The Wellness Practice Playbook

8. Research Peptides, Real Risks: What Every Doctor Needs to Know with David Bonfa, Co-founder of CRE8 Pharmacy

Alex Sidorenkov Season 1 Episode 8

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0:00 | 52:25

In this episode of The Wellness Practice Playbook, we dive deep into the rapidly shifting landscape of compounding pharmacy regulations and the future of peptide therapy. As the medical wellness space faces increased scrutiny, understanding the legal and safety hurdles of sourcing medications is more critical than ever for modern practitioners.

We are joined by David Bonfa, Co-founder of CRE8 Pharmacy and owner of 3AD Consulting Group. With 25 years of experience in functional medicine, David provides an insider’s look at the FDA’s recent "P-word" crackdown, the risks of research-grade peptides, and the truth behind Big Pharma’s "attack" on the compounding industry. This conversation is essential for medical providers looking to protect their licenses while maintaining medical freedom and patient safety. 

Don't miss this insightful conversation! Listen now on our website, Spotify, Apple Podcasts, and YouTube.

If something were to happen to that patient, legally speaking, that patient could go after the doctor, even though the doctor didn't prescribe. And there's a lot of things going on with medical practices being shut down. 

And I've seen, I've heard some crazy stories. Without a doctor, without a pharmacy, without the right source, without any blood work, without any consult, they've just gone on their own. Welcome everybody to our podcast. 

Today we're interviewing David Bonfa Co-founder of CRE8 Pharmacy, located in Coral Springs, Florida, and is licensed in 44 states. David also owns 3AD Consulting Group, a triad consulting group where he consults with clinics around the world. 

He has an extensive 25 years experience in this industry, specifically in compounding and functional medicine space. So I thought it would be an amazing opportunity to bring him to our podcast, for him to share what's happening in compounds and pharmacy with peptides, with guidance, and everything else that concerns cash paying medical wellness space. 

So David, thank you for joining and welcome to the podcast. Thank you, Alex, for having me. This is an incredible 25 years experience. I can imagine you went through a lot of ups and downs. You've seen how this industry shifted, changed, changed. 

Tell us how you started, what led you to where you are right now. Yeah, well, my start into this industry was really selling all of the active ingredients to compounding pharmacies. The company is still open today. 

I worked there for, I started in 2000, and I had the opportunity just to call on many different states, many different compounding pharmacies, and just find out if they needed more powders and devices, small devices. 

I mean, it was just everything for the compounding pharmacy. But I ended up getting Florida as a state to kind of handle. And that kind of shifted a lot of my focus because back in the early 2000s, Florida was kind of a hub for age management, preventive medicine. 

So I just started to dig in a little bit on that because it interested me and ended up dealing with many of the top clinics, excuse me, top pharmacies, compounding pharmacies in the U.S. A lot of them kind of stemmed and started in Florida. 

Now we see them all over the place. But it was very, very early on. You know, hormone replacement and, you know, peptides were not even that known in the early 2000s. They only kind of came to the map around 2005, 2006. 

But I was there just kind of speaking with them and we were able to import with the company I worked with all of these different active ingredients. And that's kind of how I, you know, started in the industry, just really promoting active ingredients and devices and equipment to compounding pharmacies. 

In 2006, I'm going to say, end of 2005, 2006, the first peptide kind of came in front of me, which is a very popular peptide that a lot of people know today. It's called surmarellin, surmarellin acetate. 

Now, a lot of people don't know this, but this was a commercially available product made by Serrano, who decided to just let it go. They did not want to continue to provide it to the U.S. market, and they just stopped it. 

There was no side effects, you know, there was no contraindications, there was no deaths, there was no big issue that made them kind of turn off that machine. And if you go today, you'll just see like just, you know, they discontinued the fabrication of it. 

And so the company I was with decided, well, there might be a market for this. Let's try and import this chemical. And that's kind of how I started looking at, you know, some of these pharmacies that were looking into the age management and functional medicine space and started to sell, you know, sarmrellin as a powder. 

That was the first peptide, you know, that we started to promote. And here we are almost 20 years later, still a lot of pharmacies are compounding that particular one. So yeah, so you know, a lot has happened in the 20 years since Summer Ellen kind of came to the mix. 

But just to kind of fast forward a little bit in 2008, I got bored selling powder. And so I ended up working for a compounding pharmacy in Florida and, you know, was traveling a lot and just kind of doing a lot of the conferences, a lot of the marketing, business development. 

And I did that for eight years. And then in 2000, eight years after that, around 2016, I just decided to, you know, get together with some friends and open up Create Pharmacy, which is what I'm a co-founder and proud of it. 

And that business is just going well. And I'm there to kind of give my insight and my knowledge where and when I can. So it's been a, as you said, a very twisty-turny road. And I've seen, you know, the calming, calm days, I guess we'll call them. 

