Weight loss medications, particularly those in the GLP-1 receptor agonist class like Ozempic and Wegovy, have become increasingly popular for their effectiveness in aiding weight loss and managing type 2 diabetes. These drugs work by mimicking the GLP-1 hormone, which helps regulate blood sugar levels and promotes a feeling of fullness. However, the surge in demand has led to the emergence of compounded versions of these medications, raising significant safety concerns. Some patients accidentally received doses up to twenty times higher than prescribed or with significant impurities. In some cases, this led to serious side effects such as nausea, vomiting, low blood sugar, fainting, and even hospitalization.
The US Food and Drug Administration (FDA) has issued warnings regarding the use of compounded semaglutide, the active ingredient in Ozempic and Wegovy. Compounded medications are custom-made by pharmacies to meet individual patient needs but are not subject to the detailed testing and approval processes that FDA-approved drugs undergo. This lack of oversight can result in significant risks.
In response to these concerns, the FDA has announced plans to stop the sale of compounded semaglutide. To facilitate a smooth transition, the FDA has provided specific timelines for phasing out compounded semaglutide. Compounding will be allowed until May 22 or until the district court issues a decision regarding a lawsuit from the Outsourcing Facilities Association (OFA).
Novo Nordisk, the manufacturer of Ozempic and Wegovy, played a central role in the FDA’s decision to end the allowance for compounded semaglutide. After working closely with the company, the FDA confirmed that Novo Nordisk’s manufacturing capacity is now sufficient to meet both current and anticipated national demand for semaglutide. This development was a key factor in the agency’s determination that the shortage—which had been ongoing since 2022 due to skyrocketing demand—was officially resolved in early 2025. With the shortage no longer in effect, the FDA moved forward with plans to stop pharmacies and outsourcing facilities from producing compounded versions of the drug.
Hims & Hers, a telehealth company offering healthcare services and medications, has been significantly impacted by recent regulatory changes regarding compounded semaglutide. In 2024, GLP-1 drugs made up approximately fifteen percent of Hims & Hers sales. Now that Hims & Hers will no longer be selling compounded semaglutide, its stock price has declined sharply.
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