FDA declares the semaglutide shortage resolved

The U.S. Food and Drug Administration issued a declaratory order on February 21, 2025 finding that the shortage of injectable semaglutide — the active ingredient in Novo Nordisk's Ozempic and Wegovy — is resolved ^[1]. The decision starts a countdown for the compounded versions that hundreds of thousands of Americans have been buying through telehealth companies and pharmacies ^[3].

Semaglutide injection had been on FDA's shortage list since March 31, 2022 for Wegovy and August 23, 2022 for Ozempic, driven by increased demand ^[1][2]. FDA said it reviewed Novo Nordisk's production, inventory and wholesaler data, along with input from telehealth companies, compounders, trade groups and individual patients, and concluded that the company's supply "is currently meeting or exceeding demand" and that reserves of finished and semi-finished product mean supply should meet projected demand as well ^[1]. Novo Nordisk said all semaglutide doses were being "continuously shipped" to wholesalers ^[3].

The wind-down dates

Under federal law, compounders may make near-copies of an approved drug when it is in shortage. With the shortage declared over, FDA set two deadlines during which it does not intend to take action against compounders for violations tied to the drug's shortage-list status ^[1][2]:

• State-licensed pharmacies and physicians compounding under section 503A: 60 days, until April 22, 2025 ^[1][2].
• Outsourcing facilities under section 503B: 90 days, until May 22, 2025 ^[1][2].

FDA said it may still act on other violations, such as products that appear to be of substandard quality or otherwise unsafe ^[2].

The agency acknowledged that it has received reports that some patients and pharmacists still cannot get the approved drugs, and that "a substantial amount of semaglutide compounding is occurring" ^[1]. It said intermittent local gaps are most likely explained by supply-chain dynamics between Novo Nordisk, wholesalers and pharmacies rather than a national shortage ^[1]. FDA also noted that patients and prescribers "may still see intermittent and limited localized supply disruptions" ^[2].

Other GLP-1 drugs were not covered by the order. As of February 21, 2025, dulaglutide injection remained listed in shortage with all presentations reported available, and liraglutide injection remained in shortage with two presentations available and three with limited availability ^[2]. Rybelsus, the oral semaglutide tablet, was not in shortage ^[1].

Why it matters for patients

The practical effect is that compounded semaglutide — which was never reviewed or approved by FDA — is scheduled to stop being legally available on the dates above, and people using it face a switch to Ozempic or Wegovy, which requires a prescription for an FDA-approved product ^[1][3]. The approved products come in fixed pen strengths: Ozempic in 2 mg/3 mL, 4 mg/3 mL and 8 mg/3 mL pens, and Wegovy in 0.25, 0.5, 1, 1.7 and 2.4 mg single-dose pens ^[1]. Compounded vials were often sold at "personalized" doses that do not match those steps, a point that analysts flagged as central to telehealth business models ^[3].

Cost is the other issue. A month's supply of Wegovy or Ozempic typically costs north of $1,000, while subscriptions for compounded GLP-1s ran less than $200 a month, according to Taylor Kantor, M.D., of telehealth company Ivim Health, who said he worries patients will be pushed toward counterfeit products sold online ^[3]. Scott Brunner, CEO of the Alliance for Pharmacy Compounding, questioned whether FDA accounted for "the number of patients who'll need to be transitioned from a compounded version to a FDA-approved version," which he estimated at "likely hundreds of thousands" ^[3]. The Outsourcing Facilities Association told FDA that compounders filled roughly 80 million semaglutide prescriptions in the prior 12 months, per a Washington Post report ^[3].

Sources disagree on whether supply is truly stable. FDA and Novo Nordisk say it is ^[1][3], while the American Society of Health-System Pharmacists' shortage list continued to show semaglutide and tirzepatide injection in shortage ^[3]. Shares of Hims & Hers fell 25% the day of the announcement ^[3].

What happens next

The Outsourcing Facilities Association sued FDA over the semaglutide decision in the Northern District of Texas (OFA v. FDA, 4:25-cv-00174) ^[2]. On March 10, 2025, FDA said the wind-down dates would run until April 22 and May 22, 2025, or the date of the court's ruling on a preliminary injunction, whichever was later ^[2]. The court denied that motion on April 24, 2025, so the 503A discretion period ended and the 503B period ran to May 22, 2025 ^[2]. FDA said it will keep monitoring supply and could return semaglutide to the shortage list if warranted ^[1].