Wegovy joined FDA's shortage list in March 2022, ten months after approval
The 2022 Wegovy shortage led to nearly three years of tight supply and widespread compounding of semaglutide, a period that ended in February 2025.
Wegovy (semaglutide) was added to the Food and Drug Administration's national drug shortage list on March 31, 2022, about ten months after the weight-loss drug was approved [1]. Ozempic, the same molecule approved for type 2 diabetes, followed onto the list on August 23, 2022 [1].
Under federal law, a shortage is "a period of time when the demand or projected demand for the drug within the United States exceeds the supply of the drug," and FDA judges that condition nationwide, across the whole market, not pharmacy by pharmacy [1].
Wegovy had been approved in June 2021 and is sold as single-dose prefilled pens in five strengths, from 0.25 mg to 2.4 mg [1]. Ozempic was approved in December 2017 and comes in prefilled pens in several strengths, including 2 mg/3 mL, 4 mg/3 mL, 8 mg/3 mL and 2 mg/1.5 mL [1]. The FDA order notes that the 2 mg/1.5 mL strength is not currently marketed by Novo Nordisk [1].
The shortage ran almost three years. In an order dated February 21, 2025, FDA said Novo Nordisk's data showed its supply was "currently meeting or exceeding demand" for the semaglutide injections and that the company held reserves of finished product plus significant units of semi-finished product, enough that supply would meet or exceed projected demand [1].
FDA also weighed information from telehealth companies, pharmacy compounders, associations representing compounders and outsourcing facilities, and individuals. The agency concluded that this outside information had "important limitations" and did not outweigh the company's data [1]. At the same time, FDA acknowledged reports that some patients and pharmacists could not obtain the approved drugs and that "a substantial amount of semaglutide compounding" was happening. The agency said such intermittent problems are most likely explained by the practical dynamics of the part of the supply chain between Novo Nordisk and its customers, including wholesale distributors and pharmacies, rather than a continuing national shortage [1].
Supply had been tightening for months before the formal decision. On October 2, 2024, FDA listed semaglutide injections as in shortage but noted Novo Nordisk had "reported all but one of the presentations are available"; on December 19, 2024, FDA said the company had reported all presentations available and that the agency was working to determine whether demand exceeded supply [1].
Why it matters for patients
Drug shortage status is what allowed compounding pharmacies to make semaglutide injections that are essentially copies of Ozempic and Wegovy. Once FDA declared the shortage resolved, that pathway began to close. The order says FDA does not intend to take action for 60 calendar days, until April 22, 2025, against state-licensed pharmacists or physicians compounding under section 503A, and for 90 calendar days, until May 22, 2025, against outsourcing facilities under section 503B [1].
That means people who have been receiving compounded semaglutide injections face a supply change tied to those dates, and how it plays out depends on their prescriber and pharmacy. The order does not address what individual patients should do.
FDA also makes clear that a resolved national shortage does not guarantee every pharmacy has the drug on hand. The agency says patients and prescribers "may still see intermittent localized supply disruptions as products move through the supply chain from the manufacturer, to wholesalers and distributors, and to local pharmacies" [1].
Rybelsus, the oral semaglutide tablet, was not part of the shortage [1].
What happens next
Two dated deadlines follow from the order: April 22, 2025, for 503A compounders and May 22, 2025, for 503B outsourcing facilities [1].
FDA says it will keep monitoring supply and demand for these products and consider whether any semaglutide injection product should go back on the shortage list [1]. The order does not include Novo Nordisk's confidential commercial information, so the specific production, inventory and demand figures behind the decision have not been made public [1].
Sources
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