Big Buttons

• End Drug Shortages Act intro’d in Congress

  The legislation would expand the sources the FDA may use to declare drug shortages. read more →

• FDA tirzepatide ‘reconsideration’ period extended

  FDA agreed to extend until December 19 a final report on tirzepatide availability to the court.  read more →

• NPR hits the GLP-1 nail on the head

  A National Public Radio piece this week tackled the issue of compounded GLP-1 drugs and got the facts and nuance just right. read more →

• CALL TO ACTION: Tell FDA to deny drugmakers’ request

  Drugmakers are urging FDA to prohibit compounded GLP-1s. FDA needs to hear from you and your patients NOW! read more →

• APC to FDA: Just say no to Lilly

  This week APC's lawyers sent a formal comment to the FDA about Eli Lilly’s request that tirzepatide be added to the Demonstrably Difficult to Compound list. read more →

• California BOP sends proposed compounding regs to comment period

  The California State Board of Pharmacy decided to move the modified proposed sterile compounding regulations forward to a 30-day comment period. read more →

• Checking in on the post-Chevron fallout

  What’s happened in the world of federal regulation since the end of Chevron? read more →

• Hi, Noom!

  Welcome to our newest Bronze-level Corporate Patron, Noom! read more →

More News

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.