Current through Register Vol. 49, No. 18, September 16, 2024
PURPOSE: Under Article XIV, Sections 1 and 2 of the
Missouri Constitution, the Department of Health and Senior Services is
authorized to regulate and control the operations of medical and marijuana
facilities. This rule explains general operating requirements applicable to all
licensed and certificated facilities.
(1) Licensing and location.
(A) An entity must obtain a separate license
or certificate for each facility. Subject to department pre-approval, multiple
licenses or certificates may be utilized at a single location. Testing
licensees may not share space with any other facility.
(B) Each license or certification shall be
charged an annual fee once the license or certification is granted. The first
annual fee will be due thirty (30) days after a license or certification is
issued and shall be due annually on that same date as long as the license or
certification remains valid, except for in the case of microbusinesses whose
first annual fee will be due on the anniversary of their licensure. The
department shall publish the current fees, including any adjustments, on its
website. The fees due will be the amount that is effective as of that license
or certification's annual fee due date.
(C) Unless expressly allowed by the local
government, no medical or marijuana facility, including any offsite warehouses,
shall be sited, at the time of application for license, certification, or local
zoning approval, whichever is earlier, or at time of application for
relocation, within one thousand feet (1,000') of any then-existing elementary
or secondary school, daycare, or church. The method of measuring distances is
governed by Article XIV.
(D) A
dispensary or microbusiness will only be approved to relocate within the
congressional district in which they were originally licensed.
(2) Marijuana facility business
change applications. Marijuana facility licensees must apply for and obtain the
department's approval before they may-
(A)
Transfer their license to a different entity with the same ownership. Once the
department has confirmed receipt of a complete application, it will approve or
deny the application within sixty (60) days. Such a request must include at
least the following:
1. Current legal name of
the licensee, including fictitious business names, and proposed new legal name
of the licensee, including fictitious business names;
2. All owners of the licensed entity and
their individual ownership percentage, which must show the proposed new entity
is owned by the same owners as is the licensee;
3. A visual representation of the licensee's
ownership structure, including all owner entities;
4. Other documentation as requested to verify
ownership; and
5. An administrative
and processing fee of two thousand dollars ($2,000).
(B) Make any changes that would result in an
individual becoming an owner of the licensed entity who was not previously an
owner. Once the department has confirmed receipt of a complete application, it
will approve or deny the application within ninety (90) days. Such requests
must include at least the following:
1. All
current and proposed owners of the licensed entity and their proposed
individual ownership percentage;
2.
A visual representation of the licensee's proposed ownership structure,
including all owner entities;
3. A
chart comparing the previously approved ownership percentages to the proposed
ownership percentages;
4.
Verification that the change will not result in any substantially common
control, ownership, or management between a testing licensee and any other
medical or marijuana licensee;
5.
An attestation that all individuals subject to analysis for disqualifying
felony offenses will submit fingerprints within two (2) weeks after the
application submission, or have previously submitted such fingerprints, for a
state and federal fingerprint-based criminal background check to be conducted
by the Missouri State Highway Patrol;
6. For microbusinesses, if the proposed
change affects eligibility, documentation sufficient to demonstrate eligibility
for microbusiness facility ownership, as provided in the application and
selection section of this chapter;
7. Other documentation as requested to verify
ownership; and
8. An administrative
and processing fee of five thousand dollars ($5,000), which shall only be
assessed once on multiple licensed entities with identical ownership making the
same changes in ownership, when submitted at the same time;
(C) Make any changes that would
result in an overall change in ownership interests of fifty percent (50%) or
more from the last approved ownership of the licensee. Once the department has
confirmed receipt of a complete application, it will approve or deny the
application within one hundred fifty (150) days. Such requests may only be
submitted after the licensee's facility has received approval to operate and
must include at least the following:
1. All
current and proposed owners of the licensed entity and their proposed
individual ownership percentage;
2.
