Part V. Operation of a Pharmaceutical Processor
18VAC110-60-210. General provisions.
A. A pharmaceutical processor or cannabis dispensing facility shall only sell cannabis products in a child-resistant, secure, and light-resistant container. Upon a written request from the registered patient, parent, legal guardian, or registered agent, the product may be dispensed in a non-child-resistant container so long as all labeling is maintained with the product.
B. Only a pharmacist may dispense cannabis products to registered patients or parents or legal guardians of patients who are minors or incapacitated adults and who are registered with the board, or to a registered agent. A pharmacy technician who meets the requirements of 18VAC110-60-170 C may assist, under the direct supervision of a pharmacist, in the dispensing and selling of cannabis products.
C. The PIC, pharmacist, responsible party, or person who is qualified to provide supervision in accordance with 18VAC110-60-170 on duty shall restrict access to the pharmaceutical processor or cannabis dispensing facility to:
1. A person whose responsibilities necessitate access to the pharmaceutical processor or cannabis dispensing facility and then for only as long as necessary to perform the person's job duties; or
2. A person who is a registered patient, parent, legal guardian, registered agent, or a companion of the patient, in which case such person shall not be permitted behind the service counter or in other areas where Cannabis plants, extracts, or cannabis products are stored
D. A pharmacist, pharmacy technician, or an employee of the pharmaceutical processor or cannabis dispensing facility who has routine access to confidential patient data and who has signed a patient data confidentiality agreement with the processor or dispensing facility may determine eligibility for access to the processor or facility by verifying through a verification source recognized by the board that the registration of the patient, parent, legal guardian, or registered agent is current.
E. All pharmacists and pharmacy technicians shall at all times while at the pharmaceutical processor or cannabis dispensing facility have their current license or registration available for inspection by the board or the board's agent.
F. While inside the pharmaceutical processor or cannabis dispensing facility, all employees shall wear name tags or similar forms of identification that clearly identify them, including their position at the pharmaceutical processor or cannabis dispensing facility.
G. A pharmaceutical processor or cannabis dispensing facility shall be open for registered patients, parents, legal guardians, or registered agents to purchase cannabis products for a minimum of 35 hours a week, except as otherwise authorized by the board.
H. A pharmaceutical processor or cannabis dispensing facility that closes the dispensing area during its normal hours of operation shall implement procedures to notify registered patients, parents, legal guardians, and registered agents of when the pharmaceutical processor or cannabis dispensing facility will resume normal hours of operation. Such procedures may include telephone system messages and conspicuously posted signs. If the cultivation, production, or dispensing area of the pharmaceutical processor or if a cannabis dispensing facility is or will be closed during its normal hours of operation for longer than two business days, the pharmaceutical processor or cannabis dispensing facility shall immediately notify the board.
I. A pharmacist shall counsel registered patients, parents, legal guardians, and registered agents, if applicable, regarding the use of cannabis products. Such counseling shall include 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.
J. The pharmaceutical processor or cannabis dispensing facility shall establish, implement, and adhere to a written alcohol-free, drug-free, and smoke-free work place policy that shall be available to the board or the board's agent upon request.
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; Volume 38, Issue 18, eff. May 25, 2022.
18VAC110-60-215. Advertising.
A. A pharmaceutical processor or cannabis dispensing facility shall not advertise (i) through any means unless at least 85% of the audience is reasonably expected to be 18 years of age or older, as determined by reliable, up-to-date audience composition data or (ii) on television or the radio at any time outside of regular school hours for elementary and secondary schools.
B. Advertising must accurately and legibly identify the pharmaceutical processor or cannabis dispensing facility responsible for its content and include a statement that cannabis products are for use by registered patients only. Any advertisement for cannabis products that is related to the benefits, safety, or efficacy, including therapeutic or medical claims, shall:
1. Be supported by substantial, current clinical evidence or data; and
2. Include information on side effects or risks associated with the use of cannabis.
C. Advertising shall not:
1. Be misleading, deceptive, or false or contain any health-related statement that is untrue in any particular manner or tends to create a misleading impression as to the effects on health of cannabis consumption;
2. Contain a statement, design, illustration, picture, or representation that:
a. Encourages or represents the recreational use of cannabis;
b. Targets or is attractive to persons younger than 18 years of age, including a cartoon character, a mascot, or any other depiction or image that is commonly used to market products to minors;
c. Displays the use of cannabis, including the consumption, smoking, or vaping of cannabis;
d. Encourages or promotes cannabis for use as an intoxicant; or
e. Is obscene or indecent.
