W. Va. Code R. § 64-110-2

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

Section 64-110-2 - Definitions

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

2.2. "Adverse event" means an injury resulting from the use of medical cannabis dispensed at a dispensary. An injury includes physical harm, mental harm, or loss of function.

2.3. "Adverse loss" means a loss, discrepancy in inventory, diversion or theft of seeds, immature medical cannabis plants, medical cannabis plants, medical cannabis, funds, or other property of a medical cannabis organization.

2.4. "Applicant" means a person who wishes to submit or submits an application to the bureau for a permit to operate as a grower/processor or dispensary, or both, under the Act and this rule.

2.5. "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.

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

2.7. "CBD" means Cannabidiol.

2.8. "Cannabis" means all parts of the plant of the genus cannabis whether growing or not, the seeds thereof, the resin extracted from any part of the plant, and every compound, manufacture, salt, derivative, mixture, or preparation of the plant, its seeds, or its resin, including cannabis concentrate. "Cannabis" does not include industrial hemp, nor does it include fiber produced from the stalks, oil, or cake made from the seeds of the plant, sterilized seed of the plant which is incapable of germination, or the weight of any other ingredient combined with cannabis to prepare topical or oral administrations, food, drink, or other product.

2.9. "Caregiver" means the individual designated by a patient or, if the patient is under 18 years of age, and individual authorized under W. Va. Code § 16A-5-1 et seq. to deliver medical cannabis.

2.10. "Certified medical use" means the acquisition, possession, use, or transportation of medical cannabis by a patient, or the acquisition, possession, delivery, transportation, or administration of medical cannabis by a caregiver, for use as part of the treatment of the patient's serious medical condition, as authorized in a patient certification issued under the Act, including enabling the patient to tolerate treatment for the serious medical condition.

2.11. "Clinical Registrant" means an entity that:

2.11.a. Holds a permit as both a grower/processor and a dispensary.

2.11.b. Has a contractual relationship with an academic clinical research center under which the academic clinical research center or its affiliate provides advice to the entity, regarding, among other areas, patient health and safety, medical applications and dispensing, and management of controlled substances.

2.12. "Controlled substance" means a drug, substance or immediate precursor included in Schedules I though V as listed in the Uniform Controlled Substance Act (W. Va. Code §60A-2-1et seq.).

2.13. "Dispensary" means:

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

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

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

2.14.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.

2.14.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.

2.14.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.

2.15. "Employee" means an individual who is hired for a wage, salary, fee, or payment to perform work for an applicant or permittee.

2.16. "Excipients" means solvents, chemicals, or materials reported by a medical cannabis organization and approved by the bureau for use in the processing of medical cannabis.

2.17. "Facility" means a structure and other appurtenances or improvements where a medical cannabis organization grows and processes or dispenses medical cannabis.

2.18. "Financial backer" means an investor, mortgagee, bondholder, note holder, or other source of equity, capital, or other assets other than a financial institution.

2.19. "Form of medical cannabis" means the characteristics of the medical cannabis recommended or limited for a particular patient, including the method of consumption and any particular dosage, strain, variety, and quantity or percentage of medical cannabis, or particular active ingredient.

2.20. "Grower/processor means:

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

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

2.21. "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.

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

2.23. "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.

2.24. "Hydroponic nutrient solution" means a mixture of water, minerals, and essential nutrients without soil used to grow medical cannabis plants.

2.25. "Identification card" means a document issued under W. Va. Code § 16A-5-1 that authorizes access to medical cannabis under the Act.

2.26. "Immature medical cannabis plant" means a nonflowering part of a medical cannabis plant that is no taller than eight inches and no wider than eight inches produced from a cutting, clipping, or seedling and that is in a growing/cultivating container that is no larger than two inches wide and two inches tall that is sealed on the sides and bottom.

2.27. "Laboratory" means a place, establishment, or institution within the State of West Virginia that has been issued a certificate by the bureau's Office of Laboratory Services.

2.28. "Limited access area" means any area on a site or within a facility where:

2.28.a. Immature medical cannabis plants or medical cannabis plants are growing or being processed into medical cannabis.

2.28.b. Immature medical cannabis plants, medical cannabis plants, medical cannabis, or medical cannabis products are being loaded into or out of transport vehicles.

2.28.c. Medical cannabis is packaged for sale or stored.

2.28.d. Medical cannabis waste is processed, stored, or destroyed.

2.28.e. Surveillance system devices are stored.

2.29. "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.

2.30. "Medical cannabis container" means a sealed, traceable, food compliant, tamper resistant, tamper evident container used for the purpose of containment of packaged medical cannabis being transported from a grower/processor to a medical cannabis organization or a laboratory.

