A Compounding Pharmacist Explains Third-Party Testing And Why It Matters

A package shows up cold-packed at your door, your telehealth clinician says it’s from a compounding pharmacy, and suddenly you’re staring at a label thinking: how do I know what’s actually in here? That question gets even louder when the topic turns to peptides, “gray market” suppliers, and headlines that make it sound like anything goes. We wanted a real, practical breakdown from someone who lives inside the process every day, so we brought on Tom from Pharmacy Solutions to explain what quality looks like when medications are made to order.

We talk through the standards that separate a professional compounding pharmacy from risky shortcuts, including PCAB accreditation, NABP expectations, and multi-state licensing. Tom explains why pharmacies require certificates of analysis (COAs) for incoming pharmaceutical ingredients, what “pharmaceutical grade” sourcing is meant to accomplish, and why paperwork alone isn’t enough if a supplier can’t back up their claims. We also unpack what third-party testing really means, using plain language: an independent lab checks potency, and for sterile injectables it can also test sterility and endotoxins before a product is released.

Peptides add another layer because many don’t have USP monographs, so consumers don’t always have clear, standard definitions of purity or acceptable contaminants. We dig into what that gap means for safety, why reputable pharmacies quarantine sterile batches while test results are pending, and how beyond-use dating and stability studies help ensure the product remains effective for the time it’s dispensed. Then we zoom out to a simple, useful comparison: retail pharmacies dispense mass-manufactured drugs, while compounding pharmacies customise strengths and formulas, including hypoallergenic options for patients who react to dyes and fillers.

If you care about telehealth safety, compounded medications, peptide quality, or how to evaluate a pharmacy beyond the marketing, this conversation gives you a grounded checklist. Subscribe, share this with someone considering peptides, and leave a review if it helps, then tell us what questions you want us to ask Tom next.

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Transcript

Welcome And Safety Disclaimer

SPEAKER_02 0:26

Hi everyone, welcome to another episode of Tattoos and Telehealth. My name is Nicole Baldwin, and this is my good friend and colleague Kelly White. We are gonna talk to Tom today about some different things, and I'll kind of let Kelly take it from here. But uh as our lawyers like us to say, none of this is to be construed or understood as medical advice. And watching or listening to this podcast does not constitute a patient provider relationship. So, Kelly, who have we got today?

Why Patients Ask About Peptides

Kelli 0:53

All right, guys, we have Tom with us today, and I have never attempted to say your last name, Tom, because I know I'm butchered. I know I will. So I'm gonna let you do that here in just a moment. But the most important part of today that I'm excited to have, and Tom, forgive me for being a bonehead and not having you on here sooner, because you know, in the telehealth space, we work with calling in prescriptions virtually, right? We fax them in, or we more often than what we eat scribe. And you guys compound a lot of medications for patients all across the United States and you ship them to their door, you cold ship them, um, you send them overnight, they arrive in this great little package with, you know, they're frozen or they're or they're not frozen, but you know, they're cold packed and they get there and it's wonderful. Um, but the thing that I want patients to hear today is if I have a lot of patients that, especially after RFK came in and talked about the peptides that are being a little bit more um laxed on with the FDA, and I'm gonna leave it there. Um asking me a lot of questions about, you know, what does this mean? What is the gray market? What is what is what are third party, what's third-party testing mean? What is what are compounding pharmacies? What is the five of blah, blah, blah, what is all of that? And so I'm not a pharmacist, but we partner with just a very, very few less than five I can count on my hand, with fingers left over, the number of pharmacies that Nicole and I partner with on a daily basis, because we know you love you, trust you, we've vetted you. You guys are fantastic. You've been through all of the processes and y'all are like family. We we know you and trust you and love you. Um, and we know that you take great care of our patients with pure products that are appropriately tested and you guys are mandated and you do the things. And so can you kind of talk to people today about what does all that mean? Like when they go see their telehealth provider and we tell them, hey, we're gonna send your prescription to this pharmacy and it's gonna be compounded and just trust us. Why should they just trust us?

