Ala. Admin. Code r. 540-X-5-.03

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

Section 540-X-5-.03 - Revocation Or Suspension Of An Alabama Controlled Substances Certificate Registration - Grounds And Procedures Generally

(1) A registration under specified laws to manufacture, distribute, or dispense a controlled substance may be suspended or revoked by the Board upon a finding that the registrant:

(a) Has furnished false or fraudulent material information in any application filed under this article;

(b) Has been convicted of a crime under any state or federal law relating to any controlled substance;

(c) Has had his federal registration suspended or revoked to manufacture, distribute or dispense controlled substances;

(d) Has violated the provisions of Chapter 23 of Title 34 of the Code of Alabama; or

(e) Has, in the opinion of the Board, excessively dispensed controlled substances for any of his patients.

1. A registrant may be considered to have excessively dispensed controlled substances if the Board finds that either the controlled substances were dispensed for no legitimate medical purpose, or that the amount of controlled substances dispensed by the registrant is not reasonably related to the proper medical management of the patient's illness or conditions. Drug addiction shall not be considered an illness or condition which would justify continued dispensing of controlled substances, except in gradually decreasing dosages administered to the patient for the purpose of curing the addiction.

2. A registrant who is a physician licensed to practice medicine in the State of Alabama may be considered to have excessively dispensed controlled substances if he or she prescribes, orders, dispenses, administers, supplies or otherwise distributes any Schedule II amphetamine and/or Schedule II amphetamine-like anorectic drug, and/or 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, which drugs or compounds are classified under Schedule II of the Alabama Uniform Controlled Substances Act, Code of Ala. 1975, § 20-2-24, to any person except for the therapeutic treatment of:

(i) Narcolepsy;

(ii) Hyperkinesis;

(iii) Brain dysfunction of sufficiently specific diagnosis (such as Attention Deficit Disorder or Attention Deficit and Hyperactivity Disorder), or etiology which clearly indicates the need for these substances in treatment or control;

(iv) Epilepsy;

(v) Differential psychiatric evaluation of clinically significant depression; provided, however, that such treatment shall not extend beyond a period of thirty (30) days unless the patient is referred to a licensed practitioner specializing in the treatment of depression;

(vi) Clinically significant depression shown to be refractory to other therapeutic modalities; provided, however, that such treatment shall not extend beyond a period of thirty (30) days unless the patient is referred to a licensed practitioner specializing in the treatment of depression; or for the clinical investigation of the effects of such drugs or compounds, in which case an investigative protocol must be submitted to and reviewed and approved by the State Board of Medical Examiners before the investigation has begun. A physician prescribing, ordering or otherwise distributing the controlled substances listed above in the manner permitted by this subsection shall maintain a complete record which must include documentation of the diagnosis and reason for prescribing; the name, dose, strength and quantity of the drug and the date prescribed or distributed. The records required under this subsection shall be made available for inspection by the certifying board or its authorized representative upon request. Those Schedule II stimulant drugs enumerated above shall not be dispensed or prescribed for the treatment or control of exogenous obesity;

(f) Has violated any duly adopted rule or regulation of the Board of Medical Examiners pertaining to the possession, maintenance, dispensing, prescribing or distribution of any controlled substance;

(g) Has dispensed, prescribed or distributed controlled substances not authorized by his registration certificate.

(h) Has failed to maintain a registration with the U.S. Drug Enforcement Administration, has voluntarily surrendered a DEA registration or had a registration revoked.

(2) The Board may limit revocation or suspension of a registration to the particular controlled substance with respect to which grounds for revocation or suspension exist.

(3) In addition to the penalty of suspension or revocation the Board may assess an administrative fine not to exceed ten thousand dollars ($10,000.00) for each violation of any of the offenses stated in Rule 540-X-5-.03(1).

