Ala. Admin. Code r. 540-X-4-.06

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

Section 540-X-4-.06 - Controlled Substances Prescription Guidelines For Physicians

(1) All prescriptions for controlled substances shall meet the following requirements:

(a) The prescription shall be dated as of, and signed on, the day when issued;

(b) The prescription shall bear the full name and address of the patient to whom the drug is prescribed;

(c) The prescription shall bear the drug name, strength, dosage form, and quantity prescribed;

(d) The prescription shall bear directions for use of the drug;

(e) The prescription shall bear the name, address and Alabama Controlled Substances Certificate number of the physician prescribing the drug;

(2) Where an oral order is not permitted, prescriptions for controlled substances shall be written with ink or indelible pencil or typewriter and shall be manually signed by the physician issuing the prescription. For purposes of this rule, "manually signed" requires a non-electronic, handwritten signature. Oral orders are not permitted for prescriptions for Schedule II and Schedule IIN controlled substances.

(3) A prescription issued by a physician may be communicated to a pharmacist by an employee or agent of the physician.

(4) A prescription may be prepared by an employee or agent of the physician for the signature of the prescribing physician; however, the prescribing physician is ultimately responsible for insuring that the prescription meets the requirements of this regulation.

(5) When a physician prescribes a controlled substance, he or she shall not delegate the responsibility of determining the type, dosage form, frequency of application and number of refills of the drug prescribed.

(6) Every written prescription for a controlled substance issued by a physician shall contain two signature lines. Under one signature line shall be printed clearly the words "dispense as written." Under the other signature line shall be printed clearly the words "product selection permitted." The prescribing physician shall communicate instructions to the pharmacist by entering his or her non-electronic, handwritten signature on the appropriate line.

(7) It is improper for any prescription for a controlled substance to be signed by any person in the place of or on behalf of the prescribing physician.

(8) It is improper, under any circumstances, for a physician to pre-sign blank prescription pads or forms and make them available to employees or support personnel.

(9) It is improper for a physician to utilize blank prescription pads or forms upon which the signature of the physician has been mechanically or photostatically reproduced.

(10) 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 prescription guidelines provided in this rule.

(a) Upon an initial determination by the Board that any physician may have violated these rules and regulations, 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.

(b) 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.

(c) 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-.06

Filed September 19, 1986. Amended: Filed August 22, 2002; effective September 26, 2002. Amended: Filed September 19, 2002; effective October 24, 2002.

Original Rule 540-X-4-.05 was renumbered to .06 as per certification filed November 14, 2013; effective December 19, 2013.

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

Statutory Authority: Code of Ala. 1975, §§ 20-2-50; Act No. 86-451 (Reg. Session 1986); 34-24-380, 34-24-382 (as amended by Act No. 2002-140).