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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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