September 1, 2023

APC comments on 503B wholesaling guidance, drug shortages

Earlier this week, APC submitted comments to the FDA docket regarding the draft guidance for industry, “Prohibition on Wholesaling Under Section 503B of the Federal Food, Drug, and Cosmetic Act Guidance for Industry.” The comments are in support of the draft GFI but request several specific clarifications be included in a final GFI. 

Last Friday, APC submitted comments to the Energy & Commerce committee on drug shortages to encourage the inclusion of HR 167 in any legislation to address drug shortages that the committee may pursue.