Missouri Code of State Regulations
Title 19 - DEPARTMENT OF HEALTH AND SENIOR SERVICES
Division 100 - Division of Cannabis Regulation
Chapter 1 - Marijuana
Section 19 CSR 100-1.030 - Complaints, Inspections, and Investigations
Universal Citation: 19 MO Code of State Regs 100-1.030
Current through Register Vol. 49, No. 24, December 16, 2024
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
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.
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.
Disclaimer: These regulations may not be the most recent version. Missouri may have more current or accurate information. We make no warranties or guarantees about the accuracy, completeness, or adequacy of the information contained on this site or the information linked to on the state site. Please check official sources.
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