The FDA proposes to exclude Novo and Lilly GLP-1s from the combination list

The Food and Drug Administration on Thursday proposed excluding active ingredients found in the product Novo Nordiskand Eli LillyPopular obesity and diabetes drugs are among the list of drugs that outsourcing facilities can use for bulk formulation.

If the proposal is finalized, the exclusion would likely limit mass formulation — or the making of customized, often cheaper substitutes — for those drugs unless they appear on the FDA’s “drug shortage” list. The agency said it will consider public comments, which can be submitted until late June, before making a final decision.

The FDA has found “no clinical need” to outsource the formulation of bulk drug substances, the agency said in a statement.

The proposal includes semaglutide, the active ingredient in Novo’s obesity drug Wegovy, its diabetes counterpart Ozempic, and tirzepatide, found in Lilly’s weight-loss shot Zepbound and Mounjaro’s diabetes shot. It also covers the older de novo liraglutide molecule.

“When FDA-approved drugs are available, outsourcing facilities cannot legally backfill bulk drug substances unless there is a clear clinical need,” FDA Commissioner Marty McCurry said in the statement.

The agency’s proposal specifically targets 503B outsourcing facilities, which manufacture compounded drugs in large quantities with or without a prescription and are largely regulated by FDA guidelines.

The proposal does not affect 503A pharmacies, which manufacture compounded drugs according to a given patient’s individual prescriptions and are largely regulated by states rather than the Food and Drug Administration.

Lilly and Novo have invested billions to increase manufacturing capacity over the past few years, which has helped ease supply constraints. Companies also continued efforts to make their branded drugs more affordable to attract users who had flocked to cheaper combination drugs.