Latest / Gladden Longevity Podcast / Navigating the World of 503A and 503B Pharmacies - Episode 355
Transcript
- 0:00Couple weeks ago, the FDA had a pharmacy compounding committee come together
- 0:05and look at eight different peptides.
- 0:07Out of the eight, if I'm not mistaken,
- 0:09seven of them were approved, or the committee said to the FDA,
- 0:13these are ones that we feel need to be added to the 503A bolts list.
- 0:18Hey everyone, Dr. Gladden here.
- 0:20I just got off a podcast with Joshua and Nicole from Olympia
- 0:24and Wesley Pharmacies in ~ Orlando,
- 0:27Florida. They're a compounding conglomerate there.
- 0:29And it's an interesting podcast because we break down the whole 503A,
- 0:33503B compounding, what they can do,
- 0:36what they can't do. We get into the whole peptide story about what's happening with
- 0:39the FDA, with the peptides that have been suggested for approval
- 0:43and things like that. So I think you're gonna find this very interesting
- 0:46and clarifying. If you have any questions about compounding.
- 0:48pharmacies, this will be a good one to listen to.
- 0:51He went from saving hearts as a cardiologist to rewriting the entire aging playbook.
- 0:56Dr. Jeffrey Gladden believes 100 is the new 30 and he's got the science
- 1:01to back it up. This is the Gladden Longevity Podcast.
- 1:05Well, welcome Josh and Nicole to the Glad Longevity Podcast.
- 1:08It's good to see you. Glad you're joining us today.
- 1:10It should be an interesting conversation here.
- 1:12We're gonna talk about compounding pharmacies,
- 1:14which I think is a big part of what we do in the regenerative functional medicine
- 1:18space, et cetera, longevity medicine space.
- 1:20So welcome to the show. Yeah. Thanks for having us.
- 1:23So Josh, let's let's start with you.
- 1:26You're the CFO of a pharmacy in Florida.
- 1:29And you know, there's been a lot of I think confusion
- 1:33for people around compounding pharmacies.
- 1:35I think people have heard, you know,
- 1:36things thrown around 503A, 503B.
- 1:39I'm not sure people really understand the difference there.
- 1:41I know that probably the what the audience is most familiar with,
- 1:45however, is, you know, the use of peptides.
- 1:47And people have gotten comfortable using peptides.
- 1:50I got certified in peptide use with A4M back in two thousand seventeen with Dr.
- 1:55Seats and we started using them back then.
- 1:58So they've been around for a long time and we've had a lot of great experience with
- 2:01them.
- 2:02But there's a lot going on there with the FTA and things like that.
- 2:04But let's let's start off with maybe just sort of defining whoever wants
- 2:10to jump in on this, you know, what a compounding pharmacy is.
- 2:13Why why you came into existence?
- 2:15What what was the need? I can
- 2:17Can leave this off and Nicole,
- 2:18feel free to jump in. Josh Fritzler,
- 2:20president of Olympia and Wesley Pharmaceuticals.
- 2:23So, just for what we're familiar with,
- 2:25Olympia Pharmaceuticals is a 503B.
- 2:28We also have Olympia Pharmacy,
- 2:29which is a 503A, and then we have Wesley Pharmaceuticals,
- 2:33another 503B. That is the umbrella of companies and pharmacies we have.
- 2:37So what's a f what's a five three A?
- 2:39What's a five three B? Yep, so five three A
- 2:41Is more of a community pharmacy that could have ~ compounding in its facility.
- 2:46Our facility does sterile 503A compounding for testosterone,
- 2:50which is a hazardous compounding,
- 2:52and then we do non-sterile. 503A follows USP guidelines set by the state regulators.
- 2:57It has specific ways of dispensing.
- 3:00You have to dispense with a prescription,
- 3:01has to have a patient label before it leaves your facility.
- 3:04Or in very layman's terms, a 503B is an outsourcing facility.
- 3:08We have larger batch sizes of ten thousand to fifteen thousand vials,
- 3:12where a five three A has two hundred and fifty vials per batch.
- 3:15So the way the way I understand it is a five three A basically is
- 3:19a pharmacy that's making a particular compounded and we'll talk about what
- 3:24compounded actually means pharmaceutical for an individual.
- 3:28Correct. And a five three B is actually making large quantities
- 3:32of a particular compounded thing that can be used otherwise.
- 3:36Let's talk about compounding. What is what is it to be what is it
- 3:39to be compounding something, Nicole?
