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Regulating Compounding in the GLP-1 Era: A Conversatio | 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. Welcome to the Pharmacy podcast Network.
0:27
Speaker 2: Welcome back to Essential, the Pharmacy compounding podcast with the
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Speaker 2: latest news and analysis from you know it, the Alliance
0:35
Speaker 2: for Pharmacy Compounding, the voice for Pharmacy Compounding.
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Speaker 3: I'm your host, Andrew Canter.
0:41
Speaker 2: We're gonna give you a bit of pharmacy compounding news
0:44
Speaker 2: as always before we get to the main event, and
0:46
Speaker 2: that is a deep dive into how state pharmacy boards
0:50
Speaker 2: are navigating this crazy landscape of regulation.
0:54
Speaker 3: But first that news.
0:58
Speaker 2: It's the same old song from the FDA on desiccated
1:02
Speaker 2: thyroid extract DTE. The agency's latest statement was kind of
1:06
Speaker 2: like a re release of a song we've all heard before.
1:09
Speaker 2: Nothing really new. I don't know the chords have changed
1:13
Speaker 2: or something. Basically, the FDA is repeating that it now
1:18
Speaker 2: considers DT to be a biologic and thus it's not
1:22
Speaker 2: eligible for compounding. It's going to issue some guidance in
1:26
Speaker 2: August that says the same thing, and it is still wrong.
1:31
Speaker 2: The agency's own policy has always been that inactive ingredients
1:35
Speaker 2: don't determine whether a product is a biologic. Besides, the
1:39
Speaker 2: FDA is considered DTE a drug for decades, and now
1:43
Speaker 2: it's suddenly contradicting itself without a decent explanation.
1:47
Speaker 3: And it's not just US.
1:48
Speaker 2: Congressman Michael Rooley of Ohio brought this very subject up
1:52
Speaker 2: to HHS Secretary Robert F. Kennedy Junior in a recent
1:56
Speaker 2: House Energy and Commerce Committee hearing. Kennedy called it a
2:05
Speaker 2: controversy and we are totally behind that description. Something like
2:09
Speaker 2: one and a half million people could lose their thyroid
2:13
Speaker 2: therapy because they can't take synthetic drugs. And really, there's
2:17
Speaker 2: no reason for the FDA to make this change. It's
2:19
Speaker 2: definitely not science. The good news is that Kennedy said
2:23
Speaker 2: he will meet with a congressman and yes, APC will
2:26
Speaker 2: also be pushing on the issue and trying to get
2:29
Speaker 2: the FDA to act a bit more logically, and you know,
2:33
Speaker 2: keep the patients in mind.
2:34
Speaker 3: It's a crazy idea, but it just might work.
2:39
Speaker 2: So let's say you're at A five three a pharmacy
2:42
Speaker 2: and you've got a risk based audit in your future.
2:45
Speaker 3: Yeah, yeah, no fun. But some good news.
2:48
Speaker 2: The folks at the Coalition for Compounding Excellence have a
2:51
Speaker 2: new publication.
2:52
Speaker 3: Just for you.
2:53
Speaker 2: It works through every topic in that whole audit process,
2:57
Speaker 2: and then it gives you specific ways to stay ahead
3:00
Speaker 2: of exactly the kinds of issues that are likely to
3:03
Speaker 2: show up. We've got a link in the show notes
3:05
Speaker 2: to the first edition and that focuses on record keeping
3:08
Speaker 2: and quality control.
3:10
Speaker 3: And you might be.
3:10
Speaker 2: Surprised at the kind of issues that an audit is
3:13
Speaker 2: going to look for.
3:14
Speaker 3: And you know who else is going to be surprised the.
3:16
Speaker 2: People whose audits come back with potential infractions. Oh did
3:20
Speaker 2: I mention this publication? It's free, It is free. Check
3:24
Speaker 2: it out. Peptides all over the news lately. Here's what's
3:30
Speaker 2: going on. The FDA announced that it was going to
3:33
Speaker 2: remove nine peptides from Category two Oki dok from a
3:37
Speaker 2: compounding perspective, though that doesn't really mean a lot, because
3:41
Speaker 2: they still aren't eligible for compounding until they are put
3:45
Speaker 2: on the five h three A Bulks list, And even
3:48
Speaker 2: if they did get put on that list, there isn't
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Speaker 2: pharmaceutical grade API available, at least not to our knowledge,
3:54
Speaker 2: so there'd be nothing to legally compound with. Still, it
3:58
Speaker 2: is a bit of movement, and we like that. As
4:01
Speaker 2: a side note, according to NBC News, RFK Junior testified
4:05
Speaker 2: that pharmacists could now compound with peptides. It's not accurate. Actually,
4:12
Speaker 2: Kennedy made a few mistakes in his testimony, like he
4:15
Speaker 2: referred to peptides as being in category one, which they aren't.
4:20
Speaker 2: So it's a bit of a messaging mess No offense
4:22
Speaker 2: to mister Kennedy. And if you're confused, though, some good news,
4:26
Speaker 2: the folks at FDA Law Block did a pretty good
4:29
Speaker 2: job explaining it all.
4:31
Speaker 3: There's a link to that article in the show notes.
4:33
Speaker 2: The bottom line, though, at least as we're recording this,
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Speaker 2: is that peptides are still off limits for compounding.
4:40
Speaker 3: That said, the FDA does seem to be.
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Speaker 2: Moving forward towards as well, some kind of change maybe.
4:49
Speaker 2: Speaking of the FDA, it's still clarifying its glp IE
4:53
Speaker 2: policies in this post shortage era, although a lot of
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Speaker 2: its latest statement it just repeats existing guidance.
5:00
Speaker 3: But there is one interesting bit.
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Speaker 2: In talking about essentially a copy, the agency specifically named
5:08
Speaker 2: Siano Kobolaman and Semaglutide as an example of what it
5:13
Speaker 2: considers essentially a copy. What that tells us is that
5:17
Speaker 2: the FDA is definitely paying attention to specific combinations. And
5:22
Speaker 2: what's interesting about that is the agency didn't mention compounded
5:27
Speaker 2: GLP one formulations that use forms of vitamin B that
5:31
Speaker 2: aren't commercially available, So compounding those would seem to put
5:37
Speaker 2: you on firmer ground, but that's probably a question for
5:40
Speaker 2: your attorney. There's a link to the FDA's latest statement
5:44
Speaker 2: in You Guessed It the Show Notes, and with that
5:49
Speaker 2: it is time for our deep dive. So we've talked
5:58
Speaker 2: about GLP one and about peptides, and it's kind of
6:02
Speaker 2: obvious that the whole regulatory landscape is a bit hard
6:05
Speaker 2: to keep up with, and that's without mentioning.
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Speaker 3: The whole telehealth thing.
6:10
Speaker 2: If you think it's hard to keep track of, though,
6:12
Speaker 2: think of all those state boards of pharmacy and they're
6:15
Speaker 2: trying to navigate the same twists and turns.
6:18
Speaker 3: And that is why today we've got a couple of.
6:20
Speaker 2: Great guests to talk about what the heck pharmacy boards
6:23
Speaker 2: are dealing with and how they're dealing with it. Who
6:27
Speaker 2: are they, you ask, They are Al Carter, the CEO
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Speaker 2: of the National Association of Boards of Pharmacy, and Philip Smith,
6:34
Speaker 2: who is both a PC's board chair and director of
6:37
Speaker 2: Global Public Affairs at Mediska.
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Speaker 3: Gentlemen, take it away.
6:43
Speaker 4: Thank you so.
6:44
Speaker 5: Much, Al, Thanks for being with me here today and
6:47
Speaker 5: talking about these important issues for our compounders out there.
6:50
Speaker 6: Sure thanks for having me so first of all, at
6:54
Speaker 6: our high level.
6:55
Speaker 5: How are boards of pharmacy thinking about compounded gop ones
6:59
Speaker 5: right now?
7:00
Speaker 4: I will tell you this.
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Speaker 7: It is on the minds of every single board of
7:06
Speaker 7: pharmacy in the United States. It is really dominated board discussions, uh,
7:12
Speaker 7: in a way that just really we haven't seen with
7:16
Speaker 7: a single compounding category in in my recent memory, and
7:21
Speaker 7: it's nearly on every board of pharmacy agenda. We've seen
7:25
Speaker 7: increased board appearances and I probably say and a significant
7:30
Speaker 7: increase in enforcement actions related to misbranding, obtaining APIs from
7:35
Speaker 7: unsafe sources. You know, boards are really identifying serious compliance
7:41
Speaker 7: failures at scale. And then you throw in the met
7:44
Speaker 7: spot channel, which is just adding another level, another layer
7:48
Speaker 7: of complexity that really sits at the edge of traditional
7:53
Speaker 7: pharmacy oversight, and and it's you know, it's it's really noteworthy.
