FDA Proposes Excluding Weight-Loss Drugs From Compounding List

The U.S. Food and Drug Administration (FDA) proposed excluding semaglutide, tirzepatide, and liraglutide—the active ingredients in popular weight-loss drugs like Wegovy, Ozempic, Zepbound, and Mounjaro—from its 503B bulks list. The agency cited the availability of FDA-approved versions of these medications as the reason for this decision.

The FDA permits pharmacies to compound personalized drug products under its 503A regulations but regulates bulk compounding by listing drugs on its 503B list. Compounded drugs are generally less expensive than their FDA-approved counterparts, which has driven some consumers to seek them out as alternatives according to CNBC. The agency will accept public comments until June 29 before making a final determination.

FDA Commissioner Marty Makary emphasized the importance of protecting patients and preserving the integrity of the drug approval process. He stated that outsourcing facilities cannot lawfully compound using bulk drug substances unless there is a clear clinical need per UPI. The FDA had previously allowed compounding due to shortages but recently clarified that these drugs are no longer on its shortage list.

The proposal specifically targets 503B outsourcing facilities, which manufacture compounded drugs in bulk. It does not impact 503A pharmacies, which make compounded drugs according to individual prescriptions and are largely regulated by states as reported by CNBC. Novo Nordisk and Eli Lilly have invested billions to ramp up manufacturing capacity, helping alleviate supply constraints and making their branded medications more affordable.