FDA says ‘no clinical need’ for compounded weight loss drugs

The Food and Drug Administration has suggested removing the active ingredients found in popular obesity and diabetes medications from the list of substances permitted for creating specific compounded versions.

The agency has concluded there is no “clinical need” for large compounding facilities to produce substantial quantities of medications using semaglutide, which is the active ingredient in Novo Nordisk’s Wegovy for weight loss and Ozempic for diabetes, as well as tirzepatide, which is used in Eli Lilly’s Mounjaro for diabetes and Zepbound for obesity.

This ruling targets these compounders, categorized as 503B facilities in regulatory terms, following increasing debates over their involvement in the availability of weight loss treatments in recent years. The FDA, in its explanation—marking a win for Novo and Lilly and impacting consumer options—stated that these compounders no longer fulfill the legal criteria to market their products.