FDA proposes excluding Novo and Lilly weight-loss drugs from compounding list
Updated
Updated · USA TODAY · Apr 30
FDA proposes excluding Novo and Lilly weight-loss drugs from compounding list
12 articles · Updated · USA TODAY · Apr 30
The proposal covers semaglutide, tirzepatide and older Novo drug liraglutide, with public comments open until 29 June before a final decision.
If adopted, it could restrict 503B outsourcing facilities that make bulk copies for telehealth firms, while strengthening Novo Nordisk and Eli Lilly against unauthorised versions competing with Wegovy, Ozempic, Zepbound and Mounjaro.
Compounding remains allowed in limited cases, including shortages or patient-specific needs, and analysts said many telehealth companies mainly use 503A pharmacies, potentially softening the immediate operational impact.
Is the FDA's crackdown on compounded drugs a win for patient safety or for pharmaceutical company profits?
Will the FDA's proposed ban on 'copycat' Ozempic leave millions of Americans without an affordable weight-loss option?