PURPOSE: Under Article XIV, Section 1 of the Missouri Constitution, the Department of Health and Senior Services has the authority to regulate and control Medical Marijuana Facilities. This rule explains what regulations apply only to Testing Facilities. (1) Access to Testing Facility Certifications. The number of testing facility certifications will be limited to ten (10) unless the department determines the limit must be increased in order to meet the demand for medical marijuana by qualifying patients.

1. (2) Testing Facility Requirements. In addition to the requirements of 19 CSR 30-95.040, testing facilities shall also comply with the following:

   1. (A) Testing facilities must ensure all facility employees are trained in at least the following:

      1. 1. The use of security measures and

controls that have been adopted by the facility for the prevention of diversion, inversion, theft, or loss of marijuana;

1. 2. Proper use of the statewide track and

trace system; and

1. 3. Procedures for responding to an

emergency, including severe weather, fire, natural disasters, and unauthorized intrusions;

1. (B) Testing facilities shall comply with International Organization for Standardization (ISO) 17025 standards for personnel at all times;
2. (C) During any periods of time when a facility no longer complies with ISO 17025 standards for personnel, the facility shall not conduct testing of medical marijuana. Upon return to compliance, the facility shall not resume testing until the department conducts an inspection of the facility;

3. (D) Testing facilities shall become fully accredited to the standard set forth by ISO 17025 by an International Laboratory Accreditation Cooperation recognized accreditation body. Testing facilities shall achieve such accreditation within one (1) year of the date the facility receives department approval to operate and shall maintain its accreditation as long the facility holds a certification.

   1. 1. The scope of the accreditation shall

include all medical marijuana testing performed at the facility.

1. 2. Loss of accreditation shall be report-

ed to the department by the testing facility within twenty-four (24) hours of the testing facility receiving notice of the loss.

1. 3. Inspection and audit reports from the

accrediting body shall be submitted to the department by the testing facility within ten (10) days of receipt;

1. (E) Testing facilities shall participate in a proficiency testing program provided by an organization that operates in conformance with the requirements of ISO/IEC 17043 at least twice in a calendar year.

   1. 1. The facility shall notify the depart-

ment of the proficiency testing provider the facility chooses, and the department will work with the proficiency testing provider to determine the schedule the provider will follow when sending proficiency testing samples to facilities for analysis.

1. 2. The facility shall analyze proficiency

test samples using the same procedures and equipment as used for testing medical marijuana.

1. 3. Upon receipt of proficiency test

results, the facility shall submit copies of those results to the department;

1. (F) Testing facilities shall install and maintain security equipment designed to prevent unauthorized entrance into limited access areas, which shall include any area where medical marijuana is tested, stored, or disposed, and to prevent diversion and inversion of medical marijuana including:

   1. 1. Devices or a series of devices to

detect unauthorized intrusion, which may include a signal system interconnected with a radio frequency method, such as cellular or private radio signals, or other mechanical or electronic devices;

1. 2. Electronic monitoring, including:

   1. A. At least one (1) call-up monitor

that is nineteen inches (19") or more;

1. B. A printer capable of immediately

producing a clear still photo from any video camera image;

1. C. Video cameras with a recording

resolution of at least 1920 x 1080, or the equivalent, at a rate of at least fifteen (15) frames per second, that operate in such a way as to allow identification of people and activities in the monitored space, and that provide coverage of—

1. (I) All entrances and exits from

limited access areas, including windows; and

1. (II) All areas in which medical

marijuana is tested, stored, or disposed, from at least two (2) angles;

1. D. A method for storing recordings

from the video cameras for at least sixty (60) days in a secure on-site or off-site location or through a service or network that provides on-demand access to the recordings and that allows for providing copies of the recordings to the department upon request and at the expense of the facility;

1. E. A failure notification system that

provides an audible and visual notification of any failure in the electronic monitoring system; and

1. F. Sufficient battery backup for video

cameras and recording equipment to support at least sixty (60) minutes of recording in the event of a power outage;

1. 3. Controlled entry to limited access

areas, which shall be controlled by electronic card access systems, biometric identification systems, or other equivalent means. Access information shall be recorded, and all records of entry to limited access areas shall be maintained for at least one (1) year;

1. (G) Testing facilities shall maintain all sampling and testing records for five (5) years; and

2. (H) Testing facilities may only transport medical marijuana—

   1. 1. That the facility intends to test;
   2. 2. From cultivation, dispensary, manu-

facturing, and other testing facilities;

1. 3. If the facility complies with the

requirements of 19 CSR 30-95.100(2).

1. (3) Sampling Requirements.

   1. (A) Sampling and testing of medical marijuana shall be done at the lot level.

