[Federal Register Volume 67, Number 149 (Friday, August 2, 2002)]
[Notices]
[Pages 50461-50465]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 02-19530]


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DEPARTMENT OF JUSTICE

Drug Enforcement Administration

[Docket No. 00-4]


Gregory D. Owens, D.D.S.; Grant of Restricted Registration

    On October 1, 1999, the Deputy Assistant Administrator, Office of 
Diversion Control, Drug Enforcement Administration (DEA), issued an 
Order to Show Cause to Gregory D. Owens, D.D.S. (Respondent), seeking 
to revoke his DEA Certificate of Registration as a practitioner and 
deny any pending applications for renewal of such registration pursuant 
to 21 U.S.C. 823(f) for reason that his continued registration is 
inconsistent with the public interest, as defined by 21 U.S.C. 823(f) 
and 824(a)(4). The Respondent timely filed a request for a hearing on 
the allegations raised by the Order to Show Cause, and the requested 
hearing was held before Judge Gail A. Randall in Abingdon, Virginia, on 
October 4, 2000. At the hearing, each party called one witness to 
testify and the Government introduced documentary evidence. The 
Respondent offered no documentary evidence at the hearing. After the 
hearing, both parties submitted Proposed Findings of Fact, Conclusions 
of Law and Argument. On May 4, 2001, Judge Randall issued her 
Recommended Rulings, Findings of Fact, Conclusions of Law, and Decision 
of the Administrative Law Judge, recommending that Respondent's 
registration be continued subject to certain restrictions.
    On May 24, 2001, the Government filed Exceptions to Judge Randall's 
decision, and thereafter Judge Randall transmitted the record of these 
proceedings to the Deputy Administrator for final decision on June 4, 
2001.
    The 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 Deputy Administrator adopts in full the recommended rulings, 
findings of fact, conclusions of law, and decision of the 
Administrative Law Judge. His adoption is in no way diminished by any 
recitation of facts, issues, or conclusions herein, or of any failure 
to mention a matter of fact or law.
    On October 20, 1981, the Respondent received a DEA Certificate of 
Registration, number AO1188881, with a registration location of 
Knoxville, Tennessee. The registration was renewed annually until it 
expired on December 31, 1985. The last renewal of that registration 
number was given for a location in Kingsport, Tennessee.
    In 1981, the Respondent received a license to practice dentistry in 
the state of Virginia. Sometime in 1986, the Respondent moved from 
Tennessee to Virginia. The Respondent has maintained his license to 
practice dentistry in the Commonwealth of Virginia since the time he 
first received it, through the time of this hearing.
    Before July 1, 1996, licensed health care professionals in Virginia 
needed a separate Controlled Substance Registration from the Virginia 
Board of

[[Page 50462]]

