Virginia Cannabis Control Authority

Chapter **

Medical Cannabis Program Fees

3VAC10-20-10. Definitions.

In addition to words and terms defined in § 4.1-600 of the Code of Virginia, the following words and terms when used in this chapter shall have the following meanings, unless the context clearly indicates otherwise:

"Board" means the Board of Directors of the Virginia Cannabis Control Authority.

"Cannabis cultivation facility" means a location at which the board has authorized a pharmaceutical processor to cultivate cannabis plants pursuant to § 4.1-1602 of the Code of Virginia and the requirements of 3VAC10-20-160.

"Certification" means a written statement, consistent with requirements of § 4.1-1601 of the Code of Virginia, issued by a practitioner for the use of cannabis products for treatment of or to alleviate the symptoms of any diagnosed condition or disease determined by the practitioner to benefit from such use.

"Medical cannabis facility” means a pharmaceutical processor, cannabis dispensing facility, or cannabis cultivation facility.

"PIC" means the pharmacist-in-charge whose name is on the pharmaceutical processor or cannabis dispensing facility application for a permit that has been issued and who shall have oversight of the processor's dispensing area or cannabis dispensing facility.

"Production" or "produce" means the manufacture, planting, preparation, cultivation, growing, harvesting, propagation, conversion, or processing of marijuana for the creation of usable cannabis, botanical cannabis, or a cannabis product derived thereof, (i) directly or indirectly by extraction from substances of natural origin, (ii) independently by means of chemical synthesis, or (iii) by a combination of extraction and chemical synthesis. "Production" or "produce" includes any packaging or repackaging of the substance or labeling or relabeling of its container.

"Qualifying patient" means a Virginia resident who has received from a practitioner, as defined in § 4.1-1600 of the Code of Virginia, a written certification for the use of cannabis products for treatment of or to alleviate the symptoms of any diagnosed condition or disease.

"Registration" means an identification card or other document issued by the board that identifies a person as a qualifying patient, parent, legal guardian, or registered agent that has voluntarily registered with the board.

"Resident" means a person whose principal place of residence is within the Commonwealth as evidenced by a federal or state income tax return or a current Virginia driver's license. If a person is a minor, residency may be established by evidence of Virginia residency by a parent or legal guardian.

"Responsible party" means the person designated on the pharmaceutical processor application who shall have oversight of the cultivation and production areas of the pharmaceutical processor.

3VAC10-20-20. Qualifying patient, parent, legal guardian, or registered agent registration fee.

A. Registration under this section is voluntary.

B. Qualifying patient, parent, legal guardian, or registered agent registration fees are required by the board as specified in this section. Unless otherwise provided, fees listed in this section shall not be refundable.

C. Registration by a qualifying patient, parent, legal guardian, or registered agent. 1. Initial registration of a patient. $50

2. Annual renewal of registration of a patient. $50 3. Initial registration of a parent or legal guardian. $25 4. Annual renewal of registration of a parent or guardian. $25 5. Initial registration or annual renewal of a registered agent $25 6. Replacement of registration for a qualifying patient, parent, legal guardian, or registered agent whose original registration certificate has been lost, stolen, or destroyed.

$25

D. The handling fee for returned check or dishonored credit card or debit card shall be $50. 3VAC10-20-30. Pharmaceutical processor permit fee. A. Pharmaceutical processor permit fees are required by the board as specified in this section. Unless otherwise provided, fees listed in this section shall not be refundable. B. Pharmaceutical processor permit.

1. Application. $18,000

2. Initial permit. $165,000

3. Annual renewal of permit. $132,000

4. Change of name of processor. $200

5. Change of PIC or responsible party or any other information provided on the permit application.

$200

6. Change of ownership not requiring a criminal background check. $200 7. Change of ownership requiring a criminal background check. $500 8. Any acquisition, expansion, remodel, or change of location requiring an inspection.

