Administrative Code

Virginia Administrative Code
12/3/2021

Part IV. Requirements for Pharmaceutical Processor Personnel

18VAC110-60-170. Pharmaceutical processor or cannabis dispensing facility employee licenses and registrations.

A. A pharmacist with a current, unrestricted license issued by the board practicing at the location of the address on the pharmaceutical processor or cannabis dispensing facility application shall be in full and actual charge of the dispensing area of a pharmaceutical processor or of a cannabis dispensing facility and shall serve as the pharmacist-in-charge.

B. A pharmacist with a current, unrestricted license issued by the board shall provide personal supervision on the premises of the dispensing area of the pharmaceutical processor or of a cannabis dispensing facility at all times during its hours of operation.

C. The person who is designated as the responsible party for a pharmaceutical processor shall practice at the location of the address on the pharmaceutical processor application, shall have oversight of the cultivation and production areas, and shall possess:

1. A current, unrestricted license as a pharmacist issued by the board;

2. A degree in chemistry, pharmacology, or a field related to the cultivation of plants;

3. A certification recognized by the board; or

4. At least two years of verifiable experience cultivating plants or extracting chemicals from plants.

D. A person who holds a current, unrestricted registration as a pharmacy technician pursuant to § 54.1-3321 of the Code of Virginia a may perform the following duties under supervision of a pharmacist:

1. The entry of drug dispensing information and drug history into a data system or other recordkeeping system;

2. The preparation of labels for dispensing the cannabis product or patient information;

3. The removal of the cannabis product to be dispensed from inventory;

4. The measuring of the cannabis product to be dispensed;

5. The packaging and labeling of the cannabis product to be dispensed and the repackaging thereof;

6. The stocking or loading of devices used in the dispensing process;

7. The selling of the cannabis product to the registered patient, parent, legal guardian or registered agent; and

8. The performance of any other task restricted to pharmacy technicians by the board's regulations.

E. A pharmacist with a current, unrestricted license; a registered pharmacy intern who has completed the first professional year of pharmacy school; or a pharmacy technician with a current, unrestricted registration issued by the board may perform duties associated with the cultivation and extraction as authorized by the pharmaceutical processor, and duties associated with the dispensing of the products as authorized by the PIC or as otherwise authorized in law.

F. A pharmaceutical processor may employ individuals with less than two years of experience to perform cultivation-related duties under the supervision of an individual who has received a degree in a field related to the cultivation of plants or a certification recognized by the board or who has at least two years of experience cultivating plants.

G. A pharmaceutical processor may employ individuals with less than two years of experience to perform extraction-related duties under the supervision of an individual who has a degree in chemistry or pharmacology or at least two years of experience extracting chemicals from plants.

H. At no time shall the dispensing area of a pharmaceutical processor operate or be accessed without a pharmacist on duty. At no time shall the cultivation and production area operate or be accessed without an employee on duty who satisfies the requirements for providing direct supervision for the activities in the respective areas.

I. No person shall be employed by or serve as an agent of a pharmaceutical processor or cannabis dispensing facility without being at least 18 years of age.

J. No person who has had a license or registration suspended or revoked or been denied issuance of such license or registration shall serve as an employee or agent of the pharmaceutical processor or cannabis dispensing facility unless such license or registration has been reinstated and is current and unrestricted.

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.

18VAC110-60-180. Employee training.

A. All employees of a pharmaceutical processor or cannabis dispensing facility shall complete training prior to the employee commencing work at the pharmaceutical processor or cannabis dispensing facility. At a minimum, the training shall be in the following areas:

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 and cannabis products;

2. Procedures and instructions for responding to an emergency;

3. Professional conduct, ethics, and state and federal statutes and regulations regarding patient confidentiality; and

4. Developments in the field of the medical use of cannabis products.

B. Prior to regular performance of assigned tasks, the employee shall also receive on-the-job training and other related education, which shall be commensurate with the tasks assigned to the employee.

C. The PIC and the responsible party shall assure the continued competency of all employees, in the respective areas for which they have oversight, through continuing in-service training that is provided at least annually, is designed to supplement initial training, and includes any guidance specified by the board.

D. The PIC and the responsible party shall be responsible for maintaining a written record documenting the initial and continuing training of all their respective employees that shall contain:

1. The name of the person receiving the training;

2. The dates of the training;

3. A general description of the topics covered;

4. The name of the person supervising the training; and

5. The signatures of the person receiving the training and the PIC or the responsible party.

E. When a change of pharmaceutical processor or cannabis dispensing facility PIC or responsible party occurs, the new PIC or responsible party shall review the training record and sign it, indicating that the new PIC or responsible party understands its contents.

F. A pharmaceutical processor or cannabis dispensing facility shall maintain the record documenting the employee training and make it available in accordance with regulations.

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.

18VAC110-60-190. Pharmacy technicians; ratio; supervision and responsibility.

A. The ratio of pharmacy technicians to pharmacists on duty in the areas of a pharmaceutical processor a cannabis dispensing facility designated for production or dispensing shall not exceed six pharmacy technicians to one pharmacist.

