MODA Rulemaking Priorities and Suggestions 2019

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RULEMAKING PRIORITIES & SUGGESTIONS


Rulemaking Priority Rulemaking Subjects ●

Patient education standards*

Security standards*

Setting a daily purchase limit

Product testing guidelines - products should be tested and information should be supplied by cultivator or manufacturer into the STS software

Labeling standards

*Suggestions Prepared

Proposed Priority Rules DISPENSARIES Non Transferable Licenses The dispensary registration certificate issued by the Department to a dispensary is non transferable. No Sale With Other Regulated Products Dispensaries shall not offer tobacco or tobacco related products including cigarettes, tobacco vapor, e-cigs, nicotine vapor, chewing or smokeless tobacco, hookah, etc. in the same retail space or in a shared location. Dispensaries shall not offer liquor or alcohol or related products in the same retail space or in a shared location. Treatment of Minors Recommendations for patients under 18 years of age must be filled in only consumable, topical, or suppository forms.


Patient Communication Dispensaries may communicate with registered patients and caregivers through electronic means, U.S. mail or voice means, provided that written authorization for such communication has been received. This authorization may be withdrawn by the registered patient or caregiver at any time. Dispensaries shall develop the appropriate procedures and forms necessary for registered patients and caregivers to “opt in” and to “opt out” of such communications Advertising Standards Dispensaries may relay current pricing information through electronic means or social media, but shall not use pricing in print, broadcast, television, or other media as a form of advertisement. A dispensary may advertise its entity, results of customer satisfaction surveys, and/or their location of business. Pricing Standards Cultivation facilities, manufacturing facilities, and dispensaries in Missouri should be subject to an oversight board that would ensure an affordable and successful enclosed market for Missourians. Additionally, we believe patients who are interested should be able to apply for a financial designation with the state alongside their application. If qualified customers would be identified in the tracking system and statewide all dispensaries would have a sliding scale system for low income or qualifying patients.


Patient Education Suggestions Dispensary policies must include a provision that requires dispensaries to provide educational materials about marijuana to qualifying patients and their primary caregivers. Each dispensary must have, available for distribution, an adequate supply of up-to-date education material that assists the patient or primary caregiver in the selection of prepared marijuana appropriate for the patient. Educational materials must be available for inspection by the Department upon request. The educational material must include, at a minimum, the following: ● Information about the typical and potential effects of different strains of marijuana preparations, and methods of administration. Dispensaries shall provide “tracking sheets” to qualifying patients and primary caregivers who request them to keep track of the strains used and their effects. ● Information on how to achieve proper dosage for different modes of administration must be shared. Emphasis shall be on using the smallest​ ​amount possible to achieve the desired effect. The impact of potency must also be explained. ● Information on tolerance, dependence and withdrawal must be provided. ● Information regarding substance abuse signs and symptoms must be available, as well as referral information. ● Information on whether the dispensaries’ products meet organic certification standards must be provided.


Safety and Security Suggestions Dispensary security: protection of premises and persons. Registered dispensaries must implement appropriate security measures to deter and prevent unauthorized entrance into areas containing marijuana and the theft of marijuana at the registered dispensary. Security measures to protect the premises, the public, qualifying patients, primary caregivers and principal officers, board members and employees of the registered dispensary must include, but are not limited to, the following: ● Exterior lighting sufficient to deter nuisance activity and facilitate surveillance, but not disturb neighbors. ● Preventing trees, bushes and other foliage outside of a registered dispensary location to grow to such an extent that would affect the functionality of security measures ● Devices or a series of devices, including, but not limited to, a signal system interconnected with a radio frequency method such as cellular, private radio signals, or other mechanical or electronic device to detect an unauthorized intrusion. ● Interior electronic monitoring, video cameras, and panic buttons. Electronic monitoring and video camera recording records must be maintained by the dispensary for at least 14 days. An operational security alarm system at each registered location, with an immediate automatic electronic notification system. ● The alarm system and all of its components shall be tested professionally at least once a year. ● Testing shall be documented and include at a minimum, testing date, summary of activity performed, any items that required corrective action, and name of the person performing the testing. Any items requiring corrective actions must be performed in a reasonable amount of time and documented. Documentation of corrective actions shall include at least the following: the reason for repair, date of repair, name of the person performing the repair, and summary of repair activity. ● In the event the security system is non-operational due to loss of power, mechanical malfunction, or other circumstance, for more than a four hour period, the registered dispensary shall notify the Department in writing within 24 hours from the time of the event. Alternate security measures, approved by the Department, may be required until the security system is restored and fully operational. Documentation shall be maintained any time the security system is non-operational, including cause, date, corrective action taken, contactor performing corrective actions (if applicable), any alternative security measures implemented, and cardholder name and identification number documenting the event. If a violation occurs during an event, the Department shall be notified. ● Video surveillance shall monitor customer service areas, entry and egress areas, and any other areas at the registered location containing marijuana, including processing, storage, and packing areas. ● Consistent and systematic prevention of loitering.