7:58
Speaker 7: The FDA's April first memo, which I'm sure Philip. You
8:02
Speaker 7: guys have seen with the shortage designations for both semic
8:06
Speaker 7: glue tide inters eppetide that are resolved, and how that
8:10
Speaker 7: changes the legal ground really compounders.
8:13
Speaker 4: Are standing on.
8:15
Speaker 7: Some states have taken strong action, others are watching, you know,
8:20
Speaker 7: for more direct federal enforcement before committing you know, their
8:24
Speaker 7: limited resources to it. But really, when we look at
8:28
Speaker 7: it from the standpoint of regulation, regulating five or three
8:32
Speaker 7: a's is really a state responsibility. And what we've been
8:36
Speaker 7: trying to do is just equip you know, our MVP
8:41
Speaker 7: members with you know, information, tools and resources to be
8:46
Speaker 7: able to carry out the the you know, governance and
8:51
Speaker 7: regulation of that space.
8:53
Speaker 6: And that makes a lot of sense.
8:55
Speaker 5: And you're absolutely right with the state boards of pharmacy
8:57
Speaker 5: regulating the five O three A compounding. I can definitely
9:00
Speaker 5: see where you start to get variability among the states
9:04
Speaker 5: where some are doing waiting for the federal government to
9:06
Speaker 5: take the leads, some are taken into their own hands.
9:09
Speaker 5: Do you see what are some of the bigger differences
9:11
Speaker 5: that you see right now between states in terms of variability, you.
9:16
Speaker 7: Know, and I kind of mentioned it, It's like you
9:19
Speaker 7: have some states that are waiting on or looking for
9:24
Speaker 7: guidance from the FDA and federal agencies because a lot
9:28
Speaker 7: of what you're seeing is really in that five or
9:31
Speaker 7: three P space and doing more bulk compounding of some
9:38
Speaker 7: of these products that aren't that aren't really legal. I
9:46
Speaker 7: won't say aren't really they aren't legal, especially with the
9:49
Speaker 7: guidance from the FDA. And so you know, you have
9:52
Speaker 7: a lot of boards that are waiting to crack down
9:54
Speaker 7: on that because or waiting for a federal government to
9:57
Speaker 7: crack down on it because they don't have any regulatory authority.
9:59
Speaker 7: And that's and so that's one challenge, that's one difference
10:02
Speaker 7: that we're seeing. You have other states that are are
10:06
Speaker 7: trying to take further action. I mean, if you look
10:09
Speaker 7: at and I and I read a PC's you know,
10:12
Speaker 7: threads every week of how many states are trying to
10:15
Speaker 7: do take legislative action in this space. And so you
10:17
Speaker 7: see states trying to take that opposed to give boards
10:21
Speaker 7: more access, more authority over it. I think where we
10:25
Speaker 7: see some differences is or most of the differences is
10:28
Speaker 7: when it comes to met spots and you know, in
10:32
Speaker 7: most cases boards of pharmacy don't have any type of
10:35
Speaker 7: regulatory authority over met spots, but we're seeing states start
10:39
Speaker 7: to take more action in that space because you're you're
10:42
Speaker 7: true five H three A compounders that are licensed in
10:46
Speaker 7: the States. They're legitimate, they're doing the right thing. They're
10:50
Speaker 7: they're you know, providing a medication and providing medications uh
10:55
Speaker 7: to patients in a way that they should be and
10:58
Speaker 7: has always been a case. It's really where these bad
11:01
Speaker 7: actors that see that there's a money grab or whatever
11:04
Speaker 7: the case may be, that are oblivious to the Board
11:08
Speaker 7: of Pharmacy, you know, like I'm just trying to enter
11:10
Speaker 7: the space and they're doing so through the five H
11:13
Speaker 7: three B routes or through some other illegal routes, uh,
11:17
Speaker 7: you know, considering met spots or whatever the case may be.
11:21
Speaker 7: And that's where the huge challenge is. And so that's
11:23
Speaker 7: where you know, it's it's it's very interesting to see
11:27
Speaker 7: how wards are handling us because some boards have more
11:29
Speaker 7: authority than others.
11:31
Speaker 5: Yeah, you mentioned the med spas and n BP has
11:34
Speaker 5: model regulation now right regarding medspas that they're looking because
11:38
Speaker 5: met spas fall in that that sort of new BIA
11:42
Speaker 5: in between category, right between boards of pharmacy and medical
11:46
Speaker 5: You want to talk a little bit about that.
11:48
Speaker 4: Yeah, we we have drafted some.
11:51
Speaker 7: Model language, shall we say, uh, for METSPAS and for
11:54
Speaker 7: regulation and metspos really and it's really not regulation met spots.
11:59
Speaker 7: It's it's basically given board some model language to help
12:04
Speaker 7: with inspecting METS BOSS and especially those that are our
12:10
Speaker 7: compounding you know, on site or or whatever the case
12:13
Speaker 7: may be, to give them, you know, the the model
12:18
Speaker 7: language is to give them the authority to go in
12:21
Speaker 7: to inspect those facilities. And so those states have used
12:25
Speaker 7: that model language to either do rules or to do legislation.
12:30
Speaker 4: Uh.
12:31
Speaker 7: It's it's more guidance that we're coming out with a
12:33
Speaker 7: more full model language that will go into our n
12:38
Speaker 7: VP Model Act, and that'll be after our annual meeting
12:42
Speaker 7: in in the next couple of weeks in Boston that
12:45
Speaker 7: that we'll have that and we should publish that because
12:48
Speaker 7: it has to go through the full membership for approval.
12:50
Speaker 7: But that's something that we're looking at. Ohio, UH State
12:54
Speaker 7: Board of Pharmacy has authority to inspect, you know, metspas
13:02
Speaker 7: and inspect any any facility that to doing any type
13:05
Speaker 7: of compounding. And so it's it's really kind of taken
13:08
Speaker 7: some of that language to give more of a guidance
13:14
Speaker 7: to other states. I want to go in a similar path.
13:17
Speaker 6: Nice my state of Ohio.
13:18
Speaker 5: Shout out to the Ohio Board of Pharmacy. So you
13:23
Speaker 5: mentioned the the MEDSPA piece, but then you also mentioned
13:26
Speaker 5: sort of the larger pharmacies or you know, the five
13:29
Speaker 5: oh three bs, the the scale and I guess my
13:34
Speaker 5: last follow up here is just do you get the
13:36
Speaker 5: sense that the GLP one conversation that boards of pharmacy
13:41
Speaker 5: are dealing with is it specific the GLP ones or
13:45
Speaker 5: is it more about what this has become in terms
13:49
Speaker 5: of scale. I guess in terms of the scale at
13:53
Speaker 5: which this is happening.
13:54
Speaker 7: I think it's a little bit of both. I really,
13:59
Speaker 7: you know, and it's really interesting. And I'm going to
14:01
Speaker 7: go back to the met spot because the METS spot
14:05
Speaker 7: channel is is where there is a growing enforcement challenge,
14:12
Speaker 7: and and that's where there is a need for legislation
14:16
Speaker 7: to address and address clearly, you know. And so because
14:21
Speaker 7: you see what you see, as you see really compounded
14:24
Speaker 7: GLP ones moving through the met spots and similar settings
14:27
Speaker 7: at significant volumes, especially in many states, and and and
14:32
Speaker 7: boards don't have clear statutory authority to inspect and enforce
14:37
Speaker 7: in those environments. And that's a patient safety gap and
14:41
Speaker 7: that you know, that's what deserves a lot of attention.
14:45
Speaker 7: And so you know, right now it's glp ones. I
14:48
Speaker 7: think what's even more scary or scarier, so I say,
14:52
Speaker 7: is that now you have peptides that will be are
14:55
Speaker 7: being discussed and and for the longest time, even before
14:59
Speaker 7: the action in UH or notice that was taken this
15:02
Speaker 7: week with the f d A f D A UH
15:04
Speaker 7: and the previous announcements from HHS, you have peptides that
15:10
Speaker 7: have been dispensed illegally and you know they're dispensed at
15:16
Speaker 7: nutritional wellness shops or whatever the case may be. And
15:19
Speaker 7: these are vials of product that you know that are
15:24
Speaker 7: being sold to individuals and and they're injected into their body.
15:28
Speaker 7: They don't like, there's no safety measures on that, and
15:32
Speaker 7: so like that's a completely different space that at least
15:35
Speaker 7: with the gop ones there's monographs, you know, there's there's
15:38
Speaker 7: there's safety efficacy. So like you you have something to
15:41
Speaker 7: go off of, peptides, you have nothing to go off of,
15:44
Speaker 7: which is going to create another you know, whirlwind and
15:48
Speaker 7: storm that are going to be challenging for for for boards,
15:53
Speaker 7: but also going to be challenging for those compounding pharmacies
15:56
Speaker 7: that are doing it right, because you know, it's it's
15:59
Speaker 7: it's challenging because many times they're all uped into one
16:02
Speaker 7: and that's not fair. There are a lot of great
16:05
Speaker 7: compounding pharmacies that are out there, and you know, I
16:09
Speaker 7: can preach about one for my own kids. So that's
16:12
Speaker 7: a challenge that's going to be at play for regulators
16:16
Speaker 7: moving forward.
