[Federal Register Volume 61, Number 218 (Friday, November 8, 1996)]
[Notices]
[Pages 57893-57896]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-28765]
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DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. 95-17]
Stanley Alan Azen, M.D.; Grant of Restricted Registration
On January 9, 1995, the Deputy Assistant Administrator, Office of
Diversion Control, Drug Enforcement Administration (DEA), issued an
Order to Show Cause to Stanley Alan Azen, M.D. (Respondent) of Sun
Valley, California, notifying him of an opportunity to show cause as to
why DEA should not deny his application for registration as a
practitioner under 21 U.S.C. 823(f), for reason that such registration
would be inconsistent with the public interest.
By letter dated January 31, 1995, the Respondent, through counsel,
timely filed a request for a hearing, and following prehearing
procedures, a hearing was held in Long Beach, California on November
30, 1995, before Administrative Law Judge Paul A. Tenney. At the
hearing, both parties called witnesses to testify and introduced
documentary evidence. After the hearing, both sides submitted proposed
findings of fact, conclusions of law and argument. On February 22,
1996, Judge Tenney issued his Findings of Fact, Conclusions of Law and
Recommended Ruling, recommending that the Respondent's application for
a DEA Certificate of Registration should be granted subject to his
compliance with the terms of his probation with the Medical Board of
California. On March 13, 1996, Government counsel filed exceptions to
the Recommended Ruling of the Administrative Law Judge, and on March
27, 1996, Judge Tenney transmitted the record of these proceedings to
the Deputy Administrator. Subsequently, on March 29, 1996, Respondent
filed exceptions to Judge Tenney's Recommended Ruling. However,
Respondent's exceptions have not been considered by the Acting Deputy
Administrator, since they were not filed within the time period
specified in 21 CFR 1316.66, and Respondent did not request an
extension of time within which to file his exceptions.
The Acting Deputy Administrator has considered the record in its
entirety, excluding Respondent's exceptions, and pursuant to 21 CFR
1316.67, hereby issues his final order based upon findings of fact and
conclusions of law as hereinafter set forth. The Acting Deputy
Administrator adopts the findings of fact, conclusions of law, and
recommended ruling of Judge Tenney, except as noted below.
The Acting Deputy Administrator finds that Respondent previously
possessed DEA Certificate of Registration, AA8786329. On May 19, 1992,
an Order to Show Cause was issued proposing to revoke that Certificate
of Registration, alleging that Respondent had been convicted of a
controlled substance related felony offense and that his continued
registration would be inconsistent with the public interest. Following
a hearing before Administrative Law Judge Mary Ellen Bittner, the then-
Acting Administrator revoked Respondent's DEA registration effective
March 3, 1994. See, Stanley Alan Azen, M.D., 59 FR 10,168 (1994).
In the prior proceeding, the then-Acting Administrator found that
Respondent received his medical degree in 1978. Following an internship
and two residencies in emergency medicine and internal medicine,
Respondent worked since 1981, as an emergency room physician.
Respondent admitted that he first experimented with marijuana and
cocaine in the 1970's and became a regular cocaine user during the
1980's. He further admitted that he would share cocaine with his
friends, and on September 20, 1990, his girlfriend died of a cocaine
overdose. During the course of the investigation into his girlfriend's
death, allegations were made that Respondent sold cocaine; a
cooperating individual attempted to purchase cocaine from Respondent;
and a search warrant executed at Respondent's residence revealed 2
ounces of cocaine, 19 grams of marijuana, and drug paraphernalia.
Respondent was arrested and on April 16, 1991, in the Municipal Court
of Los Angeles, California, a four-count felony complaint was filed
against Respondent charging him with the sale and possession of a
controlled substance. On November 15, 1991, the Respondent pled nolo
contendere to one felony count of simple possession of a controlled
substance. In the prior proceeding, Respondent testified that as a
result of his arrest he terminated his drug habits and sought treatment
for his drug abuse.
In his March 3, 1994 final order, the then-Acting Administrator
adopted Judge Bittner's finding that the Government had not proved by a
preponderance of the evidence that Respondent sold cocaine to the
cooperating individual. However, in revoking Respondent's prior DEA
Certificate of Registration, the then-Acting Administrator found that
Respondent had a long history of drug abuse and had not demonstrated a
life-long commitment to drug rehabilitation.