3. Display cannabis or cannabis product pricing except as allowed in 18VAC110-60-215 F.
4. Display cannabis products or images of products where the advertisement is visible to members of the public from any street, sidewalk, park, or other public place; and
5. Include coupons, giveaways of free cannabis products, or distribution of merchandise that displays anything other than the facility name and contact information.
D. A pharmaceutical processor or cannabis dispensing facility may list its business in public phone books, business directories, search engines, or other places where it is reasonable for a business to maintain an informational presence of its existence and a description of the nature of the business. A pharmaceutical processor or cannabis dispensing facility shall not engage in the use of pop-up digital advertisements.
E. Any website or social media site owned, managed, or operated by a pharmaceutical processor or cannabis dispensing facility shall employ a neutral age-screening mechanism that verifies that the user is at least 18 years of age, including by using an age-gate, age-screen, or age verification mechanism.
F. A pharmaceutical processor or cannabis dispensing facility may display the following information on its website or social media site:
1. Name and location of the processor or facility;
2. Contact information for the processor or facility;
3. Hours and days the pharmaceutical processor or cannabis dispensing facility is open for dispensing cannabis products;
4. Laboratory results;
5. Product information and pricing;
6. Directions to the processor or facility; and
7. Educational materials regarding the use of cannabis products that are supported by substantial, current clinical evidence or data.
G. Communication and engagement for educational purposes with registered practitioners, registered patients, parents, legal guardians, registered agents, other health care practitioners, and the general public, including the dissemination of information permitted by 18VAC110-60-215 F and educational materials regarding the use of cannabis products available from the pharmaceutical processor or cannabis dispensing facility, is allowed.
H. No outdoor cannabis product advertising shall be placed within 1,000 feet of (i) a school or daycare; (ii) a public or private playground or similar recreational or child-centered facility; or (iii) a substance use disorder treatment facility.
I. Signs placed on the property of a pharmaceutical processor or cannabis dispensing facility shall not:
1. Display imagery of cannabis or the use of cannabis or utilize long luminous gas-discharge tubes that contain rarefied neon or other gases;
2. Draw undue attention to the facility but may be designed to assist registered patients, parents, legal guardians, and registered agents to find the pharmaceutical processor or cannabis dispensing facility; or
3. Be illuminated during non-business hours.
J. All outdoor signage must be in compliance with local or state requirements.
K. A pharmaceutical processor or cannabis dispensing facility shall not advertise at any sporting event or use any billboard advertisements.
L. No cannabis product advertising shall be on or in a public transit vehicle, public transit shelter, bus stop, taxi stand, transportation waiting area, train station, airport, or any similar transit-related location.
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.
18VAC110-60-220. Pharmaceutical processor or cannabis dispensing facility prohibitions.
A. No pharmaceutical processor shall:
1. Cultivate Cannabis plants or produce or dispense cannabis products in any place except the approved facility at the address of record on the application for the pharmaceutical processor permit;
2. Sell, deliver, transport, or distribute Cannabis, including cannabis products, to any other facility except for wholesale distribution between pharmaceutical processors and to a cannabis dispensing facility pursuant to 18VAC110-60-251;
3. Produce or manufacture cannabis products for use outside of Virginia; or
4. Provide cannabis products samples.
B. No cannabis dispensing facility shall:
1. Dispense cannabis products in any place except the approved facility at the address of record on the application for the cannabis dispensing facility permit;
2. Sell, deliver, transport, or distribute cannabis products to any other facility, except that it may distribute cannabis products back to the pharmaceutical processor from which it obtained the products or distribute cannabis oil products between cannabis dispensing facilities; or
3. Provide cannabis product samples.
C. Except for certain employee access to secured areas designated for cultivation and production and authorized by the responsible party pursuant to § 54.1-3442.6 of the Code of Virginia, no pharmaceutical processor or cannabis dispensing facility shall be open or in operation, and no person shall be in the dispensing area of a pharmaceutical processor or in a cannabis dispensing facility, unless a pharmacist is on the premises and directly supervising the activity within the dispensing area of the pharmaceutical processor or a cannabis dispensing facility. At all other times, the dispensing area of the pharmaceutical processor or the cannabis dispensing facility shall be closed and properly secured.
