Peptides, Policy, and PBMs: 2026 Quarter 3 Pharmacy Update with Annie West and Dae Lee

Speaker A: Sykes the Bottom Line Pharmacy Podcast. We've got a great show for you this week. But before we get into the show, if you find this episode valuable, please like share and subscribe so we can help more independent pharmacy owners. Also Visit us@pharmacyaccounting.com if you're overpaying in tax, if you're prepping to start, buy or sell a pharmacy, or just have a gut feeling that your financials aren't quite right. We have a suite of services for every need your pharmacy is facing. Go to pharmacyaccounting. And we can help. Okay, now on to this show. Welcome everyone to another episode of Bottom Line. Typical host here is always Scotty Sykes. 007. Bonnie Bond here. Um, and today we've got two very special guests. Anne west, uh, she's um, the clinical pharmacy director over at Atrium 24 and and Day Lee, he is the um, one the lead attorneys for the pharmacy division at uh, Buchanan. Um, so um, day and thanks so much for uh, jumping on with us today.

Speaker B: Yeah, thank you so much for having me, you know.

Speaker A: Yes, absolutely.

Speaker B: Here from Atrium 24. But you know I think I lucked out. She was on vacation today so I got line in and make my debut there.

Speaker A: I was about to say more like we got lucky that we got Ann instead of Nicolette. So we'll have to tell Nicolette that. But um, yeah, just our typical quarterly uh, pharmacy update um, that we usually have with Atrium M24. This time we've got a really jam packed episode. We're talking about the peptide and the uh, the information that came on the tail end of the peacock, uh, committee meeting recap. So I guess let's start there um, day and give us whoever wants to go first but give us an overview of what was the information that was kind of relayed like what's new with this stuff. Um, you know, give us a 30, 000 foot view of and I might

Speaker C: add, hey, you were there live right? You were there at the uh, the meeting there that. So you saw it all go down. Give us an update there. Uh, start with day.

Speaker D: Yeah, I mean that two day event, July 23rd and 24th, um, definitely well over 100, 150 folks in the room. Um, very large conference room in the FDA campus in Maryland. Heated, heated um, arguments on both sides, right? The uh, proponents as well as the um, lack of better words, the um, opposition or haters of the Peptides uh, in the industry. Um, so the, the event was very long. Day one uh, started around, I mean started on the dot, 8:00am ended well after 6:00pm Day two, uh, started at 8:00am, probably ended after 4:00pm, close to 5:00pm um, there were exchanges between the proponents and oppositions, uh, or on the clinical safety and efficacy, but also a lot of discussion on the policy, um, aspect of the peptide. So what happened at the end of the day, the day two was that the FDA Pharmacy Compounding Advisory Committee recommended six out of seven peptides to be added to the 503A bulk list. Uh, day one they discussed BPC157Kpb, TB500MOT C. Day two, amideltide, apitalone and Cmax. And amideltide was the only one uh, that was not recommended to be added to the 538 bulk list. Uh, now to be clear, these peptides, the six peptides have not been added. It's up to the fda. Um, there will be coming in rulemaking process who know how long it's going to take. Um, could be months, could be years. Um, FDA may, you know, as they did in a traditional sense, go with what the committee actually recommended. Um, but you know, FDA may not ultimately follow the uh, committee's recommendation.

Speaker C: Historically they do follow the committee recommendation, correct?

Speaker D: Yes, historically they do. FDA does follow, but in rare instances, uh, that they have not followed are high stake cases. And I consider peptides to be high stake case.

Speaker A: Good point.

Speaker D: But at the same time, you know, you see, I mean at the same time as we speak right now you could go online, buy these peptides from gray market, you know, sellers, nobody know what's in it, but you could buy it.

Speaker C: I feel like I was in the room there, dad, you went over that.

Speaker D: But

Speaker C: yeah, what's, ah, yeah, what's your takeaway? Like, what'd you learn, you know, what's kind of your points coming out of this?

