N.D. Admin. Code 33-44-01-26

Current through Supplement No. 394, October, 2024

Section 33-44-01-26 - Manufacturing facility labeling

1. A manufacturing facility shall label all usable marijuana in accordance with the following before their sale or transfer to a dispensary:

a. A container holding dried leaves and flowers must include the following information:

(1) Manufacturers' business or trade name and registry certification number;

(2) Container identification number;

(3) Batch number;

(4) Date of harvest;

(5) Name of strain;

(6) Net weight in United States customary or metric units;

(7) Concentration of total tetrahydrocannabinol and total cannabidiol as identified by the laboratory selected by the department in accordance with section 33-44-01-36;

(8) Activation time expressed in words or through a pictogram;

(9) Expiration date;

(10) Universal symbol; and

(11) Consumer warnings that state:

(a) "This product is not approved by the Food and Drug Administration to treat, cure, or prevent any disease."

(b) "For use by North Dakota registered qualifying patients only."

(c) "Keep out of reach of children."

(d) "It is illegal to drive or to be in actual physical control of a motor vehicle while under the influence of marijuana."

b. A container holding a cannabinoid concentrate must include the following information:

(1) Manufacturing facility's business or trade name and registry certification number;

(2) Container identification number;

(3) Process lot number;

(4) Product identity;

(5) Date the concentrate was made;

(6) Net weight or volume in United States customary or metric units;

(7) If applicable, serving size and number of servings per container or amount suggested for use by the consumer or patient at any one time;

(8) Concentration or amount of total tetrahydrocannabinol, and the concentration or amount of total cannabidiol, by weight or volume in the container as identified by the laboratory selected by the department in accordance with section 33-44-01-36;

(9) Activation time, expressed in words or through a pictogram;

(10) Expiration date;

(11) A disclosure of the type of extraction process used and any solvent, gas, or other chemical used in the extraction process;

(12) Universal symbol;

(13) Pediatric symbol, if applicable; and

(14) Consumer warnings that state:

(a) "This product is not approved by the Food and Drug Administration to treat, cure, or prevent any disease."

(b) "For use by North Dakota registered qualifying patients only."

(c) "Keep out of reach of children."

(d) "It is illegal to drive or to be in actual physical control of a motor vehicle while under the influence of marijuana."

c. A container holding a medical cannabinoid product must include the following information:

(1) Manufacturers' business or trade name and registry certification number;

(2) Container identification number;

(3) Process lot number;

(4) Product identity;

(5) Date the product was made;

(6) Net weight or volume in United States customary or metric units;

(7) If applicable, serving size and number of servings per container;

(8) Concentration or amount of total tetrahydrocannabinol, and the concentration or amount of total cannabidiol, by weight or volume in each serving and in each container as identified by the laboratory selected by the department in accordance with section 33-44-01-36;

(9) List of ingredients in descending order or predominance by weight or volume used to process the medical cannabinoid product;

(10) Activation time, expressed in words or through a pictogram;

(11) Expiration date;

(12) A disclosure of the type of extraction process used and any solvent, gas, or other chemical used in the extraction process;

(13) Universal symbol;

(14) Pediatric symbol, if applicable; and

(15) Consumer warnings that state:

(a) "This product is not approved by the Food and Drug Administration to treat, cure, or prevent any disease."

(b) "For use by North Dakota registered qualifying patients only."

(c) "Keep out of reach of children."

(d) "It is illegal to drive or to be in actual physical control of a motor vehicle while under the influence of marijuana."

2. Usable marijuana labels required in accordance with this section must be no smaller than eight point, arial or calibri, font. If, due to the size of the container, sufficient space does not exist for a label containing all of the required information, the manufacturing facility may:

a. Use a peel-back or accordion label if, the peel-back or accordion label is easily identified as containing the required information; or

b. Reduce the size of the required information to six point font.

3. Usable marijuana labels may not contain the word "organic".

N.D. Admin Code 33-44-01-26

Adopted by Administrative Rules Supplement 368, April 2018, effective 4/1/2018.

Amended by Administrative Rules Supplement 374, October 2019, effective 10/1/2019.

Amended by Administrative Rules Supplement 2022-385, July 2022, effective 7/1/2022.

General Authority: NDCC 19-24.1-36

Law Implemented: NDCC 19-24.1-36