Washington Administrative Code › Title 246 - Health, Department of › PROFESSIONAL STANDARDS AND LICENSING › Chapter 246-945 - Pharmacy quality assurance commission › Part 1 - GENERAL PROVISIONS › Subpart C - Legend Drugs and Controlled Substances › Section 246-945-040 - Uniform Controlled Substance Act

Current through Register Vol. 24-14, July 15, 2024
(1) The commission
					 adopts and incorporates Title 21 of the Code of Federal Regulations in effect
					 as of March 2, 2023, by reference. The following sections of 21 C.F.R. do not
					 apply: Sec. 6.1 - 6.5, Sec. 58.1 - 58.15, Sec. 83 -98, Sec. 100 - 199, Sec. 225
					 - 226, Sec. 291, Sec. 370 - 499, Sec. 501.1 - 501.110, Sec. 502.5 - 502.19,
					 Sec. 505, Sec. 507.1 - 507.215, Sec. 508, Sec. 509.3 - 509.30, Sec. 536, 539,
					 540, 544, 546, 548, 555, and 564, Sec. 556.1 - 556.770, Sec. 558.3 - 558.665,
					 Sec. 570, 571, and 573, Sec. 579.12 - 579.40, Sec. 584, Sec. 589, Sec. 590 -
					 599, Sec. 601 - 607, Sec. 620, Sec. 630.1 - 630.40, Sec. 640.1 - 640.130, Sec.
					 650, Sec. 700 - 799, Sec. 804 - 805, Sec. 813, Sec. 897, Sec. 900, Sec. 1000 -
					 1050, Sec. 1100 - 1150, Sec. 1210.1 - 1210.31, Sec. 1220, Sec. 1240.3 -
					 1240.95, Sec. 1250.3 - 1250.96, Sec. 1251 - 1269, Sec. 1270.1 - 1270.43, Sec.
					 1271.1 - 1271.440, Sec. 1272 - 1299, Sec. 1301.13, Sec. 1301.28, Sec. 1301.33,
					 Sec. 1301.35 - 1301.46, Sec. 1308.41 - 1308.45, Sec. 1316.31 - 1316.67, and
					 Sec. 1400 through 1499. Any inconsistencies between the material incorporated
					 by reference in this subsection and the remainder of this chapter should be
					 resolved in favor of this chapter. Nothing in this chapter applies to the
					 production, processing, distribution, or possession of marijuana as authorized
					 and regulated by the Washington state liquor and cannabis board.
(2) Copies of the reference material listed
					 in subsection (1) 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. Requestors may also access copies at
https://www.ecfr.gov/current/title-21
.
(3) Registration. A separate registration is
					 required for each place of business, as defined in
					 21 C.F.R. Sec.
					 1301.12, where controlled substances are
					 manufactured, distributed, or dispensed. Application for registration must be
					 made on forms supplied by the commission, and all requested information must be
					 supplied unless the information 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.
(4) Recordkeeping and inventory. Every
					 registrant shall keep and maintain inventory records required by
					 21 C.F.R. Sec.
					 1304.04. Registrants 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 document regardless of how titled from
					 wholesalers, manufacturers, or any other entity to which the substances were
					 distributed and prescriptions 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 transferred 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.