Current through Register Vol. 42, No. 11, August 30, 2024
(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.
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.