FDA says compounding of weight loss drugs is 'clinically unnecessary'

The U.S. Food and Drug Administration has proposed excluding the active ingredients of popular obesity and diabetes drugs from the list of substances that can be used to make certain compounded versions.

The agency determined there was no “clinical need” to allow large-scale compounding facilities to manufacture large quantities of the drug, including semaglutide, an ingredient in Novo Nordisk’s Wegovy weight loss drug and Ozempic diabetes drug, and tirzepatide, an ingredient in Eli Lilly’s diabetes drug Moujaro and Zepbound obesity drug.

The decision singled out these compounders, known in regulatory parlance as 503B facilities, after growing controversy over the past several years over their role in providing weight loss treatment. In explaining its decision, the FDA said that while it is a win for Novo and Lilly and a rethinking of their options for consumers, these formulators no longer meet the legal requirements to sell their products.

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