The Department of Justice has rescheduled medical marijuana under state medical marijuana licenses and FDA-approved marijuana products to Schedule III under the Controlled Substances Act, creating an avenue for state medical marijuana licenses to register with the DEA as manufacturers. DCR recommends that licensees consult legal counsel before pursuing DEA registration and use their nine-digit licensee number and business entity name on applications to prevent discrepancies. Licensees are not required to register with the DEA to remain compliant with DCR regulations.
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Deep Dive
DCR Out Loud - Season 2 Episode 4Added:
[music] [music] [music] >> Welcome to DCR Out Loud. My name is Tera Micielli and I'm the public outreach director of the Division of Cannabis Regulation. Hey Shayna, how's it going?
It's so good. Hi everyone. I'm Shayna Art. I'm the director for patient and application services and I am glad to be back for another round of co-hosting. I know, I'm glad to see you. It's been a really crazy last couple weeks. We're going to have Rika on here talking about that. Very excited to hear what she has to say. What else we got going on? Well, there's lots of big movement yeah, that we're going to be covering with Rika.
Um, we're going to start out talking to her about rescheduling and we're going to have a packaging and labeling update and some exciting opportunities for the podcast.
And then we'll also be talking about micro business round three, which I know is a hot topic that everyone wants to know about. Okay, so we've got a pretty full show today. You ready to get to it?
>> Let's get to it.
>> [music] >> Today we have Dr. Rika Yu here to talk about the recent Department of Justice final order and final rules regarding the rescheduling of certain marijuana and marijuana products to schedule three under the Controlled Substances Act.
>> Hi Rika, welcome to DCR Out Loud. Hey. I know this isn't your first rodeo. You've been here with us before, right?
>> Yes, this is what I think my third time now. Yeah, oh, yeah, you're seasoned now. Yeah, I'm an expert.
>> A pro. Yeah. Welcome back. So, the last couple weeks have been a little crazy.
Yes, very. For you and your office. So, tell us what's been going on? Yeah, so at the end of April, the Department of Justice filed an order to amend rule and it federally rescheduled medical marijuana under a state medical marijuana license and FDA approved marijuana products as schedule three substances. The order also creates an avenue for state medical marijuana licenses to register with the DEA as a manufacturer, which includes cultivation, distributor, and dispensary. It's interesting. So, what is DCR currently doing in response to the order?
>> DCR is trying to communicate with as many parties as possible so that we are fully informed and up-to-date on everything. It might be more information or guidance from federal agencies or to understand how other states are dealing with this development. Has DCR been asked by the DEA to verify state medical cannabis licenses or licensee standing?
No, DCR hasn't received any communication or request for licensee information from the DEA. Should licensees obtain or submit any state issued license verification, certificate of good standing, facility license records, or similar documents to the DEA portal? So, DCR hasn't received any guidance from the DEA for the format of license verification. What we are recommending to each licensee is that they consult with their legal counsel if they wish to pursue DEA registration. I will note that um licensees are not required to register to stay compliant with DCR, but if a licensee does determine it needs license records from DCR, they can request these records through the normal channels or they can reach out to Tara. So, should licensees who wish to register with the DEA use any particular state license number, facility identifier, business name DBA, or address format in that application?
If a licensee wants to pursue DEA registration, they should be using their nine-digit licensee number and the business entity name that appears on their license. And this will help prevent any discrepancies if the DEA comes to DCR for license verification.
Okay, that makes sense. Is DCR aware of any upcoming bulletin, FAQ, memorandum, rulemaking, or policy statement related to the DEA registration process?
>> We're unaware of any upcoming guidance from the DEA. We're also wondering, has the DEA provided a designated contact or liaison for questions relating to the DEA portal? Unfortunately, also at this time, we're unaware of any point of contact for the DEA regarding this. So, is there an opportunity for a comprehensive license to convert to medical marijuana license or otherwise receive a medical designation for purposes of registration with the DEA?
Right now, DCR doesn't have a pathway to convert a comprehensive license to a medical marijuana license. However, we want to note that the DEA has not released any guidance that comprehensive licenses are unable to register with the DEA. It will be up to the DEA to decide if a license type that serves both medical and adult use populations will be eligible for the DEA registration.
