Where Does Compound Tirzepatide Stand 3/19/25

The legal fight over compounded tirzepatide is drawing to a close in Texas District Court. Judge Mark Pittman has scheduled a hearing for summary judgment on April 24, 2025, at 1:30 p.m. in the Eldon B. Mahon United States Courthouse in Fort Worth, Texas, marking the next major showdown between the Outsourcing Facilities Association (OFA) and the FDA over whether compounding pharmacies should be allowed to continue producing tirzepatide.

This comes after OFA filed an appeal of Pittman’s denial of its preliminary injunction with the United States Court of Appeals for the Fifth Circuit under Case No. 25-10385. OFA and North American Custom Laboratories LLC Partners are seeking to overturn the lower court’s decision that allowed the FDA to begin enforcing its ban on compounded tirzepatide.

Pittman, however, has made it clear that the legal process in his courtroom will not slow down for the appeal. On March 17, 2025, he denied OFA’s request for a stay pending appeal, stating that he does not anticipate granting any continuances on dispositive motion deadlines. In short, the case is moving forward, and OFA will have to fight both battles at once, one in district court and one in the Fifth Circuit.

What Happens Next?

The April 24 summary judgment hearing is now the biggest moment in the case so far. If Pittman rules in favor of the FDA, it could end the lawsuit at the district court level, cementing the agency’s authority to restrict compounded tirzepatide without further legal challenges. If OFA wins, it would keep the case alive and potentially open new legal pathways to challenge the FDA’s actions.

Judge Pittman’s handling of this case is also being closely watched because he is overseeing a separate but similar lawsuit involving compounded semaglutide. In that case, Novo Nordisk initially failed to intervene due to a procedural mistake but has since been granted entry into the case alongside the FDA. If Pittman grants summary judgment for the FDA in the tirzepatide case, it could foreshadow his approach to the semaglutide lawsuit, which could have even broader implications for compounded GLP-1 medications.

The Industry Shift Away from Compounding

Meanwhile, the timing of all this coincides with Novo Nordisk and Eli Lilly launching direct-to-consumer programs offering their branded GLP-1 medications for $499 per month. Lilly’s LillyDirect and Novo’s NovoCare Pharmacy provide direct access to FDA-approved Mounjaro, Zepbound, and Wegovy, making it clear that pharmaceutical manufacturers are not just relying on legal victories but also reshaping the market to compete directly with compounders.

What This Means for Patients and Compounders

Mass compounding of tirzepatide is likely over. The FDA’s enforcement deadlines remain in place, meaning state-licensed 503A pharmacies should have already stopped production as of February 18, while outsourcing 503B facilities must cease operations by today, March 19.

With Pittman’s ruling on summary judgment potentially deciding the case entirely, and the judge making it clear he wants this case out of his court,the industry is facing a major inflection point. When compounded tirzepatide is taken off the market for good, patients relying on more affordable alternatives may be forced into the branded market, or worse yet, custom formulations, or the grey market. Whether OFA’s appeal in the Fifth Circuit changes that trajectory remains to be seen, but the pressure is now on both sides to make their case, both in district court and at the appellate level.

The next six weeks will ultimately determine the future of compounded tirzepatide and how aggressively the FDA will move against compounded GLP-1 medications. On The Pen will continue tracking every development.