reglab/statecodes huggingface dataset:
West Virginia Code of State Rules › Agency 64 - Health › Title 64 - LEGISLATIVE RULE WEST VIRGINIA DEPARTMENT OF HEALTH AND HUMAN RESOURCES › Series 64-110 - Medical Cannabis Program - Growers/Processors › Section 64-110-15 - Sanitation and safety in a facility

Current through Register Vol. XLI, No. 28, July 12, 2024
15.1. A grower/processor must maintain its
				facility in a sanitary condition to limit the potential for contamination or
				adulteration of the medical cannabis grown and processed in the facility. The
				following apply:
15.1.a. Equipment and
				surfaces, including floors, counters, walls, and ceilings, must be cleaned and
				sanitized as frequently as necessary to protect against contamination, using a
				sanitizing agent registered by the United States Environmental Protection
				Agency, in accordance with the instructions printed on the label. Equipment and
				utensils must be so designed and of such material and workmanship as to be
				capable of being adequately cleaned.
15.1.b. Trash must be properly
				removed.
15.1.c. Floors, walls and
				ceilings must be kept in good repair.
15.1.d. Equipment, counters and surfaces for
				processing must be food grade quality and may not react adversely with any
				solvent being used.
15.1.e.
				Adequate protection against pests must be provided through the use of
				integrated pest management practices and techniques that identify and manage
				plant pathogens and pest problems, and the regular disposal of trash to prevent
				infestation.
15.1.f. Toxic cleaning
				compounds, sanitizing agents, solvents used in the growing and processing of
				medical cannabis, and pesticide chemicals must be labeled and stored in a
				manner that prevents contamination of seeds, immature medical cannabis plants,
				medical cannabis plants, and medical cannabis, and in a manner that otherwise
				complies with other applicable laws, rules, and
				regulations.
West Virginia Code of State Rules › Agency 64 - Health › Title 64 - LEGISLATIVE RULE WEST VIRGINIA DEPARTMENT OF HEALTH AND HUMAN RESOURCES › Series 64-110 - Medical Cannabis Program - Growers/Processors › Section 64-110-16 - Packaging and labeling of medical cannabis

Current through Register Vol. XLI, No. 28, July 12, 2024
16.1. A grower/processor must package and
				label at its facility each form of medical cannabis prepared for sale. The
				original seal of a package may not be broken, except for quality control
				testing at an approved laboratory, for adverse loss investigations conducted by
				the bureau or by a dispensary that purchased the medical cannabis.
16.2. A grower/processor must package the
				medical cannabis in a package that minimizes exposure to oxygen and that is:
16.2.a. Child-resistant;
16.2.b. Tamper-proof or
				tamper-evident;
16.2.c.
				Light-resistant and opaque; and
16.2.d. Resealable.
West Virginia Code of State Rules › Agency 64 - Health › Title 64 - LEGISLATIVE RULE WEST VIRGINIA DEPARTMENT OF HEALTH AND HUMAN RESOURCES › Series 64-110 - Medical Cannabis Program - Growers/Processors › Section 64-110-17 - Transportation of medical cannabis

Current through Register Vol. XLI, No. 28, July 12, 2024
17.1. A grower/processor may transport and
				deliver medical cannabis to a medical cannabis organization or an approved
				laboratory in this state in accordance with this section. The following apply:
17.1.a. A grower/processor may deliver
				medical cannabis to a medical cannabis organization or an approved laboratory
				only between 7:00 a.m. and 9:00 p.m.;
17.1.b. A grower/processor may contract with
				a third-party contractor for delivery so long as the contractor complies with
				this section;
17.1.c. A
				grower/processor may not transport medical cannabis to any location outside of
				this state; and
17.1.d. A
				grower/processor must use a global positioning system to ensure safe, efficient
				delivery of the medical cannabis to a medical cannabis organization or an
				approved laboratory.
West Virginia Code of State Rules › Agency 64 - Health › Title 64 - LEGISLATIVE RULE WEST VIRGINIA DEPARTMENT OF HEALTH AND HUMAN RESOURCES › Series 64-110 - Medical Cannabis Program - Growers/Processors › Section 64-110-18 - Transport manifest

Current through Register Vol. XLI, No. 28, July 12, 2024
18.1. A
				grower/processor must generate a printed or electronic transport manifest that
				accompanies every transport vehicle and contains the following information:
18.1.a. The name, address, and permit number
				of the grower/processor and the name of and contact information for a
				representative of the grower/processor who has direct knowledge of the
				transport;
18.1.b. The name,
				address, and permit number of the medical cannabis organization or approved
				laboratory receiving the delivery and the name of and contact information for a
				representative of the medical cannabis organization or approved
				laboratory;
18.1.c. The quantity,
				by weight or unit, of each medical cannabis harvest batch, harvest lot, or
				process lot contained in the transport, along with the identification number
				for each batch or lot;
18.1.d. The
				date and approximate time of departure;
18.1.e. The date and approximate time of
				arrival;
18.1.f. The transport
				vehicle's make and model and license plate number; and
18.1.g. The identification number of each
				member of the delivery team accompanying the transport.
West Virginia Code of State Rules › Agency 64 - Health › Title 64 - LEGISLATIVE RULE WEST VIRGINIA DEPARTMENT OF HEALTH AND HUMAN RESOURCES › Series 64-110 - Medical Cannabis Program - Growers/Processors › Section 64-110-19 - Transportation of seeds, immature medical cannabis plants and medical cannabis plants

