FDA Proposal Limits Compounding of Obesity Drugs

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.