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 100-1.130 - Inventory Control and Seed-to-Sale Tracking
Universal Citation: 19 MO Code of State Regs 100-1.130
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 has the authority to regulate and control medical and marijuana licensees. This rule explains what regulations apply to medical and marijuana facility inventory control systems and procedures as well as to certification and operations of seed-to-sale tracking systems.
(1) Inventory control systems and procedures. All licensees shall implement inventory control systems and procedures as follows:
(A) Each licensee shall designate,
in writing, a facility agent who is generally responsible for the inventory
control systems and procedures for that facility;
(B) Licensees shall maintain all records
required by this section for at least five (5) years;
(C) All weighing and measuring of marijuana
product and marijuana waste required by this rule must be conducted with a
National Type Evaluation Program (NTEP) approved scale, which shall be
recalibrated by a certified entity at least yearly.
1. Scales shall be tested and approved in
accordance with the requirements in Chapter 413, RSMo, prior to being placed
into service.
2. Facility agents
shall inspect and log the inspection of each scale to verify it is clean and
reading accurately at least once a month and each time the scale is
moved.
3. Scale inspection logs
shall indicate the date, method of accuracy verification, and by whom the
accuracy is verified.
4. The
licensee's scale shall be designed for the type of weighing or measuring needed
for the licensee's facility type;
(D) Each licensee shall use the state-wide
track and trace system as its system of record to track marijuana product from
seed or immature plant stage until the marijuana product is either purchased by
a consumer, qualifying patient, or primary caregiver; expended during testing;
or destroyed;
(E) All marijuana
product in a medical or marijuana facility must be traceable in the statewide
track and trace system at all times.
1. All
immature plants at least eight (8) inches tall or eight (8) inches wide shall
be tagged with traceability information.
2. All packaged marijuana product shall bear
a tag with traceability information.
3. Licensees shall place a new package tag on
marijuana product any time-
A. A marijuana
product changes product category; or
B. The marijuana product is incorporated into
a different marijuana product;
(F) Licensees must enter into the statewide
track and trace system each day's beginning inventory, harvests, acquisitions,
sales, disbursements, remediations, disposals, transfers, deliveries, ending
inventory, and any other data necessary to complete the inventory control
records in the statewide track and trace system. Records will not be considered
complete unless all available fields for a particular action are completed,
including the identity of the facility agent making the record;
(G) Discrepancies in marijuana product
inventory records shall not be corrected by entering an inventory adjustment
without first being documented, investigated by management personnel, and
reported to the department within twenty-four (24) hours of discovering the
discrepancy. A discrepancy is a situation where the marijuana product may not
be accounted for physically or in the state-wide track and trace system;
(H) If a licensee identifies a
reduction in the amount of marijuana product in the inventory of the facility
due to suspected criminal activity by a facility agent, the licensee shall
report the facility agent to the department and to the appropriate law
enforcement agencies within twenty-four (24) hours of discovering the suspected
criminal activity;
(I) Licensees
must provide to the department a monthly physical inventory report that
includes all adjustments and adjustment reasons and that demonstrates the
physical inventory reconciles with the inventory recorded in the statewide
track and trace system;
(J)
Cultivation licensees must-
1. Report in the
state-wide track and trace system all seeds and all plants of any size;
and
2. Report in the state-wide
track and trace system, by plant or location-
A. All pesticides, herbicides, fertilizers,
and other agricultural chemicals applied to marijuana plants and growing medium
during production and processing at its facility; and
B. All ingredients contained in each
pesticide, herbicide, fertilizer, and other agricultural chemical applied to
the marijuana plants and growing medium during production and processing at its
facility.
(K)
Manufacturing licensees shall-
1. Establish
and maintain a perpetual inventory system that documents the flow of all
non-marijuana materials through the manufacturing process;
2. Establish procedures to reconcile the raw
marijuana material with the finished product on the basis of each process
lot;
3. Record in the state-wide
track and trace system all active and inactive ingredients in each final
manufactured product; and
4. Record
in the state-wide track and trace system the serving or, in the case of medical
marijuana product, dosage amounts for each final manufactured
product.
(L) Dispensary
licensees shall be responsible for ensuring that every amount of marijuana
product sold or disbursed to a consumer, qualifying patient, or primary
caregiver is immediately recorded in the state-wide track and trace system.
Amounts of marijuana product shall be recorded-
1. For dried, unprocessed marijuana and
prerolls, in grams;
2. For
concentrates and infused prerolls, in grams; or
3. For infused products, by milligrams of
THC;
(M) All licensees
must ensure the accuracy of information entered into the state-wide track and
trace system on a daily basis.
