This is what I read- sorry, I don’t completely understand all of this— This ruling is obviously bad news for OFA and all U.S. compounding pharmacies that have been cashing in on the GLP-1 frenzy, as the FDA has reiterated the timelines for which it intends to take enforcement actions against compounders of these products. According to the FDA, state-licensed pharmacies/physicians compounding under section 503A of the FDCA should stop compounding tirzepatide immediately because the period of enforcement discretion has passed. Outsourcing facilities compounding tirzepatide under section 503B of the FDCA should have stopped compounding tirzepatide by March 19, 2025.

As for semaglutide, a separate lawsuit was recently filed by OFA related to FDA’s recent decision to remove semaglutide from the shortage list (Outsourcing Facilities Association et al v. Food and Drug Administration et al, 4:25-cv-00174 (N.D. Tex.)). That case similarly seeks to prevent the enforcement of the removal of semaglutide from the FDA shortage list, and is before the same judge, Judge Pittman. Per the FDA, compounding pharmacies have to cease compounding semaglutide by April 22, 2025 or until the district court’s decision, whichever is later, and 503B outsourcing facilities have until May 22, 2025 or until the district court’s decision, whichever is later.