Chapter 3796:8-2 | Form of Doses

Rule 3796:8-2-01 | Authorized medical marijuana forms and methods of administration.

• Effective: September 8, 2017
• Promulgated Under: 119.03

(A) Pursuant to section 3796.06 of the Revised Code, approved medical marijuana products include the following forms and routes of administration:

(1) Oil, tincture, capsule, or edible form for oral administration;

(2) Metered oil or solid preparation for vaporization;

(3) Patches for transdermal administration or lotions, creams, or ointments for topical administration; and

(4) Plant material for administration with the use of vaporizing devices.

(B) The following limitations apply to vaporizing devices used to administer medical marijuana:

(1) No vaporizing device, the design of which places medical marijuana in direct contact with the device's heating element, may be used to vaporize the resin contained within, or an extract of, medical marijuana;

(2) Vaporizing devices shall not be capable of being heated to temperatures at which medical marijuana plant material will burn.

Supplemental Information

Authorized By: 3796.04
Amplifies: 3796.04, 3796.06
Five Year Review Date: 9/7/2023

Rule 3796:8-2-02 | Establishment of additional forms or methods of administration.

• Effective: September 5, 2022
• Promulgated Under: 119.03

(A) New forms of medical marijuana or methods of administration shall not be purchased by, stored, possessed, offered for sale, or sold by a dispensary unless the form or method has been approved by the state board of pharmacy.

(B) Persons seeking to add a form or method of administration shall submit a petition in accordance with section 3796.061 of the Revised Code to the state board of pharmacy, which can be accessed by visiting medicalmarijuana.ohio.gov.

(C) The board shall only consider a petition if it includes all of the following:

(1) Scientific evidence, capable of being reproduced by multiple scientific experts, supporting the addition of the form or method of administration;

(2) An opinion from at least one scientific expert supporting the addition of the form or method of administration. The scientific expert must have specialized knowledge acquired through experience, education or observation, or study that is not possessed by the average layperson;

(3) The extent to which the prospective form or method of administration is generally accepted by the medical community;

(4) Information or studies known to the petitioner regarding any benefit or adverse effects from the use of the proposed form or method of administration; and

(5) Benefits to approving the proposed form or method of administration.

(D) If a form or method has been previously considered and rejected by the board, or is determined by the board to be substantially similar to a rejected form or method of administration, the board may deny the petition without first considering the appropriateness, unless new scientific research supporting the request is included in the petition.

(E) In addition to information provided in a petition, the board may examine scientific, medical or other evidence and research pertaining to the petition and may gather information, in person or in writing, from other persons knowledgeable about the form or method of administration included in the petition.

(F) The board shall consider, and approve or deny, each petition for a new form or method of administration at a public meeting.

(G) If the board approves a form or method of administration contained within the petition, the board shall proceed to adopt a rule, in accordance with Chapter 119. of the Revised Code.

Last updated September 6, 2022 at 8:37 AM

Supplemental Information

Authorized By: 3796.04
Amplifies: 3796.04, 3796.06, 3796.061
Five Year Review Date: 9/5/2027

Rule 3796:8-2-03 | Forms and form variations considered attractive to children.

• Effective: February 14, 2022
• Promulgated Under: 119.03

(A) All medical marijuana accepted by a dispensary shall be packaged in a child-resistant container.

(B) Pursuant to division (C) of section 3796.06 of the Revised Code, the following medical marijuana products are prohibited as attractive to children:

(1) Any product bearing any resemblance to a cartoon character, fictional character whose target audience is children or youth, or pop culture figure;

(2) Any product bearing a reasonable resemblance to a product available for consumption as a commercially available candy;

(3) Any product whose design resembles, by any means, another object commonly recognized as appealing to, or intended for use by, children;

(4) Any product whose shape bears the likeness or contains characteristics of a realistic or fictional human, animal, or fruit, including artistic, caricature, or cartoon renderings;

(5) Any medical marijuana product that otherwise targets persons under the age of eighteen.

(C) Pursuant to division (C) of section 3796.06 of the Revised Code, the following restrictions apply to the administration of medical marijuana by vaporization, as attractive to children:

(1) Characterizing flavors, except those intended to mimic marijuana strains, are prohibited from all products intended for use in the vaporization of medical marijuana;

(2) Vaporization is not an authorized method of administration for registered patients under the age of eighteen.

Last updated February 14, 2022 at 8:59 AM

Supplemental Information

Authorized By: 3796.04
Amplifies: 3796.04, 3796.06
Five Year Review Date: 2/14/2027
Prior Effective Dates: 9/8/2017

Rule 3796:8-2-04 | Quantity of medical marijuana that may be purchased by a patient or caregiver.

