FDA Proposes to Exclude Ozempic, Mounjaro From Compounding List

The FDA is proposing to exclude the key ingredients of the most popular, blockbuster weight loss drugs from a federal list that would allow them to be legally compounded.

The proposal filed Thursday in the Federal Register seeks to leave off semaglutide, tirzepatide, and liraglutide from the 503B bulk list, which identifies drug substances that outsourcing facilities may legally use in compounding under Section 503B of the Federal Food, Drug, and Cosmetic Act. If final, the move would be a win for Novo Nordisk A/S and Eli Lilly & Co., which have fought hard to rein in unapproved, copycat versions ...