FDA Proposes Exclusion of Semaglutide, Tirzepatide, and Liraglutide from 503B Bulks List, Citing No Clinical Need
The U.S. Food and Drug Administration (FDA) has announced a proposal to exclude semaglutide, tirzepatide, and liraglutide from the 503B bulks list, which identifies bulk drug substances that outsourcing facilities may use in compounding. This decision follows a review process where the FDA found no clinical need for these drugs to be compounded from bulk substances. The 503B bulks list is part of the Federal Food, Drug, and Cosmetic Act, which regulates the compounding of drugs by outsourcing facilities. The FDA's proposal is based on the availability of FDA-approved drugs and the lack of sufficient evidence to justify the inclusion of these substances on the list. The agency is inviting public comments on this proposal until June 29, 2026, before making a final determination. 
