Legal Challenges and Practical Impacts of the FDA’s Declaratory Order on Semaglutide Injection Products

FDA’s Decision on Semaglutide Injection Products Sparks Legal Challenges and Practical Impacts

In a recent development, the U.S. Food and Drug Administration (FDA) issued a Declaratory Order resolving the shortage of semaglutide injection products Wegovy and Ozempic. This decision has significant implications for compounding pharmacies, as the FDA clarified that drug compounders must soon cease compounding semaglutide injection products or face enforcement action.

The FDA’s decision was met with legal challenges, as the Outsourcing Facilities Association (OFA) filed a lawsuit against the FDA over its resolution and sought a preliminary injunction to prevent the removal of semaglutide from the drug shortage list. U.S. District Court Judge Mark Pittman accepted Novo Nordisk’s motion to intervene in the case, supporting the company’s claim that it can meet the high demand for its products.

To provide a transition period for patients and pharmacies, the FDA announced that enforcement action against compounders will be delayed until April 22, 2025, for state-licensed pharmacists or physicians compounding under Section 503A of the FD&C, and until May 22, 2025, for outsourcing facilities compounding under Section 503B of the FD&C.

The FDA’s decision was based on the requirement to maintain an up-to-date list of drugs in shortage in the U.S., with a shortage defined as a period when demand exceeds supply. The FDA considered input from various stakeholders, including Novo Nordisk, and concluded that the company’s supply of semaglutide injection products meets or exceeds demand.

Despite the FDA’s decision, some compounding pharmacies may continue to compound modified versions of semaglutide, potentially leading to legal action from drug manufacturers. It is advised that any compounding of drugs not on the shortage list should be approached cautiously given the current legal and regulatory landscape.

The outcome of the legal challenges and the impact on compounding pharmacies remain to be seen as the situation continues to unfold. Stay tuned for further updates on this developing story.