Public Health, Welfare and Labor Committee - Senate and House
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Members in the house, good morning. We are in session. Representative Rye, you ready to go to work? Thank you, sir. First order businesses called order we have call to order. The next one is consideration to approve the May 14th, 2025 meeting minutes, which is uh exhibit B.
And without objection, this is reviewed. Moving on. Item C, the Arkansas Department of Health. Division of Health Protection, pharmacy section review of rules and list of controlled substances. Without objection. Well, there they are.
And you are recognized if you'll cover your name and, uh, And we'll get
Speaker 7
9:21
started. Thank you, Mr. Chair. I'm Laura Shu. I'm general counsel for the Department of Health.
Speaker 9
9:26
Shane David Bran Chief Health Systems licensing and certification for the Department of Health. I'm Nick Shaw. I'm the
Speaker 13
9:33
section chief for pharmacy services and drug control within the Department of Health. Thank you, Mr. Chair. Members
Speaker 14
9:40
of the committee, we're here today to present two rules. The first rule being the list of controlled substances. As you know, we come before you on a
regular basis to update the list of controlled substances because by law, we're mandated to update the list every year, uh, right now we're about on a 6 month schedule, so every 6 months we come before
Speaker 11
9:59
you to update the rules. This rule, uh, draft, the promulgation was started, um, in the fall of 2024. The governor's office approved this, um, uh, the amendments to add these, uh, substances and the Board of Health approved it in, uh, October of 2024, and I'm going to have, um, our experts here discuss, uh, the additions to the rule.
Speaker 18
10:21
Thank you, I appreciate the opportunity to be here. Um, uh, on the, uh, summary for the list of, uh, proposed amendments to the Controlled Substance list, items, uh, 1 through 9 are fentanyl-related substances to follow the DEA would be included into Schedule One, item number 10 is 33 substances that we already have listed as Schedule One, EOdes notine and Palodino etonatazine and protonnatazine to follow the DEA. They have added those to their
Controlled Substance list, and we have controlled substance ID numbers opposite of those. Uh, the next product, the synthetic opioid 2 methyl AP 237 to follow the DEA also be included as Schedule one, Items 1213. Uh, or, uh, substances that have been identified by the DEA as isomers of current substances that we have on our list. First one is 3 methyl methcathanone.
Uh, or 3 MMC, uh, this product has been, uh, identified as a positional isomerphedrone, which is currently listed on the controlled substance list. Uh, this drug without a recognized medical use would be included in the Schedule one also, uh, the next product is alpha Pyrolodino iso hexanophenone, this substance has been identified as a synthetic cathenone positional isomer of alpha PHP are are also already currently listed. As a controlled substance.
Uh, items 14 or items that have been marked for cleanup on the list. Uh, item 15 is xylozine, the potential adverse health effects when abused are increasing prevalence of this being an adulterant additive to uh other controlled substances, uh, would be, uh, included as a Schedule 3 controlled substance. Um, with exceptions made for, uh, veterinary and pharmacy use to provide exemptions for those under this, uh, language.
And item 16 is Zoranolone, which is actually an FDA approved medication, uh, that has been identified and will be included by the DEA's Schedule 4 to mirror that, we would include it as Schedule 4 of this item is used for oral treatment for postpartum depression, and lastly, we have a synthetic cannabinoid ADB butanaka DEA as identified this synthetic cannabinoid as a positional isomer of AB Penaka and therefore we would uh also mirror that language and add that to the list for clarity.
Speaker 14
12:59
ific ation We did have one public comment from the cannabis Industry Association, and we did address that comment in our agency response. We're currently reviewing, uh, the article that was submitted and
Speaker 11
13:13
the concerns that were expressed, um, we're also trying to balance the, um, acts that are challenged in litigation at this time, uh, from 2023 and also the new acts that were passed in 2025 to address the concerns. We're happy to take any questions.
Sent to love you, sir. Thank you, Mr.
Senator Fredrick J. Love
Unverified
13:35
Chair. I'm, I'm just gonna ask when, when you, when you talk about like say for number 17 position on Imer. What, what, what does that, what does that technically kind of explain to me what
Speaker 18
13:48
that means. Sure, um, that's a great question. So, um, an isomer, uh, just burned over, oversimplification is just basically a product that has the same molecular formula, so you would have the same number of carbons, hydrogens, and oxygens.
