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

The Food and Drug Administration has proposed excluding the active ingredients in wildly popular obesity and diabetes drugs from a list of substances that can be used for making certain compounded versions.

The agency determined there is no “clinical need” to allow large compounding facilities to make large quantities of medicines from semaglutide, the ingredient in Novo Nordisk’s Wegovy weight loss and Ozempic diabetes treatments, as well as tirzepatide, the ingredient in Eli Lilly’s Mounjaro diabetes drug and Zepbound obesity medicine.

The decision singled out these compounders, which are known as 503B facilities in regulatory parlance, after growing controversy over their role in making weight loss treatments available over the past few years. In explaining its decision — which is a victory for Novo and Lilly and will rework choices for consumers — the FDA explained these compounders no longer meet the legal requirements to market their products.