2.31. "Medical cannabis organization" means:

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

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

2.32. "Medical cannabis plant" means a plant which is greater than 8 vertical inches in height from where the base of the stalk emerges from the growth medium to the tallest point of the plant, or greater than 8 horizontal inches in width from the end of one branch to the end of another branch.

2.33. "Medical cannabis program" means the program authorized under the Act and implemented by the bureau.

2.34. "Medical cannabis waste" means:

2.34.a. Solid, liquid, semi-solid, or contained gaseous materials that are generated by a grower/processor or an approved laboratory.

2.34.b. The term includes:

2.34.b.1. Unused, surplus, returned, recalled, contaminated, or expired medical cannabis.

2.34.b.2. Any medical cannabis plant material that is not used in the growing, harvesting, or processing of medical cannabis, including flowers, stems, trim, leaves, seeds, dead medical cannabis plants, dead immature medical cannabis plants, unused medical cannabis plant parts, and unused immature medical cannabis plant parts or roots.

2.34.b.3. Spent hydroponic nutrient solution.

2.34.b.4. Unused containers for growing immature medical cannabis plants or medical cannabis plants or for use in the growing and processing of medical cannabis.

2.34.b.5. Unused fertilizers and pesticides.

2.34.b.6. Unused excipients.

2.34.b.7. Wastewater.

2.35. "Municipality" incorporated city or town in this state.

2.36. "Nutrient" means the essential elements and compounds necessary for the growth, metabolism, and development of medical cannabis plants.

2.37. "Nutrient practice" means the use by a grower/processor of essential elements and compounds necessary for the growth, metabolism, and development of seeds, immature medical cannabis plants, or medical cannabis plants.

2.38. "Operations" means the time at which the bureau determines that a medical cannabis organization is ready, willing, and able to properly carry on the activity for which a permit has been issued under this rule, including the implementation of an electronic tracking system.

2.39. "Operator" means an individual who directly oversees or manages the day-to-day business functions for an applicant or permittee and has the ability to direct employee activities onsite and offsite or within a facility for which a permit is sought or has been issued under this rule.

2.40. "Patient" means an individual who:

2.40.a. Has a serious medical condition.

2.40.b. Has met the requirements for certification under the Act.

2.40.c. Is a resident of the State of West Virginia.

2.41. "Permit" means an authorization issued by the bureau to an applicant to conduct activities authorized under the Act.

2.42. "Permittee" means a person who has been issued an authorization to operate as a medical cannabis organization under the Act and this rule.

2.43. "Person" means a natural person, corporation, foundation, organization, business trust, estate, limited liability company, licensed corporation, trust, partnership, limited liability partnership, association, or other form of legal business entity.

2.44. "Practitioner" means a physician who is registered with the bureau under W. Va. Code § 16A-4-1.

2.45. "Principal" means an officer, director, or person who directly or beneficially owns securities of an applicant or permittee, or a person who has a controlling interest in an applicant or permittee, or who has the ability to elect the majority of the board of directors of an applicant or permittee, or otherwise control an applicant or permittee, other than a financial institution.

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

2.47. "Serious medical condition" means any of the following conditions:

2.47.a. Cancer;

2.47.b. Positive status for Human Immunodeficiency Virus or Acquired Immune Deficiency Syndrome;

2.47.c. Amyotrophic lateral sclerosis;

2.47.d. Parkinson's disease;

2.47.e. Multiple sclerosis;

2.47.f. Damage to the nervous tissue of the spinal cord with objective neurological indication of intractable spasticity;

2.47.g. Epilepsy;

2.47.h. Neuropathies;

2.47.i. Huntington's disease;

2.47.j. Crohn's disease;

2.47.k. Post-traumatic stress disorder;

2.47.l. Intractable seizures;

2.47.m. Sickle cell anemia;

2.47.n. Severe chronic or intractable pain of neuropathic origin, or severe chronic or intractable pain.; or

2.47.o. Terminally ill.

2.48. "Site" means the total area contained within the property line boundaries in which a facility is operated by a medical cannabis organization.

2.49. "Solid waste" means the term as defined in W. Va. Code § 22-15-2(31) of the Solid Waste Management Act.

2.50. "Spent hydroponic nutrient solution" means hydroponic nutrient solution that has been used and can no longer serve the purpose for which it was produced.

2.51. "Terminally ill" means a medical prognosis of life expectancy of approximately one year or less if the illness runs its normal course.

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

2.53. "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.

2.54. "THC" means Tetrahydrocannabinol.

2.55. "Transport vehicle" means a vehicle that meets the requirements of the Act and is used to transport medical cannabis between medical cannabis organizations or between medical cannabis organizations and a laboratory.

2.56. "Unit" means the weight or volume of total usable medical cannabis in the finished product, calculated in metric units.

W. Va. Code R. § 64-110-2