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The Peptide Possibilities Edition | Essential: The Pharmacy Compounding Podcast · Pharmacy Podcast Network

• 0:05
  Speaker 1: You are listening to the global network of podcasters dedicated
• 0:09
  Speaker 1: to the pharmacy profession.
• 0:10
  Speaker 2: Welcome to the Pharmacy Podcast Network.
• 0:24
  Speaker 1: Welcome to Essential, the pharmacy compounding news and analysis from
• 0:28
  Speaker 1: the Alliance for Pharmacy Compounding. I'm Andrew Cantor. As usual,
• 0:32
  Speaker 1: let's start with a bit of compounding news before we
• 0:35
  Speaker 1: get to the main event. That's where we'll talk about peptides,
• 0:38
  Speaker 1: specifically the guardrails that can make them available in a
• 0:41
  Speaker 1: much safer and smarter way than the current wild west
• 0:45
  Speaker 1: of plain brown wrappers and shady websites. But first, let's
• 0:50
  Speaker 1: do some news. Federal prosecutors charged two Indian nationals with
• 0:57
  Speaker 1: conspiracy and smuggling for, allegedly, trying to bring into the
• 1:01
  Speaker 1: country counterfeit ozempic they obtained from unauthorized Chinese sources. We're
• 1:06
  Speaker 1: not talking just the drug, but packaging, inserts, labeling, needles,
• 1:09
  Speaker 1: the whole shebang. And this, ladies and gents, is actual counterfeiting.
• 1:14
  Speaker 1: It's clearly a very different animal than licensed pharmacy compounding,
• 1:19
  Speaker 1: no matter how much drug makers try to muddy those waters.
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  Speaker 1: And it also makes pretty clear that regulators have and
• 1:25
  Speaker 1: use their ability to fight counterfeiters. We are 100% behind that.
• 1:33
  Speaker 1: Some of the big issues in the compounding world that
• 1:36
  Speaker 1: we've covered here are pretty complex. And APC has just
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  Speaker 1: published a couple of pages on our website to help
• 1:42
  Speaker 1: make sense out of them and how we think regulators
• 1:45
  Speaker 1: ought to handle them. The first is peptides.
• 1:47
  Speaker 3: Yeah, that again. It's important.
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  Speaker 1: We'll talk in detail about peptide policy in a minute
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  Speaker 1: with our deep dive, but we have created a one-stop
• 1:55
  Speaker 1: shop for all the background on the issue, along with
• 1:59
  Speaker 1: our recommendations for how it should be handled and how
• 2:02
  Speaker 1: it can help keep patients safe and away from these
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  Speaker 1: shady pop-up peptide shops. You'll find this at a4pc. org slash peptides,
• 2:13
  Speaker 1: and there's a link in the show notes. The other
• 2:15
  Speaker 1: page we've launched covers animal-derived thyroid products, ADT or DTE
• 2:21
  Speaker 1: for desiccated thyroid extract. The FDA says it's a biologic
• 2:26
  Speaker 1: and thus it's off limits for compounding.
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  Speaker 3: But honestly, it's not.
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  Speaker 1: We've compiled a bunch of information on the subject, including
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  Speaker 1: what your patients can do to protect their access. Think
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  Speaker 1: of it as showing our work. You'll find it at a4pc. org
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  Speaker 1: slash DTE. And of course, there's a link in the
• 2:45
  Speaker 1: show notes. If you dispense compounded meds to California, but
• 2:51
  Speaker 1: you don't live there, you might be aware that the
• 2:54
  Speaker 1: State Board of Pharmacy is proposing raising the annual fees
• 2:58
  Speaker 1: for out-of-state compounding pharmacies and outsourcing facilities. Pharmacies would see
• 3:04
  Speaker 1: the fee jump a whopping 76% to $ 15, 000 a year,
• 3:09
  Speaker 1: while out-of-state outsourcing facilities would see an increase of 32%
• 3:12
  Speaker 1: to $ 37, 500 a year. And that is not chump change.
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  Speaker 1: It can be a real burden, especially for smaller operations.
• 3:21
  Speaker 1: APC has submitted official comments to the California board, and
• 3:26
  Speaker 1: we point out that such big increases, they can make
• 3:28
  Speaker 1: it harder for California patients to get the compounded medications
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  Speaker 1: they need. You can read that, too, with the link
• 3:35
  Speaker 1: in the show notes. And with that, it is time
• 3:40
  Speaker 1: for our deep dive. Peptides, definitely a hot topic and
• 3:44
  Speaker 1: one that's getting a lot of attention from the FDA, policymakers,
• 3:47
  Speaker 1: and obviously patients. For a while, APC has been making
• 3:51
  Speaker 1: the case that there's a middle ground, a sensible middle ground,
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  Speaker 1: between what's basically an unregulated gray market for peptides today
• 3:58
  Speaker 1: and a blanket prohibition against pharmacies compounding the substances that
• 4:03
  Speaker 1: prescribers and patients are interested in, very interested in. the
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  Speaker 1: middle ground. It's a framework of meaningful guardrails. We're talking
• 4:11
  Speaker 1: safeguards for ingredient quality and patient safety, plus regulatory oversight
• 4:17
  Speaker 1: that could allow certain peptides to be compounded responsibly by
• 4:21
  Speaker 1: licensed pharmacies. And a critical part of that is making
• 4:25
  Speaker 1: sure pharmacies can rely on the quality of the ingredients
• 4:28
  Speaker 1: they're using, especially when those ingredients are going to be
• 4:31
  Speaker 1: injected into patients. So, here to talk about APC's proposed
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  Speaker 1: approach and what it could mean if the FDA does
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  Speaker 1: decide to open a pathway for compounding peptides, we've got
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  Speaker 1: APC Board Chair Philip Smith and CEO Scott Bruner.
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  Speaker 3: Philip, Scott, welcome. Hey, Philip. Sir.
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  Speaker 2: You want to buy a peptide?
• 4:55
  Speaker 3: If I had a nickel for every time.
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  Speaker 2: Really, for all those emails that are landing in your
• 5:00
  Speaker 2: email box, yeah.
