On April 1, the U.S. Food and Drug Administration (FDA) clarified its policies on compounded drugs, including compounded versions of GLP-1 products. Compounders are permitted to produce copies of approved drugs only while those drugs are listed in FDA’s shortage database.
GLP-1 products are used primarily for weight loss and diabetes. They include semaglutide (used in the branded drugs Ozempic and Wegovy) and tirzepatide (used in Zepbound and Mounjaro), among others. The explosion in growth of direct-to-consumer marketing of GLP-1s for weight loss over the past few years caused a shortage of the drugs, and compounders stepped in to fill the void. However, compounded drugs are not FDA-approved.
Although FDA removed semaglutide from its shortage list in February 2025, some specific dosages of semaglutide, and certain dosages of tirzepatide (particularly starting doses), are still sometimes hard to find in the branded versions. Compounders can also produce “in-between” dosages that are not available at all in the branded drugs, and can add secondary ingredients like B-vitamins to create a “different” product to circumvent the prohibition on production of a compounded GLP-1.
Last month, FDA announced that it sent warning letters to 30 telehealth companies that FDA claimed were illegally marketing compounded GLP-1s. The main violations FDA identified were false or misleading claims that the compounded drugs were equivalent to FDA-approved drugs, and advertising suggesting that the telehealth companies did the compounding themselves.
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