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STATE OF OKLAHOMA
2nd Session of the 58th Legislature (2022)
SENATE BILL 1847 By: Rogers
AS INTRODUCED
An Act relating to medical marijuana; amending 63
O.S. 2021, Section 427.17, which rel ates to medical
marijuana testing laboratory license; allowing
process validation as an acceptable testing practi ce;
requiring process validation not to be mandatory by a
licensee; allowing for mi nimum testing once a
licensee achieves process v alidation; providing
retention policies for the validation process;
providing conditions to be maintained if significant
process changes are made by licensee; allowing for
inspection or audit by Authority; providing
punishment for violation; accessing a registration
fee; allowing for no law, rule , or regulation to
prohibit testing labs for offering services to
licensees; providing for samples consistent with
process validation rules; declaring an emergency.
BE IT ENACTED BY THE PEOPLE OF THE STATE OF OKLAHO MA:
SECTION 1. AMENDATORY 63 O.S. 2021, Section 427.17, is
amended to read as follows:
Section 427.17. A. There is hereby created a medical marijuana
testing laboratory license as a category of the medical marijuana
business license. The Oklahoma Medical Marijuana Authority is
hereby enabled to monitor, inspec t and audit a licensed testing
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laboratory under the Oklahoma Medical Marijuana and Patient
Protection Act.
B. The Authority is hereby authorized to contract with a
private laboratory for the purpose of conducting complian ce testing
of medical marijuana t esting laboratories licensed in this state .
Any such laboratory under contract for compliance testing shall be
prohibited from conducting any other commercial medical marij uana
testing in this state . The laboratory the Au thority contracts with
for compliance testing shall not employ, or be owned by, the
following:
1. Any individual that has a direct or indirect interest in a
licensed medical marijuana business; or
2. Any individual or his or her spouse, parent, child, sp ouse
of a child, sibling or spo use of a sibling that has an application
for a medical marijuana business license pending before the
Department or is a member of the board of directors of a medical
marijuana business, or is an individual financially interes ted in
any licensee or medical marijuana business located within this
state.
C. The Authority shall develop acceptable testin g practices
including, but not limited to, testing, standards, quality control
analysis, equipment certification and calibration, process
validation, and chemical identification an d substances used.
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D. A person who is a direct beneficial owner of a medical
marijuana dispensary, medical marijuana commercial grower or medical
marijuana processor shall not be an owner of a laboratory.
E. A laboratory and a l aboratory applicant sha ll comply with
all applicable local or dinances including, but not limited to,
zoning, occupancy, licensing and building codes.
F. A separate license shall be required for each specific
laboratory.
G. A medical marijuana testing lab oratory license may b e issued
to a person who performs testin g on medical marijuana and medical
marijuana products for medical marijuana businesses, medical
marijuana research facili ties, medical marijuana education
facilities, and testing on marijuana and marijuana products g rown or
produced by a patient or caregiv er on behalf of a patient, upon
verification of registration . A medical marijuana testing
laboratory may also conduct re search related to the development and
improvement of its testing practices and procedures. No state-
approved medical marijuana testing facility shall operate unless a
medical laboratory director is on site during operational hours.
H. Laboratory applicants and licensees shall comply with the
application requirements of this se ction and shall submit such other
information as required for a medical marijuana business applicant,
in addition to any information the Authority may request for initial
approval and periodic evaluations during the approval period.
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I. A medical marijuana testing laboratory may accept samples of
medical marijuana, medical marijuana concentrate or medical
marijuana product from a medical marijuana business , medical
marijuana research facility or medical marijuana education facility
for testing purposes only, which purposes may include the provision
of testing services for samples submitted by a medical marijuana
business for product development . The Department may require a
medical marijuana business to submit a sample of medical mar ijuana,
medical marijuana concentrate or medical marijuana product to a
medical marijuana testing or quality assurance laboratory upon
demand.
J. A medical marijuana testing laboratory may accept samples o f
medical marijuana, medical marijuana concentrate or medical
marijuana product from an individual person for testing only under
the following conditions:
1. The individual person is a patient or caregiver pursuant t o
the Oklahoma Medical Marijuana and Pa tient Protection Act or is a
participant in an app roved clinical or observ ational study conducted
by a research facility; and
2. The medical marijuana testing laboratory shall require the
patient or caregiver to produce a valid patient license and current
and valid photo identification.
K. A medical marijuana testing laborator y may transfer samples
to another medical marijuana testing l aboratory for testing. All
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laboratory reports provided to or by a medical marijuana business or
to a patient or caregive r shall identify the medical marijuana
testing laboratory that actually co nducted the test.
L. A medical marijuana testing laboratory may utilize a
licensed medical marijuana transporter to transport samples of
medical marijuana, medical marijuana concent rate and medical
marijuana product for testing, in accordance with the Oklahoma
Medical Marijuana and Patient Protection Act and the rules adopted
pursuant thereto, between the originating medical marijuana business
requesting testing services and the dest ination laboratory
performing testing services.
