[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