Virginia Law

Part VI. Cultivation, Production, and Dispensing of Cannabis Products

18VAC110-60-280. 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 18VAC110-60-281, 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. 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 18VAC110-60-281.

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 18VAC110-60-281 regarding flammable solvents as defined in that section;

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

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

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

D. 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 are 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. A pharmaceutical processor acquiring oil from 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. A pharmaceutical processor shall maintain policies and procedures for the proper storage and handling of industrial hemp extracts, to include a process for executing or responding to mandatory and voluntary recalls in a manner that complies with 18VAC110-60-250.

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

Statutory Authority

§ 54.1-3442.6 of the Code of Virginia.

Historical Notes

Derived from Virginia Register Volume 35, Issue 23, eff. August 7, 2019; amended, Virginia Register Volume 37, Issue 01, eff. September 30, 2020; Volume 37, Issue 12, eff. March 18, 2021; Volume 37, Issue 25, eff. September 1, 2021; Volume 39, Issue 24, eff. August 16, 2023.

18VAC110-60-281. Use of hydrocarbon-based solvents or other flammable solvents.

A. The following words and phrases used in this section shall have the following meanings, unless the context clearly indicates otherwise:

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, 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 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.

5. A pharmaceutical processor using hydrocarbon-based solvents maintains sole responsibility for any adverse outcomes or violations of federal or Virginia state 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 a certification from a licensed engineer that certifies that the system was commercially manufactured, is safe for its intended use, and has been built to codes of recognized and generally accepted good engineering practices, such as (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 the following:

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 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 an amount of flammable solvents on site that 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.

Statutory Authority

§ 54.1-3442.6 of the Code of Virginia.

Historical Notes

Derived from Virginia Register Volume 39, Issue 24, eff. August 16, 2023.

18VAC110-60-285. Registration of products.

A. A pharmaceutical processor shall assign a brand name to each product of cannabis. The pharmaceutical processor shall register each brand name with the board on a form prescribed by the board prior to any dispensing and shall associate each brand name with a specific laboratory test that includes 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 brand name unless the laboratory test results for each product indicate that they contain the same level of each active ingredient listed in subsection A of this section within a range of 90% to 110%, except (i) where 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) where 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 brand 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 name of a previously approved cannabis oil product brand name;

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; or

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

Statutory Authority

§ 54.1-3442.6 of the Code of Virginia.

Historical Notes

Derived from Virginia Register Volume 35, Issue 23, eff. August 7, 2019; amended, Virginia Register Volume 37, Issue 1, eff. September 30, 2020; Volume 37, Issue 25, eff. September 1, 2021; Volume 39, Issue 24, eff. August 16, 2023.

18VAC110-60-290. Labeling of batch of cannabis products.

A. Cannabis products produced as a batch shall not be adulterated.

B. Cannabis products produced as a batch shall be:

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

2. Labeled with:

a. The name and address of the pharmaceutical processor;

b. The brand name of the cannabis product that was registered with the board pursuant to 18VAC110-20-285;

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;

d. The date of testing and packaging;

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;

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

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

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

(1) Tetrahydrocannabinol (THC);

(2) Tetrahydrocannabinol acid (THC-A);

(3) Cannabidiol (CBD); and

(4) Cannabidiolic acid (CBDA).

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

i. 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

j. 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, and the potency.

Statutory Authority

§ 54.1-3442.6 of the Code of Virginia.

Historical Notes

Derived from Virginia Register Volume 35, Issue 23, eff. August 7, 2019; amended, Virginia Register Volume 37, Issue 1, eff. September 30, 2020; Volume 37, Issue 25, eff. September 1, 2021; Volume 39, Issue 24, eff. August 16, 2023.

18VAC110-60-295. Labeling of bulk cannabis oil, botanical cannabis, and usable cannabis.

