Nonrulemaking

Requests that the FDA within 180 days of the date of this Citizen Petition, 1. Publish a notice in the Federal Register excluding semaglutide from the 503B Bulks List; 2. Rescind in its entirety the Interim Policy on Compounding Using Bulk Drug Substances Under Section 503B of the Federal Food, Drug, and Cosmetic Act (“503B Interim Policy”); 3. Exclude semaglutide from Category 1

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