FDA ends semaglutide shortage; compounding wind-down set

The Food and Drug Administration determined on February 21, 2025 that the shortage of semaglutide injection products, the active ingredient in Ozempic and Wegovy, was resolved. FDA said it had confirmed with the manufacturer “that their stated product availability and manufacturing capacity can meet the present and projected national demand.” The products had been in shortage since 2022.

Two months earlier, on December 19, 2024, FDA had issued a decision that the tirzepatide injection shortage (Mounjaro, Zepbound) was resolved. That reversed course after the agency re-evaluated an October 2, 2024 determination.

Why shortage status mattered

The FD&C Act generally bars pharmacies and outsourcing facilities from compounding drugs that are “essentially a copy” of an FDA-approved drug. A drug on FDA’s shortage list is treated differently, and that exception is what allowed large-scale compounding of semaglutide and tirzepatide during 2022-2024. Once the shortages ended, the exception went with them.

The wind-down dates

To avoid disrupting patients, FDA said it would not act against shortage-dependent compounding for a limited period:

*Or the date of the district court’s decision on the preliminary-injunction motion in Outsourcing Facilities Association v. FDA (N.D. Tex.), whichever was later.

FDA noted it “may still take action regarding violations of any other statutory or regulatory requirements,” such as substandard quality, at any time.

The link to research peptides

After the wind-down, sellers of GLP-1 products labeled “research use only” became a regular target of FDA warning letters. These sellers had never been covered by the shortage exception, which applies only to licensed compounders (December 2024 letters; 2026 letters). Our explainer on GLP-1 compounding after the shortage covers what remains lawful.