FDA ends semaglutide shortage

The Food and Drug Administration says the U.S. semaglutide shortage is over, ending the main legal opening that let mass-market compounders make copycat versions. (fda.gov) The agency made that determination on February 21, 2025, after reviewing supply information for Novo Nordisk’s semaglutide injections, Ozempic and Wegovy. FDA said U.S. supply now meets or exceeds current and projected demand. (fda.gov) That change carried deadlines for compounders. FDA said state-licensed pharmacies and physicians operating under section 503A could keep compounding semaglutide injections until April 22, 2025, while larger outsourcing facilities under section 503B had until May 22, 2025, after a Texas court denied a preliminary injunction on April 24, 2025. (fda.gov) Semaglutide is the active ingredient in Ozempic and Wegovy, part of a class of drugs called glucagon-like peptide-1 agonists that are used for diabetes and obesity. When a drug is on the FDA shortage list, compounders can more easily make versions of it; when the shortage ends, that exception largely disappears. (fda.gov) The shortage lasted nearly three years after demand surged. A JAMA Health Forum research letter found monthly semaglutide fills rose 442%, from 471,876 in January 2021 to 2,555,308 in December 2023. (jamanetwork.com) Patients may still run into gaps at the pharmacy counter even after the national shortage designation ended. Pharmacy Times reported on February 27, 2025, that localized availability problems could persist as supply moves through wholesalers, pharmacies, and specific dose strengths. (pharmacytimes.com) The end of the shortage also sharpened a legal fight with the Outsourcing Facilities Association, which sued the FDA in federal court in Texas and argued the agency acted too quickly in declaring the shortage resolved. FDA’s April 28, 2025 update says the court denied the group’s preliminary injunction request. (fda.gov) Since then, FDA has widened its scrutiny beyond supply. On March 12, 2026, the agency said it sent 30 warning letters to telehealth companies over “false and misleading” claims about compounded glucagon-like peptide-1 products sold online. (fda.gov) FDA has also warned that compounded glucagon-like peptide-1 drugs are not FDA-approved and that some injectable products have arrived warm, with inadequate ice packs, or with quality concerns tied to imported active ingredients. The agency said patients should use a prescription from a clinician and fill it at a state-licensed pharmacy. (fda.gov) For patients, the practical shift is simple: Ozempic and Wegovy are no longer officially in shortage, but access may still depend on dose, pharmacy inventory, and whether a seller is offering an FDA-approved drug or a compounded substitute. (fda.gov)