On December 19, 2024, FDA issued a new decision determining that the tirzepatide drug shortage was resolved. FDA initially added tirzepatide to the drug shortage list in December 2022, which allowed state-licensed pharmacies under 503A of the Food, Drug, and Cosmetics Act (FD&C Act) and 503B outsourcing facilities to compound the product to meet consumer demand. In October 2024, FDA determined that the tirzepatide shortage was resolved and removed it from the drug shortage list. However, the Outsourcing Facilities Association subsequently sued FDA, arguing that this decision was contrary to law and should be vacated immediately. As a result,  FDA’s decision was remanded to the agency for reevaluation. During this reevaluation period, compounders were permitted to continue manufacturing tirzepatide.

FDA's decision to remove tirzepatide from the shortage list was based on information provided by tirzepatide’s NDA holder, which demonstrated that its supply was meeting or exceeding demand. The NDA holder presented data showing it had developed reserves in its finished product inventory, along with significant quantities of semi-finished product, and had scheduled substantial additional production in the coming months. Specifically, the NDA holder submitted detailed information and data on production and inventory including stock reports that outlined quantities supplied and demanded, cumulative quantities supplied to and demanded by its customers in 2024, projected future demand and supply, and wholesaler inventory data. FDA also considered input from patients, healthcare providers, and compounders in making this decision.

Consequently, compounders will no longer be permitted to manufacturer tirzepatide. To prevent disruption in patient treatment, FDA will not take action against compounders for violations of the FD&C Act related to tirzepatide’s inclusion on the drug shortage list in the following cases:

1. State-licensed pharmacies under section 503A of the FD&C Act compounding, distributing, or dispensing tirzepatide within 60 days from the decision, until February 18, 2025. 
2. 503B outsourcing facilities compounding, distributing, or dispensing tirzepatide within 90 days from the decision, until March 19, 2025.

Following this decision, FDA and the Outsourcing Facilities Association filed a joint status report in their case. Both parties agreed that the case should continue to be stayed, with plans to file another joint status report by January 2, 2025.

FDA’s decision can be found on their website and the joint status report can be found here.

If any party needs help with navigating the issues regarding compounding and drug shortages, Buchanan's attorneys can assist with these issues.