Why is the FDA advising against using compounded medicines as substitutes for Ozempic, Rybelsus, and Wegovy?

The FDA is advising people to avoid using compounded medicines as substitutes for popular weight loss and diabetes drugs like Ozempic, Rybelsus, and Wegovy. Compounded medicines are not FDA-approved but can be made during an official drug shortage. Currently, Ozempic and Wegovy are on the FDA’s shortage list. However, the FDA has received reports of adverse events from people using compounded versions of these drugs. The concern is that these compounded versions may contain ingredients that sound similar to the active ingredient in the brand name drugs, semaglutide, but are actually different because they are in salt form. These salt forms, such as semaglutide sodium and semaglutide acetate, have not been proven to be safe and effective. The FDA has stated that these salt forms do not meet the criteria for compounding during a shortage. The FDA also emphasized that compounded drugs are not FDA-approved, and their safety and effectiveness are not verified by the agency. The Alliance for Pharmacy Compounding acknowledged that some arguments for the use of semaglutide sodium are worth discussing but did not endorse these arguments. For those using online pharmacies, the FDA recommends checking the credentials on the FDA’s BeSafeRx website.