Pharmacy. After July 1, 1996, a valid Virginia license to practice 
dentistry also conferred upon the license state authorization to handle 
controlled substances without a separate certificate from the Board of 
Pharmacy.
    On August 29, 1987, the Respondent received a Controlled Substances 
Registration Certificate, number 0204-030208, from the Virginia Board 
of Pharmacy. The Respondent maintained the registration until its 
expiration on December 31, 1992.
    On November 5, 1996, the Virginia Board of Dentistry, Department of 
Health Professions, conducted an unannounced inspection of the 
Respondent's practice. The Board of Dentistry found that the Respondent 
had hired an unlicensed hygienist, that the Respondent failed to keep 
records for two patients, and that he did not keep records for any 
prescriptions written on the weekends for any patient.
    The Government alleged in the Order to Show Cause, and the 
Respondent agreed, that the Respondent issued prescriptions without a 
valid state license to handle controlled substances and with an expired 
DEA Certificate of Registration.
    The Respondent testified that he did not realize that his DEA 
Certificate of Registration had expired until the Board of Dentistry 
inspected his office. The Respondent testified that he now understands 
that he must maintain a DEA registration if he wants to prescribe 
controlled substances.
    On or about December 16, 1996, the DEA received an application from 
the Respondent for a controlled substances registration. The Respondent 
testified that he sent in the application after discussing his expired 
registration with the DEA on the telephone. The Respondent testified 
that he did not remember who told him that the DEA registration had 
expired. That application was granted, for on February 4, 1997, the DEA 
issued to the Respondent the DEA Certificate of Registration number 
BO5201366, and renewed it on October 25, 1999. An additional pending 
application for renewal is at issued in this proceeding.
    Between the time that the DEA received the Respondent's 1996 
application and the time that the DEA issued the certificate of 
registration at issue, the Respondent continued to prescribe controlled 
substances. A DEA Diversion Investigator (DI) testified that, on March 
3, 1997, he received a tip from a Special Agent (SA) of the Virginia 
State Police that the Respondent may have prescribed controlled 
substances without authorization from either the DEA or the 
Commonwealth of Virginia. Consequently, the DI and SA began an 
investigation of area pharmacies.
    The DI discovered that the Respondent used his expired DEA number, 
AO1188881, to prescribe controlled substances from January 1990 to 
January 1997. In addition, from December 31, 1992 to July 1, 1996, the 
Respondent lacked state authorization when he wrote prescriptions for 
controlled substances. The DI also testified that he found no evidence 
of diversion to the illicit market by the Respondent of any controlled 
substances. Furthermore, he testified that there was no indication by 
the regulatory agencies of Virginia, or by the DEA, that the Respondent 
had intentionally refused to renew a license or registration.
    The DI testified that the Respondent called in a prescription to 
East Gate Drugstore for Darvocet on or about January 3, 1997, and again 
on or about January 15, 1997.
    The Respondent credibly testified that he did not know, prior to 
this hearing, that Darvocet was a controlled substance, and further, at 
the hearing he stated that he did not understand what `Schedule IV' 
meant.
    While the Respondent awaited action on his December 16, 1996 
application, he pleaded guilty to a misdemeanor in the U.S. District 
Court for the Western District of Virginia for failure to file income 
tax returns from 1990-94. Upon the Respondent's plea entered on January 
30, 1997, the District Court sentenced him with a fine of $10,000 plus 
cost of $125 and five months in the Virginia Community Correctional 
Center, where the Respondent was allowed daily work release.
    The Respondent testified that he was wrong not to file his taxes. 
He explained that he believed that he was not legally obligated to pay 
federal income taxes, and that he had so written to the IRS. The IRS 
chose not to pursue the matter at the time. The Respondent testified 
that he now understands that he is obligated to pay taxes, having 
learned ``the hard way.''
    On June 30, 1997, the Respondent pleaded guilty to a second 
misdemeanor in the Western District of Virginia, this time for failure 
to report his change of address to the DEA. The District Court 
sentenced the Respondent to two years of probation, a $5,000 fine and 
$25 in costs.
    On November 24, 1997, the Board of Dentistry for the Commonwealth 
of Virginia (Board) issued an Order, placing the Respondent on 
indefinite probation and imposing various terms and conditions on his 
continued dental license. For example, the Respondent was ordered to 
attend fifteen hours of continuing education for the renewal of his 
license, with a specific course on OSHA. The Respondent must provide 
the Board with certificates of his attendance within six months of the 
date that the Order became final. The Order also required the 
Respondent to provide a copy of his ``current DEA registration/
certificate'' within two weeks of that same date of finality. The 
Respondent credibly testified that he had completed these requirements, 
and the Government presented no evidence to the contrary. 
Significantly, the Board's Order did not limit the Respondent's 
authority to handle controlled substances, despite a finding that the 
Respondent prescribed controlled substances at a time when he did not 
have authority from either Virginia or the DEA to do so. The Respondent 
consented to one annual unannounced inspection of his patent records by 
the Board, and he further consented to the Board's observing the on-
site treatment of his patients. Also, the Board required that the 
Respondent's conduct be commensurate with Virginia's statutes that 
regulate dentistry, specifically Virginia Code sections 54.1-2700-2729, 
and Virginia's Drug Control Act, Virginia Code sections 54.1-3400-3472.
    The DEA last renewed the Respondent's registration, number 
BO5201366, on October 1, 1999. That registration expired on December 
31, 1999. On November 17, 1999, the DEA received the Respondent's 
renewal application, which was dated November 8, 1999. The address on 
the Certificate of Registration is current.
    On March 30, 2000, the DI approved the Respondent's renewal 
application and sent it to DEA Headquarters.
    Pursuant to 21 U.S.C. 823(f), and subdelegations of authority 
thereunder found at 28 CFR 0.100(b) and 0.104, the Deputy Administrator 
may deny an application for registration as a practitioner, if he 
determines that the issuance of such a registration would be 
inconsistent with the public interest. Section 823(f) requires that the 
following factors be considered in evaluating the public interest:
    (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;

[[Page 50463]]

