STAT+: FDA wants to exclude weight loss drugs from a compounding list

STAT PlusPharmalot FDA wants to exclude weight loss drugs from a compounding list Agency says there’s no ‘clinical need’ for compounders to make meds from semaglutide and tirzepatide Manage alerts for this article Email this article Share this article By Ed SilvermanApril 30, 2026 Pharmalot Columnist, Senior Writer Ed Silverman[email protected]Ed Silverman, a senior writer and Pharmalot columnist at STAT, has been covering the pharmaceutical industry for nearly three decades. He is also the author of the morning Pharmalittle newsletter and the afternoon Pharmalot newsletter. 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.Advertisement 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. STAT+ Exclusive Story Already have an account?

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Request A Quote Request A Quote Savings start at 25%! 2-10 Users $300 Annually per user $300/year Get Started $300 Annually per user View All Plans To read the rest of this story subscribe to STAT+. Subscribe Log In Compounding, drug development, FDA, Obesity, Pharmaceuticals, Policy, STAT+, weightloss Submit a correction requestReprints Ed Silverman Pharmalot Columnist, Senior Writer Ed Silverman, a senior writer and Pharmalot columnist at STAT, has been covering the pharmaceutical industry for nearly three decades.

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