W. Va. Code R. § 64-109-2

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

Section 64-109-2 - 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. "Advertising" means the publication, dissemination, solicitation, or circulation, for a fee, that is visual, oral, written, or electronic to induce directly or indirectly an individual to patronize a particular dispensary or to purchase particular medical cannabis.

2.5. "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 these rules.

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

2.7. "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.

2.8. "CBD" means Cannabidiol.

2.9. "Caregiver" means an individual designated by a patient or, if the patient is under 18 years of age, an individual authorized under W. Va. Code § 16A-5-1et 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. "Change in control" means the acquisition by a person or group of persons acting in concert of a controlling interest in an applicant or permittee either all at one time or over the span of a 12-consecutive-month period.

2.12. "Change in ownership" means the addition or removal of a principal, operator, or financial backer, or a change in control of a medical cannabis organization after the bureau approves an initial permit application or a permit renewal application.

2.13. "Clinical Registrant" means an entity that:

2.13.a. Holds a permit as both a grower/processor and a dispensary; and

2.13.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.

2.14. "Controlled substance" means a drug, substance, or immediate precursor included in Schedules I through V of the West Virginia Uniform Controlled Substance Act (W. Va. Code § 60A-2-1et seq.).

2.15. "Controlling interest" means:

2.15.a. For a publicly traded company, voting rights that entitle a person to elect or appoint one or more of the members of the board of directors or other governing board, or the ownership or beneficial holding of five percent or more of the securities of the publicly traded company; or

2.15.b. For a privately held entity, the ownership of any security in the entity.

2.16. "Dispensary" means:

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

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

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

2.17.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;

2.17.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; and

2.17.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.

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

2.19. "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.

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

2.21. "Family or household member" has the same meaning as it does in W. Va. Code § 48-27-204.

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

2.23. "Financial institution" means:

2.23.a. Any bank or savings association;

2.23.b. A person who is an institution-affiliated party, as that term is defined in the Federal Deposit Insurance Act, 12 U.S.C. § 1813(u);

2.23.c. Any federal credit union or state-chartered credit union, including an institution-affiliated party of a credit union; and

2.23.d. Any benefit association, insurance company, safe deposit company, money-market mutual fund, or similar entity authorized to do business in this state.

2.24. "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.

2.25. "Fund" means the Medical Cannabis Program Fund established in W. Va. Code § 16A-9-2.

2.26. "Grower/processor means:

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

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

2.27. "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.

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

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

2.30. "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.

2.31. "Immediate family" has the same meaning as it does in W.Va. Code § 6B-1-3(f).

2.32. "Industrial hemp" means the plant Cannabis, sativa L., and any part of the plant, whether growing or not, containing no greater than one percent tetrahydrocannabinol.

2.33. "Initial permit application" means the document submitted to the bureau by an applicant that, if approved, grants a permit to an applicant.

2.34. "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.

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

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

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

2.35.c. Medical cannabis is packaged for sale or stored;

2.35.d. Medical cannabis waste is processed, stored, or destroyed; and

2.35.e. Surveillance system devices are stored.

2.36. "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.

2.37. "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.

2.38. "Medical cannabis organization" means:

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

2.38.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.

2.39. "Medical cannabis plant" means a plant which is greater than eight 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 eight horizontal inches in width from the end of one branch to the end of another branch.

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

2.41. "Medical cannabis waste" means:

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

2.41.b. The term includes:

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

2.41.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;

2.41.b.3. Spent hydroponic nutrient solution;

2.41.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;

2.41.b.5. Unused fertilizers and pesticides;

2.41.b.6. Unused excipients; and

2.41.b.7. Wastewater.

2.42. "Municipality" means an incorporated city or town in this state.

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

2.44. "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.

2.45. "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 these rules, including the implementation of an electronic tracking system.

2.46. "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 off site or within a facility for which a permit is sought or has been issued under these rules.

2.47. "Patient" means an individual who:

2.47.a. Has a serious medical condition;

2.47.b. Has met the requirements for certification under the Act; and

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

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

2.49. "Permittee" means a person who has been issued an authorization to operate as a medical cannabis organization under the Act and these rules.

2.50. "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.

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

2.52. "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.

2.53. "Publicly traded company" means a person other than an individual who:

2.53.a. Has a class or series of securities registered under the Securities Exchange Act of 1934 ( 15 U.S.C.A. §§ 78a-78pp) or on a foreign stock exchange determined by the bureau to have similar listing and reporting requirements to exchanges that are regulated under the Securities Exchange Act of 1934;

2.53.b. Is a registered management company under the Investment Company Act of 1940 ( 15 U.S.C.A. §§ 80a-1-80 a-64); or

2.53.c. Is subject to the reporting obligations imposed by section 15(d) of the Securities Exchange Act of 1934 ( 15 U.S.C.A. § 78o(d)) , by reason of having filed a registration statement which has become effective under the Securities Act of 1933 ( 15 U.S.C.A. §§ 77a-77aa).

2.54. "Security" means the term as defined in W. Va. Code § 32-4-401(n) of the Uniform Securities Act.

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

2.55.a. Cancer;

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

2.55.c. Amyotrophic lateral sclerosis;

2.55.d. Parkinson's disease;

2.55.e. Multiple sclerosis;

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

2.55.g. Epilepsy;

2.55.h. Neuropathies;

2.55.i. Huntington's disease;

2.55.j. Crohn's disease;

2.55.k. Post-traumatic stress disorder;

2.55.l. Intractable seizures;

2.55.m. Sickle cell anemia;

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

2.55.o. Terminally ill.

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

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

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

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

2.60. "THC" means Tetrahydrocannabinol.

2.61. "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.

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

2.63. "Vaporization or nebulization" means the generation of medical cannabis in the form of vapor or fine spray for medicinal inhalation.

W. Va. Code R. § 64-109-2