FDA wants to limit compounded versions of weight loss drugs
( NewsNation ) — The Food and Drug Administration has proposed removing popular weight loss drugs such as Ozempic and Wegovy from a key compounding list, a move that could limit large‑scale production by outsourcing facilities.
If finalized, the change could affect telehealth companies that rely on compounded versions of the drugs, while strengthening efforts by manufacturers Novo Nordisk and Eli Lilly to curb unauthorized versions that undercut their sales.
In a news release , the FDA said it found no clinical need for outsourcing facilities to compound semaglutide, the active ingredient in Wegovy and Ozempic, or tirzepatide, which is used in Zepbound and Mounjaro.
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Compounding is a process in which pharmacies mix or alter ingredients to create customized medications or produce versions of drugs at different dosages.
“The agency’s notice today reaffirms that compounding is meant to be a rare and limited exception to FDA’s gold‑standard drug approval framework,” a Novo Nordisk spokesperson said in a statement.
The FDA has opened a public comment period on the proposal through June 29 before issuing a final decision.
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