From CNBC: 2025-03-21 12:56:00

Compounding pharmacies were set to stop making copycat versions of Eli Lilly’s Zepbound and Mounjaro this week, but online ads for tirzepatide are still prevalent. Mochi Health plans to continue offering personalized versions despite FDA crackdown. The agency aims to end mass compounding of tirzepatide due to availability of the brand drug.

The FDA has listed GLP-1 drugs like Mounjaro and Zepbound as in short supply, leading to a surge in compounding. However, FDA removed Mounjaro and Zepbound from shortage list, prompting crackdown on mass compounding. Compounding pharmacies are challenged to comply with FDA rules on creating personalized prescriptions.

The FDA is enforcing rules to halt mass compounding of tirzepatide, with larger facilities no longer allowed to compound it. Smaller pharmacies are restricted from making drug copies closely resembling the brand version. Compounding pharmacies like Mochi Health are emphasizing personalized prescriptions to navigate FDA regulations.

Pharmacies are facing legal risks if they continue to compound tirzepatide after the deadline. Patients are concerned about losing access to compounded drugs. Compounded tirzepatide was offered at lower prices than the brand drug, creating affordability for patients. The future of compounding pharmacies remains uncertain.

The FDA will oversee the ban on mass compounding of tirzepatide, with potential legal challenges from companies like Eli Lilly. Mochi Health CEO is confident in the personalized approach taken by their providers. The FDA deadline for ending mass compounding of semaglutide is approaching, with Hims & Hers Health already planning to comply.



Read more at CNBC: Zepbound copycats remain online despite FDA ban