W. Va. Code R. § 64-111-2

Current through Register Vol. XLI, No. 50, December 13, 2024

Section 64-111-2 - Definitions

2.1. "Act" means the West Virginia Medical Cannabis Act (W. Va. Code § 16A-1-1et seq.).

2.2. "Accreditation body" means an organization which:

2.2.a. Certifies the competency, expertise and integrity of a laboratory and operates in conformance with the current version of International Organization Standard ISO/IEC 17011;

2.2.b. Determines a laboratory's compliance with and conformance to the relevant standards established by the International Organization for Standardization, including ISO/IEC 17025;

2.2.c. Is a signatory to the International Laboratory Accreditation Cooperation Mutual Recognition Arrangement for Testing; and

2.2.d. Is not affiliated with a laboratory applicant for which it has or will issue a certificate of accreditation.

2.3. "Approved laboratory" means a laboratory that has applied for, and received, the approval of the bureau to identify, collect, handle, and conduct tests on samples from a grower/processor and test samples from the bureau used in the growing, processing, or dispensing of medical cannabis as required by the Act and this rule.

2.4. "Bureau" means the West Virginia Bureau for Public Health within the West Virginia Department of Health and Human Resources.

2.5. "Certificate of accreditation" means a document issued by an accreditation body evidencing that a laboratory is in compliance with International Organization for Standardization Standard ISO/IEC 17025 and other requirements relevant to the operation of laboratories conducting tests on medical cannabis and other items used in the growing, processing, or dispensing of medical cannabis.

2.6. "Certificate of analysis" means a document that confirms that the test performed by an approved laboratory on a harvest batch, harvest lot, or process lot meets the testing requirements set forth by the bureau.

2.7. "Chain of custody" means the written procedures used by employees of an approved laboratory to record the possession and transfer of samples and test samples from the time the samples and test samples are collected until the test of the sample or test sample is completed.

2.8. "Dispensary" means:

2.8.a. A person who holds a permit issued by the bureau to dispense medical cannabis.

2.8.b. The term does not include a health care medical cannabis organization as defined under W. Va. Code § 16A-13-1et seq.

2.9. "Electronic tracking system" means an electronic seed-to-sale system prescribed by the bureau that is implemented by:

2.9.a. A grower/processor to log, verify, and monitor the receipt, use and sale of seeds, immature medical cannabis plants, or medical cannabis plants, the funds received by a grower/processor for the sale of medical cannabis to another medical cannabis organization, the disposal of medical cannabis waste, and the recall of defective medical cannabis.

2.9.b. A dispensary to log, verify, and monitor the receipt of medical cannabis product from a grower/processor, the verification of the validity of an identification card presented by a patient or caregiver, the dispensing of medical cannabis product to a patient or caregiver, the disposal of medical cannabis waste, and the recall of defective medical cannabis.

2.9.c. An approved laboratory to log, verify, and monitor the receipt of samples and test samples for testing, the results of tests performed by the approved laboratory, and the disposal of tested and untested samples.

2.10. "Grower/processor means:

2.10.a. A person who holds a permit from the bureau under the act to grow or process medical cannabis.

2.10.b. The term does not include a health care medical cannabis organization as defined under W. Va. Code § 16A-13-1et seq.

2.11. "Harvest batch" means a specifically identified quantity of medical cannabis plant that is uniform in strain, cultivated utilizing the same growing practices, harvested at the same time and at the same location, and cured under uniform conditions.

2.12. "Harvest lot" means a specifically identified quantity of medical cannabis plant taken from a harvest batch.

2.13. "Health care medical cannabis organization" means a vertically integrated health system approved by the bureau to dispense medical cannabis or grow and process medical cannabis, or both, in accordance with a research study under W. Va. Code § 16A-13-1et seq.

2.14. "Laboratory applicant" means a laboratory that submits an application to the bureau for approval to identify, collect, handle, and test medical cannabis and other items used by a medical cannabis organization in the growing, processing, or dispensing of medical cannabis as required under the Act and this rule for the bureau or a grower/processor.

2.15. "Medical cannabis" means cannabis that is grown and sold pursuant to the provisions for certified medical use as set forth in the Act and in a form set forth in the provisions of § 64-110-10.

2.16. "Medical cannabis extract" means a substance obtained by separating cannabinoids from medical cannabis plants by a mechanical, chemical, or other process.

2.17. "Medical cannabis organization" means:

2.17.a. A dispensary or a grower/processor.

2.17.b. The term does not include a health care medical cannabis organization under W. Va. Code § 16A-13-1et seq. or a clinical registrant under W. Va. Code § 16A-14-1et seq.

2.18. "Medical cannabis product" means the final form and dosage of medical cannabis that is grown, processed, produced, sealed, labeled, and tested by a grower/processor and sold to a dispensary.

2.19. "Pharmacist" has the same meaning as the term does in W. Va. Code § 30-5-1et seq. (The Larry W. Border Pharmacy Practice Act).

2.20. "Physician" has the same meaning as the term does in W. Va. Code § 30-3-1et seq. (The West Virginia Medical Practice Act) and W. Va. Code § 30-14-1et seq. (Osteopathic Physicians and Surgeons).

2.21. "Process lot" means any amount of a medical cannabis product of the same type and processed using the same medical cannabis extract, standard operating procedures, and the same or combination of different harvest lots.

2.22. "Processing" means the compounding or conversion of medical cannabis extract by a grower/processor into a medical cannabis product.

2.23. "Sample" means medical cannabis collected by an employee of an approved laboratory from a grower/processor for testing by the laboratory.

2.24. "Test sample" means an amount of medical cannabis or an amount of soil, growing medium, water, or solvents used to grow or process medical cannabis, dust, or other particles obtained from the swab of a counter or equipment used in the growing or processing of medical cannabis, or other item used in the growing or processing of medical cannabis in a facility taken by an employee of an approved laboratory or an agent of the bureau at the request of the bureau from a grower/processor and provided to an approved laboratory for testing.

W. Va. Code R. § 64-111-2