(4) All administrative 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 an appeal is instituted pursuant to Code of Ala. 1975, § 20-2-53, pertaining to appeals from decisions of the Board of Medical Examiners as a certifying board under the Alabama Uniform Controlled Substances Act, in which event the fine is due and payable to the Board thirty (30) days after the final disposition of the appeal. When a fine has been assessed and is not subject to appeal, the name of the physician against whom the fine was assessed 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.

(5) 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.

(6) Administrative Costs:

(a) If the Board finds that a registrant is guilty of any offense stated in Rule 540-X-5-.03(1), the Board may order that administrative costs be assessed against and paid by the registrant.

(b) Administrative costs are the actual costs, fees and expenses incurred by the Board in connection with any Board proceeding resulting in a finding that the registrant has violated any provision of Rule 540-X-5-.03(1) and include the following:

1. Costs of independent medical review and expert testimony.

2. Reasonable and necessary attorney fees and expenses.

3. Travel expenses for Board staff.

4. Costs and expenses for documentary evidence.

5. Deposition costs, court reporter fees and costs, and transcript costs.

6. Witness fees and expenses.

7. Fees and costs for necessary interpreter services.

8. Fees and expenses for necessary consultants.

(c) Claims for administrative costs shall be submitted for review by the Board pursuant to a verified bill of costs on a form approved by the Board. The bill of costs shall be filed with the Board Secretary within fourteen (14) days from the date of any order assessing costs against the registrant. Any ruling on administrative costs shall be made by the Board at the scheduled monthly meeting following submission of the bill of costs.

(d) Payment of the administrative costs ordered by the Board shall be made and enforced in the same manner as an administrative fine as stated in Rule 540-X-5-.03(4).

(7) If the Board suspends or revokes a registration, all controlled substances owned or possessed by the registrant at the time of suspension or the effective date of the revocation order may be placed under seal. No disposition may be made of substances under seal until the time for taking an appeal has elapsed or until all appeals have been concluded unless a court, upon application therefor, orders the sale of perishable substances and the deposit of the proceeds of the sale with the court. Upon a revocation order becoming final, all controlled substances may be forfeited to the state.

(8) The Board shall promptly notify the Drug Enforcement Administration of all orders suspending or revoking registration and all forfeitures of controlled substances.

(9) For the purpose of the treatment of clinically significant depression as outlined in Rule 540-X-5-.03(1)(e)2.(v) and clinically significant depression shown to be refractory to other therapeutic modalities as outlined in Rule 540-X-5-.03(1)(e)2.(vi) above when a diagnosis of clinically significant depression has been confirmed by a licensed practitioner specializing in the treatment of depression (as that term is defined in these rules) and the practitioner has recommended the use of or continuation of a Schedule II amphetamine, amphetamine-like anorectic drug, sympathomimetic amine drug, or other Schedule II stimulant drug for the therapeutic treatment of the depression, then such drug or drugs may be prescribed by the patient's regular or attending physician for such period of time as is required to remediate the condition being treated.

Ala. Admin. Code r. 540-X-5-.03

Filed November 9, 1982 as Rule No. 540X3. 03. Readopted: Filed February 8, 1983. Amended: Filed March 23, 1984. Rules reorganizedrule number changed to 540X5. 03 (see conversion table at end of code): Filed June 14, 1984 (without publication in AAM). Amended: Filed May 16, 1985; August 22, 1986. Amended: Filed August 22, 2002; effective September 26, 2002. Amended: Filed November 13, 2007; effective December 18, 2007.

Amended by Alabama Administrative Monthly Volume XXXVI, Issue No. 07, April 30, 2018, eff. 5/6/2018.

Amended by Alabama Administrative Monthly Volume XL, Issue No. 03, December 30, 2021, eff. 2/13/2022.

Author: Alabama Board of Medical Examiners

Statutory Authority:Code of Ala. 1975, §§ 20-2-54, 20-2-71, Act No. 86-451 (Reg. Session 1986); Act No. 07-402.