The FDA Wins. The OFA Loses. And Semaglutide Is Off the Shortage List for Good

On Friday, June 13, a federal judge officially sided with the FDA and Novo Nordisk in the lawsuit brought by the Outsourcing Facilities Association over compounded semaglutide. The ruling was sealed at the time but was just unsealed today, Tuesday, June 17.

In simple terms, the OFA lost. The FDA won. And unless this is appealed and reversed, which is unlikely, mass-compounded 503B semaglutide is staying off the drug shortage list for good.

This means 503B pharmacies can no longer legally compound semaglutide using the shortage exemption. That door is closed. What remains are 503A custom doses and formulations which have flooded the market in the wake of the ending of essential copies.

If this feels familiar, it is because it is. The judge’s reasoning in this case closely tracks his ruling in the tirzepatide lawsuit earlier this year. That case involved Eli Lilly and compounded versions of Zepbound and Mounjaro. In both cases, Judge Pittman concluded that the FDA had the authority to delist the drugs without going through public comment, and that their decision was not arbitrary or capricious. The court again showed deference to the FDA’s judgment and the underlying data provided by the manufacturer.

Let’s break down what just happened and what it means.

The OFA had claimed the FDA did not follow the law when it removed Ozempic and Wegovy from the official shortage list back in February. They argued that the delisting was actually a rule and should have gone through public notice and comment. They also claimed the FDA did not properly weigh the data or consider how much demand is still being met by compounders.

The judge rejected all of it.

The court said the FDA did not make a sweeping new rule. Instead, it made a case by case decision based on real data from Novo Nordisk and internal review. That kind of decision does not require public input, and the judge made it clear the FDA is allowed to work this way.

The OFA also pointed to a quote from Novo’s CEO in a media interview, where he said demand still exceeds supply. They tried to use that to prove shortages were still happening. But the court was not buying it. The judge said the FDA had already asked Novo about that quote, and Novo clarified it was referring to the global market, not the US market, and not just to semaglutide.

The court also dismissed the OFA’s evidence from screenshots of pharmacy websites and consumer surveys as untrustworthy, outdated, or flawed. The judge emphasized the FDA was right to rely more on structured reporting from Novo than on anecdotal data from Hims and Hers or unverified claims from compounders.

In what might be the most biting part of the whole thing, the court suggested the OFA repeatedly misread or misrepresented the facts. There is even a line where the judge said their consistent and pervasive pattern of similar mistakes made it hard to keep assuming it was just an accident.

That is not the kind of thing you want to hear from a federal judge.

So what does this all mean?

It means the 503b semaglutide chapter of this legal fight is over, and the compounders lost. Any mass-compounded semaglutide products being sold right now are skating on legal ice, and the FDA is poised to enforce at their discretion.

Tirzepatide is still pending its appeal, but this decision cements the court’s stance. If the FDA’s reasoning holds up for tirzepatide, then it is highly likely it will hold up again if challenged. This is the legal blueprint now.

For the millions of patients using compounded versions of these drugs because insurance will not cover the brand names, this is devastating news. It makes the fight for affordable, accessible, FDA approved GLP 1 medications even more urgent.

If you have been relying on compounded semaglutide, this is your moment to get loud. Talk to your provider. Call your senator. Post your story. Share this article. The only way we change the system is together.

We continue to call on Novo Nordisk to cement their “special June cash pay offering” of $199 for all doses, and make the change permanent.

Use hashtag #Wegovy199

And if you want to keep getting updates like this, without the pharma spin, without the legal jargon, and always from the patient’s side, become a paid subscriber to On The Pen. This is not just news. It is a movement.