1. (a)

   1. (1) The purpose of this section is to set the minimum standards for the labeling of usable marijuana that is sold to a qualifying patient or designated caregiver by a dispensary or given by a qualifying patient or designated to another qualifying patient or designated caregiver.
   2. (2) Usable marijuana received or transferred by a dispensary, qualifying patient, or designated caregiver must meet the labeling requirements in this part.

   3. (3) A dispensary must:

      1. (A) Return usable marijuana that does not meet the labeling requirements in this part to the individual who transferred it to the dispensary and document to whom the item was returned, what was returned, and the date of the return; or
      2. (B) Dispose of any usable marijuana that does not meet labeling requirements and that cannot be returned in a manner specified by the Department of Health.

2. (b) Usable marijuana labeling requirements. Prior to usable marijuana being sold or transferred to a qualifying patient or designated caregiver, the container holding the usable marijuana must have a label that has the following information:

   1. (1) Producer’s business or trade name and cultivation facility or dispensary number;
   2. (2) Business or trade name of cultivation facility or dispensary, or cultivation facility or dispensary that packaged or distributed the product, if different from the producer;
   3. (3) A unique identification number;
   4. (4) Date of harvest;
   5. (5) Name of strain;
   6. (6) Net weight in United States customary and metric units;
   7. (7) Concentration of THC and CBD;
   8. (8) Activation time expressed in words or through a pictogram;
   9. (9) Name of the lab that performed any test, any associated test batch number, and any test analysis date;
   10. (10) Universal symbol;
   11. (11) A warning that states, "For use by qualified patients only. Keep out of reach of children.";
   12. (12) A warning that states, “Marijuana use during pregnancy or breastfeeding poses potential harms.”; and
   13. (13) A warning that states, "This product is not approved by the FDA to treat, cure, or prevent any disease".

3. (c) Cannabinoid concentrates and extracts. Prior to a cannabinoid concentrate or extract being sold or transferred to a qualifying patient or designated caregiver, the container holding the concentrate or extract must have a label that has the following information:

   1. (1) Cultivation facility’s or dispensary’s business or trade name and cultivation facility or dispensary number;
   2. (2) Business or trade name of cultivation facility or dispensary that packaged or distributed the product, if different from the cultivation facility or dispensary;
   3. (3) A unique identification number;
   4. (4) Product identity (concentrate or extract);
   5. (5) Date the concentrate or extract was made;
   6. (6) Net weight or volume in United States customary and metric units;
   7. (7) If applicable, serving size and number of servings per container or amount suggested for use by the qualifying patient at any one time;
   8. (8) Concentration or amount by weight or volume of THC and CBD in each amount suggested for use and in the container;
   9. (9) Activation time, expressed in words or through a pictogram;
   10. (10) Name of the lab that performed any test, any associated test batch number, and any test analysis date;
   11. (11) Universal symbol;

   12. (12) A statement that reads:

       1. (A) "This product is not approved by the FDA to treat, cure, or prevent any disease";
       2. (B) "For use by qualifying patients only. Keep out of reach of children.";
       3. (C) "DO NOT EAT" in bold, capital letters; and
       4. (D) “Marijuana use during pregnancy or breastfeeding poses potential harms.”.

4. (d) General label requirement — Prohibitions and exceptions.

   1. (1) Principal display panel.

      1. (A) Every container that contains usable marijuana for sale or transfer to a qualifying patient or designated caregiver must have a principal display panel.
      2. (B) If a container is placed within packaging for purposes of displaying the marijuana item for sale or transfer to a qualifying patient or designated caregiver, the packaging must have a principal display panel.
      3. (C) The principal display panel must contain the product identity, net weight, and universal symbol, if applicable.

   2. (2) A label required by this part must:

      1. (A) Be placed on the container and on any packaging that is used to display the marijuana item for sale or transfer to a qualified patient or designated caregiver;
      2. (B) Comply with the National Institute of Standards and Technology (NIST) Handbook 130 (2017), Uniform Packaging and Labeling Regulation, incorporated by reference;
      3. (C)

5. (i) Be in no smaller than eight-point Times New Roman, Helvetica, or Arial font.

   1. (ii) Statements required by subdivisions (c)(12)(B) and (D) of this section must be in at least eighteen-point font;

      1. (D) Be in English, though it can also be in other languages; and
      2. (E) Be unobstructed and conspicuous.
   2. (3) Usable marijuana may have one (1) or more labels affixed to the container or packaging.

   3. (4) Usable marijuana that is in a container that because of its size does not have sufficient space for a label that contains all the information required for compliance with this part:

      1. (A) May have a label on the container that contains usable marijuana and on any packaging that is used to display usable marijuana for sale or transfer to a qualifying patient or designated caregiver that includes at least the following:

         1. (i) Information required on a principal display panel, if applicable for the type of usable marijuana;
         2. (ii) Cultivation facility or dispensary business or trade name and cultivation facility or dispensary number;
         3. (iii) For cultivation facility or dispensaries, a package-unique identification number;
         4. (iv) Concentration of THC and CBD; and
         5. (v) Required warnings; and

      2. (B) Must include all other required label information not listed in subdivision (d)(4)(A) of this section on:

         1. (i) An outer container or package; or
         2. (ii) On a leaflet that accompanies the usable marijuana.
   4. (5) Usable marijuana in a container that is placed in packaging that is used to display the usable marijuana for sale or transfer to a qualifying patient or designated caregiver must comply with the labeling requirements in this part, even if the container qualifies for the exception under subdivision (d)(4) of this section.

   5. (6) The universal symbol:

      1. (A) Must be at least forty-eight hundredths of an inch wide by thirty-five hundredths of an inch high (0.48” x 0.35”);
      2. (B) May only be used by a cultivation facility or dispensary; and
      3. (C) May be downloaded at: https://healthy.arkansas.gov/programs-services/data-statistics-registries/medical-marijuana/.

   6. (7) A label may not:

      1. (A) Contain any untruthful or misleading statements including, but not limited to, a health claim that is not supported by the totality of publicly available scientific evidence (including evidence from well-designed studies conducted in a manner that is consistent with generally recognized scientific procedures and principles), and for which there is significant scientific agreement among experts qualified by scientific training and experience to evaluate such claims; or
      2. (B) Be attractive to minors.
   7. (8) Usable marijuana that falls within more than one (1) category must comply with the labeling requirements that apply to both categories, with the exception of the "DO NOT EAT" warning if the product is intended for human consumption.
   8. (9) The THC and CBD amount required to be on a label must be the value calculated by the laboratory that did the testing.
   9. (10) If usable marijuana has more than one (1) test batch number, laboratory, or test analysis date associated with the usable marijuana that is being sold or transferred, each test batch number, laboratory, and test analysis date must be included on a label.
   10. (11) If usable marijuana is placed in a package that is being reused, the old label or labels must be removed and it must have a new label or labels.
   11. (12) Exit packaging must contain a label that reads, "Keep out of the reach of children.".

Codification Notes: “FDA” means the Food and Drug Administration.