Okla. Stat. tit. 63, § 63-427.17v1

Requirements.

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, the Oklahoma

State Bureau of Narcotics and Dangerous Drugs Control, the Oklahoma

State Bureau of Investigation, and the Attorney General are hereby

enabled to monitor, inspect and audit a licensed testing laboratory

under the Oklahoma Medical Marijuana and Patient Protection Act.

B. The Authority is hereby authorized to operate a quality

assurance laboratory or to contract with a private laboratory for

the purpose of conducting compliance testing of medical marijuana

testing laboratories licensed in this state. Any such laboratory

under contract for compliance testing shall be prohibited from

conducting any other commercial medical marijuana testing in this

state. If the Authority contracts with a private laboratory to

implement the requirements of this section:

1. The laboratory shall not employ, or be owned by, the

following:

a. any individual that has a direct or indirect interest

in a licensed medical marijuana business, or

b. any individual or his or her spouse, parent, child,

spouse of a child, sibling or spouse of a sibling that

has an application for a medical marijuana business

license pending before the Authority or is a member of

the board of directors of a medical marijuana

business, or is an individual financially interested

in any licensee or medical marijuana business located

within this state; and

2. The laboratory and a board or committee comprised of

licensed Oklahoma medical marijuana laboratories currently

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accredited by the International Organization for Standardization

(ISO) shall provide to the Authority its recommendations for all

equipment and standards to be utilized by licensed medical marijuana

testing laboratories when testing samples of medical marijuana,

medical marijuana concentrate, and medical marijuana products as

well as standard operating procedures when extracting and testing

medical marijuana, medical marijuana concentrate, and medical

marijuana products. The recommendations shall be submitted to the

Authority no later than June 1, 2023. The Authority shall have

ninety (90) days from the date it receives the recommendations to

promulgate new rules or modify its current rules for laboratory

standards and testing. Beginning June 1, 2024, medical marijuana

testing laboratories renewing their medical marijuana business

license shall be subject to and comply with any new or modified

rules relating to the testing of medical marijuana, medical

marijuana concentrate, and medical marijuana products. The refusal

or failure of a medical marijuana testing laboratory licensee to

comply with new or modified rules relating to laboratory standards

and testing procedures promulgated under the provisions of this

paragraph shall result in the permanent revocation of the medical

marijuana testing laboratory license.

C. The Authority shall develop acceptable testing practices

including, but not limited to, testing, standards, quality control

analysis, equipment certification and calibration, process

validation, and chemical identification and substances used.

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 laboratory applicant shall comply with

all applicable local ordinances 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 laboratory license may be issued

to a person who performs testing on medical marijuana and medical

marijuana products for medical marijuana businesses, medical
nt shall comply with

all applicable local ordinances 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 laboratory license may be issued

to a person who performs testing on medical marijuana and medical

marijuana products for medical marijuana businesses, medical

marijuana research facilities, medical marijuana education

facilities, and testing on marijuana and marijuana products grown or

produced by a patient or caregiver on behalf of a patient, upon

verification of registration. A medical marijuana testing

laboratory may also conduct research 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 section and shall submit such other

information as required for a medical marijuana business applicant,

Oklahoma Statutes - Title 63. Public Health and Safety Page 1174

in addition to any information the Authority may request for initial

approval and periodic evaluations during the approval period.

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 Authority may require a

medical marijuana business to submit a sample of medical marijuana,

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 of

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 to

the Oklahoma Medical Marijuana and Patient Protection Act or is a

participant in an approved clinical or observational 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 laboratory may transfer samples

to another medical marijuana testing laboratory for testing. All

laboratory reports provided to or by a medical marijuana business or

to a patient or caregiver shall identify the medical marijuana

testing laboratory that actually conducted the test.

L. A medical marijuana testing laboratory may utilize a

licensed medical marijuana transporter to transport samples of

medical marijuana, medical marijuana concentrate 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 destination laboratory

performing testing services.

M. The medical marijuana testing laboratory shall establish

policies to prevent the existence of or appearance of undue

commercial, financial or other influences that may diminish the

competency, impartiality and integrity of the testing processes or

results of the laboratory, or that may diminish public confidence in

the competency, impartiality 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 participate in

any aspect of the analysis and results of a sample are prohibited
ncy, impartiality and integrity of the testing processes or

results of the laboratory, or that may diminish public confidence in

the competency, impartiality 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 participate in

any aspect of the analysis and results of a sample are prohibited

from improperly influencing the testing process, improperly

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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

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 ownership or

financial interest in the medical marijuana business.