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  Speaker 3: You know, you Google enough things and this is what
• 5:03
  Speaker 3: you get.
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  Speaker 2: Absolutely, yeah.
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  Speaker 4: For about three weeks now, we've been hearing that the
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  Speaker 4: FDA or the Trump administration is just about to announce
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  Speaker 4: something on peptides. And depending on who you talk to,
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  Speaker 4: it's coming yesterday, it's coming tomorrow, it's coming next week.
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  Speaker 4: It was supposed to happen last Friday. Philip, I know
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  Speaker 4: you've been hearing some of the same things.
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  Speaker 2: What do you make of this?
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  Speaker 5: You know, these have been rumors for a long time.
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  Speaker 5: We've been hearing it really for the last year or so,
• 5:31
  Speaker 5: I would say. But I will say that they've become
• 5:34
  Speaker 5: more frequent, and I think they're coming from— more and
• 5:39
  Speaker 5: more reputable sources that where there's smoke, there's fire. I
• 5:43
  Speaker 5: do think that we're getting close to an announcement. I
• 5:47
  Speaker 5: wouldn't speculate on when this would happen, though.
• 5:51
  Speaker 4: Regardless of what they announce or how they announce it,
• 5:54
  Speaker 4: we've been making the case, APC has been making the case,
• 5:57
  Speaker 4: that there needs to be a safety framework built specifically
• 6:02
  Speaker 4: for these substances. You know, and sort of an easy question,
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  Speaker 4: but why not let pharmacies get on with compounding them
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  Speaker 4: without guardrails?
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  Speaker 5: Yeah, I mean, that is sort of the question, and
• 6:15
  Speaker 5: some people put that out there. But I think we
• 6:18
  Speaker 5: really have to recognize that there are– This is a
• 6:22
  Speaker 5: very binary discussion, right? Like you're even posing it in
• 6:25
  Speaker 5: that way. You know, do you want peptides to be allowed?
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  Speaker 5: Do you not want peptides to be allowed? Are you
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  Speaker 5: for peptides against peptides? And, you know, I think from
• 6:34
  Speaker 5: our standpoint, we believe that it's a little bit more
• 6:37
  Speaker 5: nuanced conversation than that.
• 6:41
  Speaker 3: I've been putting it as a yes, but approach.
• 6:45
  Speaker 5: You know, yes, we do think that there's a need
• 6:50
  Speaker 5: for these products to be available via compounding, right? Like
• 6:55
  Speaker 5: we do feel that this is a much better pathway
• 6:58
  Speaker 5: than what exists right now, which is outside of the
• 7:01
  Speaker 5: controls of a healthcare system that's built to protect patients.
• 7:06
  Speaker 5: And the patients are searching for it. Yes, we are
• 7:09
  Speaker 5: better than that. But we do need to look at,
• 7:13
  Speaker 5: you know, what we're calling guardrails, but, you know, really
• 7:16
  Speaker 5: it's stewardship for these products. You know, how can we
• 7:19
  Speaker 5: make these as reputable and safe as we possibly can
• 7:24
  Speaker 5: for the inpatient that's going to use that, knowing what
• 7:27
  Speaker 5: we know about this space?
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  Speaker 3: And I think that's really where this stems from.
• 7:34
  Speaker 5: Restricting regulated access doesn't eliminate access. It just eliminates regulated access.
• 7:42
  Speaker 3: Absolutely.
• 7:43
  Speaker 4: And the growth of that illicit market is an existing
• 7:47
  Speaker 4: public health threat that we've urged FDA to attend to.
• 7:52
  Speaker 2: So we call our proposal guardrails.
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  Speaker 4: We've also spoken of it, as you just have, as
• 7:57
  Speaker 4: sort of a third way, neither blanket prohibition nor unrestricted
• 8:02
  Speaker 4: compounding of these substances.
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  Speaker 2: And our aim is a.
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  Speaker 4: Responsible pathway that is only for patient-specific compounding under Section
• 8:13
  Speaker 4: 503A and that has an informed patient and also patient
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  Speaker 4: safety in mind. Our guardrails include qualified API sourcing, and
• 8:23
  Speaker 4: that's really one of the more important planks in the
• 8:27
  Speaker 4: four or five guardrails that we have proposed, an enhanced
• 8:31
  Speaker 4: patient disclosure, serious adverse events reporting, and then some limited
• 8:36
  Speaker 4: amount of utilization data reporting.
• 8:40
  Speaker 2: We have argued that.
• 8:42
  Speaker 4: FDA oversight matters, but so does state acceptance. I think
• 8:48
  Speaker 4: something that not everybody realizes is that if FDA does
• 8:53
  Speaker 4: decide for some interim period to take an enforcement discretion approach,
• 9:00
  Speaker 4: it does not bind state boards of pharmacy to go
• 9:03
  Speaker 4: along with that. Typically, if FDA announces enforcement discretion on
• 9:08
  Speaker 4: one issue or another.
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  Speaker 2: The states do go along. They give FDA the benefit
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  Speaker 2: of the doubt.
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  Speaker 4: We are concerned that if we have an announcement that
• 9:17
  Speaker 4: is unfettered compounding of these six or so peptides that
• 9:23
  Speaker 4: were recommended by PCAC to FDA, that states may not
• 9:28
  Speaker 4: be inclined to go along without some substantive guardrail.
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  Speaker 2: So, there's a lot in play here.
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  Speaker 4: We think that certainly it's going to be better to
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  Speaker 4: have states in sync with FDA rather than individual states
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  Speaker 4: creating their own enforcement regime on these things. and we
• 9:46
  Speaker 4: end up with an uneven patchwork. So all the elements
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  Speaker 4: of our guardrails, I think, matter. I've already indicated, though,
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  Speaker 4: I think one is foundational to the others, and that's
• 10:00
  Speaker 4: about the API itself.
