Ala. Admin. Code r. 540-X-4-.05

Current through Register Vol. 43, No. 1, October 31, 2024

Section 540-X-4-.05 - Registration of Dispensing Physicians

(1) Every dispensing physician, as defined by this rule, is hereby required to register with the State Board of Medical Examiners as a dispensing physician. Registration shall be accomplished on a form provided by the Board. After initially registering as a dispensing physician, it shall be the obligation of the registrant to advise the Board of any change in the practice location within the State of Alabama of that dispensing physician.

(2) For the purposes of this rule a "dispensing physician" shall mean any physician or osteopath licensed to practice medicine in Alabama who shall dispense or distribute to a patient for the patient's use any controlled substance, except prepackaged samples and/or starter packs, where such controlled substances are purchased by the physician or osteopath for resale to a patient whether or not a separate charge is made for the controlled substance.

(3) Prepackaged samples and starter packs shall mean those controlled substances which are packaged and labeled by the manufacturer in individual or small dosage units and which are intended to be distributed to patients for consumption or administration within a limited period of time.

(4) Controlled substances which are consumed by or which are administered to patients while being treated in the physician's office, clinic, hospital or other facility are not considered to be dispensed for the purposes of this rule.

(5) This registration requirement shall be applicable to all physicians or osteopaths who dispense or cause to be dispensed controlled substances for consumption or administration by patients off the premises of the clinic, hospital or other facility where the physician or osteopath practices, without respect to whether such controlled substances are purchased by an individual physician or osteopath, a professional association or professional corporation, a for-profit or not-for-profit corporation, a hospital, clinic or other medical facility.

(6) This registration requirement shall not apply to the dispensing of controlled substances to patients treated in any hospital emergency room provided that;

(a) The patient has registered for treatment in the hospital emergency room and was treated by the emergency room physician on duty; and

(b) The controlled substances dispensed are subject to inventory, accounting and security controls and policies of the hospital pharmacy or the emergency room department.

(7) A controlled substance is any drug or substance listed in Schedules II through V of the Alabama Uniform Controlled Substance Act, Code of Ala. 1975, §§ 20-2-1, et seq.

(8) The form for registration of dispensing physicians shall elicit the following information:

(a) Physician name and license number;

(b) Primary practice/dispensing location;

(c) Any and all additional practice/dispensing locations;

(d) Primary practice/dispensing location DEA number and expiration date.

(9) Any physician who acts as a "dispensing physician," as defined in this rule, and who has not registered with the Board as required by this rule may be assessed by the Board an administrative fine not to exceed Ten Thousand Dollars ($10,000.00), in addition to any other penalty authorized pursuant to Code of Ala. 1975, § 20-2-54.

(10) Every dispensing physician registered with the Board shall report controlled substances information to the Alabama Department of Public Health according to the requirements of Code of Ala. 1975, § 20-2-213 and regulations promulgated by the Alabama Department of Public Health pursuant to Code of Ala. 1975, § 20-2-210, et. seq., concerning the controlled substances prescription database.

(11) A dispensing physician registered with the Board may be assessed an administrative fine not to exceed Ten Thousand Dollars ($10,000.00) for each failure to report to the Alabama Department of Public Health as required by this rule.

Ala. Admin. Code r. 540-X-4-.05

Filed September 19, 1986. Amended: Filed August 19, 1999; effective September 23, 1999. Amended: Filed April 13, 2006; effective May 18, 2006.

Amended by Alabama Administrative Monthly Volume XXXVI, Issue No. 03, December 29, 2017, eff. 1/28/2018.

Amended by Alabama Administrative Monthly Volume XLI, Issue No. 03, December 30, 2022, eff. 2/13/2023.

Original Rule 540-X-4-.04 was renumbered to .05 as per certification filed November 14, 2013; effective December 19, 2013.

Author: Alabama Board of Medical Examiners

Statutory Authority:Code of Ala. 1975, §2 0-2-50.