M. The medical marijuana testing laboratory shall establish
policies to prevent the ex istence of or appearance of undue
commercial, financial or other influences that may diminish the
competency, impartialit y and integrity of the testing processes or
results of the laboratory, or that may diminish public confidence in
the competency, impart iality and integrity of the testing processes
or results of the laboratory . At a minimum, employees, owners or
agents of a medical marijuana testing laboratory who partic ipate in
any aspect of the analysis and results of a sample are prohibited
from improperly influencing the testing process, improperly
manipulating data or improperly benefiting from any ongoing
financial, employment, personal or business relationship with the
medical marijuana business that provided the sample. A medical
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marijuana testing laboratory shall not test samples for any medical
marijuana business in which an owner, employee or agent of the
medical marijuana testing laboratory has any form of own ership or
financial interest in the medical marijuana business.
N. The Department, pursuant to rules promulgated by the State
Commissioner of Health, shall develop standards, policies and
procedures as necessary for:
1. The cleanliness and orderliness of a laboratory premises a nd
the location of the laboratory in a secure location, and i nspection,
cleaning and maintenance of any equipment or utensils used for the
analysis of test samples;
2. Testing procedures, testing standards for cannabinoid and
terpenoid potency and safe le vels of contaminants, process
validation, and remediation procedures. Process validation shall be
voluntary, and no licensee shall be required to validate their
process. The Department shall develop standards and requirements
for a licensee to achieve process validation. The standards,
policies, and procedures for process validation shall include, but
not be limited to:
a. initial requirements to achieve process validation and
ongoing minimum testing requirements once a licensee
has achieved process validation ,
b. requiring licensees to track their marijuana and
marijuana product inventory with the Department's
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designated seed-to-sale system provided the Department
has selected a seed-to-sale system. This requirement
for compliance with the seed-to-sale system shall be
mandatory for licensees whether compliance with seed-
to-sale system is mandatory for all licensees ,
c. record and document retention policies, which at a
minimum shall require licensees to retain all
documents and records related to process val idation.
Such records shall be main tained by the licensee for
as long as the licensee is continuing to operate under
that validated process. L icensees must retain all
such documents and records for at least four (4) years
after the licensee has stopped using the validated
process or after the licensee has made a significant
process change to a validated process change. Any
significant process to a licensee's validated
processes is subject to the same document retention
requirements and must be retained for as long as the
significant process change is part of an ongoing
validated process, and for at least four (4) years
after the licensee has stopped using the validated
process or after the licensee has made a subsequent
significant process change to the validated process ,
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d. testing requirements to maintain process validation
when a licensee has made a significant process change
to a validated process,
e. requiring licensees to keep all records and documents
related to their pro cess validation read y and
accessible at the address listed on their marijuana
business license for inspection or audit by the
Authority without any notice from the Authority,
f. a process to revoke a lice nsee's authority to operate
under process validation,
g. punishment for willful violations of process
validation that, at a min imum, would prohibit a
licensee from operating under process validation for
five (5) years and the assessment of fine and fees by
the Authority as allowed by law,
h. an annual registration fee not to exceed Two Thousand
Five Hundred Dollars ($2,500.00) per licensee to be
deposited in the Oklahoma Medical Marijuana Revolving
Fund for the enforcement of law and regulation by the
Authority, and
i. provided no law, rule, or regulation sh all prohibit
medical marijuana testing labs from offering services
to licensees to achieve and manage pro cess validation
for consideration;
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3. Controlled access areas for storage of medical mariju ana and
medical marijuana product test samples, waste and r eference
standards;
4. Records to be retained and computer systems to be utilized
by the laboratory;
5. The possession, storage and use by the laborator y of
reagents, solutions and reference stan dards;
6. A certificate of analysis (COA) for each lot of reference
standard;
7. The transport and disposal of unused marijuana, marijuana
products and waste;
8. The mandatory use by a laboratory of an inventor y tracking
system to ensure all harvest and production batches or samples
containing medical marijuana , medical marijuana concentrate or
medical marijuana products are identified and tracked f rom the point
they are transferred from a medical marijuana busi ness, a patient or
a caregiver through the point of transfer, destruction or disposal .