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  Speaker 5: Yeah, but I'm really glad you pointed out, though, because
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  Speaker 5: we kind of skipped over at the beginning, that we're
• 10:09
  Speaker 5: not talking about all peptides here. You know, let's be clear,
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  Speaker 5: we're using it as a shorthand for these designated peptides
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  Speaker 5: that have been reviewed and recommended by the PCAC. But
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  Speaker 5: as Tennille will tell you, peptides are a category, they're
• 10:20
  Speaker 5: not a product. Yeah, so we're talking about this on
• 10:23
  Speaker 5: our team.
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  Speaker 3: Yeah, yeah, absolutely. So I have to say that or
• 10:26
  Speaker 3: I'll get an earful. But you're absolutely right.
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  Speaker 5: I mean, look, in the best case model, what we
• 10:32
  Speaker 5: want here, you have a licensed provider who understands the
• 10:35
  Speaker 5: evidence that exists for a And they even understand the
• 10:39
  Speaker 5: limitations of what that evidence represents. And they determine in
• 10:43
  Speaker 5: their professional judgment, this is appropriate for an individual patient.
• 10:47
  Speaker 5: That patient then understands what they're receiving and makes an
• 10:50
  Speaker 5: informed decision. with input from their provider and a conversation
• 10:55
  Speaker 5: with their provider. That prescription then goes to a licensed
• 10:58
  Speaker 5: compounding pharmacy that operates under all of the applicable pharmacy standards.
• 11:04
  Speaker 3: The active pharmaceutical.
• 11:06
  Speaker 5: Ingredient, as you mentioned, has moved through an accountable compounding
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  Speaker 5: supply chain and undergone appropriate quality controls and testing for
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  Speaker 5: the end product that's being dispensed in route of administration.
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  Speaker 5: That preparation is appropriately labeled. The patient is counseled, and
• 11:24
  Speaker 5: the patient then, even after receiving this product, they would
• 11:27
  Speaker 5: remain under the care of that licensed healthcare professional. And
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  Speaker 5: I think you and I, and hopefully everyone listening to this,
• 11:35
  Speaker 5: understands that that scenario that I just laid out is
• 11:38
  Speaker 5: fundamentally different than what exists right now. And I think
• 11:43
  Speaker 5: our guardrails, for what they're worth, are trying to get
• 11:47
  Speaker 5: as close as possible to this without impeding access for
• 11:51
  Speaker 5: the patient to obtain that medication when required by their
• 11:57
  Speaker 5: healthcare professionals.
• 11:59
  Speaker 2: Absolutely.
• 12:00
  Speaker 4: Let's talk about API quality and sourcing. You and I
• 12:06
  Speaker 4: joked at the beginning of this conversation about some of
• 12:09
  Speaker 4: the remarkably strange marketing we're seeing of peptides from entities
• 12:16
  Speaker 4: that we have no idea who they are or whether
• 12:20
  Speaker 4: the substances have been properly.
• 12:22
  Speaker 2: Vetted and all of that.
• 12:24
  Speaker 4: And we really do think, frankly, it's bad for the industry,
• 12:28
  Speaker 4: but more than that, it's bad for patients who may
• 12:31
  Speaker 4: or may not be getting a substance that is what
• 12:35
  Speaker 4: it says it is. So let's talk in particular about
• 12:41
  Speaker 4: the API. If FDA opens a pathway for these peptides,
• 12:44
  Speaker 4: demand's going to be enormous. And the basic question is,
• 12:48
  Speaker 4: where's all that API going to come from? How will
• 12:50
  Speaker 4: pharmacies know they can rely on it?
• 12:54
  Speaker 5: Yeah, I think you're right to start here because it's
• 12:57
  Speaker 5: the first point, right? Like if we're talking about quality
• 13:01
  Speaker 5: of the end product getting to these patients, you know,
• 13:04
  Speaker 5: it starts.
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  Speaker 3: With the API itself.
• 13:07
  Speaker 5: And I think we should go back then and look
• 13:09
  Speaker 5: at what Section 503A, like their requirements here.
• 13:13
  Speaker 3: You know, they look to make sure.
• 13:15
  Speaker 5: That the drug product is coming from a FDA-registered manufacturer
• 13:21
  Speaker 5: and contains a valid C of A and is appropriate
• 13:27
  Speaker 5: to be used or on their list. But looking at
• 13:30
  Speaker 5: just those two requirements, there's a lot missing and also
• 13:35
  Speaker 5: a lot that remains unsaid. You know, FDA registration, and
• 13:39
  Speaker 5: I think maybe we start there, you could assume that
• 13:42
  Speaker 5: if a manufacturer is FDA registered, that that answers sort
• 13:45
  Speaker 5: of the quality question because it's registered with the FDA,
• 13:47
  Speaker 5: but it.
• 13:47
  Speaker 2: Really, really doesn't. But we know it doesn't.
• 13:49
  Speaker 3: It does not.
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  Speaker 5: So FDA registration is absolutely the floor. Registration, all it
• 13:56
  Speaker 5: does is identifies this establishment to the FDA. It tells
• 13:59
  Speaker 5: the agency what it's manufacturing. That's pretty much it. You
• 14:04
  Speaker 5: can go online, you can register, and the next day
• 14:07
  Speaker 5: you're registered with the FDA.
• 14:08
  Speaker 3: That does not.
• 14:09
  Speaker 5: Mean the FDA has inspected that facility. It does not
• 14:13
  Speaker 5: mean that it's operating in compliance with good manufacturing practices.
• 14:17
  Speaker 5: It doesn't verify the quality of the specific material that
• 14:23
  Speaker 5: they're producing either. And we've seen this be a problem.
• 14:27
  Speaker 5: And the FDA, for their side, knows this is a problem. Like,
• 14:30
  Speaker 5: if you go back during the GLP-1 shortage and the
• 14:34
  Speaker 5: infamous FDA import alert that also created the green list,
• 14:38
  Speaker 5: which was fraught, but a good idea. You know, the
• 14:43
  Speaker 5: reason they tried to create the green list to begin
• 14:46
  Speaker 5: with is that they saw.
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  Speaker 5: A number of manufacturers who would register with the FDA,
• 14:52
  Speaker 5: sell product until they got inspected by the FDA, then
• 14:55
  Speaker 5: shut down. And they saw this over and over again.
