The Wholesaling Prohibition (Potentially) Demystified? FDA’s Take on Supply Chains for Section 503B Outsourcing Facilities
FDA Law Blog
JULY 5, 2023
Palmer — Last week FDA published a long-awaited Draft Guidance for outsourcing facilities addressing the Prohibition on Wholesaling Under Section 503B of the Federal Food, Drug, and Cosmetic Act (Draft Guidance). See 21 U.S.C. 353b(a)(8). Section II at 2. the wholesale distributor, repackager, relabeler).
Let's personalize your content