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 diagnose develop a treatment plan for the patient or confirm another medical provider's diagnosis. This, which shall include an examination of the patient and the patient's medical history, prescription history, and current medical condition;

2. Develop a treatment plan for 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.

G. If the authority determines that a practitioner has violated, attempted to violate, solicited any person to violate, or consented to any violation of this chapter, the authority may restrict that practitioner's ability to issue written certifications for patients in the future or report information to the applicable licensing board.

A medical cannabis facility may engage in marketing activities related to products, the medical cannabis program, the pharmaceutical processor company, and related communications, except those marketing activities that:

1. Include false or misleading statements;

2. Promote excessive consumption;

3. Depict a person younger than 21 years of age consuming cannabis;

4. Include any image designed or likely to appeal to minors, specifically including cartoons, toys, animals, fruit, children, or any other likeness to images, character, or phrases that are popularly used to advertise to children;

5. Depict products or product packaging or labeling that bears reasonable resemblance to any product legally available for consumption as a candy or that promotes cannabis consumption; or

6. Contain any seal, flag, crest, coat of arms, or other insignia that is likely to mislead patients or the general public to believe that the cannabis product has been endorsed, made, or used by the Commonwealth of Virginia or any of its representatives except where specifically authorized.

A. Prior to transporting medical cannabis to another medical cannabis facility or offering cannabis delivery to patients, a medical cannabis facility shall submit the following items to the authority:

1. A list of the employees authorized to transport or deliver cannabis, along with a copy of each authorized employee's valid driver license; and

2. For each transport or delivery vehicle:

a. License plate number, vehicle identification number, make, and model;

b. An attestation that the vehicle is properly registered and insured;

c. A description of the locked, safe, and secure storage compartments in the vehicle; and

d. A description of the security system, form of secure communication, global positioning system (GPS) monitoring device, and any other equipment or system required pursuant to 3VAC10-40-240.

B. A medical cannabis facility shall provide written notice to the authority, along with the documentation required in subsection A of this section, in the event the facility adds or removes a transport or delivery vehicle or an authorized employee.

C. No medical cannabis facility shall advertise, offer, or commence delivery or transport operations prior to receiving written approval from the authority.

A. All transport or delivery vehicles shall be properly registered with the Commonwealth and be insured in the Commonwealth. Medical cannabis facilities shall maintain registration and insurance documents and provide the documents to the authority and law-enforcement officials upon request.

B. A transport or delivery vehicle shall bear no marking or outward appearance, including brand or company names, that would indicate to a reasonable person that the vehicle is used to transport cannabis.

C. At all times during the transportation of cannabis, a transport or delivery vehicle shall be equipped with the following functioning features:

1. Heating and air conditioning systems sufficient for maintaining appropriate temperatures for the storage of cannabis during transport in accordance with recommendations provided by the originating medical cannabis facility to protect the quality and integrity of the cannabis;

2. A locked, safe, and secure storage compartment where cannabis will be stored during transport that (i) is a secured part of the vehicle, (ii) is not easily removed, and (iii) ensures cannabis is not visible from the outside of the vehicle;

3. A global positioning system (GPS) monitoring device that is secured to the vehicle in a manner not easily removed and able to remain powered on when the transport vehicle is not running, the information from which shall be maintained in accordance with 3VAC10-40-260;

4. A secure form of communication between the transporting agent and the transporting facility, and any originating facility if required by 3VAC10-40-260 G, at all times during the transportation of cannabis. Secure forms of communication shall include a two-way digital or analog radio, cellular telephone, and satellite telephone, taking into consideration the functionality of the communication device within the geographic area of the transport; and

5. An adequate vehicle security system to prevent adulteration, diversion, theft, and loss of cannabis, including an audible alarm system.

D. Access to transport vehicle security equipment and records shall be limited to (i) persons who are essential to security operations, (ii) law-enforcement agencies, (iii) security system service employees, (iv) the authority, and (v) other persons approved by the authority. A transporting facility shall maintain a current list of all individuals who have access to any transport vehicle security equipment and records.

E. The authority may inspect a transport or delivery vehicle as well as its equipment, including security systems, forms of secure communication, and GPS monitoring devices at any time without prior notice. If the authority determines that the transport or delivery vehicle does not satisfy the requirements of this section, or that such transport or delivery vehicle requires additional security measures to address public health and safety concerns, the medical cannabis facility shall not use the transport vehicle until such time as it receives a satisfactory inspection from the authority.

