Compounded GLP-1s vs. Counterfeits: FDA Finally Draws the Line

For over two years, drugmakers and their PR machines have blurred the line between two very different things.

On one side, you have legally compounded GLP-1 medications made by licensed pharmacies during periods of shortage or customized for patient needs, prescribed by licensed providers, and filled by patients who have no other option.

On the other side, you have illegally marketed, research-grade knockoffs sold in group chats and TikTok comment sections, often mislabeled, sometimes dangerous, and always unregulated.

Until now, the messaging out of the FDA allowed those two worlds to be conflated. The silence was deafening. The vagueness was strategic.

But this week, the FDA finally did something that matters.

They separated the real from the unregulated.

A clear distinction that cannot be ignored

The FDA’s newest communication is not perfect, but it does something the drugmakers never wanted.

It makes a clear and public distinction between:

• Legally compounded GLP-1s filled at state-licensed pharmacies

• Not for human consumption research chemicals and counterfeit products

This matters more than most people realize. For years, large pharmaceutical companies have attempted to collapse those two categories into one, insisting that any compounded GLP-1 is dangerous, unregulated, or illegitimate. They have pointed to online sellers and fake labels and tried to pin the danger on the entire compounding space.

But now, the FDA is making a clear distinction, and perhaps signaling how they will handle compounding of GLP-1s in the future:

The problem is not compounding. The problem is unregulated and untested counterfeits or research chemicals not fit for human consumption.

Let’s talk about what the FDA actually said

Here are the key takeaways from the FDA’s new guidance:

• Compounded semaglutide and tirzepatide are allowed under federal law when the brand-name product is not commercially available

• Research-grade semaglutide and tirzepatide sold online are illegal and dangerous, and in some cases falsely labeled with the names of legitimate pharmacies

• Salt forms of semaglutide, including semaglutide sodium and semaglutide acetate, are not the same as the ingredient used in FDA-approved drugs and have no lawful basis for compounding

• Retatrutide and cagrilintide cannot legally be used in compounding at all

• Patients are advised to use only state-licensed pharmacies and to report any suspicious products to the FDA directly

One of the most overlooked lines in the FDA’s update reveals something Pharma would probably rather you not notice. Not all compounders are exempt from safety reporting. While federal law does not require traditional state licensed pharmacies to submit adverse events, 503B outsourcing facilities are required to report. This is important because drugmakers have spent the past year implying that all compounded medications are unregulated and untraceable. That simply is not true. The reality is more nuanced, and the FDA just confirmed it in writing. The most regulated compounders, those operating at scale as 503B facilities, are already required to report adverse events directly to the FDA. So when Pharma paints compounding as a wild west of untracked risk, they are hoping you will not look closely at the difference between a licensed outsourcing facility and a 503A pharmacy. But the FDA just drew that line, and it is worth paying attention to.

Pharma will love some of this guidance and hate some of it too

This is not just a safety bulletin. It is a direct contradiction to the messaging pushed by some of the largest players in the space.

They have tried to paint all compounders with the same brush. They have spent months arguing that patient safety demands a crackdown on compounded medications, while avoiding any acknowledgment that their own inability to supply product an affordable or accessible product is what forced patients to seek other options in the first place.

Now, the FDA has come out and said what advocates have been yelling since the beginning:

There is a difference. A real, important, legal difference.

And no amount of spin can erase that.

However, the calling out of compounding of retatrutide and cagrilintide will come as a welcome message for pharma as these investigational therapies have yet to finish phase 3 trials and achieve FDA approval.

Two years ago, at On The Pen, we were the only ones in the patient community talking about the promising breakthrough therapies of retatrutide and cagrilintide. Fast forward to today, you can’t move on social media without running into people who are already taking these peptides in research forms. In fairness, many of them seeing the benefits we have been touting from the beginning.

What this means for patients

If you are using compounded GLP-1s from a reputable, state-licensed pharmacy, this announcement should not scare you. If anything, it should validate what you already knew. You are not doing something reckless. You are trying to stay on life-changing treatment during a time when the branded option is either unavailable, intolerable, or unaffordable.

However, if you are buying vials from a Telegram group or using a mystery vial labeled “not for human use,” this guidance may give you pause (but let’s be honest, probably not). The FDA has already issued warning letters. They are actively investigating counterfeits, and they are urging consumers to know exactly where their medication is coming from.

Just so we’re clear

This is not about compounding versus brands. It is not about semaglutide versus tirzepatide. It is about clearing up confusion fueled by a campaign waged by big Pharma against, as Dr. Spencer Nadolsky puts it, little Pharma. Thankfully, the FDA just made it a little easier to tell the difference.

There is still work to do. There are still games being played. But this much is now clear:

The people who compound responsibly are not the real threat.

That clarity matters.

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