FDA proposes removing semaglutide, tirzepatide, liraglutide from 503B compounding list

The FDA has proposed removing the active ingredients of several popular GLP‑1 drugs from the 503B compounding list.

The agency says there is no clinical need for large compounding facilities to produce bulk semaglutide, the ingredient in Novo Nordisk’s Wegovy and Ozempic, or tirzepatide, used in Eli Lilly’s Mounjaro and Zepbound, as well as liraglutide.

The decision follows controversy over compounding pharmacies supplying weight‑loss medicines and is described as a win for Novo Nordisk and Eli Lilly, potentially limiting alternative sources for patients.

By tightening the list, the FDA aims to preserve supply from the original manufacturers, which could impact compounding businesses while safeguarding brand drug distribution.