Big Moves in the OFA v. FDA Case—But Does It Even Matter?

The legal showdown over compounded Tirzepatide is heating up, with a major court ruling just around the corner. But here’s the twist: the FDA has already told the Alliance for Pharmacy Compounding (APC) that they don’t plan to enforce a compounding ban while the case is ongoing.

Yep. You read that right.

That means the court’s decision on a preliminary injunction—which would normally decide whether compounding can continue during the lawsuit—might not even matter. But that doesn’t mean this case isn’t a big deal.

Let’s break it down.

What’s Happening Right Now?

🗓️ February 18 – The FDA must file its response to OFA’s request for an injunction, explaining why they think 503b compounding should end now that shortages are over.

🗓️ February 25 – OFA & FarmaKeio get one week to respond to whatever the FDA says.

From there, the judge can rule at any time on whether compounding is allowed while the case plays out. But if the FDA isn’t planning to enforce a ban anyway, then the ruling is basically just a legal formality.

What Happens Next?

Right now, there’s no hearing scheduled—which means the judge could do one of two things:

1️⃣ Rule on the injunction quickly – This would officially decide whether compounded Tirzepatide is allowed during the lawsuit (but again, the FDA already said they aren’t enforcing anything).

2️⃣ Ask for more arguments (not likely) – This would slow things down and push a decision further into the future.

Either way, the real battle is in the final ruling—not the injunction.

So… Does This Injunction Even Matter?

Honestly? Not really.

Since the FDA has assured the APC that they’re not cracking down on compounding during the trial, the injunction ruling won’t actually change anything for now. But it will give us a big clue about how the judge feels about the case.

✅ If the judge grants the injunction, it’s a good sign that OFA’s arguments are strong, and the court might eventually rule against the FDA.

❌ If the judge denies the injunction, it could mean the court is leaning in favor of the FDA—which would be bad news for compounding long-term.

The Real Fight is Coming

Once the injunction ruling is out of the way, expect the next big legal move:

📌 Motions for Summary Judgment – Both sides will try to convince the judge to end the case without a full trial.

If granted, the case could wrap up quickly. If not, we’re looking at months (or longer) of legal drama before we get a final answer.

Why This Still Matters

Even though the FDA says they won’t enforce the compounding ban right now, this lawsuit decides the future of compounded Tirzepatide.

If OFA wins, compounding stays in play—potentially long-term.

If the FDA wins, 503b compounded Tirzepatide is likely done unless something changes at a policy level.

So, while the injunction ruling might not shake things up, the final decision absolutely will.

Stay Tuned—We’re Watching This Closely

As soon as the FDA files their response on February 18, we’ll have a better idea of where this is headed. If you want real-time updates, keep following On The Pen—we’ll break it all down as it happens.

And if you’re in Facebook groups or Reddit forums about GLP-1 meds, share this with your community—because the fight for access isn’t over yet.