FDA winds down enforcement discretion for compounded tirzepatide and semaglutide after shortages resolve

After years of shortages that let compounders make copies of the branded incretin drugs, the FDA declared the tirzepatide shortage resolved in December 2024 and the semaglutide shortage resolved in February 2025. On 27 February 2025 the agency published guidance winding down the enforcement discretion that had permitted compounding.

For tirzepatide, 503A state-licensed pharmacies lost enforcement discretion effective in early March 2025, while 503B outsourcing facilities had until 19 March 2025. For semaglutide, the FDA set deadlines of 22 April 2025 for 503A pharmacies and 22 May 2025 for 503B outsourcing facilities.

The branded products are tirzepatide (Mounjaro, Zepbound) and semaglutide (Ozempic, Wegovy, Rybelsus). Compounded versions had proliferated during the shortage, and the FDA cited safety concerns including dosing errors and quality of compounded product.

The Outsourcing Facilities Association filed federal lawsuits challenging the determinations, but courts declined to grant preliminary injunctions and the enforcement deadlines held.