FDA Eyes Curbs on Compounded Weight-Loss Drugs

The U.S. Food and Drug Administration (FDA) on Thursday proposed excluding the active ingredients of Novo Nordisk and Eli Lilly's weight-loss medications from the list of drugs that outsourcing facilities can compound. This regulatory action, if finalized, would restrict the compounding of these medicines unless they are officially listed on the agency's drug shortage list.

The FDA stated that it found no clinical necessity for outsourcing facilities to compound semaglutide, the active ingredient in Novo Nordisk's Wegovy and Ozempic, and tirzepatide, sold as Zepbound and Mounjaro by Eli Lilly, from bulk drug substances. The proposal also encompasses Novo Nordisk's older molecule, liraglutide.

FDA Commissioner Marty Makary emphasized that when FDA-approved drugs are available, outsourcing facilities are not lawfully permitted to compound using bulk drug substances unless a clear clinical need is established. This measure aims to ensure that compounded versions are not produced when approved alternatives are readily accessible, thereby maintaining regulatory oversight and product quality.