Enforcement discretion ends for pharmacies compounding semaglutide

The 60-day period during which the FDA said it did not intend to act against state-licensed pharmacies and physicians compounding semaglutide under section 503A expired. Two days later, on 24 April 2025, a district court declined to disturb the agency’s determination that the shortage was over, removing the remaining legal argument for continuing. Outsourcing facilities operating under section 503B had a further month, until 22 May 2025.

Sources: FDA — FDA clarifies policies for compounders as national GLP-1 supply begins to stabilize