FDA Alert on Compounded Semaglutide

FDA is alerting patients and healthcare providers to concerns about compounded semaglutide that is being produced as an alternative to approved versions Ozempic, Rybelsus and Wegovy, which have been reported to be in short supply. The glucagon-like peptide-1 receptor agonists are used for treating diabetes and obesity.

The agency says it has received adverse event reports after patients used compounded semaglutide. “Patients should not use a compounded drug if an approved drug is available to treat a patient,” the alert says. “Additionally, FDA has received reports that in some cases, compounders may be using salt forms of semaglutide, including semaglutide sodium and semaglutide acetate. The salt forms are different active ingredients than is used the approved drugs, which contain the base form of semaglutide. The agency is not aware of any basis for compounding using the salt forms that would meet the FD&C requirements for types of active ingredients that can be compounded.”