Source: https://townhall.virginia.gov/L/ViewXML.cfm?textid=11552
Timestamp: 2020-07-02 22:57:48
Document Index: 751368485

Matched Legal Cases: ['§ 54', '§ 54', '§ 54', '§ 54', '§ 54', '§54', 'art 111', 'art 205', 'art 1700']

New Regulations Governing Pharmaceutical Processors
4/20/17 1:01 PM [latest] 4/10/17 10:24 AM 11/3/16 12:21 PM 10/19/16 2:51 PM
"Electronic tracking system" means an electronic radio-frequency identification (RFID) seed-to-sale tracking system which tracks the Cannabis from either the seed or immature plant stage until the cannabidiol oil and THC-A oil are sold to a registered patient, parent, or legal guardian 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, standard and ad hoc reporting functions as required by the board, and be capable of otherwise satisfying required recordkeeping.
"Intractable epilepsy" means drug-resistant epilepsy (DRE) which is defined as failure of adequate trials of two tolerated, appropriately chosen and used antiepileptic drug schedules (whether as monotherapies or in combination) to achieve sustained seizure freedom.
"One-month supply" means the amount of cannabidiol oil or THC-A oil reasonably necessary to ensure an uninterrupted availability of supply for a thirty-day period for registered patients, which cannot exceed 20 fluid ounces.
"Production" or "produce" means the manufacture, planting, preparation, cultivation, growing, harvesting, propagation, conversion or processing of marijuana, either directly or indirectly by extraction from substances of natural origin, or independently by means of chemical synthesis, or by a combination of extraction and chemical synthesis, and includes any packaging or repackaging of the substance or labeling or relabeling of its container.
"Qualifying patient" means a Virginia resident who has received a written certification for the use of cannabidiol or THC-A oil for treatment of intractable epilepsy from a practitioner, as defined in § 54.1-3408.3 of the Code.
"Registration" means an identification card or other document issued by the board that identifies a person as a practitioner, qualifying patient or parent or legal guardian.
3. Replacement of registration for a qualifying practitioner whose information has changed or whose original registration certificate has been lost, stolen or destroyed
3. Replacement of registration for a qualifying patient or parent or legal guardian whose information has changed or whose original registration certificate has been lost, stolen or destroyed
Part II. Requirements for Practitioners and Patients.
A. Prior to issuing a certification for cannabidiol oil or THC-A oil for the treatment or to alleviate symptoms of intractable epilepsy, the practitioner shall meet the requirements of § 54.1-3408.3 of the Code, submit an application and fee as prescribed in 18VAC110-60-20, and shall be registered with the board.
1. Conduct an assessment and evaluation of the patient in order to develop a treatment plan for the patient, which shall include an examination of the patient and the patient's medical history, prescription history and current medical condition, including an in-person physical examination;
4. Explain proper administration and the potential risks and benefits of the cannabidiol oil or THC­-A oil to the qualifying patient and, if the qualifying patient lacks legal capacity, to a parent or legal guardian, prior to issuing the written certification;
5. Be available or ensure that another practitioner, as defined in § 54.1-3408.3 of the Code, is available to provide follow-up care and treatment to the qualifying patient including, but not limited to, physical examinations, to determine the efficacy of cannabidiol oil or THC­­-A oil for treating the intractable epilepsy;
F. A practitioner shall not issue certifications for cannabidiol oil or THC-A oil to more than 600 patients at any given time. However, the practitioner may petition the Boards of Pharmacy and Medicine for an increased number of patients for whom certifications may be issued, upon submission of evidence that the limitation represents potential patient harm.
G. Upon request, a practitioner shall make a copy of medical records available to an agent of the Boards of Medicine or Pharmacy for the purpose of enabling the board to ensure compliance with the law and regulations or to investigate a possible violation.
2. Offer a discount or any other thing of value to a qualifying patient, parent or guardian based on the patient's agreement or decision to use a particular pharmaceutical processor or cannabidiol oil or THC-A oil product;
B. A practitioner who issues certifications, and such practitioner's co-worker, employee, spouse, parent or child, shall not have a direct or indirect financial interest in a pharmaceutical processor or any other entity that may benefit from a qualifying patient's acquisition, purchase or use of cannabidiol oil or THC-A oil, including any formal or informal agreement whereby a pharmaceutical processor or other person provides compensation if the practitioner issues a certification for a qualifying patient or steers a qualifying patient to a specific pharmaceutical processor or cannabidiol oil or THC-A oil product.
