FDA Declares End to Tirzepatide Shortage, Impacting Compounded Versions of Mounjaro and Zepbound

Shortage Resolution:
The FDA has officially declared the shortage of tirzepatide injection (Mounjaro, Zepbound) resolved as of October 2, 2024.

Impact on Compounding:
With the shortage resolved, compounding pharmacies are no longer permitted to prepare and dispense compounded versions of these drugs, as they are now considered commercially available.

Supply Chain Disruptions:
Despite the resolution, intermittent localized supply disruptions may still occur as the products move through the supply chain.

Patient Impact:
Patients currently using compounded versions of tirzepatide may face challenges transitioning to FDA-approved versions, including potential delays in obtaining new prescriptions and affordability issues.

Regulatory Context:
The FDA's decision is based on the manufacturer's ability to meet current and projected national demand, and the agency will continue to monitor the situation to ensure an adequate supply.

Broader GLP-1 Shortages:
Other GLP-1 drugs, such as dulaglutide and semaglutide injections, remain in shortage, with varying levels of availability.