A. Bulk cannabis oil, botanical cannabis, and usable cannabis shall not be adulterated.

B. Bulk cannabis oil, botanical cannabis, and usable cannabis produced for wholesale distribution shall be:

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, except as exempted in this section;

2. Packaged in a tamper-evident container; and

3. Labeled with:

a. The name and addresses of the pharmaceutical processor distributing the product and the pharmaceutical processor receiving the product;

b. The quantity or weight of the cannabis oil, botanical cannabis, or usable cannabis in the container;

c. Identification of the contents of the container, including a brief description of the type or form of cannabis oil, botanical cannabis, or usable cannabis and the strain or name, as appropriate;

d. The statement "Not Packaged for Final Sale" displayed prominently;

e. A unique serial number that will match a cannabis product with the cultivator and manufacturer and lot or batch number so as to facilitate any warnings or recalls the board or pharmaceutical processor deem appropriate; and

f. The dates of harvest and packaging.

C. Cannabis products produced from bulk cannabis oil, botanical cannabis, and usable cannabis shall comply with all laboratory testing and labeling requirements prior to dispensing.

Statutory Authority

§ 54.1-3442.6 of the Code of Virginia.

Historical Notes

Derived from Virginia Register Volume 39, Issue 24, eff. August 16, 2023.

18VAC110-60-300. Laboratory requirements; testing.

A. No pharmaceutical processor shall utilize a laboratory to handle, test, or analyze cannabis products unless such laboratory:

1. Is independent from all other persons involved in the cannabis industry in Virginia, which shall mean that no person with a direct or indirect interest in the laboratory shall have a direct or indirect financial interest in a pharmacist, pharmaceutical processor, cannabis dispensing facility, certifying practitioner, or any other entity that may benefit from the production, manufacture, dispensing, sale, purchase, or use of cannabis products; and

2. Has employed at least one person to oversee and be responsible for the laboratory testing who has earned from a college or university accredited by a national or regional certifying authority at least (i) a master's level degree in chemical or biological sciences and a minimum of two years of post-degree laboratory experience or (ii) a bachelor's degree in chemical or biological sciences and a minimum of four years of post-degree laboratory experience.

3. Has obtained a controlled substances registration certificate pursuant to § 54.1-3423 of the Code of Virginia authorizing the testing of cannabis products.

4. Has provided proof to the board of accreditation in testing and calibration in accordance with the most current version of the International Standard for Organization and the ISO/IEC 17025 or proof that the laboratory has applied for accreditation in testing and calibration in the most current version of ISO/IEC 17025. Any testing and calibration method utilized to perform a cannabis-related analysis for pharmaceutical processors shall be in accordance with the laboratory's ISO/IEC 17025 accreditation. The accrediting body shall be recognized by International Laboratory Accreditation Cooperation.

a. A laboratory applying for authorization to provide cannabis-related analytical tests for pharmaceutical processors shall receive ISO/IEC 17025 accreditation within two years from the date the laboratory applied for ISO/IEC 17025 accreditation. A laboratory may request, and the board may grant for good cause shown, additional time for the laboratory to receive ISO/IEC 17025 accreditation.

b. A laboratory shall send proof of ISO/IEC 17025 accreditation to the board for cannabis-related analytical test methods for pharmaceutical processors for which it has received ISO/IEC 17025 accreditation no later than five business days after the date in which the accreditation was received.

c. A laboratory may use nonaccredited analytical test methods so long as the laboratory has commenced an application for ISO/IEC 17025 accreditation for analytical test methods for cannabis-related analysis for pharmaceutical processors. No laboratory shall use nonaccredited analytical test methods for cannabis-related analysis for pharmaceutical processors if it has applied for and has not received ISO/IEC 17025 accreditation within two years. The laboratory may request and the board may grant for good cause shown additional time for the laboratory to utilize nonaccredited analytical test methods for cannabis-related analysis.

d. At such time that a laboratory loses its ISO/IEC 17025 accreditation for any cannabis-related analytical test methods for pharmaceutical processors, it shall inform the board within 24 hours. The laboratory shall immediately stop handling, testing, or analyzing Cannabis for pharmaceutical processors.

5. Complies with a transportation protocol for transporting Cannabis or cannabis products to or from itself or to or from pharmaceutical processors.

B. After processing and before dispensing the cannabis oil product, a pharmaceutical processor shall make a sample available from each homogenized batch of product for a laboratory to (i) test for microbiological contaminants, mycotoxins, heavy metals, residual solvents, and pesticide chemical residue; and (ii) conduct an active ingredient analysis and terpenes profile. Each laboratory shall determine a valid sample size for testing, which may vary due to sample matrix, analytical method, and laboratory-specific procedures. A minimum sample size of 0.5% of individual units for dispensing or distribution from each homogenized batch of cannabis oil is required to achieve a representative sample for analysis.

