Tirzepatide Shortage Ends

On December 19, 2024, the U.S. Food and Drug Administration (FDA) issued a declaratory order (linked here) officially ending the shortage of popular weight loss drug Tirzepatide, the active ingredient in Eli Lilly’s diabetes and weight-loss drugs Mounjaro and Zepbound. Due to demand, these medications have been on the FDA’s Drug Shortages List for the last couple of years. When a medication is on this list, compounding pharmacies can compound the drug to help increase the supply. In August 2024, the FDA updated Tirzepatide’s shortage status to “resolved.” However, the FDA chose to review this decision as the result of a court case. You can read our previous reporting on these developments here and here.

With this order, the compounding of Tirzepatide under this shortage exemption is ended. However, the FDA has chosen to exercise a period of discretion on enforcing this and are allowing compounding pharmacies a short window to distribute their remaining supplies. 503A compounding pharmacies have 60 days—until February 18, 2025—and 503B bulk compounding facilities have a 90-day period—until March 19, 2025. So, compounded Tirzepatide may still be available for a short time. If your practice currently offers compounded Tirzepatide, you will want to contact your pharmacy and review your practices to remain in compliance with state and federal rules.