N. The Authority, pursuant to rules promulgated by the

Executive Director of the Authority, shall develop standards,

policies and procedures as necessary for:

1. The cleanliness and orderliness of a laboratory premises and

the location of the laboratory in a secure location, and inspection,

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 levels of contaminants, process

validation, and remediation procedures. Process validation shall be

voluntary, and no licensee shall be required to validate their

process. The Authority shall develop standards and requirements for

a licensee to achieve process validation by January 1, 2024. 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 Authority’s

designated seed-to-sale system provided the Authority

has selected a seed-to-sale system. This requirement

for compliance with the seed-to-sale system shall be

mandatory for licensees seeking to achieve process

validation whether or not compliance with a seed-to-

sale system is mandatory for all licensees,

c. requiring licensees that are utilizing process

validation to use a laboratory that is certified as a

certified process validation testing laboratory,

d. requiring licensees to record and document retention

policies, which at a minimum shall require licensees

to retain all documents and records related to process

validation. Such records shall be maintained by the

licensee for as long as the licensee is continuing to

operate under that validated process. Licensees shall

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.

Any significant process change to the validated

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processes of a licensee is subject to the same

document retention requirements and shall be retained

for as long as the significant process change is part

of an ongoing validated process, and for at least four
licensee has made a

significant process change to a validated process.

Any significant process change to the validated

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processes of a licensee is subject to the same

document retention requirements and shall 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. The Authority shall promulgate rules for any

modifications to the validated processes,

e. requiring licensees to keep all records and documents

related to their process validation ready 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 for biannual inspections by the Authority

that, at a minimum, includes random testing of

products being produced under process validation. The

Authority shall be the entity that obtains the random

sample during the biannual inspections and shall have

access to all products being produced or grown under

process validation. The Authority shall take samples

to the quality assurance laboratory,

g. a process to revoke the authority of licensees to

operate under process validation,

h. punishment for violations of process validation that,

at a minimum, would prohibit a licensee from operating

under process validation for five (5) years and the

assessment of a fine not to exceed Fifty Thousand

Dollars ($50,000.00). Any such fine levied against a

licensee found to have violated the laws or rules of

process validation shall be remitted to the Department

of Mental Health and Substance Abuse Services,

i. punishment for violations if an adulterated product

that was produced under process validation fails

testing and the batch or lot has been sold to a

dispensary, the first violation shall be the

assessment of a fine not to exceed Ten Thousand

Dollars ($10,000.00) and a public recall of the

product. The licensee shall further be required to

revalidate the process. A second violation within two

(2) years of a previous violation shall be the

assessment of a fine not to exceed Seventy-five

Thousand Dollars ($75,000.00) and a public recall of

the product. The licensee shall further be prohibited

from utilizing process validation for a minimum of

five (5) years. A third violation within two (2)

years of a previous violation shall be the assessment

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of a fine of Two Hundred Fifty Thousand Dollars