- 3:41So when you compound something,
- 3:42you are actually making something that's not commercially available.
- 3:47So for us, we're in the health and wellness.
- 3:50So we do a lot of vitamins, minerals,
- 3:52things like that. There is sterile,
- 3:54which goes through a process that means it's gonna be injected somehow,
- 3:58or IV. And then there's non-sterile,
- 4:00which is what we see typically in your community pharmacies,
- 4:03these your creams, tablets, capsules,
- 4:05anything that doesn't actually have to be injected.
- 4:08Mm-hmm. So you can make things sterily and non sterily.
- 4:11And why would somebody want something compounded?
- 4:14Why why would why would somebody want that?
- 4:16Great question, because when you get something compounded,
- 4:19you can make it directly for that patient.
- 4:21Some patients might not be able to handle the doses that are out there from
- 4:25a commercial standpoint or some of the fillers that they have if they have
- 4:29an intolerance to say lactose or soy,
- 4:33or it's just maybe not available commercially,
- 4:35the dosing that they need to in order to service them.
- 4:38So you're a pharmacy that basically has all of the access to all
- 4:43of the medications that somebody would find at Walgreens or C V S.
- 4:46And what you can do is you can actually make those in different concentrations
- 4:51or different doses or things like that that somebody couldn't just walk into
- 4:56C V S and get it off the shelf in the doses that the manufacturer made.
- 5:00Correct. Combine certain products.
- 5:03So like creams, like putting two to three creams together or ~ solutions that you're
- 5:08not gonna find you're right at the local pharmacy.
- 5:10Right. So this can be of value to a client because all of a sudden,
- 5:15~ maybe there's a hormone combination that they want to have that
- 5:20is not available and they know from testing or whatever else that they need this
- 5:24amount of estrogen and this amount of progesterone and you know,
- 5:27whatever else, testosterone, and all of a sudden they can get that into
- 5:31a compounded product that they couldn't find anywhere else.
- 5:34Right. So there's there's a convenience element,
- 5:37but then there's also kind of a precision.
- 5:40element to all this where what you're really doing is getting
- 5:44the individual exactly what they need,
- 5:46right? Right. In conjunction with these particular drugs,
- 5:50one drug or could it be several drugs.
- 5:52And that's that's really why compounding pharmacies came into exist existence
- 5:57was to meet the need of people that,
- 5:59you know, couldn't get along with just the standard dosing.
- 6:03Is that how we should understand it?
- 6:05Exactly.
- 6:05Or the standard products. They needed something that was specifically made
- 6:10for them and their condition or what they were looking to treat,
- 6:14something like that. And so that's where compounding comes in.
- 6:17It offers you that ~ a la carte,
- 6:20make it for this patient and get what they truly need.
- 6:23need.
- 6:24So with the 503A's, they're gonna function.
- 6:27If if you haven't ever walked into a compounding pharmacy and you're listening
- 6:31to this, if you walk into a five three A,
- 6:33it's gonna look kind of like pharmacy.
- 6:34I mean you're gonna see, you know,
- 6:36shelves with stuff on it and different creams and things like that.
- 6:40But then there's a counter where you can actually submit a s prescription from
- 6:44a physician and they can make an actual product just for you.
- 6:48And again it functions a lot like a regular pharmacy.
- 6:51Now it's interesting to note that
- 6:53These are not, even though let's say the drug off the shelf is FDA approved,
- 6:58the compounded formulation is not FDA approved,
- 7:02right? Correct. And it's interesting that it's not approved.
- 7:05And the reason the FDA doesn't approve it is I suppose because they can't really
- 7:09cover all the different potential,
- 7:10you know, combinations and doses and all of that sort of thing,
- 7:14right? So it's important to understand that if you're getting something from
- 7:17a confounded pharmacy, even though it's an FDA approved drug.
- 7:21The form in which you're getting it in and of itself is not FDA approved.
- 7:24Yeah.
- 7:25Or it's a combination of FDA approved ~ ingredients.
- 7:29Correct. That's an interesting thing.
- 7:31So from a safety and efficacy standpoint,
- 7:34I can tell you that functional physicians and longevity physicians,
- 7:38regenerative physicians, have gotten very,
- 7:39very comfortable with pharmacies that are very meticulous in the way they
- 7:44put things together. For example,
- 7:46combining ~ T three thyroid with T four thyroid,
- 7:49things like that. There's skill that's involved with this,
- 7:52and all not all compounding pharmacies are the same,
- 7:55but you can go in and you can actually
- 7:58think about it this way that I'm getting exactly what I need.