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  Speaker 5: I think that their findings found 21%, I think, of
• 15:02
  Speaker 5: the manufacturers were not in compliance with And this sort
• 15:09
  Speaker 5: of pointed out the gap that can exist between manufactured
• 15:15
  Speaker 5: product and compounded product, because in a manufactured product, just
• 15:18
  Speaker 5: like our 503B friends will know, the validation testing and
• 15:22
  Speaker 5: everything that you have to go through would capture any,
• 15:26
  Speaker 5: hopefully capture any issue that would go on at the
• 15:29
  Speaker 5: manufacturing level before it ever reaches the patient. But without
• 15:32
  Speaker 5: that validation testing being done at the pharmacy level and
• 15:35
  Speaker 5: validating those APIs, it really creates a gap where poorly
• 15:41
  Speaker 5: made product or non-GMP, non-compliant product can ultimately end up inpatient.
• 15:47
  Speaker 5: And we can all agree that that is not what
• 15:50
  Speaker 5: we want. And so one of the ways that we
• 15:53
  Speaker 5: as an industry have built around mitigating that is through
• 15:56
  Speaker 5: the use of FDA-registered repackagers and relabelers, who assume some
• 16:00
  Speaker 5: of that You know, they will do the vendor qualification,
• 16:05
  Speaker 5: do the validation testing, verify the C of A, because
• 16:08
  Speaker 5: the other part, you know, I mentioned FDA registered manufacturers.
• 16:11
  Speaker 5: The other part of that is that it contains a
• 16:13
  Speaker 5: valid C of A. invalid, and that's where I think
• 16:20
  Speaker 5: the devil's in the details here. You need to make
• 16:23
  Speaker 5: sure that the specifications that are used are appropriate for
• 16:27
  Speaker 5: that product and the end dosage form that's being done,
• 16:30
  Speaker 5: being produced for the patient. That becomes very, very difficult
• 16:36
  Speaker 5: when we start talking about non-monograph products. It's a little
• 16:41
  Speaker 5: bit simpler when you have a monograph product. Here are
• 16:43
  Speaker 5: the standards. Here's what it looks like. Here's how you
• 16:45
  Speaker 5: would test against that. The manufacturers know to align with that.
• 16:49
  Speaker 5: It's a little bit more of a straightforward process.
• 16:51
  Speaker 3: I still say not that easy.
• 16:55
  Speaker 5: But when you have a non-monograph product, this becomes increasingly
• 16:58
  Speaker 5: more difficult.
• 16:59
  Speaker 3: Because then you have to dig further and see if the.
• 17:02
  Speaker 5: Even the specifications on the C of A are appropriate
• 17:05
  Speaker 5: for that product before you even understand whether or not
• 17:10
  Speaker 5: all of the elements within that C of A are.
• 17:12
  Speaker 5: So it becomes a very difficult question for every single
• 17:17
  Speaker 5: compounding pharmacy to have to wrestle with. And so that
• 17:21
  Speaker 5: became our recommendation here is that these particular products should
• 17:25
  Speaker 5: move through FDA-registered repackager relabelers because, as I said, it
• 17:32
  Speaker 5: sort of pushes that responsibility upstream where it can be
• 17:37
  Speaker 5: centralized with people who have that expertise in order to
• 17:40
  Speaker 5: do that testing and qualification of that material before it
• 17:43
  Speaker 5: ever reaches pharmacy level. And I would also say that
• 17:47
  Speaker 5: it provides a really important inflection point for the FDA,
• 17:51
  Speaker 5: for the agency itself, who will have to grapple with
• 17:55
  Speaker 5: the importation and the quality of all of these products.
• 17:58
  Speaker 5: And you can imagine, I don't think any of us
• 18:00
  Speaker 5: want the FDA coming into all thousands of compounding pharmacies
• 18:04
  Speaker 5: across the U.S. and digging into how we're validating that
• 18:09
  Speaker 5: C of A from that manufacturer to make sure that
• 18:11
  Speaker 5: it's appropriate for the patient.
• 18:13
  Speaker 3: So instead, we concentrate that.
• 18:16
  Speaker 5: It's much easier for the FDA to come to these
• 18:19
  Speaker 5: US-based repackager relabelers, go into their facilities, as they do
• 18:24
  Speaker 5: pretty much yearly, if not more often, and validate that
• 18:28
  Speaker 5: this is correct before it ever reaches the pharmacy.
• 18:30
  Speaker 4: Well, and I want to point out that this is
• 18:33
  Speaker 4: not some new regulatory structure.
• 18:35
  Speaker 2: That we're recommending be created.
• 18:37
  Speaker 4: These entities, repackagers and resellers, are who most compounding pharmacies,
• 18:42
  Speaker 4: the overwhelming majority of compounding pharmacies, are not ordering active
• 18:48
  Speaker 4: pharmaceutical ingredient directly from the manufacturer. They are, as a
• 18:52
  Speaker 4: matter of routine, going through these FDA-registered repackagers, resellers, who
• 18:57
  Speaker 4: are doing exactly the sort of vendor validation, validation certificate
• 19:03
  Speaker 4: of analysis, the requisite testing, and all before the pharmacy
• 19:08
  Speaker 4: ever acquires the API from that repackager or reseller. In
• 19:13
  Speaker 4: light of all the nonsense that we talked about at
• 19:15
  Speaker 4: the start of this discussion with all these entities purporting
• 19:21
  Speaker 4: to sell to pharmacies active ingredient for these peptides with
• 19:28
  Speaker 4: a certificate of analysis, et cetera, we are funneling, in
• 19:33
  Speaker 4: the interest of patient safety and API quality, We're funneling
• 19:38
  Speaker 4: these through repackagers and resellers who would be required.
• 19:42
  Speaker 2: To conduct that testing and do that validation.
• 19:45
  Speaker 4: So it's truly an extra layer of protection for patients.
• 19:50
  Speaker 2: Yes, but absolutely for the pharmacy. as well.
