CEimpact Podcast

Why Is Everyone Talking About Peptides?

• CEimpact

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Interest in peptide therapies has grown rapidly, with increasing patient questions driven by social media, wellness trends, and evolving access through compounding and online sources. This course reviews what peptides are, the current state of evidence supporting their use, and key safety and regulatory considerations relevant to patient care. You will be better prepared to apply an evidence-based approach when discussing peptides, including evaluating risks, addressing misconceptions, and guiding patients toward safe and informed decisions.

HOST
Rachel Maynard, PharmD
GameChangers Podcast Host and Lead, Clinical & Partnership Education, CEimpact

GUEST
Nicolette Mathey, PharmD
Founder & CEO, 
Atrium24

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 CPE INFORMATION
Learning Objectives
Upon successful completion of this knowledge-based activity, participants should be able to:
1. Describe the role of peptides in human physiology and the current evidence supporting their therapeutic use.
2. Identify safety, regulatory, and patient-specific considerations relevant to the use of peptides in clinical practice.

Rachel Maynard and Nicolette Mathey have no relevant financial relationships to disclose.

0.1 CEU/1.0 Hr
UAN: 0107-0000-26-240-H01-P
Initial release date: 6/15/2026
Expiration date: 6/15/2027
Additional CPE details can be found here.

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Welcome And CE Credit Details

SPEAKER_00

Here on Game Changers, we're all about helping you stay ahead of pharmacy practice. But why stop at listening? You can earn CE credit for this episode and hundreds more by visiting CEimpact.com and logging into your account or creating a new one. Get credit, get inspired, and make your learning count. Hey, CE Impact subscribers. Welcome to the Game Changers Clinical Update podcast. I'm your host, Rachel Maynard. I've been excited to dive right into our topic today about peptides. Peptides seem to be popping up everywhere these days, from social media to wellness clinics to patient questions at the pharmacy counter. But what's driving that surge in interest and how much of it is evidence-based? Well, today we'll break down what peptides are, what the evidence actually shows, and what pharmacists need to know right now, especially as regulatory discussions continue to evolve. And I'm very excited to welcome our expert guest, Dr. Nicolette Matthew, to help navigate these tricky questions. So welcome, Nicolette. And if you want to just give a little bit of background about yourself, I'm sure our listeners would be very interested to know a little bit about your current role, your background, and why you're interested in this topic.

SPEAKER_01

Sure. Thank you, Rachel. Thanks for having me. My name is Nicolette. I'm a pharmacist and I've been working in pharmacy for over 25 years. I started uh with a big chain pharmacy. And then from there, I went into some hospital outpatient pharmacy and some uh meds to beds programs and things like that. And uh then I got into the world of independent pharmacy and compounding pharmacy. So I've been doing that for quite a while. And uh it's been really interesting to see you know the compounding pharmacy market and patient-specific customized dosing for certain therapies and what's been happening with the peptides in the market. And especially the most interesting thing I think I'm seeing is patient demand and patient driving, you know, the medications and things like that. So I currently own a software company. I sold my large independent pharmacy that I owned a couple of years ago, and now I own a software company where I work with hundreds of pharmacies across the country, regular retail pharmacies, hybrid pharmacies, community pharmacies, compounding pharmacies. And I also have been working really closely the past few years with 503B manufacture pharmacies. And so they kind of sit in the middle between your big pharma manufacturers and your independent community pharmacy compounders. 503B has a whole FDA rule set and more pharma manufacturer type policies that they follow. So the peptides fit right in on all of that supply chain. And so it's been really interesting to watch all the changes that have been happening.

SPEAKER_00

Absolutely. Well, it sounds like you've got a very unique background and experience to bring to this discussion. And as you said, it it fits right in with where I think peptides are being looked at and considered for lots of different reasons. So let's just

What Peptides Mean To Patients

SPEAKER_00

get right into it. Um and let's just start with what peptides are. I think most of us as pharmacists are probably familiar with the idea of peptides broadly. And we have examples that we've been familiar with, like insulin and uh GLP1s, glucagon-like peptide one agonists. Um but beyond those examples, what are some, what are some of the considerations? What what how how peptides are categorized and how they work in the body? What how would you generally describe what peptides are and how they work?

