FDA tracker
Tirzepatide: FDA regulatory status
FDA approvedUpdated Apr 23, 2026
FDA approved 2022 (T2D), 2023 (obesity)
Editorially reviewedThe Peptide Examiner editorial team, Editorial review · Reviewed Apr 23, 2026
Regulatory timeline
Dec 19, 2024 · Shortage
FDA declares tirzepatide shortage resolved
503A compounding discretion ended February 18, 2025; 503B by March 19, 2025. Compounded tirzepatide no longer broadly legal.
Dec 10, 2024 · Warning letter
FDA warning letters to research peptide vendors
Multiple vendors received warning letters for selling tirzepatide as unapproved drug.
What this means for patients
Tirzepatide is FDA approved. Access is through a clinician prescription and a licensed pharmacy. Insurance coverage depends on the approved indication and your plan's formulary.