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fda warning glp-1 compounded semaglutide september 2025 September 2, 2025: U.S. compounding restrictions have stemmed a flood of compounded semaglutide and tirzepatide – Partnership for Safe Medicines

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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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