And I've seen the erratic, crazy days. Most probably recent. Recent days have been more bumpy than the past. But it is what it is. And we understand the risks of this industry. I love this industry. I don't see myself doing anything else. 

It's what I've known. It's kind of a language now that I have. It's 25 years speaking a particular language. You get to learn the ups and downs with it. So yeah, it's an exciting time. Yeah, and we've been attending A4M Men since its inception, and I've seen a lot of pharmacists come and go. 

Yours really caught our attention because we first saw it with a smaller booth. And then all of a sudden, you guys have been coming to every single event and become more prominent player in the AFM space. 

It was incredible to watch your company grow, which is a good testament to its success. Yeah, this December makes 25 years that I've attended the A4M, you know, and I remember speaking with some of the people there who are kind of running the show. 

And I'm like, I can't believe, you know, this is my 25th year in December, right? There's been so many other conferences that we've done, but A4M specifically, it's since, yeah, since 2001 that I've been attending that show, you know, with different companies, obviously with Create and my consulting company, it's kind of a mix of stuff. 

But yeah, it's been an amazing ride. And as you mentioned, there are a lot of pharmacies trying to get into this space, spending big marketing dollars, getting into this big A4M event. And then you don't usually see them the next show. 

So there are a few that have a little bit more stable, I would say, a little few who understand the industry and understand what buttons to push and what buttons not to push. And I sometimes, you know, I get a rash when I walk around the aisles and I see what some of these guys are doing. 

And I'm like, all right, you know, have fun because I don't know if that's going to last long. So we've always taken, yeah, we've always taken the kind of the longer approach to this industry. You know, you have one reputation, you have one life to live. 

So let's make it worthwhile and let's build it on a strong foundation rather than a very quick sprint to make a couple of bucks. And that's true. They do whatever they want. They don't follow guidelines and then we see them disappearing. 

It was also incredible to watch how hormone therapy changed. It used to be like, no, no, don't do. Now it is such a popular thing, very well accepted. Talk to us about guidance, because pharmacy is, I would assume, a highly regulated industry because you guys making actual stuff that physicians will sell. 

Yeah, I think this is probably the most frustrating aspect of this industry as, you know, recent. This, I don't know how else to call it, but I would just say this attack on compounding by both Big Pharma, they're taking one-page ads, you know, in the New York Times just to discount and to discredit the compounding industry in general. 

And it's so frustrating to see because, I mean, if anyone visits any facility that you're using nowadays, I mean, if you're a substantial player in the industry and you have a pretty nice business or a good compounding pharmacy, I encourage your listeners to go and visit them and to walk and to see the amount of guidelines and scrutiny and restrictions and machinery and equipment. 

I mean, it is astronomical, the things that we are having to do in order to keep the doors open. And so when you see this other side of just really discrediting it and saying, you know, compounders are buying from unreliable sources, they're not being inspected. 

Their chemicals are bad. I mean, everything you're hearing nowadays is extremely frustrating to someone who's been in the industry as long as I have. And I'm sure there's other good compounding pharmacies out there that have done the same. 

That's probably the most frustrating thing, especially with regards to inspections, whether it's, I mean, we're licensed in 44 states. They come in and they inspect our pharmacy at any point that they want. 

Plus our state board of pharmacy, plus the FDA can come and inspect, plus the DEA can come and inspect. I mean, the list goes on and on and on. So to be ready for these inspections where they're looking, you know, for errors and issues, and still many pharmacies pass and contain their licensing. 

It is something that I think most pharmacies are complaining highly right now about this story that we're not regulated and we're not guided. And it's really frustrating. But again, unless you're in the industry, you don't know what we go through, you know, and you don't know the hoops and the hurdles that we have to jump to pass inspection, to get the right machinery, to get the right filtration, 

to order the right chemicals, to train the right staff. I mean, there's so much investment in that. And we continue to push forward for that. And for medical practices, I imagine it's a nightmare if they work with one pharmacy and then it disappeared or it didn't follow regulations, then it's probably that responsibility kind of flows on medical practices. 

Would it affect that? You know, I would say not as much. I mean, I love medical practices. I speak to them all the time, but I don't think they're under the same scrutiny as a compounding pharmacy. Because if someone, you know, if a compounding pharmacy closes or has to shut down their clean room or has issues or delays, you know, a medical provider can just find another pharmacy. 

It's an easy fix. But the ripple effect that it has on the whole entire pharmacy. Yeah. And here's the thing. You said something earlier, Alex, about some bad players or some people who are just kind of cutting corners out there. 

There's a lot of ways to save money. There's a lot of ways to cut corners in this industry. And to each his own, if you want to take that road, go right ahead. But the problem happens when everyone is painted with the same brush based on one particular pharmacy. 