C. A pharmaceutical processor shall make a sample available from each harvest batch of botanical cannabis product to (i) test for microbiological contaminants, mycotoxins, heavy metals, pesticide chemical reside, water activity, and moisture content and (ii) conduct an active ingredient analysis and terpenes profile. In determining the minimum sample size for testing from each batch of botanical cannabis, the certified testing laboratory may determine the minimum sample size. The sample must be representative of the entire batch to include selection from various points in the batch lot and be of sufficient sample size to allow for analysis of all required tests.

D. From the time that a batch of cannabis product has been sampled for testing until the laboratory provides the results from its tests and analysis, the pharmaceutical processor shall segregate and withhold from use the entire batch, except the samples that have been removed by the laboratory for testing. During this period of segregation, the pharmaceutical processor shall maintain the batch in a secure, cool, and dry location so as to prevent the batch from becoming contaminated or losing its efficacy.

E. Under no circumstances shall a pharmaceutical processor or cannabis dispensing facility sell a cannabis product prior to the time that the laboratory has completed its testing and analysis and provided a certificate of analysis to the pharmaceutical processor or other designated facility employee.

F. The processor shall require the laboratory to immediately return or properly dispose of any cannabis products and materials upon the completion of any testing, use, or research.

G. If a sample of cannabis oil product does not pass the microbiological, mycotoxin, heavy metal, or residual solvent test based on the standards set forth in this subsection, the batch may be remediated with further processing. A cannabis oil product that does not pass the pesticide chemical residue test cannot be remediated. After further processing, the batch shall be retested for microbiological, mycotoxin, heavy metal, pesticide chemical residue, and residual solvent, and an active ingredient analysis and terpenes profile shall be conducted.

1. For purposes of the microbiological test, a cannabis oil sample shall be deemed to have passed if it satisfies the standards set forth in Section 1111 of the United States Pharmacopeia.

2. For purposes of the mycotoxin test, a sample of cannabis oil product shall be deemed to have passed if it meets the following standards:

3. For purposes of the heavy metal test, a sample of cannabis oil product shall be deemed to have passed if it meets the following standards:

4. For purposes of the pesticide chemical residue test, a sample of cannabis oil product shall be deemed to have passed if it satisfies the most stringent acceptable standard for a pesticide chemical residue in any food item as set forth in Subpart C of the federal Environmental Protection Agency's regulations for Tolerances and Exemptions for Pesticide Chemical Residues in Food, 40 CFR Part 180.

5. For purposes of the active ingredient analysis, a sample of the cannabis oil product shall be tested for:

a. Tetrahydrocannabinol (THC);

b. Tetrahydrocannabinol acid (THC-A);

c. Cannabidiols (CBD); and

d. Cannabidiolic acid (CBDA).

6. For the purposes of the residual solvent test, a sample of the cannabis oil product shall be deemed to have passed if it meets the standards and limits recommended by the American Herbal Pharmacopoeia for Cannabis Inflorescence.

H. If a sample of botanical cannabis product does not pass the microbiological, mycotoxin, heavy metal, water activity, or moisture content test based on the standards set forth in this subsection, the batch may be remediated. A botanical cannabis product that does not pass the pesticide chemical residue test cannot be remediated. Once remediated, the batch shall be retested for microbiological, mycotoxin, heavy metal, pesticide chemical residue, water activity, and moisture content, and an active ingredient analysis and terpenes profile shall be conducted. If the botanical cannabis batch fails retesting, it shall be considered usable cannabis and may be processed into cannabis oil, unless the failure is related to pesticide requirements, in which case the batch shall not be considered usable cannabis and shall not be processed into cannabis oil. Any batch processed into cannabis oil shall comply with all testing standards set forth in subsection G of this section.

1. For purposes of the microbiological test, a botanical cannabis product sample shall be deemed to have passed if it satisfies the standards set forth in the most current American Herbal Pharmacopoeia Cannabis Inflorescence Standards of Identity, Analysis, and Quality Control.