• 19:55
  Speaker 5: That's a really important point because ultimately it is the
• 19:59
  Speaker 5: pharmacy that's going to be responsible for the quality of
• 20:01
  Speaker 5: these products regardless. And so if I were a pharmacy,
• 20:06
  Speaker 5: I would want as many checks before I ever received
• 20:10
  Speaker 5: it to make sure that the quality of that API
• 20:12
  Speaker 5: is correct. And then you can audit your repackagers, relabelers
• 20:16
  Speaker 5: to make sure that they're operating within.
• 20:17
  Speaker 3: That as well.
• 20:19
  Speaker 5: So I think that that's a really, really important point
• 20:23
  Speaker 5: to make here. I also say that it's becoming a
• 20:26
  Speaker 5: more crowded field. You know, anytime you see this, right,
• 20:28
  Speaker 5: the peptides are in the news.
• 20:29
  Speaker 3: There's lots of news. Everyone's interested in it.
• 20:32
  Speaker 5: You have a lot of new entities that are popping
• 20:34
  Speaker 5: up that are and some of them legitimately just interested
• 20:38
  Speaker 5: in this business and want to create high quality products.
• 20:41
  Speaker 3: But there are a lot that aren't.
• 20:43
  Speaker 5: That are just interested in getting in and making as
• 20:46
  Speaker 5: much money as possible and getting out. And so it's
• 20:48
  Speaker 5: going to become a much more crowded manufacturing field that
• 20:51
  Speaker 5: becomes much more difficult for an average pharmacy to vet
• 20:54
  Speaker 5: through when all of them are telling you that this
• 20:57
  Speaker 5: is API pharmaceutical quality. But oftentimes, if you dig a
• 21:01
  Speaker 5: little bit beneath that veneer, you find that it's painted
• 21:05
  Speaker 5: gold and not necessarily gold.
• 21:07
  Speaker 2: Yeah.
• 21:08
  Speaker 4: Well, and the point for the pharmacy, if pharmacy owners
• 21:10
  Speaker 4: are listening to this, this adds no additional responsibility on
• 21:13
  Speaker 4: the pharmacy itself.
• 21:14
  Speaker 2: The overwhelming majority of them are already sourcing API through FDA-registered.
• 21:19
  Speaker 4: Repackagers and resellers who are conducting the testing and all
• 21:25
  Speaker 4: of that. A bit of a tangent, I know we
• 21:28
  Speaker 4: want to talk about our guardrails. API quality is important.
• 21:31
  Speaker 4: So is API access. What would happen if we get
• 21:35
  Speaker 4: an announcement this afternoon from FDA that immediately it's going
• 21:40
  Speaker 4: to allow pharmacies to prepare these six peptides recommended by PCAP?
• 21:46
  Speaker 5: Yeah, I mean, that is sort of the scenario.
• 21:48
  Speaker 3: We have to play out all of these scenarios.
• 21:51
  Speaker 5: And I imagine that a big announcement, you know, likely,
• 21:54
  Speaker 5: especially if it comes from the White House, it gets
• 21:56
  Speaker 5: picked up by all the press, it gets pushed out
• 21:58
  Speaker 5: there to.
• 21:59
  Speaker 3: Every patient and every.
• 22:02
  Speaker 5: Provider who are interested in this, and all of them
• 22:05
  Speaker 5: immediately go to their compounding pharmacy and.
• 22:07
  Speaker 3: Say, okay, it's ready, I want it.
• 22:09
  Speaker 5: That puts a lot of pressure on on the pharmacies
• 22:12
  Speaker 5: to be able to provide these products that right now
• 22:15
  Speaker 5: there is no FDA registered pharmaceutical quality API that can
• 22:23
  Speaker 5: be used for the route of administration that most of
• 22:25
  Speaker 5: these products are. asking to be used. It's not to
• 22:29
  Speaker 5: say that there aren't a lot of people working really
• 22:31
  Speaker 5: hard to get there really fast. But as of today,
• 22:34
  Speaker 5: you can't even register it as a pharmaceutical API.
• 22:37
  Speaker 2: What you're saying is the pharmacy can't access it right now.
• 22:40
  Speaker 2: That's the issue.
• 22:41
  Speaker 4: Patient walks in waving the prescription, the pharmacist is going
• 22:44
  Speaker 4: to have to say, I'd love to fill that prescription, Mr. Jones,
• 22:47
  Speaker 4: but I don't have access to the API required for
• 22:51
  Speaker 4: use in human drugs.
• 22:52
  Speaker 5: And the vast, vast majority of compounding pharmacies are upstanding
• 22:56
  Speaker 5: people who want to serve their patients.
• 22:58
  Speaker 3: They want to follow the rules. They want to serve
• 23:00
  Speaker 3: their patients.
• 23:01
  Speaker 5: In any industry, there are people who are more interested
• 23:05
  Speaker 5: in other things.
• 23:07
  Speaker 3: Like making money.
• 23:08
  Speaker 5: And my fear, my big, what keeps me up at
• 23:10
  Speaker 5: night is, you know, you would turn these patients away
• 23:14
  Speaker 5: and tell them, I can't get that yet. It's coming.
• 23:17
  Speaker 5: It was just announced. There are certain things that have
• 23:19
  Speaker 5: to go through. There's going to be a gap before
• 23:21
  Speaker 5: we can provide it to you. But my fear is
• 23:24
  Speaker 5: that somebody is going to be out there saying, well,
• 23:26
  Speaker 5: I can do it today. And heaven forbid that anyone
• 23:31
  Speaker 5: get hurt or injured. My biggest fear here is the
• 23:34
  Speaker 5: snapback that we see. Even when somebody is already operating
• 23:38
  Speaker 5: outside of the existing rules and regulations, when something bad occurs...
• 23:44
  Speaker 5: it snaps back too far. There's always an overcorrection. And
• 23:48
  Speaker 5: I have a huge fear of things like these peptides
• 23:50
  Speaker 5: impacting our normal patients. Because if somebody got injured, what
• 23:55
  Speaker 5: if Congress or somebody decides that sterile products need to
• 23:59
  Speaker 5: have additional restrictions in general, even though they were already
• 24:02
  Speaker 5: operating outside? So that's sort of the doomsday scenario. I
• 24:05
  Speaker 5: think you have to play both ends, right? That likely
• 24:08
  Speaker 5: will not happen. That We will be much better stewards
• 24:14
  Speaker 5: of this than maybe past transgressions or things that have happened.
