FDA ends enforcement discretion for tirzepatide injection copies prepared by 503As

Announcement follows court’s denial of OFA preliminary injunction motion in lawsuit

FDA today announced that the period of enforcement discretion for 503A state-licensed pharmacies preparing copies of tirzepatide injection has ended.

The announcement follows a federal court judge’s March 5 denial of the Outsourcing Facilities Association’s motion for preliminary injunction against FDA for what OFA said was the agency’s arbitrary October 2 resolution of the tirzepatide injection shortage.

FDA says the enforcement discretion period for 503B outsourcing facilities will end March 19.

Today’s announcement is consistent with the agency’s February 11 statement that it would allow compounding of tirzepatide copies by 503As until February 18 and by 503Bs until March 19 or until the federal court ruled on the OFA preliminary injunction motion, whichever is later. 

Now that the court has acted on that motion, the drug is formally out of shortage, and 503As may no longer prepare copies of tirzepatide injection drugs in inordinate amounts.

“Having read the judge’s decision, I'm torn between respect for the court's desire to assure that FDA's Drug Shortage List can be a reasonably real-time tool – one that guides shortage-drug compounding – and the fact that the agency in October ended the tirzepatide injection shortage prematurely based on representations from drugmakers and incomplete data on demand for compounded versions of the drug,” said APC CEO Scott Brunner, CAE. “That premature decision resulted in unnecessary patient angst and interruptions of therapy when pharmacies could not access the FDA-approved drugs for those patients. When pharmacies consistently can't obtain the FDA-approved drug in quantities they need to meet patient demand, that drug is not commercially available – the very definition of a shortage.” 

On February 22, FDA also announced enforcement discretion on compounding of copies of semaglutide injection, also dependent on resolution of the preliminary injection phase of litigation or deadlines set by the agency, whichever is later. 

“Certain questions remain about the implications of today’s announcement by FDA,” said Brunner. “For instance, may 503As that source sterile tirzepatide injectables from a 503B continue to dispense those drugs through the beyond-use date on the drug, or must all dispensing of compounded copies prepared by 503Bs end on March 19?  What about for 503As that prepare tirzepatide injectables: May they continue to dispense those through the BUD?”

APC has submitted these questions to FDA and urged the agency to provide timely answers. 

Also today, OFA announced that it would appeal the federal court’s denial of its preliminary injunction motion in its lawsuit against FDA over resolution of the tirzepatide shortage.