1. An error
occurs when information is recorded incorrectly into the state-wide track and
trace system, but the marijuana product can be accounted for.
2. Errors identified within the system must
be immediately corrected. All corrections should be accompanied with a detailed
note in the system clearly outlining the error that occurred and the corrective
action taken.
3. Errors involving
consumer and patient allotments must be reported to the department and
corrected in the state-wide track and trace system within twenty-four (24)
hours of being identified;
(N) In order to facilitate the use of the
state-wide track and trace system, facilities may also employ a
department-certified seed-to-sale tracking system that integrates with the
statewide track and trace system; and
(O) In case of seed-to-sale system failure or
loss of connection between the seed-to-sale system and the state-wide track and
trace system, a licensee must cease performing all actions that are required to
be tracked.
1. Upon system restoration, the
licensee must confirm all inventory and tracking information is accurately
reflected in the state-wide track and trace system.
2. Any such system failure or loss of
connection must be reported to the department within three (3) hours of
identifying the seed-to-sale system failure or loss of connection between the
seed-to-sale system and the state-wide track and trace system.
(2) Seed-to-sale tracking.
(A) Access to seed-to-sale tracking
system certifications.
1. Any entity certified
to conduct seed-to-sale tracking for medical marijuana product as of the
effective date of this section shall be deemed certified to conduct those
activities with respect to all marijuana product.
2. The department will accept applications
for seed-to-sale tracking system certifications via the online application
system.
3. Incomplete applications
for certification of seed-to-sale tracking systems may be denied.
4. The department shall charge an application
fee for a seed-to-sale certification and also an annual fee once a
certification is offered.
A. The first annual
fee will be due thirty (30) days after a certification is offered and shall be
due annually on that same date as long as the certification remains
valid.
B. The department shall
publish the current fees, including any adjustments, on its website. The fees
due will be the fee that is effective as of the due date for the fee.
(B)
Application Requirements. All applications for seed-to-sale tracking system
certifications shall include at least the following information:
1. Name and address of the
applicant;
2. Legal name of the
entity, including any fictitious business names;
3. An attestation by an owner or principle of
the entity that the seed-to-sale tracking system can and will comply with this
rule; and
4. All applicable fees or
proof that all applicable fees have already been paid.
(C) Seed-to-Sale Tracking System
Requirements. All seed-to-sale tracking systems used by licensees shall be
capable of-
1. Interfacing with the statewide
track and trace system such that a licensee's employees may enter and access
information in the statewide track and trace system as required for inventory
control and tracking and for purchase limitations set forth in this
chapter;
2. Providing the
department with access to all information stored in the system's
database;
3. Maintaining the
confidentiality of all patient and consumer data and records accessed or stored
by the system such that all persons or entities other than the department may
only access the information in the system that they are authorized by law to
access; and
4. Producing analytical
reports to the department regarding-
A. Total
quantity of daily, monthly, and yearly sales at the facility per product
type;
B. Average prices of daily,
monthly, and yearly sales at the facility per product type;
C. Total inventory or sales record
adjustments at the facility; and
D.
API error report showing how many times the seed-to-sale tracking system failed
to upload information to the statewide track and trace system, or failed in
some other way.
(D) Seed-to-sale tracking system
prohibitions.
1. No certified seed-to-sale
tracking system entities may begin operations before receiving the department's
written approval to do so and signing the department's Marijuana Application
Programming Interface User Agreement.
2. No seed-to-sale tracking system entity may
be owned by or affiliated with an entity that holds a contract with the state
of Missouri for any product or service related to the department's marijuana
program.
(E)
Tracking-related discipline.
1. The
department may impose a fine of up to five thousand dollars ($5,000), and may
restrict, suspend, or revoke a seed-to-sale tracking system entity
certification for the following reasons:
A.
Failure of a seed-to-sale tracking system entity to comply with this
rule;
B. Failure to abide by the
department's Marijuana Application Programming Interface User
Agreement;
C. Failure of a
seed-to-sale tracking system entity to timely interface with the state-wide
track and trace system;
D.
Persistent failure to interface with the state-wide track and trace system;
or
E. Providing false or misleading
information to the state-wide track and trace system.
2. If a licensee or its employees or
contractors fail to comply with the state-wide track and trace system
requirements or intentionally misuses or falsifies state-wide track and trace
system tracking data, the department may impose a fine of up to fifty thousand
dollars ($50,000), and may restrict, suspend, or revoke the facility's
license.
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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