$5,000

9. Reinspection fee. $5,000

10. Registration of each cannabis product. $50

C. The handling fee for returned check or dishonored credit card or debit card shall be $50. 3VAC10-20-40. Cannabis dispensing facility permit fee. A. Cannabis dispensing facility permit fees are required by the board as specified in this section. Unless otherwise provided, fees listed in this section shall not be refundable. B. Cannabis dispensing facility permit.

1. Application. $5,000

2. Initial permit. $80,000

3. Annual renewal of permit. $64,000

4. Change of name of dispensing facility. $200

5. Change of PIC or any other information provided on the permit application.

$200

6. Change of ownership not requiring a criminal background check. $200 7. Change of ownership requiring a criminal background check. $500 8. Any acquisition, expansion, remodel, or change of location requiring an inspection.

$5,000

9. Reinspection fee. $5,000

C. The handling fee for returned check or dishonored credit card or debit card shall be $50. 3VAC10-20-50. Cannabis cultivation facility permit fee. A. Cannabis cultivation facility permit fees are required by the board as specified in this section. Unless otherwise provided, fees listed in this section shall not be refundable. B. Cannabis cultivation facility permit.

1. Application. $5,000

2. Initial permit. $80,000

3. Annual renewal of permit. $64,000

4. Change of PIC or any other information provided on the permit application.

$200

5. Change of ownership not requiring a criminal background check. $200 6. Change of ownership requiring a criminal background check. $500 7. Any acquisition, expansion, remodel, or change of location requiring an inspection.

$5,000

8. Reinspection fee. $5,000

C. The handling fee for returned check or dishonored credit card or debit card shall be $50. Chapter 30

Applications, Licenses, Permits, and Registrations 3VAC10-30-10. Definitions.

In addition to words and terms defined in § 4.1-600 of the Code of Virginia, the following words and terms when used in this chapter shall have the following meanings, unless the context clearly indicates otherwise:

"90-day supply" means the amount of cannabis products reasonably necessary to ensure an uninterrupted availability of supply for a 90-day period for patients with a valid, unexpired written certification issued by a practitioner for the use of cannabis products.

"Board" means the Board of Directors of the Cannabis Control Authority.

"Cannabis cultivation facility" means a location at which the board has authorized a pharmaceutical processor to cultivate cannabis plants pursuant to § 4.1-1602 of the Code of Virginia and the requirements of 3VAC10-30-160.

"Certification" means a written statement, consistent with requirements of § 4.1-1601 of the Code of Virginia, issued by a practitioner for the use of cannabis products for treatment of or to alleviate the symptoms of any diagnosed condition or disease determined by the practitioner to benefit from such use.

"Electronic tracking system" means an electronic radio-frequency identification (RFID) seed- to-sale tracking system that tracks the cannabis from either the seed or immature plant stage until the cannabis product is sold to a patient, parent, legal guardian, or registered agent or until the cannabis, including the seeds, parts of plants, and extracts, are destroyed. The electronic tracking system shall include, at a minimum, a central inventory management system and standard and ad hoc reporting functions as required by the board and shall be capable of otherwise satisfying required recordkeeping.

"Medical cannabis facility" means a pharmaceutical processor, cannabis dispensing facility, or cannabis cultivation facility.

"On duty" means that a pharmacist, the responsible party, or a person who is qualified to provide supervision in accordance with 3VAC10-30-90 is on the premises at the address of the permitted pharmaceutical processor and is available as needed.

"PIC" means the pharmacist-in-charge whose name is on the pharmaceutical processor or cannabis dispensing facility application for a permit that has been issued and who shall have oversight of the processor's dispensing area or cannabis dispensing facility.

"Production" or "produce" means the manufacture, planting, preparation, cultivation, growing, harvesting, propagation, conversion, or processing of marijuana for the creation of usable cannabis, botanical cannabis, or a cannabis product derived thereof, (i) directly or indirectly by extraction from substances of natural origin, (ii) independently by means of chemical synthesis, or (iii) by a combination of extraction and chemical synthesis. "Production" or "produce" includes any packaging or repackaging of the substance or labeling or relabeling of its container.

