TITLE 3. ALCOHOLIC BEVERAGE AND CANNABIS CONTROL

BOARD OF DIRECTORS OF THE VIRGINIA CANNABIS CONTROL AUTHORITY

Proposed Regulation

Title of Regulation: 3VAC10-50. Cannabis Products (amending 3VAC10-50-10, 3VAC10-50-50 through 3VAC10-50-80, 3VAC10-50-110).

Statutory Authority: §§ 4.1-601, 4.1-604, and 4.1-606 of the Code of Virginia.

Public Hearing Information: No public hearing is currently scheduled.

Public Comment Deadline: January 16, 2025.

Agency Contact: Jake Shuford, Legislative and Regulatory Manager, Virginia Cannabis Control Authority, 333 East Franklin Street, Richmond, VA 23219, telephone (804) 873-9038, or email jake.shuford@cca.virginia.gov.

Summary:

The amendments (i) adopt a common practice in the industry of restricting non-cannabinoid additives that could increase the potency, toxicity, or addictive properties of cannabis to protect patients and the integrity of medicinal cannabis products; (ii) codify a list of previously approved chemicals for use in the cultivation, extraction, production, or manufacturing of cannabis products to avoid potential patient exposure to harmful chemicals; and (iii) ensure patients are offered the opportunity to consult with a pharmacist or pharmacy technician during the patient's initial visit to a dispensary. Other amendments relocate certain provisions within the medical cannabis program regulations and remove the redundant requirement for a pharmacist or pharmacy technician to physically witness certain actions that are required to be conducted under video surveillance.

3VAC10-50-10. Definitions.

In addition to words and terms defined in the Cannabis Control Act (§ 4.1-600 et seq. 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 either included on a valid, unexpired written certification issued by a practitioner for the use of cannabis products or established by a pharmacist during initial consultation.

"Batch" means a quantity of (i) cannabis oil from a production lot or (ii) harvested botanical cannabis product that is identified by a batch number or other unique identifier.

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

"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.

"Dispensing error" means one or more of the following was discovered after the final verification by the pharmacist, regardless of whether the patient received the product:

1. Variation from the intended product to be dispensed, including:

a. Incorrect product;

b. Incorrect product strength;

c. Incorrect dosage form;

d. Incorrect patient; or

e. Inadequate or incorrect packaging, labeling, or directions.

2. Failure to exercise professional judgment in identifying and managing:

a. Known therapeutic duplication;

b. Known drug-disease contraindications;

c. Known drug-drug interactions;

d. Incorrect drug dosage or duration of drug treatment;

e. Known drug-allergy interactions;

f. A clinically significant, avoidable delay in therapy; or

g. Any other significant, actual, or potential problem with a patient's drug therapy.

3. Delivery of a cannabis product to the incorrect patient.

4. An act or omission relating to the dispensing of cannabis product that results in, or may reasonably be expected to result in, injury to or death of a patient or results in any detrimental change to the medical treatment for the patient.

"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.

"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.

3VAC10-50-50. Cultivation and production of cannabis products.

A. No cannabis products shall have had pesticide chemicals or petroleum-based solvents, except for hydrocarbon-based solvents described in this chapter, used during the cultivation, extraction, production, or manufacturing process, except that the board may authorize the use of pesticide chemicals for purposes of addressing an infestation that could result in a catastrophic loss of cannabis crops.

B. No cannabis product shall contain any of the following:

1. Any regulated drug or controlled substance other than cannabis.

2. Non-cannabinoid additives that are psychotropic or would increase the potency, toxicity, or addictive properties of cannabis, including alcohol, caffeine, and nicotine. This prohibition shall not apply to the combination of cannabis with sugar or a product in which caffeine is naturally occurring, such as chocolate.

C. Cultivation methods for cannabis plants, extraction methods used to produce the cannabis products, and the manufacturing of cannabis products shall be performed in a manner deemed safe and effective based on current standards or scientific literature.

1. The cultivation, extraction, production, and manufacturing of cannabis products may include the use of hydrocarbon-based solvents as described in 3VAC10-50-60.

