Our tirzepatide memo

The whole legal saga surrounding tirzepatide has meant there’s a lot of confusion, even among state boards of pharmacy. That’s why we wrote a simple, 2-page memo for those state boards that explains the current legal and regulatory situation around compounding tirzepatide. 

In short, FDA has made clear that it will exercise “enforcement discretion” related to tirzepatide compounding (i.e., it won’t take action against either 503A pharmacies or 503B facilities) at least in terms of shortage compounding; it will obviously still take action for other issues, such as quality or safety.

That discretion will last until the US district court rules on the Outsourcing Facilities Association’s motion for a preliminary injunction in its suit against FDA (or until March 19, 2025 for 503B facilities, if that comes later).

If your state BoP isn’t aware of the agency’s decision about enforcement, please download a copy of our memo and share it with them. It may help cut through some of the confusion.