A. Prior to transporting cannabis between medical cannabis facilities or from a medical cannabis facility to a testing laboratory:

1. The originating facility shall prepare a transport manifest on a form and in a manner prescribed by the authority, itemizing all cannabis to be transported. A separate copy of the transport manifest shall be provided to the transporting employee to accompany the itemized cannabis at all times during transport.

2. The originating facility shall securely transmit a copy of the transport manifest to the receiving facility at least 24 hours prior to transport.

3. An authorized transportation employee shall review the transport manifest prepared by the originating facility and confirm that it accurately describes the type and quantity of cannabis in the transport vehicle to be transported by the transporting employee, in the aggregate and for each delivery.

B. Prior to delivering cannabis to a qualifying patient, parent, legal guardian, or registered agent:

1. The pharmaceutical processor or cannabis dispensing facility shall prepare a delivery manifest on a form and in a manner prescribed by the authority, itemizing all cannabis to be delivered. A separate copy of the delivery manifest shall be provided to the delivery employee to accompany the itemized cannabis at all times during transport.

2. The delivery employee shall review the delivery manifest prepared by the medical cannabis facility and confirm that it includes sufficient identifying information for each patient, parent, legal guardian, or registered agent, including name and day and month of birth.

C. No transport vehicle shall carry any cannabis for which a manifest has not been provided, and all cannabis shall be packaged in sealed, labeled, and tamper-resistant packaging at all times.

A. A transporting employee shall remain with the transport vehicle at all times that the vehicle contains cannabis, provided that if there is only one transporting employee, the transporting employee may leave the vehicle, which shall be securely locked, only for:

1. Delivering or transferring cannabis to a qualifying patient, parent, legal guardian, registered agent, or medical cannabis facility;

2. Meals, when the transport lasts more than three hours round trip;

3. Rest periods required by law;

4. Refueling; or

5. Exigent circumstances, including collisions, traffic stops, mechanical breakdowns, weather emergencies, or medical emergencies.

B. A transporting employee shall carry transportation credentials at all times during the transportation of cannabis and display such credentials to the appropriate persons at the originating facility prior to each instance of transportation of cannabis, and to any law-enforcement official or authorized authority representative upon request. For purposes of this section, "transportation credentials" shall mean the transporting employee's valid driver's license, a copy of the medical cannabis facility's permit, and all transport or delivery manifests for cannabis contained in the transport vehicle.

C. A transporting facility shall inspect and test all security systems, secure communications, and global positioning system (GPS) monitoring devices of each transport vehicle at least once per day of use, prior to the transport vehicle's first departure. The individual conducting the inspection on behalf of the transporting facility shall create a signed record of the inspection that includes (i) the name of the individual, (ii) the vehicle identification number of the transport vehicle, (iii) the date of inspection, and (iv) the status of all inspected systems, equipment, and devices. The transporting facility shall maintain all inspection records.

D. No transport vehicle shall transport cannabis unless every security system, form of secure communication, and GPS monitoring device is in good working order and functioning properly.

E. If any security system, form of secure communication, or GPS monitoring device fails during the transportation of cannabis, the transporting employee shall immediately notify the transporting facility and all impacted originating facilities of the specific failure and return directly to the transporting facility or originating facility. Such transport vehicle shall not resume transportation of cannabis until all systems resume full functioning capacity.

F. The transporting facility shall create a confidential delivery schedule within 24 hours of the transport and only provide the transporting employee with a copy of such confidential delivery schedule immediately prior to departure.

G. A transporting employee shall communicate with the transporting facility upon arriving at and departing from each scheduled delivery location.

H. A transporting employee shall strictly adhere to the delivery schedule provided by the transporting facility and not make any unscheduled stops. In the case of an emergency unscheduled stop, the transport vehicle shall remain securely locked, and the transporting employee shall verbally communicate with the transporting facility, describing the reason for the emergency unscheduled stop, the location and the duration of the emergency unscheduled stop, any activities of the transporting employee, and the identities and activities of any persons interacting with the transport vehicle or the transporting employee. The transporting facility shall maintain a record of any communications related to an unscheduled stop.

I. For a period of not less than 90 days, a transporting facility shall maintain a record of the GPS information of each of its transport vehicles for the entire duration of any transportation of cannabis and make such information available to the authority upon request. A transporting facility may contract with the GPS provider or similar service provider to conduct GPS monitoring, provided that any such third-party GPS monitor shall comply with all applicable state and federal laws regarding patient confidentiality.

J. A transporting employee shall return any undeliverable cannabis to the respective originating facility directly after the last scheduled delivery.

K. No cannabis shall be stored in a transport vehicle after the facility's hours of operation, and in no event longer than 24 hours, unless the vehicle is contained within an enclosed, secure part of the facility.

