Following the FDA’s decision on 21 February 2025 to remove Novo Nordisk’s semaglutide products (Ozempic® and Wegovy®) from the Drug Shortages List, the regulator has been sued by the Outsourcing Facilities Association, a compounding industry group, and FarmaKeio Superior Custom Compounding, a Texas based compounding pharmacy.
The Complaint, lodged on 24 February 2025, alleges that the FDA’s decision was arbitrary and reckless and is contrary to law.
In removing semaglutide from the Drug Shortages List, the FDA confirmed it will take action from 22 April 2025 against state-licensed pharmacies which sell compounded versions of the drug and from 22 May 2025 against outsourcing facilities which compound, distribute or sell semaglutide copies.
Novo Nordisk has argued that semaglutide is challenging to produce safely due to its complex formulation involving yeast-based recombinant DNA technology. Furthermore, compounded versions lack clinical testing, exhibit different impurity profiles, and have raised safety concerns. This is consistent with alerts issued by the FDA to US healthcare providers in July 2024 in relation to risks associated with compounded semaglutide, and the position taken by the Australian Therapeutic Goods Administration (TGA) which has banned compounded copies of Ozempic® since 1 October 2024 due to serious safety concerns.