effective 7/1/20.]
WAC 246-945-345 Prescription transfers. (1) Subsections (2)

through (5) of this section apply to the transfer of prescription in-
formation for noncontrolled drugs. The transfer of controlled sub-
stance prescription information must conform to the requirements of 21
C.F.R. Sec. 1306.25.
(2) Upon patient request, a prescription may be transferred with-
in the limits of state and federal law.
(3) Sufficient information needs to be exchanged in the transfer
of a prescription to maintain an auditable trail, and all elements of
a valid prescription.
(4) Pharmacies sharing a secure real-time database are not re-
quired to transfer prescription information for dispensing.
(5) Prescriptions must be transferred by electronic means or fac-
simile, except in emergent situations.

18.64.044, 18.64.045, 18.64.046, 18.64.370, 18.64.460, 69.50.310,
18.64.011, 18.64.245, 18.64.470, 18.64.255, 18.64.205, 18.64.253,
18.64.410, 18.64.500, 18.64.590. WSR 20-12-072, § 246-945-345, filed
6/1/20, effective 7/1/20.]
WAC 246-945-350 Collaborative drug therapy agreements. (1) A

pharmacist exercising prescriptive authority in their practice must
have a valid CDTA on file with the commission and their practice loca-
tion.
(2) A CDTA must include:
(a) A statement identifying the practitioner authorized to pre-
scribe and the name of each pharmacist who is party to the agreement;
(i) The practitioner authorized to prescribe must be in active
practice; and
(ii) The authority granted must be within the scope of the prac-
titioners' current practice.
(b) A statement of the type of prescriptive authority decisions
which the pharmacist is authorized to make, which includes:
(i) A statement of the types of diseases, drugs, or drug catego-
ries involved, and the type of prescriptive authority activity (e.g.,
modification or initiation of drug therapy) authorized in each case.
(ii) A general statement of the training required, procedures,
decision criteria, or plan the pharmacist is to follow when making
therapeutic decisions, particularly when modification or initiation of
drug therapy is involved.
(c) A statement of the activities the pharmacist is to follow in
the course of exercising prescriptive authority, including:
(i) Documentation of decisions made; and
(ii) A plan for communication or feedback to the authorizing
practitioner concerning specific decisions made.
(3) A CDTA is only valid for two years from the date of signing.

(4) Any modification of the written guideline or protocol shall
be treated as a new CDTA.

18.64.044, 18.64.045, 18.64.046, 18.64.370, 18.64.460, 69.50.310,
18.64.011, 18.64.245, 18.64.470, 18.64.255, 18.64.205, 18.64.253,
18.64.410, 18.64.500, 18.64.590. WSR 20-12-072, § 246-945-350, filed
6/1/20, effective 7/1/20.]
WAC 246-945-355 Monitoring of drug therapy by pharmacist. In

the absence of a CDTA, the term "monitoring drug therapy" used in RCW
18.64.011 shall mean a review of the drug therapy regimen of patients
by a pharmacist for the purpose of evaluating or rendering advice to
the prescribing practitioner or patient regarding the patients drug
therapy. Monitoring of drug therapy includes, but is not limited to,
the evaluation of the patient through history taking, physical exami-
nation, ordering, administering or reviewing laboratory tests, imag-
ing, and social evaluation related to an existing diagnosis and drug
therapies for optimization of drug therapy.
18.64.044, 18.64.045, 18.64.046, 18.64.370, 18.64.460, 69.50.310,
18.64.011, 18.64.245, 18.64.470, 18.64.255, 18.64.205, 18.64.253,
18.64.410, 18.64.500, 18.64.590. WSR 20-12-072, § 246-945-355, filed
6/1/20, effective 7/1/20.]
WAC 246-945-360 Patient rights. Any person authorized to prac-

tice or assist in the practice of pharmacy shall not engage in any of
the following:
(1) Destroy unfilled lawful prescription;
(2) Refuse to return unfilled lawful prescriptions;
(3) Violate a patient's privacy;
(4) Discriminate against patients or their agent in a manner pro-
hibited by state or federal laws; or
(5) Intimidate or harass a patient.
18.64.044, 18.64.045, 18.64.046, 18.64.370, 18.64.460, 69.50.310,
18.64.011, 18.64.245, 18.64.470, 18.64.255, 18.64.205, 18.64.253,
18.64.410, 18.64.500, 18.64.590. WSR 20-12-072, § 246-945-360, filed
6/1/20, effective 7/1/20.]
WAC 246-945-365 Approval of impaired practitioner substance

abuse monitoring program. (1) The commission will approve recovery,
assistance and monitoring programs under RCW 18.130.175 for its cre-
dential holders.
(2) For the purposes of RCW 18.130.175(1), the commission will
consider a licensee to have not successfully completed the program if
they are discharged from the program for failure to comply with the
program's terms and conditions.
(3) A licensee referred or required to participate in a program
will be subject to disciplinary action under chapter 18.130 RCW if
they fail to sign or otherwise revoke a waiver allowing the program to
release information to the commission.

(4) An approved program shall report a licensee who fails to com-
ply with the program's terms and conditions within seven calendar
days.
(5) A licensee shall report themselves to the commission if they
fail to comply with RCW 18.130.175, the program's terms and condi-
tions, or any part of this section within seven calendar days. The
fact an approved program has reported under subsection (4) of this
section does not absolve the licensee of a responsibility to report.

18.64.044, 18.64.045, 18.64.046, 18.64.370, 18.64.460, 69.50.310,
18.64.011, 18.64.245, 18.64.470, 18.64.255, 18.64.205, 18.64.253,
18.64.410, 18.64.500, 18.64.590. WSR 20-12-072, § 246-945-365, filed
6/1/20, effective 7/1/20.]
WAC 246-945-370 Sexual misconduct. (1) A pharmacy health care

practitioner must not engage, or attempt to engage, in sexual miscon-
duct with a current patient, client, or key party, inside or outside
the health care setting. Sexual misconduct shall constitute grounds
for disciplinary action.
(2) Practitioner under this section shall be defined as any per-
son credentialed under RCW 18.64.080 or chapter 18.64A RCW.
(3) Sexual misconduct includes, but is not limited to:
(a) Sexual intercourse;
(b) Touching the breasts, genitals, anus or any sexualized body
part except as consistent with accepted community standards of prac-
tice within the health care practitioner's scope of practice;
(c) Rubbing against a patient, client, or key party for sexual
gratification;
(d) Kissing;
(e) Hugging, touching, fondling or caressing of a romantic or
sexual nature;
(f) Not allowing a patient or client privacy to dress or undress
except as may be necessary in emergencies or custodial situations;
(g) Not providing the patient or client a gown or draping except
as may be necessary in emergencies;
(h) Dressing or undressing in the presence of the patient, cli-
ent, or key party;
(i) Removing patient's or client's clothing or gown or draping
without consent, except emergent medical necessity or being in a cus-
todial setting;
(j) Encouraging masturbation or other sex act in the presence of
the health care provider;
(k) Masturbation or other sex act by the health care provider in
the presence of the patient, client, or key party;
(l) Suggesting or discussing the possibility of a dating, sexual
or romantic relationship after the professional relationship ends;
(m) Terminating a professional relationship for the purpose of
dating or pursuing a romantic or sexual relationship;
(n) Soliciting a date with a patient, client, or key party;
(o) Discussing the sexual history, preferences or fantasies of
the health care provider;
(p) Any behavior, gestures, or expressions that may reasonably be
interpreted as seductive or sexual;

(q) Making statements regarding the patient, client, or key par-
ty's body, appearance, sexual history, or sexual orientation other
than for legitimate health care purposes;
(r) Sexually demeaning behavior including any verbal or physical
contact which may reasonably be interpreted as demeaning, humiliating,
embarrassing, threatening or harming a patient, client, or key party;
(s) Photographing or filming the body or any body part or pose of
a patient, client, or key party, other than for legitimate health care
purposes; and
(t) Showing a patient, client, or key party sexually explicit ma-
terials, other than for legitimate health care purposes.
(4) Sexual misconduct also includes sexual contact with any per-
son involving force, intimidation, or lack of consent; or a conviction
of a sex offense as defined in RCW 9.94A.030.
(5) A health care practitioner must not:
(a) Offer to provide health care services in exchange for sexual
favors;
(b) Use health care information to contact the patient, client,
or key party for the purpose of engaging in sexual misconduct;
(c) Use health care information or access to health care informa-
tion to meet or attempt to meet the health care practitioner's sexual
needs.
(6) A health care practitioner must not engage, or attempt to en-
gage, in the activities listed in subsection (4) of this section with
a former patient, client, or key party if:
(a) There is a significant likelihood that the patient, client,
or key party will seek or require additional services from the health
care practitioner; or
(b) There is an imbalance of power, influence, opportunity, or
special knowledge of the professional relationship.
(7) When evaluating whether a health care provider engaged, or
attempted to engage, in sexual misconduct, the commission will consid-
er factors including, but not limited to:
(a) Documentation of a formal termination and the circumstances
of termination of the practitioner-patient relationship;
(b) Transfer of care to another health care practitioner;
(c) Duration of the practitioner-patient relationship;
(d) Amount of time that has passed since the last health care
services to the patient or client;
(e) Communication between the health care practitioner and the
patient or client between the last health care services rendered and
commencement of the personal relationship;
(f) Extent to which the patient's or client's personal or private
information was shared with the health care practitioner;
(g) Nature of the patient or client's health condition during and
since the professional relationship;
(h) The patient or client's emotional dependence and vulnerabili-
ty; and
(i) Normal revisit cycle for the profession and service.
(8) Patient, client, or key party initiation or consent does not
excuse or negate the health care practitioner's responsibility.
(9) These rules do not prohibit:
(a) Providing health care services in case of emergency where the
services cannot or will not be provided by another health care provid-
er;

(b) Contact that is necessary for a legitimate health care pur-
pose and that meets the standard of care appropriate to that profes-
sion; or
(c) Providing health care services for a legitimate health care
purpose to a person who is in a preexisting, established personal re-
lationship with the health care provider where there is no evidence
of, or potential for, exploiting the patient or client.

