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Virginia Administrative Code
Title 18. Professional And Occupational Licensing
Agency 110. Board of Pharmacy
Chapter 60. Regulations Governing Pharmaceutical Processors
11/30/2023

18VAC110-60-280. Cultivation and production of cannabis products.

A. No cannabis products shall have had pesticide chemicals or petroleum-based solvents, except for hydrocarbon-based solvents described in 18VAC110-60-281, 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.

B. Cultivation methods for Cannabis plants, extraction methods used to produce the cannabis products, and the manufacturing of cannabis products shall be performed in a manner deemed safe and effective based on current standards or scientific literature.

1. The cultivation, extraction, production, and manufacturing of cannabis products may include the use of hydrocarbon-based solvents as described in 18VAC110-60-281.

2. The cultivation, extraction, production, and manufacturing of cannabis products may include any other generally accepted technology, provided that:

a. The pharmaceutical processor complies with any applicable requirements contained in 18VAC110-60-281 regarding flammable solvents as defined in that section;

b. The pharmaceutical processor complies with any Virginia licensing, permitting, and general safety laws or regulations of any federal or Virginia state agency that governs the technology and use of such technology; and

c. The pharmaceutical processor maintains sole responsibility for any adverse outcomes or violations of federal or Virginia state laws or regulations caused by such use.

C. Any Cannabis plant, seed, parts of plant, extract, or cannabis products not in compliance with this section shall be deemed adulterated.

D. A pharmaceutical processor may acquire industrial hemp extract, including isolates and distillates, for the purpose of formulating such extracts into allowable dosages of cannabis products provided:

1. The pharmaceutical processor acquires the extracts from industrial hemp extract processed in Virginia and in compliance with state or federal law from a registered industrial hemp dealer or processor;

2. The extracts from industrial hemp acquired by a pharmaceutical processor are subject to the same third-party testing requirements applicable to cannabis plant extract as verified by testing performed by a laboratory located in Virginia and in compliance with state law; and

3. The industrial hemp dealer or processor provides such third-party testing results to the pharmaceutical processor before extracts from industrial hemp are acquired.

E. A pharmaceutical processor acquiring oil from industrial hemp extract shall ensure receipt of a record of the transaction that shows the date of distribution, the names and addresses of the registered industrial hemp dealer or processor distributing the product and the pharmaceutical processor receiving the product, and the kind and quantity of product being distributed. The record of the transaction shall be maintained by the pharmaceutical processor with its records of receipt. Such records shall be maintained by each pharmaceutical processor for three years.

F. A pharmaceutical processor shall maintain policies and procedures for the proper storage and handling of industrial hemp extracts, to include a process for executing or responding to mandatory and voluntary recalls in a manner that complies with 18VAC110-60-250.

G. No cannabis oil intended to be vaporized or inhaled shall contain vitamin E acetate.

Statutory Authority

§ 54.1-3442.6 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 01, eff. September 30, 2020; Volume 37, Issue 12, eff. March 18, 2021; Volume 37, Issue 25, eff. September 1, 2021; Volume 39, Issue 24, eff. August 16, 2023.

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