Okay. So, this is really great information. We have received questions from licensees and outside stakeholders, and we're just, you know, answering those as those come along. So, this is our first round of the questions that we've gotten so far and the answers that we know at this time. So, what would you recommend that they do as we continue to move through this process? Well, I will first say if you have questions, you can reach out to Tara, but also keep your eye out for any potential guidance that the DEA or FDA might come out with. And then also, I wanted to reiterate if you do decide to pursue DEA registration, we would recommend that you get with your own legal counsel before doing so. Okay.
Perfect. And And we just want to reiterate that we appreciate licensees' patience during this time and just know that DCR is working diligently to get the latest and greatest information that we can.
>> will continue to take this one thing at a time together, just like we always do when something new comes up. Rica, thank you so much for being here. It sounds like we will have you back as more becomes available, so that way we can share it with everybody. Yes, I'm excited for that. And we really do appreciate the Office of Policy and Research taking a deep dive into all of this and helping us uh break the information down into understandable bite-size pieces. We're happy to be helpful. Yeah, shout [snorts] out Dylan and Jason.
>> Yes, shout out Dylan and Jason.
Huge shout out to them. Yeah, thank you.
>> [music] [music] >> And now, it's time for micro minutes with Leslie.
Leslie's in here, Shayna. Wait.
What? Yeah, she's not here. You're doing it.
>> Where's Leslie? Whoa. You're totally doing it.
Um calm down. She'll be back, but I think that you can cover this topic for her.
Well, your your section does a lot of work with micro business applications, so yeah. I think you're right. I think I've got this.
>> I've got all the questions down here, so I think we're ready.
>> Okay. Well, in that case, it's time for micro minutes with me.
So, here's what we know so far. Rules have been filed with the Secretary of State, and they should be effective by May 30th, possibly by the time that this show airs. Leslie's going to be out doing in-person education forums. These are open to the public and will be held in June. There will also be virtual options. Be looking out for a press release coming soon with all the details of the when and the where. DCR is preparing an internal process to ensure a smooth application period, and I can confirm we are working hard on that.
There is a new pre-training that applicants will need to take before applying this time, and that will also be available soon. We are hoping to issue round three licenses this calendar year. The application window should be this summer and we will announce it on the website and statewide news media as soon as it's available. In the meantime, if you or someone you know plans to submit an application, we encourage you to start looking at the new rules and familiarizing yourself with what it entails to be a micro business licensee.
The cannabis industry is highly regulated and there are a lot of responsibilities. And to wrap it all up, if you have any questions about the program, you can contact Leslie Turley at [email protected].
Tara, I know this is something we've all been looking forward to. The micro business program is truly a division-wide effort. Absolutely and we will look forward to hearing more from Leslie next time she's back and I noticed we did we did still put her email in there so you got off the hook there. Yeah, that's true. I I could answer the follow-up questions but Leslie's your girl.
>> Yeah. All right, tune in here for more information on that. All right. Thanks for having me.
>> [music] [music] >> Today, we are welcoming Erica Zickler, our deputy division director, to give us an update about the packaging and labeling process. It's been a while since we have talked about it on the podcast. We've had it in the newsletter, some other things but I don't think we've talked about it on the podcast in a minute [music] so I know this is something division works really hard at as well as licensees to make sure the packaging is compliant, has all the information patients and consumers need so glad it's here. Same and welcome Erica. It's good to have you back.
>> Well, hello ladies. I'm glad to be here to talk about this. Since the beginning, DCR continuously looks at process improvement and make sure that we consider feedback from our licensees, not just in this area actually, in all areas. But today, I want to highlight some of the work we have done over time on packaging and labeling. So, we've discussed DCR's packaging and label approval several times, like I said earlier. But, let's review the basics of the rules and just general requirements to get people up to speed in case they haven't heard about it. That sounds great. So, recap here, DCR requires all regulated marijuana products to meet packaging, labeling, and product design requirements found in section 120 of our rules under 19 CSR 100-1. All product packaging must be approved by DCR before use in the regulated market. So, we receive packaging and labeling application submissions from licensees, and our team reviews them to ensure they meet the rules requirements. Can you remind us of the value these standards and the approval process provide to regulated marijuana products? Yes. So, these standards guarantee that all marijuana produced, packaged, and labeled safeguard public health and are designed to prevent attracting children.