2. The cultivation, extraction, production, and manufacturing of cannabis products may include any other generally accepted technology, provided that:

a. The pharmaceutical processor complies with any applicable requirements contained in 3VAC10-50-60 regarding flammable solvents as defined in that section;

b. The pharmaceutical processor complies with any licensing, permitting, and general safety laws or regulations of any state or federal agency that governs the technology and the use of such technology; and

c. The pharmaceutical processor maintains sole responsibility for any adverse outcomes or violations of state or federal laws or regulations caused by such use.

C. D. Any cannabis plant, seed, parts of plant, extract, or cannabis products not in compliance with this section shall be deemed adulterated.

D. E. A pharmaceutical processor may acquire industrial hemp extract, including isolates and distillates, for the purpose of formulating such extracts into allowable dosages of cannabis products provided:

1. The pharmaceutical processor acquires the extracts from industrial hemp extract processed in Virginia and in compliance with state or federal law from a registered industrial hemp dealer or processor;

2. The extracts from industrial hemp acquired by a pharmaceutical processor is subject to the same third-party testing requirements applicable to cannabis plant extract as verified by testing performed by a laboratory located in Virginia and in compliance with state law; and

3. The industrial hemp dealer or processor provides such third-party testing results to the pharmaceutical processor before extracts from industrial hemp are acquired.

E. F. A pharmaceutical processor acquiring industrial hemp extract shall ensure receipt of a record of the transaction that shows the date of distribution, the names and addresses of the registered industrial hemp dealer or processor distributing the product and the pharmaceutical processor receiving the product, and the kind and quantity of product being distributed. The record of the transaction shall be maintained by the pharmaceutical processor with its records of receipt. Such records shall be maintained by each pharmaceutical processor for three years.

F. G. A pharmaceutical processor shall maintain policies and procedures for the proper storage and handling of industrial hemp extracts, to include including a process for executing or responding to mandatory and voluntary recalls in a manner that complies with 3VAC10-40-210.

G. H. No cannabis oil intended to be vaporized or inhaled shall contain vitamin E acetate.

3VAC10-50-60. Use of hydrocarbon-based solvents or other flammable solvents.

A. The following words and phrases used in this section have the following meaning:

1. "Closed-loop system" means machinery in which volatile hydrocarbon substances are self-contained without the loss or escape of those substances.

2. "Flammable solvent" means a liquid that has a flash point below 100 degrees Fahrenheit. Flammable solvents include hydrocarbon-based solvents.

3. "Hydrocarbon-based solvent" means a type of solvent composed of hydrogen and carbon compounds, such as N-butane, isobutene, propane, or any isomer or combination thereof.

B. Hydrocarbon-based solvents may be used in the cultivation, extraction, production, or manufacturing of cannabis products provided that:

1. A pharmaceutical processor complies with all requirements in this section.

2. A pharmaceutical processor using hydrocarbon-based solvents shall comply with all regulations regarding use of hydrocarbon-based solvents in general industrial use as promulgated by the Occupational Safety and Health Administration and published in 29 CFR 1910 or any subsequent regulation governing such use, including regulations governing:

a. Ventilation requirements;

b. Air contaminants; and

c. Hazard communication.

3. A pharmaceutical processor using hydrocarbon-based solvents shall comply with any requirements issued by the Virginia Department of Labor and Industry regarding use of hydrocarbon-based solvents.

4. A pharmaceutical processor using hydrocarbon-based solvents shall comply with any requirements issued by the Virginia Department of Environmental Quality regarding use of hydrocarbon-based solvents promulgated.

5. A pharmaceutical processor using hydrocarbon-based solvents maintains sole responsibility for any adverse outcomes or violations of state or federal laws or regulations caused by such use.

6. A pharmaceutical processor using hydrocarbon-based solvents shall ensure that all equipment, counters, and surfaces used in the cultivation, extraction, production, or manufacturing of cannabis products are food-grade and do not react adversely with any hydrocarbon solvent used. All counters and surface areas shall be constructed in a manner that reduces the potential development of microbials, molds, and fungi and can be easily cleaned.