Current through Register Vol. XLI, No. 28, July 12, 2024
19.1. A
				grower/processor may transport seeds, immature medical cannabis plants, and
				medical cannabis plants within this state for the growing and processing of
				medical cannabis.
19.2. A
				grower/processor may not transport seeds, immature medical cannabis plants, or
				medical cannabis plants to a location outside of this state.
19.3. A grower/processor's authorization to
				transport seeds, immature medical cannabis plants, or medical cannabis plants
				are subject to the requirements of sections 17, 18 and 20 (Transportation of
				medical cannabis; transport manifest; and evidence of adverse loss during
				transport).
West Virginia Code of State Rules › Agency 64 - Health › Title 64 - LEGISLATIVE RULE WEST VIRGINIA DEPARTMENT OF HEALTH AND HUMAN RESOURCES › Series 64-110 - Medical Cannabis Program - Growers/Processors › Section 64-110-20 - Evidence of adverse loss during transport

Current through Register Vol. XLI, No. 28, July 12, 2024
20.1. If a grower/processor receiving a
				delivery of medical cannabis or medical cannabis products from a medical
				cannabis organization discovers a discrepancy in the transport manifest upon
				delivery, the grower/processor must refuse acceptance of the delivery and
				immediately report the discrepancy to the bureau either through a designated
				phone line established by the bureau or by electronic communication with the
				bureau in a manner prescribed by the bureau, and to the appropriate law
				enforcement authorities.
20.2. If a
				grower/processor discovers evidence of, or reasonably suspects, a theft, or
				diversion of medical cannabis or medical cannabis products during transport,
				the grower/processor must immediately report its findings or suspicions to the
				bureau either through a designated phone line established by the bureau or by
				electronic communication with the bureau in a manner prescribed by the bureau
				and to law enforcement.
20.3. If a
				grower/processor discovers a discrepancy in the transport manifest, the
				grower/processor must:
20.3.a. Conduct an
				investigation;
20.3.b. Amend the
				grower/processor's standard plan of operation, if necessary, to prevent future
				discrepancies between the quantity or description of inventory listed in the
				transport manifest and the quantity or description of inventory delivered;
				and
20.3.c. Submit a report of the
				investigation to the bureau. The following apply:
20.3.c.1. A written preliminary report of the
				investigation must be submitted to the bureau within seven days of discovering
				the discrepancy; and
20.3.c.2. A
				final written report of the investigation must be submitted to the bureau
				within 30 days of discovering the discrepancy.
West Virginia Code of State Rules › Agency 64 - Health › Title 64 - LEGISLATIVE RULE WEST VIRGINIA DEPARTMENT OF HEALTH AND HUMAN RESOURCES › Series 64-110 - Medical Cannabis Program - Growers/Processors › Section 64-110-21 - Electronic tracking system

Current through Register Vol. XLI, No. 28, July 12, 2024
A grower/processor must use the electronic tracking system
				  prescribed by the bureau containing the requirements in W. Va. Code §
									16A-7-1. The bureau will publish
				  notice of the electronic tracking system to be utilized by a grower/processor
				  in the State Register 60 days prior to the implementation date of the
				  system.
West Virginia Code of State Rules › Agency 64 - Health › Title 64 - LEGISLATIVE RULE WEST VIRGINIA DEPARTMENT OF HEALTH AND HUMAN RESOURCES › Series 64-110 - Medical Cannabis Program - Growers/Processors › Section 64-110-22 - Management and disposal of medical cannabis waste

Current through Register Vol. XLI, No. 28, July 12, 2024
22.1. Medical cannabis waste generated by a
				grower/processor or an approved laboratory must be stored, collected and
				transported in accordance with W. Va. Code §
									22-15-1
et seq.
(Solid Waste Management Act), provided the medical cannabis waste is not
				hazardous.
22.2. The following
				types of medical cannabis waste must be rendered unusable and unrecognizable
				prior to being transported from a grower/processor or an approved laboratory:
22.2.a. Unused, surplus, returned, recalled,
				contaminated, or expired medical cannabis; and
22.2.b. 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.
West Virginia Code of State Rules › Agency 64 - Health › Title 64 - LEGISLATIVE RULE WEST VIRGINIA DEPARTMENT OF HEALTH AND HUMAN RESOURCES › Series 64-110 - Medical Cannabis Program - Growers/Processors › Section 64-110-23 - Complaints about or recall of medical cannabis

Current through Register Vol. XLI, No. 28, July 12, 2024
23.1. A dispensary shall notify the bureau
				and the grower/processor immediately upon becoming aware of any complaint made
				to the dispensary by a patient, caregiver, or practitioner who reports an
				adverse event from using medical cannabis purchased by the dispensary from the
				grower/processor. A grower/processor must investigate the report. The following
				apply:
23.1.a. A grower/processor must
				investigate a complaint to determine if a voluntary or mandatory recall of
				medical cannabis is necessary or if any further action is required;
				and
23.1.b. If a grower/processor
				determines that further action is not required, the grower/processor must
				notify the bureau of its decision and, within 24 hours, submit a written report
				to the bureau stating its rationale for not taking further action.
West Virginia Code of State Rules › Agency 64 - Health › Title 64 - LEGISLATIVE RULE WEST VIRGINIA DEPARTMENT OF HEALTH AND HUMAN RESOURCES › Series 64-110 - Medical Cannabis Program - Growers/Processors › Section 64-110-24 - Pesticides