The review and approval process ensures that product packaging complies before distribution and promotes consistency across the regulated market. This helps consumers, patients, and the public easily identify products made by our licensees, who must adhere to strict law and regulations aimed at protecting public health and safety. Yeah, so we've been doing this for a minute, the packaging and labeling program. But, um roughly how many applications have we received since we've implemented? So, this process was implemented in September of 2023. We're roughly 2 and 1/2 years in, and we've received about 650,000 application submissions. Wow.
Yeah, it's a lot. That's impressive.
So, speaking of process improvements, DCR has a dedicated packaging and labeling team. And there's a lot of work behind the scenes and resources being devoted to improvements. What are some of those key efforts and what results have we seen? Yes, a lot going on, and I'll highlight some of the key improvements. Over the past year, we've been very focused on improving consistency, efficiency, and support for our licensees. One of the biggest steps forward was developing clear guidance documents for packaging, labeling, product design, and item submissions.
These resources are helping licensees better understand compliance requirements and navigate the application system more confidently. And I want to acknowledge our MCRC licensees in particular. Their feedback played an important role in refining the item submission guidance from an end user perspective. So, let's talk internally.
We've continued strengthening our own processes, as well. We've implemented a staff audit review process that's showing strong results. We're seeing earlier detection of non-compliant issues and more reliable approval outcomes, along with a reduction overall review days, which currently is less than 30 days. Those improvements are making a noticeable difference. That's great. We also made refinements based directly on licensee feedback.
Specifically, when we see widespread non-compliant issues that don't pose an immediate health or safety risk, we're shifting away from issuing violations, which would be the normal way of dealing with non-compliance. Instead, for now, we'll provide a communication to everyone outlining the issue and allow impacted licensees to exhaust their existing packaging with a defined time frame. So, it's a more practical and collaborative approach for everyone involved. And we hope licensees agree and will find this helpful and adjust their packaging in the time frames provided. Yeah, that's a really great process improvement. We're excited [clears throat] about about this. Um, and we think the licensees will will find it helpful. So, overall, we're encouraged by the progress we're seeing internally and with licensees. And we'll continue looking for opportunities to increase efficiency, strengthen consistency, and support our licensees and team through ongoing audit reviews, collaboration, and of course, continuous process improvement. Erica, thanks for joining us and sharing information about these efforts. What resources are available for information on DCR's packaging and labeling process? Our website has a lot of great information.
The packaging, labeling, product design, and item approval guides that I talked about earlier are on our facility and communications page. And then the application submission numbers and processing time frames we talked about, they're on a dashboard and available on the data and reports page. And then of course, the podcasts and newsletters featuring conversations and articles on packaging and labeling are available on the DCR Communications and Resource Center page. Absolutely. And then your packaging and labeling specialist that is assigned to your license, he would also be a good resource for you. But thank you so much for coming on and outlining all the different resources we have, how we've taken time to look at our process improvements, how we can do things internally. And remember, licensees, if you have something that's very facility specific, you have your packaging and labeling specialist, so reaching out to them is going to be your best bet if you have specific questions.
They're always willing to help and work through that with you. So, it's just really refreshing to hear after 2 and 1/2 years that we've implemented all of these changes and ideas and and we're we're here now. Yes, exactly. Seeing how it goes and seeing what process improvements we find next. Yeah. Yeah, so agree, reach out to your facility specialist. They have all the expertise and knowledge and uh we appreciate uh sharing the information.
>> [music] >> So, Tara, I hear there's some new news about the podcast. Are we jazzing things up?
>> Yes, I have my jazz hands out right now.
If you could see them, audience, you would love it. They're fabulous.
>> [laughter] >> But Brad, can I get a drum roll?
Please.
Well, I don't know if it's that special, but we are super excited about it. The main reason we started this podcast is because we wanted a place where we can share important and timely information related to cannabis regulation in Missouri. Our goal is to support communication, transparency, and guidance for both licensees and the public. So, this year, we are excited to open the platform to individuals interested in being our guest.
>> Woo.
So, we feel like by welcoming licensees and stakeholders onto the podcast, we can provide listeners with some diverse perspectives and insight into Missouri's evolving cannabis industry. So, we're so excited about it.
>> Exactly. And we cannot do this alone. We are excited to hear from licensees and stakeholders about their point of view in the cannabis industry. So, what types of things do we want to hear about?
>> Well, we really want to hear your ideas.
