FDA Ends Tirzepatide Shortage, Orders Compounded Versions Phased Out by March 2024

The Food and Drug Administration (FDA) confirmed Thursday that Eli Lilly’s tirzepatide-based medications, Zepbound and Mounjaro, are no longer in shortage. This decision requires compounding pharmacies to cease production of alternative versions within 60 to 90 days. “FDA may still take action regarding violations of any other statutory or regulatory requirements, such as to address findings that a product may be of substandard quality or otherwise unsafe,” an FDA spokesperson stated. The ruling follows a complex regulatory path. In October, the FDA initially declared the shortage resolved but reconsidered after the Outsourcing Facilities Association filed a lawsuit challenging the decision. … Continue reading FDA Ends Tirzepatide Shortage, Orders Compounded Versions Phased Out by March 2024