In this April 20, 2026 YouTube explainer, Dr. Ashley Frazee clarifies the FDA's April 15, 2026 decision to remove eleven peptides (twelve compounds total) from the Category 2 “Do Not Compound” list, a move that had effectively banned their compounding since 2023. She explains that the removal does not instantly permit pharmacies to compound these substances; instead, the compounds now sit in regulatory limbo pending evaluation by the Pharmacy Compounding Advisory Committee (PCAC) in July 2026 and again in February 2027 for additional peptides. Frazee outlines the specific peptides under review (e.g., BPC‑157 for ulcerative colitis, TB‑500 for wound healing, MOTS‑c for obesity/osteoporosis, DSIP for opioid withdrawal and insomnia, etc.) and the intended indications. She discusses how the 2023 ban forced patients and doctors into the unregulated research‑chemical market, leading to quality‑purity concerns because many vendors lack mandatory batch testing and sterile compounding standards. The video emphasizes the importance of returning peptides to the regulated bulk‑drug (Category 1) list to ensure safety and quality, while warning viewers not to assume immediate availability. Frazee invites clinicians and patients to submit real‑world outcomes to the FDA docket (FDA‑2025‑N‑6895, comment deadline July 9) and promotes her “Peptide Mastery” course as a resource for learning the science and clinical applications of these peptides.
Chapters
RFK Jr. told us it was happening, and finally on April 15th, 2026, the FDA got the entire peptide community buzzing. And I feel a responsibility to tell you what's happened here, because what people are saying what happened and what actually happened are a little different. So here's what happened. Well, the FDA just removed 11 peptides and 12 compounds overall from the Category 2, or Do Not Compound list, which since 2023 has been the regulatory equivalent of a ban on compounding these substances in pharmacies. Basically, they said stop making peptides. And since then, you've been able to get Sermorelin, PT-141, oxytocin, and topical GHK copper from compounding pharmacies. And that might be it. So if you wanted any of the other popular peptides like BPC-157, TB-500, and MOTS-c, well, your doctor and your pharmacy were no longer allowed to get them to you. So then all of a sudden peptides became this thing that we couldn't talk about anymore. And I mean we as in doctors. And it also caused a lot of doctors to say, well, because the FDA says these are a no-no, I will shame you if you try to use them or dare ask me for them. Medicine is just good at stuff like that. It's not my cup of tea, but it's just what happens. And as RFK Jr. put it, this move, putting so many peptides on the do not compound list, forced peptides into the black market. And since then, peptides have been the wild, wild west. Which is why it was bold for someone like me, a licensed physician, to come out and start talking about them. Because I can only educate on what the peptides have been studied for, really. I can share what people are doing and what people are saying their experiences are. I just have to walk a really fine line. And I'll be honest with you, that has been really tough. Well, where have people been getting their peptides from? It's a very popular question. Well, most people have been purchasing peptides from companies selling them as research chemicals. not intended for human use and using them anyway. And you can get them from certain pharmacies, but you have to understand what's been going on here. See, I've seen a lot of comments from people saying you can still get peptides from pharmacies, but you have to understand they're still research compounds not intended for human use, no matter where they came from. Somebody somewhere had to sign a waiver that they understood that. So this is exactly why RFK Jr.'s administration pushed to get several peptides back into the hands of compounders. So basically what RFK Jr. told Joe Rogan when he let this secret out was that the ban in 2023, well, what that did was push people who were using or seeking peptides straight into the unregulated black market or research market. And the biggest issue with that is that research peptide companies, well, a lot of them were just doing it to sell peptides and make a buck, Which I'm all about free commerce, but some of the companies weren't batch testing their products often enough, meaning that they weren't sending the compounds to get verified as 99% pure. And the FDA caught several imported peptides that were being sold to humans and found that the purity in some of these batches were terribly low. So we really don't know how common that was, but it was scary enough to make everybody think harder about what they were buying and putting into their bodies. And the reason this is important— well, pharmacies have regulations and standards that they have to follow, such as this batch testing and how frequently they test and how sterile they make the compounding environment, things like that. But research labs or companies or the ones that are making peptides don't necessarily have those regulations. They have no standards or rules that they have to follow, and that's why peptides are the wild, wild west. Not necessarily because they're actually dangerous. I mean, there's more to that that I'll explain in a minute. But all that to be said, the ban didn't stop demand for peptides. It just made supply chains a lot more risky. So the point of bringing 12 compounds and 11 peptides back into the bulk drug list, or the Category 1 list, is about bringing peptides back into a regulated system where quality can