SPEAKER_01

Yeah, and so the the most general definition of a peptide, it's uh less than 40 amino acids, right, in a chain. And so exactly, insulin is the most well-known, long-standing, most studied peptide that's been keeping people alive for decades. And then, you know, we all started, it became a household name, peptides, GLPs, Ozempic, things like that. And when I think of peptides and are peptides safe, or when it when household names just throw around peptide, that's the same as asking medicine. Is medicine safe? You know, it's like, well, drugs, are drugs safe? Well, you know, we're gonna need to be more specific. So you have your GLPs, the there's a lot of other peptides that are, and again, it's just meeting that definition of the amino acid change uh chain. So other peptides, BPC 157 has become popular, TB500 has become popular, you know, wellness circles and med spas and clinics have started stacking. So you'll hear about stacks, you'll hear about the wolverine stack or the glow stack, and it's just combinations of these different peptides. Um, so what you know, what are peptides? By definition, it's an amino acid definition, it's a scientific definition, but that's on our science side. Household side, you know, peptides are things that help you lose weight, things that give you energy, things, you know, and so that's on the household side. Now we have to be careful as clinicians and as pharmacists not to make claims. So we can't say, you know, BPC 157 will heal your injuries. You can't, you can't say that because it's not an FDA-approved indication. It's not, it's not for that. Um, so even compounding pharmacies, when they're putting out, you know, patient education information or prescriber education information about the compounds they make in their own pharmacy, they have to be very careful legally not to make claims, even if they're compounding hormone replacement therapy or just any any type of compound that you make, uh, dermatology compounds, creams, if it's not all compounds are not FDA approved. Not because there's anything wrong with them, that's just not a requirement to go through that uh FDA drug approval channel to compound medications. So there's a whole because it's not practical, right?

SPEAKER_00

I mean, these are as you say, they're individualized for each patient and not something each product could get that FDA approval. So sorry to interrupt.

SPEAKER_01

Yeah, yeah, no, that's exactly right. And so you we I always look at it between two lenses, you know, like when my patient's coming and asking a question, how are they framing it? And what does it look like in their world? And then when we pharmacists are talking about the same type of therapy, you know, we're looking at it clinically, we're looking at it legally, we're looking at it a lot of different ways that they don't necessarily in the household terms. So when we look at a peptide as pharmacists, what is a peptide? Well, it's you know 40 or less amino acids. Greater

Peptides Versus Biologics And 503B

SPEAKER_01

than that, a lot a longer chain of amino acids is a biologic. And so you'll see biologics medications in specialty pharmacies, branded pharma, very expensive typically. And interestingly, just a little side note here there's a lot of additional weight loss peptides in different phase trials with big pharma and with the FDA. And even um one of the latest things to be filed uh is with uh Red A2 tride, and their pharma manufacturer is trying to file and have the FDA classify it as a biologic. So it's just a little different nuance because if it does get categorized as a biologic, then compounding pharmacies won't be able to make it, even if it goes on a shortage. So there's a lot of different legal nuance going on. And actually, um, I follow and read a lot from the OFA, the Outsourcing Facilities Association. And that's a legal and an advocacy association for the 503B manufacturers. And 503Bs are the companies that stepped in and at large scale manufactured semaglutide, terzepatide commercial copies when those drugs were on shortage. So they still had a patent, but pharma couldn't keep up with the demand. And you know, all of our wholesalers were out of stock on these brand names. You couldn't get them in at your pharmacy. So the FDA put them on the shortage list. Then 503Bs came in and made commercial copies, exact copies of, you know, inactives, actives, commercial copies of the semabutide and the terzepitide. So the OFA they put out a lot of information and they're really good to follow if you want to see just kind of what's the 503B's stance, you know. Sure. Okay. So that's been uh an interest, interesting read. And the OFA actually just filed an amicus brief, which is like a friend of the courts, as I understand that. I'm no lawyer, but I I try to read everything I can. Um, but it's a just to put out why the OFA doesn't believe that RETA should be a biologic.

SPEAKER_00

Okay. Okay. So there's a, as you said, it's nuanced there, right? Like there's a lot of considerations we're talking about. And and I I like how you called out the idea of the clinical side that we think about as pharmacists, and then sort of that patient-facing side and what they're seeing at home on social media from their friends and family. And I think you described well the sort of definition of a peptide and the fact that there are these FDA-approved peptides that we have been used to, and also some of these other products, and you named a few examples that are being promoted for a lot of different uses. And the considerations with pharmacists being careful about that, but that patients are hearing about anti-aging, you know, weight loss, improving recovery after injury, all of these sorts of considerations are being promoted. And I think that's why we're seeing such a rise in use and the stacking, as you said, and a lot of social media-driven influencer sort of claims being made about these peptides, which I think is why they're getting a lot of traction and interest. And then you talked about some of those regulatory considerations, but could you give a little historical background, a little more detail around what happened a couple of years ago with some of these peptides and why they're now sort of being brought back to the forefront, some of those examples that you listed and what is coming in terms of FDA's consideration with these products?

SPEAKER_01

Sure.

