Part V. Records, Storage, and Administration
3VAC10-40-200. Recordkeeping requirements.
A. If a medical cannabis facility uses an electronic system for the storage and retrieval of patient information or other records related to cultivating, producing, and dispensing cannabis products, as applicable, the pharmaceutical processor or cannabis dispensing facility shall use a system that:
1. Guarantees the confidentiality of the information contained in the system;
2. Is capable of safeguarding against erasures and unauthorized changes in data after the information has been entered and verified by the pharmacist or responsible party; and
3. Is capable of being reconstructed in the event of a computer malfunction or accident resulting in the destruction of the data bank.
B. All records relating to inventory, laboratory results, and dispensing shall be maintained for a period of three years and shall be made available to the board upon request.
Statutory Authority
§§ 4.1-601, 4.1-604, and 4.1-606 of the Code of Virginia.
Historical Notes
Derived from Virginia Register Volume 40, Issue 11, eff. January 1, 2024.
3VAC10-40-210. Storage and handling requirements.
A. A medical cannabis facility shall:
1. Have storage areas that provide adequate lighting, ventilation, sanitation, space, equipment, and security conditions for the cultivation of cannabis and the production and dispensing of cannabis products;
2. Have storage areas with 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% |
3. Store cannabis plants, seeds, parts of plants, extracts, including cannabis products, that are outdated, damaged, deteriorated, misbranded, adulterated, or whose containers or packaging have been opened or breached, in a separate quarantined storage area until such cannabis plants, seeds, parts of plants, extracts, or cannabis products are destroyed;
4. Be maintained in a clean, sanitary, and orderly condition; and
5. Be free from infestation by insects, rodents, birds, or vermin of any kind.
B. A medical cannabis facility shall compartmentalize all areas in the facility based on function and shall restrict access between compartments.
C. The pharmaceutical processor or cannabis cultivation facility shall establish, maintain, and comply with written policies and procedures regarding best practices for the secure and proper cultivation of cannabis and production of cannabis products. These shall include policies and procedures that:
1. Restrict movement between compartments;
2. Provide for different colored identification cards for employees based on the compartment to which the employees are assigned at a given time so as to ensure that only employees necessary for a particular function have access to that compartment of the facility;
3. Require pocketless clothing for all employees working in an area containing cannabis plants, seeds, and extracts, including cannabis oil and cannabis products; and
4. Document the chain of custody of all cannabis plants, parts of plants, seeds, extracts, and cannabis products.
D. A cannabis dispensing facility shall establish, maintain, and comply with written policies and procedures regarding best practices for the secure and proper dispensing of cannabis products, including a requirement for pocketless clothing for all facility employees working in an area containing cannabis products.
E. The PIC or responsible party of a medical cannabis facility shall establish, maintain, and comply with written policies and procedures for the cultivation, production, security, storage, and inventory of cannabis, including the seeds, parts of plants, extracts, and cannabis products, as applicable. Such policies and procedures shall include methods for identifying, recording, and reporting diversion, theft, or loss and for correcting all errors and inaccuracies in inventories. Medical cannabis facilities shall include in their written policies and procedures a process for:
1. Handling mandatory and voluntary recalls of cannabis products and bulk cannabis oil, botanical cannabis, and usable cannabis distributed or received via wholesale distribution. The process shall be adequate to deal with recalls due to any action initiated at the request of the board and any voluntary action by the pharmaceutical processor or cannabis dispensing facility to (i) remove defective or potentially defective cannabis products from the market or (ii) promote public health and safety by replacing existing cannabis products with improved products or packaging;
2. Preparing for, protecting against, and handling any crises that affect the security or operation of any facility in the event of strike, fire, flood, or other natural disaster, or other situations of local, state, or national emergency;
3. Ensuring that any outdated, damaged, deteriorated, misbranded, or adulterated cannabis, including seeds, parts of plants, extracts, and cannabis products, is segregated from all other cannabis, seeds, parts of plants, extracts, and cannabis products and destroyed. This procedure shall provide for written documentation of the cannabis, including seeds, parts of plants, extracts, and cannabis product disposition; and
4. Ensuring the oldest stock of cannabis, including seeds, parts of plants, extracts, and cannabis products are used first. The procedure may permit deviation from this requirement if such deviation is temporary and appropriate.
