June 3, 2025
Senator Dave Wallace 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 called to order. The next one is consideration to approve the May 14, 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-- well, there they are. And you are recognized if you'll give your name. And we'll get started.
Laura Shue Thank you, Mr. Chair. I'm Laura Shue. I am general counsel for the Department of Health.
Shane David Shane David, branch chief, health systems licensing and certification for the Department of Health.
Nick Shull I'm Nick Shull. I'm the section chief for pharmacy services and drug control within the Department of Health.
Laura Shue 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 substance 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 to update the rules. This rule draft, the promulgation was started in the fall of 2024. The governor's office approved the amendments to add these substances and the Board of Health approved it in October of 2024. And I'm going to have our experts here discuss the additions to the rule.
Shane David Thank you. I appreciate the opportunity to be here. On the summary for the list of proposed amendments to the control substance list, items one through nine are fentanyl-related substances to follow the DEA would be included into schedule one. Item number 10 is three substances that we already have listed as schedule one, etodesnitazine and parolidinoethonitazin and protonitizine 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 2-methyl AP-237 to follow the DEA also be included as schedule one. Items 12, 13 are substances that have been identified by the DEA as isomers. Of current substances that we have on our list, first one is 3-methylmethcathinone, or 3-MMC. This product has been identified as a positional isomeromephedrum, which is currently listed on the controlled substance list. This drug without a recognized medical use would be included in schedule one also. The next product is alpha-pyrolidinoisohexanophenone. 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 are items that have been marked for cleanup on the list. Item 15 is xylazine. 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 Zirinalone, which is actually an FDA-approved medication that has been identified and will be included by the DEA's Schedule IV. To mirror that, we would include it as Schedule IV. 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.
Laura Shue 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 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. And we're happy to take any questions.
Senator Dave Wallace Senator Love, you're recognized, sir.
Senator Fredrick Love Thank you, Mr. Chair. I'm just going to ask, when you talk about, say, for number 17 positional isomer, what does that technically? Kind of explain to me what that means.
Shane David 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.
Senator Fredrick Love Okay, and so with the arrangement of the molecules differently, you mean that it impacts the body differently?
Shane David Well, its structure may be different. But in this instance, it still interacts with the receptors 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 a similar effect.
Senator Fredrick Love I think that's all the questions that I had. Thank you, Mr. Chair.
Senator Dave Wallace Thank you, sir. Senator Payton, you're recognized, sir.
Senator John Payton Thank you, Mr. Chair. So you mentioned the fact that you had one public comment and I was reading it here. And I'm on the medical marijuana oversight committee. Can you simplify what his concern was in regards to being enforcement and the DEA, the guidance being similar and us using the same guidance as the DEA?
Shane David Sure, another great question. So the item that was 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. From my understanding with the comment would be 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.
Senator John Payton Well, I can't pretend to understand that. But my concern is where he mentions that his suggestion would bring us more in line, more consistent with federal guidance. So, is that not beneficial that we'd be more consistent with the federal guidance?
Shane David Yes, it would be. With Act 629 of 2025, some of the definitions 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.
Senator John Payton So incorporating his suggestion is already underway.
Shane David Yes, under the act. That would be the idea behind that.
Senator John Payton Okay, thank you.
Senator Dave Wallace Are there any other questions for item C? Seeing none, this has been reviewed. Without objection, this has been reviewed. Members, we're now moving on to item D. You may continue.
Laura Shue Thank you, Mr. Chair, members of the committee. The next rule that 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 to take any questions.
Nick Shull 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 or 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 cleanup changes. And I'll be happy to take any questions.
Senator Dave Wallace Senator Love, you are recognized, sir.
Senator Fredrick Love Thank you, Mr. Chair. I haven't had a chance to review that number two section, that section seven. Why would we want to remove hospitals from being adherent to this regulation?
Nick Shull 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 it up.
Senator Fredrick Love Okay, so they were required under this law to submit them to us, but they hadn't been doing it. So I guess who has the oversight?
Nick Shull Yeah, so with them being DEA registrants, the DEA has direct oversight over hospital-controlled substances.
Senator Fredrick Love Okay, so I'm just, it's 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 the rule at all?
Laura Shue Senator, if I could answer that question, the hospital rules are currently reflecting this amendment. We're just updating this rule for the rules that control substances to reflect our current rule for hospitals.
Senator Fredrick Love Hold on for a second. The current rule or is it the current practice?
Laura Shue Both.
Senator Fredrick Love Because you're saying that we have this rule and now we're changing it?
Laura Shue Right, we're updating it.
Senator Fredrick Love 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?
Laura Shue 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 law.
Senator Fredrick Love Okay, I guess you're not understanding what I'm asking you.
Laura Shue 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 our general rules for controlled substance 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.
Senator Fredrick Love I mean, I hear what you're saying. But I'm saying we had a rule on the books that we just weren't adhering to.
Laura Shue We try to update our rules as we go and we catch things and sometimes we don't. And so we're catching it now and we're making sure that it's reflected properly in the law, in the rule 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.
Senator Fredrick Love Okay. All right. Thank you.
Senator Dave Wallace Members, are there any other questions on item D? Seeing none, without objection, item D has been reviewed. Thank you all. Members, Item E, other business. Does anybody have any business to bring to the committee? Seeing none, folks, thank you all for being here today and we are adjourned.