The inventory tracking system reporting shall include the results of
any tests that are conducted on med ical marijuana, medical marijuana
concentrate or medical marijua na product;
9. Standards of performance;
10. The employment of laboratory personnel;
11. A written standard operating procedure manual to be
maintained and updated by the laboratory;
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12. The successful participation in a Department -approved
proficiency testing program for each testing category listed in this
section, in order to obtain and maintain cer tification;
13. The establishment of and adherence to a quality assurance
and quality control program to ensure sufficient monitoring of
laboratory processes and quality of results reported;
14. The immediate recall of medical marijuana or medical
marijuana products that test above allowable thresholds or are
otherwise determined to be unsa fe;
15. The establishment by the laboratory of a system to docume nt
the complete chain of custody for sample s from receipt through
disposal;
16. The establishment by the laboratory of a system to retain
and maintain all required records , including business records, and
processes to ensure results are reported in a time ly and accurate
manner; and
17. Any other aspect of laboratory testing of medical marijuana
or medical marijuana product deemed necessary by the Department.
O. A medical marijuana test ing laboratory shall promptly
provide the Department or designee of th e Department access to a
report of a test and any underlying data that is conducted on a
sample at the request of a medical marijuana business or qualified
patient. A medical marijuana testing laboratory shall also provide
access to the Department or desi gnee of the Department to laboratory
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premises and to any material or information requested by the
Department to determine compliance with the requirements of this
section.
P. A medical marijuana testing laboratory shall retain all
results of laboratory te sts conducted on marijuana or products for a
period of at least seven (7) years and shall make them av ailable to
the Department upon request.
Q. A medical marijuana testing laboratory shall test samples
from each harvest batch or, product batch, or samples consistent
with the promulgated rules fo r process validation, as appropriate,
of medical marijuana, medical marijuana concentrate and medical
marijuana product for each of the following categories of testi ng,
consistent with standards developed by the Co mmissioner:
1. Microbials;
2. Mycotoxins;
3. Residual solvents;
4. Pesticides;
5. Tetrahydrocannabinol (THC) and other cannabinoid potency;
6. Terpenoid type and concentration ; and
7. Heavy metals.
R. A licensed medical marijuana testing laboratory shall test
each individual harvest batch . A grower shall separate each harvest
lot of usable marijua na into harvest batches containing no more tha n
fifteen (15) pounds, with the exception of any plant mate rial to be
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sold to a licensed processor for the purposes of turning the plant
material into concentrate which may be separated into harvest
batches of no more than fifty (50) pounds . A processor shall
separate each medical marijuana production lot into pr oduction
batches containing no more tha n four (4) liters of concentrate or
nine (9) pounds for nonliquid products, and for final products, the
Oklahoma Medical Marijuana Authority shall be authorized to
promulgate rules on final products as necessary . Provided, however,
the Authority shall not req uire testing of final products less often
than every one thousand (1,000) grams of THC. As used in this
subsection, "final products" shall include, but not be limited to,
cookies, brownies, candies, gummies, beve rages and chocolates .
S. Medical marijuana testing laboratory licensure shall be
contingent upon successful on-site inspection, successful
participation in proficiency testing and ongoing compliance with the
applicable requirements in this section.
T. A medical marijuana testing laboratory shal l be inspected
prior to initial licensure and up to two (2) times per year
thereafter by an inspector approved by the Authority. The Authority
may enter the licensed premises of a testing laboratory to conduct
investigations and additional inspections whe n the Authority
believes an investigation or additi onal inspection is necessary due
to a possible violation of applicable laws, rules or regulations.
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U. Medical marijuana testing laboratories shall obtain
accreditation by an accrediting body approved by the Commissioner
within one (1) year of the date the initial license is issued.
Renewal of any medical marijua na testing laboratory license shall be
contingent upon accreditation in accordance with this subsection .
All medical marijuana testing laborator ies shall obtain
accreditation prior to applying for and receiving a medical
marijuana testing laboratory licen se.
V. Unless authorized by the provisions of this section, a
commercial grower shall not transfer or se ll medical marijuana and a
processor shall not transfer, sell or process into a concentrate or
product any medical marijuana, medical marijuana concent rate or
medical marijuana product unless samples from each harvest batch or,
production batch, or samples consistent with the promulgated rules
for process validation from which that medical mariju ana, medical
marijuana concentrate or med ical marijuana product was derived has
been tested by a medical marijuana testin g laboratory and passed all
contaminant tests required by the Oklahoma Medical Marijuana and
Patient Protection Act and applicable laws , rules and regulations.
A licensed commercial grower may transfer medical marijuana that has
failed testing to a licensed processor only for the purposes of
decontamination or remediation and only in accordance with the
provisions of the Oklahoma Medical Marijuana and Patient Protection
Act and the rules and regulations of the Department . Remediated and
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decontaminated medical marijuana may be returned only to the
originating licensed commercial grower.
W. Kief shall not be transferred or sold except as authorized
in the rules and regulations o f the Department.
SECTION 2. It being immediately neces sary for the preservation
of the public peace, health or safety, an emergency is hereby
declared to exist, by reason whereof this act shall take effec t and
be in full force from and after its passage an d approval.
58-2-2763 MR 1/20/2022 10:31:26 PM