In the Declaratory Order: Resolution of Shortages of Semaglutide Injection Products (Ozempic and Wegovy) issued by the FDA on February 21, 2025 (here ), the Agency indicates that the supply of the innovator products either meet or exceed demand for Semaglutide Injection products.
While the FDA acknowledges that there may be some patients that continue to have some difficulty finding the brand name products, based on Agency investigations the semaglutide is officially over. However, the Agency has indicated that “[T]o avoid unnecessary disruption to patient treatment and to help facilitate an orderly transition, the FDA does not intend to take action against a compounder that is not registered as an outsourcing facility for compounding, distributing, or dispensing Semaglutide Injection products that are essentially a copy of a commercially available drug product within 60 days of this decision. In addition, the FDA does not intend to take action against an outsourcing facility for use of the bulk drug substance semaglutide to compound, distribute, or dispense a drug product that appeared on FDA’s drug shortage list, or for compounding, distributing, or dispensing Semaglutide Injection products that are essentially a copy of an FDA‐approved drug product, within 90 days of this decision.” Therefore, based on the type of compounding facility there is either a 60- or 90-day window for which enforcement discretion will be exercised.
This has been an ongoing saga for the last two years and it appears to have finally come to an end. The FDA has described its decision-making process in the declaratory order cited above. We must now wait to see if those compounders impacted by this “final” decision will take further legal action in the face of the declaratory order.
Reuters reports (here) that: “Several companies, such as Hims and Hers [the company that ran the controversial Super-Bowl ad for its compounded product] and WeightWatchers, offer compounded semaglutide, the active ingredient in Ozempic and Wegovy. Shares of Hims and Hers tumbled 19% in premarket trading” after the FDA’s declaratory order was made public.
