#compounding-ban

1 article tagged #compounding-ban.

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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: 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 closes June 29, 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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