[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]
BILLING CODE 4410-09-M