Speaker D: Well, I was a bit surprised um, at the, what was discussed. Like I said, like clinical safety and efficacy was one of them. But there was a lot of policy argument because right now the public can buy these peptides from gray market sellers. Is it safe, isn't it safer for FDA to actually add these to the list so that it can be dispensed only by licensed, uh, professionals, licensed facilities. Um, you know I'm big proponent of that because right now there's no regulation. Like again, Google whatever your search engine is, go online, type in peptide BPC157 within a few clicks of your, you know, uh, phone or laptop, you could buy it. And I was, I think there was some concern as to the um, what's in it? Because someone at the uh, meeting actually said that they tested one of the vials and it had. And I think they said, what? Trace up mdma?

Speaker B: Yeah, yeah. And that was one. I think she brought up another one too. And it was a. One of the providers there that was, you know, proponent, um, to add them to the bulk list. Um, and another one she said was laced with fentanyl, which, you know, we know that even if these, you know, dangerous drugs are not getting in there, we know that it's so difficult really to make sure that you're getting a real sterile product in the end. Um, so even things that, you know, a pharmacy that's going through doing all their testing might throw out a batch because of some certain ah, level, you know, there's, there's just none of that testing going on and there really is nobody regulating, um, you know, the black gray market, however you want to put it. So it just puts everyone in such a dangerous position and unfortunately everyone is hearing so much about them and they know so many people who are, who are doing peptides. So the general public really doesn't understand, well, what's the difference between, you know, this one that I ordered here or one that I'm getting, you know, through an actual pharmacy. I just went even on um, Venmo, I had to Venmo someone and I saw my neighbor. I don't know why they, um, you know, why people like to keep their, their public. But one of them is like, peptides, she's paying another neighbor for peptides and I'm just like, it's just rampant, it's everywhere. So yeah, I totally agree with Day. I mean most of the time these PCAC meetings are very focused on, you know, the clinical background of the drug, an overview of the drug, what we know based on. Have there been any, you know, human studies? What are their animal studies, what is potential immunogenicity of each product? Um, but it really was a lot of focus on regulatory, uh, guidance and what are we going to do? And you know, a lot of making them aware of, of how much this really is currently in the market. So it was interesting. I, I, um, was watching from home, but they did have a live feed. Um, so I was popping in and out while I was trying to get some other deadlines, um, done. But it was a very interesting two, uh, days for sure. Um, of course, as a pharmacist, I love to listen to both sides. I think that if you're not listening to both sides on on any topic that you're always going to miss something. Uh, so it's important for sure to think, um, just think it through. What are, what are the implications, you know, as Dave said, if we don't, if we don't actually get these added and through a legitimate way for patients to make sure that they are at least getting some type of safety regarding the medication that they're actually injecting into themselves.

Speaker A: Mhm. Yeah. So what's next? I mean, I think um, isn't there another PCAC meeting expected before um, the end of February? Um, but you know, given that you just had this meeting, you know, what's kind of next for all this stuff?

Speaker D: Well, I mean the next like legally speaking, um, after the next peng meeting, you know, or during, you know, in the meantime, FDA process will take place. You know, um, common rulemaking process again. Could be months, could be years. Um, nobody has a real good pulse on it. But the industry will continue to move on. That's, that's the issue. You know, and uh, legal world, right? Industry moves fast, the law takes shape slowly. That's, that's how it is. And it will always be like that. And the industry right now, you know, are, well, industry is moving very fast. I think um, we're at um, what's this saying, point of no return. You cannot regulate this um, anymore. Uh, unless there is something drastic happens in the market, something drastic happens by the regulatory bodies whoever is going to um, monitor and penalize those gray marketing uh, sellers out there. Um, of course, you know there are pharmacies, 538 compounding pharmacies that are dispensing products containing these six peptides. Um, certain border pharmacies um, are exercising their enforcement authority. Certain border pharmacies are not. Um, there's no rhyme or reason. Um, I mean, uh, do I think those order pharmacies who uh, have you know, who have not exercised enforcement authority, do not have any idea on their pharmacy? State, state pharmacies, No, I think they know, uh, they're not just exercising their enforcement authority. But on the brighter side, if the drugs are being dispensed at a 503A compounding pharmacy and USB797 compliant pharmacy, these products are being tested. You know, sterility, stability, um, endot endotoxins, all those, at least they are being tested and they have the results to back it up. And being dispensed and compounds historically and still today is not approved by the fda. Compounding has been with the pharmacy since the birth of pharmacy you know, leave it to the professionals.

