Yesterday, on the deadline FDA was to report back to the court on its reconsideration of the resolution of the tirzepatide injection shortage, FDA and the plaintiffs released a joint status report agreeing to extend until December 19 a final report to the court.
Kudos to the Outsourcing Facilities Association and Farmakeio for their continued work to provide the agency evidence that tirzepatide is still in shortage. And a big thank you to all of our members who have continued to submit screenshots from your wholesalers — those were presented as part of that evidence, and it’s making a difference.
Absent any coming statement to the contrary from FDA (which is unlikely), we presume FDA will continue to take enforcement discretion — at least through the now-extended review period — in the case of 503A sterile compounding pharmacies that continue to prepare compounded copies of tirzepatide injection pursuant to a prescription. In short: no news is no news.