3 Va. Admin. Code § 10-70-20

Current through Register Vol. 40, No. 22, June 17, 2024

Section 3VAC10-70-20 - 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 cannabis product name 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);

i. For botanical cannabis products, list of only total cannabidiol (CBD) and total tetrahydrocannabinol (THC);

j. 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

k. 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.

3 Va. Admin. Code § 10-70-20

Derived from Virginia Register Volume 40, Issue 11, eff. 1/1/2024.

Statutory Authority: §§ 4.1-601, 4.1-604, and 4.1-606 of the Code of Virginia.