C. A practitioner shall not issue a certification for himself or for family members, employees or co-workers.
D. A practitioner shall not provide product samples containing cannabidiol oil or THC-A oil other than those approved by the United States Food and Drug Administration.
18VAC110-60-50. Registration of a patient, parent or legal guardian.
4. Proof of the qualifying patient's age in the form of a birth certification or other government-issued identification;
18VAC110-60-60. Denial of a qualifying patient or parent or legal guardian registration application.
A. The board may deny an application or renewal of the registration of a qualifying patient or parent or legal guardian if the applicant:
2. Does not provide acceptable proof of identity, residency or age of the patient to the board;
3. Provides false, misleading or incorrect information to the board;
4. Has had a qualifying registration of a qualifying patient or parent or legal guardian denied, suspended or revoked by the board in the previous six months;
A. A practitioner shall report to the board, on a form prescribed by the board, the death of a registered patient or a change in status involving a registered patient for whom the practitioner has issued a certification, if such change affects the patient's continued eligibility to use cannabidiol oil or THC-A oil, or his inability to continue treating the patient. A practitioner shall report such death or change of status, or inability to continue treatment not more than 15 days after the practitioner becomes aware of such fact.
B. A patient, parent, or legal guardian who has been issued a registration shall notify the board of any change in the information provided to the board not later than 15 days after such change. The patient, parent, or legal guardian shall report changes that include, but are not limited to, a change in name, address, contact information, medical status of the patient or change of the certifying practitioner. The patient, parent, or legal guardian shall report such changes on a form prescribed by the board.
C. If a patient or parent or legal guardian notifies the board of any change that results in information on the patient, parent, or legal guardian's registration being inaccurate, the patient or parent or legal guardian shall submit the fee for a replacement registration. Upon receipt of a new registration, the qualifying patient or parent or legal guardian shall destroy in a non-recoverable manner the registration that was replaced.
D. If a patient or parent or legal guardian becomes aware of the loss, theft or destruction of the registration of such patient or parent or legal guardian, the patient or parent or legal guardian shall notify the board not later than five business days of becoming aware of the loss, theft or destruction, and submit the fee for a replacement registration. The board shall inactivate the initial registration upon receiving such notice and issue a replacement registration upon receiving the applicable fee provided the applicant continues to satisfy the requirements of law and regulation.
18VAC110-60-80. Proper storage and disposal of cannabidiol oil or THC-A oil by patients or parents or legal guardians.
A. A registered patient, parent, or legal guardian shall exercise reasonable caution to store cannabidiol oil or THC-A oil in a manner to prevent theft, loss or access by unauthorized persons.
B. A registered patient or parent or legal guardian shall dispose of all usable cannabidiol oil or THC-A oil in the registered patient or parent or legal guardian's possession no later than ten calendar days after the expiration of the patient's registration, if such registration is not renewed, or sooner should the patient no longer wish to possess cannabidiol oil or THC-A oil. A registered patient or parent or legal guardian shall complete such disposal by one of the following methods:
1. By removing the oil from the original container and mixing it with an undesirable substance such as used coffee grounds, dirt or kitty litter. The mixture shall be placed in a sealable bag, empty can or other container to prevent the drug from leaking or breaking out of a garbage bag.
18VAC110-60-90. Revocation or suspension of a qualifying patient or parent or legal guardian registration.
The board may revoke or suspend the registration of a patient or a parent or legal guardian under the following circumstances:
1. The patient's practitioner notifies the board that the practitioner is withdrawing the written certification submitted on behalf of the patient and, thirty days after the practitioner's withdrawal of the written certification, the patient has not obtained a valid written certification from a different practitioner;
2. The patient or parent or legal guardian provided false, misleading or incorrect information to the board;
5. The patient, parent, or legal guardian provided or sold cannabidiol oil or THC-A oil to any person, including another registered patient or parent or legal guardian;
7. The patient, parent, or legal guardian tampered, falsified, altered, modified or allowed another person to tamper, falsify, alter or modify, the patient, parent, or legal guardian's registration;
8. The patient, parent, or legal guardian's registration was lost, stolen or destroyed and the patient, parent, or legal guardian failed to notify the board or notified the board of such incident more than five business days after becoming aware that the registration was lost, stolen or destroyed;
Part III. Application and Approval Process for Pharmaceutical Processors.