D. No pharmaceutical processor or cannabis dispensing facility shall sell anything other than cannabis products except for devices for administration of dispensed products or 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.
E. No cannabis products shall be consumed on the premises of a pharmaceutical processor or cannabis dispensing facility, except for emergency administration to a registered patient. Such administration shall be recorded and a file maintained for a period of two years.
F. No person except a pharmaceutical processor or cannabis dispensing facility employee or a registered patient, parent, legal guardian, registered agent, or a companion of a patient shall be allowed on the premises of a processor or facility with the following exceptions: laboratory staff may enter a processor for the sole purpose of identifying and collecting Cannabis or cannabis products samples for purposes of conducting laboratory tests; the board or the board's authorized representative may waive the prohibition upon prior written request.
G. All persons who have been authorized in writing to enter the facility by the board or the board's authorized representative shall obtain a visitor identification badge from a pharmaceutical processor or cannabis dispensing facility employee prior to entering the processor or facility.
1. An employee shall escort and monitor an authorized visitor at all times the visitor is in the pharmaceutical processor or cannabis dispensing facility.
2. A visitor shall visibly display the visitor identification badge at all times the visitor is in the pharmaceutical processor or cannabis dispensing facility and shall return the visitor identification badge to an employee upon exiting the processor or facility.
3. All visitors shall log in and out. The pharmaceutical processor or cannabis dispensing facility shall maintain the visitor log that shall include the date, time, and purpose of the visit and that shall be available to the board.
4. If an emergency requires the presence of a visitor and makes it impractical for the pharmaceutical processor or cannabis dispensing facility to obtain a waiver from the board, the processor or facility shall provide written notice to the board as soon as practicable after the onset of the emergency. Such notice shall include the name and company affiliation of the visitor, the purpose of the visit, and the date and time of the visit. A pharmaceutical processor or cannabis dispensing facility shall monitor the visitor and maintain a log of such visit as required by this subsection.
H. No cannabis products shall be sold, dispensed, or distributed via a delivery service or any other manner outside of a pharmaceutical processor or cannabis dispensing facility, except that a registered parent legal guardian, or registered agent or an agent of the processor or cannabis dispensing facility may deliver cannabis products to the registered patient or in accordance with 18VAC110-60-310 A.
I. Notwithstanding the requirements of subsection F of this section, an agent of the board or local law enforcement or other federal, state, or local government officials may enter any area of a pharmaceutical processor or cannabis dispensing facility if necessary to perform their governmental duties.
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.
18VAC110-60-230. Inventory requirements.
A. Each pharmaceutical processor or cannabis dispensing facility prior to commencing business shall:
1. Conduct an initial comprehensive inventory of all Cannabis plants, including the seeds, parts of plants, extracts, and cannabis products, at the facility. The responsible party shall ensure all required inventories are performed in the cultivation and production areas, and the PIC shall ensure all required inventories are performed in the dispensing area. The inventories shall include, at a minimum, the date of the inventory, a summary of the inventory findings, and the name, signature, and title of the pharmacist, pharmacy technician, responsible party, or person authorized by the responsible party who provides supervision of cultivation or production-related activities who conducted the inventory. If a facility commences business with no Cannabis or cannabis products on hand, the pharmacist or responsible party shall record this fact as the initial inventory; and
2. Establish ongoing inventory controls and procedures for the conduct of inventory reviews and comprehensive inventories of all Cannabis plants, including the seeds, parts of plants, extracts, and cannabis products that shall enable the facility to detect any diversion, theft, or loss in a timely manner.
B. Upon commencing business, each pharmaceutical processor shall conduct a weekly inventory of all Cannabis plants, including the seeds, parts of plants, and cannabis products in stock, that shall include, at a minimum, the date of the inventory, a summary of the inventory findings, and the name, signature, and title of the pharmacist, pharmacy technician, responsible party, or person authorized by the responsible party who provides supervision of cultivation or production-related activities who conducted the inventory.
C. Upon commencing business, each cannabis dispensing facility shall maintain a perpetual inventory of all cannabis products received and dispensed that accurately indicates the physical count of each cannabis product on hand at the time of performing the inventory. The perpetual inventory shall include a reconciliation of each cannabis product at least monthly with a written explanation for any difference between the physical count and the theoretical count.
