PEPTOKING
EN

FDA declares semaglutide shortage resolved, ending mass compounding of copies

Regulatory

The FDA determined that the shortage of semaglutide injection products (Ozempic, Wegovy), listed since 2022, was resolved. It gave state-licensed compounding pharmacies until April 22, 2025 and outsourcing facilities until May 22, 2025 to stop making what are essentially copies of the approved drugs. Together with the earlier tirzepatide decision, this ended the shortage exception that had allowed large-scale sales of compounded GLP-1 injections.

Sources

  1. 01FDA clarifies policies for compounders as national GLP-1 supply begins to stabilize(opens the source in a new tab) U.S. Food and Drug Administration
  2. 02Declaratory Order: Resolution of Shortages of Semaglutide Injection Products(opens the source in a new tab) U.S. Food and Drug Administration

Peptides involved

  1. ApprovedSemaglutideGLP-1 receptor agonist31