On April 15, 1994, Respondent submitted an application for a new
DEA registration in Schedules IV and V. That application is the subject
of these proceedings. The Acting Deputy Administrator concludes that
the then-Acting Administrator's March 3, 1994 decision regarding
Respondent is res judicata for purposes of this proceeding. See,
Liberty Discount Drugs, Inc., 57 FR 2788 (1992) (where the findings in
a previous revocation proceeding were held to be res judicata in a
subsequent administrative proceeding.) The then-Acting Administrator's
determination of the facts relating to the previous revocation of the
Respondent's DEA registration is conclusive. Accordingly, the Acting
Deputy Administrator adopts the March 3, 1994 final order in its
entirety. The Acting Deputy Administrator concludes that the critical
issue in this proceeding is whether the circumstances, which existed at
the time of the prior
[[Page 57894]]
proceeding, have changed sufficiently to support a conclusion that
Respondent's registration would be in the public interest.
According to Respondent, he has not abused drugs since April 1991,
when he was admitted to the out-patient program at the Betty Ford
Center for treatment of chemical dependency due to cocaine and
marijuana abuse. This program required participation in alcohol or
cocaine anonymous programs, and random urinalysis. Early in the
program, Respondent had two positive drug screens for marijuana and one
for cocaine. These results appear to have been from residual amounts of
the drugs in his system. From his criminal conviction in November 1991
until his successful completion of probation in November 1994,
Respondent has been subjected to approximately 30 random drug screens.
All tests have been negative. Since October 1993, Respondent has met
approximately once a week with a clinical psychologist, in an effort to
cope with the various stresses in his life resulting from the death of
his girlfriend, and the loss of professional status and employment
opportunities. Respondent testified that he sought this treatment on
his own volition and plans to continue the sessions. Respondent
continues to be involved with Cocaine Anonymous and Narcotics
Anonymous.
Judge Tenney found that in August 1994, the Medical Board of
California (Board) revoked Respondent's medical license, stayed the
revocation, and placed Respondent on probation for six years subject
to, among other things, the following terms and conditions:
(1) Respondent is not to prescribe, administer, dispense, order, or
possess any controlled substances as defined by the California Uniform
Controlled Substances Act, except for the drugs in Schedules IV and V.
However, Respondent is permitted to prescribe, administer, dispense, or
order the drugs listed in Schedules II and III for inpatients in
hospital settings, but not otherwise.
(2) Respondent is to abstain completely from personal use or
possession of controlled substances and dangerous drugs.
(3) Respondent is to maintain a record of all controlled substances
prescribed, dispensed, or administered showing the following
information: (a) the name and address of the patient, (b) the date, and
(c) the character and quantity of the controlled substance furnished.
Respondent shall make these records available for inspection by the
Board or its designee.
(4) Respondent is to abstain completely from the use of alcoholic
beverages.
(5) Respondent shall submit to biological fluid testing upon the
request of the Board.
As support for this finding, Judge Tenney relied upon a document
admitted into evidence entitled ``Proposed Decision'' signed by a state
administrative law judge. However, Respondent testified at the hearing
in this matter, and asserted in his post-hearing filing, that there are
no restrictions on his ability to prescribe any drug. Nonetheless, the
Acting Deputy Administrator adopts the finding of Judge Tenney, since
Respondent did not file exceptions regarding Judge Tenney's
characterization of the current status of Respondent's medical license
or his recommendation to grant Respondent's application subject to
continued compliance with the Board's terms and conditions.
As of the date of the hearing before Judge Tenney, Respondent had
been in compliance with the Board's terms of probation for 13 months.
In addition, all of Respondent's drug screens requested by the Board
have tested negative.
Beginning in 1991, Respondent worked as an emergency services
doctor at Pacifica Hospital. Under the hospital's bylaws, physicians
are required to possess a valid DEA Certificate of Registration as a
condition of employment. On or about March 11, 1994, Respondent's
attorney received a letter from DEA notifying him that Respondent's
previous DEA Certificate of Registration was revoked ``effective
immediately''. A few days after the revocation, Respondent, through
counsel, filed an appeal of the revocation order, as well as a request
for a stay of the final order pending resolution of the appeal, in the
United States Court of Appeals for the Ninth Circuit.\1\
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\1\ There is no evidence in the record regarding the outcome of
Respondent's appeal of the March 3, 1994 revocation of his DEA
Certificate of Registration filed in the United States Circuit Court
of Appeals for the Ninth Circuit.