   2. (B) Sampling and testing of each harvest lot or process lot shall be conducted with representative samples such that there is assurance that all lots are adequately assessed for contaminants and that the cannabinoid profile is consistent throughout.

      1. 1. In the case of dry, unprocessed mari-

juana, the maximum amount of marijuana from which a sample may be selected is fifteen pounds (15 lbs.), and a minimum of zero point five percent (0.5%) of a harvest lot will be sampled for testing.

1. 2. In the case of concentrates and

extracts, the amount of material required for

10+ 4.58+ 32

1. 3. In the case of all other infused prod-

ucts, the amount of material required for sampling is—

3,201 – 35,000+ 20

1. (4) Testing Requirements.

   1. (A) Testing facilities shall test all lots of medical marijuana produced by cultivation or 19 CSR 30-95

infused products manufacturing facilities. Testing shall only be performed on the final medical marijuana product equivalent to what will be dispensed to the patient.

1. (B) Mandatory testing requirements may only be met through testing of samples collected by the testing facility according to section (3) of this rule.

2. (C) Upon request from a licensed cultivation, manufacturing, or dispensary facility, testing facilities may also test material received directly from the facility, including:

   1. 1. Medical marijuana plants at any stage

of growth;

1. 2. Infused products at any stage of pro-

duction; and

1. 3. Components used for the production

of final medical marijuana product, such as water or growing materials.

1. (D) Within five (5) business days of collecting a sample, the testing facility shall file a report in the statewide track and trace system detailing all test results and stating whether the lot passed or failed each required test. Filing of this report must coincide with or precede any notice of test results to the originating facility.

2. (E) Testing of the cannabinoid profile of the final medical marijuana product shall include those analytes listed below, and the acceptable limits for each analyte will be a percentage deviation from the mean in concentration throughout the lot of fifteen per-

   1. 5. Cannabinol (CBN), CAS number

521-35-7.

1. (F) Testing for contaminants in the final medical marijuana product shall include, but shall not be limited to:

   1. 1. Microbial screening. A test will fail if

detectable in 1 gram;

1. 2. Chemical residue screening. A test

will fail if it shows—

AND SENIOR SERVICES

Trifloxystrobin 141517-21-7 > 0.2

* Permethrins cumulative residue of cisand trans-permethrin isomers + Pyrethrins cumulative residues of pyrethrin 1, cinerin 1 and jasmolin 1

1. 3. Heavy metal screening. A test will

Mercury > 0.1

1. 4. Residual solvents. A test will fail if it

Total Xylenes (ortho-, meta-, para-) 1330-20-7

1. 5. Water activity and moisture content

screening. A test will fail if it shows, for dry, unprocessed marijuana, water activity that exceeds 0.65 Aw and moisture content that is not between 5.0% and 13.0%; and

1. 6. Foreign matter screening. A test will

fail if it shows—

1. A. More than 5.0% of stems 3 mm or

more in diameter; or

1. B. More than 2.0% of other foreign

matter (mites, hair, dirt, etc.).

1. (5) Medical marijuana that fails mandatory testing shall not be retested and will be immediately placed on hold by the testing facility through the statewide track and trace system pending disposal or remediation.

2. (6) Testing facilities may acquire from cultivation, manufacturing, and dispensary facili- > 3.0

   > 150 > 2170

ties raw material, such as plant material, concentrates, extracts, and infused products, for testing method development.

1. (7) Testing facilities shall retain any portion of a sample that was not used in the testing process for, at a minimum, forty-five (45) business days after testing is complete.

   1. (A) Excess sample material shall be securely stored in a manner that prohibits sample degradation, contamination, and tampering and available to the department upon request.
   2. (B) When no longer subject to retention, sample material shall be disposed pursuant to 19 CSR 30-90.070(4)(E).