And we see this now. We are still talking about a pharmacy that had a meningitis outbreak in 2012. I understand they did something wrong. I understand they need to pay for their issue and it hurt a lot of people. 

I'm not discounting any of that. I think it was a very serious issue. However, we are 2026, you know, and yet we are still talking about this one issue that happened in 2012. You know, it just keeps coming back up. 

So the industry has become safer. The industry has become more guided and way more restrictions and things to follow. And I think some of the leading pharmacies that are out there in the U.S. have done this. 

They've put their money forward. They've put their time and effort forward. And they're really being as careful as they possibly can to make sure that what leaves their pharmacy will never have an issue like that again. 

But every article you read about compounding, well, remember 2020, you know, 2012? And I mean, it just, they always go back to, you know, the big, big story. I mean, can you imagine if we did that with everything in life? 

Oh, remember? I guess somebody has an agenda. That's it. This is just an agenda to discredit pharmacies, take them off. Exactly. But then how are we going to get our medications? How are we going to get our anti-agent stuff that we want? 

Well, look, I think, I believe wholeheartedly that there is a way to, I don't like to use the word fight, but there's a way to push back at what is happening. And, you know, with a legal team, with lobbyists and getting together in coalitions that exist and banding together, I do believe there's a way to speak with the FDA and Big Pharma and say, look, this is not correct, what you guys are doing. 

Give us more guidelines. Give us the limitations of what we're able to do, but stop painting everybody with the same brush and stop blocking every little corner you can. Because at the end of the day, the medical freedom for your practitioners and mine is being attacked. 

And they have no medical freedom to justifiably prescribe something that they feel medically is needed for their patient. And little by little, components are being removed. And, you know, you can only drive a car so far if you have a flat tire. 

But if you remove the tire, you know, and then you remove the steering wheel and you, you know, slowly, but you start taking these pieces away, you're going to end up just on the side of the road. And this is what I don't want to see with, you know, with compounding. 

I mean, this is what we're seeing now. And so we're, you know, we're conversing with the right groups. We're pushing back in the right way. I do see a positive light to compounding, believe it or not, in the last six, seven months. 

There's a group of about five pharmacies that have been really fighting in Washington and speaking up to this kind of one-sided fight, you know, that we feel we can never win. But people are listening, you know, and yeah, we're just going to keep pushing forward the right way. 

Not just, well, let me just do it and I don't care what happens. That's definitely not the right approach. And as you mentioned, some pharmacies are taking that approach. You know, they're just saying, well, it's so confusing now and I'm just going to do it until they come in and tell me to stop. 

Okay. But remember, they paint everybody with that same brush. So if one guy does something bad, that means I did the same thing. So it gets tricky. Yeah. One of the items you mentioned, peptides, which I see become super popular. 

And there's so many of them, different peptides now. What do you see happening in the landscape of peptides? Oh, boy. The P-word, Alex. Yes. You know what? The popularity of peptides right now has never been this big. 

It is the highest trending thing in the medical, you know, age management or preventive space. And this is, again, this is my opinion. I believe that the removal back in September of 2023, I can't believe it's been that long, you know, it's over two years ago, when the FDA made a notification on their website to classify about 18 or 17 or 18 peptides on what's called a category two list, which is a list compiled of insufficient data or safety risk. 

It's just kind of this group of ingredients that kind of just stays in this holding pattern. We have category one, which is accepted, category three, not accepted. And category two is this kind of, we're not sure. 

It's insufficient data, safety risks. There's all these little unknowns, but it's really like a jail. It's a holding cell for anything they feel to just stop. And it's not like they're really digging in and learning more about it. 

They just throw it in this group and they assume that everyone's going to stop compounding whatever's in that group. So we've seen ingredients and active, you know, active pharmaceutical ingredients, APIs, we'll call them. 

We've seen a few pop in there every now and then, but never like this. This was like an overnight thing. We all woke up and 18 peptides were put into this category too. And this shook up the whole peptide world. 

Now, what was funny about this, Alex, is that if you eliminate the pharmacy from getting their product as they can no longer compound it, then you also eliminate the doctor from prescribing it, and then you also eliminate the patient from getting it. 

But here's the problem that I don't think the FDA really knew what happened. It was a massive explosion, which I don't think they were prepared for what we've seen in the last two years, where the patient at the end of the road is now saying, you can't stop me from taking that. 

I have a license on the wall, Alex. The doctor has a license on the wall. We have certain rules we need to follow, so we will listen. But a patient doesn't have a license on the wall. So what do they do? 

They go off. They go to any other places. It creates a void in the market. And not only that, then you've got this influencer culture that it's always been there. Influencers have been there forever. 

But now, how many have come to the table as a health functional medical, they are using these terms with no degree, no license, and they're becoming influencers on what? Peptides, because they know that their audience doesn't have anything to lose. 

