Big Buttons

• 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 →

• PFMs can get 2.5% credit card processing

  A new benefit for APC’s Pharmacy/Facility Members: They may be able to cut their credit card processing fees to just 2.5% – 2.8%. read more →

• Phoenix compounders, rise!

  The latest of APC’s new regional meetings — CompoundED UpDATE — is coming to the Phoenix area December 5. read more →

• APC election results: directors and bylaws

  See the results of APC's elections, including four new directors and several changes to our bylaws. read more →

More News

Yesterday, a federal court issued an unusual order in the lawsuit filed by the Outsourcing Facilities Association and APC member pharmacy FarmaKeio against the FDA. The lawsuit asserted that FDA had been cavalier in marking the tirzepatide shortage resolved, failing to follow proper administrative process, and relying on incomplete shortage data.

In an extraordinary and unexpected move, the FDA has filed an unopposed motion requesting a stay to the court proceeding and a remand back to itself (the FDA) so that the agency can reconsider its decision to remove tirzepatide from the shortage list. In its motion, the FDA signaled that its reconsideration may make the case moot. In other words, it appears the FDA is reconsidering calling the shortage resolved.  

The court ordered a status conference by the parties be presented on November 21. During the stay, the FDA indicated that it will not take any adverse action against the plaintiffs. This is a federal action. It is worthwhile to note that the motion would not protect the plaintiffs from state actions, although the taking of such action would be unlikely since there is a pending matter in federal court. It also doesn’t shield anyone from a lawsuit by the drugmaker, Eli Lilly — although we think that would be unlikely as well.  

What does this mean for pharmacies that are not plaintiffs in the OFA lawsuit? It’s not entirely clear. Just like we don’t think the states or Lilly would take action against the plaintiffs, we think it’s equally unlikely the FDA will take enforcement action against any pharmacy during this stay. But that’s what we think, not what we know. 

APC is working this weekend with our lawyers to submit a formal request for clarification to the FDA. Our aim is to get in writing that FDA will take enforcement discretion related to all pharmacies compounding copies of tirzepatide injection at this time. We’ll also assert again that the FDA-approved drug simply is not commercially available in quantities needed to meet the demand and the drug should be added back to the shortage list. Until we receive such confirmation, we suggest 503As continue to stand down on compounding tirzepatide copies. 

This is an extraordinary win for the Outsourcing Facilities Association and Lee Rosebush’s BakerHostetler team —  we’re grateful to them — and a strong signal that the FDA may reverse its abrupt October 2 decision.