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

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

t 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 8/28/2030