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GLP-1 medications like semaglutide (Ozempic) and tirzepatide (Mounjaro) have traditionally been used to treat diabetes. They work by mimicking a natural hormone called GLP-1, which helps regulate blood sugar levels and appetite.

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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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