What's Next for Compounded Peptides: Q&A with Nate Hill

In a conversation with Pharmaceutical Executive, Nate Hill, Co-Founder & CEO of Strive Pharmacy, discussed the regulatory uncertainty surrounding compounded peptides and how the industry is preparing for the FDA's anticipated move to shift these products to Category one.

Hill drew a sharp distinction between regulated compound pharmacies, which operate under state boards of pharmacy and FDA-aligned protocols for sourcing, testing, and batch production, and the "research grade" gray market, where products are sold without oversight despite being marketed for human use. He explained that the Pharmacy Compounding Advisory Committee's (PCAC) recommendation to move peptides to Category 1 marked a pivotal step, giving providers a trusted channel instead of leaving patients to seek unregulated sources on their own.

He also detailed how Strive is preparing for approval while managing risk, sourcing active pharmaceutical ingredients, running stability studies, and testing potency and sterility on a limited set of higher-demand SKUs, without committing to full inventory until the FDA finalizes its decision. Hill emphasized that Strive will not produce peptides until the category shift is official, citing the company's obligation to its employees, licenses, and patients.

Hill pointed to two key milestones for patients and providers to watch: the completed PCAC hearing and the forthcoming FDA final announcement, which he noted could arrive within months, though timelines have shifted before. He remained cautiously optimistic that momentum, including engagement from MAHA advocates, signals real progress toward expanding access to compounded peptides through trusted, regulated channels.

A transcript of Hill's conversation with Pharmaceutical Executive can be found below.

Pharmaceutical Executive: If the FDA moves to restrict compounded peptides, does the population currently sourcing from the “Gray market” migrate to safer channels or deeper into unregulated ones?
Nate Hill: For one thing, they have disclaimers on their websites that it's for research grade only, so I think that right there is a red flag that they're not saying that this is for human use, which I think is where lies a problem there that that's really, and I think everyone knows, that's what they are producing these medications for, is for individuals to use them for human use.

The concern with this is that it's not in a regulated space, so compound pharmacies, we already know that they are regulated by state boards of pharmacy, which adhere to FDA guidelines that are provided, and so we have to follow those guidelines. There's a lot of protocols that we have to follow as far as where we source our API, or active pharmaceutical ingredient, there's testing that we have to do, we're limited to batch sizes on our products as well, and so those are things that we're already currently doing where we have to work with reputable wholesalers and API suppliers that are FDA regulated and inspected and follow GMP standards.

These research grade companies there's all different channels that they're sourcing their products from, and it's not to say that some of these products aren't quality, but there's really no way of regulating that if it is not under the discretion, or under the regulatory boards like boards of pharmacy or the FDA, and so if there's an issue with the medication, if it's not what they say it is, or there's companies that are using their marketing to claim that, well, this is quality, we have a certificate of analysis on this product, those are all things that if that wasn't the case, who is going to regulate them, and who's going to find out if they're deceiving the general public with the med just to sell their product. So there's a lot of areas that raise concerns with the research grade.

We already know that compound pharmacies are a regulated and lawful industry, and we've been doing it for years. It hasn't been until GLP-1s and peptides where there's been a really big spotlight on compound pharmacies, but whenever there's a natural disaster, or there's a national shortage on products, or there's hospitals that need specific medications, they're going to compound pharmacies to produce these, and they've been trusted to do this as well. But now, as it has to do with GLP-1s or peptides, all of a sudden people are raising a red flag around compound pharmacies where it has worked very well for our healthcare system, and there's always going to be a need for compound pharmacies to provide different and unique medications that may not be commercially available through big pharmaceutical companies.

PE: What would a Category One designation mean for Peptides?
Hill: If this gets moved and the FDA does approve, which in history, when the Pharmacy Compounding Advisory Committee (PCAC) committee, votes to recommend a product to be moved to Category one, typically you see the FDA agree with that decision and that's not always the case, but typically that is the process we've seen if you look back at history. And so we're all optimistic about it being moved onto category one, but there's a lot of weird shenanigans that have been going on, and so we're not holding our breath until it actually happens. But we do have to acknowledge that we've made, some of these small victories, and this is the approval process for them to go, move to category one and be products that compound pharmacies can step in and, and produce.

But I think a big reason why this is important is because I was actually present at the PCAC hearing, and you had doctors that were getting up and testifying and talking about how the question isn't whether patients are going to use peptides or not, they're going to use them. They're going to find different channels where a provider recommends a source that they've heard about, there are compound pharmacies that are currently producing these that are willing to take the risks. Strive will not. That's our stance, we're not going to produce them until it is moved over to category one. There's too much for our company to risk and we have to ensure that we are compliant in all aspects of our company. We have a lot of employees, we have a lot of licenses, we have a lot of patients that we just can't take those risks.

