Is compounded tirzepatide legal in 2026?

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Researched By Dr. Parmis · Medical Researcher · Western University of Health Sciences

Medically Reviewed By Dr. Jonathan Snipes, MD · Kim Callender, NP (FNP-BC)

Last medically reviewed: · This page is informational and does not constitute medical advice.

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Compounding is legal when a state-licensed 503A pharmacy prepares a drug for an individual prescription and it is not essentially a copy of an approved product; since FDA declared the tirzepatide shortage over (December 19, 2024), large-scale copying is not allowed. In April 2026 FDA proposed keeping tirzepatide off the 503B bulks list, with no final decision published by October 15, 2026, and in September 2026 it sent warning letter 738238 to Empower Pharmacy over additive formulations.

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