16:18
Speaker 6: I think you're absolutely right.
16:19
Speaker 5: I think closing these gaps in the regulatory authority is
16:23
Speaker 5: going to be increasingly important as we move into the
16:27
Speaker 5: more broad peptide era, if that is what's going to happen.
16:31
Speaker 5: And I think you're also right that we don't have
16:34
Speaker 5: to look back in history too far to see that
16:36
Speaker 5: single bad actors greatly influence an industry and paint an
16:40
Speaker 5: entire industry in a certain way. So the more we
16:44
Speaker 5: can avoid that, the more guardrails we can set up
16:46
Speaker 5: to further legitimize the space and patient safety at the forefront.
16:53
Speaker 5: I think is absolutely true. And the scale sort of
16:56
Speaker 5: turns us to the other piece of this, just telehealth,
17:00
Speaker 5: and I think this also dovetails into the broader peptide
17:04
Speaker 5: conversation as we go. I mean, telehealth's really changed how
17:08
Speaker 5: patients access medicine in general, but certainly that's true for
17:11
Speaker 5: compounded therapies. And what are the boards still trying to
17:15
Speaker 5: figure out in terms of that model, especially when you
17:18
Speaker 5: see it where prescribing platforms and dispensing all are interconnected.
17:25
Speaker 4: Yeah.
17:25
Speaker 7: Well, I'd say first that the practice of pharmacy and
17:30
Speaker 7: the practice of medicine is going to look different as
17:35
Speaker 7: these modalities have changed and continue to change. But the
17:40
Speaker 7: practice of pharmacy in itself hasn't changed. Pharmacy is still
17:46
Speaker 7: required to ensure that you know, there's a legitimate patient
17:49
Speaker 7: prescribed relationship. They still must ensure that each prescription receives
17:54
Speaker 7: both value and legal and you know there there is
17:59
Speaker 7: that pharmacist pay relationship, and and you know now they're
18:03
Speaker 7: going to have to have this robust profile with tele
18:05
Speaker 7: telehealth telepharmacy going into space. I think the challenge that
18:09
Speaker 7: we're going to see from from a regulator standpoint is
18:13
Speaker 7: when you have a single pharmacy or telehealth or whatever
18:17
Speaker 7: that is dispensing or compounding GLP ones at a massive
18:22
Speaker 7: scale through this telehealth funnel boards have to ask, you know,
18:28
Speaker 7: whether what has happened is genuinely patient specific compounding.
18:34
Speaker 4: Or are they behaving more like a five or three B.
18:38
Speaker 7: Under you know, a pharmacy license or what have you.
18:42
Speaker 7: And as you know, and we all know the Fiber
18:46
Speaker 7: three A framework, it was built for individualized care and
18:51
Speaker 7: so high volume standardized compounding kind of not kind of
18:56
Speaker 7: but you know, strange that premise considerably.
19:00
Speaker 2: And so.
19:01
Speaker 7: These models can make it difficult to understand who is
19:05
Speaker 7: ultimately driving the prescribing of the gp ones and making
19:08
Speaker 7: the determination that you know, a compound of drug product
19:11
Speaker 7: is necessary to meet the clinical needs of the patient.
19:14
Speaker 7: And that's where there's going to be a struggle in
19:17
Speaker 7: a telehealth environment, or has been and will continue to be.
19:21
Speaker 5: Yeah, because I think you're absolutely right, because it becomes
19:24
Speaker 5: where do you draw that line? Because at the end
19:27
Speaker 5: of the day, if five oh through one has specific
19:29
Speaker 5: rules that they follow and despite the scale, they still
19:32
Speaker 5: follow those rules. You know, it is by a provider,
19:36
Speaker 5: it is for an individual patient pursuant to a prescription.
19:40
Speaker 6: So you don't want to.
19:43
Speaker 5: Punish a pharmacy for success for scaling that and meeting
19:47
Speaker 5: the individual needs. Of more patients. But to your point,
19:52
Speaker 5: the five O three B model is different. It is
19:55
Speaker 5: not pursuant to a prescription. They have more authority, but
19:59
Speaker 5: they're tighter regulated because they affect more individual patients. So
20:04
Speaker 5: you know, from I imagine from your perspective and from
20:08
Speaker 5: a enforcement and regulatory side, you look at that and
20:12
Speaker 5: you see, if you affect more patients, we need to
20:15
Speaker 5: inspect you more often, or we need to make sure
20:18
Speaker 5: that things are safe in that facility. Is that a
20:22
Speaker 5: fair way that boards would be looking at it?
20:24
Speaker 4: Yeah?
20:25
Speaker 7: I think what you've said, you know, Philip, is very
20:29
Speaker 7: accurate as to the approach the board's going to take.
20:33
Speaker 6: And is there.
20:36
Speaker 5: I guess part of me wonders if it's not a
20:38
Speaker 5: concern about, not necessarily the technology itself. I think meeting
20:41
Speaker 5: people where they are and having convenience, especially in this
20:45
Speaker 5: time where we're losing so many pharmacies, is important for
20:48
Speaker 5: patient care. But I imagine, is it more how quickly
20:53
Speaker 5: this model has appeared and scaled before we had frameworks
20:59
Speaker 5: at the pharmacy level to adapt to it.
21:02
Speaker 7: No, because you know, this model has been here for
21:05
Speaker 7: a couple of years now. I mean it's been here
21:07
Speaker 7: before there was a shortage of GP ones and there
21:13
Speaker 7: were ways to handle it, and it's not going to
21:15
Speaker 7: go away. I think the concern here now is that
21:21
Speaker 7: you have some of these let's say, bad actors that
21:26
Speaker 7: are hiding behind the telehealth or hiding in the telehealth channel,
21:32
Speaker 7: and that's where there's a concern because you can't really
21:35
Speaker 7: you know, you can't really determine based off of telehealth
21:39
Speaker 7: rules that true patient prescriber relationship as it pertains to
21:43
Speaker 7: compounding and individualized care to say, all right, you know
21:48
Speaker 7: this pharmacy is compounding two hundred and fifty thousand units
21:53
Speaker 7: of this, but is it truly a patient specific you know,
22:02
Speaker 7: prescription that they're doing us for or is there a
22:05
Speaker 7: doctor who is pushing a prescriber not necessarily doctor prescriber,
22:10
Speaker 7: who is pushing a specific product to justice pharmacy through
22:14
Speaker 7: some other type of network or or contract or what
22:19
Speaker 7: a case may be, that's leading to this, And that's
22:22
Speaker 7: where it's like, that's illegal, and so that's where it's
22:27
Speaker 7: harder to monitor that and to regulate that in this
22:31
Speaker 7: space compared to you know, your your your compounding, you
22:36
Speaker 7: know your true your true corner compounding store or facility.
22:42
Speaker 7: That's that's doing things correctly, and that's you know, you
22:44
Speaker 7: can regulate it, can go in and touch and and
22:47
Speaker 7: talk to and be educated on the process and in
22:50
Speaker 7: their patient base and everything else.
22:52
Speaker 5: Yeah, and I think it does get kind of muddy
22:56
Speaker 5: because there is sort of a I don't know if
23:00
Speaker 5: i'd call it a history per se, but you know
23:02
Speaker 5: you have had you know, mail order pharmacies for instance,
23:06
Speaker 5: that you know, the insurances sort of shuffle people toward
23:09
Speaker 5: an individual pharmacy, but the doctors can't. It gets into
23:12
Speaker 5: a muddy area when you start getting into what's the
23:18
Speaker 5: term leading no, but sending prescriptions to a specific pharmacy
23:24
Speaker 5: instead of having it available to any pharmacy to produce.
23:28
Speaker 4: Right.
23:29
Speaker 5: So, looking into that, I assume would be a very
23:31
Speaker 5: difficult task for boards of pharmacy, and it is, and
23:35
Speaker 5: it sort of leads to my next question, are are
23:37
Speaker 5: these boards equipped for the speed and the scale of
23:41
Speaker 5: this new compounding environment you mentioned medspas for instance, you.
23:45
Speaker 6: Know, are they equipped to they have.
23:47
Speaker 5: What they need in order to inspect these these med
23:50
Speaker 5: spas as well as the pharmacies as well as the
23:53
Speaker 5: compounding pharmacies.
23:54
Speaker 7: Yeah, and one of the things that naturally occurs is
23:59
Speaker 7: is boards are going to follow the risk and so
24:03
Speaker 7: you know, so there there's always that rational response, UH
24:07
Speaker 7: to limited resources. But I think there's challenges that come
24:11
Speaker 7: in place.