A chart comparing the previously approved ownership percentages to the proposed
ownership percentages;
3. A visual
representation of the licensee's proposed ownership structure including all
owner entities;
4. Verification
that the change will not result in any substantially common control, ownership,
or management between a testing licensee and any other marijuana
licensee;
5. An attestation that
all proposed owners will submit fingerprints within two (2) weeks after the
application submission, or have previously submitted such fingerprints, for a
state and federal fingerprint-based criminal background check to be conducted
by the Missouri State Highway Patrol;
6. In the case of full asset transfer to a
different entity, applications must also include:
A. Asset purchase agreement;
B. Merger, sale, transfer, Memorandum of
Understanding (MOU), or other like agreement between the licensee and
transferee;
C. Brand, management,
consultant agreements or contracts, or any other agreement or contracts;
and
D. Location lease agreement or
proof of ownership;
7.
For microbusinesses, documentation sufficient to demonstrate eligibility for
microbusiness facility ownership, as provided in the application and selection
section of this chapter;
8. Other
documentation as requested to verify ownership; and
9. An administrative and processing fee of
eight thousand dollars ($8,000), which shall only be assessed once on multiple
licensed entities with identical ownership making the same changes in
ownership, when submitted at the same time;
(D) Change the licensee's facility or
warehouse location. Once the department has confirmed receipt of a complete
application, it will approve or deny the application within ninety (90) days.
Such requests shall include at least the following:
1. Proposed blueprints that outline the
entire facility and feature all rooms and areas clearly labeled, including
purpose and square footage, camera locations, limited access areas, and access
permissions;
2. Documentation from
the local government with jurisdiction over the facility's location confirming
that the proposed location complies with local distance requirements, or
stating that there are none;
3. If
the local government in which the facility will be located has enacted
applicable zoning restrictions, documentation from the local government with
jurisdiction over the facility's location confirming that the proposed location
complies with applicable zoning restrictions;
4. Location lease agreement and/or proof of
ownership; and
5. An administrative
and processing fee of five thousand dollars ($5000);
(E) Any administrative and processing fee for
a microbusiness change application shall be half the amount listed in (A)-(D)
of this section; and
(F) Change
applications will be approved if the request contains all of the documents,
fees, and information required by this section, and the resulting change in
ownership or ownership interests does not violate any provision of this chapter
or Article XIV. Change requests will be denied if the request does not contain
all the documents, fees, and information required by this section, or if the
resulting change violates any provision of this chapter or Article
XIV.
(3) Medical facility
business change applications. Medical facility licensees must apply for and
obtain the department's approval before they may-
(A) Transfer their license to a different
entity with the same ownership. Such a request must include at least the
following:
1. Current legal name of the
licensee, including fictitious business names, and proposed new legal name of
the licensee, including fictitious business names;
2. Any entity that owns any part of the
licensed entity and their individual ownership percentage, which must show the
proposed new entity is owned by the same entities as is the licensee;
3. A visual representation of the licensee's
ownership structure, including all entities that own any part of the licensed
entity;
4. Other documentation as
requested to verify ownership; and
5. An administrative and processing fee of
two thousand dollars ($2000);
(B) Make any changes that would result in an
overall change in financial or voting interests of fifty percent (50%) or more
from the last approved ownership of the licensee. Such requests may only be
submitted after the licensee's facility has received approval to operate and
must include at least the following:
1. All
current and proposed entities with any financial or voting interest in the
licensed entity and their proposed individual ownership percentage;
2. A chart comparing the previously approved
ownership percentages to the proposed ownership percentages;
3. A visual representation of the licensee's
proposed ownership structure including all entities;
4. Verification that the change will not
result in any substantially common control, ownership, or management between a
testing licensee and any other medical licensee;
5. An attestation that all individuals
subject to analysis for disqualifying felony offenses will submit fingerprints
within two (2) weeks after the application submission, or have previously
submitted such fingerprints, for a state and federal fingerprint-based criminal
background check to be conducted by the Missouri State Highway
Patrol;
6. In the case of full
asset transfer to a different entity, applications must also include:
A. Asset purchase agreement;
B. Merger, sale, transfer, MOU, or other like
agreement between the licensee and transferee;
C. Brand, management, consultant agreements
or contracts, or any other agreement or contracts; and
D. Location lease agreement or proof of
ownership.
