On December 19, 2024, the FDA removed tirzepatide injection from its shortage list after slightly over two years. Tirzepatide is the active ingredient of Eli Lilly’s Mounjaro and Zepbound, two injectable drugs used to treat weight loss and diabetes. The FDA had initially declared the tirzepatide shortage over in early October, however, a compounding pharmacy trade group sued, claiming the drug was still in shortage. In its new decision, the FDA gave 503A state-licensed pharmacies until February 18, 2025 and 503B outsourcing facilities until March 19, 2025 to continue to compound, distribute, or dispense of the injections
On January 1, 2025, Eli Lilly filed a request to become a defendant in the ongoing litigation challenging the FDA’s decision to remove tirzepatide from the agency’s shortage list. Plaintiffs—the Outsourcing Facilities Association, a trade association advocating for FDA-registered 503B outsourcing facilities—argue that the shortage is not over and that compounding pharmacies should still be allowed to produce off-brand versions of tirzepatide. Despite a recent FDA order reaffirming that tirzepatide shortage is resolved, Lilly contends it must protect its own interests in court because it cannot rely on the FDA to do so. On January 6, 2025, Eli Lilly’s motion to intervene was granted.