SECTION 310:681-4-5. Inventory tracking, records, and reports

(a)   Monthly reports. Research facility licensees shall submit monthly reports to the Department, which shall include:

(1)   The amount of marijuana purchased from medical marijuana businesses and research facilities in pounds;

(2)   The amount of medical marijuana grown and used for research in pounds;

(3)   The amount of marijuana waste in pounds;

(4)   If necessary, a detailed explanation of why any marijuana cannot be accounted for as having been purchased, used for research, or maintained in current inventory; and

(5)   Any information the Department determines is necessary to ensure that all marijuana grown in Oklahoma is accounted for as required under 63 O.S. § 420 et seq. the Oklahoma Medical Marijuana and Patient Protection Act, 63 O.S. § 427.1 et seq.

(b)   Transfer or sale. A research facility licensee and an educational facility licensee may only transfer, by sale or donation, marijuana grown within its operation to medical marijuana research licensees. Research facility and education facility licensees shall keep records for every transaction related to the donation or sale of marijuana. Records related to the donation or sale shall include at a minimum the following:

(1)   The name and license number of the medical marijuana researcher licensee that purchased or received the medical marijuana;

(2)   The address and phone number of each recipient;

(3)   The type of marijuana donated or sold;

(4)   The amount of marijuana donated or sold in pounds; and

(5)   The date of the donation or sale.

(c)   Records. Pursuant to the Department's audit and inspection responsibilities, research facility and education facility licensees shall keep onsite and readily accessible, either in paper or electronic form, a copy of the records listed below. Except as otherwise specifically provided in Oklahoma law and this Chapter, all records shall be maintained for at least seven (7) years from the date of creation.

(1)   Business records, which may include but are not limited to employee records, organizational documents or other records relating to the governance and structure of the licensee, manual or computerized records of assets and liabilities, monetary transactions, tax records, journals, ledgers, and supporting documents, including agreements, checks, invoices, receipts, and vouchers.

(2)   As applicable, any documents related to the processing, preparation, and/or testing of medical marijuana and medical marijuana products, including but not limited to lab reports, testing records, equipment inspections, training materials, and standard operating procedures.

(3)   Documentation of every instance in which medical marijuana was sold or otherwise transferred to or purchased or otherwise obtained from another licensee, which shall include, but is not limited to:

(A)   The name, license number, address, and phone number of all licensees involved in each transaction; and

(B)   The quantity and type of medical marijuana or medical marijuana products involved in each transaction;

(C)   The batch number of the medical marijuana or medical marijuana products involved in each transaction;

(D)   The date of each transaction;

(E)   The monetary value of the medical marijuana or medical marijuana products involved in each transaction, including the total sale or purchase amounts;

(F)   All point-of-sale and tax records; and

(G)   All inventory manifests and other documentation relating to the transport of medical marijuana and medical marijuana products.

(4)   Any and all documents relating to the disposal or destruction of medical marijuana, medical marijuana products, and medical marijuana waste.

(d)   Inventory. Each research facility and education facility shall use the seed-to-sale tracking system established by the Department or a seed-to-sale tracking system that integrates with the Department-established system at the time of its implementation. The system utilized by each licensee shall be a system that:

(1)   Documents the chain of custody of all medical marijuana and medical marijuana products, including every transaction with another licensee, patient, or caregiver;

(2)   Establishes ongoing inventory controls and procedures for the conduct of inventory reviews and comprehensive inventories of medical marijuana and medical marijuana products for traceability which shall enable the licensee to detect any diversion, theft, or loss in a timely manner;

(3)   Identifies and allows for tracking and documentation of the entire life span of a licensee's stock of medical marijuana and medical marijuana products, including, at a minimum:

(A)   when medical marijuana seeds are planted;

(B)   when medical marijuana plants are harvested and/or destroyed;

(C)   when medical marijuana is transported, sold, stolen, diverted, or lost;

(D)   a complete inventory of all medical marijuana; seeds; plant tissue; clones; usable marijuana; trim; leaves; other plant matter; and medical marijuana products;

(E)   all samples sent to a testing laboratory or used for internal quality testing or other purposes;

(4)   In event of a serious adverse event or recall, is capable of tracking medical marijuana or medical marijuana product from a patient back to the source of the medical marijuana or medical marijuana product; and

(5)   Tracks medical marijuana using an assigned batch number and bar code.

(e)   Audits. The Department may perform on-site audits of all research facility and education facility licensees to ensure the accuracy of the research facility's monthly reports and to ensure that all marijuana grown in Oklahoma is accounted for. Submission of an application for a research facility or education facility license constitutes permission for entry to any licensed premises and auditing of the licensee during hours of operation and other reasonable times. Refusal to permit the Department entry or refusal to permit the Department to inspect all books and records shall constitute grounds for the nonrenewal, suspension, or revocation of a license.

(1)   The Department may review any and all records and information of a research facility or education facility licensee and may require and conduct interviews with such persons or entities and persons affiliated with such licensees, for the purpose of determining compliance with Department rules and applicable laws. Failure to make documents or other requested information available to the Department and/or refusal to appear or cooperate with an interview shall constitute grounds for nonrenewal, suspension, or revocation of a license, or any other remedy or relief provided under law. All records shall be kept on-site and readily accessible.

(2)   Licensees shall comply with all written requests from the Department to produce or provide access to records and information within ten (10) business days.

(3)   If the Department identifies a violation of 63 O.S. § 420 et seq., the Oklahoma Medical Marijuana and Patient Protection Act, 63 O.S. § 427.1 et seq.; or these Rules during an audit of the licensee, the Department shall take administrative action against the licensee in accordance with Oklahoma law, including the Oklahoma Administrative Procedures Act, 75 O.S. § 250 et seq.

(4)   The Department may refer all complaints alleging criminal activity or other violations of Oklahoma law that are made against a licensee to appropriate Oklahoma state or local law enforcement or regulatory authorities.

(5)   If the Department discovers what it reasonably believes to be criminal activity or other violations of Oklahoma law during an audit, the Department may refer the matter to appropriate Oklahoma state or local law enforcement or regulatory authorities for further investigation.

(6)   Except as is otherwise provided in Oklahoma law or these Rules, correctable violations identified during an audit shall be corrected within thirty (30) days of receipt of a written notice of violation.

(7)   If a licensee fails to correct violations within thirty (30) days, the licensee will be subject to a fine of $500.00 for each violation and any other administrative action and penalty authorized by law.

[Source: Added at 37 Ok Reg 168, eff 11-1-19 (emergency); Added at 37 Ok Reg 1461, eff 9-11-20]