"Qualifying patient" means a Virginia resident who has received from a practitioner, as defined in § 4.1-1600 of the Code of Virginia, a written certification for the use of cannabis products for treatment of or to alleviate the symptoms of any diagnosed condition or disease.

"Registration" means an identification card or other document issued by the board that identifies a person as a qualifying patient, parent, legal guardian, or registered agent that has voluntarily registered with the board.

"Resident" means a person whose principal place of residence is within the Commonwealth as evidenced by a federal or state income tax return or a current Virginia driver's license. If a person is a minor, residency may be established by evidence of Virginia residency by a parent or legal guardian.

"Responsible party" means the person designated on the pharmaceutical processor application who shall have oversight of the cultivation and production areas of the pharmaceutical processor.

"Temporary residency" means a person does not maintain a principal place of residence within Virginia but resides in Virginia on a temporary basis as evidenced by documentation substantiating such temporary residence.

3VAC10-30-20. Reserved.

3VAC10-30-30. Requirements for practitioner issuing a certification. A. Prior to issuing a certification for cannabis products for any diagnosed condition or disease, the practitioner shall meet the requirements of § 4.1-1601 of the Code of Virginia. B. A practitioner issuing a certification shall:

1. Conduct an assessment and evaluation of the patient in order to develop a treatment plan for the patient, which shall include an examination of the patient and the patient's medical history, prescription history, and current medical condition; 2. Diagnose the patient;

3. Be of the opinion that the potential benefits of cannabis products would likely outweigh the health risks of such use to the qualifying patient; 4. Authorize on the written certification the use of botanical cannabis for a minor patient if the practitioner determines such use is consistent with the standard of care to dispense botanical cannabis to a minor. If not specifically included on the initial written certification, authorization for botanical cannabis may be communicated verbally or in writing to the pharmacist at the time of dispensing;

5. Explain proper administration and the potential risks and benefits of the cannabis product to the qualifying patient, and if the qualifying patient lacks legal capacity, to a parent or legal guardian prior to issuing the written certification; 6. Be available or ensure that another practitioner, as defined in § 4.1-1600 of the Code of Virginia, is available to provide follow-up care and treatment to the qualifying patient, including physical examinations, to determine the efficacy of cannabis products for treating the diagnosed condition or disease;

7. Comply with generally accepted standards of medical practice, except to the extent such standards would counsel against certifying a qualifying patient for cannabis products; 8. Maintain medical records in accordance with 18VAC85-20-26 for all patients for whom the practitioner has issued a certification; and

9. Access or direct the practitioner's delegate to access the Virginia Prescription Monitoring Program of the Department of Health Professions for the purpose of determining which, if any, covered substances have been dispensed to the patient. C. The practitioner shall use the practitioner's professional judgment to determine the manner and frequency of patient care and evaluation, which may include the use of telemedicine, provided that the use of telemedicine:

1. Includes the delivery of patient care through real-time interactive audio-visual technology;

2. Conforms to the standard of care expected for in-person care; and 3. Transmits information in a manner that protects patient confidentiality. D. A practitioner shall not delegate the responsibility of diagnosing a patient or determining whether a patient should be issued a certification. Employees under the direct supervision of the practitioner may assist with preparing a certification, so long as the final certification is approved and signed by the practitioner before it is issued to the patient. E. The practitioner shall provide instructions for the use of cannabis products to the patient, parent, or guardian, as applicable, and shall also securely transmit such instructions to the permitted pharmaceutical processor.