    (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 properly rely on any one or any combination of these 
factors, and may give each factor the weight he deems appropriate in 
determining whether an application for registration should be denied. 
See Henry J. Schwarz, M.D., 54 FR 16,422 (1989). As an initial matter, 
the Government bears the burden of proving that registration of the 
Respondent is not in the public interest. See Shatz v. United States 
Dep't of Justice, 873 F.2d 1089, 1091 (8th Cir. 1989).
    Regarding factor one, the recommendation of the State licensing 
board, Judge Randall found the Virginia Board of Dentistry has not made 
any official recommendation regarding this proceeding's outcome. The 
record shows that Respondent's dental license is currently on 
indefinite probation, under the conditions imposed by the Board's 
Order.
    Judge Randall found it significant that the Board's Order did not 
limit Respondent's authority to handle controlled substances, despite a 
finding that Respondent prescribed controlled substances during a 
period when he was not authorized to do so by either the State of 
Virginia nor by DEA. The parties did not dispute that Respondent 
currently has state authority to handle controlled substances.
    The Deputy Administrator concurs with Judge Randall's noting that a 
review of the Respondent's terms of probation serves to shed light on 
what the Board believed was necessary to protect the public interest. 
The following terms are relevant: the Respondent must attend fifteen 
hours of continuing education for the renewal of his license, with a 
specific course on OSHA, and must provide the Board with certificates 
of his attendance; the Respondent must submit to the Board quarterly 
reports of his current address and current employment, if any; the 
Respondent must consent to one annual unannounced inspection of his 
patient records by the Board; the Respondent must also consent to the 
Board's observation of the on-site treatment of his patients, if 
requested; and finally, the Board required Respondent to comply with 
Virginia's statues that regulate dentistry, specifically Virginia Code 
Sections 54.1-2700-2729, and Virginia's Drug Control Act, Virginia Code 
Sections 54.1-3400-3472.
    The Deputy Administrator concurs with Judge Randall's conclusion 
that the Board's placement of Respondent's license on probation 
reflects favorably upon Respondent's retaining his DEA Certificate of 
Registration, and upon DEA's granting Respondent's pending renewal 
application. Instead of suspending or limiting Respondent's authority 
to handle controlled substances, the Board simply chose to heighten 
monitoring of Respondent's practice. The Deputy Administrator concurs 
with Judge Randall's conclusion that such action by the Board 
demonstrates that the Board does not believe Respondent poses a danger 
to the public health or safety, to the extent that he cannot be trusted 
with the serious responsibilities of practicing dentistry and handling 
controlled substances.
    Regarding factors two and four, experience in dispensing controlled 
substances, and compliance with laws related to controlled substances, 
the Deputy Administrator concurs with Judge Randall's finding that the 
record shows Respondent clearly has demonstrated a lack of attention to 
maintaining the necessary state licenses and federal registration to 
handle controlled substances. While maintaining his license to practice 
dentistry in Virginia since 1981, Respondent allowed his state license 
to handle controlled substances lapse in December 1992. The record 
further shows Respondent continued to prescribe controlled substances 
without a valid DEA registration number from January 1990 to January 
1997, and without state authority from January 1993 to July 1996. The 
Government correctly asserts that the Respondent's conduct was 
proscribed by 21 U.S.C. 822(b), 841(a)(1), and 843(a)(2), as well as 21 
CFR 1306.03.
    The Deputy Administrator concurs with Judge Randall's finding that 
Respondent's admitted ignorance of his responsibilities as a 
practitioner are extremely troubling. Not only did Respondent forget to 
renew his state license and DEA registration over the years, but he 
also continued to prescribe controlled substances without the authority 
granted by these licenses. Judge Randall noted that Respondent 
prescribed Darvocet for a patient in January 1997, while his initial 
application for the DEA registration at issue was pending. Respondent 
testified at the hearing that he did not know Darvocet was a controlled 
substance or in what schedule it was. In fact, Respondent testified he 
did not know what the term ``Schedule IV'' meant.
    The Deputy Administrator concurs with Judge Randall's conclusion 
that Respondent's past failures to pay attention to his state license 
to handle controlled substances and his DEA registration provide ample 
evidence for the revocation of his DEA Certificate of Registration and 
the denial of any pending applications for renewal.
    The Deputy Administrator also concurs, however, with Judge 
Randall's findings that Respondent credibly testified that he has been 
made acutely aware of his licensing obligations since the Board's 
involvement in his practice since 1997, and also the significance of 
the Board's decision to continue Respondent's state authorization to 
handle controlled substances, with conditions, as discussed pursuant to 
factor one, above.
    Regarding factor three, convictions under Federal or State laws 
relating to controlled substances, the Deputy Administrator finds the 
record contains no evidence that Respondent has been convicted of a 
crime related to his handling of controlled substances. Respondent does 
have a federal misdemeanor conviction for his failure to report his 
change of address to the DEA.
    Regarding factor five, other conduct which may threaten the public 
health or safety, Judge Randall found the Government's reliance on 
Respondent's conduct prior to the 1999 DEA renewal of Respondent's 
registration as a basis for denial was inappropriate. The Deputy 
Administrator concurs with Judge Randall's conclusion that since the 
Government knew about this conduct before it renewed Respondent's 
registration in 1999, it would be inconsistent to now allow the 
Government to use this information as a basis to revoke Respondent's 
registration and deny his application for renewal, especially since 
there is no information in the record of any additional or subsequent 
misconduct that would warrant a change in DEA's position. The Deputy 
Administrator has considered and rejected the Government's Exceptions 
to this finding.
    The Deputy Administrator further concurs with Judge Randall's 
findings that the record demonstrates that Respondent has learned from 
his past mistakes and has demonstrated sufficient willingness to accept 
responsibility, as shown by his 1997 guilty pleas to the charges of 
federal income tax evasion and failure to notify DEA of his change of 
address. The Deputy Administrator has considered and rejected the 
Government's

