On March 5, 2025, the U.S. District Court for the Northern District of Texas denied the Outsourcing Facilities Association’s motion for a preliminary injunction to prevent the U.S. Food and Drug Administration (FDA) from removing tirzepatide products (Mounjaro and Zepbound; Eli Lilly and Company) from the FDA’s drug shortage list.1 This denial keeps in place the FDA’s declaratory order determining that the shortage of diabetes and weight-loss tirzepatide products has been resolved and phases out compounded tirzepatide, which Wilson Sonsini reported about here.
The court refused to grant the plaintiffs’ request for a preliminary injunction because it found the plaintiffs were unlikely to succeed on the merits of the case. Notably, the court rejected the plaintiffs’ argument that the FDA was required to undergo notice-and-comment rulemaking before delisting tirzepatide products from the shortage list as incompatible with Congress’s mandate to timely update the list. If the FDA were required to engage in rulemaking, then it could not act on the latest information available.
Following the court’s decision, the FDA reiterated the timelines for which it intends to take enforcement action against compounders of tirzepatide products.2 According to the FDA, state-licensed pharmacists or physicians compounding under section 503A of the Federal Food, Drug, and Cosmetic Act (FDCA) should stop compounding tirzepatide immediately because the period of enforcement discretion has passed. Outsourcing facilities compounding under section 503B of the FDCA should stop compounding tirzepatide by March 19, 2025.
[1] Outsourcing Facilities Ass’n v. U.S. Food & Drug Admin., Opinion and Order (D.I. 101), C.A. No. 4:24-cv-00953-P (N.D. Tex. Mar. 10, 2025) (J. Pittman).
[2] U.S. Food and Drug Admin., FDA Clarifies Policies for Compounders as National GLP-1 Supply Begins to Stabilize, https://www.fda.gov/drugs/drug-safety-and-availability/fda-clarifies-policies-compounders-national-glp-1-supply-begins-stabilize (updated Mar. 10, 2025).