F. Upon request, a practitioner shall make a copy of medical records available to an agent of the Board of Medicine or Board of Pharmacy for the purpose of enabling the board to ensure compliance with the law and regulations or to investigate a possible violation. 3VAC10-30-40. Prohibited practices for practitioners. A. A practitioner who issues certifications shall not: 1. Directly or indirectly accept, solicit, or receive anything of value from any person associated with a pharmaceutical processor or provider of paraphernalia, excluding information on products or educational materials on the benefits and risks of cannabis products;

2. Offer a discount or any other thing of value to a qualifying patient, parent, guardian, or registered agent based on the patient's agreement or decision to use a particular pharmaceutical processor or cannabis product;

3. Examine a qualifying patient for purposes of diagnosing the condition or disease at a location where cannabis products are dispensed or produced; or 4. Directly or indirectly benefit from a patient obtaining a certification. Such prohibition shall not prohibit a practitioner from charging an appropriate fee for the patient visit. B. A practitioner who issues certifications and such practitioner's coworker, employee, spouse, parent, or child shall not have a direct or indirect financial interest in a pharmaceutical processor, a cannabis dispensing facility, or any other entity that may benefit from a qualifying patient's acquisition, purchase, or use of cannabis products, including any formal or informal agreement whereby a pharmaceutical processor or other person provides compensation if the practitioner issues a certification for a qualifying patient or steers a qualifying patient to a specific pharmaceutical processor or cannabis product.

C. A practitioner shall not issue a certification for himself or for family members, employees, or coworkers.

D. A practitioner shall not provide product samples containing cannabis other than those approved by the U.S. Food and Drug Administration. 3VAC10-30-50. Registration of a patient, parent, legal guardian, or registered agent. A. A qualifying patient, or a parent or legal guardian of a minor or vulnerable adult, for whom a practitioner has issued a certification may voluntarily request registration in accordance with this section. For issuance of a registration, the following items shall be submitted: 1. A copy of the certification issued by a practitioner; 2. Proof of residency of the qualifying patient and proof of residency of a parent or legal guardian, if applicable, such as a government-issued identification card or tax receipt or proof of temporary residency, if applicable, such as a current academic identification card from a Virginia institution of higher learning, rental agreement, utility bill, or attestation on a form prescribed by the board that contains information sufficient to document temporary residency in Virginia;

3. Proof of identity of the qualifying patient, and if the patient is a minor, proof of identity of the parent or legal guardian in the form of a government-issued identification card; 4. Proof of the qualifying patient's age in the form of a birth certificate or other government- issued identification;

5. Payment of the appropriate fees; and

6. Such other information as the board may require to determine the applicant's suitability for registration or to protect public health and safety. B. A patient or the patient's parent or legal guardian may choose a registered agent to receive cannabis products on behalf of the patient. An individual may serve as a registered agent for no more than two patients. For a voluntary registration application to be approved, the following shall be submitted:

1. The name, address, and birth date of each patient for whom the individual intends to act as a registered agent;

2. A copy of the written certification issued to the patient for the use of cannabis products for treatment of or to alleviate the symptoms of any diagnosed condition or disease; 3. Proof of identity in the form of a copy of a government-issued identification card; 4. Payment of the applicable fee; and

5. Such other information as the board may require to determine the applicant's suitability for registration or to protect public health and safety. C. A qualifying patient shall not be issued a written certification by more than one practitioner during a given time period.

3VAC10-30-60. Denial of a patient, parent, legal guardian, or registered agent registration application.

A. The board may deny an application or renewal of the registration of a registered agent or the voluntary registration or renewal of a patient, parent, or legal guardian if the applicant: 1. Does not meet the requirements set forth in law or regulation or fails to provide complete information on the application form;

2. Does not provide acceptable proof of identity, residency or temporary residency, or age of the patient to the board;

3. Provides false, misleading, or incorrect information to the board; 4. Has had a registration request denied or registered agent status denied, suspended, or revoked by the board in the previous six months;

5. Has presented a certification issued by a practitioner who is not authorized to certify patients for cannabis products; or

6. Has a prior conviction of a violation of any law pertaining to controlled substances. B. If the board denies an application or renewal of a patient, parent, legal guardian, or registered agent applicant, the board shall provide the applicant with notice of the grounds for the denial and shall inform the applicant of the right to request a hearing pursuant to § 2.2-4019 of the Code of Virginia.