Current through Register Vol. XLI, No. 28, July 12, 2024
24.1. The use of a
				pesticide by a grower/processor in the growing or processing of medical
				cannabis must be in accordance with the West Virginia Pesticide Control Act (W.
				Va. Code §
									19-16A-1
et seq.
)
				and this rule.
24.2. The bureau and
				the West Virginia Department of Agriculture will cooperate to inspect for and
				enforce the requirements of this section.
24.3. The following apply regarding
				recordkeeping requirements for pesticide applications:
24.3.a. The grower/processor shall maintain a
				record of each application of a pesticide. The record must include the
				following information:
24.3.a.1. The date of
				application. For a pesticide requiring a re-entry time, the date of application
				must include the hour completed;
24.3.a.2. The place of application, including
				the specific block, section, or immature medical cannabis plants or medical
				cannabis plants treated;
24.3.a.3.
				The size of the area treated;
24.3.a.4. The product name of every pesticide
				used;
24.3.a.5. The United States
				Environmental Protection Agency product registration number. This requirement
				is unnecessary for products exempted under section 25 of the Federal
				Insecticide, Fungicide, and Rodenticide Act (7 U.S.C.A. §
												136w) ;
24.3.a.6. The total amount of every pesticide
				used in pounds, ounces, gallons, or liters applied to a treated area;
24.3.a.7. The dosage or rate of application
				of every pesticide used;
24.3.a.8.
				If applicable, the employee identification numbers of the individuals involved
				in making the pesticide and the permit or certification numbers of the
				individuals making or supervising the application; and
24.3.a.9. Copies of pesticide labels and
				Safety Data Sheets for the pesticides used at the facility.
West Virginia Code of State Rules › Agency 64 - Health › Title 64 - LEGISLATIVE RULE WEST VIRGINIA DEPARTMENT OF HEALTH AND HUMAN RESOURCES › Series 64-110 - Medical Cannabis Program - Growers/Processors › Section 64-110-25 - Treatment and quarantine orders

Current through Register Vol. XLI, No. 28, July 12, 2024
25.1. If a grower/processor fails or refuses
				to eradicate a plant pest that is found at its facility, the bureau, in
				cooperation with the West Virginia Department of Agriculture, may issue and
				enforce a treatment order against the grower/processor, including an order to
				eradicate, for any immature medical cannabis plants or medical cannabis plants
				that may carry or harbor the plant pest. The order will be issued in writing
				and set forth the necessary treatment, control or eradication measures
				required. If the grower/processor fails or refuses to comply with the order,
				the bureau, acting in cooperation with the West Virginia Department of
				Agriculture, may carry out the control measures established in the treatment
				order with all expenses associated with the measures accruing to the
				grower/processor.
25.2. The West
				Virginia Department of Agriculture, acting with the cooperation of the bureau,
				may establish a quarantine to prevent the dissemination of plant pests within
				this state or to prevent or delay the introduction of a plant pest into this
				state from any country, state, or territory. The following apply:
25.2.a. Upon finding a plant pest in a
				facility that has the potential to cause serious damage to other
				grower/processors or to agriculture in general, the geographic area in which
				the plant pest was found and any adjacent areas as the West Virginia Department
				of Agriculture deems necessary may be quarantined.
25.2.b. The quarantine order will establish
				conditions and restrictions determined by the West Virginia Department of
				Agriculture to be necessary to prevent or reduce the movement of the plant pest
				from the quarantined area. Vehicles or any means of conveyance suspected of
				carrying the plant pest may also be subject to quarantine and a treatment order
				under subsection 25.1. may be issued as necessary to eradicate the plant
				pest.
25.2.c. The quarantine order
				may regulate the planting, growing, or harvesting of any immature medical
				cannabis plants, or medical cannabis plants that serve as a host or reservoir
				for the plant pest within the quarantined area and may include prohibiting the
				processing of a specific harvest batch or harvest lot of medical cannabis
				within a specific geographic area or during a specified time period. An
				immature medical cannabis plant or medical cannabis plant suspected of
				harboring the plant pest may be ordered to be treated or destroyed.
West Virginia Code of State Rules › Agency 64 - Health › Title 64 - LEGISLATIVE RULE WEST VIRGINIA DEPARTMENT OF HEALTH AND HUMAN RESOURCES › Series 64-111 - Medical Cannabis Program - Laboratories › Section 64-111-1 - General

Current through Register Vol. XLI, No. 28, July 12, 2024
1.1. Scope. The
				provisions of this rule regulate the certification and operation of
				laboratories that provide testing services to medical cannabis organizations
				authorized by the West Virginia Medical Cannabis Act (W. Va. Code §
									16A-1-1
et
				seq.
)
1.2. Authority. W.
				Va. Code §
									16A-3-1(b)
				and §
									16A-7-3.
1.3. Filing Date. April 21, 2020.
1.4. Effective Date. April 21,
				2020.
1.5. Sunset Provision. This
				rule will terminate and have no further force or effect on April 21,
				2025.
1.6. Applicability. This rule
				applies to a person or entity that desires to hold a permit as a medical
				cannabis organization in the state.
West Virginia Code of State Rules › Agency 64 - Health › Title 64 - LEGISLATIVE RULE WEST VIRGINIA DEPARTMENT OF HEALTH AND HUMAN RESOURCES › Series 64-111 - Medical Cannabis Program - Laboratories › Section 64-111-2 - Definitions

Current through Register Vol. XLI, No. 28, July 12, 2024
2.1. "Act" means
				the West Virginia Medical Cannabis Act (W. Va. Code §
									16A-1-1
et
				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.
West Virginia Code of State Rules › Agency 64 - Health › Title 64 - LEGISLATIVE RULE WEST VIRGINIA DEPARTMENT OF HEALTH AND HUMAN RESOURCES › Series 64-111 - Medical Cannabis Program - Laboratories › Section 64-111-3 - Laboratories generally

