Ohio Admin. Code 3796:8-2-02 - Establishment of additional forms or methods of administration

(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 being considered included in the petition.

(F) At least five members of the board, which constitutes a quorum, The board shall consider, and approve or deny, each proposed petition for a new form or method of administration. A majority of the board members present at the hearing where each proposed form or method was publicly considered shall concur in the decision to approve or deny the addition of the proposed form or method at a public meeting.

(G) If after consideration the board concludes that the form or method of administration should be added to the list of approved forms and methods 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, expanding the list accordingly.

Notes

Ohio Admin. Code 3796:8-2-02

Effective: 9/5/2022
Five Year Review (FYR) Dates: 2/3/2022 and 09/05/2027
Promulgated Under: 119.03
Statutory Authority: 3796.04
Rule Amplifies: 3796.04, 3796.06, 3796.061
Prior Effective Dates: 09/08/2017