actually be verified. And that's a win whether you like the FDA or not. Now just to be clear about what's going on, the bulk drug list— this is your Category 1 list of substances that can be used by compounding pharmacies and sold to you or I. They have enough safety data that licensed pharmacies can compound them while the FDA is still evaluating them. Category 2, where most peptides have been living since 2023. These are substances that the FDA flag as either risky or lacking sufficient human data, banned from compounding. And so this is what I mean. No matter what pharmacy has been offering peptides, If the peptides were on this list, they weren't supposed to be making them. No judgment here, but the clarity needs to be offered. Now, what happened on April 15th is that these 11 peptides got pulled out of the Category 2 list, meaning the formal prohibition is lifted, and now they're sitting in regulatory limbo, kind of a no man's land. So what happens next? Well, now, and this is important, just because these 12 compounds were moved off of the Do Not Compound list Well, pharmacies legally cannot start compounding these today based on this alone. If a pharmacy tells you otherwise, that's a red flag because removed from Category II is not the same as okay to compound yet. And here are the specifics. There's a federal advisory committee called the PCAC, the Pharmacy Compounding Advisory Committee, and they are the body that formally evaluates whether these substances should be placed on the approved compounding list. At the end of July 2026, the committee will meet to evaluate. They're going to evaluate BPC-157 specifically for what we know it can do for ulcerative colitis and gut healing, TB-500 for wound healing, KPV, the anti-inflammatory peptide, for wound healing and inflammatory conditions, MOTS-c, the mitochondrial peptide, for obesity and osteoporosis. And these ones got me because People aren't using MOTS-c for obesity and osteoporosis, I can tell you that. But okay, I get it, because there's specific published rodent data showing MOTS-c preventing bone loss in mice when they had their ovaries removed, so postmenopausal, and a study that showed reversed weight gain in mice on a high-fat diet. They're looking at C-Max for cerebral ischemia or stroke, migraines, and trigeminal neuralgia. They're looking at epithelin for insomnia and DSIP, delta sleep inducing peptide, for opioid withdrawal, which this one is really cool because there is a really great study on the effects of DSIP with people withdrawing from opioids, which I actually touched on in my peptide mastery course. And if you want a link for that, it's in my description. And then DSIP is also being evaluated for chronic insomnia and narcolepsy. In February of 2027, the peptides melanotan-2, dihexa, LL-37, and GHK copper for Injectable use will be reviewed. I personally don't get the melanotan two one. There's case studies of people trying this peptide and coming down with melanoma just weeks later. But, but okay. So down the road, even after this July hearing, a favorable recommendation from the committee still doesn't instantly make these legal. It just triggers a rulemaking process, and it also triggers a public comment period. So we're still talking months after the hearing before pharmacies get like a clear legal green light for these. But it's Coming. And I should also explain here a nuance. In the regulatory world, if the FDA approves BPC-157 for ulcerative colitis, it becomes legal for a pharmacy to make it. And once it's legal, then physicians and prescribers can still technically use it off-label for things like tendon tears or inflammatory conditions. The ulcerative colitis indication is just the key that unlocks the door To the pharmacy. So if you've been waiting to get prescribable peptides, you may do so soon, but it's still months away. The pathway is opening, and providers interested in getting into peptide therapy, now is the time to brush up and learn as much as you can. And I know there are lots of courses out there, but if you like hearing things in a way that's easy to understand and concise and not boring, check out my Peptide Mastery course where I put as much research and real-world thinking about how peptides can apply to humans. And if you take it, you'll be Pretty darn prepared for the first patient that comes around the corner asking about them. See the link in my description for that. Oh, and here's something pretty cool. If you want to participate in this whole process, the FDA docket is open for public comment until July 9th. So docket number FDA 2025-N-6895. If you've had real outcomes using any of these 12 compounds or 11 peptides, Well, that kind of matters to this committee. I mean, they'll really like it if you've used the peptide for the indications that they're looking at them for. But people's experience really matters, and you can submit comments at regulations.gov. So bottom line, this is legitimately significant. The regulatory tide is turning. But to say that the ban is lifting and that you can get these tomorrow are two very different things, and I just need you to know the difference. I've actually covered most of the peptides on this list in depth on my channel, and if you want to understand the actual science behind what BPC-157 or MOTS-c or Semax does before these hit licensed pharmacies again, well, please check those out or consider my course. I've done the homework for you. I'm Dr. Ashley Frazee. I like peptides. It's not a secret. Just trying to keep people informed and safe. If you like this video, please hit like for me and subscribe to my channel, and I hope you have the best day.
