A federal judge has blocked compounding pharmacies from producing their own versions of Eli Lilly’s weight loss and diabetes drugs Zepbound and Mounjaro, citing concerns over patient safety. The decision comes after the FDA lifted its temporary hold on declaring the medicines’ active ingredient, tirzepatide, no longer in shortage.
A trade organization representing compounding pharmacies, the Outsourcing Facilities Association (OFA), had alleged that the FDA’s decision was “abruptly depriving patients of much-needed treatment” and artificially inflating prices. The agency had allowed hundreds of thousands of compounded versions to be produced, but only after considering their safety.
However, drug companies and some obesity specialists had expressed concerns that not all compounded products were approved by the FDA. The FDA had given compounding pharmacies a transition period to avoid patient care disruption, with smaller pharmacies stopping production by February 18 and larger facilities by March 19.
The judge’s decision has been welcomed by Eli Lilly, which said it marked “the end of the road for mass compounding” of unapproved knockoff medications. The company warned that any facility continuing to compound tirzepatide would be breaking the law and working with regulators and law enforcement to stop it.
Source: https://thehill.com/policy/healthcare/5181343-court-ruling-compounding-pharmacies-fda-tirzepatide