7. A pharmaceutical processor using hydrocarbon-based solvents shall ensure that any room in which hydrocarbon-based solvents will be used contains an emergency eye-wash station.

8. A pharmaceutical processor using hydrocarbon-based solvents shall ensure that a professional grade, closed-loop extraction system capable of recovering solvent is used in the cultivation, extraction, production, or manufacturing of cannabis products.

a. Closed-loop extraction systems must be commercially manufactured and bear a permanently affixed and visible serial number.

b. A pharmaceutical processor using a closed-loop extraction system must obtain certification from a licensed engineer that certifies that the system was commercially manufactured, is safe for its intended use, and is built to codes of recognized and generally accepted good engineering practices, such as the following: (i) the American Society of Mechanical Engineers (ASME); (ii) American National Standards Institute (ANSI); (iii) Underwriters Laboratories (UL); or (iv) the American Society for Testing and Materials (ASTM).

c. The certification must contain the signature and stamp of a professional engineer and include the serial number of the extraction unit certified.

9. A pharmaceutical processor using hydrocarbon-based solvents shall obtain a safety data sheet for each hydrocarbon-based solvent used and store such data sheet on the premises. All such records shall be subject to inspection by the board.

10. A pharmaceutical processor using hydrocarbon-based solvents shall develop standard operating procedures, good manufacturing practices, and a training plan prior to using such solvents. Standard operating procedures shall specifically address:

a. Safe and proper handling and use of hydrocarbon-based solvents;

b. Safe and proper operation of machinery and equipment;

c. Adequate cleaning and maintenance of machinery and equipment;

d. Incident reporting for any instances where the operator does not follow the stated standard operating procedures that identifies (i) the operator's name; (ii) the date and time of the incident; (iii) the supervising employees to which whom the incident report will be sent; and (iv) an incident summary that includes whether any cannabis products or other substances escaped from the closed-loop system, the amount of escaped material, whether the material was destroyed, and how the incident was resolved; and

e. Safe and proper disposal of waste created during processes using hydrocarbon-based solvents.

11. A pharmaceutical processor using hydrocarbon-based solvents shall ensure that any person using such solvents in a closed-loop system:

a. Is fully trained on how to use the system;

b. Has direct access to applicable material safety data sheets; and

c. Handles and stores the solvents safely.

C. If a pharmaceutical processor intends to use a flammable solvent, then a designated industrial hygienist or professional engineer that is not an employee of the pharmaceutical processor must:

1. Establish a maximum amount of flammable solvents and other flammable materials that may be stored within the pharmaceutical processor facility in accordance with applicable laws and regulations;

2. Determine what type of electrical equipment must be installed within the room in which flammable solvents are to be stored in accordance with applicable laws and regulations;

3. Determine whether a gas monitoring system must be installed within the room in which flammable solvents are to be used or stored, and if required, the system's specifications in accordance with applicable laws and regulations;

4. Determine whether a fire suppression system must be installed within the room in which the flammable solvents are to be used or stored, and if required, the system's specifications in accordance with applicable laws and regulations; and

5. Determine whether a fume vent hood or exhaust system must be installed within the room in which a flammable solvent will be used, and if required, the system's specifications in accordance with applicable laws and regulations.

D. If a pharmaceutical processor makes a material change to its use of flammable solvents in any part of the manufacturing process, a designated industrial hygienist or professional engineer who is not an employee of the pharmaceutical processor must recertify the standard operating procedures for use of flammable solvents determined under subsection C of this section.

E. A pharmaceutical processor shall maintain copies of all reports generated by or received from the designated industrial hygienist or professional engineer for inspection by the board.

F. A pharmaceutical processor shall not store more flammable solvents onsite that on site than exceeds the maximum amount allowable as identified by the designated industrial hygienist or professional engineer.

G. A pharmaceutical processor shall ensure that all appropriate safety and sanitary equipment, including personal protective equipment, is provided to and appropriately used by each employee handling a flammable solvent.

