FDA & regulation

FDA lists Ozempic and Wegovy as available after two years of shortage

The FDA's database began showing every dose of Ozempic and Wegovy as available in late October 2024, but the agency did not formally declare the semaglutide shortage resolved until February 21, 2025.

By the Semaglutides news desk··OzempicWegovy
FDA lists Ozempic and Wegovy as available after two years of shortage
Image: thehill.com

The Food and Drug Administration's drug shortage database stopped listing Ozempic and Wegovy as "currently in shortage" at the end of October 2024, after more than two years in which supply of the semaglutide injections could not keep up with demand [1]. The drugs technically stayed on the shortage list at that point, and the FDA did not issue a formal order ending the shortage until roughly four months later [1][2].

Both products are semaglutide, a GLP-1 receptor agonist made by Novo Nordisk. Wegovy was added to the FDA shortage list on March 31, 2022, and Ozempic followed on August 23, 2022 [2].

An "available" listing is not the same as a resolved shortage

At the time of the October update, an FDA spokesperson told The Hill that the agency was "currently working to determine whether the demand or projected demand for semaglutide within the United States exceeds the available supply," adding that "although all dosages of a drug may currently be listed as available, the criteria for moving a drug off the Drug Shortages list must still be met" [1].

A Novo Nordisk spokesperson confirmed the two medicines were "available" and credited "significant investment in capacity and ongoing communication with the FDA" [1]. The company also cautioned that "even when a medication is available, patients may not always be able to immediately fill their prescription at a particular pharmacy," and that "patients may experience variability at a particular pharmacy location regardless of whether a drug is in shortage" [1].

FDA's own public updates tracked the gradual shift. On October 2, 2024, the agency said semaglutide injection products were in shortage but that Novo Nordisk had "reported all but one of the presentations are available." By December 19, 2024, FDA said Novo Nordisk had "reported all presentations are available" while the agency continued monitoring drug availability [2].

The formal step came on February 21, 2025, when FDA issued a declaratory order finding the semaglutide injection shortage resolved. The agency said Novo Nordisk's supply was meeting or exceeding demand, that the company had built reserves of finished product plus significant semi-finished product, and that supply would meet or exceed projected demand [2].

The compounding link

The shortage listing mattered far beyond inventory reports. Under federal law, compounders can make copies of a drug while it is on the shortage list. The October news came less than a month after tirzepatide — Mounjaro and Zepbound — was declared no longer in shortage, which set off a dispute with compounding pharmacies that had been selling unbranded copies [1]. Companies including Hims & Hers and Noom had been selling compounded semaglutide online, and Hims & Hers bought its own compounding pharmacy [1].

Lee H. Rosebush, chairman of the Outsourcing Facilities Association, said at the time that "semaglutide injection remains listed as currently in shortage per FDA," and that the group hoped FDA would "fully and fairly consider patient access to medical treatments prescribed by their physicians" [1].

The February order set wind-down windows: FDA said it did not intend to act against state-licensed pharmacists or physicians compounding under section 503A for 60 days, until April 22, 2025, or against outsourcing facilities under section 503B for 90 days, until May 22, 2025 [2].

Why it matters for patients

FDA judges shortages nationally, across the whole market, not pharmacy by pharmacy. The agency explicitly acknowledged that "even when a shortage is considered resolved, patients and prescribers may still see intermittent localized supply disruptions" as product moves from manufacturer to wholesalers to local pharmacies [2]. So an "available" listing did not guarantee that any given pharmacy had a specific dose in stock [1][2].

FDA also noted it had received reports that some patients and pharmacists could not obtain the approved drugs and that "a substantial amount of semaglutide compounding" was occurring, but concluded those reports did not outweigh Novo Nordisk's supply data [2]. The agency said it expected some patients on compounded products to seek the approved drugs once compounding was curtailed [2].

Rybelsus, the oral semaglutide tablet, was not in shortage [2].

What happens next

FDA said it would keep monitoring supply and demand and would consider whether any semaglutide injection products should be added back to the shortage list in the future [2]. The compounding grace periods ran to April 22, 2025 for 503A pharmacies and May 22, 2025 for 503B outsourcing facilities [2].

Images from the sources

FDA lists Ozempic and Wegovy as available after two years of shortage
thehill.com

Sources

  1. https://thehill.com/policy/healthcare/4962699-ozempic-wegovy-considered-available/
  2. https://www.fda.gov/media/185526/download

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