Current through Register Vol. XLI, No. 28, July 12, 2024
3.1. A
				laboratory may not identify, collect, handle, or conduct tests on samples from
				a grower/processor or conduct tests on test samples for the bureau unless the
				laboratory has been approved by the bureau under section 4 of this rule and has
				entered into a written contract with the grower/processor under section 10 of
				this rule.
3.2. The bureau will
				post on its web site a current list of approved laboratories.
3.3. An approved laboratory must employ at
				least one director to oversee and be responsible for the identification,
				collection, handling, and testing operations of the approved laboratory. A
				director must have earned, from a college or university accredited by a
				national or regional accrediting authority, at least one of the following:
3.3.a. A doctorate of science or an
				equivalent degree in chemistry, biology, or a subdiscipline of chemistry or
				biology;
3.3.b. A master's level
				degree in a chemical or biological science and a minimum of two years post
				graduate degree laboratory experience related to testing of medicinal or
				pharmaceutical products or other experience as approved by the bureau;
				or
3.3.c. A bachelor's degree in a
				biological science and a minimum of four years post graduate degree laboratory
				experience related to testing of medicinal or pharmaceutical products or other
				experience as approved by the bureau.
West Virginia Code of State Rules › Agency 64 - Health › Title 64 - LEGISLATIVE RULE WEST VIRGINIA DEPARTMENT OF HEALTH AND HUMAN RESOURCES › Series 64-111 - Medical Cannabis Program - Laboratories › Section 64-111-4 - Approval of laboratories

Current through Register Vol. XLI, No. 28, July 12, 2024
4.1. A
				laboratory intending to identify, collect, handle and conduct tests on samples
				and test samples and other items used by a grower/processor in the growing and
				processing of medical cannabis as required under the Act and this rule must
				submit an application for approval to the bureau on a form and in a manner
				prescribed by the bureau, in addition to the prescribed fee. The application is
				available on the bureau's website.
4.2. An application submitted under this
				section must include the following information:
4.2.a. The name and address of the laboratory
				applicant or its authorized agent.
4.2.b. The name and address of the owner of
				the laboratory applicant, and, if applicable, the medical or pharmacy licensure
				information regarding the owner.
4.2.c. The name of the laboratory applicant's
				proposed director and technical personnel who are or will be employed by the
				laboratory at the location to be approved.
4.2.d. A copy of the laboratory applicant's
				most recent valid certificate of accreditation granted from an ILAC MRA
				recognized accreditation body.
4.2.e. Copies of the standard operating
				procedures and sampling procedures adopted by the laboratory applicant and
				approved by the accreditation body that issued the certificate of accreditation
				to the laboratory applicant.
4.2.f.
				A list of the specialized laboratory equipment utilized or to be utilized by
				the laboratory applicant in its testing operations, including the
				manufacturer's name and the serial and model number of the equipment, and other
				specifications as may be required by the bureau.
4.2.g. A description of the accredited tests
				which are capable of being conducted by the laboratory applicant at the
				location to be approved.
4.2.h. A
				description of the laboratory applicant's quality assurance program, which must
				be in compliance with section 13 of this rule.
4.2.i. The procedures to be followed to
				establish chain of custody when collecting samples or test samples.
4.2.j. A copy of the evaluation process that
				the laboratory applicant uses or will use to monitor, evaluate and document the
				competency of employees when testing samples and test samples and overseeing
				quality assurance controls.
4.2.k.
				Other information required by the bureau.
West Virginia Code of State Rules › Agency 64 - Health › Title 64 - LEGISLATIVE RULE WEST VIRGINIA DEPARTMENT OF HEALTH AND HUMAN RESOURCES › Series 64-111 - Medical Cannabis Program - Laboratories › Section 64-111-5 - Suspension or revocation of an approval issued to a laboratory

Current through Register Vol. XLI, No. 28, July 12, 2024
5.1. An approval
				issued by the bureau under this rule may be suspended or revoked if the bureau
				determines that the approved laboratory has engaged in unethical practices or
				has failed to do any of the following:
5.1.a.
				Maintain proper standards of accuracy.
5.1.b. Comply with the requirements of the
				Act or this rule applicable to the approved laboratory.
West Virginia Code of State Rules › Agency 64 - Health › Title 64 - LEGISLATIVE RULE WEST VIRGINIA DEPARTMENT OF HEALTH AND HUMAN RESOURCES › Series 64-111 - Medical Cannabis Program - Laboratories › Section 64-111-6 - Renewal of an approval issued to a laboratory

Current through Register Vol. XLI, No. 28, July 12, 2024
An approved laboratory intending to renew the approval issued
				  to the laboratory under this rule must, not more than six months nor less than
				  four months prior to the expiration of the approval, submit an application
				  under section 4 of this rule and update all of the information required to be
				  submitted with the application.
West Virginia Code of State Rules › Agency 64 - Health › Title 64 - LEGISLATIVE RULE WEST VIRGINIA DEPARTMENT OF HEALTH AND HUMAN RESOURCES › Series 64-111 - Medical Cannabis Program - Laboratories › Section 64-111-7 - Stability testing and retention of samples