($250,000.00) and a public recall of the product. The

licensee shall further be prohibited from utilizing

process validation,

j. any willful violation of process validation shall

result in the assessment of a fine of Two Hundred

Fifty Thousand Dollars ($250,000.00) and a license

revocation hearing. A second willful violation of

process validation shall result in the assessment of a

fine of One Million Dollars ($1,000,000.00) and a

hearing to permanently revoke the license,

k. an annual registration fee of Five Thousand Dollars

($5,000.00) per licensee, in addition to any other

fees due by the licensee, to be deposited in the

Oklahoma Medical Marijuana Authority Revolving Fund

for the enforcement of the laws and regulations of the

Authority,

l. establishing criteria for eligibility of testing

laboratories to be certified as a Certified Process

Validation Testing Laboratory and to conduct testing

for licensees pursuing or operating under process

validation. The criteria shall, at a minimum, pass

five (5) consecutive blind proficiency tests without a

failure over the course of six (6) months. The

proficiency tests shall be administered by the quality

assurance laboratory,
testing

laboratories to be certified as a Certified Process

Validation Testing Laboratory and to conduct testing

for licensees pursuing or operating under process

validation. The criteria shall, at a minimum, pass

five (5) consecutive blind proficiency tests without a

failure over the course of six (6) months. The

proficiency tests shall be administered by the quality

assurance laboratory,

m. punishment for violations by a Certified Process

Validation Testing Laboratory that has been found to

have been falsifying data, providing misinformation,

or any unethical practices related to process

validation at a minimum shall prohibit a licensee from

operating under process validation for up to twenty-

five (25) years and the assessment of a fine not to

exceed One Million Dollars ($1,000,000.00). Any such

fine levied against a licensee shall be remitted to

the Authority for deposit into the Oklahoma Medical

Marijuana Authority Revolving Fund. In addition to

this fine, in response to a finding of a willful

violation of process validation by the Authority, the

Authority shall also be authorized to collect, levy,

or impose any other fee, fine, penalty, or action as

allowed by law, and

n. a process to revoke the certification of a testing

laboratory that is seeking to be a Certified Process

Validation Testing Laboratory;

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3. Controlled access areas for storage of medical marijuana and

medical marijuana product test samples, waste and reference

standards;

4. Records to be retained and computer systems to be utilized

by the laboratory;

5. The possession, storage and use by the laboratory of

reagents, solutions and reference standards;

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 inventory 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 from the point

they are transferred from a medical marijuana business, 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 medical marijuana, medical marijuana

concentrate or medical marijuana 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;

12. The successful participation in a proficiency testing

program approved by the Executive Director for each testing category

listed in this section, in order to obtain and maintain

certification;

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 unsafe;

15. The establishment by the laboratory of a system to document

the complete chain of custody for samples 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 timely and accurate

manner; and

17. Any other aspect of laboratory testing of medical marijuana

or medical marijuana product deemed necessary by the Executive

Director.

O. A medical marijuana testing laboratory shall promptly

provide the Authority or designee of the Authority access to a

report of a test and any underlying data that is conducted on a

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er; and

17. Any other aspect of laboratory testing of medical marijuana

or medical marijuana product deemed necessary by the Executive

Director.

O. A medical marijuana testing laboratory shall promptly

provide the Authority or designee of the Authority access to a

report of a test and any underlying data that is conducted on a

Oklahoma Statutes - Title 63. Public Health and Safety Page 1179

sample at the request of a medical marijuana business or qualified

patient. A medical marijuana testing laboratory shall also provide

access to the Authority or designee of the Authority to laboratory

premises and to any material or information requested by the

Authority to determine compliance with the requirements of this

section.

P. A medical marijuana testing laboratory shall retain all

results of laboratory tests conducted on marijuana or products for a

period of at least seven (7) years and shall make them available to

the Authority upon request.

Q. A medical marijuana testing laboratory shall test samples

from each harvest batch or, product batch, or samples consistent

with the rules promulgated for process validation, as appropriate,

of medical marijuana, medical marijuana concentrate and medical

marijuana product for each of the following categories of testing,

consistent with standards developed by the Executive Director:

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 marijuana into harvest batches containing no more than

fifteen (15) pounds, with the exception of any plant material to be

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 production

batches containing no more than 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 require 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, beverages 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 shall 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

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investigations and additional inspections when the Authority

believes an investigation or additional inspection is necessary due

to a possible violation of applicable laws, rules or regulations.

U. Medical marijuana testing laboratories shall obtain

accreditation by an accrediting body approved by the Executive

Director or the Authority’s quality assurance laboratory within one
ety Page 1180

investigations and additional inspections when the Authority

believes an investigation or additional inspection is necessary due

to a possible violation of applicable laws, rules or regulations.

U. Medical marijuana testing laboratories shall obtain

accreditation by an accrediting body approved by the Executive

Director or the Authority’s quality assurance laboratory within one

(1) year of the date the initial license is issued. Renewal of any

medical marijuana testing laboratory license shall be contingent

upon accreditation in accordance with this subsection. All medical

marijuana testing laboratories shall obtain accreditation prior to

applying for and receiving a medical marijuana testing laboratory

license.

V. Unless authorized by the provisions of this section, a

commercial grower shall not transfer or sell medical marijuana and a

processor shall not transfer, sell or process into a concentrate or

product any medical marijuana, medical marijuana concentrate or

medical marijuana product unless samples from each harvest batch or,

production batch, or samples consistent with the rules promulgated

for process validation, from which that medical marijuana, medical

marijuana concentrate or medical marijuana product was derived has

been tested by a medical marijuana testing 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 promulgated by the Executive

Director. Remediated and 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 promulgated by the Executive Director.