(1) Manufacturers shall comply with the applicable requirements in 21 C.F.R., Sec. 210, "Current Good Manufacturing Practice in Manufacturing, Processing, Packing, or Holding of Drugs"; and 21 C.F.R., Sec. 211, "Current Good Manufacturing Practice for Finished Pharmaceuticals; General" in effect as of March 7, 2024.
(2) Manufacturers required to register with the FDA as an outsourcing facility as defined in 21 U.S.C. Sec. 353b (d)(4)(A) in effect as of March 7, 2024, shall also comply with FDA guidance document.
(3) Virtual manufacturers shall ensure its own drugs are manufactured in compliance with this section.
(4) Copies of the reference material listed in 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.
[Statutory Authority: RCW
18.64.005,
69.41.075, and
69.50.301. WSR 24-21-069, s 246-945-550, filed 10/11/24, effective 11/11/24. 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, § 246-945-550, filed 6/1/20, effective 7/1/20.]