18.64.044, 18.64.045, 18.64.046, 18.64.370, 18.64.460, 69.50.310,
18.64.011, 18.64.245, 18.64.470, 18.64.255, 18.64.205, 18.64.253,
18.64.410, 18.64.500, 18.64.590. WSR 20-12-072, § 246-945-370, filed
6/1/20, effective 7/1/20.]
PART 4 – OPERATIONAL STANDARDS
Subpart A – Pharmacies, HCEs and HPACs
WAC 246-945-405 Applicability. (1) The rules in this chapter

apply to pharmacies, health care entities (HCE), and hospital pharmacy
associated clinics (HPAC).
(2) Unless specified, the term "facility" as used in this part
includes pharmacies, HCEs, and HPACs.

18.64.044, 18.64.045, 18.64.046, 18.64.370, 18.64.460, 69.50.310,
18.64.011, 18.64.245, 18.64.470, 18.64.255, 18.64.205, 18.64.253,
18.64.410, 18.64.500, 18.64.590. WSR 20-12-072, § 246-945-405, filed
6/1/20, effective 7/1/20.]
WAC 246-945-410 Facility standards. A facility must meet the

following minimum requirements:
(1) The facility shall be constructed and equipped with adequate
security to protect equipment, records, and supply of drugs, devices,
and other restricted sale items from unauthorized access, acquisition,
or use.
(2) The facility shall be properly equipped to ensure the safe,
clean, and sanitary condition necessary for the proper operation, the
safe preparation of prescriptions, and to safeguard product integrity.
(3) The facility shall be staffed sufficiently to allow appropri-
ate supervision, operate safely and, if applicable, remain open during
posted hours of operation.
(4) The facility shall be adequately stocked to maintain at all
times a representative assortment of drugs in order to meet the phar-
maceutical needs of its patients in compliance with WAC 246-945-415.
(5) The facility shall designate a responsible pharmacy manager:
(a) By the date of opening; and
(b) Within thirty calendar days of a vacancy.
(6) The facility shall create and implement policies and proce-
dures related to:

(a) Purchasing, ordering, storing, compounding, delivering, dis-
pensing, and administering legend drugs, including controlled substan-
ces.
(b) Accuracy of inventory records, patient medical records as re-
lated to the administration of controlled substances and legend drugs,
and any other records required to be kept by state and federal laws.
(c) Adequate security of legend drugs, including controlled sub-
stances.
(d) Controlling access to legend drugs, including controlled sub-
stances.
(7) Prescription drugs must only be dispensed pursuant to a valid
prescription as required by WAC 246-945-011.
(8) A drug utilization review of each prescription before dis-
pensing and delivery shall occur except in emergent medical situa-
tions, or if:
(a) The drug is a subsequent dose from a previously reviewed pre-
scription;
(b) The prescriber is in the immediate vicinity and controls the
drug dispensing process;
(c) The medication delivery system is being used to provide ac-
cess to medications on override and only a quantity sufficient to meet
the immediate need of the patient is removed; or
(d) Twenty-four hour pharmacy services are not available, and a
pharmacist will review all prescriptions added to a patient's profile
within six hours of the facility opening.
(9) Each drug dispensed and delivered to a patient must bear a
complete and accurate label as required by WAC 246-945-015 through
246-945-018. The information contained on the label shall be supple-
mented by oral or written information as required by WAC 246-945-325.
(10) Access to the drug storage area located within the facility
should be limited to pharmacists unless one of the following applies:
(a) A pharmacy intern, or pharmacy ancillary personnel enter un-
der the immediate supervision of a pharmacist; or
(b) A pharmacist authorizes temporary access to an individual
performing a legitimate nonpharmacy function under the immediate su-
pervision of the pharmacist; or
(c) The facility has a policy and procedure restricting access to
a health care professional licensed under the chapters specified in
RCW 18.130.040, and the actions of the health care professional are
within their scope of practice.
(11) In accordance with RCW 18.64A.060 prior to utilizing pharma-
cy ancillary personnel a facility shall submit to the commission a
utilization plan for pharmacy technicians and pharmacy assistants:
(a) Utilization plan for pharmacy technicians. The application
for approval must describe the manner in which the pharmacy techni-
cians will be utilized and supervised, including job descriptions,
task analysis or similar type documents that define the duties per-
formed and the conditions under which they are performed, number of
positions in each category, as well as other information as may be re-
quired by the commission. The commission will be notified of all
changes to the utilization plan. A copy of the utilization plan must
be maintained in the pharmacy. The utilization plan must comply with
WAC 246-945-315 and 246-945-320.
(b) Utilization plan for pharmacy assistants. The application for
approval shall list the job title or function of the pharmacy assis-
tant and comply with WAC 246-945-315(3).

(12) A facility's paper prescriptions must be maintained in ac-
cordance with WAC 246-945-020 and as follows:
(a) Paper prescriptions for Schedule II drugs must be maintained
as a separate file from other prescriptions.
(b) Paper prescriptions for Schedule III, IV, and V drugs must be
maintained as a separate file, or maintained in a separate file with
prescriptions for noncontrolled legend drugs as allowed under federal
law.

18.64.044, 18.64.045, 18.64.046, 18.64.370, 18.64.460, 69.50.310,
18.64.011, 18.64.245, 18.64.470, 18.64.255, 18.64.205, 18.64.253,
18.64.410, 18.64.500, 18.64.590. WSR 20-12-072, § 246-945-410, filed
6/1/20, effective 7/1/20.]
WAC 246-945-415 Dispensing and delivery of prescription drugs.

(1) A pharmacy may deliver filled prescriptions as long as appropriate
measures are taken to ensure product integrity and receipt by the pa-
tient or patient's agent.
(2) Pharmacies have a duty to deliver lawfully prescribed drugs
or devices to patients and to distribute drugs and devices approved by
the U.S. Food and Drug Administration for restricted distribution by
pharmacies, or provide a therapeutically equivalent drug or device in
a timely manner consistent with reasonable expectations for filling
the prescription, except for the following or substantially similar
circumstances:
(a) Prescriptions containing an obvious or known error, inadequa-
cies in the instructions, known contraindications, or incompatible
prescriptions, or prescriptions requiring action in accordance with
WAC 246-945-410(8) or 246-945-335;
(b) National or state emergencies or guidelines affecting availa-
bility, usage, or supplies of drugs or devices;
(c) Lack of specialized equipment or expertise needed to safely
produce, store, or dispense drugs or devices, such as certain drug
compounding or storage for nuclear medicine;
(d) Potentially fraudulent prescriptions; or
(e) Unavailability of drug or device despite good faith compli-
ance with WAC 246-945-410(4).
(3) Nothing in this section requires pharmacies to deliver a drug
or device without payment of their usual and customary or contracted
charge.
(4) If despite good faith compliance with WAC 246-945-410(4), the
lawfully prescribed drug or device is not in stock, or the prescrip-
tion cannot be filled pursuant to subsection (2)(a) of this section,
the pharmacy shall provide the patient or agent a timely alternative
for appropriate therapy which, consistent with customary pharmacy
practice, may include obtaining the drug or device. These alternatives
include, but are not limited to:
(a) Contact the prescriber to address concerns such as those
identified in subsection (2)(a) of this section or to obtain authori-
zation to provide a therapeutically equivalent product;
(b) If requested by the patient or their agent, return unfilled
lawful prescriptions to the patient or agent; or
(c) If requested by the patient or their agent, communicate or
transmit, as permitted by law, the original prescription information

to a pharmacy of the patient's choice that will fill the prescription
in a timely manner.
(5) Engaging in or permitting any of the following shall consti-
tute grounds for discipline or other enforcement actions:
(a) Destroy unfilled lawful prescriptions;
(b) Refuse to return unfilled lawful prescriptions;
(c) Violate a patient's privacy;
(d) Discriminate against patients or their agent in a manner pro-
hibited by state or federal laws; and
(e) Intimidate or harass a patient.
(6) Filled prescriptions may be picked up or returned for deliv-
ery by authorized personnel when the pharmacy is closed for business
if the prescriptions are placed in a secured delivery area outside of
the drug storage area. The secured delivery area must be a part of a
licensed pharmacy, and equipped with adequate security, including an
alarm or comparable monitoring system, to prevent unauthorized entry,
theft, or diversion. Access to the secured delivery area must be ad-
dressed by the policies and procedures developed by the responsible
pharmacy manager.
(7) HCEs shall dispense in accordance with RCW 18.64.450.
(8) A licensed hospital pharmacy dispensing appropriately la-
beled, patient specific drugs to a HPAC licensed under the parent hos-
pital pharmacy may do so only pursuant to a valid prescription and
prescription information is authenticated in the medical record of the
patient to whom the legend drug or controlled substance will be provi-
ded according to the policy and procedures of the parent hospital
pharmacy.

