Compounding Problems: Recent Decisions On Tirzepatide Highlight Interplay Between FDA Anti-Compounding Enforcement And Private Intellectual Property Rights

Earlier this month, a federal district court denied the Outsourcing Facilities Association's preliminary injunction motion, which sought to preclude FDA from taking enforcement action against compounded tirzepatide products.¹ Tirzepatide is the active pharmaceutical ingredient in Eli Lilly & Co.'s blockbuster weight loss and diabetes drugs Zepbound and Mounjaro. The Outsourcing Facilities Association, a trade association representing compounding pharmacies, challenged FDA's October 2, 2024 decision to remove tirzepatide from the drug shortage list established under Section 506E of the Federal Food, Drug, and Cosmetic Act (“FD&C Act”). The Section 506E drug shortage list permits otherwise prohibited compounding use of certain pharmaceutical ingredients (or “drug substances”) when FDA determines that a qualifying need exists.²