- 8:00And th even though it's an FDA approved drug,
- 8:03it may not be FDA approved in this format.
- 8:05But the safety profile that we've experienced for people is that it's it's actually
- 8:10very safe. So I don't know what your what your rate of complaints might
- 8:14be in terms of, you know, reactions or something like that,
- 8:17but I suspect it's not very high at all.
- 8:19It's not and most of the time it's usually patients more of a sensitivity
- 8:24or didn't follow directions, something along those lines is what we see.
- 8:28But as far as the product itself,
- 8:31no.
- 8:32So many times what people are reacting to also,
- 8:35~ either in a over the counter C V S Walgreens kind of scenario,
- 8:40or even in a compounding pharmacy,
- 8:42is that they may there may be a carrier molecule.
- 8:44There may be something else that's that's not the active ingredient that they're
- 8:48reacting to. And you know, if all you had available to you
- 8:51was a traditional pharmacy, you'd kind of be stuck.
- 8:54Because that's how it comes. But you can then go to a compounding pharmacy,
- 8:58say, I like, I need this, but I can't get along with a carrier.
- 9:01Can you put it with a different carrier?
- 9:03Right. Now all of a sudden, now they can tolerate it.
- 9:06Now they can actually get what it is they came to get,
- 9:09right? So that's kind of the beauty of it.
- 9:10Absolutely. That's what we see in our line at our five three A is
- 9:14we do have patients that they just can't tolerate what's available commercially,
- 9:18whether it be a carrier, a stabilizer,
- 9:20preservative, whatever it is. And so they're like,
- 9:22This is my last chance. Can you help me?
- 9:25And of course, you know, we'll do everything we can to help our patients.
- 9:28And that's why, you know, we're able to to compound it for them so that they're able
- 9:32to get the the treatment they need.
- 9:34Mm-hmm. And the the pharmacies themselves are regulated by the state pharmacy boards
- 9:40and also by the FDA, if I'm not mistaken,
- 9:43right? So even though the actual compounded drug may not be FDA approved
- 9:48in that particular configuration,
- 9:50the pharmacy itself has to be FDA approved and comply with all
- 9:54the state pharmacy laws and all this kind of thing.
- 9:56So there are many, many different safeguards,
- 9:59if you will, from the consumer's perspective.
- 10:01To make sure that they're getting what they say they're getting,
- 10:04that the pharmacy says they're getting,
- 10:05and that things are being handled in a very safe manner.
- 10:08So
- 10:09That that's where like the states will have label requirements,
- 10:12the FDA will have label label requirements,
- 10:14testing requirements, and then there's obviously a list that the
- 10:18FDA puts together of ingredients we can even use.
- 10:21Yeah, exactly. So that kind of covers a little bit of the five three A.
- 10:25So it's gonna look kind of like a pharmacy you've always always seen.
- 10:27And then compounding pharmacies sometimes will mail things to your home
- 10:31or or that kind of thing, which is kind of an added convenience.
- 10:34You'll still need a physician to prescribe it for you,
- 10:36somebody that's facile with how to write that prescription,
- 10:39what goes into it, etcetera. So you have that.
- 10:42And then there's the five three B.
- 10:44Which is a little bit of a different animal.
- 10:45And you talked about Josh that you've got a couple of those and they
- 10:48can make larger quantities of things.
- 10:51And why have a five three B in contrast to a five three A?
- 10:55Sure.
- 10:56There's couple main large scale differences.
- 10:58USP governs 503A's, the FDA governs 503.
- 11:04US pharmacology standards I would say that kind of set the regulatory compliance
- 11:09for ~ compounding. Whereas C G and P,
- 11:12which is current good manufacturing processes,
- 11:14is what governs a five hundred three B's ability to compound and those
- 11:17are the those are the rules we have to follow to make sure anything compounded
- 11:21at a B is C G and P versus A has a little bit lower
- 11:25Which is the same requirements that pharmaceutical companies have to have to go to.
- 11:30Five O three B is like a pharmaceutical company in a sense.
- 11:33They have to follow the same guidelines that the FDA sets for those companies
- 11:37as well. Whereas on the five O three A side,
- 11:40you're governed more by the states.