18.64.044, 18.64.045, 18.64.046, 18.64.370, 18.64.460, 69.50.310,
18.64.011, 18.64.245, 18.64.470, 18.64.255, 18.64.205, 18.64.253,
18.64.410, 18.64.500, 18.64.590. WSR 20-12-072, § 246-945-415, filed
6/1/20, effective 7/1/20.]
WAC 246-945-417 Electronic systems for patient medication re-

cords, prescriptions, chart orders, and controlled substance records.
(1) A pharmacy shall use an electronic recordkeeping system to estab-
lish and store patient medication records, including patient aller-
gies, idiosyncrasies or chronic conditions, and prescription, refill,
transfer information, and other information necessary to provide safe
and appropriate patient care.
(a) Systems must prevent auto-population of user identification
information.
(b) Pharmacies that provide off-site pharmacy services without a
pharmacist for product fulfillment or prescription processing must
track the identity of each individual involved in each step of the
off-site pharmacy services.
(2) The electronic recordkeeping system must be capable of real-
time retrieval of information pertaining to the ordering, verifica-
tion, and processing of the prescription where possible.
(3) The electronic recordkeeping system must include security
features to protect the confidentiality and integrity of patient re-
cords including:
(a) Safeguards designed to prevent and detect unauthorized ac-
cess, modification, or manipulation of prescription information and
patient medication records; and

(b) Functionality that documents any alteration of prescription
information after a prescription is dispensed, including the identifi-
cation of the individual responsible for the alteration.
(4) The pharmacy shall have policies and procedures in place for
system downtime.
(a) The procedure shall provide for the maintenance of all pa-
tient recordkeeping information as required by this chapter.
(b) Upon restoration of operation of the electronic recordkeeping
system the information placed in the auxiliary recordkeeping procedure
shall be entered in each patient's records within two working days,
after which the auxiliary records may be destroyed.
(c) This section does not require that a permanent dual record-
keeping system be maintained.
(5) The pharmacy shall maintain records in accordance with WAC
246-945-020.
(6) Electronic prescriptions for prescription drugs must be main-
tained by the pharmacy in a system that meets the requirements of 21
C.F.R. Sec. 1311.
(7) HCEs or HPACs that maintain an electronic record system must
be done in accordance with subsections (2) through (7) of this sec-
tion.

18.64.044, 18.64.045, 18.64.046, 18.64.370, 18.64.460, 69.50.310,
18.64.011, 18.64.245, 18.64.470, 18.64.255, 18.64.205, 18.64.253,
18.64.410, 18.64.500, 18.64.590. WSR 20-12-072, § 246-945-417, filed
6/1/20, effective 7/1/20.]
WAC 246-945-418 Paper recordkeeping procedure. If an HPAC or

HCE does not maintain an electronic recordkeeping system their manual
records must contain all information required in WAC 246-945-417. The
record system consists of the hard copy of the original prescription
and a card or filing procedure that contains all data on new and re-
fill prescriptions for a patient. This data must be organized in such
a fashion that information relating to all prescription drugs used by
a patient will be reviewed each time a prescription is filled.
18.64.044, 18.64.045, 18.64.046, 18.64.370, 18.64.460, 69.50.310,
18.64.011, 18.64.245, 18.64.470, 18.64.255, 18.64.205, 18.64.253,
18.64.410, 18.64.500, 18.64.590. WSR 20-12-072, § 246-945-418, filed
6/1/20, effective 7/1/20.]
WAC 246-945-420 Facility inventory requirements. (1) A facility

shall conduct its own separate inventory of prescription drugs when it
closes in accordance WAC 246-945-480.
(2) A facility shall conduct an inventory of controlled substan-
ces every two years.
(3) A facility shall conduct its own separate inventory of con-
trolled substances in the following situations:
(a) Within thirty days of designating a responsible pharmacy man-
ager. The incoming responsible pharmacy manager, or designee, shall
conduct a complete controlled substance inventory.
(b) On the effective date of an addition of a substance to a
schedule of controlled substances. Each facility that possesses the

substance shall take an inventory of the substance on hand, and there-
after, include the substance in each inventory.
(4) A pharmacy that exclusively stores, dispenses or delivers
legend drugs, including controlled substances, without a pharmacist
on-site shall maintain a perpetual inventory.
(5) A pharmacy that exclusively stores, dispenses or delivers
prescription drugs without pharmacy ancillary personnel physically on-
site shall maintain a perpetual inventory.

18.64.044, 18.64.045, 18.64.046, 18.64.370, 18.64.460, 69.50.310,
18.64.011, 18.64.245, 18.64.470, 18.64.255, 18.64.205, 18.64.253,
18.64.410, 18.64.500, 18.64.590. WSR 20-12-072, § 246-945-420, filed
6/1/20, effective 7/1/20.]
WAC 246-945-425 Shared pharmacy services. Pharmacy services may

be provided off-site at one or more locations. When the services being
performed are related to prescription fulfillment or processing, the
pharmacy or pharmacist must comply with the following:
(1) Long term care shared pharmacy services in accordance with
RCW 18.64.570.
(2) Central fill shared pharmacy services in accordance with the
following conditions:
(a) The originating pharmacy shall have written policies and pro-
cedures outlining the off-site pharmacy services to be provided by the
central fill pharmacy, or the off-site pharmacist or pharmacy techni-
cian, and the responsibilities of each party;
(b) The parties shall share a secure real-time database or uti-
lize other secure technology, including a private, encrypted connec-
tion that allows access by the central pharmacy or off-site pharmacist
or pharmacy technician to the information necessary to perform off-
site pharmacy services; and
(c) A single prescription may be shared by an originating pharma-
cy and a central fill pharmacy or off-site pharmacist or pharmacy
technician. The fulfillment, processing and delivery of a prescription
by one pharmacy for another pursuant to this section will not be con-
strued as the fulfillment of a transferred prescription or as a whole-
sale distribution.

18.64.044, 18.64.045, 18.64.046, 18.64.370, 18.64.460, 69.50.310,
18.64.011, 18.64.245, 18.64.470, 18.64.255, 18.64.205, 18.64.253,
18.64.410, 18.64.500, 18.64.590. WSR 20-12-072, § 246-945-425, filed
6/1/20, effective 7/1/20.]
WAC 246-945-430 Pharmacies storing, dispensing and delivering

drugs to patients without a pharmacist on-site. (1) The following re-
quirements apply to pharmacies storing, dispensing and delivering
drugs to patients without a pharmacist on-site and are in addition to
applicable state and federal laws applying to pharmacies.
(2) The pharmacy is required to have adequate visual surveillance
of the full pharmacy and retain a high quality recording for a minimum
of thirty calendar days.
(3) Access to a pharmacy by individuals must be limited, author-
ized, and regularly monitored.

(4) A visual and audio communication system used to counsel and
interact with each patient or patient's caregiver, must be clear, se-
cure, and HIPAA compliant.
(5) The responsible pharmacy manager, or designee, shall complete
and retain, in accordance with WAC 246-945-005 a monthly in-person in-
spection of the pharmacy.
(6) A pharmacist must be capable of being on-site at the pharmacy
within three hours if an emergency arises.
(7) The pharmacy must be closed to the public if any component of
the surveillance or visual and audio communication system is malfunc-
tioning, and remain closed until system corrections or repairs are
completed or a pharmacist is on-site to oversee pharmacy operations.
18.64.044, 18.64.045, 18.64.046, 18.64.370, 18.64.460, 69.50.310,
18.64.011, 18.64.245, 18.64.470, 18.64.255, 18.64.205, 18.64.253,
18.64.410, 18.64.500, 18.64.590. WSR 20-12-072, § 246-945-430, filed
6/1/20, effective 7/1/20.]
WAC 246-945-435 Provision of emergency department discharge med-

ication when pharmacy services are unavailable. (1) The responsible
pharmacy manager of a hospital or free standing emergency department
may, in collaboration with the appropriate medical staff committee of
the hospital, develop policies and procedures to provide discharge
medications to patients released from hospital emergency departments
during hours when community or outpatient hospital pharmacy services
are not available.
(2) The policies and procedures in subsection (1) of this section
shall:
(a) Comply with all requirements of RCW 70.41.480;
(b) Ensure all prepackaged medications are affixed with a label
that complies with WAC 246-945-018;
(c) Require oral or electronically transmitted chart orders be
verified by the practitioner in writing within seventy-two hours;
(d) The medications distributed as discharge medications are
stored in compliance with the laws concerning security and access; and
(e) Ensure discharge medications are labeled appropriately.
(3) The delivery of a single dose for immediate administration to
the patient is not subject to this regulation.

18.64.044, 18.64.045, 18.64.046, 18.64.370, 18.64.460, 69.50.310,
18.64.011, 18.64.245, 18.64.470, 18.64.255, 18.64.205, 18.64.253,
18.64.410, 18.64.500, 18.64.590. WSR 20-12-072, § 246-945-435, filed
6/1/20, effective 7/1/20.]
WAC 246-945-440 Administration of patient owned medications.

Facilities shall develop written policies and procedures for the ad-
ministration of patient owned medications.

