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 of business is call to order. We have call to order. The next one is consideration to approve the May 14th, 2025 meeting minutes, which is 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, oh, there they are. and you are recognized if you'll cover your name and uh and we'll get started thank you
Speaker 7
9:17
mr. chair i'm laura shu i'm general counsel for the department of
Speaker 9
9:21
health shane david branch chief health systems licensing and certification for the department of health i'm nick
Speaker 13
9:28
shull i'm the section chief for pharmacy services and drug control within the department of health
Speaker 14
9:35
thank you mr chair members 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 right now we're about on a six month schedule so every six months we come before you
Speaker 11
9:54
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 October of 2024. And I'm going to have, um, our experts here discuss, uh, the additions to the rule. Thank you. I appreciate the opportunity to be here.
Speaker 18
10:18
On the summary for the list of proposed amendments to the controlled substance list, items 1 through 9 are fentanyl-related substances to follow the DEA would be included into Schedule 1. Item number 10 is three substances that we already have listed as Schedule 1, etodesnatazine and parolodenoedonazine and protonazine to follow the DEA. they have added those to their controlled substance list and we have placed
controlled substance ID numbers opposite of those the next product synthetic opioid to methyl ap237 to follow the DEA also be included as schedule one items 1213 are substances that have been identified by the DEA as isomers of current substances that we have on our list. The first one is 3-methyl methcathenone or 3-MMC.
This product has been identified as a positional isomer mephedrome which is currently listed on the control substance list. This drug without a recognized medical use would be included in the schedule one also. The next product is alpha-pyrolideno isohexanophenone. This substance has been identified as a synthetic cathinone positional isomer of alpha php are also already currently listed as a controlled substance items 14 or items
that have been marked for cleanup on the list item 15 is xylosine the potential adverse health effects when abused or increasing prevalence of this being an adulterant additive to other controlled substances would be included as a schedule 3 controlled substance with exceptions made for veterinary and pharmacy use to provide exemptions for those under this language and item 16 is xoranolone which is actually an fda approved
medication that has been identified and will be included by the dea's schedule 4 to mirror that we would include it as schedule 4 this item is used for oral treatment for postpartum depression And lastly, we have a synthetic cannabinoid ADB-Butanaca. DEA has identified this synthetic cannabinoid as a positional isomer of AB-Panaca. And therefore, we would also mirror that language and add that to the list for clarification.
Speaker 14
12:57
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 the article that was submitted and the concerns that
Speaker 11
13:08
were expressed. We're also trying to balance the acts that are challenged in litigation at this time from 2023 and also the new acts that were passed in 2025 to address the concerns. We're happy to take any questions. Senator Love, you're recognized, sir.
Senator Fredrick J. Love
Unverified
13:28
Thank you, Mr. Chair. I'm just going to ask, when you talk about, like, say, for a number 17 positional isomer, what does that technically kind of
Speaker 18
13:43
explain to me what that means? Sure. That's a great question. So an isomer just for an 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, 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. Okay, and so with
Senator Fredrick J. Love
Unverified
14:30
the arrangement of the molecules differently, you mean it impacts the body differently?
Speaker 29
14:36
Well, its structure may be different, but in this instance, it still interacts with the receptors that these other
Speaker 18
14:43
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. Okay. All right. I think that's all
Senator Fredrick J. Love
Unverified
14:55
the questions that I had. Thank you, Mr. Chair. Thank you, sir.
Senator John Payton
Unverified
15:07
Senator Payton, you're recognized, sir. 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 in regards to being uh enforcement and the dea and you know the guidance being similar and us us using the same guidance as the dea sure
Speaker 38
15:42
another great question so the item
that was pointed out is
Speaker 18
15:48
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 THC a would be included as a controlled substance and with current legislative acts that have been passed certain instances where these items were identified were included so that they could potentially set total THC requirements to include those both into the definition of THC well I can't pretend to
Senator John Payton
Unverified
16:44
understand that but my concern is where he he he
mentions that 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
Speaker 29
17:08
would be it would be with act 629 of 2025 some of the definitions
Speaker 18
17:15
had been clarified to include this thc component and upon our scheduling action with the next
controlled substance list and current litigation that would be our intent would be to update that to reflect that language so incorporating his suggestion is
Senator John Payton
Unverified
17:33
already underway yes okay under the act that
Speaker 45
17:36
would that would be the the idea behind that yes sir okay thank you
members are there any other questions for item c seeing none this has been reviewed
Without objection, this has been reviewed. Members, we're now
Speaker 14
18:10
continue. Thank you, Mr. Chair, members of the committee. The next rule that
Speaker 11
18:15
we're presenting today for 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 last fall of 2024. The Board of Health approved the rule amendments in October of 2024,
and we'll have our experts give you all more details, and we're happy
Speaker 13
18:39
to take any questions. Yes, good morning. So we just had a few minor changes to our controlled substance rule for Arkansas, first one being Section 6C4 on page 8, 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 Section 7B on page 9. Again, pursuant to the CFR 1317 language was updated removing hospitals as entities required to surrender unwanted controlled substances to pharmacy services and drug control. Hospitals are DEA registrants and are required to comply with DEA disposal processes as outlined in 1317. So we removed hospitals from our rule. And then just a few other minor changes updated the rule to remove the word regulation as applicable
and just a few other BLR recommended
Senator Fredrick J. Love
Unverified
19:54
take any questions. Senator Love, you're a recognizer. Thank you, Mr. Chair. I haven't had a chance to review that number two section, that's section seven. Now, why would we want to
remove hospitals from being adherent to
Speaker 13
20:09
this regulation? So the way our drug take back 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 needed to remove the word hospitals to clear that up.
Senator Fredrick J. Love
Unverified
20:50
They 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 who who has an oversight did Yeah,
Speaker 13
21:04
so with them being da registrants the DEA has direct oversight over hospital controlled substances Okay, so I'm just, it's
Senator Fredrick J. Love
Unverified
21:15
going to be, no, I don't want to say, I'm going to assume, but this rule was in effect.
We weren't adhering to the rule. Was the Arkansas Department of
Health just, they just weren't adhering to
Speaker 14
21:33
the rule at all? Senator, if I could answer that question. The hospital rules are currently reflecting this amendment. We are just updating this rule for the rules of controlled substances to reflect our current
Senator Fredrick J. Love
Unverified
21:46
rule for hospitals. Is it the current
rule or is it the current practice? Both. Because you're saying that we have this
rule and now we're changing it. Right, we're updating it.
Okay, but I guess since it's a rule in effect, then if we have the 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?
Speaker 14
22:09
There's no issue 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 as long as that has been updated.
So this is just an update to be uniform with the hospital rules and the DEA registrants' rules and federal
Senator Fredrick J. Love
Unverified
22:38
law. Okay, I guess you're not understanding what I'm asking you.
Speaker 61
22:43
Okay, and I'm happy to further discuss it. I think the rule for controlled substances 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,
Speaker 14
23:01
our general rules for 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. okay i mean i hear what you're
Senator Fredrick J. Love
Unverified
23:12
saying but i'm saying we had a rule on the books that we just weren't adhering to we try
Speaker 14
23:18
to update our rules 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. Okay. All right. Thank you Members are there any other questions on item D Seeing none without objection item 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 folks. Thank you all for being here today, and we are adjourned
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 45
Speaker 46
Speaker 49
Speaker 61