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US FDA proposes excluding weight-loss drugs from compounding list
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April 30 (Reuters) - The U.S. Food and Drug Administration on Thursday proposed excluding active ingredients for Novo Nordisk and Eli Lilly's weight-loss drugs on the list of drugs outsourcing facilities can use for compounding. If finalized, the exclusion would limit compounding of these medicines unless they appear on the agency's drug shortage list. The FDA said it did not identify a clinical need for outsourcing facilities to compound semaglutide, the active ingredient of Novo's Wegovy and Ozempic, and tirzepatide, sold as Zepbound and Mounjaro by Lilly, from bulk drug substances. The proposal also includes Novo's older molecule liraglutide. "When FDA-approved drugs are available, outsourcing facilities cannot lawfully compound using bulk drug substances unless there is a clear clinical need," FDA Commissioner Marty Makary said. (Reporting by Mrinalika Roy and Mariam Sunny in Bengaluru; Editing by Leroy Leo)