Speaker B: Yeah, I think that was another piece too that they really needed to separate out and even for kind of the committee to understand for some of them was that if we are adding these onto uh, the bulk's list, it does not mean that you are giving full FDA approval of an approved drug that has, you know, that safety and efficacy stamp behind it. Um, so I think that's a really important, important piece that ah, you know, just because they add it where it can be opened up, you know, in a legitimate way for these pharmacies, for these safety reasons for these patients, it's not saying, oh, the FDA has looked at this and said yes, it's safe and effective to the same level that it does with its approved drugs. So it's definitely a little bit nuanced and historically day, I mean it takes the FDA a long time for final rulemaking. Right. But right now we've seen um, with the current administration, do you see any possibility that maybe we move a little bit faster just because we have seen them a little bit more reactive than we have in the past? Do you think um, that's possible? Because everything I'm seeing in the industry is really pointing towards a yes for these peptides. Um, so do you think that's possible? My next question is do you think they could um, do something a little bit different? Which one of the proponents brought up as well is maybe putting them just back on category one while continued rulemaking happens, which would be something new.

Speaker D: I mean I would definitely, I mean number one, they, I think um, given the administration's posture towards these temperature towards the peptides, um, it can be expedited and they can and I think they should add it to the category one while the comments that we're making uh, is going on and also, just because FDA approved a brand name drug does not mean that that drug is, you know, has no side effect. There are side effects and there's a laundry list of side effects associated with a particular drug. If you look at package insert, you know, that small little paper, you know, it becomes a map. And then there's number of, well, hundreds if not thousands of product liability litigation that is going on that has happened involving drug products. Um, in fact there is one going on uh, with one of the um, brand name uh, GLP1 whereby, wherein the plaintiffs alleging that the plaintiff suffered um, what is it, um, the loss of sight or some other uh, uh, adverse events. So those lawsuits have happened and is still happening as we speak. So from my point of view Where I represent independent pharmacies of all sizes of all different types, from mom and pop to private equity backed pharmacies. We are, you know, we're treating, I mean my clients are treating the patients, right. And they're monitoring the patient's um, health progress. And these are beneficial. Definitely brought um, positive impact on the patient's life. At the same time, it brought a lot of business opportunities that independent, ah, pharmacies never had before. You know, we're, you know, independent pharmacies are squeezing, you know, dollar or even cents here and there because this insurance market is monetized by the pharmacy benefit managers, the Legacy, the top three PBMs. So this is like breath of, you know, fresh uh, air. You know, they are, it's giving them an opportunity to better service their patient, but also financial opportunity.

Speaker B: Yep. Yeah.

Speaker C: Gets into my next question because Ann, I know, you know, you guys, Nicolette are working on how pharmacies can learn about it, learn uh, about this stuff, eventually roll it out, implement it, you know, and adopt these peptides in a meaningful way for their patients. What, what, what can pharmacies do now in this period of wait, I guess, until there's comments and the FDA makes some decisions. What, what can pharmacies do now in terms of getting ready for uh, this potentially opening up for them? And we're talking retail pharmacies who do not compound. You know, are there going to be opportunities for them? And of course compounders as well?

