Last Friday, February 14th, Justin Marti and Julia Cantu Hendrick hosted a live discussion regarding updates on tirzepatide compounding. (Their discussion is recorded in the video below.) It came as concerned providers approached February 18th, a date that marks the end of a grace period the organization had set for compounders to continue to create generic versions of tirzepatide.
We've written extensively about the lawsuit between OFA and FDA over the tirzepatide shortage. As the legal battle continues, the previously-set deadlines from the FDA are creating confusion for providers and compounders. Do these deadlines still stand in the midst of the lawsuit? Will they be enforced? What is happening in the lawsuit, and what happens next for providers?
Julia and Justin discuss these and other questions in this video. But first, let's set some context on the FDA's recent statement.
A Statement from the FDA
On February 11th, the FDA released a statement on their website in an attempt to clarify when the agency would plan to take action against compounders. It included:
For a state-licensed pharmacy or physician compounding under section 503A of the FD&C Act until February 18, 2025, or until the date of the district court’s decision on the plaintiffs’ preliminary injunction motion in Outsourcing Facilities Association (OFA) v. FDA (N.D. Tex.), whichever is longer.
For outsourcing facilities under section 503B until March 19, 2025, or until the date of the district court’s decision on the plaintiffs’ preliminary injunction motion in OFA v. FDA, whichever is longer.
How does this statement factor into next steps? Our own Julia Cantu Hendrick has conducted extensive research (and even attended the hearing in person) in order to offer her analysis below.