Complete Dispensary Rule Suggestions Residency Requirement All employees, principal officers and board members of a registered dispensary must be residents of the State of Missouri with no disqualifying criminal charges. Dispensary must maintain documentation of State of Missouri residency for each employee, principal officer and board member including: Copy of current dispensary registry identification card and copy of a Missouri driver’s license or other Missouri issued photographic identification card. Employment application and required documentation. Documentation of background checks. Dispensary Registry Identification Cards The dispensary must obtain registry identification cards for its principal officers, board members, and employees in accordance with this rule and the statute. A dispensary may not apply for a registry identification card for a principal officer, board member or employee who is not a Missouri resident or who has been convicted of a disqualifying drug offense. A dispensary may not employ a person under the age of 21. An applicant must submit a completed application for a registry identification card which includes, but is not limited to, the following information: Residency information required for a criminal history record check; Social Security Number or sales tax ID number for tax reporting purposes The Department may deny an application for a registry identification card if the applicant failed to provide required information or provided false information.

Inspections Registered dispensaries are subject to inspection at least annually by the Department in accordance with this rule. Submission of an application for a dispensary registration certificate constitutes permission for entry and inspection of the dispensary location(s). Failure to cooperate with required inspections may be grounds to revoke the dispensary’s registration certificate. During an inspection, the Department may identify violations of this rule, the statute and the dispensary’s policies and procedures. The dispensary shall receive written notice of the nature of the violations.


The dispensary shall notify the Department in writing with a postmark date within ten business days of the date of the notice of violations and identify the corrective actions taken and the date of the correction. Quality control To ensure the safety of qualifying patients, the registered dispensary shall provide samples to the Department or assigned testing facility upon request during announced and unannounced inspections for product quality control. Sample collection and labeling. During an inspection of the registered dispensary, the Department shall: procure samples of products containing marijuana at the dispensary; place the dispensary’s registration number on each sample container; label the sample containers with the description and quantity of its content; seal sample containers; and have dispensary and Department staff initial each sample container. Chain of custody of samples. Chain of custody documentation shall be maintained by the Department. The Department shall provide a receipt for the collected samples to the dispensary’s representative. The Department shall maintain an accounting of all collected sample containers for control purposes. Sample testing. The Department shall test samples for pests, mold, mildew, heavy metals and the presence of pesticides. Additional testing may be conducted. Written results shall be reported to the dispensaries.

Dispensary Policies, Procedures and Records The operating documents of a registered dispensary must include procedures for the oversight of the registered dispensary and procedures to ensure accurate record keeping. Dispensaries must develop, implement and comply with dispensary policies and procedures. When changes are made to its policies or procedures, the dispensary must notify the Department in writing at least ten days before implementation of the change, except when immediate implementation is required, in which case, the dispensary must simultaneously notify the Department when it implements the changed policy or procedure. The written simultaneous notice must include an explanation of why it was necessary to implement the change before giving the Department at least ten days’ notice. The dispensary policies, procedures, and records must be available for inspection by the Department, upon request. Dispensary records subject to inspection include, but are not limited to: Personnel Files The registered dispensary must maintain a confidential personnel file on each principal officer, board member, and employee. The personnel files shall include at least the following information:


Copy of current dispensary registry identification card and copy of a Missouri driver’s license or other Missouri issued photographic identification card. Employment application and required documentation. Documented verification of references. Documentation of background checks. Job description or employment contract. Residency requirement policy ​All employees, principal officers and board members of a registered dispensary must be residents of the State of Missouri. Documentation of current State of Missouri residency shall be maintained in the personnel files of employees, principal officers and board members and shall include, but not be limited to, a copy of a Missouri driver’s license or other Missouri-issued photo identification and physical home address (not mailing address) in Missouri To maintain Missouri residency status, each employee, principal officer and board member of the dispensary must have a physical street home address in Missouri and, in the aggregate, spend more than 183 days of the year in Missouri.

Authorized Dispensaries Conduct Policy In addition to other applicable requirements contained in these rules, a registered dispensary: Must comply with the authorized possession limit at all times Must comply with any daily sales limitations Must verify that the amount of marijuana and marijuana-infused products dispensed will not cause a registered patient or caregiver to exceed either limit. May communicate with registered patients and caregivers through electronic means, U.S. mail or voice means, provided that written authorization for such communication has been received. This authorization may be withdrawn by the registered patient or caregiver at any time. Shall develop the appropriate procedures and forms necessary for registered patients and caregivers to “opt in” and to “opt out” of such communications May relay pricing information through electronic means or social media, but shall not use pricing in print or television media as a form of advertisement. A dispensary may advertise its entity, results of customer satisfaction surveys, and/or their location of business. Authorized Dispensaries Conduct Policy Incident Reporting A registered dispensary must submit a Department-approved incident report form on the next business day after it discovers a violation of the requirements set out in this rule and the statute regarding the operation of dispensaries. The report must indicate the nature of the breach and the corrective actions taken by the dispensary. For the purposes of this rule, an incident includes: Confidential information accessed or disclosed in violation of this rule and the statute;


