FDA issues statements on counterfeit, compounded semaglutide
The agency warned about a single lot of counterfeit semaglutide and announced that it would begin enforcing regulations against pharmacies and physicians compounding the drug now that the shortage is over.
The FDA recently warned the public about some counterfeit semaglutide (Ozempic) injections, 1 mg, in the U.S. drug supply chain. The medication's manufacturer, Novo Nordisk, notified the FDA of the counterfeit drugs on April 3, and the FDA seized them on April 9. In an April 14 press release, the FDA advised patients and clinicians to check the semaglutide products they have received and not use or distribute products labeled with lot number PAR0362 and serial number starting with the digits 51746517. FDA is aware of six adverse event reports associated with this lot, none of which appear to be associated with the counterfeit product.
The FDA also recently provided an update on its policy regarding compounded semaglutide. Based on an April 24 decision by a district court, the FDA will no longer refrain from enforcing section 503A of the FD&C Act against any state-licensed pharmacy or physician compounding, dispensing, or distributing semaglutide injection products. Regarding outsourcing facilities that are compounding, distributing, or dispensing semaglutide under section 503B, the agency does not intend to take action before May 22. The agency declared the shortage of semaglutide over on Feb. 21.