Overview

• U.S. District Judge Mark Pittman denied compounding pharmacies' request for a preliminary injunction, preventing them from continuing to produce unapproved versions of Novo Nordisk's Ozempic and Wegovy.
• The ruling supports the FDA's determination that semaglutide, the active ingredient in these drugs, is no longer in shortage in the United States.
• The FDA has set a May 22 deadline for federally regulated 503B outsourcing facilities to stop producing compounded semaglutide, while smaller 503A pharmacies must cease immediately.
• Novo Nordisk praised the decision as a victory for patient safety and validation of the FDA's data-driven assessment of drug supply.
• The FDA is now poised to take enforcement actions, including product seizures and warning letters, against non-compliant compounding pharmacies.