Semaglutide injection shortage resolved
FDA's February 2025 order ends the Ozempic and Wegovy shortage. Compounding transition windows are now closing.
As of February 21, 2025, FDA determined that the national shortage of semaglutide injection products (Ozempic and Wegovy) is resolved. Compounded copies must now comply with standard 503A/503B copy restrictions.
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On February 21, 2025, FDA issued a declaratory order finding that Novo Nordisk's supply of semaglutide injection products meets or exceeds demand. The agency therefore resolved the shortage that had applied to Ozempic and Wegovy since 2022.
The order includes 60- and 90-day enforcement-discretion windows for 503A and 503B compounders, respectively, to allow patients to transition to FDA-approved products. After those windows, compounded copies are generally subject to the usual statutory restrictions.
What did not change
Approved indications, routes, and strengths for Ozempic, Rybelsus, and Wegovy did not change. No new semaglutide product was approved by this order.
Key takeaways
- ✓ Ozempic and Wegovy are no longer on FDA's national drug shortage list.
- ✓ 503A transition period ended April 22, 2025; 503B transition ended May 22, 2025.
- ✓ Oral Rybelsus was not in shortage.
What changed
National shortage status ended for semaglutide injection products.
What did not change
No new semaglutide approval or indication was created. Rybelsus remained out of shortage.
Next step
FDA will continue to monitor supply and demand and can relist products if national conditions change.
Affected records
Controlling documents
- Declaratory Order: Resolution of Shortages of Semaglutide Injection Products
U.S. Food and Drug Administration · Declaratory order · Drug Shortages