• 24:18
  Speaker 3: But you have to play out the doomsday scenario.
• 24:21
  Speaker 5: But what I would love to see more is a
• 24:25
  Speaker 5: date not too far in the future that is clearly
• 24:29
  Speaker 5: indicated to the market saying this date matters. they will
• 24:34
  Speaker 5: be allowed and be available to be compounded by a patient,
• 24:39
  Speaker 5: by a prescription, by a provider following these regulations. If
• 24:43
  Speaker 5: we put it a little bit in the future, that
• 24:46
  Speaker 5: gives a clear shield for any pharmacy that's being asked, say,
• 24:50
  Speaker 5: you know what, it says January 1st, or it says
• 24:53
  Speaker 5: February 1st, it says October, whatever it is. you know,
• 24:57
  Speaker 5: that gives them that clear indication to the market it's
• 25:01
  Speaker 5: not yet ready.
• 25:02
  Speaker 4: Well, I was going to say it's also a sure
• 25:04
  Speaker 4: sign to the manufacturer that their investment in CGMP-compliant API
• 25:09
  Speaker 4: is likely to pay off. I think that's, I mean,
• 25:12
  Speaker 4: we talk about research-grade product. Research-grade product is not authorized
• 25:15
  Speaker 4: for use in human drugs. I cannot imagine an enforcement
• 25:19
  Speaker 4: discretion scenario from FDA in which they would allow compounding
• 25:23
  Speaker 4: with research-grade API of anything, peptides or otherwise. And so
• 25:29
  Speaker 4: if FDA will send that signal a point, as you say,
• 25:32
  Speaker 4: not too far in the future, then the manufacturers can
• 25:35
  Speaker 4: ramp up to CGMP compliance.
• 25:38
  Speaker 3: API.
• 25:38
  Speaker 4: I also think, and this is my opinion, you may
• 25:41
  Speaker 4: not agree, Philip, that the introduction into the space of
• 25:46
  Speaker 4: pharmaceutical-grade API, I know that's a term of art, but
• 25:49
  Speaker 4: CGM-applied API for these peptides is likely to diminish greatly
• 25:56
  Speaker 4: the amount of research-grade product that is in the market
• 25:59
  Speaker 4: right now. I mean, if pharmacies and others can source
• 26:03
  Speaker 4: the appropriate API, they're going to be much more likely
• 26:08
  Speaker 4: to use that. And I think we'll see a vast
• 26:10
  Speaker 4: reduction in some of these substances through med spas and
• 26:15
  Speaker 4: others that are supposedly research-grade product.
• 26:19
  Speaker 3: No, 100%.
• 26:20
  Speaker 5: You know, I can't imagine a scenario where compounding pharmacies
• 26:25
  Speaker 5: continue to use research grade. You know, that isn't to
• 26:28
  Speaker 5: say that the entire black market or illicit market, sorry, Scott,
• 26:32
  Speaker 5: the entire illicit markets.
• 26:35
  Speaker 3: Would immediately disappear.
• 26:37
  Speaker 5: You know, I do think that patients unfortunately follow their
• 26:40
  Speaker 5: own experience and they say, well, I've been using this,
• 26:43
  Speaker 5: it worked, I'm going to continue doing it. And that's
• 26:45
  Speaker 5: great until it doesn't. But I do think that pharmacies
• 26:49
  Speaker 5: would stop doing that. I think that as time went on,
• 26:53
  Speaker 5: that illicit market will become less and less.
• 26:56
  Speaker 3: More of a rounding error than the norm that it
• 26:59
  Speaker 3: is today.
• 27:01
  Speaker 4: So supply chain quality, absolutely important. And we've labored over
• 27:06
  Speaker 4: it here in the conversation. It's not the only piece
• 27:08
  Speaker 4: of our guardrails approach. And we ought to touch on
• 27:11
  Speaker 4: the other guardrails. And I think they're what help hold
• 27:15
  Speaker 4: the proposal together.
• 27:17
  Speaker 2: You want to run through the other planks. There are
• 27:19
  Speaker 2: four or five of them.
• 27:21
  Speaker 5: Yeah, yeah, absolutely. So I think clear communication is key here.
• 27:26
  Speaker 5: And that has to do with communicating to the patients
• 27:29
  Speaker 5: and providers that these are not FDA registered, right? I
• 27:32
  Speaker 5: think we're in favor of a labeling requirement, not on
• 27:35
  Speaker 5: the actual label per se, but in terms of like
• 27:38
  Speaker 5: an insert or something that accompanies your prescription, the package
• 27:42
  Speaker 5: insert or whatnot, that would dictate that these are not
• 27:47
  Speaker 5: an FDA approved product. And maybe even go so far
• 27:50
  Speaker 5: as saying, the active ingredients in these have not yet
• 27:55
  Speaker 5: been proven to be safe or effective for any specific
• 27:58
  Speaker 5: indication by the FDA.
• 28:01
  Speaker 3: I think that.
• 28:03
  Speaker 5: We just need to make sure that we're transparent with everyone,
• 28:05
  Speaker 5: that everyone's going into this eyes open. I think that
• 28:09
  Speaker 5: patients and providers will make their own judgments. You know,
• 28:12
  Speaker 5: that's what medical freedom is all about. But they should
• 28:15
  Speaker 5: understand both the possible benefits that are being shown, but
• 28:19
  Speaker 5: also the limitations of those.
• 28:22
  Speaker 4: Yeah, it's not an unreasonable disclosure for these particular substances,
• 28:27
  Speaker 4: I think.
• 28:30
  Speaker 3: Yeah.
