On February 21, 2025, the U.S. Food and Drug Administration (FDA) announced that the shortage of semaglutide injection products, including Ozempic and Wegovy, has been resolved. These medications, used for diabetes management and weight loss, had been in short supply since 2022 due to increased demand. The manufacturer has confirmed sufficient production capacity to meet current and future national needs, though minor local supply disruptions may still occur as distribution normalizes.
In light of the resolved shortage, the FDA has outlined a transition period for compounding pharmacies and outsourcing facilities that have been producing compounded versions of semaglutide:
State-licensed pharmacies or physicians compounding under section 503A of the Federal Food, Drug, and Cosmetic Act (FD&C Act) are permitted to continue compounding, distributing, or dispensing semaglutide injection products that are essentially copies of FDA-approved products until April 22, 2025 (60 days from the announcement).
Outsourcing facilities under section 503B of the FD&C Act have until May 22, 2025 (90 days from the announcement) to cease such activities.
This grace period aims to prevent unnecessary disruptions in patient care. The FDA may still take action against any violations unrelated to the shortage status, particularly if a product is found to be of substandard quality or poses safety concerns.
The resolution of the semaglutide shortage has also impacted the market, notably leading to a significant drop in the stock price of Hims & Hers Health Inc., a company that had been providing compounded versions of these medications during the shortage.
In contrast, major pharmaceutical companies that manufacture these drugs saw positive movements in their stock prices. Novo Nordisk's shares rose by 5.1%, and Eli Lilly's shares increased by 1.7% following the FDA's announcement.
For a link to the FDA’s announcement today, click here.
