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FDA wind-down of enforcement discretion for compounded tirzepatide

The FDA’s wind-down of enforcement discretion for compounded tirzepatide ended the agency’s temporary tolerance for compounding copies of commercially available tirzepatide products

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Jan 23, 2026
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How did the FDA’s March 19, 2025 decision changing enforcement discretion for compounded tirzepatide affect access and legal liability?

March 19, 2025 wind‑down of enforcement discretion for compounded tirzepatide ended the agency’s temporary tolerance for compounding copies of commercially available tirzepatide products and signaled ...