Breaking GLP-1 updates: FDA actions, drug launches, Medicare changes, compounding enforcement.
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FDA resolved the semaglutide shortage on February 21, 2025 and ended temporary shortage-based enforcement discretion on April 22 for 503A pharmacies and May 22 for 503B facilities. This guide separates those dates from FDA's pending 503B bulk-list proposal and compares paths to discuss with a prescriber.
June 19, 2026
13 min read
Verified May 8, 2026, Updated August 30, 2026: On April 30, FDA proposed excluding semaglutide, tirzepatide, and liraglutide from the list of bulk substances that 503B outsourcing facilities may use based on clinical need. The public comment period closed July 30, 2026 (Docket FDA-2018-N-3240; extension notice 91 FR 38719, published June 26, 2026). Separately, on August 27, 2026 the Fifth Circuit affirmed the district court in both shortage-delisting appeals, Nos. 25-10600 (tirzepatide) and 25-10758 (semaglutide), leaving the 2024 and 2025 delistings in place without changing what a patient can obtain today. Days before the comment deadline, the Pharmacy Compounding Advisory Committee voted on seven peptides nominated for the separate 503A list and recommended six. Those votes are advisory, not FDA approval, and the 503B proposal was not final when last checked.
May 8, 2026
7 min read
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