Accreditations And Supplier Standards

SPEAKER_00 2:48

Okay. Those are great considerations, and and thank you very much for the uh kind words you said about our pharmacy and the dedication that we have, you know, primarily to your patients. And um, that's always been foremost with us is taking care of our taking care of the patients and doing doing it the right way. And in light of that, you know, we've sought a lot of uh additional accreditations to back up what we say and what we do. You know, a pharmacy saying they have they have this or they do that is one thing, but to to have several accreditations and being licensed in 48 states holds our feet to a lot of different fires. Um we are uh PCAB accredited, uh, which requires uh annual uh re-accreditation, and we are NABP and National Association of Boards of Pharmacy accredited, which holds us to the standards of the 50 states. So we take all of those things seriously, and there's a lot of things that go, there are a lot of guidelines that go into that. Um I really won't get off into the weeds and into that, but there um the things that we look at um are we have to have a certificate of analysis on any of the chemicals that we have that we bring in. All of the chemicals that we bring in have to be from a uh FDA licensed um pharmaceutical supplier, and they have to be pharmaceutical grade. And so having said that, this kind of segues into a lot of what JFK said, and there's a lot of confusion and a lot of a lot of nomenclature, a lot of big words, a lot of nomenclature used in in that um press meeting that I think is confusing to a lot of the the lay public, and um there's a lot a lot of language in there that uh may be um unclear as to the exact uh meaning of them and how it affects us and uh primarily the the peptide market. Um and we can go into that a little bit if you want to on the peptides and what he said, or we can, you know, kind of stay with your topic about the things that we do as a as a pharmacy. But one of the things that that we do, uh one of the things that we are mandated to do is to do testing of our products.

Kelli 4:59

And that's that's the third-party testing, right? The third party testing that patients asked me about.

SPEAKER_00 5:04

Yes, that's third party testing. What is that? So we use an outside laboratory, and and it's it's kind of um interesting that all the products that we test. Well, do you test creams? Yes, we have to. Do you test your capsules? Yes, we we have to. Do you test your you know, your sublingual tablets that do let's say we do a sublingual progesterone or testosterone? Do you have to have those tested? Yes. So any of the products and any of the technicians in our pharmacy compound over the course of the year, we have to do random testing on the selected line of products. You know, and we we we we do that on a very on a very scheduled basis.

Kelli 5:39

No, but all of them are when you say an outside lab, third-party tested, this is someone who does not have a monetary or vested interest in your company. This is completely outside, like they are not benefiting from doing this test for you.

What Third-Party Testing Checks

SPEAKER_00 5:54

Oh, yeah, that's that's a great question. No, we have to pay for this testing, and so a lot of times there's different things that go into testing. Um, we'll go into an injectable product and all the things that we have to do on that. And that would be kind of a wake-up call and a moniker, you know, to the patients out there that are getting injectable peptides or injectable drugs. But no, it is an outside uh testing laboratory that we use and they test for purity, they test for if it's an injectable, they test for sterility, they'll test for endotoxins, um, and then they'll test for potency too. So when we send like a cream, we are testing for potency. So if we say it has 50 milligrams of progesterone per gram of that cream, then they're gonna test it. It has to fall within certain guidelines. And so we shoot, uh, we shoot for you know one to two percent, and the margins are allowed is 10%. But we we shoot for those and we typically hit those regularly. If we don't, then we go back and we do we do a a complete uh investigation to what happened, you know, where did we have a breakdown in this? And a lot of times it has to do with the reference that the laboratory is using for their products. It's a little more information you needed. But there's a lot, there's a lot that goes into this.

Kelli 7:02

Is that where you get the COA, the certificate of analysis that comes back with the product that says it is what it is?

COAs, USP Gaps, And Confusion

SPEAKER_00 7:08

Yes. And so all of the products, and um, that's one of the things with using USP or United States U.S. pharmacopoeia drugs, uh, and none of the none of the FD none of the peptides actually fall into the USP monograph, and that's one of the hiccups that the FDA's had with that. It not necessarily mean that all drugs that if a drug doesn't appear in the USP, doesn't have a USP monograph that that you can't use it or it's not approved by the FDA, that's not true. You can, but unfortunately the peptides don't fall on that. That was one of the the criteria that the FDA used to blanketly go against uh peptides. But for like a sterile product, if we're going to do a uh sterile product and we're going to have we have to have beyond use dates. We have to have beyond use dates and we're controlled by those. We can't just we just can't just create like a progesterone cream and put it out there and say, well, it's got a year's expiration date. That's we can't do that. We don't have anything to back that up. But a lot of times, if it's a product that we do enough of, we will pay for a long-term stability study. And we have done that multiple times. We did it on our pellets, we do it on our injectable drugs, um, we do it on some of the creams we do or some of the long the hair hair products that we do. We've paid for very expensive, you know, thousands of dollars to do a long-term um stability study. And there's a lot that goes into that. They have to do a method suitability study first. And there's just a lot that goes into our testing of our products, but it's important to us. It's important to protect our patients, and that's the reason that we do that. Unfortunately, there are a lot of players in the market, and especially, you know, right now with peptides, they aren't regulated. Um, there are some quite a few. There's one large manufacturer of the uh peptides in the United States, and we've asked them repeatedly to give us their uh FDA certificate that they have, that's that they're FDA supplier of these peptides, and they can't do that, or they have not as of yet. So we're very careful in looking at our suppliers, first of all, that we want them to be registered with the FDA. It's not that we think the FDA is uh say all and be all, and nor do we actually even trust the FDA totally, but it is one of the markers that we use as a criteria for our companies is that they are registered with the FDA. That gives us a little more credence in the certificate of analysis that we get back because they have to they have to supply information and they're they're held um kind of holding the their feet to the fire for their products that they bring in that they're tested externally and internally, and then after distribution, and then they're also testing for impurities as well. So that's really, really important to us. Unfortunately, with the peptides right now, and a lot of the players in the market, uh, they don't have this testing. They don't have the the purity or these these the uh sterility or the long-term studies to back up what they're sending out. So that's one of the hesitancies and one of the expenses of of doing these products is the testing that goes into them.