L. A transporting facility shall report to the authority and local law enforcement any transport vehicle accidents, transport vehicle theft, cannabis diversion, loss, or adulteration, and any other event deemed by the authority to be a reportable event in connection with the transportation of cannabis within 24 hours of such event being discovered.

A. Medical cannabis facilities offering delivery shall require each qualifying patient, parent, legal guardian, or registered agent who purchases cannabis for delivery to provide the medical cannabis facility with the full legal name, date of birth, address, email address, and telephone number of the qualifying patient and, if applicable, the legal name, date of birth, and address of the parent, legal guardian, or registered agent.

B. For each delivery of cannabis to a qualifying patient, parent, legal guardian, or registered agent, a transporting employee shall confirm from a valid driver's license or other valid, government-issued photographic identification that the identity of the individual accepting the cannabis delivery is the same as the individual who ordered the cannabis and confirm the qualifying patient's registration number.

C. If the identity, age, or registration of the individual accepting the cannabis delivery remains in question after presentation of the required documentation, the transporting employee shall (i) immediately alert the originating facility and (ii) return the cannabis to the originating facility directly after the last scheduled delivery.

D. Medical cannabis may only be delivered to a residence in Virginia. "Residence" means a dwelling such as a house, apartment, nursing home, or retirement center. It does not include a dormitory, hotel, motel, bed and breakfast, or other commercial business.

E. Medical cannabis may only be delivered between the hours of 6 a.m. and midnight.

A. A pharmaceutical processor transporting or delivering medical cannabis must report any traffic stop, breakdown, collision, or unscheduled stop lasting more than two hours to the authority with 24 hours.

B. An originating facility's authorized employees shall make a good faith effort to contact the authority if exigent circumstances require removal of cannabis or cannabis products from the vehicle prior to arrival at the destination listed on the transport manifest. Authorized employees shall make a good faith effort to protect the shipment from diversion.

A. A pharmacist in good faith may dispense cannabis products to any patient, parent, legal guardian, or registered agent as indicated on the written certification.

1. Prior to the initial dispensing of cannabis products pursuant to each written certification, the pharmacist or pharmacy technician at the location of the pharmaceutical processor or cannabis dispensing facility shall:

a. Offer patients, parents, legal guardians, and registered agents the opportunity to consult with a pharmacist regarding the use of cannabis products, including information related to safe techniques for proper use and storage of cannabis products and for disposal of the products in a manner that renders them nonrecoverable;

b. View in person or by audiovisual means a current photo identification of the patient, parent, legal guardian, or registered agent; and

c. Verify in the Virginia Prescription Monitoring Program of the Department of Health Professions or other program recognized by the board that the written certification is valid and the date and quantity of the last dispensing of cannabis products to the patient.

2. A pharmacist or pharmacy technician employed by the pharmaceutical processor or cannabis dispensing facility shall make a paper or electronic copy of the current written certification that provides an exact image of the document that is clearly legible and shall maintain it on site or by electronic means for two years. The pharmaceutical processor and cannabis dispensing facility shall also provide an electronic copy of the written certification to the board.

3. Prior to any subsequent dispensing, the pharmacist or pharmacy technician shall verify that the written certification on file has not expired. An employee or delivery agent shall view a current photo identification and current registration of the patient, parent, legal guardian, or registered agent and shall maintain record of such viewing in accordance with policies and procedures of the pharmaceutical processor or cannabis dispensing facility.

B. A pharmacist may dispense a portion of a patient's 90-day supply of cannabis product. The pharmacist may dispense the remaining portion of the 90-day supply of cannabis products at any time except that no patient, parent, legal guardian, or registered agent shall receive more than a 90-day supply of cannabis products for a patient in a 90-day period from any pharmaceutical processor or cannabis dispensing facility. A pharmaceutical processor or cannabis dispensing facility may dispense more than one cannabis product to a patient at one time. However, no more than four ounces of botanical cannabis shall be dispensed for each 30-day period for which botanical cannabis is dispensed. In determining the appropriate amount of cannabis product to be dispensed to a patient, a pharmacist shall consider all cannabis products dispensed and adjust the amount dispensed accordingly.