18.64.044, 18.64.045, 18.64.046, 18.64.370, 18.64.460, 69.50.310,
18.64.011, 18.64.245, 18.64.470, 18.64.255, 18.64.205, 18.64.253,
18.64.410, 18.64.500, 18.64.590. WSR 20-12-072, § 246-945-440, filed
6/1/20, effective 7/1/20.]

WAC 246-945-445 Investigational drugs. (1) The responsible
pharmacy manager or their designee is responsible for the storage,
distribution, and control of approved investigational drugs used in an
institutional facility. The pharmacy shall be responsible for main-
taining and providing information on approved investigational drugs.
(2) Under the explicit direction of the authorized principal in-
vestigator, coinvestigator(s), or per study protocol requirements, in-
vestigational drugs must be properly labeled and stored for use. An
appropriate medical staff committee, institution review board, or
equivalent committee, shall approve the use of such drugs.
18.64.044, 18.64.045, 18.64.046, 18.64.370, 18.64.460, 69.50.310,
18.64.011, 18.64.245, 18.64.470, 18.64.255, 18.64.205, 18.64.253,
18.64.410, 18.64.500, 18.64.590. WSR 20-12-072, § 246-945-445, filed
6/1/20, effective 7/1/20.]
WAC 246-945-450 Accessing technology used to dispense—Nursing

students. (1) Nursing students may be given access privileges to
technology used to dispense medications for patient administration as
provided for in this section.
(2) Nursing students must be enrolled in a nursing program ap-
proved by the Washington state nursing care quality assurance commis-
sion in accordance with WAC 246-840-510.
(3) A facility that provides a clinical opportunity to nursing
students must meet the following to grant access to technology used to
dispense medications for patient administration:
(a) The facility, in collaboration with the nursing program,
shall provide nursing students with orientation and practice experien-
ces that include the demonstration of competency of skills prior to
using the dispensing technology;
(b) Nursing programs and participating facilities shall provide
adequate training for students accessing dispensing technology;
(c) The nursing programs and participating facilities shall have
policies and procedures for nursing students to provide safe adminis-
tration of medications; and
(d) The nursing program and participating facilities shall devel-
op and have a way of reporting and resolving any nursing student medi-
cation errors, adverse events, and alleged diversion.
18.64.044, 18.64.045, 18.64.046, 18.64.370, 18.64.460, 69.50.310,
18.64.011, 18.64.245, 18.64.470, 18.64.255, 18.64.205, 18.64.253,
18.64.410, 18.64.500, 18.64.590. WSR 20-12-072, § 246-945-450, filed
6/1/20, effective 7/1/20.]
WAC 246-945-455 Drugs stored outside of the pharmacy. (1) In

order for drugs to be stored in a designated area outside the pharmacy
including, but not limited to, floor stock, in an emergency cabinet,
in an emergency kit, or as emergency outpatient drug delivery from an
emergency department at a registered institutional facility, the fol-
lowing conditions must be met:
(a) Drugs stored in such a manner shall remain under the control
of, and be routinely monitored by, the supplying pharmacy;

(b) The supplying pharmacy shall develop and implement policies
and procedures to prevent and detect unauthorized access, document
drugs used, returned and wasted, and regular inventory procedures;
(c) Access must be limited to health care professionals licensed
under the chapters specified in RCW 18.130.040 acting within their
scope, and nursing students as provided in WAC 246-945-450;
(d) The area is appropriately equipped to ensure security and
protection from diversion or tampering; and
(e) The facility is able to possess and store drugs.
(2) For nursing homes and hospice programs an emergency kit or
supplemental dose kit must comply with RCW 18.64.560.
18.64.044, 18.64.045, 18.64.046, 18.64.370, 18.64.460, 69.50.310,
18.64.011, 18.64.245, 18.64.470, 18.64.255, 18.64.205, 18.64.253,
18.64.410, 18.64.500, 18.64.590. WSR 20-12-072, § 246-945-455, filed
6/1/20, effective 7/1/20.]
WAC 246-945-460 Staffing and supervision of pharmacy staff. (1)

The ratio of pharmacy technicians to pharmacist(s) on duty is to be
determined by the responsible pharmacy manager.
(2) The responsible pharmacy manager will ensure that the number
of pharmacy technicians on duty can be satisfactorily supervised by
the pharmacist(s) on duty.

18.64.044, 18.64.045, 18.64.046, 18.64.370, 18.64.460, 69.50.310,
18.64.011, 18.64.245, 18.64.470, 18.64.255, 18.64.205, 18.64.253,
18.64.410, 18.64.500, 18.64.590. WSR 20-12-072, § 246-945-460, filed
6/1/20, effective 7/1/20.]
WAC 246-945-480 Facility reporting requirements. (1) The outgo-

ing and incoming responsible pharmacy manager must report in writing
to the commission a change in a responsible manager designation within
ten business days of the change.
(2) Unless otherwise specified, when permanently closing a fa-
cility, the facility must:
(a) Report to the commission in writing, no later than thirty
calendar days prior to closing:
(i) The date the facility will close;
(ii) The names and addresses of the persons who shall have custo-
dy of the prescription files, bulk compounding records, repackaging
records, invoices and controlled substances inventory records of the
pharmacy to be closed; and
(iii) The names and addresses of any person(s) who will acquire
any legend drugs from the facility to be closed, if known at the time
the notification is filed.
(b) Provide notification to customers noting the last day the
pharmacy will be open, name and address of the pharmacy to which pre-
scription records will be transferred and instructions on how patients
can arrange for transfer of their prescription records to a pharmacy
of their choice and the last day a transfer may be initiated. Notifi-
cation should include:
(i) Distribution by direct mail; or

(ii) Public notice in a newspaper of general circulation in the
area served by the pharmacy; and
(iii) Posting a closing notice sign in a conspicuous place in the
public area of the pharmacy.
(c) No later than fifteen days after closing:
(i) Return the facility license;
(ii) Confirm that all legend drugs were transferred or destroyed.
If the legend drugs were transferred, provide the names and addresses
of the person(s) to whom they were transferred;
(iii) Confirm if controlled substances were transferred, includ-
ing the date of transfer, names, addresses, and a detailed inventory
of the drugs transferred;
(iv) Confirm return of DEA registration and all unused DEA 222
forms to the DEA;
(v) Confirm all pharmacy labels and blank prescriptions were de-
stroyed; and
(vi) Confirm all signs and symbols indicating the presence of the
pharmacy have been removed.
(3) The commission may conduct an inspection to verify all re-
quirements in subsection (2) of this section have been completed.
(4) The facility shall immediately report to the commission any
disasters, accidents and emergencies which may affect the strength,
purity, or labeling of drugs, medications, devices or other materials
used in the diagnosis or the treatment of injury, illness, and dis-
ease.
(5) Any facility credentialed by the commission must report to
the commission any disciplinary action, including denial, revocation,
suspension, or restriction to practice by another state, federal, or
foreign authority.

18.64.044, 18.64.045, 18.64.046, 18.64.370, 18.64.460, 69.50.310,
18.64.011, 18.64.245, 18.64.470, 18.64.255, 18.64.205, 18.64.253,
18.64.410, 18.64.500, 18.64.590. WSR 20-12-072, § 246-945-480, filed
6/1/20, effective 7/1/20.]
WAC 246-945-485 Destruction or return of drugs or devices—Re-

strictions. (1) A dispensed drug or prescription device must only be
accepted for return and reuse as follows:
(a) Noncontrolled legend drugs that have been maintained in the
custody and control of the institutional facility, dispensing pharma-
cy, or their related facilities under common control may be returned
and reused if product integrity can be assured.
(b) Those that qualify for return under the provisions of chapter
69.70 RCW.
(2) A dispensed drug or prescription device may be accepted for
return and destruction if:
(a) The dispensed drug or prescription device was dispensed in a
manner inconsistent with the prescriber's instructions;
(b) The return is in compliance with the Washington state safe
medication return program laws and rules, chapters 69.48 RCW and
246-480 WAC; or
(c) The return and destruction is in compliance with the facili-
ty's policies and procedures.