Their audience doesn't have a license to lose. They're speaking to a patient who can go on Google and chat, Dr. ChatGPT, and say, these are my symptoms. What do you suggest? And then find a, you know, a research and development website, which God only knows, you know, where these are coming from. 

Okay. And now they've, here's the problem. They've had two and a half years to use this stuff without a doctor, without a pharmacy, without the right source, without any blood work, without any consult. 

They've just gone on their own. And so this ballooned this peptide industry to a point that you cannot shut this valve off. And our argument is very simple. Our argument is give us the responsible ones here, the ones with licenses, the ones that have something to lose, give us the guidelines and the responsibility back. 

Give the doctors the responsibility and guidelines back and allow us to compound and formulate and provide and, you know, for doctors to provide that for their patients in a responsible way. But you've taken away what the FDA didn't realize is they've taken away the two most responsible people at the table that have everything to lose, and they've allowed patients who they are there to protect to just do whatever they want. 

Right. And so now, even if you tell somebody, you know, this is illegal, they're going to find it. They've been on these peptides for years and they're going to find some website. You could shut a website down today and you're going to find another one tomorrow. 

It's, they're going to be around. But what is coming into this? So they're trying to stop things at the border. They're trying to, you know, I understand they're trying to control the research and development market. 

But everybody in the industry knows that the research and development companies that are out there, they understand the game and they are making money hand over fist with very, very little liability. 

Very little. Because if you go to their website and you look at their bottle and you look at their invoice and you look everywhere, not for human use. Exactly. And they know that if you have an issue with one of our, you know, our injections, good luck. 

Good luck coming after us because you were supposed to be a rat and you're not. So what happened? What did you, you understand? But when you look at, here's the problem. When you look at the volume of what is being, you know, shipped and used in the U.S., I'll bet you my life, this is not laboratories or universities studying this for themselves. 

These are real patients living at home and just injecting stuff that they really have no idea where it's coming from. Now, let me just say this. I'm not saying that these might not work. You know, the source of where these are coming from, I'm not saying that all of them are, you know, you're going to die if you're in. 

I'm not saying that. But what I am saying is that in the U.S., there are guidelines and there are legitimate ways to obtain medication. And that is not being followed. And so the FDA sees this. And I know they know what's happening because they're trying to shut that valve off right now. 

And they're having a heck of a time trying to do that. I don't believe they'll be able to just completely close off, you know, peptides. They're not going to. So our approach is... It's going to restrict something, it creates a void and it creates this thing like, oh, I can't get it. 

I want to get it. What have we learned? Yeah, what have we learned in the past five years about telling someone they shouldn't be doing something? They're going to do it 10 times more. Yeah, and that's where the proper approach would be, like you said, bring the pharmacies in place, give them regulations, give them rules. 

Then the medical team now also has, they oversee health of the patients. So now they're going to know, okay, this peptide is good for you for this. And at least it is oversight. There is an oversight of the medical professional. 

There's jurisdiction. And I'm okay with jurisdiction. I really, really am. I mean, we have so much jurisdiction over us. Like, there's all kinds of boards around, you know, just flying around our pharmacy all the time. 

We're understanding that. I get it. I don't want to eliminate guidelines and jurisdiction. That's not what I'm saying. But to think that you can just say, we're going to stop pharmacies from making it and doctors can't prescribe it, that we're going to stop the industry. 

You've made it worse. Well, one, you've made it bigger. So now everybody and their mother wants to be on peptides. But two, you've made it worse because you've removed the responsibles from the table. 

And I don't think they'll admit this, but I know they know that this is what's happening. So that's why they're listening to a few voices that are pushing back saying, look, this just opened up. Like, this is not a door that opened up. 

This is an airport hangar that opened up. And everyone is invited now to walk inside this with no issue, if any. So we're trying to say, look, we need to kind of pull back. I don't care. You don't need to apologize, but let's get these back. 

Let's do this the right way. And let's, you know, let's provide real active ingredient compounded in a right way, tested in the right way to a doctor who has actually sat with a patient and looking at blood. 

Let's get back to those days. What kind of peptides are right now allowed to be compounded or prescribed? So this is a very, a very tricky question because if we look at what the FDA has on their website, you know, they have a very small list because their requirement is two things. 

One, is it a U.S. approved drug or was it a U.S. approved drug? And two, does it have a USP, which is United States pharmacopia monograph? Okay. Now, there are a lot of peptides that have different pharmacopia monographs, not necessarily USP, and there's a lot of peptides that are approved in other countries. 

