[Federal Register Volume 62, Number 159 (Monday, August 18, 1997)]
[Notices]
[Pages 44018-44021]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-21834]
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DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. 96-9]
Oscar I. Ordonez, M.D.; Conditional Grant of Registration
On November 8, 1995, the Deputy Assistant Administrator, Office of
Diversion Control, Drug Enforcement Administration (DEA), issued an
Order to Show Cause to Oscar I. Ordonez, M.D., (Respondent) of
Winchester, Indiana, notifying him of an opportunity to show cause as
to why DEA should not deny pending applications for registration as a
practitioner pursuant to 21 U.S.C. 823(f), for reason that his
registration would be inconsistent with the public interest. By letter
dated November 28, 1995, Respondent, through counsel, timely filed a
request for a hearing, and following prehearing procedures, a hearing
was held in Indianapolis, Indiana on June 19, 1996, before
Administrative Law Judge Mary Ellen Bittner. At the hearing, both
parties called witnesses to testify and introduced documentary
evidence. After the hearing, both parties submitted proposed findings
of fact, conclusions of law and argument.
On June 17, 1997, Judge Bittner issued her Opinion and Recommended
Ruling, Findings of Fact, Conclusions of Law and Decision, recommending
that the Deputy Administrator grant Respondent's application upon
Respondent's filing of a certificate or other demonstration of
completion of a course of at least sixteen hours of formal training in
the regulation and proper handling of controlled substances. Neither
party filed exceptions to the Administrative Law Judge's recommended
decision, and on July 18,
[[Page 44019]]
1997, Judge Bittner transmitted the record of these proceedings to the
Acting Deputy Administrator.
Subsequently, by letter dated July 22, 1997 to the Acting Deputy
Administrator, Respondent requested that the decision in this matter be
expedited, that the Acting Deputy Administrator approve a program which
Respondent intends to attend in November 1997, and that the Acting
Deputy Administrator grant Respondent a temporary DEA registration upon
proof that Respondent has registered for the program and a permanent
registration upon evidence of successful completion of the course. In
his letter, Respondent indicated that Government counsel had no
objections to this petition. By letter to the Acting Deputy
Administrator dated July 25, 1997, Government counsel indicated that
she had not reviewed the information about the program Respondent
intends to attend not any petition for an expedited determination, and
has not agreed or stipulated to such petition. The regulations do not
provide for the submission of additional information after the record
has been transmitted to the Deputy Administrator, but before the Deputy
Administrator renders his decision, but under the circumstances of this
case, the Deputy Acting Administrator has nonetheless considered these
two letters in rendering his decision in this matter.
The Acting Deputy Administrator has considered the record in its
entirety, 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, in full, the opinion and
recommended ruling of the Administrative Law Judge, and his adoption is
in no manner diminished by any recitation of facts, issued and
conclusions herein, or of any failure to mention a matter of fact or
law.
The Acting Deputy Administrator finds that Respondent graduated
from medical school in 1983, and in July 1984, began a one year
pediatric residency in New York. He then moved to Miami, Florida to
accommodate his then-wife, where he worked as a physician's assistant
because he was unable to find a residency program there. In July 1987,
Respondent moved to Cincinnati, Ohio upon acceptance to a residency
program in internal medicine, however, his wife remained in Miami.
While in Ohio, Respondent's marriage suffered as a result of
financial concerns, other personal problems, and the fact that his wife
still lived in Miami. In an effort to save his marriage and to
alleviate some of his financial concerns, Respondent entered into an
arrangement with his wife's brother, whereby the brother would mail
Respondent packages of illicit cocaine, which Respondent repackaged and
then mailed to their final destination. Respondent testified that he
knew that what he was doing was wrong, and was in the process of
deciding to divorce his wife and stop this arrangement, when in
November 1988, he was arrested. On January 18, 1989, Respondent pled
guilty in the Hamilton County, Ohio Court of Common Pleas, to one
felony count of trafficking. He was fined $5,000 and served 12 months
of an 18 month sentence. Respondent was released from prison on January
18, 1990.
Respondent and his first wife divorced, and after his release from
prison, Respondent remarried and participated in a residency program in
internal medicine in New York from July 1, 1990, until June 3, 1991.