FDA Categories And Compounding Limits

SPEAKER_01

So I believe it was, I believe it was 2023 that a lot of peptides were moved to a category two with the FDA. So category two is do not compound. So these category two peptides and any substance on the category two list cannot be compounded, dispensed through the traditional pharmacy channels. And so BPC 157 has been on there since 2023. And so recently, you know, there's been a lot uh changing in the administration in this country, a lot changing in the FDA. And uh RFK went on the Joe Rogan podcast of all things and uh talked about peptides, talked how he uses peptides. He's a big advocate of peptides, and he talked about how the FDA is going to be removing some of those peptides from category two. Well, again, in the social media world, a lot of people were like, that's great. He said it now we can get all of these peptides through pharmacy channels. Well, that's not that's not how the process worked. So uh recently in April, so just last month, uh 12 peptides were removed from category two, but but they were not placed into category one. Category one is where we may compound these medications under uh some enforcement discretion, like Sumorlin is another one that's on category one right now. And just to round it out, so category one um on the 503A bulks list, that's where these categories live. 503A is, I remember we talked about 503B being manufactured. 503A is the pharmacies we all know. They're the traditional compounding pharmacies, traditional community pharmacies, those are 503A. So on that 503A bulks list, there's category one, category two, category three. Category one, we can compound them. There's a lot of rules and nuance, but essentially that's the Cliff Notes version. Category two, do not compound. Category three is where there's insufficient data to to evaluate. So in in April, RFK and the FDA removed 12 peptides from category two, but they didn't put them anywhere yet. So so then uh now it moves to to uh the the PCAC uh pharmacy compounding advisory committee, I believe.

SPEAKER_00

So the PCA FDA's yep, the FDA Advisory Committee, exactly.

July PCAC Meeting What’s On Deck

SPEAKER_00

Yep.

SPEAKER_01

Yes, so the PCAC is actually having a meeting in late July, July 23rd and 24th, 2026. The PCAC is going to meet, they're doing a two-day meeting. On day one, they are going to review BPC 157. They're actually looking at it for ulcerative colitis, KPV, they're looking at that for wound healing and inflammatory conditions. TB500, uh, they're looking at that for wound healing. And then uh MOTC for obesity and osteoporosis. And it's funny I mentioned the stacks. BPC 157 and TB500 are sometimes put together in a in a wolverine stack.

SPEAKER_00

Okay. Okay.

SPEAKER_01

So we're hearing all these things and all these worlds collide. Uh and then on day two, on July 24th, they're gonna look at a few other not as well-known ones. I don't even know how to pronounce some of the deltide. I like to call that one DSIP because that's another term for it, but yeah, emadeltide. They're looking at that one for opioid withdrawal, chronic insomnia and narcolepsy. And then uh CMAX, they're looking at that for cerebral ischemia, migraine, trigeminal neuralgia, and then epitolon for insomnia. So some of these are not in the longevity wellness tick tock space. Some are, but that that PCAC meeting has to happen in July. Well, this is the plan because you could always have an executive order that overrides all of this and just moves them somewhere.

SPEAKER_00

Or the advisory committee could change, they could delay, or all sorts of things could happen. Yeah, but I so I think you summarized well that uh that these under 20 peptides were moved removed from that category two list, but not necessarily recategorized. So they're sort of in this gray area. We have this list that you just ran through that's going to be discussed at this FDA advisory committee if it goes through at the end of July, and that would presumably help then determine at least those peptides where they would fall.

SPEAKER_01

Presumably. And the interesting thing is it's like, okay, this sounds great. The FDA said let's take this specific list of peptides, let's have an advisory committee review them. Well, what is the advisory committee going to review? And I think this is the biggest uh kind of rock and a hard place that pharmacists find themselves in because we don't have a lot of studies for these peptides. Right. So it would be one thing if the if the advisory committee could review and review all the data and all the evidence, and it could all be in a nice, neat and tidy package, and they can just put a bow on it and say, okay, these are great. Let's move them to category one. Let's give some real parameters and guidelines on dosing and drug interactions and patient counseling points. And we don't have that.

SPEAKER_00

Mm-hmm. Mm-hmm. Yeah. And I I think the other thing, my understanding that's complicating what's happened since 2023 is that once those were moved to that category two list, those peptides, compounding pharmacies were no longer able to make them, as you laid out. And

How The Gray Market Emerged

SPEAKER_00

but there was still sort of this demand for them potentially, and there was sort of a gray market that emerged from that and uh potentially products being shipped um internationally and leading to under the under the premise of for research. And so patients were still able to get these, but not through compounded pharmacies. So speak a little bit about that. I see you nodding your head.