24:12
Speaker 4: And so.
24:14
Speaker 7: Without mandatory you know, adverse reporting, without significant you know,
24:19
Speaker 7: without any other acknowledgement of activity going on, you know,
24:25
Speaker 7: significant risks accumulate and can accumulate before boards have enough
24:29
Speaker 7: information or have the information they need to respond. And
24:32
Speaker 7: so that's the challenges is you know, it's not necessarily
24:36
Speaker 7: that it's ramping up, because it is and we know
24:40
Speaker 7: that you know, the volume of inspections will likely need
24:43
Speaker 7: to increase or will increase as new entities join this
24:46
Speaker 7: community to bring more to ocs to patients and what
24:48
Speaker 7: have you and it, and they're still going to focus.
24:51
Speaker 7: The boards are still going to focus on their mission
24:54
Speaker 7: to protect public health. But the gap happens when you
24:59
Speaker 7: know you have the significant increase and you find out
25:03
Speaker 7: three months later that you know, a batch of compounding
25:08
Speaker 7: products impacted a patient because there isn't any real time
25:13
Speaker 7: adverse reporting and so you don't really so you don't
25:18
Speaker 7: really find out real time that there is an issue.
25:21
Speaker 7: You find out later on down the road and by
25:23
Speaker 7: that time, you know that huge gap has started. And
25:27
Speaker 7: that's when your problem starts, when a board actually really
25:30
Speaker 7: learns of the window when patients are starting to hurt.
25:34
Speaker 7: And I think, you know, the the lack of having
25:39
Speaker 7: and Scott, this is something that Scott and I have
25:41
Speaker 7: talked about numerous times, and I think a PC is
25:45
Speaker 7: supportive of this. Is you know, that lack of adverse
25:49
Speaker 7: you know, event reporting for Calmtown products is one of
25:52
Speaker 7: the most significant gaps that you know occur in a
25:55
Speaker 7: current system. And and you know, at the volumes that
25:59
Speaker 7: we're seeing gop ones and and sue to be seeing
26:04
Speaker 7: with peptides, the absence of data is.
26:09
Speaker 4: A serious patient safety concern.
26:11
Speaker 7: And then you know, and you bring in peptides and
26:15
Speaker 7: it becomes even a greater patient concern.
26:17
Speaker 6: And I don't know how we solve that now unless we.
26:22
Speaker 7: Go down the path of some type of reporting adverse events.
26:26
Speaker 7: And it's not you know, it's not to penalize people
26:30
Speaker 7: for it, but it's more just culture. It's more to
26:34
Speaker 7: become aware and so that we can learn from this
26:37
Speaker 7: and that you know, confounds can learn from this and
26:39
Speaker 7: and change it. Because I think you mentioned at the
26:42
Speaker 7: beginning of our discussion here is like, you know, there's
26:46
Speaker 7: one event that everybody remembers from you know, fourteen years ago,
26:49
Speaker 7: fifteen years ago. We don't want that event to happen again,
26:53
Speaker 7: and so boards of pharmacy know that there. You know,
26:58
Speaker 7: their responsibility is to public health, and the increase of
27:03
Speaker 7: this with the lack of reporting, kind of increases at
27:08
Speaker 7: risk in some aspects.
27:10
Speaker 4: To be able to do.
27:11
Speaker 5: That great points aal you mentioned adverse event reporting.
27:14
Speaker 6: You're absolutely right.
27:16
Speaker 5: APC has put together in the past a model to
27:22
Speaker 5: replace the MoU where we're looking at reporting serious adverse events,
27:27
Speaker 5: and I do think that that's important for public health because,
27:29
Speaker 5: as you mentioned, no one wants to harm patients, especially
27:33
Speaker 5: not on the scale of what has happened in the past.
27:37
Speaker 6: And I think a lot's changed since then. I think
27:40
Speaker 6: it's much.
27:40
Speaker 5: Less of a risk than it was back then from
27:44
Speaker 5: the pharmacies that I've seen, but the risk is never zero.
27:48
Speaker 5: And you mentioned too, something that I wanted to touch on.
27:51
Speaker 5: You mentioned that you don't know that there's a bad
27:54
Speaker 5: batch until it's already out in the field, and I
27:56
Speaker 5: would argue that the same is true of finished drug products.
28:00
Speaker 4: Too.
28:01
Speaker 5: The scale is certainly different, but you never really know
28:04
Speaker 5: until there is an adverse events. You can have all
28:06
Speaker 5: the controls in the world, but you don't know. Luckily,
28:09
Speaker 5: with compounding, especially with five to three A, with the
28:12
Speaker 5: limited batch sizes of these injectable products, it's a much
28:14
Speaker 5: smaller pool of those that would be harmed. But you
28:20
Speaker 5: don't want any adverse events if you can help it.
28:23
Speaker 7: That's correct, and you do have you know, there is
28:26
Speaker 7: adverse event reporting to the FDA for finished products, you know,
28:32
Speaker 7: so there is a process in a stream to communicate
28:35
Speaker 7: that so that FDA can work with manufacturers for recalls
28:38
Speaker 7: whatevery case may be. And you know, I think what
28:43
Speaker 7: you're saying, what we agree to as well, is that
28:46
Speaker 7: there needs to be some type of, like you said,
28:48
Speaker 7: serious events adverse event reporting for compounded products as well
28:53
Speaker 7: to to kind of follow in line with that as well.
28:58
Speaker 4: Yeah.
28:58
Speaker 5: Absolutely, So where do you feel like the boards have
29:01
Speaker 5: sort of, uh, the biggest gap?
29:03
Speaker 6: Is it the data that we're talking about right now?
29:06
Speaker 5: Is it their resources in order to engage or is
29:10
Speaker 5: it the authority like we mentioned with medspas and and
29:14
Speaker 5: what's the biggest gap right now?
29:16
Speaker 4: For see I think I think it's twofold uh is.
29:22
Speaker 7: I don't think it's resources because they have you know,
29:25
Speaker 7: most boards have resources. We assist them with resources as
29:29
Speaker 7: well to aid and do an inspection and what have you.
29:33
Speaker 7: Data is always key. Not having enough of it does
29:37
Speaker 7: not help. And and being able to regulate uh. And
29:42
Speaker 7: so I think that's a gap. I think also authority
29:45
Speaker 7: you know over met spas and some of these other
29:48
Speaker 7: you know, uh, facilities or entities that are doing compounding
29:53
Speaker 7: and and and within the borders or within the confinements
29:57
Speaker 7: of their state is another issue because most state boards
30:02
Speaker 7: don't have authority to inspect some of these practices. And and
30:08
Speaker 7: that's a safety that's a public safety concern. And that's
30:11
Speaker 7: a huge gap. And hopefully, you know, over the course
30:14
Speaker 7: of the next next you know, year or a couple
30:18
Speaker 7: of years that you know, they'll be granted regulatory authority
30:22
Speaker 7: through new laws or whatever the case may be. But
30:24
Speaker 7: that is a gap in many states.
30:28
Speaker 6: That makes sense.
30:29
Speaker 5: So what does good board enforcement look like now today?
30:32
Speaker 5: In a moment like this, how do you focus, like
30:34
Speaker 5: you said, on the risk, the real risk, without sweeping
30:37
Speaker 5: in and overcorrecting for compliant pharmacies and into impacting patient
30:43
Speaker 5: care negatively in order to stop these bad actors.
30:48
Speaker 7: Yeah, I think I think good board enforcement is is
30:51
Speaker 7: consistency interpretation in the interpretation of the regulations. And I
30:56
Speaker 7: think it's also continuously bringing education to their licenses. If
31:02
Speaker 7: you you know, if if you're following USB seven ninety seven, UH,
31:07
Speaker 7: maintaining robust quality systems, sourcing API from legitimate suppliers, and
31:12
Speaker 7: compounding based on documented patient prescriber or patient specific need,
31:20
Speaker 7: I think a board inspection shouldn't concern anyone. And that
31:25
Speaker 7: is exactly what the you know, regulatory framework is designed
31:30
Speaker 7: to is designed to do to protect and preserve And
31:34
Speaker 7: I think the scrutiny that is coming is aim squarely
31:39
Speaker 7: at those operations that are cutting corners on sterility standards,
31:43
Speaker 7: operating at volumes that strain any reasonable definition of patient
31:48
Speaker 7: specific compounding or sourcing API without proper verification.
31:54
Speaker 4: And so, you know, as I look.