- 11:42FDA does have oversight and they follow most states are adopting
- 11:47~ compounding regulations, especially with the big GLP one compounding.
- 11:52So
- 11:53We're starting to see kind of a shift in regulatory to ensure patient safety.
- 11:57Yeah, and it's US pharmacopia,
- 11:59I think, is what USP stands for,
- 12:00but that's a state regulation essentially of how they govern 503As.
- 12:04So 503B is FDA governed, FDA licensed,
- 12:08frequent FDA audits, or an A, it's less frequent FDA audits.
- 12:12~ so as a B we do state and FDA audits.
- 12:15Larger batch sizes because we are able to sell without a prescription directly
- 12:20to a clinic.
- 12:21That's where the CGMP guidelines for manufacturing comes in.
- 12:24We also have a different set of ingredients we can compound with than a 503A.
- 12:29And then that's our larger batch sizes.
- 12:30It's it's much more large scale manufacturing.
- 12:33And then our report card essentially from the FDA is public.
- 12:37~
- 12:37So when you
- 12:38say when you say that from from a five three B that you can sell directly
- 12:42to the public without a prescription,
- 12:43does that mean that you're bypassing a prescription or people can just walk
- 12:49in and say, Hey, want testosterone?
- 12:50or what what is that? How does that be a
- 12:52licensed
- 12:53clinic with a licensed medical director on file,
- 12:55we would sh be were able to ship to a clinic for use in the office.
- 13:00You're
- 13:00purchasing it for office use and then from there the clinic can determine
- 13:04if they're going to administer it in the office or dispense it to
- 13:08the patient via prescription from their office.
- 13:11And that and that's that's also where we're allowed to sell directly to a pharmacy.
- 13:15Crowdsourcing and that pharmacy can hold our product as inventory like they would
- 13:20a generic drug and then fill trips with our inventory.
- 13:23and then the second big difference between a five three B would be
- 13:27the shortage list of products that are on FDA shortage,
- 13:30meaning a brand new manufacturer,
- 13:33generic manufacturer can't keep up with the demand.
- 13:35You can then fill the gap by making those products as a five three B.
- 13:39Yeah, and this became very evident with the whole GLP one story,
- 13:43right? Things got exceeded demand or a demand exceeded capacity.
- 13:47And so then all of a sudden the compounding pharmacies were able
- 13:51to manufacture the five O three Bs and the Five O three A's were able to dispense.
- 13:55So and then the interesting thing is that's a little bit of an elastic situation,
- 14:00right? Because you can have a shortage,
- 14:02it can last for three months, and then the shortage goes away,
- 14:05and now the pharmacy is no longer able to make that exact same
- 14:09drug. That is one thing to understand is that the compounding pharmacy can't make
- 14:14exactly what the manufacturer is making,
- 14:16right? And I believe that's true for both the A's and the B's.
- 14:19Right.
- 14:20You can't make a commercial
- 14:21~
- 14:22Over under a ten percent difference for to be considered non-commercially available.
- 14:27Okay. So it has to be non commercially available,
- 14:30which means it's gonna differ by ten percent up or down.
- 14:33At least, yeah, exactly. Basically,
- 14:34yeah. Okay, just so the audience understands how this all works a little bit.
- 14:38Cause I I think it's everybody's heard about this,
- 14:40but I I think it's been confusing for people at the same time.
- 14:43Yeah.
- 14:44Then a a lot of what you see too with Big Pharma is they group compounding together,
- 14:48which they both serve such a unique purpose from customized medication from
- 14:52a 503A to large scale manufacturing,
- 14:55shortage and or clinic use, office use.
- 14:58And like they are two different facilities licensed differently,
- 15:01but it is very common for them to be branded the same.
- 15:04So I appreciate you kind of letting us explain that.
- 15:07Yep.
- 15:07Yeah.
- 15:08And then what about research molecules and things like that?
- 15:10So if there are research trials and things and you don't have
- 15:14an FDA approved medication, pharma could basically supply
- 15:20a not yet FDA approved drug into a clinical trial.
- 15:23And then it's also possible for compounding pharmacies to get involved
- 15:27in clinical trials where somebody has devised a particular combination of
- 15:34medications that could be FDA approved or maybe not FDA approved
- 15:38and then bring those forward inside of a clinical trial.
- 15:40Is that part of what you do as well?
- 15:43So we don't actively do that. What I believe you're referring to is an ANDA.
