Mo. Code Regs. tit. 19 § 100-1.030

Current through Register Vol. 49, No. 20, October 15, 2024

Section 19 CSR 100-1.030 - Complaints, Inspections, and Investigations

PURPOSE: Article XIV, Sections 1 and 2 of the Missouri Constitution, authorizes the Department of Health and Senior Services to promulgate rules for the implementation and enforcement of the Article and to ensure the right to, availability, and safe use of marijuana product. This section applies to complaints, inspections, and investigations of licensed or certified facilities and identification card holders.

(1) Complaints. The department may receive complaints related to any medical or marijuana facility or licensee, or any individual holding a department issued identification card. Complaints may be submitted through the department website.

(A) Upon receipt of a complaint, the department will determine whether the allegations in the complaint warrant further investigation. The department can either close the complaint or conduct an investigation.

(B) If the department determines a complaint against a licensed facility warrants further investigation, the department will advise the licensee of the nature of the allegations in the complaint and provide the licensee with opportunity to respond.

(C) Current and former employees, contractors, owners, and volunteers of a licensee who, in good faith, report potential rule violations to the department may not be subjected to retaliation of any kind by the licensee because of their report.

(2) Inspections and investigations.

(A) The department may conduct an investigation related to an individual card-holder if the department has reason to believe the individual has or is violating any rule in this chapter or provision of Article XIV that could affect the individual's right to continue holding the authority granted by the department.

(B) The department may conduct an inspection or investigation of a licensee or facility at any time, including an inspection of any part of the premises or records of a licensed or certified entity.

1. No medical or marijuana facility licensee may refuse representatives of the department the right to inspect the facility or to audit records of the licensee, including records created or maintained by a third party under an agreement with a licensee.

2. A department employee conducting an inspection or investigation may access all areas of the licensed or certified facility, including vehicles utilized by or on behalf of a licensee, without a warrant and without prior notice to the licensee or its third party contractors.

3. Licensees must provide documents or records requested as part of an inspection or investigation within seven (7) days of the department issuing the request unless additional time is requested and granted.

A. Failure to timely provide requested documents or records may result in a fine of up to five thousand dollars ($5,000) for every day the requested documents or records have not been provided after the deadline.

B. A department request for documents or records made as part of reviewing an application submitted by a licensee, such as a change request, shall be considered an inspection of records.

4. The department may request to interview any employees, contractors, owners, or volunteers of a licensed or certified facility, and the licensee shall arrange for the interview to occur as soon as possible but not later than seven (7) days after the department makes the request to the designated contact on file with the department.

5. Upon receiving a notice of investigation, licensees must preserve all records of any type related to the subject of the investigation at the expense of the licensee, including video camera recordings and facility access control records, until the licensee receives notice that the investigation is concluded.

6. As part of an investigation, the department may take any reasonable action to enforce this chapter, including coordinating with law enforcement.

7. As part of an inspection or investigation, the department may direct the licensee to have marijuana product tested by a certified marijuana testing facility, at the cost of the licensee, when the department finds good cause to do so, which may include credible allegations of rule violations or other indications that the marijuana product does or would create a threat to the health or safety of the public.

8. In the course of any investigation of a licensee, the department may issue an investigative subpoena or subpoena duces tecum to any entity with documents or information relevant to the investigation. The department may enforce its subpoena by applying to the circuit court of Cole County or the county where the premises, records, or entities are located.

(C) Applicants and licensees must cooperate in any investigation conducted by the department. Failure to cooperate with a department investigation may be grounds for denial of an application, penalties, or other remedies not inconsistent with this chapter or Article XIV.

(D) Applicants and licensees must cooperate in any investigation conducted by the department. Failure to cooperate with a department investigation may be grounds for denial of an application or for administrative action against a licensee.

(3) Commencement inspections.

(A) Licensees must request and pass a commencement inspection before they may do any of the following: begin operations under a new license or certification; occupy or utilize new space for which the licensee has not previously received approval to operate, including vehicles; share space with another licensee; change the use of spaces; or, in the case of microbusiness wholesale facilities, begin cultivating or manufacturing where that activity was not already approved after inspection.

1. Requests to begin operations under a new license or certification or new location after change request is approved must be submitted when the licensee believes it will, within thirty (30) days, be ready to begin operations at the facility, and the request must include at least the following:

A. Blueprints of the facility labeling the intended use of all spaces and how those spaces comply with the physical security requirements applicable to them;

B. All SOPs necessary for the licensee to conduct operations in compliance with regulations applicable to it;

C. Records documenting the completion of all required training regarding compliant operation of the state-wide track and trace system; and D. Documentation showing compliance with all applicable federal, state, and local requirements for the facility.

2. Requests to occupy new space at an operational facility must be submitted prior to beginning construction or renovation, and the request must include at least the following:

A. The proposed blueprints for the facility labeling the intended use of all spaces and how those spaces comply with the physical security requirements applicable to them;

B. Documentation to demonstrate compliance with applicable rules as related to the commencement inspection request, including but not limited to SOPs, licenses, permits, certifications, training plans, contracts, etc.;

C. A written explanation of any changes that will occur within the existing space due to the addition of new space and how those changes will comply with applicable regulations; and

D. An attestation that the proposed new space complies with the facility location requirements of this chapter and any location and zoning requirements of the local government.

