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
4/22/2024

18VAC110-60-251. Wholesale distribution of cannabis products, bulk cannabis oil, botanical cannabis, and usable cannabis.

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, between a pharmaceutical processor and a cannabis dispensing facility, and between cannabis dispensing facilities.

B. Bulk cannabis oil, botanical cannabis, and usable cannabis that has not been packaged for sale and has not passed the tests required in 18VAC110-60-300 G and H and does not bear an appropriate expiration date may be wholesale distributed between pharmaceutical processors. Prior to distribution, the bulk cannabis oil, botanical cannabis, and usable cannabis shall be labeled in compliance with 18VAC110-60-295.

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 wholesale distributing bulk cannabis oil, botanical cannabis, and usable cannabis shall create a record of the transaction that shows (i) the date of distribution; (ii) the names and addresses of the processor distributing the bulk cannabis oil, botanical cannabis, and usable cannabis and the processor receiving the bulk cannabis oil, botanical cannabis, and usable cannabis; (iii) the quantity or weight of the bulk cannabis oil, botanical cannabis, and usable cannabis in each container; (iv) the quantity of each type of container being distributed; (v) the identification of the contents of each container, including a brief description of the type or form of cannabis oil, botanical cannabis, or usable cannabis and the strain name, as appropriate; (vi) the lot or batch number or unique identifier so as to facilitate any warnings or recalls the board or pharmaceutical processor deem appropriate; and (vii) the dates of harvest and packaging. The record of the transaction shall be maintained by the distributing pharmaceutical processor with its records of distribution, and a copy of the record shall be provided to and maintained by the processor receiving the product in its records of receipt. Such records shall be maintained by each processor for three years in compliance with 18VAC110-60-260.

E. 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 patients, parents, legal guardians, registered agents, registered practitioners who have certified qualifying patients, or an agent of the board.

F. A pharmaceutical processor or cannabis dispensing facility wholesale distributing cannabis products and pharmaceutical processors wholesale distributing bulk cannabis oil, botanical cannabis, and usable cannabis shall store and handle the items 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.

G. If a pharmaceutical processor or cannabis dispensing facility participating in wholesale distribution uses an electronic system for the storage and retrieval of records related to distributing, the pharmaceutical processor shall use a system that is compliant with 18VAC110-60-260.

Statutory Authority

§ 54.1-3442.6 of the Code of Virginia.

Historical Notes

Derived from Virginia Register Volume 37, Issue 25, eff. September 1, 2021; amended, Virginia Register Volume 39, Issue 24, eff. August 16, 2023.

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