b. The location within the health service area established by the Board of Health for the pharmaceutical processor that is to be operated under such permit;
c. Detailed information regarding the applicant's financial position, indicating all assets, liabilities, income and net worth, to demonstrate the financial capacity of the applicant to build and operate a facility to cultivate Cannabis plants intended only for the production and dispensing of cannabidiol oil and THC-A oil pursuant to §§ 54.1-3442.6 and 54.1-3442.7 of the Code, which may include evidence of an escrow account, letter of credit or performance surety bond;
d. Details regarding the applicant's plans for security to maintain adequate control against the diversion, theft or loss of the Cannabis plants and the cannabidiol oil or THC-A oil;
e. Documents sufficient to establish that the applicant is authorized to conduct business in Virginia and that all applicable state and local building, fire and zoning requirements and local ordinances are met or will be met prior to issuance of a permit;
h. Whether the person has ever applied for a permit or registration related to medical cannabidiol oil or THC-A oil in any state and, if so, the status of that application, permit or registration, to include any disciplinary action taken by any state on the permit, registration, or an associated license;
k. A blueprint of the proposed pharmaceutical processor, which shall show and identify the square footage of each area of the facility, to include the location of all safes or vaults used to store the Cannabis plants and oils and the location of all areas that may contain Cannabis plants, cannabidiol oil or THC-A oil, showing the placement of walls, partitions, counters and all areas of ingress and egress;
D. No person who has been convicted of a felony or of any offense in violation of Article 1 (18.2-247 et seq) or Article 1.1 (18.2-265.1) of Chapter 7 of Title 18.2 shall have any form of ownership, be employed by or act as an agent of a pharmaceutical processor.
1. The results of the criminal background checks required in 18VAC110-60-110 B (3) or any history of disciplinary action imposed by a state or federal regulatory agency;
3. The applicant's ability to maintain adequate control against the diversion, theft and loss of the Cannabis, to include the seeds, any parts or extracts of the Cannabis plants, the cannabidiol oil or THC-A oil;
4. The applicant's ability to maintain the knowledge, understanding, judgment, procedures, security controls and ethics to ensure optimal safety and accuracy in the dispensing and sale of cannabidiol oil or THC-A oil;
5. The extent to which the applicant or any of the applicant's pharmaceutical processor owners have a financial interest in another license, permit, registrant or applicant; and
1. Submits an incomplete, false, inaccurate or misleading application;
B. The permit shall not be awarded until any deficiencies identified by inspectors have been corrected and the facility has been satisfactorily re-inspected, if warranted.
B. The proposed disposition of all Cannabis, dispensing records, patient information records, and other required records shall be reported to the board. If the Cannabis and records are to be transferred to another processor located in Virginia, the owner shall inform the board and the patients and include on public notice the name and address of the processor to whom the Cannabis and records are being transferred and the date of transfer.
In addition to the bases enumerated in § 54.1-3316 of the Code of Virginia, the board may suspend, revoke or refuse to grant or renew a permit issued, or place such permit on probation, place conditions on such permit, or take other actions permitted by statute or regulation on the following grounds:
1. Any criminal conviction under federal or state statutes or regulations or local ordinances, unless the conviction was based on a federal statute or regulation related to the possession, purchase or sale of cannabidiol oil or THC-A oil that is authorized under state law and regulations;
2. Any civil action under any federal or state statute or regulation or local ordinance relating to the applicant's, licensee's, permit holder's or registrant's profession, or involving drugs, medical devices or fraudulent practices, including, but not limited to, fraudulent billing practices;
3. Failure to maintain effective controls against diversion, theft or loss of Cannabis, cannabidiol oil or THC-A oil or other controlled substances;
5. Permitting another person to use the permit of a permit holder or registration of a qualifying patient or parent or legal guardian;
7. Discontinuance of business for more than sixty days, unless the board approves an extension of such period for good cause shown, upon a written request from a pharmaceutical processor. Good cause includes exigent circumstances that necessitate the closing of the facility. Good cause shall not include a voluntary closing of the pharmaceutical processor or production facility.
Part IV. Requirements for Pharmaceutical Processor Personnel.