Loss of inventory by theft, diversion or any other means; Intrusion of the retail dispensary or the cultivation site, if marijuana is not cultivated at the retail site; and Any other violations of this rule or the statute governing operation of the dispensary. Illegal activity reporting. Any suspected illegal activity involving dispensary operations must be reported within 24 hours of suspicion to law enforcement and the Department. The dispensary must submit a written report to the Department using the dispensary’s incident report form. Job Description and Employment Contract Policies The policy regarding job descriptions and employment contracts shall include duties, authority, responsibilities, qualifications, supervision, training in, and adherence to, confidentiality requirements, periodic performance evaluations and disciplinary actions. Alcohol and drug-free workplace policy. A registered dispensary must have and adhere to a written alcohol and drug-free workplace policy. The policy must be available to the Department upon request. The policy must include at least the following provisions: Applicants: substance abuse testing. Applicants who have been offered employment by the registered dispensary must submit to a substance abuse test. The offer of employment must be conditioned on the applicant receiving a negative test result. Substance abuse testing must comply state guidelines. This does not apply if an applicant, who is also a qualifying patient, fails the drug test solely because of the presence of marijuana in a confirmed positive test result. Employees: substance abuse testing. The registered dispensary must have a policy providing for probable cause substance abuse testing consistent with state guidelines. Substances or groups of substances shall include amphetamine/methamphetamine, barbiturates, cannabinoids, benzodiazepines, cocaine and/or metabolites, phencyclidine, opiates, methaqualone, methadone and alcohol. Testing for specific substances of abuse. The registered dispensary shall request a report from the qualified testing laboratory disclosing the presence or absence of, minimally, the following specific substances of abuse: Marijuana, except that the dispensary policy may specify that the reporting of the presence of marijuana for an employee who possesses a valid written certification is not required and the employee’s status as a qualifying patient is confidential. Cocaine. Opiates – opium and codeine derivatives. Amphetamines – amphetamines and methamphetamines. Phencyclidine – PCP. Notify Department: failed drug test. The registered dispensary must notify the Department within one business day of receipt of a confirmed positive result to a lawfully administered substance abuse test of its employees. Repeat failure of drug test. The Department shall refuse to issue or renew a registry identification card to a person who within the 12 months prior to the date of application has had a confirmed positive result to a lawfully administered substance abuse test that occurred within


12 months of another confirmed positive result. This does not apply if that individual failed the drug test solely because of the presence of marijuana in the confirmed positive test result and that person is a qualifying patient. Authorized Dispensaries Conduct Policy Inventory and Supply Records The dispensary shall report the dispensary’s inventory supply. The dispensary shall record the marijuana strains and amounts held by the dispensary and the marijuana products and amounts furnished by the dispensary. Inventory supply records must be available upon request by the Department. Inventory must be included in accessible Seed to Store tracking (STS). Daily inventory must be kept, tracked, logged, and accessible to STS or inventory control system. Prepared marijuana must be kept under double lock and inventoried daily and logged in STS or inventory control system and verified by two cardholders. Quantities of prepared marijuana must be weighed, logged in and signed out when dispensed, must be entered into STS or inventory control tracking system. Quantities of marijuana products must be weighed, logged in and signed out when dispensed, must be entered into STS or inventory control tracking system. Authorized Dispensaries Conduct Policy Transportation and Storage Dispensaries may transport cannabis, cannabis-infused products and cannabis supplies to registered patients and caregivers as permitted by these rules May acquire, possess, transfer, transport, supply, sell, and dispense hemp and hemp-infused products for symptom relief as permitted by these rules Shall store cannabis and cannabis-infused products in a manner utilizing approved security measures including a double lock system Shall verify the identity of each registered patient or caregiver prior to dispensing cannabis at his or her initial appointment Shall verify that a registered patient’s or caregiver’s registry identification card is valid prior to dispensing cannabis Shall provide all revisions to policies, procedures, and educational information to the Department within 10 business days of change Shall provide notification to the department when a registered dispensary cardholder is no longer affiliated with their registered dispensary; Shall ensure registered patients and caregivers do not have direct access to cannabis and cannabis-infused products, except upon the request to examine a specific product. Only one product may be examined at a time and then immediately returned to its proper location, unless the registered patient or caregiver has elected to purchase the product.


Trip Ticket Distribution of marijuana for medical use to a qualifying patient or a primary caregiver for use by a qualifying patient must be labeled with a trip ticket to identify: the dispensary, the patient number or a unique identifier assigned by the dispensary to qualifying patients, or the caregiver number or a unique identifier assigned by the dispensary to the primary caregiver, the product, the amount and form, the time and date of origin, and destination of the product. A primary caregiver or cardholder authorized to transport marijuana may be required to possess a trip ticket as proof of authorized conduct. Persons authorized to transport marijuana on behalf of a patient shall take reasonable steps to deliver the product directly to the qualifying patient as a safety precaution and to alleviate concerns about drug diversion. Patient Designation Reporting The registered dispensary must submit a monthly report of the total number of patients who have designated the dispensary. This report is due to the Department before the tenth day of the each month. The report must include the unique numeric patient identifier that appears on the patient’s valid written certification, date of designation and, if applicable, date of rescission.


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