18.64.044, 18.64.045, 18.64.046, 18.64.370, 18.64.460, 69.50.310,
18.64.011, 18.64.245, 18.64.470, 18.64.255, 18.64.205, 18.64.253,
18.64.410, 18.64.500, 18.64.590. WSR 20-12-072, § 246-945-485, filed
6/1/20, effective 7/1/20.]
WAC 246-945-490 Nuclear pharmacies. (1) The commission shall

issue a permit to operate a nuclear pharmacy providing radiopharma-
ceutical services to a qualified nuclear pharmacist. The qualified nu-
clear pharmacist shall:
(a) Supervise all personnel performing tasks in the preparation
and distribution of radiopharmaceuticals.
(b) Be responsible for all operations of the licensed area.
(c) Designate one or more qualified health care professionals li-
censed under the chapters specified in RCW 18.130.040, to have access
to the licensed area in emergency situations and in the nuclear phar-
macist's absence. These individuals may obtain radiopharmaceuticals
for the immediate emergency and must document such withdrawals in the
control system.
(2) A nuclear pharmacy shall have adequate space that is appro-
priate with the scope of services provided, including meeting the fol-
lowing requirements:
(a) The nuclear pharmacy area shall be separate from the pharmacy
areas for nonradiopharmaceuticals and shall be secured from access by
unauthorized personnel;
(b) A nuclear pharmacy handling radiopharmaceuticals exclusively
may be exempted from the general space requirements for pharmacies by
obtaining a waiver from the commission; and
(c) Detailed floor plans shall be submitted to the commission and
the state radiation control agency before approval of the pharmacy li-
cense.
(3) A nuclear pharmacy shall prepare, compound, and dispense ra-
diopharmaceuticals in accordance with USP <825˃.
(4) The preparation of nuclear pharmaceuticals requires the com-
pounding skills of the nuclear pharmacist and shall be done to assure
that the final drug product meets USP <825˃.
(5) A nuclear pharmacy shall maintain records of acquisition and
disposition of all radiopharmaceuticals in accordance with applicable
regulations of the commission, the state radiation control agency and
other state and federal agencies.
(6) For a nuclear pharmacy handling radiopharmaceuticals exclu-
sively, the commission may waive regulations pertaining to the pharma-
cy permits for nonradiopharmaceuticals for requirements that do not
pertain to the practice of nuclear pharmacy.
(7) Radiopharmaceuticals are to be dispensed only upon a pre-
scription from a practitioner authorized to possess, use and adminis-
ter radiopharmaceuticals. A nuclear pharmacy may also furnish radio-
pharmaceuticals for office use to these practitioners. In absence of a
prescription for an individual identified patient, the statement "Of-
fice Use Only" should be applied.
(8) A nuclear pharmacist may transfer to authorized persons radi-
oactive materials not intended for drug use, in accordance with regu-
lations of the state radiation control agency.
(9) In addition to labeling requirements of WAC 246-945-015
through 246-945-017 for nonradiopharmaceuticals, the immediate outer

container of the radiopharmaceutical to be dispensed shall also be la-
beled with:
(a) Standard radiation symbol;
(b) The words "caution-radioactive material";
(c) Radionuclide and chemical form (generic name);
(d) Activity dispensed with units (millicuries or microcuries) at
calibration date and time;
(e) If a liquid, the volume in milliliters;
(f) Calibration date and time for the dose;
(g) BUD and special storage and handling instructions for nonim-
mediate use;
(h) Specific concentration of radioactivity; and
(i) The patient name/identifier, and number of dosage units dis-
pensed, for all therapeutic and blood-products.
(10) The immediate container of the radiopharmaceutical to be
dispensed shall be labeled with:
(a) The standard radiation symbol;
(b) The words "caution-radioactive material";
(c) The name of the nuclear pharmacy;
(d) The prescription number;
(e) Radionuclide and chemical form (generic name)";
(f) The date;
(g) Activity dispensed with units (millicuries or microcuries) at
calibration date and time; and
(h) The patient name/identifier for all therapeutic and blood-
products.
(11) The amount of radioactivity shall be determined by radiomet-
ric methods for each individual preparation immediately prior to dis-
pensing.
(12) A nuclear pharmacy may redistribute NDA approved radiophar-
maceuticals if the pharmacy does not process the radiopharmaceuticals
in any manner or violate the product packaging.
(13) The nuclear pharmacy shall have readily available the cur-
rent applicable state laws and regulations of the commission and state
radiation control agency.
(14) The nuclear pharmacy shall maintain, and submit to the com-
mission and state radiation control agency, a library commensurate
with the level of radiopharmaceutical service to be provided before
approval of the license.

18.64.044, 18.64.045, 18.64.046, 18.64.370, 18.64.460, 69.50.310,
18.64.011, 18.64.245, 18.64.470, 18.64.255, 18.64.205, 18.64.253,
18.64.410, 18.64.500, 18.64.590. WSR 20-12-072, § 246-945-490, filed
6/1/20, effective 7/1/20.]
WAC 246-945-492 Nuclear pharmacies—Equipment requirements. (1)

A nuclear pharmacy shall have adequate equipment appropriate with the
scope of radiopharmaceutical services to be provided. The nuclear
pharmacy shall submit to the commission and the radiation control
agency a detailed list of equipment and description of use before ap-
proval of the license.
(2) The commission may, for good cause shown, waive regulations
pertaining to the equipment and supplies required for a nuclear phar-
macy handling radiopharmaceuticals exclusively.

18.64.044, 18.64.045, 18.64.046, 18.64.370, 18.64.460, 69.50.310,
18.64.011, 18.64.245, 18.64.470, 18.64.255, 18.64.205, 18.64.253,
18.64.410, 18.64.500, 18.64.590. WSR 20-12-072, § 246-945-492, filed
6/1/20, effective 7/1/20.]
Subpart B – Registrations
WAC 246-945-500 Humane societies, animal control agencies, and

department of fish and wildlife chemical capture programs—Designated
person. (1) Each registered humane society, animal control agency,
and department of fish and wildlife chemical capture program location
shall have a designated person.
(2) The designated person is responsible for:
(a) Ordering, possession, safe storage and use of all approved
drugs;
(b) Maintaining all records required by WAC 246-945-510; and
(c) Ensuring all records required by WAC 246-945-510 are availa-
ble for inspection by the commission or its designee.
(3) A registered humane society, animal control agency, or de-
partment of fish and wildlife chemical capture program shall notify
the commission within ten calendar days of a change in the designated
person.

18.64.044, 18.64.045, 18.64.046, 18.64.370, 18.64.460, 69.50.310,
18.64.011, 18.64.245, 18.64.470, 18.64.255, 18.64.205, 18.64.253,
18.64.410, 18.64.500, 18.64.590. WSR 20-12-072, § 246-945-500, filed
6/1/20, effective 7/1/20.]

department of fish and wildlife chemical capture programs—Authorized
personnel. (1) Each registered humane society, animal control agency,
and department of fish and wildlife chemical capture program location
shall ensure only authorized personnel possess or administer approved
legend drugs and approved controlled substances at the registered lo-
cation.
(2) For registered humane societies and animal control agencies,
authorized personnel are those individuals who have:
(a) Completed a commission-approved training program or training
that is substantially equivalent; and
(b) Been approved by the designated person.
(3) For registered department of fish and wildlife chemical cap-
ture programs, authorized personnel are those individuals who have:
(a) Completed a commission-approved training program or training
that is substantially equivalent;
(b) Been approved by the department of fish and wildlife; and
(c) Are a department of fish and wildlife officer, biologist, or
veterinarian.
(4) A commission-approved training program shall include didactic
and practical training under the direction of a licensed veterinarian.
The commission-approved training program should ensure that authorized

personnel shall be able to demonstrate adequate knowledge of the po-
tential hazards and proper techniques used in administering approved
legend and controlled substances.

18.64.044, 18.64.045, 18.64.046, 18.64.370, 18.64.460, 69.50.310,
18.64.011, 18.64.245, 18.64.470, 18.64.255, 18.64.205, 18.64.253,
18.64.410, 18.64.500, 18.64.590. WSR 20-12-072, § 246-945-503, filed
6/1/20, effective 7/1/20.]
WAC 246-945-505 Humane societies and animal control agencies—

Approved legend drugs and approved controlled substances. (1) The
following legend drugs are designated as "approved legend drugs" for
use by registered humane societies and animal control agencies for
pre-euthanasia sedation:
(a) Acetylpromazine;
(b) Dexmedetomidine;
(c) Medetomidine; and
(d) Xylazine.
(2) Registered humane societies and animal control agencies may
only use sodium pentobarbital to euthanize injured, sick, homeless or
unwanted domestic pets, and domestic or wild animals.
(3) Any approved drug used by the registered humane society and
animal control agency shall be marked "for veterinary use only."
(4) Staff of registered humane societies and animal control agen-
cies may administer legend drugs and controlled substances which have
been prescribed by a licensed veterinarian for a specific animal,
which have been dispensed by a pharmacy or a veterinarian and are
properly labeled in accordance with either RCW 18.64.246 or 69.41.050
and WAC 246-945-015 through 246-945-017.
18.64.044, 18.64.045, 18.64.046, 18.64.370, 18.64.460, 69.50.310,
18.64.011, 18.64.245, 18.64.470, 18.64.255, 18.64.205, 18.64.253,
18.64.410, 18.64.500, 18.64.590. WSR 20-12-072, § 246-945-505, filed
6/1/20, effective 7/1/20.]
WAC 246-945-507 Department of fish and wildlife chemical capture

programs—Approved legend drugs and approved controlled substances.
(1) The following legend drugs are designated as "approved legend
drugs" for use by registered department of fish and wildlife chemical
capture programs:
(a) Acetylpromazine;
(b) Atipamezole;
(c) Azaperone;
(d) Detomidine;
(e) Dexmedetomidine;
(f) Isoflurane;
(g) Medetomidine;
(h) Naltrexone;
(i) Tolazoline;
(j) Xylazine; and
(k) Yohimbine.

(2) The following controlled substances are controlled substances
approved for use by registered department of fish and wildlife chemi-
cal capture programs:
(a) Butorphanol;
(b) Diazepam;
(c) Diprenorphine;
(d) Carfentanil;
(e) Fentanyl;
(f) Ketamine;
(g) Midazolam;
(h) Tiletamine; and
(i) Zolazepam.
(3) Staff of registered department of fish and wildlife chemical
capture programs may administer legend drugs and controlled substances
which have been prescribed by a licensed veterinarian for a specific
animal or management group of animals, which have been dispensed by a
pharmacy or a veterinarian and are properly labeled in accordance with
either RCW 18.64.246 or 69.41.050 and WAC 246-945-015 through
246-945-017 or 246-933-340 (5)(a) and (b).

