FDA Proposes Ban on Compounded Ozempic, Wegovy and Mounjaro

The US Food and Drug Administration has proposed new limits on compounding certain popular weight-loss and diabetes medications. Later this month, the FDA plans to remove key ingredients—semaglutide, tirzepatide and liraglutide—from its bulk substances list for compounding. Under the proposal, pharmacies could only compound these drugs during officially declared shortages. The agency noted there is no clinical justification for local compounding when approved products are available, citing safety and quality concerns around dosage accuracy and oversight. Public comments are open until June 29 before any final rule is issued. News of the proposal sent shares of Novo Nordisk and Eli Lilly sharply higher, reflecting investor confidence in tighter controls on generic alternatives.

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