Compounding pharmacies dealt a blow in fight over end of semaglutide shortage

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FDA Ruling Forces Compounding Pharmacies to Cease Semaglutide Production as Shortage Ends

The FDA has declared an official end to the national shortage of semaglutide, the active ingredient in the popular drugs Wegovy and Ozempic4.
As a result, compounding pharmacies—which were permitted to produce compounded versions of semaglutide during the shortage—are now required to halt production or face potential FDA enforcement actions2 3.
Large compounding facilities (outsourcing facilities) have until May 22, 2025, to cease making compounded semaglutide, while smaller, state-licensed compounding pharmacies must stop immediately or risk enforcement2 5.
Only FDA-approved semaglutide injection products (Wegovy and Ozempic) are now permitted; compounding copies are no longer allowed under the Federal Food, Drug, and Cosmetic Act since the shortage is resolved3.
Compounded semaglutide versions surged in popularity due to being cheaper and more accessible, especially as many insurance companies did not cover branded products5.
The change is expected to result in “sticker shock” for patients as they return to higher-priced branded medications5.
Legal challenges have been mounted by compounding pharmacy associations, but courts have so far upheld the FDA’s ruling3 5.
The FDA’s phased timeline provides a short “off-ramp” for compounders to comply, but after these deadlines, enforcement is expected to begin5.
The FDA’s policy clarification is intended to maintain drug safety and support the return to exclusively FDA-approved sources as supply stabilizes1 4.