April 1 (Reuters) – The U.S. Food and Drug Administration on Wednesday clarified its policies on compounded versions of popular GLP-1 drugs, signaling tighter limits on their production as national supply conditions improve.
The agency said compounders are permitted to produce copies of approved medicines only while those drugs are listed on the FDA’s shortage database.
Once a product is no longer in shortage, pharmacies and outsourcing facilities must stop making versions that are “essentially copies” of commercially available treatments.
The FDA said this exemption is temporary and strictly tied to supply disruptions. As availability of GLP-1 therapies begins to stabilize, the agency said compounders should transition away from routine production of these drugs.
It also warned that any continued manufacturing outside these boundaries could prompt enforcement action.
GLP-1 drugs, widely used for diabetes and weight loss, saw demand surge in recent years, prompting temporary shortages that allowed compounders to step in under existing rules.
The FDA’s clarification follows tensions between Novo Nordisk and telehealth firm Hims & Hers Health.
Novo’s launch of an oral version of Wegovy led to a legal dispute over the offer of compounded alternatives, before the two companies struck a deal.
Earlier in the day, the FDA approved Lilly’s weight-loss pill, Foundayo, which the company will begin selling on April 6 through its LillyDirect program.
The regulator said compounded drugs do not undergo FDA approval and must meet specific conditions under federal law, including restrictions on bulk manufacturing and requirements that prescriptions be patient-specific in many cases.
(Reporting by Christy Santhosh in Bengaluru; Editing by Shreya Biswas)
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