3796:6-3-09 Labeling requirements for medical marijuana sold at a dispensary and accompanying materials.

(A) A dispensary shall ensure that the following information is clearly provided on the outside of each container or package containing medical marijuana, prior to sale:

(1) The business or trade name and the license number of the cultivator that cultivated the marijuana;

(2) The product identifier;

(3) The date and quantity dispensed, including the net weight measured in ounces and grams or by volume, as appropriate;

(4) The name and registry number of the patient and, if applicable, the name of his or her designated caregiver;

(5) The name, address and license number of the dispensary;

(6) The cannabinoid profile and concentration levels and terpenoid profile as determined by the testing laboratory;

(7) A warning that states: "This product may cause impairment and may be habit-forming;"

(8) The statement: "This product may be unlawful outside of the State of Ohio;"

(9) The date on which the marijuana was harvested;

(10) If the product is in a form other than plant material, the following must be included:

(a) The date on which the product was manufactured and the name and license number of the processor that manufactured the product;

(b) A list of all ingredients and all major food allergens as identified in 21 USC 343 ;

(c) A warning that states: "Caution: When eaten or swallowed, the effects and impairment caused by this drug may be delayed;" and

(d) If a marijuana extract was added to the product, a disclosure of the type of extraction process and any solvent, gas or other chemical used in the extraction process or any other compound added to the extract.

(B) The requirements set forth under paragraph (A) of this rule may be partially satisfied if required information is included on the cultivator or processor-created package. A dispensary shall include on its affixed label, any required information that is also included on the cultivator or processor-created package if that information is obscured, in whole or in part, by the affixed label.

(C) A dispensary must provide with all medical marijuana dispensed, accompanying material that discloses any pesticide applied to the marijuana plants and growing medium during production and process and that contains the following warnings:

(1) "Warning: This product may cause impairment and may be habit-forming. Smoking medical marijuana is not permitted in the State of Ohio."

(2) "There may be health risks associated with consumption of this product."

(3) "Should not be used by women who are pregnant or breastfeeding."

(4) "For use only by the person named on the label of the dispensed product. Keep out of reach of children."

(5) "Marijuana can impair concentration, coordination and judgment. Do not operate a vehicle or machinery under the influence of this drug."

(6) The toll-free telephone line established by the state board of pharmacy in accordance with section 3796.17 of the Revised Code

(7) The text used on all accompanying material must be printed in at least twelve-point font and may not be in italics.

(D) A dispensary shall include the following printed statement on the receipt or in the bag or other similar packaging in which dispensed medical marijuana is transferred from the dispensary to a patient or caregiver: "If you have a concern that an error may have occurred in the dispensing of your medical marijuana, you may contact the State of Ohio Board of Pharmacy, using the contact information found at medicalmarijuana.ohio.gov." Such language shall be in a size and font that is easily readable by patients.

Cite as Ohio Admin. Code 3796:6-3-09

Effective: 9/8/2017
Five Year Review (FYR) Dates: 09/08/2022
Promulgated Under: 119.03
Statutory Authority: 3796.04
Rule Amplifies: 3796.04 , 3796.17, 3769.20