Chapter 1301:18-4 | Manufacturing Practices, Administration, Testing, and Customer Sales of Cannabis

Rule 1301:18-4-03 | Petition for Additional Forms and Methods.

• Effective: August 28, 2025
• Promulgated Under: 119.03

(A) A person seeking to add an approved form or method of administration as outlined under rule 1301:18-4-03 of the Administrative Code shall apply in a manner prescribed by the division of cannabis control and demonstrate the following:

(1) Multiple scientific experts support the addition of the form or method of administration.

The scientific experts must have specialized knowledge acquired through experience, education or observation, or study that is not possessed by the average layperson.

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

(3) 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

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

(B) In addition to information provided in a petition, the division 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.

(C) Division review of application.

(1) Upon receipt of an application pursuant to paragraph (A) of this rule, the division will review the application and within sixty calendar days may:

(a) Approve the form or method;

(b) Deny the application; or

(c) Advise in writing that the applicant failed to meet all application requirements.

(2) Upon determination by the division that an applicant failed to meet all requirements of paragraph (A) of this rule, the division will notify the applicant in writing of all deficiencies contained within the application.

(3) Within ten business days of receipt of written notification from the division, the applicant shall ensure that all deficiencies outlined are alleviated and submit any further documentation requested by the division.

(4) Should an applicant fail to cure all application deficiencies, the application shall be deemed abandoned.

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

Last updated August 28, 2025 at 7:33 AM

Supplemental Information

Authorized By: 3780.03, 3796.03
Amplifies: 3780.03, 3780.04, 3796.03, 3796.06
Five Year Review Date: 8/28/2030

Rule 1301:18-4-09 | Pre-Approval Requirement for Product Registration.

• Effective: August 28, 2025
• Promulgated Under: 119.03

(A) Each cultivator and processor shall not package, produce, transfer, distribute, or sell cannabis plant material or a cannabis product variation without prior written approval from the division of cannabis control.

(B) Each cannabis product variation shall be registered and designated by a unique identifying number to the product variation by the division.

(C) Prior to packaging, producing, transferring, distributing, or selling a cannabis product, each licensee shall apply in a manner prescribed by the division.

(D) Pursuant this rule, the division may:

(1) Pursuant to rule 1301:18-9-01 of the Administrative Code, conduct an inspection at the licensed premises and investigate any proposed product or associated procedure or equipment;

(2) Require testing or process verification pertaining to the new product;

(3) Approve the product registration;

(4) Deny the product registration; or

(5) Advise the licensee in writing that it failed to meet all mandates as established by the division.

(E) Upon receipt of written approval, the licensee may proceed with cultivating, manufacturing, and distributing the proposed product variation.

Last updated August 28, 2025 at 7:33 AM

Supplemental Information

Authorized By: 3780.03, 3796.03
Amplifies: 3780.03, 3780.04, 3796.06, 3796.061
Five Year Review Date: 8/28/2030

Rule 1301:18-4-12 | Transfer Manifests for Test Samples.

• Effective: October 9, 2025
• Promulgated Under: 119.03

Prior to a test sample collector transporting a test sample to a testing laboratory, the originating licensee shall prepare a transfer manifest utilizing the state inventory tracking system. Each transfer manifest shall include the following for each transfer:

(A) The names and facility addresses of the originating licensee and recipient testing laboratory;

(B) The time of departure and estimated time of arrival;

(C) Within each transfer the following information for each individual package:

(1) A description of each individual test sample that is part of the transport;

(2) The total number of individual test samples;

(3) The unique identifying number generated within the state inventory tracking system associated with the test sample;

(4) The units of measure as reported within the state inventory tracking system as follows:

(a) The net weight of the cannabis contained within the test sample; or

(b) The quantity of units contained within the test sample.

(5) The unique identifying number generated within the state inventory tracking system associated with the transfer manifest;

(6) The names of the registered employees transporting the cannabis and their respective badge certificate number as provided by rule 1301:18-3-09 of the Administrative Code;

(7) The license plate number and vehicle type that will transport the shipment; and

(8) The specific delivery route, which includes street names and distances.

(D) Prior to the delivery, each licensee is to provide a copy of the transfer manifest to the test sample collector and the division of cannabis control, via the state inventory tracking system.

Last updated October 9, 2025 at 8:11 AM

Supplemental Information

Authorized By: 3780.03, 3796.03
Amplifies: 3780.20, 3796.032, 3796.07
Five Year Review Date: 10/9/2030

Rule 1301:18-4-18 | Research by Testing Laboratory Licensed by Chapter 4729:5-16 of the Administrative Code.

• Effective: October 9, 2025
• Promulgated Under: 119.03

(A) Prior to any sale, transfer, or distribution of cannabis pursuant to this rule, a cultivator or processor may request in a manner prescribed by the division of cannabis control to sell cannabis to a laboratory licensed under Chapter 4729:5-16 of the Administrative Code, to possess dangerous drugs and controlled substances solely for scientific, clinical, research, or development purposes.

(B) Upon receipt of a request the division may:

(1) Approve the request;

(2) Approve the request, subject to certain mandates or limitations;

(3) Advise the licensee in writing that further information is needed;

(4) Deny the request.

(C) Upon receipt of written approval by the division, a licensee may proceed and sell cannabis pursuant to this rule.

(D) A licensee seeking to sell cannabis pursuant to this rule is to apply to the division for each sale of cannabis.

(E) Any and all associated cannabis tested pursuant to this rule must be solely intended for scientific or clinical research or development.

A licensee shall not utilize this rule to:

(1) Submit any test sample to a testing laboratory prior to any state-required testing.

(2) In place or a substitution of, any state-required testing as outlined under division 1301:18 of the Administrative Code.

(3) Attempt to circumvent any standards or mandates established by the division pertaining to state-required testing, including any procedures, requirements, directives.

(F) Unless and until a licensee receives written approval from the division, a licensee shall not transfer, sell, or distribute cannabis pursuant to this rule.

(G) Pursuant to rule 1301:18-3-14 of the Administrative Code, any cannabis transferred, sold, or distributed pursuant to this rule must be recorded in the state inventory tracking system.

Last updated October 9, 2025 at 8:11 AM

Supplemental Information

Authorized By: 3780.03, 3796.03
Amplifies: 3780.11, 3780.16
Five Year Review Date: 10/9/2030