But the prerequisite for the U.S. is US approved drug and a USP monograph. Now, here's the tricky thing. Even if the FDA says this is what it is, every state board has their own interpretation. They could either follow it by the law or they can come in and they can say, we're going to be a bit more lenient, knowing our doctors, knowing our crowd, knowing our population, knowing our state, that they will allow, 

you know, certain peptides more than other states. And then there's some other, you know, states who are like, no, that's what the FDA says. We're going to take copy paste word for word. And then this is another thing that you throw in the mix, which was the most confusing. 

And you'll see why there's so much questions regarding peptides. Back in September 2024, so a year after the FDA put a bunch of peptides on this category two list, they reopened the list for a discussion regarding six peptides. 

So they technically released out of that list six peptides to discuss at the end of 2024. And the main reason for this was there was a group that was kind of pushing the FDA saying, well, we just want to see what made you come to that decision back in September of 2023 when we all woke up and you put 18 peptides on a list, right? 

They just wanted to see what happened? Like, how did you come to that conclusion? And for a year, they pushed to get that. And the FDA didn't provide it or couldn't provide it. We don't know. But the FDA said, you know what, to kind of get you off our backs, let's remove six very popular peptides and let's remove them. 

And we're going to go and discuss these. And you could bring your team and we'll bring our team in Washington and we will discuss it. So they actually gave two dates to discuss three peptides on each of those dates. 

One was, I think, October 29. I hope I'm getting my dates correct, but these dates are sticking in my head. And the other one was December 4th or 5th, where, you know, a group of pharmacists, doctors, and clinicians went to fight and to argue how good some of these peptides are. 

And then on the other side, we had the FDA saying how dangerous and how bad they are, right? That's kind of, it's a little fight between the two sides. Well, here's where everything kind of went really tricky. 

Those meetings were not very positive for the six peptides that were removed. But they were never officially put back on the list because a new administration came in in January. And thankfully, this administration really likes peptides and really likes the medical freedom to doctors. 

So there was almost this kind of like pause or this kind of halt on just simply taking the six and putting them back on the list. They said, wait a second, what's this list? What are these categories? 

This is, you know, HSS, right, and his team. And so now you have all these pharmacies saying, wait a second, there was this list. Six of them got removed. Now they're just like floating in space. They haven't officially put them back. 

And not only that, Alex, categories altogether in February were officially removed. So some pharmacies said, oh, there's no more categories. We could do whatever we want. Well, no, that's not correct, legally speaking, unless a new system is put in place, which has not yet been put, unless a new system is put in place to replace these categories, we should be looking at those lists still. 

But there's these six that are just kind of like, just floating around. So now do you see, do you feel the tension and the confusion that doctors and pharmacies and patients have? Like, what are you doing? 

Like, what is going on? So this is how you get to this point where some pharmacies are doing everything, A to Z. Some pharmacies are doing two, you know, the only ones that have like a USP monograph and a US pharmacopia recognition. 

And some pharmacies are kind of sitting in the middle where they're saying, okay, these are not on any list. These ones are still floating in space. We're waiting for this new replacement of categories. 

So to answer the question with these are the peptides that no, we can't because it's it's all over the map. Okay. And so we've taken an approach where obviously with legal advice as well, you know, do we feel comfortable making certain peptides at this time? 

And we get inspected by a lot of state boards that'll come in and they will see our list. They know what we're doing or we're not, oh, hide everything. No, we don't do that. Like they're there. They're on the shelf. 

We're compounding them. And unless a state specifically says, do not make this, do not ship this into my state, we will follow that rule. But if a state says, it's fine, I know what you're doing and it's okay, then we're under that state board umbrella as a 503A pharmacy, which is what CREATE is. 

So this is also another frustrating point because when you do a conference like the A4M, I don't know if you were at the one in December, but you walk around and people are handing out flyers of every single thing. 

And I'm like, yeah. And doctors like, ah, finally, I can get it. And I'm like, oh, that's kind of short-sighted. I don't know if they're going to, you know, be able to do this. And they shouldn't be doing it. 

So it creates this kind of friction point with a lot of the pharmacies that are there. But again, we do what we do. Other pharmacies do what they do. I hope that your listeners are asking the right questions to their pharmacies and not just closing their eyes and whatever I can get, I can get. 

That's not the right approach. I don't think you have that type of an audience. I don't have that type of a clientele. You know, we kind of filter our clients as well. You know, we've been in the industry for very long and I just don't take anybody as a client. 

We don't because there's a lot of those. There's always the kind of like, you know, the ones that don't care, don't consult, don't do blood works and order whatever they want from whoever they want. And that's not really my, you know, our client. 

No, of course, a medical practice would never want to get in trouble, get any kind of legal notice, lose a license. That would be the end of the practice. And it's key right now because I'm telling you, we see it. 

The FDA, big pharma, they are looking for errors. They are looking for someone to make a mistake. And once someone makes a mistake, it's on the front page. And so I think as your listeners are listening to this podcast and listening to other podcasts, I hope they're finding some good guidance with their pharmacy that they're using and not the runaround and don't worry about it. 