The providers in that PCAC hearing were talking about how they are trying to facilitate and help their patients find a good source and if they don't have that tool in their tool kit, if they don't have a compound pharmacy that they trust, then they have to turn down their patients and their patients are going to find somewhere to get it. And the patients are going to do their research, they're going to ask around, they're going to find someone in their circle that is going to say, well, I have a good source, I know somewhere that I've been using them and it's worked for me, and then they're recommending them to go buy it online through whatever channel that they've found. So what this does though, if it get does get approved, it just gives doctors another tool in their tool kit, it gives them, somewhere that they can trust because of their history with working with compound pharmacies.

For example, like Strive, where we have a history of making product to the highest standards and knowing that we're going to follow those same protocols when we do roll out with peptides, as well on how we test things, on the potency, the sterility, the beyond-use dates of these peptides, ensuring that it's produced with high standards so it does give doctors more confidence in prescribing the peptides. Ultimately, these doctors are trying to put together a personalized healthcare plan for their patients, and peptides are, one of those tools that a lot of people are using and finding a lot of benefit from, and so, instead of just telling your patient, good luck, they can actually direct them and know that they're going to a good source to get these medications.

PE: How is Strive managing the uncertainty of inventory, staffing, and formulary planning around peptides?
Hill: Looking back at the history of Strive, this isn't the first medication that we've had to look at had to decide if we're willing to move forward based off of the information that we had at the time. GLP-1s is an example of that. When it was on shortage, when it was off of shortage, we still had providers and patients that were wanting unique doses that weren't commercially available.

We do work a lot with our legal counsel to have an understanding of where things are at and to feel confident in in taking certain risks associated with the business. This is one of them. Like I said before, we're not going to produce these until it's officially on category one, but there are things that we are doing currently to prepare to be ready.

We don't want to be the last ones that are producing this either, but we also aren't going to be the first ones producing this because there's people that are already producing them, and that's not going to be us. So, there's things that we can do where we can get these, we can source the API already, and we can send them out for testing so we can we can test these products to make sure that we have the right stability studies, the beyond-use dates extended, and different testing that we can do so that it's ready to go once they are approved. We are limiting it to certain SKUs that we feel are going to be, in higher demand than others. I think there was about six peptides that were approved in that PCAC hearing, so we have a limited SKUs that we are testing and that we are going to be ready to produce, and then we'll probably add in the other ones as we ramp up with the what we believe are the more popular SKUs. It's just a calculated risk that we have to take. There's certain fees that go into doing these studies, but we don't actually have to stock the inventory until it has been moved to category one.

We have good suppliers, wholesalers and suppliers of the API, to where we know that we can get the API fairly quick once it has been approved, so we're not having to spend money on those types of things, but there are things that we understand that if this didn't get approved, it would be sunk in costs until it does get approved down the road. We've been involved in conversations with our attorneys, and within MAHA, that has been very vocal about utilizing peptides and the benefits of them. We've been involved in those conversations, and through information that we've gathered, there's been information that's been said, hey, this is when we expect peptides to be approved, and that date is long gone, so we understand that we have to take everything with a grain of salt, but we are seeing progress now.

That PCAC hearing is obviously an example of the process it takes to get these approved, and so we are gaining traction, we believe, and so we're optimistic about the outcome and seeing these peptides move over to category one as we see that, we're willing to take some more risks based off the information and where it's at today.

PE: What moments in FDA’s review process should patients and providers be watching closely?
Hill:Yeah, that PCAC hearing was a big one. Everyone knew that once it got to that hearing, and it needed to be approved to get moved over to the FDA to make their final decision. I think that's why there's a lot of excitement, because the history shows that typically the FDA will move it over to Category one if the PCAC does approve these medications and votes to have them recommend that they're added to Category one.

So the next step would be the FDA making that final announcement, and, if you look online, sometimes it can take six to 12 months, but there's a lot of talk in how they expect this to move a lot quicker. We're waiting just like everyone else to see when that does happen, and there's some anticipation that it'll take place by as soon as next month, but we don't have a crystal ball to know what's going to happen. But I think that's what people should expect is the FDA to make some type of announcement on the movement of these peptides onto category one.

But those are really the two steps. It's just the PCAC, which has already taken place, and then the FDA making that final approval and giving a timeline on when compound pharmacies will be allowed to start producing.