Respondent and his family then moved to Savannah, Georgia where
Respondent completed another residency program in June 1993. Respondent
next sought employment in Indiana to be closer to his and his wife's
families.
Knowing that he wanted to practice medicine in Indiana, on December
3, 1992, Respondent applied for an Indiana medical license. On February
25, 1993, the Medical Licensing Board of Indiana (Board) denied
Respondent's application since he had been convicted of a crime ``that
has a direct bearing on [his] ability to practice competently.'' On
March 16, 1993, Respondent petitioned the Board to review its decision,
and following a hearing, the Board issued its Findings of Fact and
Order on June 14, 1993, granting Respondent's application. Thereafter,
by letter dated July 12, 1993, the Indiana Health Professions Bureau
granted Respondent an Indiana controlled substances registration.
During his state application process, Respondent was recruited by
Randolph County Hospital in Winchester, Indiana. The Chief Executive
Officer of the hospital testified that Randolph County is a designated
Health Professional Shortage Area and was in need of general internists
and that Respondent's background and communication skills impressed
him. Respondent was very candid during the interview process about his
conviction. The hospital extended Respondent an offer, and he moved to
Winchester in June 1993, and began working in the emergency room of the
hospital. On August 1, 1993, Respondent began a private practice in
Winchester in internal medicine.
In June 1993, Respondent applied for a DEA Certificate of
Registration. He indicated on the application that he had been
convicted of a crime relating to controlled substances, and as a
result, DEA initiated an investigation to determine whether to grant
Respondent's application or to issue an Order to Show Cause proposing
to deny it. In December 1993, DEA received information that a pharmacy
had received a prescription signed by Respondent for Xanax, a Schedule
IV controlled substance, with no DEA number on the prescription. As a
result, in January 1994, DEA investigators visited several pharmacies
in the vicinity where Respondent had applied with DEA to be registered,
and retrieved 21 prescriptions for Ritalin and four prescriptions for
MS Contin, both Schedule II controlled substances, written by
Respondent between August 31 and November 29, 1993. The investigators
noted that two of the prescriptions for Ritalin authorized refills,
which are not permitted for Schedule II substances.
Respondent testified at the hearing that he believed that since he
had unrestricted Indiana licenses, obtaining a DEA registration was
``just a formality.'' He further testified that he mistakenly believed
that he could use the hospital's DEA number to issue controlled
substance prescriptions, and that the director of the emergency room at
the hospital told Respondent that he could use the hospital's number.
However, a DEA investigator testified at the hearing in this matter
that DEA regulations permit a physician to use a hospital's DEA number
to administer or dispense, but not prescribe controlled substances. The
investigator further testified that 21 CFR 1301.76 provides that a
registrant shall not employ an individual with access to controlled
substances if that individual has been convicted of a felony offense
related to controlled substances. Consequently, not only was Respondent
not authorized to prescribe controlled substances using the hospital's
DEA registration, he could not be employed at the hospital with access
to controlled substances without the hospital first obtaining a waiver
of 21 CFR 1301.76.
When Respondent was advised by the hospital's attorney that he
could not write controlled substance prescriptions without his own DEA
registration, and that he could not use the hospital's DEA
registration, he ceased issuing prescriptions. On March 21, 1994,
Respondent and the hospital entered into a Physician Employment
Agreement providing that Respondent would be an employee of the
hospital,
[[Page 44020]]
contingent upon DEA's granting of a waiver of the regulation precluding
his employment in light of his felony conviction. On June 20, 1994, the
hospital filed a request with DEA for a waiver of 21 CFR 1301.76(a), in
order to employ Respondent with access to controlled substances, and
later submitted to DEA requested information regarding how the hospital
monitors and restricts access to controlled substances. As of the date
of the hearing, no action had been taken on this waiver request.
