Big Buttons

• FDA doubles down: Tirzepatide is off shortage

  ...but that doesn't mean the issue is completely settled. read more →

• A couple of state updates

  Good news from Alabama, but a problem in Massachusetts read more →

• Defending GLP-1 compounding

  The latest letters APC's been sending to oppose efforts to restrict compounding read more →

• Thumbs-up for FDA crackdown

  APC was thrilled when the FDA announced it was taking action against illegal online businesses claiming to sell “research-grade” compounds. read more →

• A PANS/PANDAS explainer

  For your patients: Information about a couple of underdiagnosed pediatric mental health conditions read more →

• What, a year?

  In the final board chair column of the year, here are our top 7 accomplishments in 2024. read more →

• “Simply not a rational approach to regulating an industry”

  This week APC offered its final (and pointed) suggestions to the California Board of Pharmacy on their proposed significant – and we would say unjustified – changes to their compounding regulations. read more →

• Get a cease and desist letter from Verrica?

  APC has heard reports from several pharmacies that have received them — here's what to know. 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.