# FDA Enforcement Discretion During the Tirzepatide Shortage

Canonical source: https://retacompare.com/research/fda-enforcement-discretion-tirzepatide-7

Compounded Peptides · 2026-01-23


    From December 2022 through October 2024, tirzepatide appeared on the FDA drug shortage list, during which time the agency exercised 'enforcement discretion' permitting compounding pharmacies to prepare the drug despite the bulk substance not being on the 503A bulks list. When FDA declared the shortage resolved, it initially provided a wind-down grace period to allow compounders to transition patients. That grace period ended in early 2025, and by late 2025 the agency began a coordinated inspection and warning letter campaign. Throughout 2026 the FDA has continued clarifying that enforcement discretion was a narrow, shortage-specific accommodation — not a permanent pathway.


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