- 15:46So it's an abbreviated new drug application where we'd be able to help either
- 15:50a brand of manufacturer or big pharma kind of create that drug for trials.
- 15:55We are not involved in that currently,
- 15:56but there's definitely manufacturers that do aid in that.
- 16:00It's just a different approval process and different drug application.
- 16:04We're only making drugs that are on a list of ingredients for bulk's list
- 16:08or shortage.
- 16:09Okay, fair enough. And then talk to us a little bit about licensure
- 16:14and interstate commerce and things like that,
- 16:16right? Because this is a big deal.
- 16:18Your license, let's say you're licensed in Florida.
- 16:20I don't really know where your licensures extend to,
- 16:22but let's say you're only licensed in Florida,
- 16:24just as a matter of illustration.
- 16:26Then if a doctor saw a person from Georgia in Florida and wrote
- 16:31a prescription and they went back to Georgia and wanted to get that filled,
- 16:35is that possible? You can send it to them in Georgia or
- 16:38Explain to people how that works,
- 16:40right?
- 16:40Yeah.
- 16:41So depending on ~ the states that the pharmacy is licensed in is the states they
- 16:45can ship to. You're right. Your state commerce is a big thing in the pharmacy world,
- 16:50whether it's compounding specialty.
- 16:51So the pharmacies have to be licensed in that state and there's certain requirements
- 16:56for the pharmacies, again, depending on their specialty in order to ship
- 17:00to those states. So for us, we're able to ship to 49 states.
- 17:05including Puerto Rico, and then we're able to service patients in
- 17:09all of those states and providers.
- 17:11Okay. Which state did you leave out?
- 17:14California. Yeah, for now. We do have them scheduled to come to
- 17:17our Wesley five three B at the end of this year,
- 17:20Q four. Much information as they kinda give you.
- 17:23but so the easy way to think of it as well is licensure like our state licensure,
- 17:28our medication needs to only be in those states.
- 17:31Mm-hmm. Got it. Okay. So that's helpful for people to hear about that because
- 17:34sometimes people get caught out with,
- 17:36you know, I I got this prescription when I was in Florida,
- 17:39you know, I got it filled there by the doctor,
- 17:41but now I want to get more of it.
- 17:42And now I can't get it because I'm in Georgia.
- 17:44Right. And so yeah, important for you to understand the restrictions that
- 17:48are around that. So typically if somebody and you're licensed
- 17:51in Forty United States, but not in California.
- 17:53So let's say you had a client that saw you in Florida,
- 17:55a Florida doctor, they got the prescription there,
- 17:58but they went home to California,
- 17:59they want to get more of it.
- 18:00Now the the pickle that they're in,
- 18:02so to speak, is to find a compound pharmacy in California or one that's licensed
- 18:07in California that can actually provide that to them.
- 18:11Correct. And we run into that quite often just because,
- 18:15you know, the way people travel,
- 18:16they have multiple homes. Obviously a lot of patients come to Florida for vacation.
- 18:21They might see someone here, get the meds.
- 18:23So yeah, we try to do our best to kind of navigate through that to
- 18:27see what options they might have.
- 18:28Yeah. And then let's talk a little bit about peptides because,
- 18:31you know, everybody's been aware that,
- 18:33you know, the peptide world kind of got clamped down on by the FDA and
- 18:37and then they started going after some of the research only
- 18:40use peptide manufacturers, which is a little bit of a a mixed bag,
- 18:44right? I mean, there are people out there that are selling garbage
- 18:47and there are people out there that that probably selling high quality stuff.
- 18:50And then with the peptides now,
- 18:52the FDA has
- 18:53I think recommended nobody's approved anything,
- 18:56but what I understand they've recommended I think about eight different peptides
- 18:59for consideration for some sort of approval.
- 19:03Do you wanna walk us through kind of where where the FDA is with that?
- 19:06Yeah, absolutely. So ~ a couple weeks ago the FDA had
- 19:10a pharmacy compounding committee come together and look at eight different peptides.
- 19:15Out of the eight, if I'm not mistaken,
- 19:18seven of them were approved, or the committee said to the FDA,
- 19:22these are ones that we feel need to be added to the 503A Bulk's list.
- 19:27Now from there, the FDA still has to make their determination on if they want
- 19:32to approve them and put them on the list.
- 19:35for pharmacies, 503A pharmacies to compound or not.
- 19:39Really nothing has been decided by the FDA.