3VAC10-30-70. Reporting requirements for practitioners, patients, parents, legal guardians, or registered agents.

A. A practitioner shall report to the board, in a manner prescribed by the board, the death of a patient or a change in status of a patient for whom the practitioner has issued a certification if such change affects the patient's continued eligibility to use cannabis products or the practitioner's inability to continue treating the patient. A practitioner shall report such death, change of status, or inability to continue treatment not more than 15 days after the practitioner becomes aware of such fact.

B. A patient, parent, or legal guardian who has been issued a registration shall notify the board of any change in the information provided to the board not later than 15 days after such change. The patient, parent, or legal guardian shall report changes that include a change in name, address, contact information, medical status of the patient, or change of the certifying practitioner. The patient, parent, or legal guardian shall report such changes on a form prescribed by the board.

C. A registered agent who has been issued a registration shall notify the board of any change in the information provided to the board not later than 15 days after such change, to include a change in the identifying information of the patient for whom the registered agent is serving as a registered agent.

D. If a patient, parent, legal guardian, or registered agent notifies the board of any change that results in information on the registration of the patient, parent, legal guardian, or registered agent being inaccurate, the board shall issue a replacement registration. Upon receipt of a new registration, the qualifying patient, parent, legal guardian, or registered agent shall destroy in a nonrecoverable manner the registration that was replaced. E. If a patient, parent, legal guardian, or registered agent becomes aware of the loss, theft, or destruction of the registration of such patient, parent, legal guardian, or registered agent, the registrant shall notify the board not later than five business days after becoming aware of the loss, theft, or destruction and submit the fee for a replacement registration. The board shall issue a replacement registration upon receiving the applicable fee, provided the applicant continues to satisfy the requirements of law and regulation.

3VAC10-30-80. Invalidation of the voluntary registration of a patient, parent, legal guardian, or registered agent.

The board may invalidate the voluntary registration of a patient, parent, legal guardian, or registered agent under the following circumstances: 1. The patient's practitioner notifies the board that the practitioner is withdrawing the written certification submitted on behalf of the patient, and 30 days after the practitioner's withdrawal of the written certification, the patient has not obtained a valid written certification from a different practitioner;

2. The voluntarily registered patient, parent, legal guardian, or registered agent provided false, misleading, or incorrect information to the board; 3. The voluntarily registered patient is no longer a resident of Virginia or is no longer temporarily residing in Virginia;

4. The voluntarily registered patient, parent, legal guardian, or registered agent obtained more than a 90-day supply of cannabis products in a 90-day period; 5. The voluntarily registered patient, parent, legal guardian, or registered agent sold or improperly provided cannabis products to any person, including another registered agent; 6. The voluntarily registered patient, parent, legal guardian, or registered agent permitted another person to use the registration of the voluntarily registered patient, parent, legal guardian, or registered agent, except as required for a registered agent to act on behalf of a patient;

7. The voluntarily registered patient, parent, legal guardian, or registered agent tampered, falsified, altered, modified, or allowed another person to tamper, falsify, alter, or modify the registration of the voluntarily registered patient, parent, legal guardian, or registered agent;

8. The registration of the voluntarily registered patient, parent, legal guardian, or registered agent was lost, stolen, or destroyed, and the voluntarily registered patient, parent, legal guardian, or registered agent failed to notify the board or notified the board of such incident more than five business days after becoming aware that the registration was lost, stolen, or destroyed;

9. The voluntarily registered patient, parent, legal guardian, or registered agent failed to notify the board of a change in registration information or notified the board of such change more than 15 days after the change; or

10. The voluntarily registered patient, parent, legal guardian, or registered agent violated any federal or state law or regulation.

