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FDA restricts non-approved compounded GLP-1 weight loss products

Chronic kidney disease, complex conditions, and advancing therapeutics: new hope and challenges - The Lancet

The FDA has proposed to bar 503B outsourcing facilities from bulk compounding semaglutide and tirzepatide. The shortage-list pathway already closed in 2024 and 2025; this proposal would remove the remaining bulks-list route.

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