D. The record of all cannabis products sold, dispensed, or otherwise disposed of shall show the date of sale or disposition; the name of the pharmaceutical processor or cannabis dispensing facility; the name and address of the registered patient, parent, legal guardian, or registered agent to whom the cannabis product was sold; the kind and quantity of cannabis product sold or disposed of; and the method of disposal.
E. A complete and accurate record of all Cannabis plants, including the seeds, parts of plants, and cannabis products on hand shall be prepared annually on the anniversary of the initial inventory or such other date that the PIC or responsible party may choose, so long as it is not more than one year following the prior year's inventory.
F. All inventories, procedures, and other documents required by this section shall be maintained on the premises and made available to the board or its agent.
G. Inventory records shall be maintained for three years from the date the inventory was taken.
H. Whenever any sample or record is removed by a person authorized to enforce state or federal law for the purpose of investigation or as evidence, such person shall tender a receipt in lieu thereof and the receipt shall be kept for a period of at least three years.
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; Volume 38, Issue 11, eff. February 16, 2022.
18VAC110-60-240. Security requirements.
A. A pharmaceutical processor shall initially cultivate only the number of Cannabis plants necessary to produce cannabis products for the number of patients anticipated within the first nine months of operation. Thereafter, the processor shall
not maintain cannabis product in excess of the quantity required for normal, efficient operation.
B. At no time shall a cannabis dispensing facility maintain cannabis products in excess of the quantity required for normal, efficient operation.
C. Items a pharmaceutical processor shall properly secure include Cannabis plants, seeds, parts of plants, extracts, and cannabis products. A cannabis dispensing facility shall properly secure cannabis products. To secure these items a pharmaceutical processor and a cannabis dispensing facility shall:
1. Maintain all Cannabis plants, seeds, parts of plants, extracts, and cannabis products in a secure area or location accessible only by the minimum number of authorized employees essential for efficient operation;
2. Store all cut parts of Cannabis plants, extracts, or cannabis products in an approved safe or approved vault within the pharmaceutical processor or cannabis dispensing facility and not sell cannabis products when the pharmaceutical processor or cannabis dispensing facility is closed;
3. Keep all approved safes, approved vaults, or any other approved equipment or areas used for the production, cultivation, harvesting, processing, manufacturing, or storage of cannabis products securely locked or protected from entry, except for the actual time required to remove or replace the Cannabis, seeds, parts of plants, extracts, or cannabis products;
4. Keep all locks and security equipment in good working order;
5. Restrict access to keys or codes to all safes, approved vaults, or other approved equipment or areas in the dispensing area to pharmacists practicing at the pharmaceutical processor or cannabis dispensing facility;
6. Restrict access to keys or codes to all safes, approved vaults, or other approved equipment or areas in the cultivation and production areas to the responsible party and to those authorized by the responsible party who shall be the pharmacists practicing in the processor or persons supervising cultivation-related or production-related activities at the processor; and
7. Not allow keys to be left in the locks or accessible to persons not authorized by the PIC or responsible party.
D. Employees, other than a pharmacist or person supervising cultivation-related or production-related activities at the processor, but so designated by the PIC or responsible party, may have the ability to unlock a secured area to gain entrance to perform required job duties, but only during hours of operation of the processor or dispensing facility. At no time shall these employees have access to the security system.
E. The pharmaceutical processor or cannabis dispensing facility shall have an adequate security system to prevent and detect diversion, theft, or loss of Cannabis seeds, plants, extracts, or cannabis products. A device for the detection of breaking and a back-up alarm system with an ability to remain operational during a power outage shall be installed in each pharmaceutical processor or cannabis dispensing facility. The installation and the device shall be based on accepted alarm industry standards and subject to the following conditions:
1. The device shall be a sound, microwave, photoelectric, ultrasonic, or other generally accepted and suitable device;
2. The device shall be monitored in accordance with accepted industry standards, be maintained in operating order, have an auxiliary source of power, and be capable of sending an alarm signal to the monitoring entity when breached if the communication line is not operational;
3. The device shall fully protect the entire processor or facility and shall be capable of detecting breaking by any means when activated;
4. The device shall include a duress alarm, a panic alarm, and an automatic voice dialer; and
5. Access to the alarm system for the dispensing area of the processor or cannabis dispensing facility shall be restricted to the pharmacists working at the pharmaceutical processor or cannabis dispensing facility, and the system shall be activated whenever the processor or facility is closed for business. Access to the alarm system in areas of a pharmaceutical processor that are designated for cultivation and production shall be restricted to the responsible party and to those authorized by the responsible party who shall be the pharmacists practicing at the pharmaceutical processor or person supervising cultivation-related or production-related activities at the processor.