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In late April 1994, DEA received information from a local newspaper
reporter that Respondent was still employed at Pacifica Hospital in
spite of the revocation of his DEA registration. A DEA investigator
went to Pacifica Hospital on May 13, 1994, and confirmed that
Respondent was in fact employed there. While at the hospital, the
investigator first spoke to the Executive Director of the hospital, who
was unaware that Respondent's DEA registration was revoked effective
March 3, 1994. The investigator then called Respondent's direct
supervisor who stated that he thought Respondent's revocation was on
appeal and therefore his DEA registration was still valid. While still
at the hospital, the DEA investigator received a telephone call from
DEA's Office of Chief Counsel advising him that Respondent could use
his DEA registration while the revocation was on appeal. This
information was relayed to the Executive Director and Respondent's
supervisor. Soon thereafter, the DEA investigator received another
telephone call from DEA's Office of Chief Counsel informing him that
Respondent's DEA registration was in fact revoked effective March 3,
1994, and any use thereafter was invalid. The investigator relayed this
information to the Executive Director and left a voice mail message for
Respondent's supervisor. About a day and a half later, after speaking
to the DEA in Washington, the hospital informed Respondent that his
number was not valid pending the outcome of the appeal.
Respondent testified that until on or about May 17, 1994, he was
under the impression that his DEA registration was valid. He believed
that even though his DEA registration appeared to be expired, it was
still valid since a renewal application had been timely filed and not
finally acted upon by DEA. It was his understanding that the
registration was valid until there was a decision as to whether or not
the stay of revocation would be granted by the Court of Appeals.
Because of this belief, Respondent did not notify the hospital of the
March 3, 1994 revocation. Respondent's supervisor testified that he
believed that Respondent was very forthcoming regarding his
registration status to the best of his understanding. Respondent sent
the Credentials Committee of the hospital a letter indicating that his
DEA registration had been revoked, but that it was his understanding
that he could still use it pending the outcome of the appeal of the
revocation.
It is uncontested that Respondent issued controlled substance
prescriptions following the revocation of his previous DEA Certificate
of Registration until approximately May 17, 1994, when he was informed
that his registration was not valid. There is no evidence that
Respondent was trying to hide the fact that he was issuing controlled
substance prescriptions during this time period. Respondent has not
handled controlled substances since approximately May 17, 1994.
Respondent resigned from Pacifica Hospital after learning that he was
no
[[Page 57895]]
longer authorized to handle controlled substances.
On August 7, 1995, the Superior Court of the State of California
for the County of Los Angeles, set aside and vacated Respondent's
conviction for possession of a controlled substance, in light of his
fulfillment of the conditions of probation. The order further stated
that, ``[Respondent] is required to disclose the above conviction in
response to any direct question contained in any questionnaire or
application for public office or for licensure by any state or local
agency.''
Pursuant to 21 U.S.C. 823(f), the Deputy Administrator may deny an
application for a DEA Certificate of Registration if he determines that
such registration would be inconsistent with the public interest. In
determining the public interest, the following factors are considered:
(1) The recommendation of the appropriate State licensing board or
professional disciplinary authority.
(2) The applicant's experience in dispensing, or conducting
research with respect to controlled substances.
(3) The applicant's conviction record under Federal or State laws
relating to the manufacture, distribution, or dispensing of controlled
substances.
(4) Compliance with applicable State, Federal, or local laws
relating to controlled substances.
(5) Such other conduct which may threaten the public health and
safety.
These factors are to be considered in the disjunctive; the Deputy
Administrator may rely on any one or a combination of factors and may
give each factor the weight he deems appropriate in determining whether
a registration should be revoked or an application for registration be
denied. See Henry J. Schwarz, Jr., M.D., Docket No. 88-42, 54 FR 16,422
(1989).
The Acting Deputy Administrator concludes that all five factors are
relevant in determining whether Respondent's registration would be
inconsistent with the public interest. As to factor one, in August
1994, the Medical Board of California (Board) placed Respondent's
medical license on probation subject to strict terms and conditions for
six years. During the probationary period with the Board, Respondent
may prescribe, administer, dispense, order, or possess controlled
substances in Schedule IV and V, and may only prescribe, dispense,
administer or order Schedule II and III controlled substances to
inpatients in hospital settings. He must abstain from the use of
alcohol and controlled substances, unless prescribed for a bona fide
illness by another practitioner. He must maintain a log of his
controlled substance handling and must participate in continuing
medical education.