3. Requests to share space or modify the sharing of space with another licensee must be submitted prior to making any changes to the existing space or most recently approved plan for a space, and the request must include at least the following:

A. Descriptions, schematics, or blueprints for the facility clearly indicating what spaces will be shared or no longer shared;

B. A written explanation of the operations that will occur in each shared space for each licensee sharing the space and how those operations and any related changes to existing space will comply with applicable regulations;

C. Documentation to demonstrate compliance with applicable rules as related to the commencement inspection request, including but not limited to SOPs, licenses, permits, certifications, training plans, contracts, etc.;

D. Copies of agreements between the licensees concerning their respective roles and their relationship for management, operation, and maintenance of the shared spaces, including an acknowledgment that all licensees sharing space will be jointly responsible for compliance with the applicable department regulations for the shared spaces, or documentation showing previously provided agreements are no longer effective, if applicable; and

E. An attestation that the proposed sharing of space complies with any zoning requirements of the local government.

4. Requests to change the use of spaces must be submitted prior to making any changes to the existing space or most recently approved plan for a space, and the request must include at least the following:

A. Descriptions, schematics, or blueprints for the facility clearly indicating the spaces that will be used differently than the most recently approved use of the space;

B. A written explanation of the proposed changes and how all affected spaces will comply with applicable regulations; and

5. Requests by microbusiness wholesale licensees to begin cultivation or manufacturing processes not already approved during a prior commencement inspection must be submitted prior to beginning construction or renovation or making any changes to the existing space or most recently approved plan for a space, and the request must include at least the following:

A. Descriptions, schematics, or blueprints for the facility labeling the intended use of all spaces and how those spaces comply with the physical security requirements applicable to them;

B. A written explanation of any changes that will occur within the existing space due to the addition of new processes and how those changes will comply with applicable regulations;

C. Documentation to demonstrate compliance with applicable rules as related to the Commencement Inspection request, including but not limited to SOPs, licenses, permits, certifications, training plans, contracts, etc.;

D. Records documenting the completion of all required training in compliant operation of the state-wide track and trace system; and

E. Documentation showing compliance with all applicable federal, state, and local requirements for the facility

(B) In any commencement inspection process, if the department determines the licensee who requested the commencement inspection was not prepared to complete the commencement inspection process when it made the request, the department may set aside the request and require the licensee to make a new request once it is ready to proceed.

(C) Licensees who are constructing or renovating in an operational facility are responsible for ensuring the approved spaces are secured while the unapproved spaces are being constructed, which must include at a minimum, ensuring that all access requirements for limited access areas are maintained during construction and that operational spaces are protected from all potential contaminates related to construction.

(D) Licensees may not commence any operations that are subject to a commencement inspection until the department issues written approval to do so.

(E) After submitting a commencement inspection request, licensees are required to actively work to complete the changes outlined in the request and complete the changes within the time frame outlined by the licensee at the time of the commencement inspection request.

(4) Notices of violation.

(A) If the department determines that a licensee is not in compliance with the department's regulations, the department may issue a warning or an Initial Notice of Violation to the licensee that explains how the licensee has violated the department's regulations and what remedial actions the department expects the licensee to take.

1. Once a licensee has been issued an Initial Notice of Violation, the licensee shall, within fifteen (15) days, complete the specified remedial actions and notify the department in writing of that completion, or request additional time for remediation if necessary.

2. In its written notification to the department, if the licensee can demonstrate, to the satisfaction of the department, that the Initial Notice of Violation should not have been issued, the department will withdraw the Initial Notice of Violation.

(B) Licensees that have received an Initial Notice of Violation for more than three (3) rules in a twelve (12) month period or that have ever received more than one (1) Initial Notice of Violation for violating the same regulation in a twelve (12) month period, may be required by the department to:

1. Acquire certification or accreditation to a quality management system standard chosen by the department at the expense of the licensee; or

2. Be subject to an audit of the licensee's processes or practices relevant to the violations by a third party auditor chosen by the department at the expense of the licensee.

(C) The department may conduct a follow-up inspection or review of the licensee or its response to the Initial Notice of Violation. If during such inspection or review the department determines violations have not been cured or remedial actions have not been taken, the department may issue a Final Notice of Violation to the licensee explaining how the licensee continues to violate the department's regulations, what remedial actions the department expects the licensee to take, and that the license may be suspended or fined if the specified remedial actions are not taken or the violations are not cured within thirty (30) days.

(D) If the violations have not been cured or specified remedial actions have not been taken within thirty (30) days after a Final Notice of Violation is sent, the department may either suspend the license or fine the licensee up to an amount equal to the average daily gross receipts of the previous calendar month of the facility per day, until the corrective or remedial actions have been taken by the licensee.

(5) Licensees that receive more than three (3) notices of violation in a twelve (12) month period or that have ever received more than one (1) notice of violation for violating the same regulation may be required by the department to-

(A) Acquire certification or accreditation to a quality management system standard chosen by the department; or

(B) Be subject to an audit of the licensee's processes or practices relevant to the violations by a third party auditor chosen by the department.

19 CSR 100-1.030

Adopted by Missouri Register March 1, 2023/Volume 48, Number 5, effective 2/3/2023

Amended by Missouri Register June 15, 2023/Volume 48, Number 12, effective 7/31/2023