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4731-11-06   Waivers for new uses.

(A) Notwithstanding the limitations imposed by paragraph (B) of rule 4731-11-02 of the Administrative Code, a physician may utilize cocaine hydrochloride as a topical anesthetic where medically appropriate for injuries that do not involve mucous membranes.

(B) Notwithstanding the limitations imposed by paragraph (A) of rule 4731-11-03 of the Administrative Code, a physician may utilize a schedule ii controlled substance stimulant where medically appropriate for the treatment of closed head injuries.

(C) A physician who wishes to utilize a controlled substance for a purpose not permitted by paragraph (B) of rule 4731-11-02 or paragraph (A) of rule 4731-11-03 of the Administrative Code may file with the board a written request for a waiver of the applicable restriction.  The written request shall describe the purpose for which the physician wishes to utilize the controlled substance and shall detail the circumstances under which that utilization would occur.  The physician shall submit with the request evidence, such as professional literature and research results, demonstrating that the utilization will comply with current standards of medical practice.  If the board finds that the requested use conforms to appropriate standards of care, contributes to the welfare of patients, and does not undermine the rule's effectiveness in controlling the diversion or misuse of controlled substances, the board may grant a waiver authorizing the utilization of the controlled substance in conformance with the request.  The board may establish conditions and restrictions governing the waiver.  The board shall publicize a waiver grant by written notice to the Ohio state medical association, the Ohio osteopathic association, and the Ohio podiatric medical association, and by notice one time in any newsletter it may publish.

(D) The board may revoke, limit or restrict a waiver previously granted if it finds that the use for which the waiver was granted does not conform to appropriate standards of care, or that it serves to undermine the waived rule's effectiveness in controlling the diversion or misuse of controlled substances.

(E) If the board proposes to deny a waiver requested under this rule, or to revoke, limit or restrict a waiver previously granted, the physician or physicians who made the request shall be entitled to an adjudicatory hearing under Chapter 119. of the Revised Code with respect to the proposed action.  Any final order granting, denying, or revoking a waiver shall be by vote of the board.

(F) A physician who wishes to utilize a controlled substance for a purpose which has been approved by grant of a waiver under this rule shall notify the board in writing of the physician’s desire to so utilize the controlled substance.  Upon receipt from the board of a copy of the waiver grant, the physician shall be authorized to utilize the controlled substance in conformance therewith.

(G) If the board determines that substantial numbers of  physicians desire to utilize a controlled substance for a purpose for which a waiver has been requested or granted under this rule, the board may initiate rulemaking proceedings in accordance with Chapter 119. of the Revised Code to authorize such use by physicians generally.

Effective:    9/1/00

 

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