31:55
Speaker 7: At this, and if I'm if I'm telling a compounding
31:58
Speaker 7: pharmacist leader or leadership team, you know, I would encourage
32:04
Speaker 7: them to really you know, and compounding in any state
32:09
Speaker 7: to start continue having positive engagement with their boards, be
32:15
Speaker 7: open to having new inspectors come into your pharmacy and
32:18
Speaker 7: show them what a compliant compounding you know, pharmacy looks
32:22
Speaker 7: like it's kind of like you're doing a show and tell, like, Hey,
32:24
Speaker 7: this is what we're doing, and we're doing it very well.
32:27
Speaker 7: And you know, I've been I've had several pharmacies, compounding
32:32
Speaker 7: pharmacies open up their doors and I'm thoroughly impressed when
32:35
Speaker 7: I walk in there to know first the amount of
32:39
Speaker 7: money they've invested in the facility, the high level of
32:43
Speaker 7: quality and scrutiny that they place on their operations and processes,
32:48
Speaker 7: and just see the pure environment of the commitment that
32:51
Speaker 7: they have to making sure that they have the right product.
32:56
Speaker 7: That they've spent a lot of time and research making
32:59
Speaker 7: sure that product is right before it goes out uh
33:03
Speaker 7: to and it's dispensed to any patient. I think the
33:07
Speaker 7: other thing, you know, as we talk about what you know,
33:12
Speaker 7: that what is board enforcement that's good? Look like I
33:16
Speaker 7: think offering to be subject matter experts uh for boards,
33:20
Speaker 7: so when there is a bad actor, uh, the board
33:23
Speaker 7: members can hear directly, you know, from a compounding pharmacy
33:26
Speaker 7: that's doing you right, attending board meetings and being president there.
33:30
Speaker 7: I think it is just as important for boards of
33:33
Speaker 7: pharmacy to hear from you know, pharmacies that excel in
33:37
Speaker 7: their community and communities and may and making sure that
33:40
Speaker 7: they're taking care of their patients and taking great care
33:43
Speaker 7: of their patients, just as it is, you know, finding
33:47
Speaker 7: the bad actors that you know aren't following the the
33:51
Speaker 7: regulations or what have you. And so I think being
33:54
Speaker 7: involved in being engaged with the board, being you know,
33:57
Speaker 7: open to educating and then also to inspections and what
34:02
Speaker 7: have you. I think that's what that perfect environment looks like.
34:06
Speaker 7: And you know, because at the end of the day,
34:09
Speaker 7: boards of pharmacy are not there to have a gatcha moment.
34:12
Speaker 7: They're they're there to protect and protect public health and
34:17
Speaker 7: preserve public health. And most of the times that first
34:22
Speaker 7: interaction with the board of pharmacy is more of an
34:25
Speaker 7: education and it may be education on both sides, but
34:28
Speaker 7: it isn't like I'm going in here and I want
34:30
Speaker 7: to make sure I find ten things wrong so that
34:34
Speaker 7: I can find, you know, five thousand dollars the where
34:37
Speaker 7: the case. Maybe that's that's not how boards of pharmacy act.
34:41
Speaker 7: And so understanding that and being engaged and proactive and
34:45
Speaker 7: working with them I think, you know, prepares a good
34:50
Speaker 7: regulatory environment for everyone.
34:52
Speaker 6: Yeah. Wow, you hit on some really good things there.
34:56
Speaker 5: I think being engaged is so important, and I know
34:58
Speaker 5: our pharmacies here this whole the time. Be engaged nationally,
35:02
Speaker 5: be engaged at your state level with your political figures,
35:07
Speaker 5: but also at your board of pharmacy level, because I
35:10
Speaker 5: imagine at a board of pharmacy, the majority of times
35:13
Speaker 5: that you see pharmacies it's for negative reasons.
35:17
Speaker 6: It's for you know.
35:18
Speaker 5: They're being brought for a warning or something that went wrong,
35:22
Speaker 5: or somebody may have been harmed, and I can imagine
35:25
Speaker 5: that would start to skew your.
35:27
Speaker 6: Vision of what this industry is or what these people are.
35:30
Speaker 5: And so being able to see and communicate regularly with
35:33
Speaker 5: people that are helping individual patients every day, who keep
35:37
Speaker 5: up with the latest regulations, make sure that they have
35:40
Speaker 5: the best technology that they're doing this for their patients
35:44
Speaker 5: would be incredibly helpful, even just from a human side
35:49
Speaker 5: of keeping them aware that there's a lot of good
35:52
Speaker 5: happening in patient care today. So that's such a good point.
35:57
Speaker 4: Yeah, completely agree.
35:59
Speaker 6: Clear, And then the other thing that you mentioned.
36:04
Speaker 5: When boards of pharmacy inspect You know, we all sort
36:07
Speaker 5: of have this scary oh my gosh, the board's here.
36:09
Speaker 6: It's a negative thing.
36:10
Speaker 5: But ideally it is more communicating, it is more here,
36:14
Speaker 5: let me show you. Is there a better way for
36:16
Speaker 5: me to be doing this, because if there is, I
36:18
Speaker 5: would love to improve my workflow. I would love to
36:21
Speaker 5: improve my patient's safety at the end of the day
36:24
Speaker 5: for these products, my consistency, and if there are things
36:27
Speaker 5: that I could be doing to do that, you know,
36:29
Speaker 5: I would welcome that.
36:31
Speaker 6: So ideally you have that now.
36:32
Speaker 5: I hear so many stories of pharmacies that do educate
36:35
Speaker 5: their inspectors.
36:37
Speaker 6: Their inspectors come and they say, hey.
36:38
Speaker 5: Here, let me show you this new thing we have,
36:41
Speaker 5: and then the inspectors learn from this.
36:44
Speaker 4: So yes, it works both ways.
36:50
Speaker 7: I mean, training and education is something that is always
36:54
Speaker 7: there and always will be there. Learning new techniques, understanding
36:58
Speaker 7: new techniques that are working and having a day. You know,
37:00
Speaker 7: it always goes back to data and what you have
37:04
Speaker 7: to be able to do your job and do it better,
37:06
Speaker 7: both for a regulator inspector as well as for a
37:10
Speaker 7: compounding pharmacist or any pharmacist for that matter.
37:14
Speaker 5: Yeah, and I imagine it's hard for boards of pharmacy
37:17
Speaker 5: to prioritize their focus.
37:20
Speaker 4: You know.
37:20
Speaker 5: I think oftentimes when we're in an environment where there's
37:25
Speaker 5: a new product and there's money coming in, right, you know,
37:29
Speaker 5: with that when the glps were we were taking care
37:33
Speaker 5: of those patients during the shortage, and there were a
37:35
Speaker 5: lot of people coming into this space.
37:36
Speaker 6: There were a lot of new sterile pharmacies.
37:39
Speaker 5: Is that something that you guys look for when when
37:42
Speaker 5: there's a new pharmacy come up. Does that sort of
37:44
Speaker 5: flag the attention? Is it more volume if you hear
37:47
Speaker 5: that people are doing a lot? Is it only waiting
37:50
Speaker 5: for an event? How do they prioritize.
37:54
Speaker 7: It's a little bit of all the above, you know.
37:57
Speaker 7: So new pharmacies that come up usually have to go
37:59
Speaker 7: through through a more strenuous, more specific process before they're
38:05
Speaker 7: able to receive a license and operate at least for
38:08
Speaker 7: five or three a and so you know that first
38:11
Speaker 7: inspection or that first set of inspections, there's a lot
38:16
Speaker 7: of scrutiny placed on that facility to make sure that
38:20
Speaker 7: it is set up appropriate, that is set up correctly,
38:22
Speaker 7: and that it's set up in a way that is
38:24
Speaker 7: going to be safe for everything that's coming out of
38:28
Speaker 7: it too that's going to a patient. I think after
38:31
Speaker 7: that then it goes to what you just say to
38:34
Speaker 7: like larger quantities, larger you know, production of if your
38:40
Speaker 7: production increases significantly or if there are patient complaints that
38:46
Speaker 7: lead to an investigation, that's where you start to see
38:50
Speaker 7: a spike and regulatory activity.
38:53
Speaker 4: In those facilities.
38:55
Speaker 7: But those are going to be the two I think
38:57
Speaker 7: the two differences that you're going to see is one
39:00
Speaker 7: new is going to be placed into that just increased
39:03
Speaker 7: scrutiny just to make sure everything is in place to
39:05
Speaker 7: be able to operate as a pharmacy, because that's the
39:08
Speaker 7: first instance that that person is go or is going
39:11
Speaker 7: to be educated on you know, all the specifics around UH,
39:16
Speaker 7: around compounding or around practicing pharmacy in that space. And
39:20
Speaker 7: then afterwards it's it's complaint driven or or if you know,
39:25
Speaker 7: when the routine inspection that occurs every year based off
39:29
Speaker 7: of state regulations, there's activity that's seen there and that
39:32
Speaker 7: leads to UH, you know, a different type of scrutiny
39:36
Speaker 7: placed on the practice to make sure that what they're
39:39
Speaker 7: doing is correct and if it isn't correct, that they
39:41
Speaker 7: that they mediate it very quickly.
