The FDA removed semaglutide from its Drug Shortages list on February 21, 2025, formally ending the 2022–2024 supply constraint that fueled the legal basis for compounded semaglutide production by 503A pharmacies and 503B outsourcing facilities.
Under section 503A(b)(1)(D) of the Federal Food, Drug, and Cosmetic Act, pharmacies generally cannot compound a drug product that is essentially a copy of a commercially available drug — but the rule has long carried exceptions for documented medical necessity and, importantly, for products on the FDA Drug Shortages list. The shortage exception is now closed for semaglutide.
Compounding of semaglutide continues to be permissible under narrower circumstances, including documented medical necessity where the FDA-approved product cannot be used (e.g., a documented allergy to an excipient). Tirzepatide was removed from the Shortages list earlier than semaglutide, in October 2024.
Practically, the post-shortage environment has pushed compounded GLP-1 telehealth toward two paths: (1) tighter clinical documentation of necessity at the prescriber level, and (2) consolidation among providers with cleaner 503A/503B compliance posture.