• Effective: February 14, 2022
• Promulgated Under: 119.03

(A) A patient and a patient's caregiver(s) may collectively purchase no less than a whole day unit at a single time. A whole day unit shall equal the amounts for each authorized form of medical marijuana as listed in the following table:

Authorized Form of Medical Marijuana	Whole Day Unit
Plant material	2.83 grams
Patch for transdermal administration, lotion, cream, or ointment	Up to 295 milligrams of THC
Oil, tincture, capsule, or edible for oral administration	Up to 110 milligrams of THC
Oil for vaporization	Up to 590 milligrams of THC

(B) A patient and the patient's caregiver(s) may collectively purchase no more than a ninety-day supply in accordance with the two forty-five-day fill period process established in rule 3796:7-2-04 of the Administrative Code. Ninety whole day units, aggregated across forms purchased, shall constitute a ninety-day supply of medical marijuana. A patient or caregiver may not purchase more whole day units of medical marijuana than days remaining in their fill periods as set forth in rule 3796:7-2-04 of the Administrative Code. A ninety-day supply is defined by form as follows:

Authorized Form of Medical Marijuana	90-Day Supply
Plant material	9 oz or 254.7 grams
Patch for transdermal administration, lotion, cream, or ointment	26.55 grams of THC
Oil, tincture, capsule, or edible for oral administration	9.9 grams of THC
Oil for vaporization	53.1 grams of THC

(C) Notwithstanding paragraph (B) of this rule, a patient who is diagnosed with a terminal illness and the patient's caregiver(s) may collectively purchase no more than a ninety- day supply in accordance with the two forty-five-day fill period process established in rule 3796:7-2-04 of the Administrative Code. Ninety whole day units, aggregated across forms purchased, shall constitute a ninety-day supply of medical marijuana. A patient or caregiver may not purchase more whole day units of medical marijuana than days remaining in their fill periods as set forth in rule 3796:7-2-04 of the Administrative Code. A ninety-day supply for patients diagnosed with a terminal illness is defined by form as follows:

Authorized Form of Medical Marijuana	90-Day Supply (Terminal Illness)
Plant material	10 oz or 283.5 grams
Patch for transdermal administration, lotion, cream, or ointment	29.5 grams of THC
Oil, tincture, capsule, or edible for oral administration	11 grams of THC
Oil for vaporization	59 grams of THC

Last updated February 14, 2022 at 8:59 AM

Supplemental Information

Authorized By: 3796.04
Amplifies: 3796.04, 3796.06, 3796.22, 3796.23
Five Year Review Date: 2/14/2027
Prior Effective Dates: 9/8/2017

Rule 3796:8-2-05 | Assignment of a product identifier.

• Effective: September 5, 2022
• Promulgated Under: 119.03

(A) Before any medical marijuana product may be sold to a dispensary, the form for each dose and packaged quantity of that product must be registered with the department pursuant to Chapter 3796:5-8 of the Administrative Code and assigned a product identifier pursuant to this rule.

(B) Each cultivator with a processor designation and processor that intends to sell medical marijuana to a dispensary shall provide the following information to the state board of pharmacy for each form and dose of each medical marijuana product:

(1) Name of the medical marijuana entity;

(2) Medical marijuana entity license issued by the department;

(3) Name of product;

(4) Product description, including but not limited to:

(a) The form and intended method or methods of administration; and

(b) An image of the product;

(5) Product dose;

(6) Days supply of the product for each product package that will be available;

(7) Product ingredients;

(8) Proof that the product has been registered with the department pursuant to Chapter 3796:5-8 of the Administrative Code;

(9) Remit required fee; and

(10) Any additional items deemed necessary by the state board of pharmacy.

(C) After reviewing the information submitted in accordance with paragraph (B) of this rule, the state board of pharmacy shall determine whether the product complies with section 3796.06 of the Revised Code and this division. Issuance of a product identifier shall serve as evidence that the registered product complies with section 3796.06 of the Revised Code and this division.

Last updated September 6, 2022 at 8:37 AM

Supplemental Information

Authorized By: 3796.04
Amplifies: 3796.04, 3796.06
Five Year Review Date: 9/5/2027
Prior Effective Dates: 9/8/2017

Rule 3796:8-2-06 | Portions, dosing, and units of medical marijuana sold at a dispensary.

• Effective: February 14, 2022
• Promulgated Under: 119.03

To be eligible for sale by a dispensary:

(A) Edible liquids containing multiple portions, or doses, of medical marijuana shall be packaged in a structure that uses a single mechanism to achieve both child-resistant properties and accurate pouring measurement of portions, or doses. The measurement component shall be included within the child-resistant cap or closure of the bottle and cannot be a separate component.

(B) No single portion or dose of medical marijuana in the following forms shall exceed fifty-five milligrams of THC:

(1) Oil, tincture, capsule, or edible form for oral administration;

(2) Strips, sprays, salves, dissolving tablets, lozenges, tinctures, and films for sublingual administration; and

(3) Patches for transdermal administration.

(C) Each portion or dose of medical marijuana shall be clearly demarked in a way that enables a reasonable person to intuitively determine how much of the product constitutes a single portion or dose.

(D) Each portion or dose of medical marijuana in patch form must be individually marked with the total target THC content indicated in the product identifier assignment application.

(E) Each portion or dose of medical marijuana shall contain not less than ninety per cent or no more than one hundred ten per cent of the concentration of total target THC content indicated in the product identifier assignment application. For plant material, a total THC concentration of less than three-tenths of one per cent will be considered as having zero per cent THC content. There is no zero per cent threshold for THC per cent in processed forms of medical marijuana.

Last updated February 14, 2022 at 8:59 AM

Supplemental Information

Authorized By: 3796.04
Amplifies: 3796.04, 3796.06
Five Year Review Date: 2/14/2027