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
12/4/2023

18VAC110-60-290. Labeling of batch of cannabis products.

A. Cannabis products produced as a batch shall not be adulterated.

B. Cannabis products produced as a batch shall be:

1. Processed, packaged, and labeled according to the U.S. Food and Drug Administration's Current Good Manufacturing Practice in Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements, 21 CFR Part 111; and

2. Labeled with:

a. The name and address of the pharmaceutical processor;

b. The brand name of the cannabis product that was registered with the board pursuant to 18VAC110-20-285;

c. A unique serial number that matches the product with the pharmaceutical processor batch and lot number, including the cultivator and manufacturer if produced from bulk cannabis oil, botanical cannabis, or usable cannabis obtained through distribution from another pharmaceutical processor, so as to facilitate any warnings or recalls the board or pharmaceutical processor deem appropriate;

d. The date of testing and packaging;

e. For products produced from bulk cannabis oil, botanical cannabis, or usable cannabis obtained through distribution from another pharmaceutical processor, the name and address of the testing laboratory;

f. The expiration date, which shall be six months or less from the date of the cannabis product registration approval, unless supported by stability testing;

g. The quantity of cannabis products contained in the batch;

h. A terpenes profile and a list of all active ingredients, including:

(1) Tetrahydrocannabinol (THC);

(2) Tetrahydrocannabinol acid (THC-A);

(3) Cannabidiol (CBD); and

(4) Cannabidiolic acid (CBDA).

For botanical cannabis products, only the total cannabidiol (CBD) and total tetrahydrocannabinol (THC) are required;

i. For cannabis oil products, pass or fail rating based on the laboratory's microbiological, mycotoxins, heavy metals, residual solvents, and pesticide chemical residue analysis; and

j. For botanical cannabis products, a pass or fail rating based on the laboratory's microbiological, mycotoxins, heavy metals, pesticide chemical residue analysis, water activity, and moisture content, and the potency.

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 1, eff. September 30, 2020; Volume 37, Issue 25, eff. September 1, 2021; Volume 39, Issue 24, eff. August 16, 2023.

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