(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.
(5) Credential holders and pharmaceutical firms shall maintain records for Schedule II drugs separately from all other records.
(6) Credential holders and pharmaceutical firms may maintain records for Schedule III, IV, and V drugs either separately or in a form that is readily retrievable from the business records of the registrant.
(7) A federal order form is required for each distribution of a Schedule I or II controlled substance. Credential holders and pharmaceutical firms must keep and make readily available these forms and other records to the commission or its designee.