39:45
Speaker 6: That makes sense.
39:46
Speaker 5: I'm gonna I'm going to go back to some of
39:48
Speaker 5: the regulations that we talked about before. So when you're
39:52
Speaker 5: seeing more at the legislative level, you know, we're outside
39:55
Speaker 5: of the Board of Pharmacy now, but there's a lot
39:57
Speaker 5: of bills going on right now, as you know, at
40:00
Speaker 5: the state legislative level. And when these lawmakers propose these
40:05
Speaker 5: these highly prospective, prescriptive, pun intended compounding bills, what concerns
40:12
Speaker 5: does that raise for boards? Are there things in there
40:14
Speaker 5: that you guys at the board level look at and
40:18
Speaker 5: go ooh, I would adjust that.
40:22
Speaker 6: Yeah, this is concerning for us.
40:25
Speaker 7: I think first, you know, boards of Pharmacy, like any
40:28
Speaker 7: other state regulators, are there for protection public health, and
40:33
Speaker 7: there's a balance the boards need to achieve.
40:36
Speaker 6: Across you know, or not really across.
40:40
Speaker 7: But when it pertains to access to li sning medications
40:44
Speaker 7: as well as drug safety, if something becomes law, the
40:50
Speaker 7: board does not have the option to use enforcement discretion,
40:55
Speaker 7: and in that, you know, that becomes a challenge. And
40:58
Speaker 7: so if we look at that in the grand scheme
41:01
Speaker 7: of things, I think the biggest concern or some of
41:05
Speaker 7: the concerns that come as statutorily state boards and pharmacy
41:08
Speaker 7: or the true enforcement arm for five or three A
41:12
Speaker 7: compounding that is not a policy preference. It is how
41:16
Speaker 7: the law is structured. And so any legislative effort that
41:21
Speaker 7: erodes boards authority in this space directly harms patients. And
41:28
Speaker 7: boards really need you know, their authority protected and resource
41:33
Speaker 7: not complicated. And I think that's what happens when you see.
41:36
Speaker 4: Some of these.
41:38
Speaker 7: Highly prescriptive compounding bills, depending on what side they're coming from,
41:43
Speaker 7: and so lawmakers need to consider that and need to
41:45
Speaker 7: consider compounding legislation. You know, the threshold questions should be simple.
41:50
Speaker 7: Does this make it easier harder for boards to do
41:53
Speaker 7: their job? You know the laws assigned exclusively to them?
41:57
Speaker 6: Period?
41:58
Speaker 7: Well question mark, like that's that, that's what lawmakers need
42:03
Speaker 7: to consider. You look at like you know, and that's
42:06
Speaker 7: that's just one entity, like from a bord authority thing.
42:08
Speaker 7: For standpoint, you look at the medical the met spat channel,
42:11
Speaker 7: medical spat channel and and you know these I V
42:13
Speaker 7: hydration clinics and you know, and the growing enforcement challenge
42:17
Speaker 7: that is tied there that you know, legislation needs to
42:22
Speaker 7: address clearly, not all the legislation there, you know, not
42:26
Speaker 7: every state has legislation that is addressing this. And and
42:29
Speaker 7: then you have you know, entities that are fighting that
42:32
Speaker 7: and and compounded g o p ones moving through met
42:35
Speaker 7: spats and similar settings in a significant volume.
42:38
Speaker 4: And in many states.
42:41
Speaker 7: You know where boards lack clear authority to to to
42:43
Speaker 7: regulate that in spectrum or enforce in those environments. And
42:46
Speaker 7: so you know, that's another patient safety gap and that
42:50
Speaker 7: really deserves direct legislative attention. I think, you know what
42:54
Speaker 7: we've talked about that versus event reporting. I but talk
42:58
Speaker 7: about glowing a faith on this topic.
43:01
Speaker 4: But that's something else that you know.
43:04
Speaker 7: That that's a legislative gap that that's not being addressed
43:07
Speaker 7: in some of these you know, legislative bills that that
43:12
Speaker 7: your team is monitoring, my team is monitoring, and and
43:15
Speaker 7: you know, and so boards are being asked to oversee
43:19
Speaker 7: high volume compounding environment with virtual no mandatory reporting infrastructure
43:24
Speaker 7: period and that's a big concern. So you know, as
43:29
Speaker 7: we look at you know, these highly prescriptive compounding bills,
43:32
Speaker 7: they're missing the mark on these three things and and
43:35
Speaker 7: probably multiple others. And you know, without it, boards are
43:41
Speaker 7: responding to crisises rather than preventing them. They're you know,
43:44
Speaker 7: you know, and so legislation really needs to create you know,
43:48
Speaker 7: meaningful adverse event reporting, the you know, the capability to
43:53
Speaker 7: to inspect in the force and these metspots, and needs
43:57
Speaker 7: to make sure that board authority remains clear and independent
44:02
Speaker 7: of other political needs and desires that are currently being
44:06
Speaker 7: put into bills by different entities, and ultimately, you know,
44:12
Speaker 7: make sure that that Board of Pharmacy authority to protect
44:19
Speaker 7: public safety is not eroded.
44:22
Speaker 6: Great points.
44:23
Speaker 5: I mean, if you're expanding the board's ability to do
44:26
Speaker 5: what it does and giving them more authority, then you're
44:30
Speaker 5: in the right zone.
44:32
Speaker 4: You know.
44:32
Speaker 5: You mentioned the med SPA, as you mentioned reporting more
44:37
Speaker 5: on the federal level probably than the state level there.
44:40
Speaker 5: But I've often wondered, I'm really happy to hear your
44:44
Speaker 5: response to that, because I've spoken at a couple of
44:46
Speaker 5: state state legislatures on these bills that are being proposed,
44:52
Speaker 5: and the biggest problem I have is that the people
44:54
Speaker 5: that are making these decisions don't have the same education
44:58
Speaker 5: as the Board of Pharmacy. And that's not against them.
45:00
Speaker 5: They have all the best intentions in the world, but
45:03
Speaker 5: you know, I spoke at one state and said, I
45:07
Speaker 5: wish we were having this discussion of the Board of
45:09
Speaker 5: Pharmacy and not here because it's too hard to educate
45:15
Speaker 5: and at the same time as have them make decisions
45:18
Speaker 5: that impact patient care. So I think we're aligned there.
45:22
Speaker 5: I think I would like to see the same things happen.
45:26
Speaker 7: Yeah, that's hopefully, you know, hopefully most states will will talk.
45:31
Speaker 4: You always, you always hope.
45:32
Speaker 7: That the state is talking to their regulatory and enforcement
45:37
Speaker 7: agency re least legislators are before they make any these decisions,
45:42
Speaker 7: because you're right, they're making these decisions based off of
45:46
Speaker 7: hearing from one side or one party or another and
45:49
Speaker 7: not having a complete understanding of the environment in their
45:53
Speaker 7: state of which they're dealing with, and that just, you know,
45:58
Speaker 7: that's a flawed process in itself, Like you have to
46:00
Speaker 7: talk to experts that are on the ground, that are
46:02
Speaker 7: seen as day in and day out and to get
46:07
Speaker 7: a full picture before making decisions on a lot of
46:09
Speaker 7: these Uh.
46:10
Speaker 5: Yeah, a law of unintended consequences. You know, you forgot
46:14
Speaker 5: to specify human in this bill. You forgot that there's
46:17
Speaker 5: more than one weight loss medication. You open the door
46:22
Speaker 5: to other individualized legislation instead of following facts, you know,
46:27
Speaker 5: and it becomes difficult when it becomes a battle of
46:31
Speaker 5: influence instead of a battle of facts in a battle.
46:35
Speaker 6: Of patient care. That becomes difficult. Are there areas where the.
46:41
Speaker 5: Boards are being asked to weigh in on issues that
46:45
Speaker 5: are really federal questions, you know. And I think that
46:49
Speaker 5: we've touched on a few things here that I think
46:51
Speaker 5: you could go with.
46:52
Speaker 7: Yeah, you know, at the end of the day, the
46:57
Speaker 7: border pharmacy is responsible for you know, protection and or
47:03
Speaker 7: really responsible for the practice of pharmacy and making sure
47:06
Speaker 7: that public health is not harmed, and that is not
47:10
Speaker 7: a federal issue. I think where you see it is
47:16
Speaker 7: there's overlapping topics such as compoundings such as controlled substances
47:21
Speaker 7: such as drug supply chain where they must comply with
47:26
Speaker 7: both federal and state regulations and in states usually have
47:33
Speaker 7: the states usually have a provision where it says you
47:35
Speaker 7: must also comply with federal law equivalent. I think where
47:41
Speaker 7: that gets blurred and where you see regulators or boards
47:46
Speaker 7: of pharmacy being asked to kind of go into both
47:49
Speaker 7: spaces is when it is outside of a five O
47:54
Speaker 7: three A. So you know, the inspection enforcement of five
47:57
Speaker 7: O three A compounding pharmacies squarely the responsibility of the
48:02
Speaker 7: state under the law. FDA, we know, does not routinely
48:07
Speaker 7: inspect five or three A pharmacies. Uh, state boards do.
