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2 articles tagged #regulation.

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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 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.

Editorial photograph illustrating Medicare GLP-1 policy and federal regulatory framework
NewsNews & PipelineApril 16, 2026• 6 min read

RFK Jr. Proposes Medicare GLP-1 'Framework' (April 2026): Glucose Monitors First, Coverage Second

HHS Secretary Robert F. Kennedy Jr. is considering a regulatory framework for Medicare and Medicaid GLP-1 coverage, but only for patients who have 'exhausted other options', specifically glucose monitors (~$80/month), diet changes, and exercise. Verified April 2026: what Kennedy said on CBS News April 15 and at the House Ways and Means hearing April 16, how the gate would work, and how it stacks with the already-announced Medicare GLP-1 Bridge live as of July 2026.

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