So, there's there's not a lot off the table. Shane is going to read some guidelines here in a few, but here are some things to help jog your creativity.
Unique or innovative processes in the industry for educational purposes, perspective on your decision to be in the Missouri cannabis industry, so tell us your story. Reverse interview of questions from the guest to the DCR staff. So, do you want to come on and ask us some questions? That could be fun. Provide lessons learned on a specific regulation, how your facility is focusing on patient consumer services, how the cannabis industry impacts another industry. And then finally, program overviews or education from other organizations, associations, or state agencies that may impact the industry, patients, or consumers. So, it doesn't have to be a licensee, it could be another organization that is impacted by cannabis legalization, Yeah. or maybe they're doing something creative and innovative in their agency that directly impacts us. I'm just really excited to hear and see different people's perspectives and ideas on the show.
Well, and that's a really great list of ideas to to get folks thinking. I think there's a lot of creativity out there that I can't wait to see what ideas we end up with. And we are a state regulatory podcast, so we do have some guidelines, of course. I will run those through real quick. So, proposals must be created for educational and informational purposes only. Topics should be relevant to the cannabis industry and or patients and consumers.
All proposals will be reviewed for relevance and appropriateness, of course. Advertising or promotion of cannabis products, brands, businesses, individuals, or entities is not going to be permitted.
Interview questions will be shared with guests prior to recording, so we can all be ready to have a great interview. Uh recordings will take place in Jefferson City. The podcast is pre-recorded, and it is subject to editing and final podcast inclusion discretion by DHSS.
And finally, guests will have an opportunity to review a draft version before publication. So, Tara, ah this is so exciting. That means that there's an application to fill out if someone would like to be a guest. Is that correct?
Yes, there is. And it's a it's a brief application, just a few questions, basically telling us what you want to talk about, what do you want to come on the show about. And um for now, you can just email me at Tara, t a r a dot mckinney at a health dot mo dot gov, and I'll shoot that link right over to you.
Our website is going through a transition right now, and it's just this is something that can wait until we've transitioned to get online. So, we're we're holding out on that. But for now, just email me, and it it will eventually be on our website, though. Yeah. And with all good things, we have to start somewhere, so email us if you want to join. We look so forward to hearing from you. Um so, hopefully this this summer we'll have our first guest on, and um you know, Amy and Shayna alternate back and forth, so depending on what month that falls, you're our guest, you'll either be with Shayna or Amy and myself.
all listening that have ever wanted to come on our podcast, this is your chance. This is the time.
>> come.
>> You could be our first guest.
Yeah, it's going to be fun. So, I think that's a wrap for today. I'm just want to remind our listeners to keep up between episodes. There are several ways for you to stay informed. Subscribe to our email list to receive emails from DCR on various topics. Customize them to your needs. Go to cannabis.mo.gov and click on join our email list. The Cannabis Connection newsletter is your information link to Missouri's Division of Cannabis Regulation. And just want to point out there that those are now coming through GovDelivery only and not through PDF. So, just throwing that out there. And for any other outreach events and more, visit cannabis.mo and click on the DCR Communication and Resource tile.
I think that's a wrap.
>> think so. Another great episode. Thanks for having me, Terra. Of course. I love having you as my podcast host. Oh, me too. And I think we're looking forward to a great and busy summer.
>> Yes, absolutely. That's a wrap. Okay.
See you next time. See you next time.
Bye.
>> Bye.
>> [music] [music] [music] >> This podcast content is intended for adults over the age of 21 years old and is best to be used for informational purposes only. The content does not constitute official compliance or regulatory guidance. The department and author assumes no responsibility or liability for [music] any errors or omissions in the content of this podcast. The information contained in this podcast is provided on an as-is basis with no guarantees of completeness, accuracy, usefulness, or timeliness. Cannabis licensees should consult with their assigned compliance officer for rules and regulations specific to their facility. The content is not intended to diagnose or treat any medical condition and should not be relied on for any medical purposes.
Patients and the public should consult with their health care providers about medical related questions and the impact of cannabis on health. If you believe you are having a medical emergency, call emergency services. The views, thoughts, and opinions expressed herein are those of the authors, presenters, and do not necessarily represent the official views of, nor an endorsement by, the US government, Missouri Department of Health and Senior Services, or the government of the state of Missouri.
>> [music] [music] [music]
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