FDA Ends GLP-1 Shortage, Pauses Enforcement Against Compounders
The U.S. Food and Drug Administration (FDA) announced Friday that it will temporarily hold off on penalizing compounders producing versions of Novo Nordisk’s (NYSE:NVO) widely used GLP-1 weight loss and obesity drugs. The move comes as the agency officially declared an end to the nationwide semaglutide shortage, which persisted for nearly three years.
Semaglutide Shortage Officially Resolved
The FDA confirmed that Novo Nordisk’s manufacturing capabilities and current product availability can now meet national demand for the popular GLP-1 medications. This milestone marks a turning point in the availability of weight loss treatments that have seen surging demand in recent years.
Market Impact: Hims & Hers Sees Billions Wiped from Market Cap
Telehealth company Hims & Hers (NYSE:HIMS), which had been providing compounded versions of semaglutide during the shortage, faced a sharp decline in market capitalization following the FDA’s announcement. With the drug no longer on the shortage list, compounding pharmacies will no longer be permitted to produce alternative versions.
FDA Allows Temporary Grace Period for Compounders
Recognizing the potential for temporary supply chain disruptions as the drug reaches pharmacies from manufacturers and distributors, the FDA has instituted a brief grace period. The agency will not take action against compounders violating the Federal Food, Drug, and Cosmetic Act (FD&C Act) for semaglutide-related infractions until:
- April 22, 2025 for compounding pharmacies
- May 22, 2025 for outsourcing facilities
What’s Next for Patients and Pharmacies?
While the resolution of the semaglutide shortage is a significant development, the FDA warns of potential localized supply fluctuations as distribution ramps up. Patients relying on compounded versions of the medication will need to transition to FDA-approved products from Novo Nordisk as the grace period ends.
With demand for GLP-1s remaining high, stakeholders—including pharmacies, healthcare providers, and investors—will be closely watching how supply stabilizes in the coming months.
