FDA Ban on Compounded GLP-1 Drugs: What to Know

People who have relied on compounded versions of popular GLP-1 drugs will likely need to find a new source for their medication. The U.S. Food and Drug Administration (FDA) ban on GLP-1 compounding took effect on May 22, and the off-brand medications are no longer allowed to be made or sold in the United States.


Starting in 2022, high demand led to shortages of semaglutide injections sold by Novo Nordisk under the brand names Ozempic and Wegovy, as well as tirzepatide injections Zepbound and Mounjaro from Eli Lilly.

“Once patients found out how effective these medications were, word of mouth really drove up demand and outpaced the ability of these drug companies to manufacture them,” says Nate Wood, MD, a primary care doctor and co-leader of the weight management clinic at the New Haven Primary Care Consortium, part of Yale New Haven Hospital in Connecticut.

When the FDA determines a patent-protected drug is in shortage, pharmacies are permitted to compound copies of the drug. Compounding is when a licensed pharmacist combines, mixes, or alters the active ingredients of a drug to create a medication that is tailored for the needs of an individual patient.


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