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Index/Topics/503A compounding protections

503A compounding protections

503A compounding protections had lapsed and that 503B facilities must cease compounding by March 19, 2025

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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 ...

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