• 28:30
  Speaker 5: And to go a little bit further, I would love
• 28:31
  Speaker 5: to see the FDA be the ones to develop that
• 28:33
  Speaker 5: so that it's standardized throughout. So it's not you have
• 28:39
  Speaker 5: to come up with it. And then if this doesn't happen,
• 28:42
  Speaker 5: you're going to get sued because of this, that, or
• 28:43
  Speaker 5: the other. No, it really needs to come from the agency,
• 28:46
  Speaker 5: I believe. And AAPC really wants to work with them
• 28:49
  Speaker 5: on what that would look like.
• 28:51
  Speaker 1: All right.
• 28:51
  Speaker 2: So enhanced patient disclosure, what next?
• 28:54
  Speaker 3: Let's see.
• 28:55
  Speaker 5: So we did API quality, enhanced patient disclosure. Okay, so
• 28:59
  Speaker 5: the adverse event reporting. So we believe that we should
• 29:04
  Speaker 5: be required to report serious adverse events of these products.
• 29:09
  Speaker 5: I think we've talked about this before, but the word
• 29:12
  Speaker 5: serious is very important here because, as we said, these
• 29:15
  Speaker 5: are not FDA-approved products. They don't have known side effects,
• 29:19
  Speaker 5: and therefore every effect of these could technically be considered
• 29:23
  Speaker 5: an adverse event.
• 29:25
  Speaker 2: Redness at the injection site. That's a natural event. It's
• 29:28
  Speaker 2: not a serial.
• 29:29
  Speaker 3: Nausea, redness at the injection site.
• 29:31
  Speaker 5: And if we were required to report all of those,
• 29:34
  Speaker 5: that would be a lot of.
• 29:35
  Speaker 3: Noise in the data.
• 29:37
  Speaker 2: The FDA would have to filter through.
• 29:40
  Speaker 5: It. Yeah, it would be very hard to figure out
• 29:42
  Speaker 5: what are actual adverse events versus just technical adverse events.
• 29:47
  Speaker 5: And so we're saying serious, and that's well defined by
• 29:50
  Speaker 5: the FDA. You know, serious injury, death, hospitalization, other serious
• 29:57
  Speaker 5: medical issues. So it's a definition that we are not
• 30:00
  Speaker 5: making up.
• 30:01
  Speaker 3: It exists.
• 30:03
  Speaker 5: The other side of that, though, and my big fear
• 30:05
  Speaker 5: there is that if we're reporting and required to report
• 30:08
  Speaker 5: all serious adverse events, That's only bad. That's really only
• 30:13
  Speaker 5: showing bad things. And you also just get a number
• 30:16
  Speaker 5: at the end of it. And you don't know what
• 30:18
  Speaker 5: that number means. If you have 10 serious adverse events
• 30:23
  Speaker 5: for a specific product, what does that even mean? It
• 30:27
  Speaker 5: means a lot if you dispense 50 prescriptions of that.
• 30:31
  Speaker 5: It does not mean a little bit less if you
• 30:32
  Speaker 5: dispense 100,000 and even less if you dispense 10 million
• 30:36
  Speaker 5: of these. So we need to be able to contextualize
• 30:39
  Speaker 5: that data.
• 30:41
  Speaker 2: We need a denominator.
• 30:43
  Speaker 3: Correct. Yeah, we need the denominator to the numerator.
• 30:47
  Speaker 5: And so what we propose is that we should also
• 30:51
  Speaker 5: be required to report data um de-identified uh dispensing data
• 30:58
  Speaker 5: and this would just go to the um active ingredients
• 31:02
  Speaker 5: being dispensed how many times was it dispensed over uh
• 31:05
  Speaker 5: the the designated time period what was the route of
• 31:08
  Speaker 5: administration because that changes the adverse event uh.
• 31:11
  Speaker 3: Profile but you know in in our um.
• 31:15
  Speaker 5: What we would like to see is that we work
• 31:18
  Speaker 5: through our association with the Rollins School of Public Health,
• 31:23
  Speaker 5: where we're looking already at capturing dispensing data, but being
• 31:27
  Speaker 5: able to utilize that same method to do this, where
• 31:30
  Speaker 5: you would submit all of the information that was required.
• 31:36
  Speaker 5: They would then de-identify it so that we aren't looking
• 31:39
  Speaker 5: at specific patients.
• 31:40
  Speaker 3: We're not looking at specific providers. We're not even looking
• 31:42
  Speaker 3: at specific pharmacies.
• 31:44
  Speaker 5: We would be pooling all of that together and then
• 31:46
  Speaker 5: giving it to the FDA so that they would know
• 31:49
  Speaker 5: that VPC was dispensed via injection in 10 million prescriptions
• 31:55
  Speaker 5: that quarter. But that provides important context to the conversation for.
• 32:02
  Speaker 3: The FDA that I think is lacking. You know, we
• 32:05
  Speaker 3: saw this before.
• 32:05
  Speaker 5: We saw this before with finasteride, where the FDA had
• 32:08
  Speaker 5: put out an alert about adverse events for finasteride. But
• 32:13
  Speaker 5: if you were able to contextualize that number.
• 32:19
  Speaker 3: I think most.
• 32:19
  Speaker 5: People that are listening to us today would understand that
• 32:23
  Speaker 5: it was not worthy of alert.
• 32:25
  Speaker 2: It was not a four-alarm fire by any chance.
• 32:26
  Speaker 3: It was not, yeah.
• 32:29
  Speaker 4: Well, I think sort of drawing us to a close here,
• 32:35
  Speaker 4: we need pharmacies to understand that.
• 32:38
  Speaker 2: To a certain degree, the devil's going to be in
• 32:40
  Speaker 2: the details here.
• 32:40
  Speaker 4: We're in a weird moment where we have these substances
• 32:44
  Speaker 4: that are very much in demand and We have a flourishing,
• 32:48
  Speaker 4: illicit market for them. And that's going to continue short
• 32:55
  Speaker 4: of FDA authorizing a path for these. I guess the
• 33:00
  Speaker 4: point I want to make is that we have patients
• 33:04
  Speaker 4: acquiring these right now. They don't know whether the substance
• 33:06
  Speaker 4: is what it says it is. They don't know about
• 33:08
  Speaker 4: the quality. They don't know much at all. Compounding pharmacies,
• 33:13
  Speaker 4: if allowed to prepare these substances, are not going to
• 33:16
  Speaker 4: be able, just by the nature of them being in
• 33:20
  Speaker 4: this supply chain, to make up for deficiencies that may
• 33:24
  Speaker 4: exist right now in.