C. No person shall perform the following duties under pharmacist supervision without maintaining a current, unrestricted registration as a pharmacy technician pursuant to §54.1-3321 of the Code and having been registered with the board or registered or certified by the board of another U. S. jurisdiction as a pharmacy technician for the previous two years:
1. The entry of drug dispensing information and drug history into a data system or other record keeping system;
D. A pharmacist with a current, unrestricted license or pharmacy technician with a current, unrestricted registration issued by the board may perform duties associated with the cultivation, extraction and dispensing of the oils, as authorized by the PIC or as otherwise authorized in law.
E. Persons who do not maintain licensure as a pharmacist or registration as a pharmacy technician, but have received a degree in horticulture or have at least two years of experience cultivating plants may perform duties associated with the cultivation of Cannabis, as authorized by the PIC.
F. Persons who do not maintain licensure as a pharmacist or registration as a pharmacy technician, but have received a degree in chemistry, pharmacology, or have at least two years of experience extracting chemicals from plants may perform duties associated with the extraction of cannabidiol oil and THC-A oil, as authorized by the PIC.
G. A pharmacist on duty shall directly supervise the activities in all areas designated for cultivation, extraction, and dispensing or have a process in place, approved by the board, which provides adequate supervision to protect the security of the Cannabis, seeds, extracts, cannabidiol oil and THC-A oil and ensure quality of the dispensed oils.
J. No person who has had a license or registration suspended or revoked or denied issuance of such license or registration shall serve as an employee or agent of the pharmaceutical processor.
1. The proper use of security measures and controls that have been adopted for the prevention of diversion, theft or loss of Cannabis, to include the seeds, any parts or extracts of the Cannabis plants, cannabidiol oil and THC-A oil;
A. The ratio of pharmacy technicians to pharmacist on-duty in the areas of a pharmaceutical processor designated for production or dispensing shall not exceed four pharmacy technicians to one pharmacist.
B. The pharmacist providing direct supervision of pharmacy technicians may be held responsible for their actions. Any violations relating to the dispensing of cannabidiol oil or THC-A oil resulting from the actions of a pharmacy technician shall constitute grounds for action against the license of the pharmacist and the registration of the pharmacy technician. As used in this subsection, "direct supervision" means a supervising pharmacist who:
1. Counsel a registered patient or the patient's parent or legal guardian regarding cannabidiol oil or THC-A oil or other drugs, either before or after cannabidiol oil or THC-A oil has been dispensed, or regarding any medical information contained in a patient medication record;
2. All record-retention requirements are met;
3. All requirements for the physical security of the Cannabis, to include the seeds, any parts or extracts of the Cannabis plants, the cannabidiol oil and THC-A oil are met;
E. An outgoing PIC shall have the opportunity to take a complete and accurate inventory of all Cannabis, to include plants, extracts, cannabidiol oil or THC-A oil on hand on the date he ceases to be the PIC, unless the owner submits written notice to the board showing good cause as to why this opportunity should not be allowed.
Part V. Operation of a Pharmaceutical Processor.
A. A pharmaceutical processor shall sell cannabidiol oil or THC-A oil only in a child-resistant, secure and light-resistant container. Upon a written request from the registered patient or parent or legal guardian, the oil may be dispensed in a non-child-resistant container so long as all labeling is maintained with the product.
C. The PIC or pharmacist on-duty shall restrict access to the pharmaceutical processor to:
2. Such person who is a registered patient or parent or legal guardian, in which case such person shall not be permitted behind the service counter or in other areas where Cannabis plants, extracts, cannabidiol oil or THC-A oil is stored.
F. A pharmaceutical processor shall be open for registered patients, parents or legal guardians to purchase cannabidiol oil or THC-A oil products for a minimum of thirty-five hours a week, except as otherwise authorized by the board.
G. A pharmaceutical processor that closes during its normal hours of operation shall implement procedures to notify registered patients, parents, and legal guardians of when the pharmaceutical processor will resume normal hours of operation. Such procedures may include, but are not limited to, telephone system messages and conspicuously posted signs. If the pharmaceutical processor is, or will be, closed during its normal hours of operation for longer than two business days, the pharmaceutical processor shall immediately notify the board.
I. The pharmaceutical processor shall establish, implement and adhere to a written alcohol-free, drug-free and smoke-free work place policy, which shall be available to the board or the board's agent upon request.
