FDA ends semaglutide shortage listing and sets spring deadlines for compounders
People who get semaglutide from a compounding pharmacy will need a new prescription, and brand-name versions typically cost more than $1,000 a month against under $200 for compounded forms [3].
On Feb. 21, 2025, the Food and Drug Administration issued a declaratory order stating that the shortage of injectable semaglutide — sold as Ozempic for type 2 diabetes and Wegovy for weight management — is over [1][2]. The same order told compounding pharmacies when they must stop making their own versions of the drug [1][2].
The order lays out the evidence FDA weighed. Wegovy went on the shortage list on March 31, 2022, and Ozempic followed on Aug. 23, 2022 [1]. FDA said Novo Nordisk, which makes both products, supplied data on production, inventory and wholesaler stock showing supply is "currently meeting or exceeding demand," and that reserves of finished and semi-finished product should keep supply at or above projected demand [1]. Ozempic and Wegovy are the only FDA-approved semaglutide injections [1].
FDA also addressed conflicting reports. It said it heard from patients, prescribers, telehealth companies, compounders and trade groups that people and pharmacies were still struggling to fill prescriptions and that a large amount of compounding was underway. The agency called that outside information limited and said it did not outweigh Novo Nordisk's figures. Difficulty filling a prescription at a given pharmacy, FDA wrote, most likely reflects how product moves through wholesalers and distributors rather than a national shortage [1]. Intermittent, localized gaps may still occur, the agency said [1][2].
Compounders get a wind-down period
FDA said it will not pursue compounders for violations that depend on semaglutide's place on the shortage list — for 60 calendar days, through April 22, 2025, for state-licensed pharmacies and physicians working under section 503A of the Federal Food, Drug, and Cosmetic Act, and for 90 days, through May 22, 2025, for outsourcing facilities under section 503B [1][2]. FDA described the windows as a way "to avoid unnecessary disruption to patient treatment" [2]. The agency said it can still act on other violations, such as a product that is substandard or unsafe [2].
FDA later tied the 503A date to a court ruling in Outsourcing Facilities Association v. FDA, 4:25-cv-00174 (N.D. Tex.) [2]. The court denied the group's request for a preliminary injunction on April 24, 2025, which ended enforcement discretion for 503A compounders, while the 503B window ran to May 22, 2025 [2].
Market reaction and scale
Hims & Hers, which sells compounded GLP-1 medicines, saw its stock fall 25% the day of the announcement [3]. Chief executive Andrew Dudum said the company would keep offering personalized treatments "as allowed by law to meet patient needs" and would watch for future shortages, pointing to Novo Nordisk's recent talk of "capacity limitations" and "expected continued periodic supply constraints" [3]. Ro said it would follow FDA rules and guidelines [3].
Novo Nordisk said all semaglutide doses were being shipped continuously to wholesalers and were meeting or exceeding expected U.S. demand [3]. The Outsourcing Facilities Association, in a comment to FDA reported by The Washington Post, estimated that compounding pharmacies filled about 80 million semaglutide prescriptions over the previous 12 months [3]. Scott Brunner, chief executive of the Alliance for Pharmacy Compounding, said the number of patients who would have to move from a compounded version to an approved one is "likely hundreds of thousands" [3].
The American Society of Health-System Pharmacists listed both semaglutide and tirzepatide injections as in shortage [3]. Taylor Kantor, co-founder and chief medical officer of telehealth company Ivim Health, said his clinicians kept seeing supply problems, and that closing off compounded options could push more patients toward branded drugs [3].
Why it matters for patients
People using a compounded semaglutide injection will eventually need a prescription for an FDA-approved product, because compounded copies are permitted only while the approved drug is in shortage [1]. Compounded semaglutide is not FDA-approved, though it is subject to state pharmacy board oversight and USP compounding standards [3].
Cost is the open question. A month of Wegovy or Ozempic typically runs more than $1,000, while compounded GLP-1 subscriptions cost less than $200 a month [3]. Kantor said he worried that patients facing that gap would seek out counterfeit products sold online [3]. FDA's order does not cover insurance coverage, pricing, or how a prescriber should move a patient from a compounded product to an approved one; those details have not been disclosed.
What happens next
The 503A enforcement window closed April 22, 2025, and the 503B window closed May 22, 2025 [1][2]. FDA said it will keep monitoring supply and demand and may return semaglutide injection products to the shortage list if warranted [1]. Litigation over the earlier removal of tirzepatide from the shortage list is still being argued [3].
Sources
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