November 22, 2024
FDA tirzepatide ‘reconsideration’ period extended
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.
