#compounding-ban

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Editorial lifestyle photograph of official documents on an oak desk illustrating a regulatory proposal

News News & PipelineMay 8, 2026• 7 min read

FDA Proposes 503B Bulk-Compounding Exclusions for Semaglutide, Tirzepatide & Liraglutide

Verified May 8, 2026, Updated August 12, 2026: On April 30, FDA proposed excluding semaglutide, tirzepatide, and liraglutide from the list of bulk substances that 503B outsourcing facilities may use based on clinical need. The public comment period closed July 30, 2026 (Docket FDA-2018-N-3240; extension notice 91 FR 38719, published June 26, 2026). Days before that deadline, the Pharmacy Compounding Advisory Committee voted on seven peptides nominated for the separate 503A list and recommended six. Those votes are advisory, not FDA approval, and the 503B proposal was not final when last checked.

#compounding-ban

FDA Proposes 503B Bulk-Compounding Exclusions for Semaglutide, Tirzepatide & Liraglutide

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