SPEAKER_01

Yeah, yeah. So the gray market that became a real thing, and and that's exactly right. Even legitimate pharmacies now, very well renowned, respected pharmacies in this country now. I won't name names, but um, they are putting these compounds through their research and development process. They're looking at things like uh purity, stability, sterility, endotoxin testing. They try to get their own uh beyond use dating. Once they first compound it, they get a very minimal expiration date, beyond use date for compounding, and then they have to put it through rigorous studies over that amount of time. If they want a 90-day beyond use date, well, they have to compound it and they have to test it and watch it for 90 days. If they want 180 days, it's so it takes that long and even longer. But the problem to your point, and exactly what you said, is all the API, all the active pharmaceutical ingredient ingredients, all the raw powder of these peptides is research grade only. Because there is no channel right now legally that that in this country that these peptides can be purchased from pharmaceutical supply chain and and have you know that that rigor of testing. Typically, compounding pharmacies they purchase APIs from FDA registered manufacturers. It comes with a C of A, which is a certificate of analysis, and it's it's uh 97% pure, let's say, or or more, you know, right around there. What we're seeing on the gray market, uh, it could have a 5% purity because those testing requirements, those registrations, those FDA inspections are not required of research grade market.

SPEAKER_02

Okay.

SPEAKER_01

So what I find really fascinating there, I went down a rabbit hole. Uh, and I won't, well, we we have pharmacists on the call, so you'll probably want a rabbit hole with me, but I won't bore you too much with it. I I asked, you know, I'm like, how does how do these powders actually get made? How does API powder get made? And and it was a really fascinating read, just because you know, organic chemistry and all that, we learned about it. It's the same kind of stuff. So they're building uh one amino acid at a time, they're building these chains on a plastic bead. It was uh a process by Merrifield in 1963, I learned, and they even won a Nobel Prize for it. Um, but then you build these amino acid chains, but you do so by using all these different connectors, and then you have to do all these washing steps to cleave extra things off and put it through um these machines and and cleave off, purify by HPLC, freeze-dry it into powder, do all these kinds of things. And um, even if you get a crude product, it might only be 30 to 70 percent pure, and then you're having to keep clean it and do more cycles and more testing and more now that's the difference. So the gray market is not doing these purification steps because they're not financially incentivized to do so and they're not required to do so. So, pharma grade is that's what the FDA is looking for, and that's why they have these C of A's, and that's why they have this testing. These large compounding pharmacies in our country, when they receive the API powdered pure drug product, not only are they receiving a certificate of analysis, but they're doing their own testing, right? When they receive it from a third-party lab to verify that is this what is it's purported to be based on the CMA? Research grade is not doing that. Research grade is maybe 5%, maybe 30%. And in medicine, we can't use the word maybe.

SPEAKER_00

Yeah, of course, right. Yeah, yeah. And so to your point, it raises questions about quality, consistency considerations that, as you say, when it comes to clinical use in patients, uh, we we don't have that same uh wiggle room, perhaps. And so the the thing I think that sticks out to me is the fact that since those products were moved to the category two list in 2023 and fast forward to where we are now in April 2026, there's no change in data that we have in terms of why these products would have been moved or declassified as category two is my understanding. But I I guess that transitions into the evidence for these products more

Evidence So Far And Big Gaps

SPEAKER_00

broadly. And so thinking about peptides, which I know, as you said, is a very broad term. And when we think about each particular product, specific uses that they might be promoted for, there it's a very broad uh there's a lot to be thinking about in terms of evidence-based use and whether specific products have any evidence for specific uses in specific patients. But could you provide a high-level summary of what the evidence base is for peptides in general, maybe some examples for specific uses? Because thinking about that clinical perspective, we want to be sure that patients are getting evidence-based therapies. And so, how would you sort of summarize that, which I know is a very difficult question?

SPEAKER_01

Yeah, it it is. And if we if we put our pharmacist hat on and our evidence-based hat on, and we try not to be influenced by the financial aspect, the pharma aspect, what pharma's telling us, you know, and if we just look at it, like, okay, let's look at a clean slate, what's going on here? We have strong FDA approved peptides, some, and the evidence, you know, insulin, semaglutide, terzepitide, semorin, pt 141, all of those. Peptides either are part of FDA approved drugs and products. They're being used by millions and millions of people. They have been for a long time. We have a lot of evidence there. So that's not in question. There are some peptides that have some substantial evidence and are approved abroad. So thymocin alpha is a peptide that's approved and studied in 35 plus countries, more than 30 clinical trials for that. When we look at BPC 157, there's some limited human trials, studies. There's three small studies. There are no randomized control trials yet. And again, we have to look at why. Why do we not have if it's so popular, why do we not have this? It's like you said, you know, while they were put on the do not compound list in 2023 for no outstanding reason. They were just kind of quietly re-categorized in 2023. It wasn't that patients were being hurt, it wasn't that there was a big issue where we had to, you know, keep everyone safe and move these drugs to category two. That's been um hotly contested in the compounding community and in the longevity and wellness community for years, that that they shouldn't have been moved to category two. Because, like you said, now we can't practice patient-specific medicine and and watch anecdotally and have pharma approved, you know, FDA approved supply chains, a prescriber prescribing these medications for this patient, observing this patient, having it go through licensed, registered pharmacies, following the rules, doing the right things. So that's why overturning what happened in 2023 is important. So that we can get back to practicing medicine the way that that we'd like to.