As to factor two, Respondent's experience in dispensing controlled
substances, it is not disputed that Respondent prescribed controlled
substances without a valid DEA registration from on or about March 3
through May 17, 1994. However, Respondent presented credible evidence
that he was under the impression that he could use his DEA Certificate
of Registration pending the outcome of his appeal of the revocation of
his previous DEA registration. There is no evidence in the record that
he attempted to hide his use of his DEA registration during that time
period. There is also no evidence in the record that Respondent
prescribed controlled substances for no legitimate medical purpose. In
fact, as Judge Tenney noted, Respondent's former supervisor testified
at the earlier proceeding that Respondent's abilities as a doctor were
excellent, and that Respondent was one of the best emergency room
physicians he has known. At the hearing before Judge Tenney,
Respondent's supervisor at Pacifica Hospital testified that he was
impressed with Respondent's academic abilities and that Respondent was
an invaluable member of his emergency services group.
Unlike Judge Tenney, the Acting Deputy Administrator finds that
factor three is relevant in determining the public interest in this
matter. Respondent pled nolo contendere to one state felony count for
possession of a controlled substance. Judge Tenney found that this
conviction was set aside and vacated on July 18, 1995, pursuant to
California Penal Code Sec. 1203.4, and therefore did not consider the
conviction under factor three. The Acting Deputy Administrator
concludes however, that Respondent's April 1991 conviction is still a
conviction for purposes of determining the public interest. The Acting
Deputy Administrator relies upon an earlier case where the then-
Administrator of DEA held that a felony conviction dismissed under
Sec. 1203.4 is a conviction for purposes of 21 U.S.C. 824. The then-
Administrator found:
that the California court's action under California statute does not
``erase'' the conviction for purposes of 21 U.S.C. 824. This finding
is based upon decisions of federal courts interpreting the
relationship of California Penal Code section 1203.4 to actions by
federal agencies predicated upon dismissed felony convictions, the
language of the Penal Code Section itself, and agency precedent
affording the term ``conviction'' with the broadest possible
meaning. Donald Patsy Rocco, D.D.S., 50 FR 34,210 (1985).
Regarding factor four, the Government contends that Respondent
violated 21 U.S.C. 822(a)(1) and 841(a)(1) and 21 CFR 1306.03(a) by
prescribing controlled substances without a valid DEA registration.
Respondent admits to writing controlled substance prescriptions after
the effective date of the revocation of his DEA registration. In his
opinion, the Administrative Law Judge cited several cases for the
proposition that, ``a physician is exempt from the provisions of the
Controlled Substance [sic] Act if dispensing or prescribing controlled
substances in good faith to patients in the regular course of
professional practice.'' See U.S. v. Carroll, 518 F.2d 187 (1975), U.S.
v. DeBoer, 966 F.2d 1066 (1992). These cases dealt with the assessment
of criminal liability. The Acting Deputy Administrator agrees that if
acting in good faith, a physician would be exempt from criminal
liability, because there would be no intent to violate the law. But,
this is an administrative proceeding, seeking to protect the public
interest, not to assess liability. A physician must possess a valid DEA
registration in order to legally prescribe controlled substances.
Respondent was not exempt from this requirement when he issued
prescriptions using his revoked DEA registration. However, if
Respondent issued these prescriptions under the good faith belief that
his DEA registration was valid, that certainly is a mitigating factor
in determining the public interest.
The evidence clearly shows that Respondent possessed such a good
faith belief when he issued controlled substance prescriptions between
March 3 and May 17, 1994. Respondent believed that his DEA registration
remained valid pending the outcome of the request for a stay and appeal
of his earlier revocation. In an attempt to clarify his registration
status, Respondent misinterpreted the Federal regulations. He thought
that since his renewal application had not been acted upon by the DEA,
his expired DEA registration continued pending the outcome of the
appeal in the Ninth Circuit. He did not attempt to conceal this belief,
and in fact wrote a letter to the Credentials Committee at Pacifica
Hospital stating this position. The Acting Deputy Administrator does
not find this to be an unreasonable explanation, especially in light of
the fact that it appears that DEA was confused as to the status of
Respondent's registration pending the outcome of the appeal. The DEA
[[Page 57896]]
investigator who testified at the hearing stated that, ``there was some
ambiguity.'' Therefore, the Acting Deputy Administrator does not find
Respondent's prescribing of controlled substances with his revoked DEA
registration to be of significant concern in assessing the public
interest. Particularly since Respondent immediately ceased writing
controlled substance prescriptions upon being advised that his DEA
registration was not valid.