7. Other
documentation as requested to verify ownership; and
8. An administrative and processing fee of
eight thousand dollars ($8,000), which shall only be assessed once on multiple
licensed entities with identical ownership making the same changes in
ownership, when submitted at the same time;
(C) Change the licensee's facility location.
Such requests shall include at least the following:
1. Proposed blueprints for the facility that
outline the entire facility and feature all rooms and areas clearly labeled,
including purpose and square footage, camera locations, limited access areas,
and access permissions;
2.
Documentation from the local government with jurisdiction over the facility's
location confirming that the proposed location complies with local distance
requirements, or stating that there are none;
3. If the local government in which the
facility will be located has enacted applicable zoning restrictions,
documentation from the local government with jurisdiction over the facility's
location confirming that the proposed location complies with applicable zoning
restrictions;
4. Location lease
agreement and/or proof of ownership; and
5. An administrative and processing fee of
five thousand dollars ($5,000); and
(D) Change applications will be approved if
the request contains all of the documents and information required by this
section and the resulting change in ownership or ownership interests does not
violate any provision of this chapter or Article XIV.
(4) General operations.
(A) Licenses shall be displayed within twenty
feet (20') of the main entrance to a facility at all times.
(B) A medical or marijuana facility may not
allow cultivation, manufacturing, sale, or display of marijuana product or
marijuana accessories to be visible from a public place outside of the
marijuana facility without the use of binoculars, aircraft, or other optical
aids.
(C) All licensees must comply
at all times with applicable state, local, and federal requirements.
(D) Licensees shall implement a quality
management system using a published standard, such as those offered by
International Organization for Standardization, ASTM International, Cannabis
Safety and Quality, or Foundation of Cannabis Unified Standards, within one (1)
year of the date the facility receives department approval to operate. The
chosen standard shall be applicable to the licensee's facility type and be
implemented with emphasis on regulatory compliance.
(E) All licensees must receive approval to
operate within one (1) year of being issued a license or certification; except
microbusiness licensees, which must receive approval to operate within two (2)
years of issuance. Absent a granted waiver or variance, licenses may be revoked
or sanctioned if not operational and active within the required time
frame.
(F) In the event a licensee
loses control of their approved location, facility, or license, the license
shall be suspended or restricted until a new location is approved or access to
the facility or license is restored.
(G) Only licensees may hold rights to
marijuana product within licensed facilities.
(H) All marijuana-infused products shall be
manufactured in a licensed manufacturing facility. Any facility that extracts
resins from marijuana using combustible gases or other dangerous materials,
without a manufacturing license, shall incur a penalty of ten thousand dollars
($10,000).
(I) All marijuana
product sold in Missouri shall have originated from marijuana grown and
cultivated in a licensed cultivation facility located in Missouri.
(J) All licensees shall establish and follow
SOPs in the event the facility is suspended or ordered to cease
operations.
(K) All licensees shall
establish and follow detailed SOPs for marijuana product remediation.
(L) All licensees shall establish and follow
SOPs to ensure marijuana remains free from contaminants. The systems,
equipment, and documentation necessary to follow procedures must address, at a
minimum:
1. The flow through a facility of any
equipment or supplies that will come in contact with marijuana including
receipt and storage;
2. Employee
health and sanitation; and
3.
Environmental factors, such as-
A. In all
areas of the facility where marijuana is or will be present, floors, walls, and
ceilings made of smooth, hard surfaces that are easily cleaned;
B. Temperature and humidity
controls;
C. A system for
monitoring environmental conditions;
D. A system for cleaning and sanitizing rooms
and equipment;
E. A system for
maintaining any equipment used to control sanitary conditions; and
F. For cultivation and manufacturing
facilities, an air supply filtered through high-efficiency particulate air
filters under positive pressure.
(M) Consumption of marijuana product on the
licensed premises, including in any approved transport vehicles, is prohibited.
All licensees shall post a sign at the employee and public access points to the
facility that consumption of marijuana product is not allowed on the licensed
premises.
(N) If a licensee enters
into a contract with a management company or other entity to run all or part of
the regulated marijuana operations under this chapter, the contract must permit
the licensee to access the licensee-related records of the management company
or other entity at the request of the department during an investigation or
inspection.