Current through Register Vol. XLI, No. 28, July 12, 2024
7.1. A grower/processor must request that a
				sample be identified and collected by an approved laboratory from each harvest
				batch sufficient to perform stability testing at six-month intervals for a
				one-year period.
7.2. The stability
				test must be performed to ensure product potency and purity and provide support
				for expiration dating.
7.3. An
				approved laboratory must retain a sample from each harvest batch sufficient to
				provide for stability testing and properly store the sample for one
				year.
West Virginia Code of State Rules › Agency 64 - Health › Title 64 - LEGISLATIVE RULE WEST VIRGINIA DEPARTMENT OF HEALTH AND HUMAN RESOURCES › Series 64-111 - Medical Cannabis Program - Laboratories › Section 64-111-8 - Sampling procedures for testing

Current through Register Vol. XLI, No. 28, July 12, 2024
8.1. An approved laboratory must ensure that
				its employees prepare all samples in accordance with policies and procedures
				that include appropriate information necessary for identifying, collecting and
				transporting samples in a manner that does not endanger the integrity of the
				samples for any testing required by this rule.
8.2. The sampling policies must at a minimum
				be:
8.2.a. Appropriate to the matrix being
				sampled.
8.2.b. In accordance with
				guidance provided by the bureau.
West Virginia Code of State Rules › Agency 64 - Health › Title 64 - LEGISLATIVE RULE WEST VIRGINIA DEPARTMENT OF HEALTH AND HUMAN RESOURCES › Series 64-111 - Medical Cannabis Program - Laboratories › Section 64-111-9 - Selection protocols for samples

Current through Register Vol. XLI, No. 28, July 12, 2024
9.1. An employee of an approved laboratory
				may only enter a facility operated by a grower/processor for the purpose of
				identifying and collecting samples and must have access to limited access areas
				in the facility for these purposes.
9.2. An employee identifying and collecting
				samples under subsection 9.1.of this rule must follow the chain of custody
				procedures included in the approved laboratory's application and approved by
				the bureau.
9.3. While at a
				facility operated by a grower/processor, an employee of an approved laboratory
				must identify and collect the following for testing:
9.3.a. Samples at the time of
				harvest.
9.3.b. Samples of medical
				cannabis product before being sold or provided to a dispensary.
9.3.c. Test samples at other times when
				requested by the bureau.
West Virginia Code of State Rules › Agency 64 - Health › Title 64 - LEGISLATIVE RULE WEST VIRGINIA DEPARTMENT OF HEALTH AND HUMAN RESOURCES › Series 64-111 - Medical Cannabis Program - Laboratories › Section 64-111-10 - Testing requirements

Current through Register Vol. XLI, No. 28, July 12, 2024
10.1.
				Prior to conducting any testing of a sample at the request of a
				grower/processor, an approved laboratory must enter into a written contract
				with the grower/processor for testing services. The approved laboratory must
				provide a copy of the contract to the bureau within two days following the
				bureau's request.
10.2. A
				grower/processor must submit through the electronic tracking system a request
				to the approved laboratory with which it has a written contract under
				subsection 10.1. of this rule for each test to be conducted.
10.3. At a minimum, an approved laboratory
				must perform tests as prescribed by the bureau on the following:
10.3.a. Samples from a harvest batch or
				harvest lot prior to being used to produce a medical cannabis
				product.
10.3.b. Samples from each
				process lot before the medical cannabis is sold or offered for sale to another
				medical cannabis organization.
West Virginia Code of State Rules › Agency 64 - Health › Title 64 - LEGISLATIVE RULE WEST VIRGINIA DEPARTMENT OF HEALTH AND HUMAN RESOURCES › Series 64-111 - Medical Cannabis Program - Laboratories › Section 64-111-11 - Standards for testing

Current through Register Vol. XLI, No. 28, July 12, 2024
An approved laboratory must follow the methodologiesand
				  parameters acceptable to the bureau which are contained in the scope of the
				  certificate of accreditation issued to the laboratory.
West Virginia Code of State Rules › Agency 64 - Health › Title 64 - LEGISLATIVE RULE WEST VIRGINIA DEPARTMENT OF HEALTH AND HUMAN RESOURCES › Series 64-111 - Medical Cannabis Program - Laboratories › Section 64-111-12 - Test results and reporting

Current through Register Vol. XLI, No. 28, July 12, 2024
12.1.
				Only the results of the following tests are in compliance with the testing
				requirements of this rule:
12.1.a. Tests
				conducted on harvest batch samples or harvest lot samples requested by a
				grower/processor under section 10 of this rule and identified and collected by
				an employee of an approved laboratory.
12.1.b. Tests conducted on process lot
				samples requested by a grower/processor under section 10 of this rule and
				identified and collected by either an employee of a grower/processor or an
				employee of an approved laboratory.
West Virginia Code of State Rules › Agency 64 - Health › Title 64 - LEGISLATIVE RULE WEST VIRGINIA DEPARTMENT OF HEALTH AND HUMAN RESOURCES › Series 64-111 - Medical Cannabis Program - Laboratories › Section 64-111-13 - Quality assurance program