During the course of investigating Respondent's application for
registration, DEA investigators met with the pharmacy technician of the
hospital on July 31, 1995, and obtained records, known as proof of use
sheets, which seemingly indicated that on a number of occasions,
Respondent ordered controlled substances for hospitalized patients. The
pharmacy technician told the investigators that a nurse usually fills
out the sheets, and that the doctor listed on the form is the one who
authorized the administration of the controlled substance. However, the
Director of Pharmacy for the hospital testified at the hearing before
Judge Bittner that there was no consistent method for filling out the
sheets, and therefore it was not possible to determine by looking at
these sheets whether the doctor listed was the admitting or attending
physician, or the physician who ordered the controlled substance. The
Director of Pharmacy testified that he checked each entry on the
controlled substance proof of use sheets which listed Respondent as the
physician against the actual medical orders, and in each instance the
physician ordering the administration of the controlled substance was
someone other than Respondent.
Respondent testified at the hearing that he did not order
controlled substances for hospitalized patients, but that his name
appeared on the proof of use sheets because he was the attending
physician. Respondent further testified that as the attending
physician, if he determined that a patient required a controlled
substance, he would consult with another physician and have that
physician order the medication for the patient.
As of the date of the hearing, Respondent was the Chief of Staff at
the hospital, having been elected to that position by his peers. Also,
since January 1, 1996, Respondent has been a member of the hospital's
Board of Trustees.
Pursuant to 21 U.S.C. 823(f), the Deputy Administrator may deny any
pending applications for a DEA Certificate of Registration, if he
determines that the registration would be inconsistent with the public
interest. Section 823(f) requires that the following factors be
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 or
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 16422
(1989).
Regarding factor one, it is undisputed that on June 14, 1993, the
Board granted Respondent an unrestricted license to practice medicine
in the State of Indiana, and thereafter, he was issued an Indiana
controlled substances registration. While this certainly weighs in
favor of Respondent being issued a DEA registration, it is not
dispositive of the issue.
As to Respondent's experience in dispensing controlled substances
and his compliance with applicable laws relating to controlled
substances, it is undisputed that Respondent engaged in the unlawful
trafficking of cocaine in violation of Ohio state law. It is also
undisputed that during a three-month period in 1993, Respondent issued
a number of Schedule II prescriptions while not registered with DEA to
do so, in violation of 21 U.S.C. 822. It is equally clear, that
Respondent was not permitted to use the hospital's DEA registration
number to issue such prescriptions. In light of 21 CFR 1301.76(a), the
hospital could not employ Respondent with access to controlled
substances since he had been convicted of a controlled substance
related felony offense. Even if the hospital had obtained a waiver of
this regulation, Respondent could still not use the hospital's DEA
registration to prescribe controlled substances. The regulation in
effect at the time of the events at issue in this proceeding would have
only allowed Respondent to administer or dispense controlled
substances, but not prescribe, using the hospital's DEA number. See 21
CFR 1301.24 (1993).
Accordingly, the Acting Deputy Administrator concludes that
Respondent unlawfully issued prescriptions for Schedule II controlled
substances. The Acting Deputy Administrator concurs with Judge
Bittner's finding that ``Respondent did not intentionally violate [21
U.S.C. 822]; however, this finding does not resolve the issue because
an applicant for a DEA registration is properly expected to have some
familiarity with, and understanding of, the Controlled Substances Act
and its implementing regulations and the obligations they impose upon
registrants.'' Yet, the Acting Deputy Administrator is cognizant of the
fact that Respondent issued these prescriptions over a three-month
period in 1993, and he stopped writing such prescriptions upon being
told that he was not authorized to do so.
In addition, Respondent violated 21 U.S.C. 829 and 21 CFR 1306.12,
by authorizing the refilling of two Schedule II prescriptions. Like
Judge Bittner, the Acting Deputy Administrator finds that ``[a]lthough
it does not appear that Respondent intended to violate the [Controlled
Substances Act], his ignorance of its requirements is troubling.''
Further, the Acting Deputy Administrator finds that the evidence
does not support a finding that Respondent improperly ordered
controlled substances for hospitalized patients. While Respondent's
name appeared on the proof of use sheets, the testimony of Respondent
and the Director of Pharmacy of the hospital, as well as documentary
evidence, indicate that Respondent was not in fact the physician who
ordered the administration of the controlled substances.
