The U.S. FDA has begun a crackdown on illegally imported active pharmaceutical ingredients used to make GLP-1 weight loss drugs.
Although Novo Nordisk (NVO) and Eli Lilly (NYSE:LLY) market their own GLP-1 obesity therapies, Wegovy (semaglutide) and Zepbound (tirzepatide), the two companies have been contending with copycat versions sold on the Internet that are compounded.
The FDA is creating a “green list” of GLP-1 APIs from foreign facilities that the agency has either inspected or has determined are in compliance with its standards.
The agency added that compounded versions of Novo and Lilly’s therapies should only be used when an individual’s medical needs cannot be supported by the name-brand drugs.
The FDA also noted it is aware of issues with compounded semaglutide and tirzepatide such as dosing errors and adverse events, including some requiring hospitalization.
Telehealth outlets such as as Hims & Hers Health (HIMS) were making compounded versions of GLP-1 drugs while both were in shortage, which is legal. Despite legal challenges to allow compounding pharmacies to continue doing so after the ending of the shortage, courts have ruled against the pharmacies.