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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.

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.

HHS Secretary Robert F. Kennedy Jr. is considering a regulatory framework for Medicare and Medicaid GLP-1 coverage, but only for patients who have 'exhausted other options', specifically glucose monitors (~$80/month), diet changes, and exercise. Verified April 2026: what Kennedy said on CBS News April 15 and at the House Ways and Means hearing April 16, how the gate would work, and how it stacks with the already-announced Medicare GLP-1 Bridge live as of July 2026.

Launch record updated August 14, 2026: Foundayo began shipping April 6. Its $649 figure is WAC/list price, not the current LillyDirect self-pay total. Cash pricing now runs $149-$349 by dose and refill timing; eligible commercial-insurance savings may lower the copay.

A source-bounded guide to FDA warning letters involving compounded GLP-1 marketing, labeling, and manufacturing. Our linked tracker is finite and does not certify safety or compliance.

The FDA just approved Eli Lilly's Foundayo (orforglipron), the only GLP-1 weight loss pill with no food, water, or timing restrictions. Here's what it costs, how it works, and how it compares to Wegovy and Zepbound.