Compounding tirzepatide copies ends for 503As

503Bs have until March 19

Cutting to the chase — per the FDA:

• As of Monday, March 10, 503A pharmacies are no longer permitted to prepare copies of tirzepatide injections.
• The enforcement discretion period for 503B outsourcing facilities will end March 19.

This follows a federal judge’s ruling on March 5 that denied the Outsourcing Facilities Association’s motion for preliminary injunction against FDA. OFA had sued the agency for what it saw as its arbitrary resolution of the tirzepatide injection shortage in October.

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. (This jibes with FDA’s Feb. 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.)

Questions remain. For example, can 503As continue to dispense tirzepatide injections through the beyond-use date (whether they’ve prepared their own or sourced them from 503Bs)? We’ve asked FDA, and we’re (wishin’ and) hoping for timely answers. In the meantime, read our full statement here.

(Side note: OFA has announced that it will appeal the federal court’s decision. We’ll keep you updated on that, of course.)