Current through Register Vol. XLI, No. 28, July 12, 2024
13.1. An approved laboratory must establish
				and implement a quality assurance program to ensure that measurements are
				accurate, errors are controlled, and devices used for testing are routinely and
				properly calibrated.
13.2. The
				quality assurance program required under subsection 13.1. of this rule must
				include the following components:
13.2.a. An
				organizational chart that includes the testing responsibilities of each
				employee of the approved laboratory named in the chart.
13.2.b. A description of sampling procedures
				to be utilized.
13.2.c. Appropriate
				chain of custody protocols.
13.2.d.
				Analytical procedures.
13.2.e. Data
				reduction and validation procedures.
13.2.f. A plan for implementing corrective
				action, when necessary.
13.2.g. A
				requirement for the provision of quality assurance reports to
				management.
13.2.h. A description
				of the internal and external quality control systems.
West Virginia Code of State Rules › Agency 64 - Health › Title 64 - LEGISLATIVE RULE WEST VIRGINIA DEPARTMENT OF HEALTH AND HUMAN RESOURCES › Series 64-111 - Medical Cannabis Program - Laboratories › Section 64-111-14 - Transporting samples

Current through Register Vol. XLI, No. 28, July 12, 2024
14.1. An
				employee of an approved laboratory, grower/processor, or third-party contractor
				must follow the transportation requirements under 64CSR110.17 and 64CSR110.18
				(Transportation of medical cannabis; and Transport manifest) when transporting
				a sample or test sample under this rule.
14.2. An employee of an approved laboratory,
				grower/processor, or third-party contractor who transports process lot samples
				from a grower/processor to an approved laboratory must:
14.2.a. Protect the physical integrity of the
				sample.
14.2.b. Keep the
				composition of the sample intact.
14.2.c. Protect the sample against factors
				that will interfere with the validity of testing results, including the factors
				of time, temperature and other environmental factors that may work to
				jeopardize the integrity of the sample.
West Virginia Code of State Rules › Agency 64 - Health › Title 64 - LEGISLATIVE RULE WEST VIRGINIA DEPARTMENT OF HEALTH AND HUMAN RESOURCES › Series 64-111 - Medical Cannabis Program - Laboratories › Section 64-111-15 - Bureau request for testing

Current through Register Vol. XLI, No. 28, July 12, 2024
15.1. The
				bureau may identify and collect a test sample from a grower/processor at any
				time and request an approved laboratory to conduct tests.
15.2. The approved laboratory must provide
				the bureau with a written report of the test results from a test sample tested
				under subsection 15.1. of this rule within seven days of the collection of the
				test sample, or sooner if requested by the bureau.
West Virginia Code of State Rules › Agency 64 - Health › Title 64 - LEGISLATIVE RULE WEST VIRGINIA DEPARTMENT OF HEALTH AND HUMAN RESOURCES › Series 64-111 - Medical Cannabis Program - Laboratories › Section 64-111-16 - Laboratory reporting

Current through Register Vol. XLI, No. 28, July 12, 2024
16.1. An
				approved laboratory must enter into the electronic tracking system the
				following information for each sample collected and each test conducted:
16.1.a. The unique sample identification
				number the approved laboratory assigns to the sample.
16.1.b. The name of the grower/processor that
				supplied the sample.
16.1.c. The
				employee identification number of the employee of the approved laboratory who
				identified and collected the sample at the request of the
				grower/processor.
16.1.d. The date
				and time the sample was collected from the grower/processor.
16.1.e. The date and time the sample was
				received by the approved laboratory.
16.1.f. The date the test was
				completed.
16.1.g. The condition of
				the sample when it was received by the approved laboratory.
16.1.h. A description of each test
				performed.
16.1.i. The results from
				the certificate of analysis issued under section 12 of this rule.
16.1.j. The date the testing results were
				provided to the grower/processor under section 12 of this rule or the bureau
				under section 15 of this rule.
West Virginia Code of State Rules › Agency 64 - Health › Title 64 - LEGISLATIVE RULE WEST VIRGINIA DEPARTMENT OF HEALTH AND HUMAN RESOURCES › Series 64-111 - Medical Cannabis Program - Laboratories › Section 64-111-17 - Advertising

Current through Register Vol. XLI, No. 28, July 12, 2024
17.1. An approved
				laboratory may not advertise, market, or otherwise promote its medical cannabis
				testing services to the general public. An approved laboratory may advertise,
				market, or otherwise promote its medical cannabis testing services to a
				grower/processor as provided in this section.
17.2. Advertising, marketing, and promotional
				materials proposed to be used by an approved laboratory under this section must
				be reviewed and approved by the bureau prior to circulation or other
				use.
17.3. Personal solicitation by
				an employee, representative or agent of an approved laboratory to a
				grower/processor is considered advertising, marketing, or otherwise promoting
				its medical cannabis testing services for the purposes of this
				section.
17.4. An approved
				laboratory may only advertise, market or otherwise promote its medical cannabis
				testing services that are performed onsite at the location designated in the
				laboratory's application.
17.5. A
				sign installed at the location of an approved laboratory that is designed to
				identify the laboratory or access to the laboratory is permissible as long as
				the sign meets local zoning requirements and does not violate the provisions of
				this section.
West Virginia Code of State Rules › Agency 64 - Health › Title 64 - LEGISLATIVE RULE WEST VIRGINIA DEPARTMENT OF HEALTH AND HUMAN RESOURCES › Series 64-111 - Medical Cannabis Program - Laboratories › Section 64-111-18 - Ownership prohibition

Current through Register Vol. XLI, No. 28, July 12, 2024
18.1. The
				following individuals may not have a management or a direct or indirect
				financial or other ownership interest in an approved laboratory:
18.1.a. A principal, owner, financial backer
				or employee of a medical cannabis organization.
18.1.b. A practitioner.
18.1.c. A physician or pharmacist who is
				currently employed by a medical cannabis organization.
18.1.d. Any other person, other than a
				patient, who may receive a direct or indirect financial benefit from the
				growing, processing, transporting, dispensing or selling of medical
				cannabis.
West Virginia Code of State Rules › Agency 64 - Health › Title 64 - LEGISLATIVE RULE WEST VIRGINIA DEPARTMENT OF HEALTH AND HUMAN RESOURCES › Series 64-112 - Medical Cannabis Program - Dispensaries › Section 64-112-1 - General

