Compounded Tirzepatide: We Now Have the Judge’s Opinion, in Massive Blow to 503B’s

It’s officially, official. The federal judge in Texas has unsealed his ruling against the Outsourcing Facilities Association (OFA) in their case against the FDA over tirzepatide’s shortage status, a decision that could close the chapter on mass compounded copies of Zepbound and Mounjaro.

Let me break down what this means, why it matters, and where we go from here.

The Backstory

Last year, Eli Lilly pushed hard to get Zepbound and Mounjaro off the FDA shortage list. Once removed, 503B compounders could no longer legally make their own versions. OFA stepped in to fight the delisting, arguing the shortage was ongoing and that patients relying on compounded meds were about to get boxed out. They sued the FDA, trying to force the agency to reverse its decision.