That's not the right answer. You know, ask the right questions. Ask for the right documentation. Ask for testing results. These are all things that doctors ask us all the time. And we're an open book. 

Here you go. This is what we have. And I think that builds a lot more trust. That's why we're where we're at. That's why there's a few pharmacies that are consistently out there and being present at some of the larger conferences that are out there. 

That's why we do that. For medical practice, what are the questions to ask? Because we do hear from medical practices, like, hey, I'm working with this pharmacy, but I'm concerned about, let's say, prescribing GLP-1. 

Yeah. There's many other peptides too. What are the questions they should ask to ensure that they're not going to get in trouble? Yeah, I think, you know, just with regards to GLP-1s, I think an important question is, you know, is the product that they're getting that they're using, the active ingredient from an approved source? 

Because the FDA does have a green list of sources around the world that can, you know, ship into the country. So, you know, is the pharmacy using a reputable source? That, I think, is a valid question. 

Number two, I would say, you know, the copycat rule, you know, is a compounding pharmacy making the identical product to what is commercially available? You know, that's rule number one in compounding. 

You don't do that. You don't make something, you don't compound or formulate something that's commercially available unless it's on back order, unless there's a discontinuation of the product. Yeah, there's a few reasons. 

But right now, officially, there is no back order on a lot of these GLP ones, even though there has been for years. And even though it's still very difficult for us to get it, we're still able to get it. 

So the formulas that pharmacies are making should be personalized. They should be compounded for their patient based on the issues that the patient has. That could be nausea. That could be, you know, muscle wasting. 

That could be energy loss. So you can make certain combinations, which, you know, if that's what you're using, good. You know, so I think the source, the formulation are super, super important. And I'll tell you why the source is important. 

This is something that I've talked about on another podcast. In the last year and a half, I don't go two weeks without getting a phone call from a brand new provider, a new broker who wants to sell me, you know, or create pharmacy an ingredient, a powder. 

And they have all the paperwork, you know, emailing, oh, we have this, we have that. Don't worry, we're FD approved. We're approved here, approved there, biggest company in the world, blah, blah, blah. 

But I don't know who these people are. Now, if you remember what I said in the beginning of this call, that was my industry start, the importation of, I understand how tough that is in the U.S. So everyone's trying to jump on this like a GLP wagon right now.  

And so some pharmacies are seeing the price of an active ingredient and it's very good. And they're like, you know what? This guy has all the paperwork, all the right paperwork and sounds like a good person. 

Let me buy from them. And so they're buying, you know, sub-par ingredient. And then they're formulating it and then it's not working as good as the last supplier. You know, so even when I try a new provider, and a lot of pharmacies do this, when they try a new provider of powder, we never switch overnight. 

We make sure that the same strengths are getting the same result. There's a method in switching providers. But because everybody wants to make a quick buck right now, you know, especially in the GLP market, we get phone calls all the time from new people. 

So it's very important that when you ask the question, you know, the source of powder, you know, are you comfortable with this source? Have you been using this source for a long time? Is this a brand new source that you just met in the last six months? 

You know, it's 16 years I use the sources that we're using for a lot of our compounds. I mean, there's a lot of history there. So that's an important question because right now, just like the, I'm not comparing it to the research and development market, right? 

But there's a lot of guys just coming in and just trying to sell powder, you know, for compounding. And we have to be very, very careful with that. So the question is, is a source you're buying from a recent or you've been working with them for a while because you don't want to be a guinea pig and getting medication for your patients from the source they just acquired. 

Exactly. Was it tested? And testing is important too. That's actually, you bring up a very good point, Alex. You should ask your pharmacy for testing results. I mean, every batch they make should have, you know, a release, a testing release before I could ship it. 

So right now at Create, you know, there's a shelf with a batch that's being tested at the lab, not our lab, another outsourced lab, and it's just sitting there. It's sitting in quarantine right now. And once we get the release that everything checks out and everything is potent, it's stable. 

There's no bacteria, there's antifungal, endotoxin. I mean, there's a lot of tests that we do with our injectable vials. Once we get the release from the lab saying everything checks out, then I release that lot. 

So another big thing that I'm noticing pharmacies do is that they're cutting the corner on testing. Maybe not, you know, completely avoiding testing altogether for a batch, but they might be avoiding a few, you know, a few checkboxes, right? 

So maybe we don't test for this today, or maybe we don't test for that today. Maybe we don't test for long-term, you know, beyond use dating and expiry. Like there's a lot of cutting corners with that, you know? 

And I take, just so you know, I take the paperwork from my supplier and when I make my formula, I test it and it should match, you know, because I'm using their math. I'm using their potency. So I'm taking their math and I'm formulating it based on that math. 