Current through Register Vol. XLI, No. 28, July 12, 2024
1.1. Scope. The
				provisions of this rule include general provisions related to dispensaries
				pursuant to the West Virginia Medical Cannabis Act (W. Va. Code §
									16A-1-1
et
				seq.
)
1.2. Authority. W.
				Va. Code §
									16A-3-1(b) and
				§
									16A-7-3.
1.3. Filing Date. March 30, 2023.
1.4. Effective Date. April 1, 2023.
1.5. Sunset Provision. This rule will
				terminate and have no further force or effect on August 1, 2028.
1.6. Applicability. This rule applies to a
				person or entity that desires to hold a permit as a medical cannabis
				organization in the state.
West Virginia Code of State Rules › Agency 64 - Health › Title 64 - LEGISLATIVE RULE WEST VIRGINIA DEPARTMENT OF HEALTH AND HUMAN RESOURCES › Series 64-112 - Medical Cannabis Program - Dispensaries › Section 64-112-2 - Definitions

Current through Register Vol. XLI, No. 28, July 12, 2024
2.1. "Act" means
				the West Virginia Medical Cannabis Act (W. Va. Code §
									16A-1-1
et
				seq.
).
2.2. "Advertise"
				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.
2.3. "Bureau"
				means the West Virginia Bureau for Public Health within the West Virginia
				Department of Health and Human Resources.
2.4. "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.
2.5. "CBD" means
				Cannabidiol.
2.6. "Caregiver" means
				the individual designated by a patient or, if the patient is under 18 years of
				age, an individual authorized under W. Va. Code §
									16A-5-1
et seq
.
				to deliver medical cannabis.
2.7.
				"Device" means an object used, intended for use, or designed for use in
				preparing, storing, ingesting, inhaling, or otherwise introducing medical
				cannabis into the human body.
2.8.
				"Dispense" means the activity of lawfully providing to a patient or caregiver
				medical cannabis in a suitable container that is appropriately labeled for
				subsequent administration or use pursuant to a patient certification issued by
				a practitioner.
2.9. "Dispensary"
				means:
2.9.a. A person who holds a permit
				issued by the bureau to dispense medical cannabis.
2.9.b. The term does not include a health
				care medical cannabis organization as defined by W. Va. Code §
										16A-13-1
et
				seq.
West Virginia Code of State Rules › Agency 64 - Health › Title 64 - LEGISLATIVE RULE WEST VIRGINIA DEPARTMENT OF HEALTH AND HUMAN RESOURCES › Series 64-112 - Medical Cannabis Program - Dispensaries › Section 64-112-3 - Dispensaries generally

Current through Register Vol. XLI, No. 28, July 12, 2024
3.1. The
				qualifications that a dispensary must meet to receive a permit are continuing
				qualifications to maintain the permit.
3.2. In addition to any other requirements in
				the Act or this rule, a dispensary must comply with the following:
3.2.a. A dispensary may not engage in the
				business of possessing, dispensing, selling, or offering to dispense or sell
				medical cannabis to a patient or caregiver in this state without first being
				issued a permit by the bureau and without first being determined operational by
				the bureau as required under 64CSR109.15.
3.2.b. A dispensary may not employ an
				individual at its facility who is under 18 years of age.
3.2.c. A dispensary may not permit a patient
				to self-administer medical cannabis at the facility unless the patient is also
				an employee of the dispensary, and the dispensary permits self-administration
				of medical cannabis at the facility by the employees.
West Virginia Code of State Rules › Agency 64 - Health › Title 64 - LEGISLATIVE RULE WEST VIRGINIA DEPARTMENT OF HEALTH AND HUMAN RESOURCES › Series 64-112 - Medical Cannabis Program - Dispensaries › Section 64-112-4 - Dispensing medical cannabis

Current through Register Vol. XLI, No. 28, July 12, 2024
4.1. A dispensary may only dispense medical
				cannabis to a patient or caregiver who presents a valid identification card to
				an employee at the facility who is authorized to dispense medical cannabis at
				the facility.
4.2. Prior to
				dispensing medical cannabis to a patient or caregiver, the dispensary must:
4.2.a. Verify the validity of the patient or
				caregiver identification card using the electronic tracking system.
4.2.b. Review the information on the
				patient's most recent certification by using the electronic tracking system to
				access the bureau's database. The following apply:
4.2.b.1. If a practitioner sets forth
				recommendations, requirements, or limitations as to the form or dosage of
				medical cannabis on the patient certification, the medical cannabis dispensed
				to a patient or a caregiver by a dispensary must conform to those
				recommendations, requirements, or limitations.
4.2.b.2. The dispensary must update the
				patient certification in the electronic tracking system by entering any
				recommendation as to the form or dosage of medical cannabis that is provided to
				the patient.
West Virginia Code of State Rules › Agency 64 - Health › Title 64 - LEGISLATIVE RULE WEST VIRGINIA DEPARTMENT OF HEALTH AND HUMAN RESOURCES › Series 64-112 - Medical Cannabis Program - Dispensaries › Section 64-112-5 - Limitations on dispensing

