§ 427.17. Medical marijuana testing laboratory license--Requirements
Oklahoma Statutes AnnotatedTitle 63. Public Health and SafetyEffective: May 26, 2022
Effective: May 26, 2022
63 Okl.St.Ann. § 427.17
§ 427.17. Medical marijuana testing laboratory license--Requirements
<Text as amended by Laws 2022, c. 251, § 17, and Laws 2022, c. 351, § 1. See, also, text as amended by Laws 2022, c. 251, § 17, Laws 2022, c. 353, § 1, Laws 2023, c. 168, § 8, and Laws 2023, c. 322, § 9.>
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, inspect and audit a licensed testing 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 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. The laboratory the Authority contracts with for compliance testing shall not employ, or be owned by, the following:
2. 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.
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, 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.
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 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 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.
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:
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,
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 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,
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,
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 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,
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,
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
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;
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 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.
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:
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.
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 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 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.
Credits
Laws 2019, c. 11, § 17; Laws 2019, c. 312, § 4, emerg. eff. May 7, 2019; Laws 2021, c. 553, § 19, eff. Nov. 1, 2021; Laws 2022, c. 251, § 17, eff. Nov. 1, 2022; Laws 2022, c. 351, § 1, emerg. eff. May 26, 2022.
63 Okl. St. Ann. § 427.17, OK ST T. 63 § 427.17
Current with emergency effective legislation through Chapter 106 of the Second Regular Session of the 59th Legislature (2024). Some sections may be more current, see credits for details.
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