Administrative Code

Virginia Administrative Code
12/3/2021

Part I. General Provisions

18VAC110-60-10. Definitions.

In addition to words and terms defined in §§ 54.1-3408.3 and 54.1-3442.5 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 registered patients.

"Advertising" means the act of providing consideration for the publication, dissemination, solicitation, or circulation of visual, oral, or written communication through any means to directly induce any person to patronize a particular pharmaceutical processor or cannabis dispensing facility or to purchase particular approved cannabis products. Advertising includes marketing.

"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 Pharmacy.

"Certification" means a written statement, consistent with requirements of § 54.1-3408.3 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 registered patient or results in any detrimental change to the medical treatment for the patient.

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

"ISO/IEC" means the joint technical committee of the International Organization for Standardization (ISO) and the International Electrotechnical Commission (IEC).

"ISO/IEC 17025" means the general requirements specified by the ISO/IEC for the competence of testing and calibration laboratories.

"On duty" means that a pharmacist, the responsible party, or a person who is qualified to provide supervision in accordance with 18VAC110-60-170 is on the premises at the address of the permitted pharmaceutical processor and is available as needed.

"Perpetual inventory" means an ongoing system for recording quantities of cannabis oil received, dispensed, or otherwise distributed by a cannabis dispensing facility.

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

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

"Qualifying patient" means a Virginia resident who has received from a practitioner, as defined in § 54.1-3408.3 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.

"Registered patient" means a qualifying patient who has been issued a registration by the board for the dispensing of cannabis products to such patient.

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

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

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

"Temperature and humidity" means temperature and humidity maintained in the following ranges:

Room or Phase

Temperature

Humidity

Mother room

65 - 85° F

50% - 75%

Nursery phase

65 - 85° F

50% - 75%

Vegetation phase

65 - 85° F

50% - 75%

Flower/harvest phase

65 - 85° F

40% - 75%

Drying/extraction rooms

< 75° F

40% - 75%

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

Statutory Authority

§§ 54.1-3442.6 and 54.1-3447 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.

18VAC110-60-20. Fees.

A. Fees are required by the board as specified in this section. Unless otherwise provided, fees listed in this section shall not be refundable.

B. Registration of practitioner.

1. Initial registration.

$50

2. Annual renewal of registration.

$50

3. Replacement of registration for a qualifying practitioner whose information has changed or whose original registration certificate has been lost, stolen, or destroyed.

$50

C. Registration by a qualifying patient, parent, legal guardian, or registered agent.

1. Initial registration of a patient.

$50

2. Annual renewal of registration of a patient.

3. Initial registration of a parent or legal guardian.

4. Annual renewal of registration of a parent or guardian.

$50

$25

$25

5. Initial registration or annual renewal of a registered agent

$25

6. Replacement of registration for a qualifying patient, parent, legal guardian, or registered agent whose original registration certificate has been lost, stolen, or destroyed.

$25

D. Pharmaceutical processor permit.

1. Application.

$10,000

2. Initial permit.

$60,000

3. Annual renewal of permit.

$10,000

4. Change of name of processor.

$100

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

$100

6. Change of ownership not requiring a criminal background check.

$100

7. Change of ownership requiring a criminal background check.

$250

8. Any acquisition, expansion, remodel, or change of location requiring an inspection.

$1,000

9. Reinspection fee.

$1,000

10. Registration of each cannabis oil product.

$25

E. Cannabis dispensing facility permit.

1. Initial permit.

$5,000

2. Annual renewal of permit.

$1,500

3. Change of name of dispensing facility.

$100

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

$100

5. Change of ownership not requiring a criminal background check.

$100

6. Change of ownership requiring a criminal background check.

$250

7. Any acquisition, expansion, remodel, or change of location requiring an inspection.

$1,000

8. Reinspection fee.

$1,000

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

Statutory Authority

§§ 54.1-3442.6 and 54.1-3447 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 12, eff. March 18, 2021; Errata 37:14 VA.R. 2151 March 1, 2021; Volume 37, Issue 25, eff. September 1, 2021.

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