C. A dispensing record shall be maintained for three years from the date of dispensing, and the pharmacist or pharmacy technician under the direct supervision of the pharmacist shall affix a label to the container of cannabis product according to 3VAC10-70-40. that contains:

D. 1. A serial number assigned to the dispensing of the product;

2. The cannabis product name that was registered with the board pursuant to 3VAC10-50-70 and its strength;

3. The serial number assigned to the product during production;

4. The date of dispensing the cannabis product;

5. The quantity of cannabis products dispensed;

6. A terpenes profile and a list of all active ingredients, including:

a. Tetrahydrocannabinol (THC);

b. Tetrahydrocannabinol acid (THC-A);

c. Cannabidiol (CBD); and

d. Cannabidiolic acid (CBDA);

For botanical cannabis products, only the total cannabidiol (CBD) and total tetrahydrocannabinol (THC) are required;

7. A pass rating based on the laboratory's microbiological, mycotoxins, heavy metals, residual solvents, pesticide chemical residue analysis, and for botanical cannabis, the water activity and moisture content analysis;

8. The name of the patient;

9. The name of the certifying practitioner;

10. Directions for use as may be included in the practitioner's written certification or otherwise provided by the practitioner;

11. For botanical cannabis, the amount recommended by the practitioner or dispensing pharmacist;

12. The name or initials of the dispensing pharmacist;

13. Name, address, and telephone number of the pharmaceutical processor or cannabis dispensing facility;

14. Any necessary cautionary statement;

15. A prominently printed expiration date based on stability testing; and

16. The pharmaceutical processor's or cannabis dispensing facility's recommended conditions of use and storage that can be read and understood by the ordinary individual.

D. The label shall be exempt from containing the items listed in subdivisions C 6, C 7, and C 15 of this section if the items are included on the batch label as required in 3VAC10-70-20 and are clearly visible to the patient.

E. A pharmaceutical processor shall not label cannabis products as "organic" unless the cannabis plants have been organically grown and the cannabis oil products have been produced, processed, manufactured, and certified to be consistent with organic standards in compliance with 7 CFR Part 205.

F. The cannabis products shall be dispensed in child-resistant packaging, except as provided in 3VAC10-40-20 A. A package shall be deemed child-resistant if it satisfies the standard for "special packaging" as set forth in the Poison Prevention Packaging Act of 1970 Regulations, 16 CFR 1700.1(b)(4).

G. No person except a pharmacist or a pharmacy technician operating under the direct supervision of a pharmacist shall alter, deface, or remove any label so affixed.

H. A pharmacist shall be responsible for verifying the accuracy of the dispensed product in all respects prior to dispensing and shall document that each verification has been performed.

E. I. A pharmacist shall document a patient's self-assessment of the effects of cannabis products in treating the patient's diagnosed condition or disease or the symptoms thereof.

F. J. If the authorization for botanical cannabis for a minor is communicated verbally or in writing to the pharmacist at the time of dispensing, the pharmacist shall also document such authorization. A pharmaceutical processor or cannabis dispensing facility shall maintain such documentation in writing or electronically for three years from the date of dispensing and such documentation shall be made available in accordance with regulation.

G. K. A pharmacist shall exercise professional judgment to determine whether to dispense cannabis products to a patient, parent, legal guardian, or registered agent if the pharmacist suspects that dispensing cannabis products to the patient, parent, legal guardian, or registered agent may have negative health or safety consequences for the patient or the public.

A. Each container and layer of packaging containing cannabis shall prominently display the universal symbol. Cannabis products produced as a batch shall not be adulterated.

B. Cannabis products produced as a batch shall be:

1. Unadulterated;

2. 1. Processed, packaged, and labeled according to the U.S. Food and Drug Administration's Current Good Manufacturing Practice in Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements (21 CFR Part 111); and

3. 2. Labeled with:

a. The name and address of the pharmaceutical processor;

b. The cannabis product name that was registered with the board pursuant to § 4.1-1603.2 of the Code of Virginia;

c. A description of the product's purpose and instructions for use;

d. Child and safety warnings, as approved by the authority, in a conspicuous font;

e. c. A unique serial number that matches the product with the pharmaceutical processor batch and lot number, including the cultivator and manufacturer if produced from bulk cannabis oil, botanical cannabis, or usable cannabis obtained through distribution from another pharmaceutical processor, so as to facilitate any warnings or recalls the board or pharmaceutical processor deem appropriate;

f. d. The date of testing and packaging;

g. e. For products produced from bulk cannabis oil, botanical cannabis, or usable cannabis obtained through distribution from another pharmaceutical processor, the name and address of the testing laboratory;

h. f. The expiration date, which shall be 12 months or less from the date of the cannabis product registration approval, unless supported by stability testing;

i. g. The quantity of cannabis products contained in the batch;

j. h. A terpenes profile and a list of all active and inactive ingredients, including:

(1) Tetrahydrocannabinol (THC);

(2) Tetrahydrocannabinol acid (THC-A);

(3) Cannabidiol (CBD); and

(4) Cannabidiolic acid (CBDA);

k. i. For botanical cannabis products, list of only total cannabidiol (CBD) and total tetrahydrocannabinol (THC);

l. j. For cannabis oil products, pass or fail rating based on the laboratory's microbiological, mycotoxins, heavy metals, residual solvents, and pesticide chemical residue analysis; and

m. k. For botanical cannabis products, a pass or fail rating based on the laboratory's microbiological, mycotoxins, heavy metals, pesticide chemical residue analysis, water activity, and moisture content.

