Rule 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 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
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