The FDA resolved the semaglutide shortage in February 2025, with wind-down deadlines in spring 2025.
The FDA resolved the semaglutide shortage in February 2025. 503A pharmacies had until Apr 22, 2025 and 503B facilities until May 22, 2025 to stop compounding. Court challenges did not secure injunctions.
The FDA resolved the tirzepatide (Dec 2024) and semaglutide (Feb 2025) shortages, and wind-down deadlines passed in 2025. On Apr 30, 2026 the FDA proposed excluding these drugs from the 503B bulks list (comment closed Jun 29, 2026). Patient-specific 503A compounding continues only narrowly, and cost alone is not a clinical need. Full regulatory status →
Compounded semaglutide and tirzepatide are not FDA-approved and are not the same as Wegovy, Ozempic, Zepbound, or Mounjaro. The FDA does not review compounded drugs for safety, effectiveness, or quality before marketing. Primary source: FDA — Human Drug Compounding.