246-945-550 - Manufacturers-Minimum standards

246-945-550. Manufacturers-Minimum standards

(1) Manufacturers shall comply with the applicable requirements in 21 C.F.R., Part 210, "Current Good Manufacturing Practice in Manufacturing, Processing, Packing, or Holding of Drugs"; and 21 C.F.R., Part 211, "Current Good Manufacturing Practice for Finished Pharmaceuticals; General."

(2) Manufacturers required to register with the FDA as an outsourcing 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 manufactured in compliance with this section.

(Adopted by WSR 20-12-072, Filed 6/1/2020, effective 7/1/2020, and 3/1/2021)

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