FDA Reaffirms End of Tirzepatide Shortage, Impacting Compounders

Tirzepatide Shortage Resolved:
The FDA has reaffirmed that the shortage of tirzepatide, a key ingredient in Eli Lilly’s diabetes and weight loss drugs Mounjaro and Zepbound, is resolved as of December 19, 202423.

Impact on Compounders:
This decision means that compounding pharmacies must halt production of tirzepatide treatments. 503A compounding pharmacies have until February 18, 2025, and 503B bulk compounding facilities have until March 19, 2025, to distribute their remaining supplies23.

Legal Background:
The FDA initially removed tirzepatide from the shortage list in October 2024 but reconsidered the decision due to a court case. The agency has now reaffirmed its stance, citing that supply meets or exceeds current and projected demand23.

Compounder Concerns:
The Alliance for Pharmacy Compounding has expressed concerns that the FDA lacks sufficient data to determine if the shortage is truly over, citing ongoing difficulties in obtaining FDA-approved tirzepatide drugs from wholesalers2.

Market Impact:
The decision affects a significant market, with an estimated 2 million Americans taking compounded versions of GLP-1 drugs, including tirzepatide2.

Sources:

2. https://www.fiercepharma.com/pharma/fda-reaffirms-decision-erase-eli-lillys-tirzepatide-shortage-list

3. https://americanmedspa.org/news/tirzepatide-shortage-ends