Action:
New Regulations Governing Pharmaceutical Processors
General Information
| Action Summary |
Chapter 577 of the 2016 Acts of the Assembly requires the Board to promulgate regulations governing issuance of a permit for a pharmaceutical processor to manufacture and provide cannabidiol oil and THC-A oil to be used for the treatment of intractable epilepsy. Part I establishes definitions and fees to be charged to applicants, registrants, and permitted processors. As specified in the legislation, Part II of the regulations establishes requirements for issuance or denial of registration for certifying physicians, patients, parents or legal guardians. Part III sets out the application and approval process for issuing a permit to a pharmaceutical processor, including the information that must be submitted, the requirements for issuing conditional and then final approval, the rules for notification to the Board of any changes or of closure of the processor, and the causes for action against a processor.
Part IV sets out the provisions for personnel at the pharmaceutical processor, including a requirement that a pharmacist with a current, unrestricted Virginia license provide personal supervision on the premises at all times during hours of operation or whenever the processor is accessed. It included requirements for employee training, supervision of pharmacy technicians, and the responsibilities of the pharmacist-in-charge. Part V sets out provisions for the operation of a pharmaceutical processor, including requirements for inventory, security, storage and handling, record-keeping, and reportable events.
Part VI establishes requirements for the cultivation, production, and dispensing of cannabidiol oil, including labeling, laboratory and testing standards, dispensing errors and quality assurance, and proper disposal.
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| Chapters Affected |
Only affects this chapter.
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| Executive Branch Review |
This action will go through the normal Executive Branch Review process.
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| RIS Project |
Yes [004878] |
| Associated Mandates |
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| New Periodic Review |
This action will be used to conduct a new periodic review.
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Stages
Stages associated with this regulatory action.
| Stage ID |
Stage Type |
Status |
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7740
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Emergency/NOIRA
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Stage complete. Emergency regulation expired on 02/06/2019. |
|
8332
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Emergency/NOIRA
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Stage complete. Emergency regulation was set to expire on 02/06/2019 and was extended until 08/08/2019. |
|
8484
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Proposed
|
Stage complete. Comment period ended 05/17/2019. |
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8648
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Final
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Stage complete. This regulation became effective on 08/07/2019. |
Contact Information
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Name / Title:
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Caroline Juran, RPh
/
Executive Director
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Address:
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9960 Mayland Drive
Suite 300
Henrico, VA 23233
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Email Address:
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caroline.juran@dhp.virginia.gov
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Phone:
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(804)367-4456
FAX: (804)527-4472
TDD: ()-
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This person is the primary contact for this board.
