#503b

2 articles tagged #503b.

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Editorial lifestyle photograph of official documents on an oak desk illustrating a regulatory proposal
NewsNews & PipelineMay 8, 2026• 7 min read

FDA Proposes Permanent 503B Compounding Ban for Semaglutide, Tirzepatide & Liraglutide

Verified May 8, 2026, Updated June 29, 2026: On April 30, FDA proposed permanently removing semaglutide, tirzepatide, and liraglutide from the 503B outsourcing bulk list, forever, not just during shortage enforcement. Public comment period extended to July 30, 2026 (from June 29 via Federal Register 2026-12937, published June 26, 2026). If finalized, no 503B pharmacy could bulk-compound these GLP-1 drugs in the future, even if a new shortage is declared. 503A patient-specific compounding under medical-necessity remains unaffected.

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