# The 2024 Outsourcing Facilities Association Lawsuit

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FDA · 2026-01-19


    In October 2024 the Outsourcing Facilities Association (OFA) filed suit in the US District Court for the Northern District of Texas challenging FDA's resolution of the tirzepatide shortage. The complaint argued that FDA's shortage determination was arbitrary and capricious under the Administrative Procedure Act, and sought injunctive relief to prevent enforcement. The court denied preliminary injunction and eventually granted summary judgment in FDA's favor, with the decision being appealed. The litigation clarified that courts will give FDA substantial deference on factual shortage determinations, a precedent that has shaped subsequent compounded peptide disputes.


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