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Deadlines For Compounding GLP1s (Semaglutide & Tirzepatide) Stay up to date on the FDA’s opinion at their website HERE. 503As must stop compounding GLP1s as of April 24, 2025. While 503Bs must stop by May 22, 2025 Tirzepatide: Injunction denied. 503As must stop compounding GLP1s as of March 5, 2025.
Rumore, PharmD, Esq, MS, LLM, FAPhA Key Takeaways The removal of tirzepatide and semaglutide from the FDA's shortage list impacts 503A compounders, requiring adherence to complex legal and regulatory frameworks. 1 For 503A pharmacy compounders, there are limited but clearly proscribed circumstances that GLP-1 compounding may continue.
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