April 30 - The U.S. Food and Drug Administration on Thursday put forward a proposal to exclude specific active ingredients used in prominent weight-loss medicines from the roster of bulk drug substances that registered outsourcing facilities may employ for compounding.
Under the proposed action, the active ingredient semaglutide - the molecule behind Novo Nordisk's Wegovy and Ozempic - along with tirzepatide, marketed by Eli Lilly as Zepbound and Mounjaro, would be removed from the list. The measure also names liraglutide, an older Novo Nordisk molecule, for exclusion.
The FDA said its review did not identify a clinical need for outsourcing facilities to compound these therapies from bulk drug substances. The agency noted that, if finalized, the exclusion would effectively restrict compounding of the listed medicines unless they appear on the FDA's drug shortage list.
FDA Commissioner Marty Makary was quoted by the agency underscoring the legal boundary on compounding: "When FDA-approved drugs are available, outsourcing facilities cannot lawfully compound using bulk drug substances unless there is a clear clinical need."
The proposal comes as market data in the article noted positive moves in the shares of the companies connected to these medicines, with Eli Lilly showing a gain of 7.62% and Novo Nordisk showing a gain of 5.27% in the referenced trading snapshot.
The proposal directly affects outsourcing facilities that compound drugs using bulk drug substances, and it centers on whether a clear clinical need exists for compounding when FDA-approved products are accessible. If the proposal advances to a final rule, compounding of semaglutide, tirzepatide and liraglutide from bulk sources would be permitted only under the limited exception tied to inclusion on the FDA's drug shortage list.
Context limitations: The agency's statement in the proposal indicates no clinical need was identified but does not provide additional operational details about how the exclusion would be implemented or timelines for finalization. The article reflects only the information provided in the agency announcement and the trading figures reported in the referenced snapshot.