C. If the immediate container is too small, then an outer layer of packaging shall include the requirements of subdivision B 3 of this section and the immediate container shall include:

1. Pharmaceutical processor name, telephone number, and email or website;

2. The cannabis product name that was registered with the board pursuant to § 4.1-1603.2 of the Code of Virginia;

3. The serial number assigned to the product during production;

4. A prominently printed expiration date;

5. The quantity of cannabis products by weight, volume, or count and weight; and

6. A list of all active ingredients, including:

a. Tetrahydrocannabinol (THC);

b. Tetrahydrocannabinol acid (THC-A);

c. Cannabidiol (CBD); and

d. Cannabidiolic acid (CBDA).

D. Labels may be accordion, expandable, extendable, or layered to permit labeling of containers of any manner of size or shape.

E. Cannabis vaporizer cartridges shall bear a universal symbol no smaller than one-quarter-inch wide by one-quarter-inch high that is engraved, printed, or affixed with a sticker.

F. No pharmaceutical processor shall label cannabis products as "organic" unless the cannabis plants have been organically grown and the cannabis oil products have been produced, processed, manufactured, and certified to be consistent with organic standards in compliance with 7 CFR Part 205.

A. The pharmacist or pharmacy technician under the direct supervision of the pharmacist shall affix a label, in a manner provided by the board, to each cannabis product, including:

1. A serial number assigned to the dispensing of the product;

2. The cannabis product name that was registered with the board pursuant to 3VAC10-50-70 and its strength;

3. The serial number assigned to the product during production;

4. The date of dispensing the cannabis product;

5. The quantity of cannabis products dispensed;

6. A terpenes profile and a list of all active ingredients, including:

a. Tetrahydrocannabinol (THC);

b. Tetrahydrocannabinol acid (THC-A);

c. Cannabidiol (CBD); and

d. Cannabidiolic acid (CBDA);

7. A pass rating based on the laboratory's microbiological, mycotoxins, heavy metals, residual solvents, and pesticide chemical residue analysis and, for botanical cannabis, the water activity and moisture content analysis;

8. The name of the patient;

9. The name of the certifying practitioner;

10. Directions for use as may be provided by the practitioner, on the written certification or otherwise, or the dispensing pharmacist;

11. For botanical cannabis, the amount recommended by the practitioner or dispensing pharmacist;

12. The name or initials of the dispensing pharmacist;

13. The name, address, and telephone number of the pharmaceutical processor or cannabis dispensing facility;

14. Any necessary cautionary statement;

15. A prominently printed expiration date; and

16. The recommended conditions of use and storage from the pharmaceutical processor or cannabis dispensing facility that can be read and understood by the ordinary individual.

B. The label shall be exempt from containing the items listed in subdivisions A 6, A 7, and A 15 of this section if the items are included on the batch label as required in 3VAC10-70-20 and are clearly visible to the patient.

C. No person, except a pharmacist or a pharmacy technician operating under the direct supervision of a pharmacist, shall alter, deface, or remove any label so affixed.

A. Packaging shall be child-resistant, except as provided in 3VAC10-40-20 A, tamper-resistant, and light-resistant based on the following standards:

1. A package shall be deemed child-resistant if it satisfies the standard for "special packaging" as set forth in the Poison Prevention Packaging Act of 1970 Regulations, 16 CFR 1700.1(b)(4). A pharmaceutical processor shall maintain a copy of the certificate showing that any packaging containing medical cannabis is child-resistant and complies with the requirements of 16 CFR 1700.15 and 16 CFR 1700.25;

2. A package shall be deemed tamper-resistant if it has one or more indicators or barriers to entry that would preclude its contents from being accessed or adulterated without indicating to a reasonable person that the package was breached; and

3. A package shall be deemed light-resistant if it is entirely and uniformly opaque and protects the whole of its contents from the effects of light.

B. No packaging shall (i) bear any reasonable resemblance to a trademarked, characteristic, or product-specialized packaging of any commercially available candy, snack, baked good, or beverage or (ii) be designed in any manner to be especially appealing to persons younger than 21 years of age.