And then my testing results should show a very similar result. But sometimes, you know, you're going to get, oh, this is so potent or so less potent. And they'll make a new batch using more powder. You know what I mean? 

They start to compensate. It's like cooking. It's like baking. You know, like they're starting to figure it all out. Well, it's not the best thing. A cake is a cake, but something that you inject in your body, if you have to start doing these equations like that, it's a little bit, it's madness, you know. 

So a lot of pharmacies, you know, and you could ask, your clients could definitely ask, a doctor should ask, hey, this batch that I just got, can you show me the testing results? I'd be curious to see what a lot of pharmacies would say. 

They should say, yes, we'll email it to you. What's the best email? That's what they should say. But they're going to be like, why do you need that? Like, they're going to be hesitant. If you start sensing the hesitancy in that, that's a sign that they're either not testing or they're getting subpar ingredient. 

David, there is a big, massive movement on this GLP-1, and there's a lot of things going on with medical practices being shut down. And I've seen, I've heard some crazy stories. Can you, I mean, you probably heard of them too. 

Why would that, something like that happen? What did they do wrong? Oh, good question. Look, I think we're in a period where the largest medicine, which is the GLP's world right now, a small portion of it is being compounded for different strengths, different combinations. 

A lot of it was also compounded when the products were on back order. So we have patients who've been using compounded product, trusted it, felt good on it, and they want that. And the big pharma movement is to protect their ingredient and to protect their product. 

And so they're throwing everything in the kitchen sink with the protection of that product, including what you just mentioned, which are cease and desist letters and lawsuits. And I mean, they're going after clinics now and they're confiscating. 

I've heard confiscating vials that they've had on, you know, in their clinic. I mean, the stuff that we're seeing in the last year with regards to GLP-1s, both on a pharmacy side and the clinic side, are unbelievable. 

We've never, ever seen something like this, ever. And I've been in the industry for 25 years. So yeah, I think at the end of the day, it's the biggest companies in the world with the biggest drug in the world trying to protect it at all costs. 

That's the nice way to say it. Intimidating little guys. And it's sad. It's really, really sad. Because look, you could, I heard a statistic. I'm not 100% on this, but I heard in 2025, over 2,500 cease and desist letters went out to various groups, whether it's pharmacies, clinics, associations. 

Over 2,500 cease and desist letters came out. And did some stick? Did some scare people to stop doing something? Of course. It's a cease and desist letter from one of the biggest companies in the world. 

Like, obviously, you're going to listen. But we've also seen some pharmacies and some doctors get together and band together and say, this is unjust. Your claims are off. And they've won. We've seen lawsuits dismissed over these accusations and these cease and assist letters and lawsuits that we've seen. 

So we've seen that. Just recently, just a few weeks ago, we saw a very large pharmacy win. Now, does that mean they're out of the, you know, they're out of the woods? No, they're not out of the woods. 

There's another one coming and they're going to keep fighting. But you have an endless budget attacking you. Right? It's an endless budget. So they'll just keep fighting and fighting and fighting until you're like, I'm done. 

Right. And this is what we're trying to push back on. It's like, this is not fair. This is, this is, it's a, you know, it's, it's an incorrect way of, you know, kind of controlling what is happening in the industry. 

But I think it's been exposed, if I can say that. And I, and I know that there are some parties who are looking at this and some groups that we're speaking to that are like, yeah, this is a little bit of an overreach. 

You know, they're pushing it a bit too much. And I get it. They're pharma. They're whoever they are. They have, you know, they can push all they want, but we need to kind of like pull the reins a little bit and kind of, you know, protect the medical freedom that we have in this country. 

And so we're seeing that. You know, we're seeing that more and more as the days go by. But yeah, it's extremely frustrating. I'm sure it's extremely frustrating for the doctors who are listening to this. 

You know, one day yes, one day no, one day maybe. This is what it's been. Demand is there. People want it. Medical provider wants to provide that, but there's constant fear, like, oh my gosh, like, I'm going to start marketing advertisement. 

Am I going to get on that list? Yeah. And you know what? What we mentioned before about like the research and development kind of issue and the influencer culture that we're dealing with, you have to remember something. 

Let's be honest. Let's say one of your friends has been using a research and development company. No doctor, no pharmacy. We could do it together. We could share our screen and I could order some right now and I'll have it tomorrow morning. 

That's how easy it is to get, right? But they're buying GLPs. You know, name the one you want. They're able to get this and they are using it on themselves at a quarter of the price. They're never going to go back if it's working. 

Even your best friend, Alex, if you tell them, hey, that's kind of dangerous, don't you think? This is risky. You're using this website that you found not intended for human use. If it's been working and they lost 50, 60 pounds, who are you? 

Who am I? Who is the doctor, right? So they're like, I don't care. And then they lose trust. And they're like, Alex, I know this is your industry. I know this is what you love to do. I know you want to try and keep me on the straight arrow. 