2. Sell, deliver, transport or distribute Cannabis, including cannabidiol oil or THC-A oil, to any other facility;
2.Contact information for the processor;
3. Hours and days it is open for dispensing cannabidiol oil or THC-A oil products;
F. No person, except a pharmaceutical processor employee or a registered patient, parent, or legal guardian shall be allowed on the premises of a processor with the following exceptions: laboratory staff may enter a processor for the sole purpose of identifying and collecting Cannabis, cannabidiol oil or THC-A oil samples for purposes of conducting laboratory tests; the board or the board's authorized representative may waive the prohibition upon prior written request.
3. All visitors shall log in and out. The pharmaceutical processor shall maintain the visitor log, which shall include the date, time and purpose of the visit and which shall be available to the board.
H. No cannabidiol oil or THC-A oil shall be sold, dispensed or distributed via a delivery service or any other manner outside of a pharmaceutical processor, except that a registered parent or legal guardian may deliver cannabidiol oil or THC-A oil to the registered patient.
I. Notwithstanding the requirements of subsection E, an agent of the board, local law enforcement or other federal, state or local government officials may enter any area of a pharmaceutical processor if necessary to perform their governmental duties.
1. Conduct an initial comprehensive inventory of all Cannabis plants, including the seeds, parts of plants, extracts, cannabidiol oil, and THC-A oil at the facility. The inventory shall include, at a minimum, the date of the inventory, a summary of the inventory findings, the name, signature and title of the pharmacist or pharmacy technician who conducted the inventory. If a facility commences business with no Cannabis on hand, the pharmacist 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, cannabidiol oil, and THC-A oil which shall enable the facility to detect any diversion, theft or loss in a timely manner.
B. Upon commencing business, each pharmaceutical processor and production facility shall conduct a weekly inventory of all Cannabis plants, including the seeds, parts of plants, cannabidiol oil, and THC-A oil in stock, which shall include, at a minimum, the date of the inventory, a summary of the inventory findings, the name, signature and title of the pharmacist or pharmacy technician who conducted the inventory. The record of all cannabidiol oil and THC-A oil sold, dispensed or otherwise disposed of shall show the date of sale, the name of the pharmaceutical processor, registered patient, parent, or legal guardian to whom the cannabidiol oil or THC-A oil was sold, the address of such person and the kind and quantity of cannabidiol oil or THC-A oil sold.
D. 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.
3. Maintain all Cannabis plants, seeds, parts of plants, extracts, cannabidiol oil and THC-A oil in a secure area or location accessible only by the minimum number of authorized employees essential for efficient operation;
4. Store all cut parts of Cannabis plants, extracts, cannabidiol oil or THC-A oil in an approved safe or approved vault within the pharmaceutical processor and shall not sell cannabidiol oil or THC-A oil products when the pharmaceutical processor is closed;
5. Keep all approved safes, approved vaults, or any other approved equipment or areas used for the production, cultivation, harvesting, processing, manufacturing or storage of cannabidiol oil or THC-A oil, securely locked or protected from entry, except for the actual time required to remove or replace the Cannabis, seeds, parts of plants, extracts, cannabidiol oil or THC-A oil;
B. The pharmaceutical processor shall have an adequate security system to prevent and detect diversion, theft or loss of Cannabis seeds, plants, extracts, cannabidiol oil or THC-A oil. 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. The installation and the device shall be based on accepted alarm industry standards, and shall be subject to the following conditions:
1. The processor shall direct cameras at all approved safes, approved vaults, dispensing areas, cannabidiol oil or THC-A oil sales areas and any other area where Cannabis plants, seeds, extracts, cannabidiol oil or THC-A oil are being produced, harvested, manufactured, stored or handled. At entry and exit points, the processor shall angle cameras so as to allow for the capture of clear and certain identification of any person entering or exiting the facility;
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 within five minutes of the failure, either by telephone, email, or text message;
d. The ability to remain operational during a power outage.
4. The processor shall make twenty-four 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 thirty days. If a processor is aware of a pending criminal, civil or administrative investigation or legal proceeding for which a recording may contain relevant information, it 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 PIC that it is not necessary to retain the recording.
