FDA Declares Semaglutide Shortage Over, Impacting Compounded Drug Market

The resolution of the Ozempic and Wegovy shortage prompts regulatory deadlines for compounding pharmacies to cease production of cheaper alternatives.

The FDA announced the end of the semaglutide shortage, which includes the weight-loss drugs Ozempic and Wegovy, signaling improved supply from manufacturers Novo Nordisk and Eli Lilly.
Compounding pharmacies, which had been producing off-brand versions during the shortage, face deadlines in April and May to stop production, depending on their regulatory classification.
Novo Nordisk and Eli Lilly have aggressively targeted compounded alternatives with lawsuits and regulatory petitions, citing safety concerns and competition impacts.
The decision raises concerns about affordability and access for patients who relied on less expensive compounded drugs, with some medical providers warning of potential health setbacks for affected individuals.
Hims & Hers Health, a telehealth company that gained from offering compounded semaglutide, saw its stock drop over 20% following the FDA's announcement, though it plans to explore legal pathways to continue providing personalized treatments.