SPEAKER_00

And in I think I think sorry, I think uh just to clarify there, I think uh part of the concern in 2023 was sort of this expanding use and telehealth and and maybe people not getting that individualized patient-centered care from uh you know working closely with their clinicians. So concerns about the telehealth aspect of it. And then I think there were some emerging potential signals around immune reactions or cancer considerations, or maybe accelerated cell growth, not necessarily cancer, but there were some safety considerations. And I think that was what was the initial drive in 2023. Although to your point, um it that took that opportunity away, where we know that in some cases when people are using compounded medications, the patient is working under the supervision of their prescriber. They are making an informed decision together to use this, that shared clinical decision making to uh to try something, even if there isn't robust, you know, randomized controlled trials to support the use. So I think that's where the tension comes in a little bit that we have um patient individualized compounds that maybe had been used under the shared clinical decision making, and that was taken away because of some of the potential telehealth considerations, potential safety considerations. And so that just to clarify, I think that's that's sort of the the problem.

SPEAKER_01

Yeah, that's fair. And really, telehealth and telemedicine went wild during COVID. Right, right. In 2023, it was right around that time. Yeah, yeah, yeah. Exactly. A lot of really weird things happened during COVID, especially to us pharmacists and to our, you know, I never thought I would in I would inject so many patients in my life. And I certainly didn't think I would immunize thousands of patients and clonal antibodies and to actively sick patients and all these swab noses. I didn't, you know, I didn't learn how to swab noses in pharmacy school, but then here we were swapping thousands of noses. Right, right, right. So uh and and you know, telemedicine during COVID, the the the FDA had to kind of open up a lot of things during COVID to make sure that patients got treated. And telemedicine was one of them. And then there were some companies that that capitalized on that and even were prescribing an abundance of ADD medications and controlled substances through telemedicine. So then you have the DEA stacked on top of the FDA, stacked on top of all. So there was a lot of issues. So maybe it was overreaching to during that time, instead of instead of locking down telemedicine, you know, which I think would have been a better move, you know, the FDA moved different drugs and therapies to category two and just kind of locked them up. And what did that do? You know, so sometimes like the Sequelier or the butterfly effect, like what did that do? It pushed all these millions of patients to the gray market. Right, right. Yes, yep. And that's not better. So I think this is a good um systematic approach to move them back to the regulated pharmacy supply chain and move them back so that now we can get real evidence. We can reclassify, open the access. Um, it creates a path forward so that we can start having some uh investigator-initiated trials at academic centers. And we can start having compounding pharmacies record their outcomes um in different registries. And actually, with my software company, I work with um APC, the Alliance for Pharmacy Compounders, and that's another advocacy group. And um, we are providing data for them from our compounding pharmacies who have opted into the data project. We provide uh compounding data to even show the FDA how big is you know the shortage or how big is the thyroid compounding market, because that came up recently. How big is HRT compounding? And when the FDA is looking at a drug and saying, oh, is this drug in shortage? Right now they only have data from one side. They only have data from the pharma manufacturer side, but they don't have data from the compounding pharmacies side. So by reclassifying these drugs, putting them through the pharmacy channels, getting them out of the gray market, regulate the gray market, regulate telemedicine, because the good actors want that regulation.

SPEAKER_02

You know, the bad actors don't.

SPEAKER_01

Um but now we can get some some real world data. And the data project that I'm involved in, um, we aggregate data from and it's it's uh few data points. It's not very invasive, intrusive. We are not pulling any patient information, we're not pulling any anything like that. It's just uh how big is this market? How much compounded product is being produced? And so that's going to some folks at Emory for the research and the analysis so that we can have some sort of data set to pull from.