Speaker B: Yep. So there's going to be, there's opportunities for everybody there. And that's such a good point, Scotty, because you know, we've been like, it's been a couple months where we're, we want our pharmacies, you know, to already be educated because you're already getting patients asking about it like day brought up in the very beginning. These patients are already using them and they want to come to their pharmacist. Right. They want to ask the person who, who they trust. Um, but traditionally in pharmacy school we did not learn about these types of things. And um, honestly there's been such a big shift recently in the way that patients are thinking about their health care. Um, I really think that changed with COVID It changed with the glp. Is it changed with telehealth. So now, um, we have just a huge influx of patients that are really thinking about ah, like longevity, uh, how do I make myself actually healthier? Um, so there's just so many patients that are already asking about it. But I say now is really the time where you really need to dig in and you need to do some education on that. So what we are putting together um, is an entire course on it. So we're breaking it into two modules. Um, module one is really going to be that kind of educational piece. Um, so we're going to really cover all the clinical aspects of these but peptides. And in addition the ones that are, you already can compound like smorelin and glutathione, um, and the GLPs, if you're getting them through, um, you know, patient specific prescriptions. Um, so we're going to go through peptide fundamentals. What are they, what are the different ways they can function within the body? Um, we're going to go over some kind of lifestyle factors so that you can help support your patients, not just give them the drug and say, you know, this is going to make you healthy, but what's really going to help support them long term. Um, and then a clinical review, uh, of these peptides broken down by class. So that way it's a little bit easier um, to understand uh, and remember what these uh, peptides are proposed, um, to be used for. So we'll go through like the big ones like regenerative medicine and immune health, weight and metabolic health, um, sexual health and fertility, neurology and cognitive health. Um, there's so many great benefits to these peptides that we want to make sure that our pharmacies feel comfortable with the knowledge that they need in the background to um, really help with their patients kind of understanding what are some condom and monitoring parameters or side effects or even what kind of patient populations would each um, peptide be really good for. And then the second module which we're going to be releasing is kind of that implementation piece. So exactly that where um, can I do this if I'm just a regular retail pharmacy? Uh, and your answer is going to be yes, there, there's um, you know, central fill, which you could do it, um, coming from another 508.3A pharmacy. We're also expecting these peptides to be available from 503bs as well, which is a, you know, another topic of discussion entirely. But we think the industry will also move that way. Um, and then kind of just understanding how would you set that up in your pharmacy and the tools to really be able to implement it, um, so you can start providing it to your patients. But that first piece, the clinical education piece, I think right now is the most important, um, because you do need that basis, uh, you know, before you really bring them into your pharmacy. And I think we still have a pre sale going on. Um, so I think, I think I'm able to share with, with the podcasters out there too. But we do have a discount code, um, peptide 20 going on I think until the 11th. So I'm not sure what day this will actually go out, Austin. But, um, I'm sure we can also get it extended if we want. Um, but you can always reach out to us. I'm sure we'll go over it at the end, but hello at Atrium 2, if you have any interested in that and. Or if you want any additional information.

Speaker A: Yeah, no, that's awesome. Usually, um, um, you know, these things are in the show notes, so if you're listening, um, you know, you can just look in the description. It'll all be there. Um, code, I think. What was it? Peptide 20 is what it was.

Speaker B: Yeah, all caps. Peptide 20. Um, that'll get you an additional 20% off while we're doing our pre sale. Um, we are also looking, um, to get it CE accredited. Um, so that is pending right now. So we can't promise it, but we want it to be, um, you know, to help get you those credits as well while you're doing this clinical education piece. Why not? So, uh, that's what's kind of holding up the timeline a little bit there. Uh, but launch will be September 1st. Presale going on right now with that, uh, peptide 20, additional 20% off.

Speaker A: Nice. Um, a little off topic, but Bonnie's black microphone is blended in with her shirt so you can't really like, can't really see it. Um, yeah, no, that's really interesting stuff. Um, so I guess the key takeaway here is, you know, there's no. Doesn't seem like there's like an immediate change to compounding rights, but it's worth monitoring closely and obviously putting your pharmacy in a position, um, for whenever, you know, these changes do. Because it looks like these changes are going to be, uh, enacted and you know, you want your pharmacy to be in a position to uh, jump on that opportunity when it, when it's available.

Speaker D: 100

Speaker B: right now that are interested to be ready. Like what. How much can you do if anything other than the education piece, obviously. You mentioned that I just asked that. What did you say?

Speaker C: I just asked my question. Oh, I didn't sleeping over there.

