Ala. Admin. Code r. 540-X-4-.04

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

Section 540-X-4-.04 - Regulation Governing Maintenance Of Records And Inventories

(1) Every physician and osteopath certified to order, prescribe, possess, distribute or dispense controlled substances by the Board shall be required to maintain the inventories, logs, and records prescribed in this rule.

(2) Inventory requirement. All controlled substances classified under Schedule II, IIN, III, IIIN, IV, and V of the Alabama Uniform Controlled Substances Act which are purchased and maintained in the office of the physician must be inventoried at least every two (2) years. This inventory shall account for all controlled substances purchased, maintained and dispensed in the office of the physician. This inventory requirement shall apply to Schedule II and IIN prepackaged samples and starter packs but does not apply to Schedule III, IIIN, IV, and V prepackaged samples and starter packs.

(3) Dispensing record. Every physician and osteopath who shall dispense Schedule II, IIN, III, IIIN controlled substances shall maintain a separate dispensing record of all such substances dispensed or distributed. The dispensing record shall contain the following information:

(a) The date the controlled substance was dispensed;

(b) The name and quantity of the controlled substance dispensed;

(c) The method of administration of the controlled substance;

(d) The name of the patient to whom the controlled substance was dispensed;

(e) For all Schedule II amphetamines, amphetamine-like anorectic drugs, or sympathomimetic amine drugs dispensed in the treatment of narcolepsy, hyperkinesis, brain dysfunction, epilepsy or depression, dispensing records shall include the diagnosis and the reason for prescribing the Schedule II amphetamine.

(4) Labeling requirement. Every physician and osteopath who shall dispense any controlled substances classified under Schedules II, IIN, III, IIIN, IV and V of the Alabama Uniform Controlled Substances Act shall ensure that all such substances dispensed be labeled containing the following information:

(a) The name of the patient to whom the controlled substance was dispensed;

(b) The date that the controlled substance was dispensed;

(c) The name and quantity of the controlled substance;

(d) Instructions for taking or administering the controlled substance;

(e) The name of the physician dispensing the controlled substance. The label required by this subsection shall be written in legible handwriting or typed and shall be permanently affixed to the package or container in which the controlled substance is dispensed. This labeling requirement shall not apply to prepackaged sample or starter packs in their original packages or containers.

(5) A physician or osteopath who prescribes a Schedule II amphetamine and/or a Schedule II amphetamine-like anorectic drug and/or a Schedule II sympathomimetic amine drug or compound thereof and/or any salt, compound, isomer, derivative or preparation of the foregoing which are chemically equivalent thereto, and/or other non-narcotic Schedule II stimulant drugs, for the treatment of narcolepsy, hyperkinesis, brain dysfunction, epilepsy or depression as permitted by Code of Ala. 1975, § 20-2-54(a) (as amended by Act No. 83-890), shall maintain a complete record of the treatment of the patient which must include documentation of the diagnosis and reason for prescribing the Schedule II amphetamine, the name, dose, strength, and quantity of the controlled substance prescribed and the date that the controlled substance was prescribed. The record required by this subsection may be maintained in the patient's medical records, provided that such medical records are maintained at the office of the physician and are available for inspection by the representatives of the Board of Medical Examiners.

(6) The inventory, separate dispensing record, and Schedule II amphetamine prescribing record required by this rule shall be maintained in the office of the physician or osteopath for a period of five (5) years from the date that the inventory is completed or the controlled substances are dispensed and shall be made available for inspection by representatives of the Board of Medical Examiners.

(7) Failure to maintain and make available for inspection the inventory and dispensing records and failure to adhere to the labeling provisions required by this rule shall be considered a failure to maintain effective controls to prevent the utilization of controlled substances for other than legitimate medical purposes and may be considered by the Board of Medical Examiners in determining whether a physician holding an Alabama Uniform Controlled Substance Registration Certificate has excessively dispensed controlled substances.

(8) The Board may assess an administrative fine not to exceed ten thousand dollars ($10,000.00) for each separate violation or failure to comply with the requirement to maintain and make available for inspection the inventory and dispensing records, and for each violation or failure to comply with the labeling requirements provided in this rule.

(9) Upon an initial determination by the Board that any physician may have violated the rules and regulations of the Board governing maintenance of records and inventories for controlled substances, the attorney for the Board shall serve upon the physician, either in person or by registered mail, an administrative complaint setting forth the specific violation or failure to comply, and shall advise the physician of his right to a hearing before the Board under the provisions of the Alabama Administrative Procedure Act, Code of Ala. 1975, §§ 41-22-1, et seq. The administrative complaint will further advise the physician that he may voluntarily execute and deliver to the Board a waiver of hearing and consent to the imposition of an administrative fine in an amount previously established by the Board. If the physician executes the voluntary waiver and consent, then the Board shall be authorized to immediately assess the established administrative fine. If the physician declines to execute the voluntary waiver and consent or makes no response, then the Board shall set a hearing to be held at least thirty (30) days after the service of the administrative complaint. The hearing shall be considered a contested case and shall be conducted under the provisions of Code of Ala. 1975, § 41-22-12.

(10) All fines assessed by the Board shall be due and payable to the Board within thirty (30) days from the date the fine is levied or assessed unless a request for judicial review under Code of Ala. 1975, § 41-22-20, is filed, in which event the fine is due and payable to the Board thirty (30) days after the final disposition of the judicial review process. The name of any physician more than sixty (60) days delinquent in the payment of a fine which has been assessed by the Board which is not subject to judicial review shall be forwarded to the Medical Licensure Commission with a request that the annual certificate of registration of that physician not be renewed until the fine has been paid and satisfied in full.

(11) All administrative fines received by the Board shall be deposited to the general revenues of the Board and may be expended for the general operation of the Board and for the development, administration and presentation of programs of continuing medical education for physicians licensed to practice medicine in Alabama.

Ala. Admin. Code r. 540-X-4-.04

Filed November 9, 1982 as Rule No. 540-X-2-.26. Readopted: Filed February 8, 1983. Repealed and new rule adopted in lieu thereof: Filed March 23, 1984. Rules reorganized--rule number changed to 540-X-4-.03 (see conversion table at end of code): Filed June 14, 1984 (without publication in AAM). Amended: Filed August 22, 1986. Amended: Filed August 22, 2002; effective September 26, 2002.

Original Rule 540-X-4-.03, Regulation Governing Maintenance Of Records And Inventories, was renumbered to .04 as per certification filed November 14, 2013; effective December 19, 2013.

Authors: Wendell R. Morgan, Esq., Patricia E. Shaner, Esq., Attorneys for the Alabama Board of Medical Examiners

Statutory Authority: Code of Ala. 1975, §§ 20-2-54 (as amended by Act No. 83-890); 20-2-56; Act No. 86-451 (Reg. Session 1986); 34-24-380; 34-24-382 (as amended by Act No. 2002-140).