The Food and Drug Administration (FDA) has proposed excluding the active ingredients in Novo Nordisk and Eli Lilly's leading obesity and diabetes medications from the list of drugs that outsourcing facilities can use for bulk compounding [1]. This move specifically targets semaglutide, found in Novo Nordisk’s Wegovy and Ozempic, tirzepatide, present in Lilly’s Zepbound and Mounjaro, as well as Novo’s older molecule liraglutide [1]. If finalized, the proposal would restrict the mass compounding of these drugs—often used to create cheaper alternatives—unless the medications are listed on the FDA's drug shortage list [1].
The FDA stated that it finds “no clinical need” for outsourcing facilities to compound these drugs from bulk substances, emphasizing that when FDA-approved drugs are available, compounding from bulk is not lawful unless there is a clear clinical need [1]. This proposal is directed at 503B outsourcing facilities, which manufacture compounded drugs in bulk and are regulated by the FDA, but does not affect 503A pharmacies that compound drugs for individual prescriptions and are regulated by states [1].
Lilly and Novo Nordisk have invested billions of dollars to expand manufacturing capacity in recent years, which has helped ease supply constraints for their branded medications [1]. Both companies have also taken steps to make their branded drugs more affordable, aiming to attract users who might otherwise turn to cheaper compounded alternatives [1].
The FDA will consider public comments on the proposal until late June before making a final decision [1].
CONCLUSION
The FDA's proposal to exclude the active ingredients in Novo Nordisk and Eli Lilly's weight loss and diabetes drugs from bulk compounding is a significant win for both companies, potentially limiting competition from cheaper compounded alternatives. The move is expected to reinforce the market positions of their branded medications, with the final decision pending after the public comment period.