Is Tirzepatide legal in United States?

Tirzepatide is FDA-approved as Mounjaro for type 2 diabetes (approved 13 May 2022) and as Zepbound for chronic weight management and for moderate to severe obstructive sleep apnea in adults with obesity (first approved 8 November 2023; the sleep apnea use was added later). FDA re-determined on 19 December 2024 that the tirzepatide injection shortage was resolved, and its enforcement-discretion periods for compounders ended in March 2025 (on 5 March for 503A pharmacies, when a court denied an injunction, and on 19 March for 503B outsourcing facilities). On 1 May 2026 FDA proposed not to add tirzepatide to the 503B bulks list; 503A pharmacies remain barred from routinely making essentially-copy products. FDA has logged more than 730 adverse event reports for compounded tirzepatide as of 31 May 2026.