The window for the public to weigh in on whether large compounding facilities should ever again be allowed to make semaglutide and tirzepatide from raw ingredients closed at 11:59 p.m. Eastern Time on July 30. FDA is now reviewing what it received, and has announced no date for a decision.
That is the entire procedural news, and it matters more than its dryness suggests. The proposal, published in the Federal Register on May 1 and extended by 30 days in June after a request for more time, would keep semaglutide, tirzepatide and liraglutide off the 503B bulks list permanently. If finalized as written, it closes the last broad legal route for industrial-scale compounding of the drugs sold as Ozempic, Wegovy, Mounjaro, Zepbound, Victoza and Saxenda.
