Appeals court upholds FDA decisions ending the tirzepatide and semaglutide shortages

The US Court of Appeals for the Fifth Circuit rejected the Outsourcing Facilities Association's challenges to the FDA's decisions to take tirzepatide and semaglutide injections off the drug shortage list, affirming lower court rulings for the agency in two unpublished opinions. The court found that any failure to use notice-and-comment procedures was harmless and that the FDA's action was not arbitrary or capricious. The shortage listing had been the legal basis for pharmacies and outsourcing facilities to compound copies of these drugs, so the rulings leave that route closed.