FDA declares the semaglutide shortage resolved, starting the clock on compounding

The FDA determined that the shortage of semaglutide injection products, in place since 2022, was resolved, after confirming with the manufacturer that stated availability and manufacturing capacity could meet present and projected national demand. Because the legal basis for compounding these products rested on their presence on the shortage list, the announcement set two deadlines: state-licensed pharmacies compounding under section 503A had 60 days, until 22 April 2025, and outsourcing facilities under section 503B had 90 days, until 22 May 2025. The agency noted patients might still see intermittent localised supply disruptions.

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