48:12
Speaker 7: So that means that when there is a question in
48:15
Speaker 7: regards to a regards to five or three A operation
48:22
Speaker 7: and whether it's operating legally, safely and within the bounds
48:25
Speaker 7: of what the framework actually permits, the state board is
48:29
Speaker 7: a responsible party.
48:30
Speaker 6: Uh.
48:31
Speaker 7: When you start getting into other spaces, you know, it's
48:38
Speaker 7: not necessarily and it's kind of like it kind of
48:40
Speaker 7: goes back to what we talked about earlier. It's like
48:42
Speaker 7: you have some of these five or three B facilities
48:46
Speaker 7: where the regulation and responsibility comes from the FDA and
48:52
Speaker 7: and so like. And we've seen a lot of notices
48:56
Speaker 7: and communications here recently about the FDA taken action on that.
49:01
Speaker 7: So that's one I think we get into the metspas
49:04
Speaker 7: that kind of you know space kind of who is
49:08
Speaker 7: responsible for what how that entity is registered. You know,
49:14
Speaker 7: is as a place where porta pharmacy regulators hands can
49:17
Speaker 7: be tied in certain instances, and so whether that is
49:21
Speaker 7: a federal state or different regulatory different agencies, regulatory responsibility
49:29
Speaker 7: becomes a challenge. I think adverse event reported we were
49:33
Speaker 7: trying to go through with you know, with FDA m
49:36
Speaker 7: o U, and that was UH was put on hold.
49:43
Speaker 4: And so.
49:45
Speaker 7: I think now there is the opportunity to look at
49:49
Speaker 7: that from potentially a safe perspective, and there's some states
49:52
Speaker 7: are looking at it a little bit differently or looking
49:55
Speaker 7: at it more intensely than others right now. And so
49:58
Speaker 7: you know, that's that that's another space where I think
50:02
Speaker 7: it gets a little blurry. Peptides we haven't even talked
50:05
Speaker 7: about peptides, and you know, that's that's really it's FDA.
50:13
Speaker 7: But you know, as I mentioned, you know, when state
50:16
Speaker 7: has a provision that you must comply with f d
50:18
Speaker 7: A law or federal law, not FDA law, but federal law,
50:23
Speaker 7: and boards go in and they inspect on that, then
50:27
Speaker 7: that kind of gets blurry also because they're reporting that
50:30
Speaker 7: information back to the FDA or to the federal agency
50:35
Speaker 7: to lead to further investigation, inspection, and what have you.
50:39
Speaker 7: And so it's it is tricky, but at the end
50:44
Speaker 7: of the day, you know, it is the Board of
50:46
Speaker 7: pharmacy responsibility to regulate practice or pharmacy, and so who
50:51
Speaker 7: they do it with and how they do it usually
50:54
Speaker 7: is a combination of efforts with both local, state and
50:59
Speaker 7: federal partners along the way.
51:02
Speaker 5: Yeah, I imagine that it is difficult, and it's only
51:04
Speaker 5: going to get more difficult, you know, as things continue
51:08
Speaker 5: to evolve.
51:10
Speaker 6: But you know, I always thought of the and push
51:13
Speaker 6: back here where I'm wrong.
51:14
Speaker 5: I always think of the FDA and the federal you know,
51:18
Speaker 5: they they say what you're allowed to compound, and then
51:21
Speaker 5: the board say how you do it? Who gets it?
51:25
Speaker 5: The processes that you do? Is that general generalization, but
51:31
Speaker 5: you know it? And so then we see it in
51:35
Speaker 5: some states where they interpret I guess the FDA different.
51:39
Speaker 5: You mentioned the letter of the law. Well, guidance isn't
51:42
Speaker 5: the letter of the law? Right, enforcement discretion isn't the
51:45
Speaker 5: letter of the law. So where does it How do
51:48
Speaker 5: you walk that line as a state board of pharmacy
51:51
Speaker 5: where the f DA maybe says, you know, these products,
51:56
Speaker 5: you know, we we haven't enforced using enforcement discretion, or
52:01
Speaker 5: we have a guidance document that says we are okay
52:06
Speaker 5: with this practice, and then you have some states that
52:10
Speaker 5: do they reinterpret that.
52:12
Speaker 6: But I guess I mean different.
52:15
Speaker 4: Yeah.
52:16
Speaker 7: I think one of the things you see here and
52:18
Speaker 7: this is this is you know, you see it with
52:21
Speaker 7: the DEA as well.
52:23
Speaker 4: You know, like you'll have the DA that has Z.
52:26
Speaker 7: Specific drugs and Schedule three or Schedule four control substances.
52:31
Speaker 7: You go in the state in a state, it's not
52:33
Speaker 7: a Schedule four in a state, it's a Schedule three
52:35
Speaker 7: in a state, or you know, or it is prohibited
52:37
Speaker 7: in a state, and so they'll have more more stringent,
52:42
Speaker 7: more rules or regulations in place for specific glasses. I
52:48
Speaker 7: think when you start seeing FDA enforcement discretion, what you
52:53
Speaker 7: see from the board is the board doesn't have to take.
52:56
Speaker 4: That enforcement discretion. The board can continue to act on that.
52:59
Speaker 7: It's up to you know, how they want to handle
53:02
Speaker 7: that based off the FDA sayd enforcement discretion because it's
53:06
Speaker 7: still in law that and and that's where it gets
53:11
Speaker 7: kind of tricky. But it's still in law, either federally
53:15
Speaker 7: or federal law, even though they're taking enforcement discretion, and
53:19
Speaker 7: state law says that you have to follow federal requirements,
53:21
Speaker 7: and so it becomes tricky and how they're do it
53:25
Speaker 7: and states handle it differently. But you know a lot
53:28
Speaker 7: of states don't necessarily observe the regulatory enforcement discretion that
53:35
Speaker 7: the FDA is having on something and still require it
53:38
Speaker 7: to be enforced in their state. And that will always
53:43
Speaker 7: I think that's something I always be there, both from
53:46
Speaker 7: the FDA DA and from all federal guidelines and regulations
53:51
Speaker 7: within the practice.
53:53
Speaker 5: And that certainly makes it different harder for you guys
53:55
Speaker 5: that we're in a sort of day and age where
53:57
Speaker 5: the FDA sort of regulates by a guide more than
54:01
Speaker 5: they do via a rule.
54:04
Speaker 4: Yeah, it's challenging.
54:06
Speaker 7: You know, you look at the different you know, different
54:10
Speaker 7: leaders over the agency, and you know that changes and
54:13
Speaker 7: so like the direction of that changes with leadership changes
54:17
Speaker 7: and how those are going to be handled, and so
54:20
Speaker 7: it does you know, there isn't necessarily a streamlined, consistent
54:25
Speaker 7: way over a long period of time because you're having
54:29
Speaker 7: these different changes that lead to different interpretations or different actions.
54:33
Speaker 7: So yeah, it does make it difficult. It makes it
54:35
Speaker 7: difficult for regulators. It also makes it difficult for those
54:37
Speaker 7: that are in that space and that are practicing in
54:39
Speaker 7: that space as well, because you're constantly changing.
54:43
Speaker 5: Also absolutely trying to keep up with it is difficult
54:48
Speaker 5: for members and.
54:49
Speaker 7: That's why it's key you know, and I mentioned earlier,
54:52
Speaker 7: that's why it's so key that you form a good
54:55
Speaker 7: relationship with your board of pharmacy and have open dial
55:00
Speaker 7: log and open communication. It makes it so much easier
55:04
Speaker 7: to move through this, you know, through this inconsistent you
55:10
Speaker 7: know or uh space and going as you know, ups
55:14
Speaker 7: and downs, because you're having those conversations, you're having an
55:18
Speaker 7: open dialogue. You're understanding you know, boards interpretation, You're understanding
55:23
Speaker 7: what actions you can do, what you can't do, how
55:26
Speaker 7: you should do it through all this change. And you know,
55:30
Speaker 7: we all know the only constant is change, and no
55:33
Speaker 7: matter what you're in and so like, as long as
55:36
Speaker 7: there's that open dialogue and that open you know, that
55:38
Speaker 7: good communication, it's going to make everybody's life so much
55:42
Speaker 7: easier and so much simpler.
55:44
Speaker 6: You know. I'll go one step further.