H. The board shall approve chemicals for use as hydrocarbon or other flammable solvents in the cultivation, extraction, production, or manufacturing of cannabis products based on availability of testing for residual material of individual solvents. Approved chemicals include:

1. Ethanol;

2. Ethyl acetate;

3. Ethyl ether;

4. Heptane;

5. Hexane;

6. Pentane;

7. 2-propanol (IPA);

8. Butane; and

9. Propane.

The board recognizes butane and propane as Class 3 solvents with a permissible daily exposure of 50 mg per day.

3VAC10-50-70. Registration of products.

A. A pharmaceutical processor shall assign a product name to each product of cannabis. The pharmaceutical processor shall register each cannabis product name with the board in a manner prescribed by the board prior to any dispensing and shall associate each registered cannabis product name with a specific laboratory test that includes the total cannabidiol (CBD) and total tetrahydrocannabinol (THC), a terpenes profile, and a list of all active ingredients, including:

1. Tetrahydrocannabinol (THC);

2. Tetrahydrocannabinol acid (THC-A);

3. Cannabidiols (CBD); and

4. Cannabidiolic acid (CBDA).

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

B. A pharmaceutical processor shall not label two products with the same registered cannabis product name unless the laboratory test results for each product indicate that the level of each listed active ingredient varies by no more than 15%. However, in cases where (i) the total tetrahydrocannabinol (THC) concentration is less than five milligrams per dose, the concentration of THC shall be within 0.5 milligrams per dose and (ii) the total cannabidiol (CBD) concentration is less than five milligrams per dose, the concentration of total CBD shall be within 0.5 milligrams per dose.

C. The board shall not register any cannabis product name that:

1. Is identical to or confusingly similar to the name of an existing commercially available product;

2. Is identical to or confusingly similar to the name of an unlawful product or substance;

3. Is confusingly similar to the registered cannabis product name of a previously approved cannabis product;

4. Is obscene or indecent;

5. May encourage the use of marijuana or cannabis products for recreational purposes;

6. May encourage the use of cannabis products for a disease or condition other than the disease or condition the practitioner intended to treat;

7. Is customarily associated with persons younger than the age of 18 years of age; or

8. Is related to the benefits, safety, or efficacy of the cannabis product unless supported by substantial evidence or substantial clinical data.

3VAC10-50-80. Dispensing of cannabis products.

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 view:

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. The pharmacist or pharmacy technician shall verify; and

c. Verify in the Virginia Prescription Monitoring Program of the Department of Health Professions or other program recognized by the board that any registrations, if applicable, are current, the written certification has not expired, 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 that contains: according to 3VAC10-70-40.

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. D. 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.

I. E. 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.

J. F. 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.

K. G. 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.

3VAC10-50-110. Disposal of cannabis products.

A. To mitigate the risk of diversion, a pharmaceutical processor shall routinely and promptly dispose of undesired, excess, unauthorized, obsolete, adulterated, misbranded, or deteriorated green waste, extracts, and cannabis products, as applicable. Green waste includes cannabis plants, seeds, and parts of plants. Green waste shall be weighed, ground, and combined with a minimum of 51% non-cannabis waste to render the mixture inactive and unrecognizable. Once rendered unrecognizable, green waste shall be considered agricultural waste and may be disposed of accordingly.

B. The destruction and disposal of green waste, extracts, and cannabis products, as applicable, shall be witnessed by a pharmacist or the responsible party of the medical cannabis facility and shall be conducted under video surveillance. The persons destroying and disposing of the green waste, extracts, or cannabis products shall maintain and make available a separate record of each occurrence of destruction and disposal indicating:

1. The date and time of destruction and disposal;

2. The manner of destruction and disposal;

3. The name and quantity of cannabis product and green waste destroyed and disposed of; and

4. The signatures of the persons destroying and disposing of the green waste, extracts, or cannabis products.

C. Disposal of green waste may be by incineration, inert composting, or any other means of disposal or destruction.

D. A pharmaceutical processor may sell or otherwise distribute inert composted green waste.

E. The record of destruction and disposal shall be maintained at the pharmaceutical processor or cannabis dispensing facility for three years from the date of destruction and disposal.