Kelli 10:14

And that's that's where people are getting this gray market product, right?

SPEAKER_00 10:18

Yeah, and and uh um uh RFK mentioned that in in the article he talked about, you know, that was you know, that's oh he's opened the market up. Yes, he did open it up, and and we are thrilled about it.

Kelli 10:30

But you guys are the gatekeeper, like you guys that are going through these processes, like these actual, and this is what I want people to hear from you is these pharmacies like Tom's and like a few others that are accredited, bored, you know, you're you guys do the work, you do the right things, and this is where patients need to hear it. Y'all are the gatekeeper there, like you're the ones that are setting the standard, like you just said, that you're not letting those gray market products go to your patients because this is what you're doing, right?

SPEAKER_00 10:58

Right. And so we we we would demand, and we have we have to, because of our accreditations, we have to have a certificate of analysis that's coming in. And on any injectable drug, again, we're we're gonna have it sent out. We're gonna have it sent out for sterility, for potency. So if we say it's say, for example, we say it's iprimorlin and we're we're doing iprimorlin or we're doing one of the other peptides, uh trig uh semaglutide, we send it off for testing before it's released. So we quarantine those. So we we compound those, we quarantine them. And so, how can you quarantine them for 14 days or till you get the testing back and then dispense it with a a date of 90 days? Well, the reason we can is because we've paid for the testing. So we we do have beyond use date testing. So if I send a prescription out to Kelly and it it goes out and we put, you know, it's expires in in 68 days. We know that it's gonna expire in 68 days. You should have used it within 45 days or 30 days. So we always look at that too. So if they reach the date of beyond use date in our patients, we don't send it out.

SPEAKER_02 12:04

I love that.

Gray Market Risks And Real Safety

SPEAKER_00 12:05

If we don't have the testing, we can't do it. You know, the kicker that Kennedy brought attention to uh was the dangers of the unregulated peptide market. Uh, and he characterized it as being very substandard while noting that consumers have no idea what they're obtaining is legitimate. And unfortunately, with and I'm not I'm not saying anything disparaging about anyone selling peptides out there because I don't know, but I know that I do know that they a lot of these aren't regulated. There are no USB monographs. So there are there is no definition of what's pure. Um, there is no definition of what's acceptable, there is no standardization of if a drug is called C CJC 1295. Do we know what's supposed to be in it? Do we know what contaminants are or contained in it? It has copper in it, but it's a copper-based product. But do we know are there other heavy metals in it? Has it been tested? And these are the things, the long-term things we don't know. So I, you know, I I am a proponent of peptides. I think there's a there's a huge um advantage of using them. But right now, where we are um until we get to a little better position with the FDA and them taking this off of a category where we can start holding the um pharmaceutical suppliers, and the FDA says comes in and says, okay, we are going to do it. Now we can hold the pharmaceutical suppliers, we can hold their feet to the fire. Okay, you said this is you know, CJC 1295. Show me the certificate analysis and let me let us look at that and to make sure that what we're doing is is pure. And they should come in with an expiration date too from the chemical supplier, too. They should know the degradation rates of these. These are all things that are outlined in USP um um that we use as a standard.

SPEAKER_02 13:52

Um I love I love that you have all of the this is like super, super good information to the patients and to just consumers in general. But I want to um and it's just fascinating to listen to you about all of the the things. It's just it's so fascinating. Um before we wrap up, can you talk about what the couple main differences is between you and retail, meaning regular go and pick up your medication at the store between them and a compound pharmacy? And then I do want you to people are gonna message us and say, What's the name of the pharmacy and all that stuff? So I I do want you to close with that information, but what is the main difference between a compound pharmacy and a retail pharmacy? Because you're either one or the other.

