Administrative Code

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Virginia Administrative Code
Title 18. Professional And Occupational Licensing
Agency 110. Board of Pharmacy
Chapter 60. Regulations Governing Pharmaceutical Processors

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.

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