FDA ·
On October 2, 2024, the FDA formally declared the tirzepatide shortage resolved, removing Mounjaro and Zepbound products from its drug shortage database. The announcement triggered a series of downstream regulatory effects that have continued to ripple through 2026. FDA provided a limited wind-down period for compounding pharmacies, which was then modified following a federal court challenge by the Outsourcing Facilities Association. By early 2025 the legal framework was largely settled in favor of FDA's interpretation, and the agency has since executed a coordinated enforcement program including inspections, warning letters, and import alerts.
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