545-X-4-.05 Acupuncture Rules and Regulations.

(1) Acupuncture is deemed by the Medical Licensure Commission to be an experimental procedure of which the safety and medical effectiveness has not been established. The Commission therefore determines that while acupuncture practice by licensed physicians should not be absolutely prohibited, some safeguards are necessary to insure that the public is not harmed or victimized by unprofessional practices, such as the unskilled or uninformed application of acupuncture treatment, or unfounded claims of effectiveness.

(2) The Commission therefore determines that it shall be deemed unprofessional conduct, and grounds for action against the license of any physician pursuant to 34-24-360(a), Ala. Code (1975) for a physician to offer or administer acupuncture treatment except in compliance with the requirements set forth by the Federal Food and Drug Administration in Federal Register Vol. 88, No. 46, p 6419 (March 9, 1973). In administering this requirement, the Commission establishes the following criteria, which must be adhered to by physicians licensed by the Commission:

(a) All acupuncture devices in this State must be labeled properly according to applicable Federal Food and Drug requirements,

(b) A physician must secure a patient's informed consent according to the guidelines established at 21 Code of Federal Regulations Section 130.37, and no claims of therapeutic or diagnostic effectiveness may be made by a physician.

(3) The Commission hereby announces its intention to require that physicians wishing to investigate and experiment with the use of acupuncture treatment must comply fully with the above state requirements of this Commission and with the requirement of the Federal Food and Drug Administration cited herein.

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