The Food and Drug Administration reiterated that it can now take action against pharmacies compounding, distributing, or dispensing semaglutide injection products that are essentially a copy of an FDA-approved product. This follows a Texas judge recently denying an injunction from the Outsourcing Facilities Association in the case Outsourcing Facilities Association v. FDA, 4:25-cv-00174 (N.D. Tex.). The FDA had originally granted discretion to pharmacies compounding semaglutide until April 22, 2025.
For outsourcing facilities compounding, distributing, or dispensing semaglutide injection products under section 503B, the FDA does not intend to take action for violations of the Federal Food, Drug, and Cosmetic Act arising from conditions that depend on semaglutide injection products’ inclusion on the FDA’s drug shortage list until May 22, 2025.
The FDA stated that it may still take action regarding violations of any other statutory or regulatory requirements, such as to address findings that a product may be of substandard quality or otherwise unsafe. NCPA will keep its members appraised of developments.
