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Grace periods for compounders ended April 22 (503A) and May 22, 2025 (503B); tirzepatide’s shortage ended December 19, 2024.
The FDA determined on February 21, 2025 that the semaglutide (Wegovy, Ozempic) shortage was resolved. Its enforcement discretion for compounding pharmacies ended April 22, 2025 for 503A pharmacies and May 22, 2025 for 503B outsourcing facilities. The tirzepatide (Zepbound, Mounjaro) shortage had been resolved on December 19, 2024, with compounder grace periods ending February 18 and March 19, 2025. This is why compounded GLP-1s are no longer broadly available as shortage copies.