Big Buttons

• FDA reconsiders on tirzepatide, big questions remain

  After a court order, the FDA agreed to reconsider taking tirzepatide off the shortage list. read more →

• Reporter briefing: Patient impacts of tirzepatide shortage resolution

  APC's media briefing shared compounders' first-hand stories with more than 30 reporters from across the country. read more →

• Be sure your marketing follows these best practices

  APC's new guide will help you stay on the right side of laws and regs. read more →

• A fake survey from a pharma-funded organization

  What the Partnership for Safe Medicines released "Ain't a legitimate survey." read more →

• Lots of letters

  On the compounding front, the FDA’s inbox is getting quite a workout lately. read more →

• Slick new dosing pen for compounders

  Love Lifesciences’ UniPen injector pen is not only a Very Big Deal, it's available at a discount for APC PFM members. read more →

• FDA says tirzepatide shortage “resolved”

  As of this afternoon, the FDA Drug Shortage List is showing that the shortage of tirzepatide injection is “resolved.” Pharmacies must immediately cease preparing and dispensing compounded copies of Mounjaro and Zepbound. read more →

• Get yer law and patient safety CE here

  We've made the most popular segment of our 15-hour legal course into a standalone 3-hour, on-demand CE program. 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.