AUTHORITY: sections 1.3.(1)(b), 1.3.(2), 1.3.(3), and 1.3.(4) of Article XIV, Mo. Const. Emergency rule filed May 24, 2019, 19 CSR 30-95 effective June 3, 2019, expired Feb. 27, 2020. apply only to Dispensary Facilities. (1) Access to Dispensary Facility Licenses. 95.040, dispensary facilities shall also comply with the following: (A) Dispensary facilities must ensure all facility employees are trained in at least the following: 1. The use of security measures and controls that have been adopted by the facility for the prevention of diversion, inversion, theft, or loss of marijuana; 2. Proper use of the statewide track and trace system; 3. Procedures for responding to an emergency, including severe weather, fire, natural disasters, and unauthorized intrusions; 4. Standards for maintaining the confi- dentiality of information related to the medical use of marijuana, including, but not limited to, compliance with the Health Insurance Portability and Accountability Act; 5. Procedures for verifying the identity and purchase limitations of qualifying patients and primary caregivers; 6. The differences in the purported AND SENIOR SERVICES effects and effectiveness of the strains of medical marijuana available for purchase at that dispensary and the methods of their use; and 7. Recognizing signs of medical mari- juana abuse in patients; (B) Dispensary facilities must make available to all customers patient education materials that include at least the following: 1. Local resources for concerns about addiction, as well as the phone number for the Substance Abuse and Mental Health Services Administration’s National Helpline; 2. Information about the different strains of medical marijuana available at that dispensary and the purported effects of the different strains; 3. Information about the purported effectiveness of various methods, forms, and routes of administering medical marijuana; 4. Information about potential risks and possible side effects of medical marijuana use, including risk of poisoning and the phone number for the closest poison control center; and 5. The prohibition on consuming mari- juana for medical use in a public place, including the definition of what constitutes a public place pursuant to this rule; (C) Dispensary facilities must, for every transaction— 1. Receive the transaction order at the dispensary directly from the qualifying patient or primary caregiver in person, by phone, or via the internet, and not from a third party; 2. At the time of sale, verify through the statewide track and trace system that the qualifying patient or primary caregiver is currently authorized to purchase the amount of medical marijuana requested and, in the case of a seed purchase, that the patient or primary caregiver is currently authorized to cultivate medical marijuana; 3. In the case of a delivery order, receive payment before the medical marijuana leaves the dispensary, subject to refund if the delivery cannot be completed; and 4. At the time of sale or delivery, require production of a qualifying patient or primary caregiver identification card, a governmentissued photo ID, and in the case of medical marijuana seed purchases, a patient cultivation identification card; (D) Dispensary facilities must report any incident of theft or attempted theft of medical marijuana to the department within twentyfour (24) hours of the incident; (E) Dispensary facilities must design their facility and staffing in such a way as to accomplish the following: 1. The general public, qualifying patients, and primary caregivers may only enter the facility through one (1) access point into an area where facility agents shall screen individuals for qualifying patient or primary caregiver status. No medical marijuana may be accessible in this area; 2. Only qualifying patients, primary caregivers, and, if requested by a qualifying patient, up to two (2) additional persons to support the qualifying patient, may enter any areas beyond the facility’s access point area; and 3. In any limited access area where medical marijuana is accessible, the facility shall only allow access at any given time for a number of qualifying patients and/or primary caregivers equal to the number of staff available to serve those individuals at that time; (F) Dispensary facilities shall not sell medical marijuana until the medical marijuana has been tested by a testing facility, according to the provisions of 19 CSR 30-95.070, and been verified as passing all required testing; (G) Dispensary facilities may only transport medical marijuana— 1. To qualifying patients, primary care- givers, testing, manufacturing, and other dispensary facilities; and 2. If the facility complies with the requirements of 19 CSR 30-95.100(2); (H) Dispensary facilities that sell ingestible medical marijuana-infused products shall comply with the applicable food safety standards set forth in 19 CSR 20-1.025; (I) Dispensary facilities shall store all medical marijuana— 1. At the approved location of the facili- ty; or 2. In offsite warehouses that comply with the security requirements of 19 CSR 30- 95.040(4)(H), the location requirements of 19 CSR 30-95.040(4)(B), and that have been approved pursuant to 19 CSR 30- 95.040(3)(C); (J) Dispensary facilities shall only sell medical marijuana seeds acquired from cultivation facilities; (K) Dispensary facilities shall not sell medical marijuana to a qualifying patient or primary caregiver in amounts greater than what that individual is currently authorized to purchase per the statewide track and trace system; (L) Dispensary facilities shall not sell medical marijuana seeds to a qualifying patient or primary caregiver who is not currently authorized to cultivate medical marijuana; (M) Dispensary facilities may accept returns and issue refunds or credits as needed except that medical marijuana that has been removed from the packaging in which it arrived at the dispensary, whether removed before sale by the dispensary or after sale by a patient or caregiver, may not be accepted as a return; (N) Dispensary facilities shall not disburse medical marijuana as part of a promotional event. If a facility disburses medical marijuana free of charge for any other reason, the facility shall record that disbursement of product in its seed-to-sale system with all relevant entries, including the qualifying patient or primary caregiver information and the amount of medical marijuana disbursed to that qualifying patient or primary caregiver; (O) Dispensary facilities shall not allow consumption of medical marijuana on their licensed premises; and (P) Dispensary facilities shall not allow physicians to meet with individuals on the dispensary’s premises for the purpose of certifying them as qualifying patients. AUTHORITY: sections 1.3.(1)(b) and 1.3.(2) of Article XIV, Mo. Const. Emergency rule filed May 24, 2019, effective June 3, 2019, expired Feb. 27, 2020. Original rule filed May 24, 2019, effective Jan. 30, 2020.