18.64.044, 18.64.045, 18.64.046, 18.64.370, 18.64.460, 69.50.310,
18.64.011, 18.64.245, 18.64.470, 18.64.255, 18.64.205, 18.64.253,
18.64.410, 18.64.500, 18.64.590. WSR 20-12-072, § 246-945-507, filed
6/1/20, effective 7/1/20.]

department of fish and wildlife chemical capture programs—Recordkeep-
ing and reports. (1) Each registered humane society, animal control
agency, and department of fish and wildlife chemical capture program
location shall record the receipt, use, and disposition of approved
drugs in a logbook or electronic record. An electronic record can meet
the requirements of this section if the electronic record is legible
and in a readily retrievable format, provided federal law does not re-
quire them to be kept in a hard copy format.
(2) The logbook or electronic record must have sufficient detail
to allow an audit of the drug usage to be performed and must include:
(a) Date and time of administration;
(b) Route of administration;
(c) Identification number or other identifier assigned to the an-
imal;
(d) Estimated weight of the animal;
(e) Estimated age and breed or species of the animal;
(f) Name of drug used;
(g) Dose of drug administered;
(h) Amount of drug wasted; and
(i) Initials of the primary person administering the drug.
(3) The logbook or electronic record may omit subsection (2)(b),
(d), and (e) of this section if the information is recorded in other
records cross-referenced by the animal identification number or other
assigned identifier.
(4) Authorized personnel of the registered entity shall document
any errors or discrepancies in the drug inventory in the logbook or
electronic record and report to the registered entity for investiga-
tion.

(5) The registered entity shall report any unresolved discrepan-
cies in writing to the commission within seven calendar days and to
the DEA if the loss includes a controlled substance.
(6) The designated person shall perform a physical inventory or
count of approved drugs every twelve months. The physical inventory
must be reconciled with the logbook or electronic record.
(7) The designated person or designee shall destroy or waste non-
controlled legend drugs that are unfit for administration. A second
member of the staff shall witness the destruction or waste of drugs.
The destruction or waste of noncontrolled legend drugs will be docu-
mented in the logbook or electronic record with the date of the event
and signatures of the individuals involved.
(8) A registered entity shall return all unwanted or unused ap-
proved controlled substances to the manufacturer or destroy them in
accordance with the rules and requirements of the commission, the DEA,
and the department of ecology. The return or destruction of controlled
substances will be documented in the logbook or electronic record with
the date of the event and signatures of the individuals involved.
(9) A registered entity must maintain a readily retrievable list
of all authorized personnel who have demonstrated the qualifications
to possess and administer approved drugs.
(10) All records of the registered entity must be available for
inspection by the commission or its designee.
(11) The registered entity must maintain the logbook and other
related records in accordance with WAC 246-945-020.

18.64.044, 18.64.045, 18.64.046, 18.64.370, 18.64.460, 69.50.310,
18.64.011, 18.64.245, 18.64.470, 18.64.255, 18.64.205, 18.64.253,
18.64.410, 18.64.500, 18.64.590. WSR 20-12-072, § 246-945-510, filed
6/1/20, effective 7/1/20.]

department of fish and wildlife chemical capture programs—Drug stor-
age and field use. (1) Each registered humane society, animal control
agency, and department of fish and wildlife chemical capture program
location must store all approved legend drugs, and approved controlled
substances in a substantially constructed securely locked cabinet or
drawer.
(2) Only authorized personnel as defined in WAC 246-945-503 (2)
and (3) shall have access to the drug storage cabinet or drawer at the
registered location.
(3) A registered humane society and animal control agency may al-
low the possession of approved drugs for field use under the following
conditions:
(a) The individual meets the requirements of an authorized person
in WAC 246-945-503(2);
(b) The individual is either:
(i) A humane officer;
(ii) An animal control enforcement officer;
(iii) An animal control authority; or
(iv) A peace officer authorized by the chief of police, sheriff,
or county commissioner.
(c) The approved drugs are stored in a locked metal box securely
attached to a vehicle;

(d) A drug inventory is completed at the beginning and end of
each shift, and recorded in a logbook or electronic record that meets
the requirements of WAC 246-945-510; and
(e) All receipts and use of approved drugs are recorded in a log-
book or electronic record that meets the requirements of WAC
246-945-510.
(4) A registered department of fish and wildlife chemical capture
program may allow the possession of approved drugs for field use under
the following conditions:
(a) The individual meets the requirements of an authorized person
in WAC 246-945-503(3);
(b) The approved drugs are stored in a locked metal box securely
attached to a vehicle;
(c) A drug inventory is completed on a monthly basis and recorded
in a logbook or electronic record that meets the requirements of WAC
246-945-510; and
(d) All receipts and use of approved drugs are recorded in a log-
book or electronic record that meets the requirements of WAC
246-945-510.

18.64.044, 18.64.045, 18.64.046, 18.64.370, 18.64.460, 69.50.310,
18.64.011, 18.64.245, 18.64.470, 18.64.255, 18.64.205, 18.64.253,
18.64.410, 18.64.500, 18.64.590. WSR 20-12-072, § 246-945-515, filed
6/1/20, effective 7/1/20.]
Subpart C – Drug Distributors
WAC 246-945-550 Manufacturers—Minimum standards. (1) Manufac-

turers shall comply with the applicable requirements in 21 C.F.R.,
Part 210, "Current Good Manufacturing Practice in Manufacturing, Pro-
cessing, Packing, or Holding of Drugs"; and 21 C.F.R., Part 211, "Cur-
rent Good Manufacturing Practice for Finished Pharmaceuticals; Gener-
al."
(2) Manufacturers required to register with the FDA as an out-
sourcing facility as defined in 21 U.S.C. Sec. 353b(d)(4)(A), shall
also comply with FDA guidance document.
(3) Virtual manufacturers shall ensure its own drugs are manufac-
tured in compliance with this section.

18.64.044, 18.64.045, 18.64.046, 18.64.370, 18.64.460, 69.50.310,
18.64.011, 18.64.245, 18.64.470, 18.64.255, 18.64.205, 18.64.253,
18.64.410, 18.64.500, 18.64.590. WSR 20-12-072, § 246-945-550, filed
6/1/20, effective 7/1/20.]
WAC 246-945-553 Teat dip containers. The reuse of teat dip con-
tainers and closures shall be allowed under the following circumstan-
ces:
(1) Teat dip containers for reuse must have attached a labeling
panel bearing product name, brand name and distributor address if mar-
keted by other than the manufacturer, manufacturer name and address,

product strength, quantity, expiration date, directions for use, and
appropriate cautionary statements for the product contained within.
(2) All reusable teat dip containers will be hot stamped for per-
manent identification as teat dip containers. The hot stamp shall im-
print on the plastic container, in an immutable manner, the words
"teat dip only" and the manufacturer's name. Teat dip manufacturers
may only refill containers bearing their company name.
(3) With cooperation from dairy producers, dairy sanitarians will
take random samples of teat dip in reusable containers while on regu-
lar farm inspections. The samples, along with appropriate label infor-
mation, will be forwarded to the commission for analysis to ensure
that the product meets label specifications and is free of contamina-
tion.
(4) Reusable teat dip containers shall not be reactive, additive,
or absorptive so as to alter the safety, identity, strength, quantity,
or purity of the product.
(5) Upon return to the manufacturer, reusable teat dip containers
shall be cleaned and sanitized. To ensure adequate cleaning occurs,
the commission may require a manufacturer to submit and have approved
a cleaning procedure. Containers showing structural damage, or any
signs of being used for substances or materials other than teat dip
shall not be reused as teat dip containers.

18.64.044, 18.64.045, 18.64.046, 18.64.370, 18.64.460, 69.50.310,
18.64.011, 18.64.245, 18.64.470, 18.64.255, 18.64.205, 18.64.253,
18.64.410, 18.64.500, 18.64.590. WSR 20-12-072, § 246-945-553, filed
6/1/20, effective 7/1/20.]
WAC 246-945-555 Wholesaler—Minimum standards—Scope. (1) WAC

246-945-560 through 246-945-600 establish the minimum standards for
facilities licensed as wholesalers, their officers, designated repre-
sentatives, agents, and employees.
(2) Virtual wholesalers shall ensure drugs they purchase or sell
are stored and distributed in compliance with WAC 246-945-560 through
246-945-600.

18.64.044, 18.64.045, 18.64.046, 18.64.370, 18.64.460, 69.50.310,
18.64.011, 18.64.245, 18.64.470, 18.64.255, 18.64.205, 18.64.253,
18.64.410, 18.64.500, 18.64.590. WSR 20-12-072, § 246-945-555, filed
6/1/20, effective 7/1/20.]
WAC 246-945-560 Wholesaler—Facility standards. (1) Facilities

used for wholesale drug distribution must:
(a) Be of suitable size, construction, and location to accommo-
date cleaning, maintenance, and proper operations;
(b) Have storage areas that provide adequate lighting, ventila-
tion, temperature, sanitation, humidity, space, equipment, and securi-
ty;
(c) Have a quarantine area for storage of drugs that are outda-
ted, damaged, deteriorated, misbranded, adulterated, counterfeit, or
suspected of being counterfeit, otherwise unfit for distribution, or

that are in immediate or sealed secondary containers that have been
opened;
(d) Be maintained in a clean and orderly condition;
(e) Be free from infestation of any kind;
(f) Be a commercial location and not a personal dwelling or resi-
dence;
(g) Provide for the secure and confidential storage of informa-
tion with restricted access and policies and procedures to protect the
integrity and confidentiality of information; and
(h) Provide and maintain appropriate inventory controls in order
to detect and document any theft, counterfeiting, or diversion of
drugs.
(2) Facilities used for wholesale drug distribution must be se-
cure from unauthorized entry, as follows:
(a) Access from outside the premises must be kept to a minimum
and well controlled;
(b) The outside perimeter of the premises must be well lit;
(c) Entry into areas where drugs are held must be limited to au-
thorized personnel;
(d) Facilities must be equipped with an alarm system to detect
entry after hours; and
(e) Facilities must be equipped with security systems sufficient
to protect against theft, diversion, or record tampering.