SPEAKER_00

Yeah, and and that's I guess uh the overarching question that continues to remain is the evidence and and the lack of evidence in a lot of cases. And and as you say, building out that data set so that we can help understand pros, cons, considerations with broader use. Because right now, if a patient um was to use one of these products potentially, um, we just don't have good data necessarily to say whether it's safe and can be effective for them. And so, and and to your point, each each peptide being discussed is different in terms of the level of evidence we have and

Why Pharmacies Want A Regulated Path

SPEAKER_00

for specific uses. But generally, I think most of the data that we have is very preliminary. So maybe animal-based data versus human-based data or preclinical data, you know, could be not randomized controlled trials that are published, but could be conference abstracts or, you know, the the benefit is seen from a pathophysiological perspective versus a clinical perspective. So some of those considerations, I think, is where again that tension is coming in in terms of you, as you said, this FDA uh advisory committee committee meeting is happening, and the those who are putting forth their materials, it will be interesting to see what materials they put forth and what kind of data we have, because we'll want to sort of that gold standard is randomized controlled trials in humans that we have for FDA approval, but we're not going to have that same level of data here. Right.

SPEAKER_01

Yeah, we're not. And we're not seeking FDA approval, full approval for these therapies. We're just seeking for them to be put through the channels of all other compounded medications. So they come from an API, FDA registered supplier, they have all the proper testing. It's a, you know, which peptide are you looking at? Where is it sourced from? It's prescribed and monitored by whom, you know, and those are the things that we're looking to put through. And then um compounding pharmacies do have to report adverse events. And so this stuff it does have to be reported. Now, the gray market is so big that I would venture to say we we could likely hear if if something were to be happening that were truly dangerous. And let's say that it was uh just the manufacturing process was really bad. And you know how we all learned in pharmacy school there was those kids that tried to make uh what was it, hydromorphone, I think they tried to make or something, and then they ended up causing Parkinson's in them in themselves or something. That was always like a scare tactic they taught us in that one, but yeah. So, and I I mean I wasn't even great at making aspirin in organic chem myself. So, so I don't know. I mean, it takes a real scientist to make these things, but right now, what's happening right now is you don't just have all Yahoos out there with these therapies. You have some really, really well-respected functional medicine physicians, providers, experts who are um sourcing APIs, they're sending it out for third-party testing, they're getting the reports back, they are using it in hundreds of their own patients, they are seeing anecdotal results from you know different patients that they have, but it is they're being monitored and it's very specific. And you know, the thing with these peptides with any drug really, if you inject it, it goes systemic. And so what is it affecting? And you have innerpatient variability, uh different underlying disease states. So medicine is medicine. Um, I just really feel like these peptides should be treated as medicine and it should bypass the pharmacy channel. You know, when when medical marijuana became medical marijuana, it completely bypassed the pharmacy channel. And that made no sense to me because we have all the legal infrastructure in place, we have all the workflow and operational infrastructure in place, we have pharmacists at the front lines who are the most well-versed in these therapies, being able to speak to both clinicians and patients at the appropriate level, being able to analyze just a lot of different data from different points and talk to patients and listen to them. Patient says, Hey, I'm feeling like this. Pharmacists are the first ones to look and say, Well, you started this medication at that date, you started these two medications at the same time, you discontinued this, you know, and have that consultation with the patient. They're accessible. So I definitely feel myself as a pharmacist that these peptides do need to be moved to category one. They do need to have a proper regulatory channel so that patients who who are seeking these out, which I don't think we've ever seen before, the only patients that used to seek out medications, you know, it's like drug seeking behavior. Remember, it was narcotics. So we have this wellness and longevity, this post-COVID, you know, realization where patients want to take control of their own health and they want to seek out their own telehealth provider and they want to get their own lab tests done and they want to own all their own information. So I really would like to give them a channel where they can have some trust in it.

How We Counsel Curious Patients

SPEAKER_00

And how would you educate patients? So say that does happen after this meeting or even before, if patients are asking about this, how do you help put all of that in perspective and educate a patient about pros and cons, considerations with the use of peptides broadly? What how do you guide that conversation?

SPEAKER_01

Yeah, I mean, I would definitely guide the patient to receive their medication from a licensed pharmacy. If it's a compound, a licensed compound pharmacy, and do your due diligence there, whether you can look up on a state registry and see if that pharmacy has the proper licensure, whether you can actually talk to someone in that pharmacy, whether you can visit that pharmacy, whatever that looks like. I know more and more things are done online as we evolve, but just being able to verify that it's a it's a valid pharmacy that has all the proper licensure, and then being being able to access a provider, whether it's through telemedicine or face-to-face, but accessing a provider that is knowledgeable and has has history with functional medicine and with peptides, treating root causes, doing lab work, you know, asking about all your medical conditions, knowing all the medications that you take, and treating it as an individualized patient approach because that's what compounding is. You know, if you if you're a patient and you just maybe see an ad on social media, click on something, fill out a quick questionnaire, get a prescription, it shows up at your door, you didn't talk to the pharmacy, you don't even know who the pharmacy is, that would be time for pause.