In it, but it might have some sort of differential position or the structure may be somewhat different. So, um, for instance, an isomer of THC or Delta 9 THC. Might have a double bond that's moved somewhere else in it, it's still the same number, but might have somewhat different interactions within the receptor that could be more potent, similar, or less potent. So it's basically the same number of molecules, but just arranged a
little bit differently depending on that. OK, and so
Senator Fredrick J. Love
Unverified
14:35
with the arrangement of the of the molecules different you mean that in it impacts the body
Speaker 29
14:41
differently? Well, it, it's structure may be different, but it may, but in this instance, it still interacts with the, uh, receptors that
Speaker 18
14:48
are that these other products would interact with, and they've been identified as the same classification in these instances as the products that we already have listed and therefore would produce similar effect. OK. All right. I think that's, I think that's
Senator Fredrick J. Love
Unverified
15:03
all the questions that I had. Thank you.
Senator John Payton
Unverified
15:13
Thank you, sir. So Peyton, you'll recognize her. Thank you, Mr. Chair. So, You mentioned the fact that you had one public
comment, and I was reading it here. And, um, I'm on the medical marijuana oversight committee. So I'm trying, can you simplify? What his concern was, uh, in regards to being
Uh, enforcement and the DEA and you know, the guidance being similar and that. Us using the same guidance as
Speaker 38
15:47
the DEA. Sure, uh, another great question. So the item that was
Speaker 18
15:53
pointed out is called THCA or tetrahydrocannabinolic acid. It's in the plant. Substance itself. However When it is burned, Or consumed with combustion, it converts into THC. So it's a precursor.
The, uh, from my understanding with the comment would be to wanted to add that language to be included into THC. So that items that are being sold over the counter with this THCA would be included as a controlled substance. And with current legislative acts that have been passed, um, certain instances where these items were identified, were included so that they could, uh, Potentially, um, set, uh,
Total THC requirements to include those both into the definition
Senator John Payton
Unverified
16:49
of THC. Well, I can't pretend to understand that, but my concern is where he, he's, he mentions. That, uh, His suggestion would bring us more in line, more consistent. With federal guidance. So with, is that not beneficial that we'd be more consistent with the federal guidance. Yes, it, it
Speaker 29
17:15
would be, it would be, um, with Act 6:29 of 2025. Some of the
Speaker 18
17:20
definitions had been clarified to include this THC component and upon our. Scheduling action with the next controlled substance list and current litigation, um, that would be our intent would be to update that to reflect that language. So incorporating his suggestion is
Senator John Payton
Unverified
17:38
already underway. OK the act that would, that
would be the, the idea behind that. Yes, sir. OK, thank you. Members, are there any other questions for item C? Seeing none, this has been reviewed. Without objection, this has been reviewed. Members were now moving on to item D, Delta. You may continue. Thank
Speaker 46
18:10
you, Mr. Chair, members of the committee. The next rule that we're presenting today for
Speaker 11
18:19
review is the rules for controlled substances. These primarily deal with the disposal of controlled substances in our facilities. We are updating the language, the governor's office approved this back, uh, last fall of 2024, the Board of Health approved the, uh, rule amendments in October of 2024 and we'll have our experts, uh, give you all more details and we're happy to take any questions. Yes, good morning. Um, so
Speaker 13
18:44
we just had a few minor changes to our controlled substance rule for Arkansas, um, first one
being section 64 on page 8's language is updated to removing unwitnessed partial doses of controlled substances being sent to pharmacy services and drug control. This language was removed to prevent confusion for DEA registered facilities regarding Title 21 CFR Part 1317 related to the disposal of controlled substances by registrants. Second change was uh section 7B on page 9. Again, pursuant to the CFR 1317 language was. Update removing hospitals as
entities required to surrender on one controlled substances to pharmacy services and drug control. Hospitals or DEA registrants that are required to comply with DEA disposal processes as outlined in 1317. So we removed hospitals from our rule. Um, and then just a few other minor changes updated uh the rule to remove the word regulation as applicable and just a few other BLR. Recommended cleanup changes. And I'll be happy to take any questions.
Senator Fredrick J. Love
Unverified
19:56
Center Love, you're a recognizer. Thank you, Mr. Chair. I haven't had a chance to review the 2 section. Um, the section 7. Now, why, why would we want to remove hospitals from. From
being adherent to this regulation, so. The
Speaker 13
20:14
way our drug takeback works is non-DEA registrants, so long-term care facilities, assisted living facilities. When they have a patient who changes meds or the patient passes away, they send those
unwanted meds back to us and we inventory them and destroy them through our process. Hospitals are DEA registrants, so they are required to follow federal DEA guidelines on disposal, which Do not involve our services, so. For that reason They're not sending them to us anyways. They haven't sent them to us in a long time, so really this rule is kind of outdated and we, we needed to remove the word hospitals. OK, so. They
Senator Fredrick J. Love
Unverified
20:53
were, they were required under this under this law to
submit them to us, but they hadn't been doing it. So I guess, I guess, uh, who, who has the oversight that. Like
Speaker 13
21:09
that. Yeah, so. With them being DEA registrants, the, the DEA. As direct oversight over hospital. control. OK, so. I'm, I'm
Senator Fredrick J. Love
Unverified
21:20
just, it's gonna be, no, I don't wanna say I'm a, I'm gonna assume, but. This rule was in effect.