3VAC10-30-90. Medical cannabis facility employee licenses and registrations. A. A pharmacist with a current, unrestricted license issued by the Board of Pharmacy practicing at the location of the address on the pharmaceutical processor or cannabis dispensing facility application shall be in full and actual charge of the dispensing area of a pharmaceutical processor or of a cannabis dispensing facility and shall serve as the pharmacist-in-charge. B. A pharmacist with a current, unrestricted license issued by the Board of Pharmacy shall provide personal supervision on the premises of the dispensing area of the pharmaceutical processor or of a cannabis dispensing facility at all times during its hours of operation, unless all cannabis products are contained in a vault or other similar container to which only the pharmacist has access controls.

C. The person who is designated as the responsible party for a pharmaceutical processor shall practice at the location of the address on the pharmaceutical processor application, shall have oversight of the cultivation and production areas, and shall possess: 1. A current, unrestricted license as a pharmacist issued by the Board of Pharmacy; 2. A degree in chemistry, pharmacology, or a field related to the cultivation of plants; 3. A certification recognized by the board; or

4. At least two years of verifiable experience cultivating plants or extracting chemicals from plants.

D. A person who holds a current, unrestricted registration as a pharmacy technician pursuant to § 54.1-3321 of the Code of Virginia may perform the following duties under supervision of a pharmacist:

1. The entry of drug dispensing information and drug history into a data system or other recordkeeping system;

2. The preparation of labels for dispensing the cannabis product or patient information; 3. The removal of the cannabis product to be dispensed from inventory; 4. The measuring of the cannabis product to be dispensed; 5. The packaging and labeling of the cannabis product to be dispensed and the repackaging thereof;

6. The packaging and labeling of bulk cannabis oil, botanical cannabis, and usable cannabis intended to be wholesale distributed pursuant to 3VAC10-40-50; 7. The stocking or loading of devices used in the dispensing process; 8. The selling of the cannabis product to the patient, parent, legal guardian or registered agent; and

9. The performance of any other task restricted to pharmacy technicians by the board of pharmacy's regulations.

E. A pharmacist with a current, unrestricted license; a registered pharmacy intern who has completed the first professional year of pharmacy school; or a pharmacy technician with a current, unrestricted registration issued by the Board of Pharmacy may perform duties associated with the cultivation and extraction as authorized by the pharmaceutical processor and duties associated with the dispensing of the products as authorized by the PIC or as otherwise authorized in law. F. A pharmaceutical processor may employ individuals with less than two years of experience to perform cultivation-related duties under the supervision of an individual who has received a degree in a field related to the cultivation of plants or a certification recognized by the board or who has at least two years of experience cultivating plants. G. A pharmaceutical processor may employ individuals with less than two years of experience to perform extraction-related duties under the supervision of an individual who has a degree in chemistry or pharmacology or at least two years of experience extracting chemicals from plants. H. At no time shall the dispensing area of a pharmaceutical processor operate or be accessed without a pharmacist on duty. At no time shall the cultivation and production area operate or be accessed without an employee on duty who satisfies the requirements for providing direct supervision for the activities in the respective areas. I. No person shall be employed by or serve as an agent of a medical cannabis facility without being at least 18 years of age.

J. No person who has had a license or registration suspended or revoked or been denied issuance of such license or registration shall serve as an employee or agent of the medical cannabis facility unless such license or registration has been reinstated and is current and unrestricted.

3VAC10-30-100. Publication of notice for submission of applications. A. The board shall publish a notice of open applications for pharmaceutical processor permits. Such notice shall include information on how to obtain and complete an application, the required fees, the criteria for issuance of a permit, and the deadline for receipt of applications. B. The board shall have the right to amend the notice of open applications prior to the deadline for submitting an application. Such amended notice shall be published in the same manner as the original notice of open applications.

C. The board shall have the right to cancel a notice of open applications prior to the award of a pharmaceutical processor permit.

3VAC10-30-110. Application process for pharmaceutical processor permits. A. The application process for permits shall occur in the following three stages: submission of initial

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