18.64.044, 18.64.045, 18.64.046, 18.64.370, 18.64.460, 69.50.310,
18.64.011, 18.64.245, 18.64.470, 18.64.255, 18.64.205, 18.64.253,
18.64.410, 18.64.500, 18.64.590. WSR 20-12-072, § 246-945-560, filed
6/1/20, effective 7/1/20.]
WAC 246-945-565 Wholesaler—Drug storage. (1) Drugs must be

stored at temperatures and under conditions required by the labeling
of the drugs, if any, or by the requirements of the 43rd edition of
USP and 38th edition of the National Formulary (USP/NF), to preserve
product identity, strength, quality, and purity. The USP/NF is availa-
ble for public inspection at the commission's office at Department of
Health, Town Center 2, 111 Israel Road S.E., Tumwater, WA 98501. Re-
questors may also contact USP directly to obtain copies.
(2) If no storage requirements are established for a drug, the
drug may be held at "controlled" room temperature, as defined in an
official compendium, to help ensure that its identity, strength, qual-
ity, and purity are not adversely affected.
(3) Temperature and humidity recording equipment, devices, and/or
logs shall be used to document proper storage of drugs.
(4) Controlled substance drugs should be isolated from noncon-
trolled substance drugs and stored in a secured area.
(5) Drugs that are outdated, damaged, deteriorated, misbranded,
or adulterated must be physically separated from other drugs in a des-
ignated quarantine area until destroyed or returned to the original
manufacturer or third party returns processor.
(6) Used drugs and those whose immediate or sealed outer or
sealed secondary containers have been opened are adulterated and must
be quarantined.
(7) Drugs must be quarantined under any condition that causes
doubt as to a drug's safety, identity, strength, quality, or purity

unless under examination, testing, or other investigation the drug is
proven to meet required standards.

18.64.044, 18.64.045, 18.64.046, 18.64.370, 18.64.460, 69.50.310,
18.64.011, 18.64.245, 18.64.470, 18.64.255, 18.64.205, 18.64.253,
18.64.410, 18.64.500, 18.64.590. WSR 20-12-072, § 246-945-565, filed
6/1/20, effective 7/1/20.]
WAC 246-945-570 Wholesaler—Drug shipment inspection. (1) Each

outside shipping container must be visually examined on receipt for
identity and to avoid acceptance of drugs that are contaminated or
otherwise unfit for distribution.
(2) Outgoing shipments must be inspected to verify the accuracy
and product integrity of the shipment contents.

18.64.044, 18.64.045, 18.64.046, 18.64.370, 18.64.460, 69.50.310,
18.64.011, 18.64.245, 18.64.470, 18.64.255, 18.64.205, 18.64.253,
18.64.410, 18.64.500, 18.64.590. WSR 20-12-072, § 246-945-570, filed
6/1/20, effective 7/1/20.]
WAC 246-945-575 Wholesaler—Recordkeeping. (1) Wholesalers and

other entities engaged in wholesale drug distribution must establish
and maintain inventories and records of transactions pertaining to the
receipt and distribution or other disposition of drugs. The records
must include at least:
(a) The source of the drugs, including the name and principal ad-
dress of the seller or transferor;
(b) The identity and quantity of the drugs received and distrib-
uted or disposed of; and
(c) The dates of receipt and distribution or other disposition of
the drugs.
(2) Records must be retained in a readily retrievable manner in
accordance with WAC 246-945-020.

18.64.044, 18.64.045, 18.64.046, 18.64.370, 18.64.460, 69.50.310,
18.64.011, 18.64.245, 18.64.470, 18.64.255, 18.64.205, 18.64.253,
18.64.410, 18.64.500, 18.64.590. WSR 20-12-072, § 246-945-575, filed
6/1/20, effective 7/1/20.]
WAC 246-945-580 Wholesaler—Personnel. (1) A wholesaler must

establish and maintain a list of officers, directors, managers, a des-
ignated representative, and other persons responsible for wholesale
drug distribution, storage, and handling and must include a descrip-
tion of each individual's duties and a summary of their qualifica-
tions.
(2) A wholesaler must employ personnel in sufficient numbers and
with adequate education, training, and experience to safely and law-
fully engage in wholesale drug distribution activities.

18.64.044, 18.64.045, 18.64.046, 18.64.370, 18.64.460, 69.50.310,
18.64.011, 18.64.245, 18.64.470, 18.64.255, 18.64.205, 18.64.253,
18.64.410, 18.64.500, 18.64.590. WSR 20-12-072, § 246-945-580, filed
6/1/20, effective 7/1/20.]
WAC 246-945-585 Wholesaler—Suspicious orders and due diligence.

(1) Wholesalers shall design and operate a system to identify and re-
port suspicious orders of controlled substances and drugs of concern
to the commission.
(a) Suspicious orders shall be submitted electronically through a
commission approved system or to the commission or within five busi-
ness days of the order being identified as suspicious by the wholesal-
er, and must include, but not necessarily limited to:
(i) Customer name;
(ii) Customer address;
(iii) Customer DEA registration number;
(iv) State license number(s);
(v) Transaction date;
(vi) Drug name;
(vii) NDC number;
(viii) Quantity ordered; and
(ix) Indication of whether the drug was shipped, and if not, the
factual basis for the refusal to supply.
(b) Zero reports shall be submitted if no suspicious orders have
been identified in a calendar month, and such reports shall be submit-
ted within fifteen business days of the end of the calendar month.
(c) Wholesalers may apply to the commission for an exemption from
the reporting requirements if they do not distribute controlled sub-
stances or drugs of concern.
(2) Except as provided in subsection (3) of this section, a
wholesaler shall exercise due diligence to identify customers ordering
or seeking to order controlled substances or drugs of concern, and es-
tablish the normal and expected transactions conducted by those cus-
tomers, as well as to identify and prevent the sale of controlled sub-
stances or drugs of concern that are likely to be diverted from legit-
imate channels. Such due diligence measures shall include, but are not
limited to, the following, which shall be conducted prior to an ini-
tial sale and on a regular basis, as necessary:
(a) Questionnaires and affirmative steps by the wholesaler to
confirm the accuracy and validity of the information provided, it
shall be considered illegal for a customer to provide false or mis-
leading information;
(b) For a customer who is a prescriber, confirmation of prescrib-
er type, specialty practice area, and if the prescriber personally
furnishes controlled substances or drugs of concern, the quantity fur-
nished;
(c) Review of drug utilization reports; and
(d) Obtaining and conducting a review of the following:
(i) Methods of payment accepted and in what ratios;
(ii) The ratio of controlled versus noncontrolled prescriptions
and overall sales;

(iii) Orders for controlled substances or drugs of concern from
other wholesalers U.S. DEA's Automation of Reports and Consolidated
Orders System (ARCOS); and
(iv) The ratio of out-of-state patients served compared to in-
state patients.
(3) A wholesaler receiving a request for an initial sale of a
controlled substance or drugs of concern may conduct the sale before
complying with subsection (2) of this section if all of the following
apply:
(a) The sale is to a new customer;
(b) The wholesaler documents that the order is to meet an emer-
gent need;
(c) The wholesaler completes the requirements of subsection (2)
of this section no later than sixty business days from the date of
sale.
(4) A wholesaler receiving a request from an existing customer to
purchase a controlled substance or drug of concern, the size/quantity
of which exceeds the established algorithm limitations or quota re-
strictions for such customer, may sell the drug of concern or control-
led substance provided the customer submit documentation explaining
the request.
(5) Any customer that is believed to be engaged in potential di-
version activity, including those to whom a wholesaler refuses to
sell, shall be electronically reported to the commission. Such reports
shall include:
(a) Customer name;
(b) Customer address;
(c) DEA number;
(d) State license number(s);
(e) A detailed explanation of why the wholesaler identified the
customer as a possible diversion risk; and
(f) Such reports shall be submitted within thirty days of refus-
al, cessation, or identification by wholesaler.
(6) All licensed wholesalers shall submit all reports to the com-
mission in a DEA ARCOS format where applicable.