Quarantine, Potency, And Beyond-Use Dates

Compounding Versus Retail Pharmacy

SPEAKER_00 14:43

Okay. There are there are some hybrid stores, and that's a great question. There are some hybrid stores that do compound kind of you know on the side and then fill regular prescriptions, which are commercially available. Um, you know, the moxicillins, the products that you take off your statin drugs, your blood pressure medications, those types of things that are just you take off the shelf and you dispense them to the patient, and you cancel the patient them on them on the side effects, and you monitor their, you know, their medication therapy. There's certainly a dire need for that. Our pharmacy is different in that we we basically we make or we customize everything that we do. So every every product that we make here is compounded in our laboratory. And we have actually we have four different pharmacies inside our pharmacy. Each of them are regulated and controlled by different rules uh and regulations. So we have our our non-sterile compounding, which does like creams and capsules and those things that are non-hazardous, and that's that's done in our 795 laboratory. And then we have a 797, which is a sterile compounding area, and that's for non-hazardous uh materials. And then we have another laboratory, which is 800 hazards. So, like if it's progesterone or testosterone or uh maybe phenesteride, something that would have potential uh or is made the hazards or neosh list for hazardous chemicals, we protect our staff, and those are compounded in those environments, which they gown up, gear up, and they're in different uh hair pressure environments. And then we have our 800 uh sterile compounding, which is designed for the same thing. Um, we don't really use it specifically for um hazardous uh chemotherapeutic drugs, but we could we use it for uh things like autologous eye drops that we make. That's it's a biohazard. We want to protect our staff from biohazards. So we have four different laboratories actually in our in our in our pharmacy that provide products to our patients. And each of those are written um from uh like Kelly and Nicole for their patients, and they have the ability to customize their medications or customize the dosage. Say, you know, Kelly has a patient that's uh completely allergic to uh gluten, allergic to any types of um dyes or fillers. We can compound hypoallergenic capsules for them for this patient, and that's that's where we step in and we're able to customize our dosages and our strengths.

Kelli 17:13

So that's a that's a thing, I will say, and that's what I love our compounding pharmacies for. I had a patient recently, just as an example, that was had an allergic reaction to the orange dye that was in the progesterone capsules that her pharmacy, her commercial pharmacy, was filling for her. And they insisted they had nothing else, it was just all they had were the orange ones, they couldn't do anything else. And you guys filled the white progesterone capsules. I'm like, I know it's available, like I know they can compound it and do this, I know it's a thing. And you guys were able to step in and get her the white capsules. I'm like, yeah, because it's a thing.

SPEAKER_00 17:44

Yeah, it's you know what what I do, I love what we do because we're able to every day we're able to to do something for a patient that no other pharmacy is able to do. And we're able to meet them, we're able to meet that need and and make a difference in their life. And that's what's so rewarding about what we do and working with providers like you guys is it's nice to work with innovative providers that see that their their patients are more important than than what's standardly available, and that you have the ability to thank and take care of your patients. So it's it's very rewarding for us too.

SPEAKER_02 18:17

So, how can patients find you online to check you out and scope out all of this stuff? How can what is your website and how can they find you? Because I know they can call you and you love talking to patients. Sure. Um, and they you know, there's so many fake capabilities that you can do. So I encourage people just you know Google it. Just Google what is a compound pharmacy and just get your basic information. But Tom, how can patients find you? Okay, outside of reaching out to us, of course, just in general, how can patients find you?

How To Reach The Pharmacy

SPEAKER_00 18:41

But uh the pharmacy is pharmacy solutions, and we're in Arlington, Texas. Um, our phone number, we have an 800 phone number, it's 800-542-5767. And then our website is rxcompound.com. And you can you can reach us or you can just email info at rxcompound.com. And now we'll go to one of our four outstanding pharmacists here at the pharmacy. And one of them will reach out. Typically, when you become a patient at the pharmacy, you're you're gonna be established with a pharmacist. And that for better or for worse, you're married to that pharmacist. He's gonna he's gonna follow you and make sure that you're taken care of and check up with you. And if you have problems, then you can reach out and talk to that specific pharmacist. You're not and we don't have an answering machine. You we answer our phone and you can ask to speak to one of our pharmacists, which is rare.

SPEAKER_02 19:29

I'd love that. I love that.

SPEAKER_00 19:31

That's one of the things I've dug. I'm I'm old-fashioned. I've dug my my heels into the the sand on that, and I won't bend on that. I think when a patient calls, they deserve more than an answering machine. And I think when providers call, they deserve more than pushing the button.

SPEAKER_02 19:45

So well, thank you so very much. We appreciate having you on and giving just the skinny on compound pharmacies and all of the intricacies. It's just so it's actually reassuring and fascinating. And um, we will certainly have you back on, and um we'll reach out, and I'm sure we'll be talking to you soon, probably today or tomorrow. We're always talking about patience. So uh thank you so much, Tom.

Kelli 20:06

If you guys have any questions, please comment below, ask your questions. Tom, we would love to have you back on. We may even have a session where it's just a QA with Tom.

SPEAKER_00 20:14

Okay, I don't know.