B. The pharmacist providing direct supervision of pharmacy technicians may be held responsible for the pharmacy technicians' actions. Any violations relating to the dispensing of cannabis products 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. Is on duty where the pharmacy technician is performing routine cannabis product production or dispensing functions; and

2. Conducts in-process and final checks on the pharmacy technician's performance.

C. Pharmacy technicians shall not:

1. Counsel a registered patient or the patient's parent legal guardian, or registered agent regarding (i) cannabis products or other drugs either before or after cannabis products have been dispensed or (ii) any medical information contained in a patient medication record;

2. Consult with the practitioner who certified the qualifying patient, or the practitioner's agent, regarding a patient or any medical information pertaining to the patient's cannabis product or any other drug the patient may be taking;

3. Interpret the patient's clinical data or provide medical advice;

4. Determine whether a different formulation of cannabis product should be substituted for the cannabis product or formulation recommended by the practitioner or requested by the registered patient or parent or legal guardian; or

5. Communicate with a practitioner who certified a registered patient, or the practitioner's agent, to obtain a clarification on a qualifying patient's written certification or instructions.

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.

18VAC110-60-195. Responsibilities of the responsible party.

A. A person may only serve as the responsible party for one pharmaceutical processor at any one time. The responsible party shall be employed full time in a managerial position at the location of the processor and shall be actively engaged in daily operations of the processor during normal hours of operation.

B. The responsible party shall be aware of and knowledgeable about all policies and procedures pertaining to the operations of the pharmaceutical processor.

C. The responsible party shall ensure compliance with all security measures to protect the Cannabis within the cultivation and production areas from diversion at all times and ensure that cultivation and production is performed in a safe and compliant manner and free of adulteration and misbranding.

D. The responsible party shall be responsible for ensuring that:

1. All employees practicing in the cultivation and production areas are properly trained;

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 and the cannabis products, within the cultivation and production area are met; and

4. Any other required filings or notifications regarding the cultivation and production areas are made on behalf of the processor as set forth in regulation.

E. When the responsible party ceases practice at a pharmaceutical processor or no longer wishes to be designated as the responsible party, he shall immediately return the pharmaceutical processor permit to the board indicating the effective date on which he ceased to be the responsible party.

F. The outgoing responsible party shall have the opportunity to take a complete and accurate inventory of all Cannabis, to include plants, extracts, or cannabis products on hand in the cultivation and production areas, on the date he ceases to be the responsible party unless the owner submits written notice to the board showing good cause as to why this opportunity should not be allowed.

G. A responsible party who is absent from practice for more than 30 consecutive days shall be deemed to no longer be the responsible party. If the responsible party knows of an upcoming absence of longer than 30 days, he shall be responsible for notifying the board and returning the permit. For unanticipated absences by the responsible party that exceed 15 days with no known return date within the next 15 days, the permit holder shall immediately notify the board and shall obtain a new responsible party.

H. An application for a permit designating the new responsible party shall be filed with the required fee within 14 days of the original date of resignation or termination of the responsible party on a form provided by the board. It shall be unlawful for a pharmaceutical processor to operate without a new permit past the 14-day deadline unless the board receives a request for an extension prior to the deadline. The executive director for the board may grant an extension for up to an additional 14 days for good cause shown.

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.

18VAC110-60-200. Responsibilities of the PIC.

A. The PIC of a pharmaceutical processor shall not serve as PIC of any other facility at any one time. A processor shall employ the PIC at the pharmaceutical processor for at least 35 hours per week, except as otherwise authorized by the board. A person may serve simultaneously as the PIC for no more than two cannabis dispensing facilities located within the same health service area at any one time.

B. The PIC or the pharmacist on duty shall control all aspects of the practice in the dispensing area of the pharmaceutical processor or in a cannabis dispensing facility. Any decision overriding such control of the PIC or other pharmacist on duty may be grounds for disciplinary action against the pharmaceutical processor or cannabis dispensing facility permit.

C. The PIC of a pharmaceutical processor or cannabis dispensing facility shall be responsible for ensuring that:

1. Pharmacy technicians are registered and properly trained;

2. All record retention requirements pertaining to the dispensing area met;

3. All requirements for the physical security of the cannabis products are met;

4. The pharmaceutical processor or cannabis dispensing facility has appropriate pharmaceutical reference materials to ensure that cannabis products can be properly dispensed;

5. The following items are conspicuously posted in the pharmaceutical processor or cannabis dispensing facility in a location and in a manner so as to be clearly and readily identifiable to registered patients, parents, legal guardians, or registered agents:

a. Pharmaceutical processor permit or cannabis dispensing facility permit;

b. Licenses for all pharmacists practicing at the pharmaceutical processor or cannabis dispensing facility; and

c. The price of all cannabis products offered by the pharmaceutical processor or cannabis dispensing facility; and

6. Any other required filings or notifications are made on behalf of the dispensing area of the pharmaceutical processor or the dispensing facility as set forth in regulation.

D. When the PIC ceases practice at a pharmaceutical processor or cannabis dispensing facility or no longer wishes to be designated as PIC, he shall immediately return the permit to the board indicating the effective date on which he ceased to be the PIC.

E. An outgoing PIC shall have the opportunity to take a complete and accurate inventory of all cannabis products on hand in the dispensing area of the pharmaceutical processor or the dispensing facility 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.

F. A PIC who is absent from practice for more than 30 consecutive days shall be deemed to no longer be the PIC. If the PIC knows of an upcoming absence of longer than 30 days, he shall be responsible for notifying the board and returning the permit. For unanticipated absences by the PIC that exceed 15 days with no known return date within the next 15 days, the permit holder shall immediately notify the board and shall obtain a new PIC.

G. An application for a permit designating the new PIC shall be filed with the required fee within 14 days of the original date of resignation or termination of the PIC on a form provided by the board. It shall be unlawful for a pharmaceutical processor or cannabis dispensing facility to operate without a new permit past the 14-day deadline unless the board receives a request for an extension prior to the deadline. The executive director for the board may grant an extension for up to an additional 14 days for good cause shown.

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.

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