SPEAKER_02

Mm-hmm. Mm-hmm.

SPEAKER_00

Yeah, I think that's a great call out. So thinking about in, and there are ways to verify that pharmacies are licensed and accredited, if you know, it making sure that the pharmacy itself has those qualifications, as you say, making sure that you are actually working with the clinicians involved to make sure that they are assessing you as a patient completely, the your medical conditions, your interactions, potential interactions, going to be monitoring how you respond, ensuring that all of that, I think you said it well at the beginning, just like any other medicine that we might be thinking about pros, cons, considerations with any medicine, that's something that we want to be discussing with patients, and that applies very much here as well. And so compounding, as we know, is meant to be individualized for that patient, and this should be no different. Uh, but but recognizing that there are some gaps in um between what we have as FDA-approved medications and the what we're talking about with peptides, and that applies also to any other compound that we're talking about. So it's a very I like thinking about it as analogous to any other compound but um the the individualized care and ensuring that patients are getting that that clinical evaluation and ongoing monitoring.

SPEAKER_02

Yeah, yeah, absolutely.

SPEAKER_00

And then as you said, the importance of ensuring it's a licensed pharmacy and that helps to prevent any considerations about quality and purity and the source of the product, that you're getting all of those boxes checked off too.

SPEAKER_01

Yeah, yeah, and from a safety perspective, and that's exactly right. We

Safety Guardrails And Adverse Reporting

SPEAKER_01

pharmacists have to know okay, if this is going to come through our channel, as it should, that's why we're here. That's why we have all these laws and regulations, and that's why we have these licenses, and that's why we study and go to college for seven, eight years now. If these peptides do come through our channel, we all need to be comfortable with where they stand now and that the evidence as it progresses, we need to have access to that and we need to stay up to date on you know what's happening with the evidence, what's in trial, what's going on. And we need to be able to iterate to patients that these are not FDA-approved products, like we do with all compounds. This is nothing new, and that the therapy is going to be individualized, and that way there has to be a treatment plan, there has to be follow-up to that. And then we also have to have a channel, and just like we did during COVID, uh, where what if something goes wrong? And I notice it as a pharmacist or a patient comes to me as a pharmacist, what's my escalation plan? What's my pathway? What's my, I think it was uh, I think it was like VARS for the vaccine and bears, yeah, yes, yep, theirs, yeah. Yeah, so that if something happened, and I had a few patients uh pass out on me in the thousands of of COVID vaccines that I gave. So what happens if a patient comes to me and they do have a reaction, or if I do notice something that's concerning? So if we are going to participate, we pharmacists are going to participate all the way.

SPEAKER_00

Mm-hmm. Mm-hmm. Yep, absolutely. So I think just, you know, in summary, there's there's limited evidence for some of these. There are practical considerations we can help patients with in terms of choosing those uh licensed pharmacies, ensuring they're getting that clinical evaluation. I think also talking with patients around some of the uses that these products are being promoted for, like longevity. There may not be a treatment for that, right? Like there may not be an anti-aging product that is going to actually work. And so helping to put that in perspective too, and maybe reinforcing some of those tried and true non-tradition, non-pharmacologic methods that we emphasize with patients around physical activity, healthy lifestyle, eating, you know, all of that is good to help reinforce too, and maybe help steer patients towards some of those non-pharmacologic options as well when appropriate. But I guess that's the other consideration is helping keep the claims in perspective because I think sometimes these products are being marketed or promoted for things that they may not ever be able to achieve given what we, you know, what we can know about therapies in general.

SPEAKER_02

Right. Yeah, that's exactly right.

SPEAKER_00

Yeah. So I guess in in summary, you know, we we know that these peptides are gaining in popularity. The evidence is potentially limited, but we are going to see this outcome of the FDA advisory committee meeting the end of July and uh see what happens after that. Um the regulation is continuing to evolve as a result of that. Um there are pros and cons with any medicine, and that also applies to these products. But uh, I mean, I, for one, will be sort of monitoring the FDA page and seeing what is being posted in the days leading up to the meeting and you every it's a public meeting. So I think that people have the ability to join if they want to actually listen to that. Um but any any other considerations high level that we might be missing or hadn't talked about yet that you just wanted to wrap up with?

