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.

Last week, the judge said no. And not just no, every single one of OFA’s arguments was dismissed. Now we have the judges opinion (hat tip to OTP friend @LeeFitsIn).

Download the Opinion Here

What the Judge Said

Judge Mark Pittman ruled that the FDA followed the law in how it removed the drugs from the shortage list. He found:

• The FDA didn’t need to go through a public notice-and-comment process. They were allowed to handle it internally.

• The agency did use up-to-date data, even though it included forecasts and was within its rights to look at national numbers, not local shortages.

• The FDA wasn’t required to count compounded tirzepatide demand when looking at past shortages.

• And even though the FDA relied heavily on data from Eli Lilly, the court ruled that was reasonable, since Lilly was the only one who had full data on supply and demand.

Most importantly, the court said the FDA gave a solid enough explanation for its decision and didn’t act in a way that was arbitrary or irrational.

Why This Is a Blow to Patients

If you’re someone who relies on compounded tirzepatide, especially because branded meds are too expensive or inaccessible, this ruling is devastating.

It means the FDA’s decision stands. As long as Mounjaro and Zepbound are technically available according to Lilly’s numbers, 503b compounding pharmacies can’t make the essentially copy versions, even if patients in the real world still can’t access the branded drugs.

The court basically said, “Trust the data.” But if you’ve been calling dozens of pharmacies, hitting refresh on every website, and hearing the word “backordered” for months, you already know data doesn’t always reflect lived experience.

What Happens Next

OFA has signaled they plan to appeal, in their statement provided exclusively to OTP last week, and I hope they do.

Their statement was as follows:

“Drug shortage determinations affect patient access to medical treatment and should be based on sound reasoning and verifiable data, not the say-so of self-interested manufacturers seeking to push competitors out of the market. We continue to hear from patients who cannot access tirzepatide. We will not stop in our efforts to ensure that patients can obtain these vital medications.”

That line is going to resonate with a lot of you. Because no matter what this court says, the reality on the ground is unchanged , too many people still can’t get what they need.

In the end, his wasn’t about safety. It wasn’t about efficacy. You can see that as tens of thousands have flocked to the GLP black market. It wasn’t about whether patients on compounded meds were doing well.

It was about power. And process. And who gets to decide when the shortage is over.

For now, that answer is: Lilly does. Because the FDA trusted their numbers. And the court trusted the FDA.

Why We Aren’t Done Following This

I’m going to keep covering this, because it’s not over. Not politically, not

practically, not morally.

If you’re someone who’s been impacted by this, I want to hear your story. If you’ve been priced out, denied by insurance, or forced to switch meds because of this ruling, tell me. I’ll be taking these stories back to Washington when I return next month.