D. The processor 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 no less than two times per year.
E. A pharmaceutical processor shall limit access to surveillance areas to persons that 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 shall make available a current list of authorized employees and security system service employees that have access to the surveillance room to the processor. The pharmaceutical processor shall keep all on-site surveillance rooms locked and shall not use such rooms for any other function.
F. If diversion, theft, or loss of Cannabis plants, seeds, parts of plants, extracts, cannabidiol oil or THC-A oil has occurred from a pharmaceutical processor, the board may require additional safeguards to ensure the security of the products.
18VAC110-60-250. Requirements for the storage and handling of Cannabis, cannabidiol oil or THC-A oil .
1. Have storage areas that provide adequate lighting, ventilation, sanitation, temperature and humidity as defined in 18VAC110-60-10, space, equipment, and security conditions for the cultivation of Cannabis, and the production and dispensing of cannabidiol oil or THC-A oil;
2. Separate for storage, in a quarantined area, Cannabis plants, seeds, parts of plants, extracts, including cannabidiol oil or THC-A oil, that is 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, cannabidiol oil or THC-A oil is destroyed;
B. A 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 cannabidiol oil or THC-A oil. These shall include, but not be limited to, policies and procedures that:
4. Document the chain of custody of all Cannabis plants, parts of plants, seeds, extracts, cannabidiol oil and THC-A oil products.
C. The PIC shall establish, maintain, and comply with written policies and procedures for the cultivation, production, security, storage, and inventory of Cannabis, including seeds, parts of plants, extracts, cannabidiol oil and THC-A oil. 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 shall include in their written policies and procedures, a process for the following:
3. Ensuring that any outdated, damaged, deteriorated, misbranded, or adulterated Cannabis, including seeds, parts of plants, extracts, cannabidiol oil and THC-A oil, is segregated from all other Cannabis, seeds, parts of plants, extracts, cannabidiol oil and THC-A oil and destroyed. This procedure shall provide for written documentation of the Cannabis, including seeds, parts of plants, extracts, cannabidiol oil and THC-A oil disposition; and
4. Ensuring the oldest stock of Cannabis, including seeds, parts of plants, extracts, cannabidiol oil and THC-A oil product is used first. The procedure may permit deviation from this requirement, if such deviation is temporary and appropriate.
D. The processor shall store all Cannabis, including seeds, parts of plants, extracts, cannabidiol oil and THC-A oil, 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, cannabidiol oil and THC-A oil 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 shall securely lock the processing area or tanks, vessels, bins, or bulk containers containing Cannabis, including the seeds, parts of plants, extracts, cannabidiol oil, and THC-A oil inside an area or building that affords adequate security.
A. Upon becoming aware of diversion, theft, loss, discrepancies identified during inventory, or unauthorized destruction of any cannabidiol oil or THC-A oil or of any loss or unauthorized alteration of records related to cannabidiol oil or THC-A oil or qualifying patients, a pharmacist or pharmaceutical processor shall immediately notify appropriate law enforcement authorities and the board.
B. A pharmacist or processor shall provide the notice required by subsection A of this section to the board by way of a signed statement which details the circumstances of the event, including an accurate inventory of the quantity and brand names of cannabidiol oil or THC-A oil diverted, stolen, lost, destroyed or damaged and confirmation that the local law enforcement authorities were notified. A pharmacist or processor shall make such notice no later than twenty-four hours after discovery of the event.
C. A pharmacist or pharmaceutical processor shall notify the board no later than the next business day, followed by written notification no later than ten business days, of any of the following:
Part VI. Cultivation, Production and Dispensing of Cannabidiol oil or THC-A oil.
18VAC110-60-280. Cultivation and production of cannabidiol oil or THC-A oil .
A. No cannabidiol oil or THC-A oil shall have had pesticide chemicals or petroleum-based solvents 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.
1. Processed, packaged and labeled according to the 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 the results of an active ingredient analysis, a microbiological contaminants analysis, a mycotoxin analysis, a heavy metal analysis and a pesticide chemical residue analysis which have been completed on a batch basis by a laboratory.
1. Is identical to, or confusingly similar to, the name of an existing non-cannabidiol oil or THC-A oil product;
8. Is related to the benefits, safety or efficacy of the cannabidiol oil or THC-A oil product unless supported by substantial evidence or substantial clinical data.
b. tetrahydrocannabinol acid (THCA); and
7. A pass or fail rating based on the laboratory's microbiological, mycotoxins, heavy metals and chemical residue analysis.