- 19:42We are just moving, in a sense,
- 19:44one step closer and the conversation is obviously opening up to allow these
- 19:49to be compounded. So we're getting there,
- 19:51but we're about halfway there.
- 19:53We're we're not to the finish line.
- 19:55And what's the timeline on that for people to just I mean,
- 19:58people are curious, right? And because some people are very adamant,
- 20:02I don't want to get it from just,
- 20:03you know, offshore or research place or something like that.
- 20:07I'm really waiting for a compounding pharmacy.
- 20:08Do we have any sense of the timing on this when the FTA's gonna meet?
- 20:12Well, we're talking about the FDA.
- 20:14So
- 20:15Yeah, right.
- 20:16they still have to go through a comment period,
- 20:19which is typically anywhere from thirty to sixty days,
- 20:21and then from there they could have thirty to sixty days to determine.
- 20:25So we are hopeful early fall we might hear something.
- 20:29But again, a lot of things get pushed back,
- 20:31plans change, meetings change.
- 20:33So we don't have a definite this is when they're supposed to make the decision.
- 20:37Yeah. the the rule of thumb right now is there's open comment period.
- 20:42So I think at the earliest it would be sixty days from the recommendation.
- 20:45But we're hopeful we're kind of keeping our ear to the wall to hear what happens.
- 20:49And then honestly more intriguing for us is if this goes on an A list,
- 20:54do they also put it on a five three B list?
- 20:56~ we don't have any clarification there either.
- 20:59But I will say though, just for the PCAT committee,
- 21:01if anyone didn't listen, there were three things that were constantly brought
- 21:05up by the FDA. One was
- 21:07Lack of FDA oversight on 503As,
- 21:10which a 503B has direct FDA oversight.
- 21:13lack of ~ adverse event reporting from an A,
- 21:17which are 503Bs required. And then also CGMP manufacturing these products,
- 21:21which is a requirement from a 503B.
- 21:23So a lot of the statements that the FDA made did kind of steer us into more 503B
- 21:28compounding of these. but again,
- 21:30we we have to kind of wait and see.
- 21:32Got it. So for the ~ for the consumer here,
- 21:35we're kind of in a holding pattern.
- 21:36It sounds like we may learn something about access to these seven different peptides
- 21:41through compounding pharmacies,
- 21:43you know, maybe later this year.
- 21:44It sounds like we're gonna know something by twenty twenty six.
- 21:46So if you're kind of sitting on the fence about whether or not to use peptides,
- 21:50these particular ones, you can think about it that way.
- 21:53What are some of the other issues that you think people need
- 21:56to understand about compounding pharmacies and kind of maybe things that even
- 22:00distinguish you from
- 22:02From other compounding pharmacies.
- 22:03Yeah.
- 22:04Can
- 22:04answer that in two parts. Do you want to speak directly to the peptides first
- 22:07and kind of what is in the market for that?
- 22:10And then I'll go and just generically ~ what I think is important
- 22:14for picking a compounding pharmacy,
- 22:16whether A or B. When it comes to these peptides as well,
- 22:19so there's no USP monograph. That was a common topic brought up of what is BPC?
- 22:24What is MOTC? So I from an from our perspective,
- 22:27we have to vet and audit every supplier of our raw ingredients.
- 22:32They're called
- 22:33Active pharmaceutical ingredients,
- 22:35which is API for short, and their powder forms of these ingredients.
- 22:38We have to audit that supplier and vet that supplier.
- 22:40So and those suppliers that we use have to be FDA registered but also FDA audited.
- 22:45So we have found a lot of peptides and just overall ingredients that
- 22:49we make through these manufacturers.
- 22:51And I think it starts there. It starts where you get your
- 22:53raw ingredients because then from there the pharmacies can compound those products
- 22:58aseptically in a sterile environment and have a finished good that is sterile.
- 23:02I think that's really important to note is is with these peptides
- 23:05or just in products in raw ingredients in general is where
- 23:08are these ingredients coming from.
- 23:09And from a 503B perspective, there's a lot of hoops,
- 23:12I would say, regulatory compliance checks that we go through to make sure that
- 23:16raw ingredients are safe to use and we do a lot of raw ingredient testing before
- 23:20using. And then I would say with these peptides specifically,
- 23:24what compounding pharmacies required to do is test for potency.
- 23:28Amongst other things, we test for assay pH colors.