F. A pharmaceutical processor or cannabis dispensing facility shall keep the outside perimeter of the premises well lit. A processor or facility shall have video cameras in all areas that may contain Cannabis plants, seeds, parts of plants, extracts, or cannabis products and at all points of entry and exit, which shall be appropriate for the normal lighting conditions of the area under surveillance.
1. The processor or facility shall direct cameras at all approved safes, approved vaults, dispensing areas, or cannabis products sales areas, and any other area where Cannabis plants, seeds, extracts, or cannabis products are being produced, harvested, manufactured, stored, or handled. At entry and exit points, the processor or facility shall angle cameras so as to allow for the capture of clear and certain identification of any person entering or exiting the facility;
2. The video system shall have:
a. A failure notification system that provides an audible, text, or visual notification of any failure in the surveillance system. The failure notification system shall provide an alert to the processor or facility within five minutes of the failure, either by telephone, email, or text message;
b. The ability to immediately produce a clear color still photo that is a minimum of 9600 dpi from any camera image, live or recorded;
c. A date and time stamp embedded on all recordings. The date and time shall be synchronized and set correctly and shall not significantly obscure the picture; and
d. The ability to remain operational during a power outage;
3. All video recordings shall allow for the exporting of still images in an industry standard image format. Exported video shall have the ability to be archived in a proprietary format that ensures authentication of the video and guarantees that no alteration of the recorded image has taken place. Exported video shall also have the ability to be saved in an industry standard file format that can be played on a standard computer operating system. A pharmaceutical processor or cannabis dispensing facility shall erase all recordings prior to disposal or sale of the facility; and
4. The processor or facility shall make 24-hour recordings from all video cameras available for immediate viewing by the board or the board's agent upon request and shall retain the recordings for at least 30 days. If a processor or facility is aware of a pending criminal, civil, or administrative investigation or legal proceeding for which a recording may contain relevant information, the processor or facility shall retain an unaltered copy of the recording until the investigation or proceeding is closed or the entity conducting the investigation or proceeding notifies the pharmaceutical processor or cannabis dispensing facility PIC that it is not necessary to retain the recording.
G. The processor or facility shall maintain all security system equipment and recordings in a secure location so as to prevent theft, loss, destruction, or alterations. All security equipment shall be maintained in good working order and shall be tested at least every six months.
H. A pharmaceutical processor or cannabis dispensing facility shall limit access to surveillance areas to persons who are essential to surveillance operations, law-enforcement agencies, security system service employees, the board or the board's agent, and others when approved by the board. A processor or facility shall make available a current list of authorized employees and security system service employees who have access to the surveillance room to the processor or facility. The pharmaceutical processor or cannabis dispensing facility shall keep all onsite surveillance rooms locked and shall not use such rooms for any other function.
I. If diversion, theft, or loss of Cannabis plants, seeds, parts of plants, extracts, or cannabis products has occurred from a pharmaceutical processor, the board may require additional safeguards to ensure the security of the products.
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; Errata, 38:1 VA.R. 172 August 30, 2021.
18VAC110-60-250. Requirements for the storage and handling of Cannabis or cannabis products.
A. A pharmaceutical processor or cannabis dispensing facility shall:
1. Have storage areas that provide adequate lighting, ventilation, sanitation, temperature, and humidity as defined in 18VAC110-60-10 and space, equipment, and security conditions for the cultivation of Cannabis and the production and dispensing of cannabis products;
2. Separate for storage in a quarantined area Cannabis plants, seeds, parts of plants, extracts, including cannabis products, that are outdated, damaged, deteriorated, misbranded, or adulterated, or whose containers or packaging have been opened or breached, until such Cannabis plants, seeds, parts of plants, extracts, or cannabis products are destroyed;
3. Be maintained in a clean, sanitary, and orderly condition; and
4. Be free from infestation by insects, rodents, birds, or vermin of any kind.
B. A pharmaceutical processor shall compartmentalize all areas in the facility based on function and shall restrict access between compartments. The processor 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 facility employees based on the compartment to which they 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.