2. For purposes of the mycotoxin test, a sample of botanical cannabis product shall be deemed to have passed if it meets the following standards:

3. For purposes of the heavy metal test, a sample of botanical cannabis product shall be deemed to have passed if it meets the following standards:

4. For purposes of the pesticide chemical residue test, a sample of botanical cannabis product shall be deemed to have passed if it satisfies the most stringent acceptable standard for a pesticide chemical residue in any food item as set forth in Subpart C of the U.S. Environmental Protection Agency's regulations for Tolerances and Exemptions for Pesticide Chemical Residues in Food (40 CFR Part 180).

5. For purposes of the active ingredient analysis, a sample of the botanical cannabis product shall be tested for:

a. Total tetrahydrocannabinol (THC); and

b. Total cannabidiol (CBD).

6. For the purposes of water activity and moisture content for botanical cannabis, the product shall be deemed to have passed if the water activity rate does not exceed 0.65Aw and the moisture content does not exceed 15%.

I. If a sample of cannabis product passes the required tests listed in subsections G and H of this section, the entire batch may be utilized by the processor for immediate packaging and labeling for sale. An expiration date shall be assigned to the product that is based upon validated stability testing that addresses product stability when opened and the shelf-life for unopened products, except stability testing shall not be required for cannabis products if an expiration date of six months or less from the date of the cannabis product registration approval is signed.

J. The processor shall require the laboratory to file with the board an electronic copy of each laboratory test result for any batch that does not pass the required tests listed in subsections G and H of this section at the same time that it transmits those results to the pharmaceutical processor. In addition, the laboratory shall maintain the laboratory test results and make them available to the board or an agent of the board.

K. Each pharmaceutical processor or cannabis dispensing facility shall have such laboratory results available upon request to patients, parents, legal guardians, registered agents, registered practitioners who have certified qualifying patients, the board, or an agent of the board.

Statutory Authority

§ 54.1-3442.6 of the Code of Virginia.

Historical Notes

Derived from Virginia Register Volume 35, Issue 23, eff. August 7, 2019; amended, Virginia Register Volume 37, Issue 1, eff. September 30, 2020; Volume 37, Issue 25, eff. September 1, 2021; Errata, 38:1 VA.R. 172 August 30, 2021; Volume 38, Issue 11, eff. February 16, 2022; Volume 39, Issue 24, eff. August 16, 2023.

18VAC110-60-310. Dispensing of cannabis products.

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

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 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 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, and the date and quantity of the last dispensing of cannabis products to the patient.

2. A pharmacist or pharmacy technician employed by the 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 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:

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

2. The brand name of cannabis product that was registered with the board pursuant to 18VAC110-60-285 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 and registration number 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 if the items are included on the batch label as required in 18VAC110-60-290 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 18VAC110-60-210 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.

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. 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.

J. 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.

Statutory Authority

§ 54.1-3442.6 of the Code of Virginia.

Historical Notes

Derived from Virginia Register Volume 35, Issue 23, eff. August 7, 2019; amended, Virginia Register Volume 37, Issue 1, eff. September 30, 2020; Volume 37, Issue 25, eff. September 1, 2021; Volume 38, Issue 18, eff. May 25, 2022; Volume 39, Issue 24, eff. August 16, 2023.

18VAC110-60-320. Dispensing error review and reporting; quality assurance program.

A. A pharmaceutical processor or cannabis dispensing facility shall implement and comply with a quality assurance program that describes in writing policies and procedures to detect, identify, and prevent dispensing errors. A pharmaceutical processor or cannabis dispensing facility shall distribute the written policies and procedures to all pharmaceutical processor or cannabis dispensing facility employees and shall make the written policies and procedures readily available on the premises of the pharmaceutical processor or cannabis dispensing facility. The policies and procedures shall include:

1. Directions for communicating the details of a dispensing error to the practitioner who certified a qualifying patient and to the qualifying patient, the patient's parent or legal guardian, the patient's registered agent, or appropriate family member if the patient is deceased or is unable to fully comprehend the communication. The communication shall describe methods of correcting the dispensing error or reducing the negative impact of the error on the qualifying patient; and