F. A pharmaceutical processor shall not label cannabidiol oil or THC-A oil products as "organic" unless the Cannabis plants have been organically grown and the cannabidiol oil or THC-A oil products have been produced, processed, manufactured and certified to be consistent with organic standards in compliance with 7 CFR Part 205.
A. No pharmaceutical processor shall utilize a laboratory to handle, test or analyze cannabidiol oil or THC-A oil unless such laboratory:
1. Is independent from all other persons involved in the cannabidiol oil or THC-A oil 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, certifying practitioner or any other entity that may benefit from the production, manufacture, dispensing, sale, purchase or use of cannabidiol oil or THC-A oil; and
B. Immediately prior to producing any cannabidiol oil or THC-A oil product, a pharmaceutical processor shall segregate all harvested Cannabis into homogenized batches. A pharmaceutical processor shall make a sample available from each batch for a laboratory to test for microbiological contaminants, mycotoxins, heavy metals and pesticide chemical residue, and for purposes of conducting an active ingredient analysis.
C. From the time that a batch of Cannabis has been homogenized for sample testing and eventual packaging, until the laboratory provides the results from its tests and analysis, the pharmaceutical processor shall segregate and withhold from use the entire batch of Cannabis, except the samples that have been removed by the laboratory for testing. During this period of segregation, the pharmaceutical processor shall maintain the Cannabis in a secure, cool and dry location so as to prevent the Cannabis from becoming contaminated or losing its efficacy.
F. If a sample of Cannabis does not pass the microbiological, mycotoxin, heavy metal or pesticide chemical residue test, based on the standards set forth in this subsection, the pharmaceutical processor shall dispose of the entire batch from which the sample was taken.
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G. If a sample of Cannabis passes the microbiological, mycotoxin, heavy metal and pesticide chemical residue test, the entire batch may be utilized by the processor for immediate manufacturing, packaging and labeling for sale.
H. 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 microbiological, mycotoxin, heavy metal or pesticide chemical residue test, 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.
I. Each pharmaceutical processor shall have such laboratory results available upon request to registered patients, parents or legal guardians and registered practitioners who have certified qualifying patients.
A. A pharmacist, in good faith, may dispense cannabidiol oil or THC-A oil to any registered patient, parent, or legal guardian as indicated on the written certification. A pharmacist or pharmacy technician shall require the presentation of a current registration for the patient and parent or legal guardian, if applicable, current written certification and current valid photographic identification issued to a registered patient or parent or legal guardian, prior to selling oil to such registered patient or parent or legal guardian. The pharmacist or pharmacy technician shall verify in the prescription monitoring program or other program recognized by the board, that the registrations are current, the written certification has not expired, and the date and quantity of the last dispensing of cannabidiol oil or THC-A oil to the registered patient.
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 oil which contains:
2. The name or kind of cannabidiol oil or THC-A oil and strength;
5. The quantity of cannabidiol oil or THC-A oil dispensed which cannot exceed 20 fluid ounces;
D. The dispensed cannabidiol oil or THC-A oil 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 Part 1700.1(b)(4).
E. 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 exercise professional judgment to determine whether to dispense cannabidiol oil or THC-A oil to a registered patient, parent or legal guardian if the pharmacist suspects that dispensing cannabidiol oil or THC-A oil to the registered patient or parent or legal guardian may have negative health or safety consequences for the registered patient or the public.
A. A pharmaceutical processor 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 shall distribute it to all pharmaceutical processor employees, and shall make it readily available on the premises of the pharmaceutical processor. Such policies and procedures shall include:
c. Documentation of contact with the registered patient, parent or legal guardian where applicable, and the practitioner who certified the patient;
A. To mitigate the risk of diversion, a pharmaceutical processor, an agent of the board, or the board's agent shall routinely and promptly dispose of undesired, excess, unauthorized, obsolete, adulterated, misbranded or deteriorated Cannabis plants, including seeds, parts of plants, extracts, cannabidiol oil or THC-A oil by disposal in the presence of an agent of the board in such a manner as to render the cannabidiol oil or THC-A oil non-recoverable.
4. The signatures of the persons disposing of the cannabidiol oil or THC-A oil, the agent of the board and any other persons present during the disposal.