FDA proposal would curb bulk compounding of Novo, Lilly weight-loss drugs

The FDA proposal could limit bulk compounding of key Novo Nordisk and Eli Lilly obesity and diabetes drugs unless they return to the shortage list.

The Food and Drug Administration on Thursday proposed excluding the active ingredients in several major Novo Nordisk and Eli Lilly obesity and diabetes drugs from the list of bulk substances that outsourcing facilities may use for compounding.

If finalized, the move would likely restrict mass compounding of medicines containing semaglutide, tirzepatide and liraglutide unless those drugs appear on the FDA’s drug shortage list. The agency said it will review public comments, which may be submitted until late June, before making a final decision.

The proposal covers semaglutide, used in Novo Nordisk’s Wegovy and Ozempic; tirzepatide, used in Eli Lilly’s Zepbound and Mounjaro; and Novo’s older molecule liraglutide. The FDA said in a release that it found “no clinical need” for outsourcing facilities to compound the ingredients from bulk drug substances.

“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 in the release.

The proposed exclusion applies to 503B outsourcing facilities, which can manufacture compounded drugs in bulk with or without individual prescriptions and are largely governed by FDA rules. It does not affect 503A pharmacies, which compound medicines for specific patients based on individual prescriptions and are generally regulated by states.

The decision would mark another turn in the market for lower-cost compounded alternatives to high-demand obesity and diabetes drugs. Novo Nordisk and Eli Lilly have spent billions of dollars expanding manufacturing capacity in recent years, helping ease earlier supply constraints, and have also taken steps aimed at making their branded products more affordable for patients who had turned to compounded versions.

The proposal is not final. The next key step is the public comment period, after which the FDA will decide whether to formally exclude the ingredients from the bulk compounding list.