C. 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.
D. The PIC and responsible party of a pharmaceutical processor or the PIC of a cannabis dispensing 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 the 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. Pharmaceutical processors and cannabis dispensing facilities shall include in their written policies and procedures a process for the following:
1. Handling mandatory and voluntary recalls of cannabis products. 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.
E. The pharmaceutical processor 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 the aforementioned 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 processor 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.
F. 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
§§ 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.
18VAC110-60-251. Wholesale distribution of cannabis oil products.
A. Cannabis oil, cannabis products, botanical cannabis, and usable cannabis from a batch that have passed the tests required in 18VAC110-60-300 G and H and are packaged and labeled for sale with an appropriate expiration date in accordance with 18VAC110-60-300 may be wholesale distributed between pharmaceutical processors and between a pharmaceutical processor and a cannabis dispensing facility.
B. Cannabis oil products from a batch that passed the microbiological, mycotoxin, heavy metal, residual solvent, and pesticide chemical residue tests and are packaged and labeled for sale with an appropriate expiration date in accordance with 18VAC110-60-300 may be wholesale distributed between cannabis dispensing facilities.
C. A pharmaceutical processor or cannabis dispensing facility wholesale distributing the products shall create a record of the transaction that shows (i) the date of distribution, (ii) the names and addresses of the processor or cannabis dispensing facility distributing the product and the processor or cannabis dispensing facility receiving the product, (iii) the kind and quantity of product being distributed, and (iv) the batch and lot identifying information to include harvest date, testing date, processing or manufacturing date, and expiration date. The record of the transaction shall be maintained by the distributing pharmaceutical processor or cannabis dispensing facility with its records of distribution, and a copy of the record shall be provided to and maintained by the processor or facility receiving the product in its records of receipt. Such records shall be maintained by each processor or facility for three years in compliance with 18VAC110-60-260.
D. A pharmaceutical processor or cannabis dispensing facility wholesale distributing cannabis products shall provide the receiving processor or cannabis dispensing facility with a copy of the lab results for the distributed product or electronic access to the information that can be shared upon request to registered patients, parents, legal guardians, registered agents, registered practitioners who have certified qualifying patients, or an agent of the board.
E. A pharmaceutical processor or cannabis dispensing facility wholesale distributing cannabis products shall store and handle products and maintain policies and procedures, to include a process for executing or responding to mandatory and voluntary recalls, in a manner that complies with 18VAC110-60-250.
F. If a pharmaceutical processor or cannabis dispensing facility wholesale distributing products uses an electronic system for the storage and retrieval of records related to distributing products, the pharmaceutical processor shall use a system that is compliant with 18VAC110-60-260.
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.
18VAC110-60-260. Recordkeeping requirements.
A. If a pharmaceutical processor or cannabis dispensing 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 providing safeguards 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 the 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
§§ 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.
18VAC110-60-270. Reportable events; security.
A. Upon becoming aware of (i) diversion, theft, loss, or discrepancies identified during inventory; (ii) unauthorized destruction of any cannabis products; or (iii) any loss or unauthorized alteration of records related to cannabis products or qualifying patients, a pharmacist, responsible party, pharmaceutical processor, or cannabis dispensing facility shall immediately notify appropriate law-enforcement authorities and the board.
B. A pharmacist, responsible party, pharmaceutical processor, or cannabis dispensing facility shall provide the notice required by subsection A of this section to the board by way of a signed statement that details the circumstances of the event, including an accurate inventory of the quantity and brand names of cannabis product diverted, stolen, lost, destroyed, or damaged and confirmation that the local law-enforcement authorities were notified. A pharmacist, responsible party, processor, or facility shall make such notice no later than 24 hours after discovery of the event.
C. A pharmacist, responsible party, pharmaceutical processor, or cannabis dispensing facility shall notify the board no later than the next business day, followed by written notification no later than 10 business days, of any of the following:
1. An alarm activation or other event that requires a response by public safety personnel;
2. A breach of security;
3. The failure of the security alarm system due to a loss of electrical support or mechanical malfunction that is expected to last longer than eight hours; and
4. Corrective measures taken if any.
D. A pharmacist, responsible party, pharmaceutical processor, or cannabis dispensing facility shall immediately notify the board of an employee convicted of a felony.
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.