While there has been no evidence of Respondent's improper handling
of controlled substances since 1993, the Acting Deputy Administrator is
concerned about Respondent's apparent lack of knowledge of the
provisions of the Controlled Substances Act and its implementing
regulations. It is the responsibility of a registrant to be familiar
with the requirements for the proper handling of controlled substances.
Respondent's past experience in dispensing controlled substances is
troubling and Respondent admitted at the hearing that he had not read
the DEA regulations.
Finally, as to factor three, it is undisputed that Respondent was
convicted of one felony count of trafficking cocaine, and as a result
[[Page 44021]]
served 12 months in an Ohio prison. The Acting Deputy Administrator is
extremely dismayed by Respondent's conduct which led to his conviction.
As Judge Bittner noted, ``[m]aintaining the boundary between the licit
and illicit drug markets is one of the greatest responsibilities placed
upon a DEA registrant.'' However, this conduct occurred in 1988, and
there is no evidence that Respondent has engaged in such behavior since
that time. Further, Respondent has expressed remorse for his past
actions.
The Administrative Law Judge concluded that Respondent practices
medicine in an underserved area, that the conduct which led to his
conviction occurred eight years before the hearing in this matter, and
that Respondent's subsequent misprescribing of controlled substances
``was due to ignorance rather than an intent to circumvent the
Controlled Substances Act and its implementing regulations.''
Therefore, Judge Bittner concluded ``that the public interest is best
served by granting Respondent's application, contingent upon his
demonstrating knowledge, understanding, and acceptance of the
obligations concomitant to a DEA registration.'' Judge Bittner
recommended that Respondent's application for registration be granted
upon demonstration of completion of a course of at least 16 hours in
the regulation and proper handling of controlled substances.
The Acting Deputy Administrator finds that the Government has
established a prima facie case for the denial of Respondent's
application for registration in light of Respondent's conviction, his
improper prescribing of controlled substances, and his apparent lack of
knowledge regarding the proper handling of controlled substances.
However, the Acting Deputy Administrator also finds that the conduct
which led to Respondent's conviction occurred in 1988, and there is no
evidence of any similar conduct since that time. His improper
prescribing of controlled substances occurred in 1993, and likewise,
there is no evidence of any similar conduct since that time.
Therefore, the Acting Deputy Administrator finds that it would not
be in the public interest at this time to deny Respondent's application
for registration. Nevertheless, in light of Respondent's apparent lack
of knowledge regarding the proper handling of controlled substances,
the Acting Deputy Administrator agrees with Judge Bittner that
Respondent should undergo at least 16 hours of formal training in the
regulation and proper handling of controlled substances before being
issued a DEA registration.
The Acting Deputy Administrator has considered Respondent's July
22, 1997 letter requesting that the Deputy Administrator approve a
program that Respondent intends to attend in November 1997, as
acceptable to meet the Administrative Law Judge's recommended condition
of registration, and that the Deputy Administrator issue Respondent a
temporary DEA registration upon proof that Respondent has registered
for the program. The Acting Deputy Administrator concludes that the
course Respondent intends to attend, or a similar course, would be
acceptable to fulfill the training condition of registration. However,
in light of Respondent's apparent lack of knowledge regarding the
proper handling of controlled substances, the Acting Deputy
Administrator declines to grant Respondent a temporary registration
pending the completion of the course. The purpose of requiring
Respondent to undergo this training is for Respondent to have an
understanding and appreciation of the laws and regulations relating to
controlled substances, before he is issued his own DEA registration to
handle such substances.
Accordingly, the Acting Deputy Administrator of the Drug
Enforcement Administration, pursuant to the authority vested in him by
U.S.C. 823 and 824 and 28 C.F.R. 0.100(b) and 0.104, hereby orders that
the application for a DEA Certificate of Registration submitted by
Oscar I. Ordonez, M.D., be, and it hereby is granted upon receipt by
the DEA Indianapolis office of evidence of successful completion of at
least 16 hours of formal training in the regulation and proper handling
of controlled substances. This order is effective August 18, 1997.
Dated: August 11, 1997.
James S. Milford,
Acting Deputy Administrator.
[FR Doc. 97-21834 Filed 8-15-97; 8:45 am]
BILLING CODE 4410-09-M