• 33:26
  Speaker 2: Safety data related to these.
• 33:28
  Speaker 4: But what pharmacies can do is assure that these peptides
• 33:35
  Speaker 4: are what they say they are and are made safe.
• 33:39
  Speaker 4: to industry standards and generally safe in terms of the
• 33:45
  Speaker 4: production process and following USP 797 and all of that
• 33:49
  Speaker 4: sort of stuff.
• 33:51
  Speaker 2: And I would argue that's a much better approach to.
• 33:55
  Speaker 4: providing patients access to these substances than the illicit markets
• 33:59
  Speaker 4: that we have. The devil's going to be in the details. Again,
• 34:02
  Speaker 4: we're back to rumors of announcements. It could be that
• 34:06
  Speaker 4: the White House announces generally that they intend immediately or
• 34:10
  Speaker 4: at some point in the future to take enforcement discretion
• 34:13
  Speaker 4: related to the six peptides issue.
• 34:16
  Speaker 2: In question. They may make an announcement and say an.
• 34:19
  Speaker 4: FDA will be developing guardrails or implementing guardrails. They may
• 34:24
  Speaker 4: make an announcement that includes, yes, we're authorizing them and
• 34:27
  Speaker 4: here are the guardrails. We're sort of in wait and
• 34:31
  Speaker 4: see right now. I do think it's a good sign
• 34:33
  Speaker 4: that FDA has invited APC twice to present to its
• 34:37
  Speaker 4: team about our guardrails approach and why we think it's
• 34:41
  Speaker 4: important not only for patient safety, but for the credibility
• 34:44
  Speaker 4: of the industry to make sure that we are insisting
• 34:47
  Speaker 4: on quality, that we are insisting on an informed patient,
• 34:51
  Speaker 4: and that FDA have some sense of serious adverse events,
• 34:54
  Speaker 4: but also utilization of these peptide drugs.
• 34:59
  Speaker 2: Philip, any closing comments?
• 35:03
  Speaker 3: I think you summed it up correctly.
• 35:05
  Speaker 5: I think it's important to state that we are not
• 35:08
  Speaker 5: trying to impede patient access.
• 35:10
  Speaker 2: Absolutely not.
• 35:10
  Speaker 5: We want this to happen. We want it to be
• 35:13
  Speaker 5: available to patients. We want it to be in the
• 35:15
  Speaker 5: most responsible, high-quality way possible for the durability of this
• 35:20
  Speaker 5: within our industry. You know, it comes to us to
• 35:23
  Speaker 5: handle this appropriately, make sure that we're giving as high
• 35:27
  Speaker 5: a quality product as possible to these patients for these
• 35:30
  Speaker 5: particular products, and be responsible. We're a much more robust
• 35:36
  Speaker 5: industry than we were 10 years ago, 15 years ago,
• 35:38
  Speaker 5: 20 years ago. And one other thing that I think
• 35:41
  Speaker 5: is hugely important, I don't like to add new things in,
• 35:44
  Speaker 5: but Scott, you reminded me that the It's also very
• 35:49
  Speaker 5: important that these be high-quality products because it's very difficult
• 35:53
  Speaker 5: to learn anything meaningful about a product if you don't
• 35:56
  Speaker 5: know that all these patients are consistently receiving the same substance.
• 36:00
  Speaker 5: Right now, there are a lot of times that we're
• 36:05
  Speaker 5: extrapolating maybe adverse events, things, but we actually don't even
• 36:08
  Speaker 5: know if the quality of the product that's being received
• 36:11
  Speaker 5: by these patients is the same. And that's something that
• 36:15
  Speaker 5: we would absolutely be able to add to this conversation,
• 36:18
  Speaker 5: is making sure that these products and the data that's
• 36:21
  Speaker 5: created by them is actually usable because we know what
• 36:24
  Speaker 5: they're receiving at the end of the day.
• 36:27
  Speaker 2: Very good.
• 36:28
  Speaker 4: Well, we will see what happens sooner or later, is
• 36:34
  Speaker 4: the rumor mill going? Just rumor or is there some
• 36:38
  Speaker 4: substance there? I would suspect and pure speculation that we're
• 36:41
  Speaker 4: going to see some sort of announcement. It's just a
• 36:43
  Speaker 4: matter of what and when. Philip, enjoyed the conversation as always.
• 36:48
  Speaker 4: Hope this was useful to our listeners.
• 36:52
  Speaker 2: And Andrew, we'll turn it back over to you.
• 36:54
  Speaker 3: Thank you both.
• 36:56
  Speaker 1: I know a lot of what you talked about is
• 36:58
  Speaker 1: speculation and honestly hope, but it's a, what's the phrase,
• 37:02
  Speaker 1: a fluid situation. And there's a lot of waiting to
• 37:05
  Speaker 1: hear what the FDA has to say. Obviously, APC will
• 37:08
  Speaker 1: keep our members and you listeners up to date on
• 37:11
  Speaker 1: whatever decisions come down the pike. So stay tuned. And
• 37:15
  Speaker 1: that is all for this episode of Essential. Remember, if
• 37:19
  Speaker 1: you're a compounding pharmacist or a technician, or if you
• 37:21
  Speaker 1: prescribe compounded meds, APC is working for you and we're
• 37:25
  Speaker 1: helping your patients. We are by far the biggest and,
• 37:29
  Speaker 1: in a good way, the loudest trade association for the
• 37:31
  Speaker 1: entire compounding profession. If you're not an APC member, you
• 37:35
  Speaker 1: really ought to be. We're working for you. We'd love
• 37:38
  Speaker 1: to have you on board. Just head over to a4pc. org
• 37:43
  Speaker 1: and check us out. Brady, it is time for that
• 37:46
  Speaker 1: outro music. Thanks for listening, everyone.