- 23:30So from a 503B, you as a prescriber will feel more confident
- 23:35in your prescription because you'll know that that that finished product
- 23:38is on between ninety and a hundred and ten percent potency.
- 23:41So they're not over-injecting a highly potent product or under injecting where it's
- 23:46not effective an an a a lower potency product.
- 23:50So I think that's really relevant.
- 23:51When it comes to picking your compounder,
- 23:53503Bs, their report card is published online.
- 23:56You can go to the FDA registry and see their last audit.
- 23:58I think that's really relevant in as a prescriber or even a patient
- 24:02of where your product's coming from.
- 24:03I think that'd be really, really beneficial to know.
- 24:05Those are a few things. I mean,
- 24:06I can dive into more if you'd like,
- 24:08but I don't want to get too gr too granular.
- 24:11Yeah. No, I think that's helpful.
- 24:12I think it's helpful for people to know that they can go look at
- 24:15a public disclosure report card really on what's how the five three B is doing,
- 24:20right? And whether they're being compliant.
- 24:22I do know that compounding pharmacies not all are equal,
- 24:25right? In terms of their rigor and precision and things like that.
- 24:29And so it's very important if you're listening to this that you work with
- 24:32a pharmacy that maybe your physician's vetted or you vetted or you know,
- 24:37you've you figure out who's really
- 24:39Providing the high quality things in your area,
- 24:41~ so you can access those.
- 24:44One of the biggest things is at least from what we hear on the phone and
- 24:47we talk to patients and providers,
- 24:49is they just really don't know what to look for.
- 24:51So yes, being able to see the 503Bs,
- 24:54their report card, understanding what infractions they might have or
- 24:58not have is very important. And then just calling the pharmacy just to
- 25:03see if their staff knows, like,
- 25:05hey, we do have a quality team,
- 25:07we do do testing, we do have a pharmacist available to talk if needed
- 25:11to either providers or patients.
- 25:13I think is a big thing that a lot of people need to understand.
- 25:16If you're gonna get that product from that pharmacy,
- 25:18you should be able to talk to someone about it at that pharmacy.
- 25:21Yeah, we found it to be, you know,
- 25:23extremely helpful. I mean, we use compounding pharmacies all the time
- 25:27for various things. And I think if you're in this space of or stepping into this
- 25:32space of functional medicine or longevity medicine,
- 25:34regenerative medicine, and you're not familiar with compounding pharmacies,
- 25:37this is a very important thing for you to get familiar with because you're gonna
- 25:41want to access that to get things that you just can't get off the shelf,
- 25:45quite honestly. Absolutely. Okay,
- 25:47well, I appreciate you guys coming on.
- 25:49Were there anything else that you wanted to cover?
- 25:51For the audience.
- 25:52I don't have anything off the top of my head.
- 25:53If there's any questions or follow ups,
- 25:55you can always email us and we can answer those questions as well.
- 25:58If you are interested in Olympia pharmaceuticals or Wesley pharmaceuticals,
- 26:02we have ask the pharmacist at olympia pharmacy dot com for any dosing questions,
- 26:06product questions, anything you can think of.
- 26:09And then all of our phones ring,
- 26:11so we are very proud that we'll answer any call that comes in,
- 26:14whether sales, accounting, clinical pharmacy.
- 26:17So we'd be happy to help. And steering the right direction,
- 26:19we don't make everything.
- 26:21We have such great connections in this industry and we definitely will
- 26:23see her in the right way because at the end of the day we want to help patients
- 26:26and we definitely want to help prescribers help their patients.
- 26:29Mm-hmm. Yeah. And you're located in Orlando,
- 26:31Florida, just so everybody knows.
- 26:33So when they go by Disney World or whatever,
- 26:35they can stop
- 26:36We can see Harry Potter's castle from our office.
- 26:39it's a lot of fireworks going on.
- 26:40So
- 26:41Yeah, for sure.
- 26:42Great. Well, thanks so much for joining us.
- 26:44Really ~ I think it's been clarifying for the people listening.
- 26:47So thank you for the
- 26:49Doctor
- 26:49for having us.
- 26:50Absolutely. Thank you guys. How do we live young for a lifetime?
- 26:53How do we make 100 the new 30?
- 26:55The answers are out there, and we send them to you every episode.
- 27:00Make sure you're subscribed. Check out more episodes right here.
- 27:04And follow us on social media so you never miss a breakthrough.
- 27:08Thanks for listening.