SPEAKER_01

Or I think that's it. I'll just leave you with a little uh, you know, because I I've started deep diving and taking some um clinical courses that are meant for functional medicine practitioners because there's not much pharmacist training

BPC 157 Origin And Open Questions

SPEAKER_01

yet. And interestingly, BPC 157, you know, I started asking questions, where did that come from? Is it is it endogenous? Is it synthetic? Are all these peptides endogenous or are they synthetic? And some of them are synthetic, some of them your body makes, and then some are engineered analogs like BPC 157. So it's body protection compound 157. And and the reason of the 157 is that's that was kind of the the chapter in the book where it was found. It was in in marker 157 of the amino acid chain, is where they found this short chain of amino acids in the body, actually in the stomach. So BPC 157 is uh it's already in the body, but of a much longer amino acid chain. And scientists started asking, well, how can the stomach cells sit in its own acid and not just get eaten away or not get, you know, just totally destroyed? And so they found that amino acid chain there and called it BPC 157, body protection compound 157, because that has to do with the amino amino acid chain. So what they did when they made the BPC 157 peptide, and this is just my interpretation of it, I'm still I'm still going through a lot of the clinical training myself because we didn't learn this in pharmacy schools. Um, but it's uh the position 157 of this larger gastric protein. So the chemists designed a fragment of that amino acid chain. Because remember, a peptide is less than 40 amino acids. So they took a fragment of that chain and they said, this is BPC 157. So is it going to act exactly the same? No. Do we have a receptor in the body where BPC 157 acts on? No. So it's being injected and it's going systemically. Now, anecdotally, we've seen a lot of patients with great success in um healing from injuries, you know, they'll tear a ligament and BPC-157 has been claimed to help with these things. So I just thought, you know, our we pharmacists love a good rabbit hole. And so um it's just interesting as we start to really look into each one of these peptides, where did it come from? How did it is it already in the body, or did it get um, you know, manipulated synthetically in a lab? Um, which most drugs, these are drugs. That's what drugs are. Yeah, so it's just fascinating.

SPEAKER_00

Yeah, it is. And and also interesting that BPC 157 in the FDA Advisory Committee, as you said before, is being evaluated for ulcerative chorales. Versus necessarily recovery. So again, there's that sort of evidence-based consideration with what it's being looked at for, promoted for, and maybe where there might be any data, whether animal or or limited human data. But all of that, I think, muddies the water in terms of coming to an evidence-based answer for a lot of these products with patients too. And that's where, you know, reiterating the importance of proper channels, clinician evaluation, follow-up, monitoring, knowing that there may be risks, considerations with any of these products. We have a lot to learn, I think.

SPEAKER_01

Yeah, we do. And that's the key of it is that we pharmacists continue learning. That's all that we can really do is rigorously apply the guardrails that we have to keep patients safe, educate as much as possible. And in order to do that, we have to keep learning. How is legislation changing? How is my state specifically differing from the FDA on this? So it's not just when we take the MJPE or just when we take the NAPLEC, or it's always changing. And then what's happening in studies? What's happening just, you know, anecdotally with these patients? What's being reported on social media? So what are my patients seeing? And what are they going to come to me with? And us just continuing to learn and continuing to watch and evolve. Because this, I believe this is a place where pharmacists can really make the difference and pharmacists can take the lead on what our patients want, which are peptides, weight loss, GLPs, longevity, telemedicine. They want to control their own health and wellness and prevention, which is great. And pharmacists and regulation and rigor and studies and all things. We don't want to repel them. We don't want to discourage them because then they go to a gray market and they're injecting themselves based off of a YouTube video and TikTok.

SPEAKER_00

Absolutely. Yes. Yep. I think that's the perfect take-home point, is our role is helping ensure safe and appropriate use of medications, just like any any medication we might be talking about with a patient. So I think that's a great take

Game Changer Takeaway And Closing

SPEAKER_00

home. And just to wrap up, it is our game changers podcast. So we always wrap up with a game changer and what you want our listeners to walk away with. So outside of that take-home point, which I love, uh what is the game changer for today's session? Do you think?

SPEAKER_01

I, you know, I really think that peptides are not the game changer. Pharmacists who can separate the gray market from medicine, that's the game changer.

SPEAKER_00

I love it. Great, great take home. Thank you so much, Nicolette. This is a fascinating discussion. And we have lots, lots to continue to learn, as you said, and lots to keep watching. So we may be talking again after July 23rd, 24th. We'll see how moving it. Yeah, all right.

SPEAKER_01

What a time to be alive. So there's always things to always things for us to learn and and to and to do what we do best, which is help.

SPEAKER_00

So thank you so much, Rachel. Absolutely. Thanks so much, Nicolette. Really appreciate you just taking the time to chat with us today. Likewise, thank you. All right. Well, listeners, be sure to claim your CE credit for this episode of Game Changers by logging in at CEimpact.com. And as always, have a great week and keep learning. I can't wait to dig into another game changing topic with you all next week.