55:45
Speaker 5: I think that every board of pharmacy, we need to
55:49
Speaker 5: have more compounders apply for Board of Pharmacy positions. You know,
55:54
Speaker 5: I think it would be great if every pharmacy had
55:56
Speaker 5: a compounder who could be that subject matter, except for
56:00
Speaker 5: the boards of pharmacy. I agree, but I took of
56:04
Speaker 5: that how you you mentioned a couple of times getting
56:07
Speaker 5: to know them.
56:07
Speaker 6: I'm just gonna ask what does that look like.
56:09
Speaker 5: I know you said showing up to meetings, you know,
56:11
Speaker 5: but is it inviting members to visit your members of.
56:14
Speaker 6: The boards of pharmacy, to visit your compounding pharmacy. What
56:18
Speaker 6: does it look like to engage with them.
56:20
Speaker 4: I think it's all the above.
56:23
Speaker 7: I think attending meetings, I think getting engaged to to
56:28
Speaker 7: be on a board of pharmacy. But you know, the
56:32
Speaker 7: one thing I will say about that about get engaged
56:35
Speaker 7: to be on a board of pharmacy, you have to
56:37
Speaker 7: remember when you're on a board of pharmacy, your first
56:40
Speaker 7: and main responsibility is about protecting public health. It's not
56:44
Speaker 7: about protecting practice, not about protecting your your your entity,
56:48
Speaker 7: your company, your pharmacy, or whatever case may be.
56:50
Speaker 4: So like, when you.
56:51
Speaker 7: Decide to do that and decide to get on a
56:54
Speaker 7: board of pharmacy, you're doing so to protect public health
56:58
Speaker 7: and educate. And I think you mentioned it's like, you know,
57:01
Speaker 7: having a compounder on a board of pharmacy, so that
57:04
Speaker 7: when a compounding you know, case gets brought up that
57:08
Speaker 7: you're canna be like, hey, Philip, can you tell me, like,
57:11
Speaker 7: what are your thoughts on this, How does your pharmacy
57:12
Speaker 7: handle this? Like, what are some things that we need
57:14
Speaker 7: to know to be able to determine how we want
57:18
Speaker 7: to take action as pharmacy that is violating you know,
57:22
Speaker 7: our statue or regulation.
57:24
Speaker 4: I think it's huge and I think it's very.
57:26
Speaker 7: Beneficial and having that expertise, just like it is for
57:30
Speaker 7: having someone from a health system, institution, a community pharmacy,
57:35
Speaker 7: whatever the case may be. Like having a very diverse
57:38
Speaker 7: board is very beneficial to moving those efforts and to
57:42
Speaker 7: making sure that all pharmacy expertise or all pharmacy, all
57:49
Speaker 7: every different type of pharmacy, Like there's some type of expertise.
57:53
Speaker 7: I mean, you're not going to get that, you know,
57:56
Speaker 7: on every pharmacy. It's not like you know, you're not
57:59
Speaker 7: going to get like a new the a pharmacist or
58:00
Speaker 7: what have you on every board or all that. But
58:03
Speaker 7: just have an expertise seven understanding to be like, all right,
58:05
Speaker 7: you know we're going to go to fill for this
58:06
Speaker 7: because he's our compounding expert.
58:08
Speaker 4: He has a compounding.
58:08
Speaker 7: Pharmacy, he's been in a space for years, and he
58:11
Speaker 7: runs a very clean tight ship. I think that's one.
58:15
Speaker 7: So that's where that's where I would say getting getting
58:17
Speaker 7: involved and get engaged with the board. I think the
58:19
Speaker 7: other thing is, like you said, open invitation, Hey we're
58:22
Speaker 7: doing this. I want to show you know some new
58:25
Speaker 7: some new processes. We're doing some new machinery that we
58:29
Speaker 7: got in that's automating a lot of process So our
58:31
Speaker 7: quality is going to go from here to here. It
58:33
Speaker 7: was already really good, but now it's going to be
58:35
Speaker 7: near perfect. Like different things like that and just having
58:39
Speaker 7: that open communication I think are hugely beneficial to just
58:44
Speaker 7: to stress relief that you'll have in your life from
58:46
Speaker 7: making sure that you're doing things right. Because I know
58:49
Speaker 7: as as a pharmacist just in general, like there's some
58:53
Speaker 7: things when you leave your practice or you leave your pharmacy,
58:57
Speaker 7: and I know I've been in a space where it's
58:59
Speaker 7: like I'm thinking about it all night, like what do
59:02
Speaker 7: I need to do different?
59:03
Speaker 4: Do I do this ride?
59:04
Speaker 7: Like you know this patient, that patient, and so like
59:06
Speaker 7: it's going to make you sleep easier knowing from that
59:09
Speaker 7: aspect that you know, if you are if you do
59:11
Speaker 7: have a question, you have a person you can call
59:14
Speaker 7: and you can get a quick answer or and you
59:17
Speaker 7: have that ongoing relationship with them, because again, they're out
59:21
Speaker 7: to educate and protect, they're not out to you know,
59:25
Speaker 7: find or or find a you know, just a gotcha moment.
59:30
Speaker 6: Makes perfect sense.
59:31
Speaker 5: You'll rest easier, you'll save money on melowtone in everybody wins,
59:35
Speaker 5: all right.
59:36
Speaker 6: If you could give one piece of advice two boards.
59:41
Speaker 5: To pharmacists and or policymakers for navigating the place that
59:48
Speaker 5: we're in right now and the place that we're moving
59:50
Speaker 5: to in the coming years in terms of pharmacy, what
59:55
Speaker 5: would you say, talk.
59:57
Speaker 7: To each other. It's it's all about communication. I mean,
1:00:01
Speaker 7: you can be on different sides and have different opinions,
1:00:05
Speaker 7: but if you don't talk to each other, you're never
1:00:08
Speaker 7: going to get anything done. It's always going to be
1:00:10
Speaker 7: one sided and it's not going to take into consideration
1:00:12
Speaker 7: everything that needs to be done. And that is for legislators,
1:00:18
Speaker 7: that's for pharmacies, that's for boards.
1:00:21
Speaker 4: It's all about good communication.
1:00:23
Speaker 7: I know we've talked about it a lot today, but
1:00:26
Speaker 7: it's the most important thing if you're I mean, it's
1:00:28
Speaker 7: the most important thing in any relationship. Like if you're
1:00:31
Speaker 7: not communicating, you're going to have other issues that are
1:00:35
Speaker 7: going to come up. And is just going to you know,
1:00:38
Speaker 7: just compound on each other based off of that, and
1:00:41
Speaker 7: so that's where it starts.
1:00:43
Speaker 6: That's where it starts.
1:00:44
Speaker 5: I appreciate that so much, and that's what we're doing
1:00:47
Speaker 5: here today talking about it. Thank you so much, Al,
1:00:50
Speaker 5: This has been an awesome conversation. I took so many notes,
1:00:53
Speaker 5: so many things away from this. Definitely for sharing your expertise.
1:00:57
Speaker 7: Greatly appreciate the invite and and I'm glad to be
1:01:01
Speaker 7: able to have you to talk with you Philip again
1:01:03
Speaker 7: the day and look forward to future conversations and communications.
1:01:06
Speaker 4: We see how I did that?
1:01:09
Speaker 3: Oh man, that was good. That was really good.
1:01:12
Speaker 2: And hey, we're a podcast, so we're all about communications. Ow,
1:01:17
Speaker 2: we are locked into this world of compounding, and I
1:01:22
Speaker 2: really appreciate a totally different perspective, one that we don't
1:01:27
Speaker 2: always think about. I know you're really busy, So a
1:01:30
Speaker 2: big thank you do you and Philip for taking the
1:01:33
Speaker 2: time to share all that with us. And I guess
1:01:36
Speaker 2: that I'm guessing most people who are listening are affected
1:01:39
Speaker 2: by state pharmacy boards. So knowing what they're thinking and
1:01:43
Speaker 2: how they're thinking, it's it's pretty darn important. So again,
1:01:48
Speaker 2: thanks for being here. All right, That is all for
1:01:51
Speaker 2: this episode of Essential. But before we play the outro music,
1:01:56
Speaker 2: something I always point out if you are a compounding
1:01:58
Speaker 2: pharmacist or technician, or if you prescribe compound admits, APC
1:02:04
Speaker 2: is almost certainly helping you and helping your patients. I'm
1:02:07
Speaker 2: not going to go through everything ABC does, but I
1:02:10
Speaker 2: will say it is the biggest, and in a good way,
1:02:13
Speaker 2: the loudest trade association for the whole compounding profession. If
1:02:17
Speaker 2: you're not a member of APC really ought to be.
1:02:20
Speaker 2: We are working for you and we'd love to have
1:02:22
Speaker 2: you on board. So just head over to a four
1:02:26
Speaker 2: PC dot org and check us out. All right, Brady,
1:02:31
Speaker 2: now you can play that outro music. Thanks for listening, everyone,