The Food and Drug Administration (FDA) announced it will allow compounding pharmacies to continue producing tirzepatide, the active ingredient in Eli Lilly’s popular diabetes and weight loss medications Mounjaro and Zepbound, as the agency reassesses its decision to remove the drug from the nationwide shortage list, NBC News reports.
The FDA’s reversal follows a lawsuit filed by the Outsourcing Facilities Association, a compounding pharmacy trade group, claiming that tirzepatide remains in short supply.
This decision, made public in a court filing last Friday, marks a significant victory for compounding pharmacies and patients. The FDA had previously announced on October 2 that the tirzepatide shortage was over, which would have forced compounding pharmacies to cease making the drug. The lawsuit prompted the FDA to reconsider, allowing continued production of compounded tirzepatide while it re-evaluates the shortage status.
The shortage of tirzepatide, along with semaglutide (found in drugs like Ozempic and Wegovy), has driven high demand for compounded alternatives, which are often cheaper and more accessible for patients. While Eli Lilly has ramped up production of tirzepatide, some reports suggest that the drug is still difficult to find in certain areas.
Patients and compounding pharmacists welcomed the FDA’s decision. Simone Williams, a patient from South Carolina, said the FDA’s decision offers hope but remains cautious until a final determination is made. Other patients, like Elizabeth Kenly from North Carolina, expressed relief that compounded tirzepatide remains available, calling it a “lifeline” for those unable to afford brand-name drugs.