We weren't adhering to the rule was the Arkansas Department of Health
just They they just weren't adhering to the
Speaker 14
21:38
rule at all. Senator, if I can answer that question, the, the hospital rules are currently reflecting this amendment. We're just updating this rule, uh, for the rules of controlled substances to reflect our current rule for hospitals. So everyone hold on
Senator Fredrick J. Love
Unverified
21:51
for a second. The current rule or is
it the current practice? because you're saying that we have this rule and now we're changing it,
but I guess since it's a rule in effect. Then If we have to rule in effect and we were not doing something, then that means we just weren't in compliance with the rule. Is that not correct? There's no issue
Speaker 14
22:14
with compliance. The hospitals are in compliance with the rules that are specifically applicable to them. This is a general rule on disposal of rules for controlled substances, so we're just updating our general rule, the specific rule for hospitals. They have been in compliance with that for, for as long as that has been updated. So we're we're, this is just an
update to be uniform with the, the hospital rules and the DEA regist. restaurants rules. And federal law. OK,
Senator Fredrick J. Love
Unverified
22:43
I guess, I guess you're not understanding what I'm asking you. OK. And
Speaker 61
22:48
I'm, I'm happy to further discuss it. I think the, the rule for controlled substances is a, is a general rule that applies to various entities. The specific hospital rule applies to hospitals. So the hospital rule was updated and we realized
the Department of Health realized our general rules for
Speaker 14
23:06
controlled substances disposal was not also updated at the same time. So we are updating. our rule for controlled substances to reflect what's currently in the specific rule for hospitals. OK. I, I mean, I, I hear what you're saying, but I'm
Senator Fredrick J. Love
Unverified
23:17
saying we had a rule on the books that we just weren't adhering to. We try to update our rules
Speaker 14
23:23
as as we go and, and we, uh, catch things and sometimes we, we don't. And so we're, we're catching it now and we're making sure that it's reflected properly in the law, in the
rule, and, and making sure everybody's on the same page, all the stakeholders were notified and so if there was any concerns, they would have let us know. We received no public comments or concerns from the stakeholders on this
rule update. OK. All right. Thank you. Members, are there any other questions? On item D. Say none without objection. Adam D has been reviewed. Thank you all. Thank you.
Members out of me. Other business Does anybody have any business to bring? to the committee. Seeing none Seeing none
Agenda
A. Call to Order
B. Consideration to Approve the May 14, 2025, Meeting Minutes [Exhibit B]
C. Arkansas Department of Health (ADH), Division for Health Protection, Pharmacy Services Section, Review of Rule, List of Controlled Substances [Exhibit C] 1. Laura Shue, Chief Legal Counsel, ADH 2. Shane David, Branch Chief Health Systems Licensing, ADH
D. ADH, Division for Health Protection, Pharmacy Services Section, Review of Rule, Rules for Controlled Substances [Exhibit D] 1. Laura Shue, Chief Legal Counsel, ADH 2. Shane David, Branch Chief Health Systems Licensing, ADH
E. Other Business
F. Adjournment
Documents
| Title | Type | Pages | Source |
|---|---|---|---|
| Agenda — PUBLIC HEALTH WELFARE AND LABOR COMMITTEE - SENATE AND HOUSE, Jun 3, 2025 | Agenda | 1 | Official source ↗ |
| Exhibit B- Draft Minutes 05-14-2025 | Exhibit | 2 | Official source ↗ |
| Exhibit C- List of Controlled Substances | Exhibit | 51 | Official source ↗ |
| Exhibit D- Controlled Substances | Exhibit | 35 | Official source ↗ |
Speakers
Senator Dave Wallace Chair
Unverified
Speaker 7
Speaker 9
Speaker 13
Speaker 14
Speaker 11
Speaker 18
Senator Fredrick J. Love
Unverified
Speaker 29
Senator John Payton
Unverified
Speaker 38
Speaker 46
Speaker 61