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The regulatory landscape for compounded tirzepatide Compounded tirzepatide's regulatory status has been contested since 2023: Initially permitted under FDA shortage list rules allowing 503A pharmacies to compound from active pharmaceutical ingredient (API) FDA removed tirzepatide from the shortage list in late 2024, with implications for compounding eligibility Litigation by compounding pharmacies and telehealth platforms followed Subsequent FDA guidance and court rulings have shifted the operational landscape multiple times As of May 2026, the situation remains in flux