The U.S. Food and Drug Administration (FDA) has officially declared the shortage of Novo Nordisk’s semaglutide products, Ozempic and Wegovy, to be over. This decision follows similar actions taken for Eli Lilly’s tirzepatide supply in late 2024, signaling the end of widespread compounding of GLP-1 receptor agonists in the U.S.
The resolution, detailed in an FDA declaratory order issued on February 21, 2025, is based on data confirming that Novo Nordisk’s supply now meets or exceeds national demand. As a result, the legal leeway that allowed compounding pharmacies to produce alternative semaglutide formulations will expire within 60 days for state-licensed pharmacists and 90 days for outsourcing facilities.
While this move is expected to curb the availability of unregulated compounded versions, it also raises concerns about patient transitions. Diana Isaacs, PharmD, of the Cleveland Clinic, cautions that the lack of oversight in compounded semaglutide has posed safety risks. “I am very concerned about the increase in compounding and lack of oversight of these alternative formulations, which can cause patient harm,” Isaacs stated.
Novo Nordisk has reinforced this position, warning that unauthorized compounded semaglutide may contain dangerous impurities or incorrect dosages. The company has ramped up production, running its facilities 24/7 to ensure continued supply.
Compounding pharmacies, which have seen significant demand for non-branded semaglutide, are now facing legal and regulatory pressure. The Alliance for Pharmacy Compounding (APC) acknowledged that pharmacists had been preparing for this shift but questioned whether the FDA’s determination accounted for the large number of patients who will need to transition to FDA-approved versions.
Despite the regulatory changes, some telehealth companies, including Hims & Hers, have continued to market compounded semaglutide. Analysts are now closely watching how these businesses will deal with the new restrictions.
The FDA has stated that it will continue to monitor semaglutide supply and demand, but for now, the era of compounded GLP-1s appears to be coming to a close.
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