But man, I've been using this for now. Remember, this is almost two years plus that potentially patients have been using a lot of these things. Fill in the blank. They've been using whatever drug under the sun. 

And let's say it's been working for two years. That I think is going to be, and let me speak to your audience here. That I think is going to be the most important conversation that they need to get better at, which is making the patient understand that even though they've been able to purchase this, even though they've been able to use it, and even though it's worked, there's still a heavy, heavy risk. 

And they need to come back to the more responsible way of doing it. Now, if I'm talking to your friend, he's going to say, I don't care what you say. Like, good luck, right? So this is the conversation you're going to have, you know, doctors are going to have to get better at because you can't compete with a $25 bottle of, you know, GLP in comparison to, you know, a brand at 300. 

You're not going to compete never. So this is what we've seen now because unfortunately it's taken two years plus in September of like, you know, 2023, you know, so October, November, December, January, like it's two years and four months now that potentially people have just been using whatever they want to use in whatever website. 

The point, David, you made that a doctor needs to learn how to have a conversation is a key here. Because in a cash pay medical, well, in the cash pay medical practice, we sell. So we need to, so doctor need to be able to explain what is the value of the patient coming to a medical clinic and speak with a provider that understands the health and stick with the provider to take the product. 

And the reason I bring this up because I just had a conversation with one of my clients and he said, Alex, so I had a patient chat GPT'd something and then found this peptide online, purchased it and said, hey, I want to buy it from you, but at this price. 

And like, what? No. Okay, fine. I want to buy it over there, but I want you to tell me what my dosage should be. And I'm like, this makes no sense. Like, he's going to buy over there. Now you, as a doctor, is going to tell him what the dosage is. 

So now automatically, you are the one who providing him recommendation, but you have no idea what's in that bottle. And I'll tell you something. If something were to happen to that patient, legally speaking, that patient could go after the doctor, even though the doctor didn't prescribe it. 

So the medical practices need to become aware of that. Oh, yeah. Need to know how to respond to that, stand their ground. Unfortunately, it is what it is. Yeah. And you know what? I'll give you one more quick story about this. 

There are now stories, maybe about five that I've heard so far in the last couple of months, where clinics have been raided because they're selling research and development peptides with their name on it directly to their patient. 

So you're now talking about a doctor who is saying, you know what? I can't get this. It's such a headache. This pharmacy has it. This pharmacy doesn't have it. Then the one that I used to get it from doesn't do it anymore. 

But it's such a, you know, such a mess. I'm done. I'm just going to get it myself. You know what? I found a company that could even put my name on it. White label it. White label it. Gets a box of a thousand vials of whatever chemical, his beautiful little name or her beautiful little name on it. 

That's a problem. This is what's happening right now. I'm not making this up. Go Google it and you'll see there are doctors who have been, you know, their license have been revoked for distributing research and development quality drug to their patient directly. 

So, you know, we've seen it all at that point, right? I mean, well, it's, it doesn't make any sense. You know, it just doesn't make any sense. But what do you see where this whole thing is leading? Where is it all going? 

Look, I like to remain an optimist and stay optimistic as possible. I do believe that in the last six months, there's been the right voices at the right place at the right time. But it is taking time. 

This is not a quick thing to flip over. But I do feel like this administration is going to say something soon and have to bring some sort of guidelines to the table. I really, really believe that. There's way too much evidence. 

There's way too much demand. And also there's way too much corruption and unguided industry standards right now. Something needs to happen. The hardest thing now is to be patient, to be patient in allowing those things to work and flow. 

But I am optimistic, Alex, that soon we will see some regulation and some change for the good. That would be great. David, you also have the Triad Consultant Group. Can you talk a little bit about that company? 

Yeah, this is just, again, this is just my experience, you know, the years that I've done this. I've met people all over the world saying, hey, I want to do this. I want to open up a clinic. I don't know what are the ways to do this. 

And with just being able to listen and see what clinics do, the good ones and the bad ones, I'm able to kind of give a bit of direction and consult. So that's just my consulting company that I do with different clinics all over the world. 

I mean, I've had some fun opportunities to work in Canada and to work in South America and to work in Europe, just to kind of like give some guidance of my industry knowledge. Yeah, so that's triad on the side. 

And then in the US, primarily, you know, create pharmacy is I kind of keep it with that. Very good. David, thank you very much for sharing your experience for this conversation. I'm going to have the contact information for anybody who wants to contact David, go into contact consultant group or the pharmacy. 

I'm going to share his information in the description of the podcast. So if any of you need help or guidance, I think David is an amazing contact for that. Thank you, Alex. I appreciate you having me on. 

And yeah, I hope this was informative, you know, and not more confusing than it already is. Very good. Thank you.