FDA Ends Shortage of Tirzepatide, Restricts Compounded Weight-Loss Drugs

The decision impacts access to affordable alternatives and raises concerns about the future of weight-loss treatments for uninsured patients.

The FDA has declared the shortage of tirzepatide, the active ingredient in Eli Lilly's Zepbound and Mounjaro, officially over, citing sufficient supply to meet demand.
This decision will restrict compounding pharmacies from producing cheaper, off-brand versions of tirzepatide by early 2025, potentially increasing costs for patients without insurance coverage.
Compounded tirzepatide has been a lifeline for many patients, offering a significantly lower price point of $250–$350 per month compared to Zepbound's $1,059 monthly list price.
Critics argue that the shortage may not be fully resolved, as patients report ongoing difficulties accessing brand-name medications, and some insurance plans still do not cover weight-loss drugs.
The FDA's move is part of broader regulatory efforts to ensure drug safety and quality, but it has sparked legal challenges and concerns about affordability and access to critical treatments.