Speaker B: No, I'm, um, not. No, no, I mean, seriously, like, I meant like regulatory wise, like what can you do? Yeah. Another, uh, it brings up another great. I've had a client ask specifically Ann recently if they Needed to actually go ahead and start an llc. I mean, I mean, that kind of thing. Like, do I need to just go ahead and I'm like, that seems. Was it a pharmacy client that you had? Yeah. So you do not need to set up anything separate. We do see a lot of pharmacies who are interested in, um, obtaining a sterile license. So we see a lot of pharmacies that are going for that additionally, um, which is great. Which is a whole. Another kind of, um, piece to it. But for a traditional pharmacy, even if they wanted to start selling it, there's not really anything they need to do differently in their business. Um, what they can do right now, besides getting educated on these peptides themselves, is start vetting, um, who they'd look to bring in for their partnerships. Um, so we'll just take, um, 1503B as an example. Uh, Olympia, um, is a 503B. They have extensive wellness products right now. So I would actually get the process rolling. Bonnie. They weren't started at all. Um, a stepwise approach, I think, is the easiest thing. You don't want to, like, wait until all of a sudden it turns, and then you're like, okay, we could do it now. What do we do? You want to be prepared beforehand. Uh, so start vetting your potential partners. So, uh, going through that, we, we also help with that. At Atrium 24, we also have a GPO, um, which is really nice. We have both central fill partners and 503 partners. And what that really helps with is to aggregate the purchasing power for us as small independent pharmacies. Um, normally, obviously, if you're doing huge volumes at these big groups, um, you're going to be able to get a discount right off the bat, whereas a smaller pharmacy is going to be paying more. Um, but our GPO really helps with that because we, um, have a lot of pharmacies in our GPO now where we're able to go to our partners and say, okay, look at us as a whole. Don't look at this one pharmacy as, say, they're doing 50 prescriptions a month. Right. Look at us doing all these thousands, you know, together, hundreds of thousands. Um, so it's really a great point to even look into the suppliers that you're looking to use, um, get familiar with the workflow. Um, so I would. I would look both into Central Phil partners right now and 503bs. You want to make sure you're going through and actually vetting them, making sure, um, good partners for you. And then I wouldn't Wait, Bonnie. I'd already be starting on the other stuff. Like NAD is such a good example. That's not a peptide, but it's in the same wellness space, um, and is lumped with them so often. And you could offer that now you can offer some more, Lin. Now there's already a growth hormone, um, peptide out there that works wonderfully. Um, so I would get those pieces in place. Now that way you get the prescribers that you're working with. If you want to bring in your own telemedicine, you can, so you can really build out that basis and just grow with it as the peptides grow. Because even though we are talking about a very specific, um, list of peptides right now, um, peptides in general are going to continue to grow. It is crazy. If you go just look at clinical trials going on right now, you type in the word peptide, you are going to get hundreds of results. Um, they are such interesting, um, developmental drugs because as they said, there are so many drugs out there that are so wonderful and useful, but they come with so many, uh, unwanted side effects that can be very dangerous. Uh, in general, peptides are really good to be able to offer very, um, specific routes of where you want to take them. So anyways, there's just, there's so much research behind it. It's going to continue, um, even not just based on these six that we're thinking about now, but it's. There's no putting them back in the box. And even, um, the huge drug manufacturers are all over as well. Uh, so we're going to see a lot in the future, so definitely get prepared for that.

Speaker A: Yeah, yeah, absolutely. Um, now this is all really, really big stuff. Uh, what are some other things as we kind of, as we kind of maybe, uh, wrap up here? Um, what are some other things that pharmacies need to be watching out for? Um, as we, you know, exit Q3, head into Q4, um, you know, some things that they need to be paying attention to around this time.

Speaker D: Well, I don't want to bore the listeners about the policies, but there's.

Speaker A: We bore the listeners all the time day, so it's okay.

Speaker D: A lot of activities at the policy, uh, level. Right. Congress, um, putting pressure, continue to put pressure on the PBM States continuing to pass or introduce laws or bills regulating pharmacy benefit managers, FTC entering into settlements with Express Scripts, FTC entering into settlement with Caremark. All those are positive developments for independent pharmacies and they should really, you know, pay attention to and then support that movement. I mean it started, you know, as a grassroot movement. Now it became national movement. A lot of folks who didn't even know what PBM stands for now, now are aware of what PBM is, what they do how you know, when I say PBM it's the legacy non transparent PBMs out there. Um, so pharmacy should be, you know, supporting and should be monitoring those policy updates.

Speaker A: Yeah, absolutely. Um, awesome. Well Day and thanks so much for jumping on with us today giving us the four, uh, 1:1 on the peptide update. Um, and uh, some things to pay attention to. Oh man. Yeah, tell me about it. Oh yeah, so um, yeah, thanks for jumping on. Thanks everybody for listening in. Um, the information for Atrium 24 and day is going to be in the show notes. Um, and yeah, we thank you guys for joining.