18.64.044, 18.64.045, 18.64.046, 18.64.370, 18.64.460, 69.50.310,
18.64.011, 18.64.245, 18.64.470, 18.64.255, 18.64.205, 18.64.253,
18.64.410, 18.64.500, 18.64.590. WSR 20-12-072, § 246-945-585, filed
6/1/20, effective 7/1/20.]
WAC 246-945-590 Wholesaler—Policies and procedures. Wholesal-

ers shall establish, maintain, and adhere to written policies and pro-
cedures, which shall be followed for the receipt, security, storage,
inventory, transport, and shipping and wholesale distribution of
drugs, including policies and procedures for identifying, recording,
and reporting losses or thefts and for correcting all errors and inac-
curacies in inventories. Wholesalers shall include the following in
their written policies and procedures:
(1) A procedure to be followed for handling recalls and withdraw-
als of drugs. Such procedure shall be adequate to deal with recalls
and withdrawals due to:

(a) Any action initiated at the request of FDA or any other fed-
eral, state, or local law enforcement or other government agency, in-
cluding the commission; or
(b) Any volunteer action by the manufacturer to remove defective
or potentially defective drugs from the market.
(2) A procedure to ensure that wholesalers prepare for, protect
against, and handle any crisis that affects security or operation of
any facility in the event of a strike, fire, flood, or other natural
disaster, or other situations of local, state, or national emergency.
(3) A procedure to ensure that any outdated drugs shall be segre-
gated from other drugs and either returned to the manufacturer or de-
stroyed in accordance with federal and state laws, including all nec-
essary documentation and the appropriate witnessing. This procedure
shall provide for written documentation of the disposition of outdated
drugs.
(4) A procedure for the destruction of outdated drugs in accord-
ance with federal and state laws.
(5) A procedure for the disposing and destruction of containers,
labels, and packaging to ensure that the containers, labels, and pack-
aging cannot be used in counterfeiting activities, including all nec-
essary documentation, and the appropriate witnessing of the destruc-
tion of any labels, packaging, immediate containers, or containers in
accordance with all applicable federal and state requirements.
(6) A procedure for identifying, investigating, and reporting
significant drug inventory discrepancies involving counterfeit, sus-
pect of being counterfeit, contraband, or suspect of being contraband,
in the inventory and reporting of such discrepancies as required to
the FDA, commission and/or appropriate federal or state agency upon
discovery of such discrepancies.
(7) A procedure for reporting criminal or suspected criminal ac-
tivities involving the inventory of drug(s) as required to the commis-
sion, FDA, and if applicable, DEA.
(8) Procedures addressing:
(a) The design and operation of the suspicious order monitoring
and reporting system;
(b) Mandatory annual training for staff responsible for identify-
ing and reporting suspicious orders and potential diversion activi-
ties. Such training must include the following:
(i) The wholesaler's suspicious order monitoring system;
(ii) The process to collect all relevant information on customers
in accordance with WAC 246-960-330; and
(iii) The requirement and process for submission of suspicious
order and information on customers who engage in potential diversion
activities.
(9) A procedure for timely responding to customers who submit
purchase orders for patients with emergent needs.

18.64.044, 18.64.045, 18.64.046, 18.64.370, 18.64.460, 69.50.310,
18.64.011, 18.64.245, 18.64.470, 18.64.255, 18.64.205, 18.64.253,
18.64.410, 18.64.500, 18.64.590. WSR 20-12-072, § 246-945-590, filed
6/1/20, effective 7/1/20.]
WAC 246-945-595 Wholesaler and manufacturer—Prohibited acts.

It is unlawful for a wholesaler or manufacturer to perform, cause the

performance of, or aid and abet any of the following acts in Washing-
ton state:
(1) The manufacture, repackaging, sale, delivery, or holding or
offering for sale any drug that is adulterated, misbranded, counter-
feit, suspected of being counterfeit, or has otherwise been rendered
unfit for distribution or wholesale distribution;
(2) The adulteration, misbranding, or counterfeiting of any drug;
(3) The alteration, mutilation, destruction, obliteration, or re-
moval of the whole or any part of the product labeling of a drug or
the commission of any other act with respect to a drug that results in
the drug being misbranded;
(4) The forging, counterfeiting, simulating, or falsely repre-
senting of any drug without the authority of the manufacturer, or us-
ing any mark, stamp, tag, label, or other identification device with-
out the authorization of the manufacturer;
(5) The purchase or receipt of a drug from a person that is not
authorized to distribute drugs to that purchaser or recipient;
(6) The sale or transfer of a drug to a person who is not legally
authorized to receive a drug;
(7) The sale or transfer of a drug from pharmacies to distribu-
tors for resale;
(8) The failure to maintain or provide records as required by
laws and rules;
(9) Providing the commission or any of its representatives or any
state or federal official with false or fraudulent records or making
false or fraudulent statements regarding any matter within the provi-
sions of these laws and rules;
(10) The obtaining of or attempting to obtain a drug by fraud,
deceit, misrepresentation or engaging in misrepresentation or fraud in
the distribution or wholesale distribution of a drug;
(11) The distribution of a drug to the patient without a pre-
scription from a practitioner licensed by law to use or prescribe the
drug; and
(12) The distribution or wholesale distribution of a drug that
was previously dispensed by a pharmacy or distributed by a practition-
er.

18.64.044, 18.64.045, 18.64.046, 18.64.370, 18.64.460, 69.50.310,
18.64.011, 18.64.245, 18.64.470, 18.64.255, 18.64.205, 18.64.253,
18.64.410, 18.64.500, 18.64.590. WSR 20-12-072, § 246-945-595, filed
6/1/20, effective 7/1/20.]
WAC 246-945-600 Salvaging and reprocessing. Wholesalers shall

be subject to the provisions of any applicable federal, state, or lo-
cal laws or rules that relate to prescription drug salvaging or re-
processing, including Chapter 21, Parts 207, 210, and 211k of the Code
of Federal Regulations.

18.64.044, 18.64.045, 18.64.046, 18.64.370, 18.64.460, 69.50.310,
18.64.011, 18.64.245, 18.64.470, 18.64.255, 18.64.205, 18.64.253,
18.64.410, 18.64.500, 18.64.590. WSR 20-12-072, § 246-945-600, filed
6/1/20, effective 7/1/20.]

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Chapter 246-945 WAC

PHARMACY QUALITY ASSURANCE COMMISSION

PART 1 - GENERAL PROVISIONS

Certified on 7/9/2020 Page 1

Subpart A – Pharmacies, HCEs and HPACs

Certified on 7/9/2020 Page 2

PART 1 - GENERAL PROVISIONS

WAC 246-945-001 Definitions. The definitions in chapters 18.64

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[Statutory Authority: RCW 18.64.005, 18.64.080, 18.130.075, 18.64.043,

Subpart A - Commission Operations

WAC 246-945-002 Administrative proceedings and appeals. (1) The

Certified on 7/9/2020 Page 9

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[Statutory Authority: RCW 18.64.005, 18.64.080, 18.130.075, 18.64.043,

Subpart B - Prescription Labeling, Records, and Advertising

WAC 246-945-010 Prescription and chart order—Minimum require-

Certified on 7/9/2020 Page 11

[Statutory Authority: RCW 18.64.005, 18.64.080, 18.130.075, 18.64.043,

WAC 246-945-011 Prescription validity. (1) Prior to dispensing

Certified on 7/9/2020 Page 12

[Statutory Authority: RCW 18.64.005, 18.64.080, 18.130.075, 18.64.043,

WAC 246-945-012 Prescription refills. (1) A prescription for a

WAC 246-945-013 Partial filling of prescriptions. (1) A pharma-

[Statutory Authority: RCW 18.64.005, 18.64.080, 18.130.075, 18.64.043,

Certified on 7/9/2020 Page 13

WAC 246-945-016 Prescriptions—Outpatient labels—Minimum re-

[Statutory Authority: RCW 18.64.005, 18.64.080, 18.130.075, 18.64.043,

Certified on 7/9/2020 Page 14

[Statutory Authority: RCW 18.64.005, 18.64.080, 18.130.075, 18.64.043,

WAC 246-945-018 Prescriptions—Labeling—Prepackage medications.

[Statutory Authority: RCW 18.64.005, 18.64.080, 18.130.075, 18.64.043,

WAC 246-945-020 Records retention period and commission access

[Statutory Authority: RCW 18.64.005, 18.64.080, 18.130.075, 18.64.043,

Certified on 7/9/2020 Page 15

[Statutory Authority: RCW 18.64.005, 18.64.080, 18.130.075, 18.64.043,

Subpart C - Legend Drugs and Controlled Substances

WAC 246-945-030 Identification of legend drugs for purposes of

Certified on 7/9/2020 Page 16

[Statutory Authority: RCW 18.64.005, 18.64.080, 18.130.075, 18.64.043,

WAC 246-945-031 Ephedrine prescription restrictions. (1) The

Certified on 7/9/2020 Page 17

(3) Ma Huang or other botanical products of genus ephedra used in

[Statutory Authority: RCW 18.64.005, 18.64.080, 18.130.075, 18.64.043,

WAC 246-945-032 Child-resistant containers. (1) All legend

Certified on 7/9/2020 Page 18

[Statutory Authority: RCW 18.64.005, 18.64.080, 18.130.075, 18.64.043,

WAC 246-945-033 Over-the-counter drugs. Except as provided in

[Statutory Authority: RCW 18.64.005, 18.64.080, 18.130.075, 18.64.043,

WAC 246-945-035 Drug sample prohibitions. (1) Except as provi-

[Statutory Authority: RCW 18.64.005, 18.64.080, 18.130.075, 18.64.043,

WAC 246-945-037 Regulated steroids. The following drugs are

Certified on 7/9/2020 Page 19

WAC 246-945-038 Availability and identity of amygdalin. (1)