2. A process to document and assess dispensing errors to determine the cause of the error and an appropriate response.

B. A pharmaceutical processor or cannabis dispensing facility shall use the findings of its quality assurance program to develop systems and workflow processes designed to prevent dispensing errors. A pharmaceutical processor or cannabis dispensing facility PIC shall:

1. Inform pharmaceutical processor or cannabis dispensing facility employees of changes to policy, procedure, systems, or processes made as a result of recommendations generated by the quality assurance program;

2. Notify all processor or facility employees that the discovery or reporting of a dispensing error shall be relayed immediately to a pharmacist on duty;

3. Ensure that a pharmacist performs a quality assurance review for each dispensing error. A pharmacist shall commence such review as soon as is reasonably possible, but no later than two business days from the date the dispensing error is discovered; and

4. Create a record of every quality assurance review. This record shall contain at least the following:

a. The date of the quality assurance review and the names and titles of the persons performing the review;

b. The pertinent data and other information relating to the dispensing error reviewed;

c. Documentation of contact with the patient, parent, legal guardian, or registered agent, where applicable, and the practitioner who certified the patient;

d. The findings and determinations generated by the quality assurance review; and

e. Recommended changes to pharmaceutical processor or cannabis dispensing facility policy, procedure, systems, or processes if any.

C. A pharmaceutical processor or cannabis dispensing facility shall maintain for three years a copy of the pharmaceutical processor's or cannabis dispensing facility's quality assurance program and records of all reported dispensing errors and quality assurance reviews in an orderly manner and filed by date.

Statutory Authority

§ 54.1-3442.6 of the Code of Virginia.

Historical Notes

Derived from Virginia Register Volume 35, Issue 23, eff. August 7, 2019; amended, Virginia Register Volume 37, Issue 25, eff. September 1, 2021; Volume 39, Issue 24, eff. August 16, 2023.

18VAC110-60-321. Devices, hemp-based CBD products, and inert product samples.

A. A pharmaceutical processor or cannabis dispensing facility may have for sale on-site devices intended for the administration of dispensed cannabis products and hemp based CBD products that meet the applicable standards set forth in state and federal law and that meet testing requirements of 18VAC110-60-280 D 2 and D 3.

B. The pharmaceutical processor or cannabis dispensing facility may use and distribute inert product samples that do not contain any active cannabinoids for patient demonstration exclusively at the pharmaceutical processor or cannabis dispensing facility without the need for a written certification. Such inert product samples may not be sold or further distributed.

Statutory Authority

§§ 54.1-3442.6 and 54.1-3447 of the Code of Virginia.

Historical Notes

Derived from Virginia Register Volume 37, Issue 25, eff. September 1, 2021.

18VAC110-60-330. 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; chemical, dangerous, and hazardous 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 oil, as applicable, shall be witnessed by a pharmacist or the responsible party of the pharmaceutical processor or cannabis dispensing facility, respectively, 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.

F. Disposal of chemical, dangerous, and hazardous waste must be conducted in a manner consistent with federal, state, and local statutes and regulations. This may include any waste product soaked in a flammable solvent.

1. Any waste that may be hazardous must be treated as hazardous waste in regard to storage, labeling, and disposal.

2. The pharmaceutical processor can, alternatively, test waste that may be hazardous for elemental impurities content.

a. When tested for elemental impurities content, materials that meet the definition of hazardous waste, as defined by the Resource Conservation and Recovery Act (RCRA) or other applicable federal, state, or local statutes and regulations, must be treated as hazardous waste. Such materials must be properly labeled, contained, stored, and disposed of in accordance with U.S. Environmental Protective Agency requirements, RCRA, and other applicable regulations for hazardous waste.

b. Materials that contain elemental impurities concentrations less than the allowable concentration limits as specified in RCRA and are not designated hazardous waste by other applicable federal, state, or local statutes and regulations, may be disposed of in accordance with this section.

Statutory Authority

§ 54.1-3442.6 of the Code of Virginia.

Historical Notes

Derived from Virginia Register Volume 35, Issue 23, eff. August 7, 2019; amended, Virginia Register Volume 37, Issue 1, eff. September 30, 2020; Volume 37, Issue 25, eff. September 1, 2021; Volume 39, Issue 24, eff. August 16, 2023.