As to factor five, the Acting Deputy Administrator is quite
concerned with Respondent's long history of substance abuse. Respondent
admitted to using cocaine and marijuana for 20 years. In the prior
administrative proceeding, the then-Acting Administrator adopted the
Administrative Law Judge's finding that ``there was insufficient
evidence to conclude that Respondent has recognized and dealt with the
severity of his problem, or that he has progressed in his recovery to
the extent that he should be permitted to continue to hold a DEA
registration.'' At the time of the hearing in this matter before Judge
Tenney, Respondent had been in rehabilitation for five years. He has
been randomly drug tested since 1991 and has not tested positive. He
continues to participate in Cocaine Anonymous and Narcotics Anonymous
and regularly receives psychological counseling. He has successfully
completed his criminal probation, and in August 1994, his medical
license was placed on probation for six years by the Medical Board of
California. As part of this probation, Respondent is subject to random
drug testing and his controlled substance handling is restricted.
Respondent testified at the hearing before Judge Tenney that, ``I'm
extremely remorseful. But I cannot change what happened.''
The Administrative Law Judge concluded that Respondent's
registration would not be inconsistent with the public interest. But
given his background of drug abuse, Judge Tenney recommended that
Respondent's application be granted subject to his compliance with all
of the terms of his probation with the Board.
The Government filed exceptions to the Administrative Law Judge's
recommendation. First, the Government took exception to Judge Tenney's
conclusion that Respondent was ``exempt'' from the provisions of the
Controlled Substances Act due to his good faith prescribing of
controlled substances when he was without a valid DEA registration. The
Acting Deputy Administrator is confused by this exception, since the
Government raised this same proposition in its post-hearing filing, but
argued that Respondent had not acted in good faith. However, the
evidence is clear that Respondent did in fact act in good faith,
believing that he had a valid DEA registration. As discussed above, the
Acting Deputy Administrator considers Respondent's good faith
assumption that he was properly registered when he issued controlled
substances prescriptions between March 3 and May 17, 1994, to be a
mitigating factor when considering his compliance with Federal laws.
The Government also took exception to Judge Tenney's recommendation
that Respondent's registration be conditioned upon compliance with the
probationary terms imposed by the Board. The Government argued that
such a disposition would be difficult to enforce since DEA would be
unaware if, or when, the probationary terms were violated or removed.
Therefore, the Government urged that ``should Respondent be granted any
DEA registration, that it be restricted to terms and conditions
established by DEA, and independent of any probationary terms currently
imposed by the California Medical Board.'' The Acting Deputy
Administrator finds that Respondent's efforts at rehabilitation are
commendable and the controls imposed by the Board are sufficient to
monitor Respondent's handling of controlled substances. Consequently,
the Acting Deputy Administrator finds that it is in the public interest
at this time to issue Respondent a DEA registration conditioned upon
his continued compliance with the terms imposed upon his California
medical license. The Acting Deputy Administrator further concludes,
however, that should the Board terminate Respondent's probation before
August 5, 2000, Respondent's DEA registration will continue to be
subject to the same terms as set forth in the Board's August 5, 1994
decision.
The Acting Deputy Administrator finds that Respondent only applied
for a DEA Certificate of Registration in Schedules IV and V. The
Board's probationary terms restrict Respondent's handling of Schedules
II and III controlled substances to inpatients in hospital settings.
However, since Respondent has not applied for Schedules II and III
privileges with DEA and no request to modify his application was made
at the hearing in this matter, the Acting Deputy Administrator can only
issue Respondent a DEA Certificate of Registration in Schedules IV and
V at this time. Nonetheless, the Acting Deputy Administrator finds that
should Respondent apply for Schedules II and III in the future, the
application should be granted and Respondent's Schedules II and III
handling should be restricted to inpatients in hospital settings, to
include emergency room patients, and be conditioned upon compliance
with the Board's terms and conditions.
Accordingly, the Acting Deputy Administrator of the Drug
Enforcement Administration, pursuant to the authority vested in him by
21 U.S.C. 823 and 28 CFR 0.100(b) and 0.104, hereby orders that the
application, submitted by Stanley Alan Azen, M.D., for a DEA
Certificate of Registration in Schedules IV and V be granted subject to
continued compliance with the terms imposed upon his California medical
license. It is further ordered, that should Dr. Azen's probation be
terminated early by the Medical Board of California, his DEA
Certificate of Registration will continue, until August 5, 2000, to be
subject to the same terms imposed by the August 5, 1994 decision of the
Medical Board of California. This order is effective December 9, 1996.
Dated: November 4, 1996.
James S. Milford, Jr.,
Acting Deputy Administrator.
[FR Doc. 96-28765 Filed 11-7-96; 8:45 am]
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