F. The pharmaceutical processor or cannabis cultivation facility shall store all cannabis, including seeds, parts of plants, extracts, and cannabis products, in the process of production, transfer, or analysis in such a manner as to prevent diversion, theft, or loss; shall make cannabis, including the seeds, parts of plants, extracts, and cannabis products accessible only to the minimum number of specifically authorized employees essential for efficient operation; and shall return such items to their secure location immediately after completion of the production, transfer, or analysis process or at the end of the scheduled business day. If a production process cannot be completed at the end of a working day, the pharmacist, responsible party, or other person authorized by the responsible party to supervise cultivation and production at the pharmaceutical processor or cannabis cultivation facility shall securely lock the processing area or tanks, vessels, bins, or bulk containers containing cannabis, including the seeds, parts of plants, extracts, and cannabis products, inside an area or building that affords adequate security.
G. The cannabis dispensing facility shall store all cannabis products in such a manner as to prevent diversion, theft, or loss; shall make cannabis products accessible only to the minimum number of specifically authorized employees essential for efficient operation; and shall return the cannabis products to their secure location at the completion of the dispensing or at end of the scheduled business day.
Statutory Authority
§§ 4.1-601, 4.1-604, and 4.1-606 of the Code of Virginia.
Historical Notes
Derived from Virginia Register Volume 40, Issue 11, eff. January 1, 2024.
3VAC10-40-220. Medical cannabis facility closings; going out of business; change of ownership.
A. At least 30 days prior to the date a medical cannabis facility closes, either temporarily or permanently, the owner shall:
1. Notify the board;
2. Send written notification to patients with current certification; and
3. Post a notice on the window or door of the medical cannabis facility.
B. The proposed disposition of all cannabis, industrial hemp extracts, cannabis products, dispensing records, patient information records, and other required records, as applicable, shall be reported to the board. If the cannabis, cannabis products, and records are to be transferred to another medical cannabis facility located in Virginia, the owner shall inform the board and the patients and include on the public notice the name and address of the processor or cannabis dispensing facility to whom the cannabis, cannabis products, and records are being transferred and the date of transfer.
C. The board may approve exceptions to the public notice requirement due to exigent circumstances, including sudden closing due to fire, destruction, natural disaster, death, property seizure, eviction, bankruptcy, or other emergency circumstances. If the medical cannabis facility is not able to meet the notification requirements, the owner shall ensure that the board and public are properly notified as soon as the owner knows of the closure and shall disclose the emergency circumstances preventing the notification within the required deadlines.
D. In the event of an exception to the notice, the PIC, responsible party, or owner shall provide notice as far in advance of closing as allowed by the circumstances.
E. At least 14 days prior to any change in ownership of an existing medical cannabis facility, the owner shall notify the board of the pending change.
1. Upon any change in ownership of an existing pharmaceutical processor or cannabis dispensing facility, the dispensing records for the two years immediately preceding the date of change of ownership and other required patient information shall be provided to the new owners on the date of change of ownership in substantially the same format as previously used immediately prior to the transfer to provide continuity of services.
2. The previous owner shall be held responsible for ensuring the proper and lawful transfer of records on the date of the transfer.
3. If a new owner's share constitutes 5.0% or greater of the total ownership, the new owner shall submit to fingerprinting and the criminal history record search required of § 4.1-1602 of the Code of Virginia.
Statutory Authority
§§ 4.1-601, 4.1-604, and 4.1-606 of the Code of Virginia.
Historical Notes
Derived from Virginia Register Volume 40, Issue 11, eff. January 1, 2024.