Current through Register Vol. XLI, No. 28, July 12, 2024
5.1. A
				dispensary may not dispense to a patient or caregiver:
5.1.a. A quantity of medical cannabis that is
				greater than the amount indicated on the patient's certification, if
				any.
5.1.b. A form or dosage of
				medical cannabis that is listed as a restriction or limitation on the patient
				certification.
5.1.c. A form of
				medical cannabis not permitted by the Act or this rule, unless otherwise
				provided in rules adopted by the bureau under W. Va. Code §
										16A-11-2.
West Virginia Code of State Rules › Agency 64 - Health › Title 64 - LEGISLATIVE RULE WEST VIRGINIA DEPARTMENT OF HEALTH AND HUMAN RESOURCES › Series 64-112 - Medical Cannabis Program - Dispensaries › Section 64-112-6 - Dispensary facilities

Current through Register Vol. XLI, No. 28, July 12, 2024
6.1. A
				dispensary may only dispense medical cannabis to a patient or caregiver in an
				indoor, enclosed, secure facility as approved by the bureau.
6.2. A dispensary may not be located:
6.2.a. Within 1,000 feet of the property line
				of a public, private or parochial school, or a day-care center;
6.2.b. At the same site used for growing and
				processing medical cannabis; or
6.2.c. In the same office space as a
				practitioner or other physician.
West Virginia Code of State Rules › Agency 64 - Health › Title 64 - LEGISLATIVE RULE WEST VIRGINIA DEPARTMENT OF HEALTH AND HUMAN RESOURCES › Series 64-112 - Medical Cannabis Program - Dispensaries › Section 64-112-7 - Items and services provided at a dispensary

Current through Register Vol. XLI, No. 28, July 12, 2024
7.1. A dispensary must dispense the form of
				medical cannabis in accordance with section 4 of this rule.
7.2. A dispensary must purchase medical
				cannabis products only from a grower/processor.
7.3. A dispensary may sell, offer for sale,
				or provide at its facility, with the prior written approval of the bureau,
				instruments, devices, and services related to the use of medical
				cannabis.
7.4. A dispensary may
				dispense a medical cannabis product so long as the dispensary purchases it from
				a grower/processor and the grower/processor obtained bureau approval under
				64CSR110.10 (Forms of medical cannabis).
7.5. A dispensary may not:
7.5.a. Advertise medical cannabis:
7.5.a.1. As a promotional item.
7.5.a.2. As part of a giveaway.
7.5.a.3. As part of a coupon
				program.
West Virginia Code of State Rules › Agency 64 - Health › Title 64 - LEGISLATIVE RULE WEST VIRGINIA DEPARTMENT OF HEALTH AND HUMAN RESOURCES › Series 64-112 - Medical Cannabis Program - Dispensaries › Section 64-112-8 - Labels and safety inserts

Current through Register Vol. XLI, No. 28, July 12, 2024
8.1.
				Medical cannabis products dispensed by a dispensary must only be identified by
				the name of the grower/processor, the name of the dispensary, the form and
				species of medical cannabis, the percentage of THC and CBD contained in the
				medical cannabis product, and any other labeling required by the
				bureau.
8.2. A dispensary must
				dispense medical cannabis to a patient or caregiver in a sealed and properly
				labeled package.
8.3. The
				dispensary must inspect the label to ensure that the label contains the
				following:
8.3.a. The information required to
				be included in the receipt in section 4 of this rule.
8.3.b. The packaging date.
8.3.c. A use by or expiration date.
8.3.d. The following warning stating: "This
				product is for medicinal use only. Women should not consume during pregnancy or
				while breastfeeding except on the advice of the practitioner who issued the
				certification and, in the case of breastfeeding, the infant's pediatrician.
				This product might impair the ability to drive or operate heavy machinery. Keep
				out of reach of children."
8.3.e.
				The number of individual doses contained within the package and the species and
				percentage of THC and CBD.
8.3.f. A
				warning that the medical cannabis must be kept in the original container in
				which it was dispensed.
8.3.g. A
				warning that unauthorized use is unlawful and will subject the purchaser or
				user to criminal penalties.
8.3.h.
				Any other information required by the bureau.
West Virginia Code of State Rules › Agency 64 - Health › Title 64 - LEGISLATIVE RULE WEST VIRGINIA DEPARTMENT OF HEALTH AND HUMAN RESOURCES › Series 64-112 - Medical Cannabis Program - Dispensaries › Section 64-112-9 - Plans of operation

Current through Register Vol. XLI, No. 28, July 12, 2024
9.1. At the
				time the bureau determines a dispensary to be operational, the dispensary must
				provide the bureau with a full and complete plan of operation for review that
				includes the following:
9.1.a. Employment
				policies and procedures.
9.1.b.
				Security policies and protocols, including:
9.1.b.1. Staff identification
				measures.
9.1.b.2. Monitoring of
				attendance of staff and visitors.
9.1.b.3. Alarm systems.
9.1.b.4. Video surveillance.
9.1.b.5. Monitoring and tracking
				inventory.
9.1.b.6. Personnel
				security.
9.1.c. A
				process for receiving, packaging, labeling, handling, tracking, transporting,
				storing, disposing, returning, and recalling products containing medical
				cannabis in accordance with all applicable laws, rules and
				regulations.
9.1.d. Workplace
				safety.
9.1.e. Maintenance,
				cleaning and sanitation of the site or facility, or both.
9.1.f. Inventory maintenance and reporting
				procedures.
9.1.g. The
				investigation of complaints and potential adverse events from other medical
				cannabis organizations, patients, caregivers, or practitioners.
9.1.h. The use of the electronic tracking
				system prescribed by the bureau.