FDA's Proposal to Exclude Novo and Lilly Weight-Loss Drugs from Compounding List

The FDA proposed removing Novo Nordisk's and Eli Lilly's weight-loss drugs from a compounding list, potentially affecting large-scale production by outsourcing facilities, while supporting drug makers' efforts against unauthorized versions. The decision might impact telehealth firms relying on these facilities, but may not affect personalized compounded doses by 503A pharmacies.

In a move that might reshape the pharmaceutical landscape, the U.S. Food and Drug Administration has proposed removing popular weight-loss drugs from Novo Nordisk and Eli Lilly from a key compounding list. This exclusion could restrict large-scale production by outsourcing facilities, impacting telehealth companies that depend on these compounds.

The value of U.S.-listed shares of these companies soared, with Novo rising by nearly 6% and Lilly surging more than 10% in afternoon trading. The FDA argued there is no clinical necessity for compounding the drugs' active ingredients, semaglutide and tirzepatide, in bulk.

This proposed change does not seem to threaten telehealth businesses significantly, such as Hims & Hers, which utilize 503A pharmacies for personalized medicine, avoiding the implicated 503B outsourcing facilities. The FDA encourages public commentary on the proposal until June 29.