(O) All licensees shall
maintain any records required by this chapter for at least five (5)
years.
(P) The department may issue
notice of marijuana product recall to licensees or the public if, in its
judgment, any particular marijuana product presents a threat or potential
threat to the health and safety of qualifying patients or consumers. All
facilities are responsible for complying with recall notices. Recalled items
must be immediately pulled from production or inventory and quarantined until
such time as the department determines the item is safe, may be remediated, or
must be destroyed.
(5)
Signage and advertising must comply with the following:
(A) A marijuana product may only be
advertised or marketed in compliance with all applicable municipal ordinances,
state law, and rules that regulate signs and advertising;
(B) No advertisement of marijuana may
contain:
1. Any representation that is false
or misleading in any way;
2. Any
statement representing that the use of marijuana has curative or therapeutic
effects or tending to create an impression that it has curative or therapeutic
effects unless such statement has been evaluated and approved by the Food and
Drug Administration;
3. Any content
that is attractive to children, including but not limited to the shape or any
part of the shape of an animal or fruit, including realistic, artistic,
caricature, or cartoon renderings, and artistic, caricature, or cartoon
renderings of the shape or any part of the shape of a human; or
4. Any statement concerning a brand of
marijuana that is inconsistent with any statement on the labeling;
(C) Outdoor signage and, if
visible from a public right of way, interior signage, must comply with any
local ordinances for signs or advertising; and
(D) No licensee shall use exterior signage or
advertising that does not accurately reflect a licensee's legal name, business
name or d/b/a, or trade name on record with the department.
(6) Licensee notification and
reporting. Licensees have a duty to keep the department apprised of certain
information as described below. Failure of a licensee to report required
information to the department may result in administrative penalties, to
include a fine of up to ten thousand dollars ($10,000), suspension, or
revocation of the license.
(A) Licensees have
a continuing duty to provide the department with up-to-date contact
information, including the individual who shall be the designated contact for
all department communications.
1. Licensees
shall notify the department in writing of any changes to the mailing addresses,
phone numbers, email addresses, and other contact information they provide the
department.
2. Licensees and
applicants are deemed to have received all communications and notifications
from the department on the date the department sends an email to the email
address of the designated contact for the licensee or applicant.
(B) Licensees must report, at
least annually-
1. For marijuana facility
licensees, all owners, with ownership percentage; and
2. For medical facility licensees, all
entities that own any part of the licensed entity, with ownership
percentage.
(C) Licensees
shall notify the department within five (5) days of the initiation and
conclusion of any legal proceedings, government investigations, or any other
activity that would impair the licensee's ability to operate in accordance with
department regulations or the department's review of an application, including
a petition for receivership, loss of lease or location, or disputes relating to
the ownership or control of the facility or license.
(D) Licensees shall notify the department
when a facility agent has been terminated for misconduct related to handling of
marijuana product, including but not limited to, inventory, product integrity,
marijuana product sales, theft, health and safety, or facility
security.
(E) Licensees shall
notify the department within twenty-four (24) hours following the occurrence of
an event that affects the health and safety of the facility or its employees,
including injury to employees or other persons at the facility resulting in
medical care being administered by a medical professional.
(F) Licensees shall notify the department
within twenty-four (24) hours of discovery of any theft or attempted theft of
marijuana product.
(G) Licensees
shall notify the department within twenty-four (24) hours of discovery of any
criminal misconduct of an employee, contractor, owner, or volunteer.
(H) Cultivation licensees shall notify the
department before changing its cultivation practice (indoor, outdoor, or
greenhouse) or modifying the ratios of cultivation practices it uses, as
provided in the cultivation section of this chapter.
(I) After the department approves a change in
location, the licensee shall request a commencement inspection as required
pursuant to this chapter.
(J)
Licensees shall notify the department of any entity name changes or fictitious
name changes.
(K) Licensees shall
notify the department in writing prior to initiating a facility update that
would be subject to 19 CSR 1001.090, such as adding point of sale equipment in
a dispensary or replacing windows or doors. Within the notification, licensees
shall provide their plan to remain in compliance with applicable rules of this
chapter and ensure security of the facility and marijuana product during the
update.