[[Page 50464]]

exceptions to Judge Randall's findings in this regard.
    Further evidence relevant to this factor was received by the Deputy 
Administrator subsequent to the transmittal of the record for his final 
decision. Judge Randall's Recommended Decision included a requirement 
that, within one year of the final order, Respondent attend a course in 
the handling and identification of controlled substances, and provide 
proof to DEA of his completion of the course. Apparently acting upon 
his own initiative following receipt of Judge Randall's Recommended 
Decision, Respondent wrote a letter to the attention of Judge Randall 
wherein he stated that he was unable to find a course concerning 
controlled substances, but instead had attended ``three minor and two 
major dental meetings'' and in a four page attachment had apparently 
taken the Virginia Board of Dentistry Statutes and Regulations and had 
apparently handwritten in outline format ``all pertinent laws'' 
relating to controlled substances. By letter dated January 25, 2002, 
Judge Randall transmitted this submission to the Office of the Deputy 
Administrator, noting also that she ``informed both parties that I am 
forwarding this letter to you for consideration with the record.'' 
While this submission's primary relevance lies in tending to show 
Respondent's apparent desire to rehabilitate himself, more concrete 
evidence was soon forthcoming.
    By letter dated March 27, 2002, Respondent submitted documentation 
to the Office of the Deputy Administrator evidencing his attendance of 
the 70th Annual Nation's Capitol Dental Meeting, held February 28 
through March 2, 2002, and sponsored by the District of Columbia Dental 
Society. Respondent's submission included a Continuing Education 
Verification Form indicating his attendance at inter alia two 
Registered Clinics entitled Pharmacology and Therapeutics I and II. The 
course outline, also submitted, indicated the clinics focused on the 
proper handling of controlled substances in a dental setting. The 
Verification Form states that, at the end of each clinical program 
listed thereon, a verification code will be announced. Respondent's 
Verification Form listed such a code beside each of the above-mentioned 
clinics. The Form further stated the verification codes could be 
checked by contacting the District of Columbia Dental Society. This was 
done, and Respondent's codes were verified as being correct, indicating 
his attendance at the clinics.
    By letter dated June 18, 2002, the Office of the Deputy 
Administrator transmitted copies of the two above-referenced 
submissions to the attention of counsel for the Government in this 
matter, and granted until close of business June 21, 2002, to provide 
any response deemed necessary. By letter dated June 21, 2002, the 
Government objected to the consideration of the submissions as an 
unauthorized attempt to re-open the record, and further objected on the 
purported grounds that the Government would be prejudiced by lack of an 
opportunity to cross-examine the Respondent and introduce rebuttal 
evidence. The Deputy Administrator hereby rejects the Government's 
objections for the following reasons. First, the Deputy Administrator 
finds that this evidence is cumulative, in that it merely reinforces 
the same conclusion he would have reached in the absence of this 
evidence. Second, of the two submissions, the March 27, 2002, 
submission of Respondent's attendance at the Registered Clinics at the 
70th Annual Nation's Capitol Dental Meeting carries far more probative 
weight, for the very reason the Government seeks to object to its 
consideration--Respondent's attendance at the clinics is objectively 
verifiable by checking the verification codes. The codes were verified 
as correct, indicating Respondent's attendance at the clinics. It is 
hard to conceive what cross examination and rebuttal evidence could 
accomplish to change that fact.
    Therefore, the Deputy Administrator has considered these two 
submissions, and finds they constitute evidence that Respondent is 
sincere in his desire to comply with the obligations of a DEA 
registrant, and that they contribute to the Deputy Administrator's 
finding that Respondent would not pose a threat to the public health or 
safety if allowed to maintain a DEA Registration.
    The Deputy Administrator concurs with Judge Randall's finding that 
the Government has met its burden of proof for revocation of the 
Respondent's Certificate of Registration and denial of the pending 
renewal application. The Deputy Administrator notes, however, that he 
must consider all of the facts and circumstances of a particular case 
when deciding the appropriate remedy. See Martha Hernandez, M.D., 62 FR 
61,145, 61,147 (1997). The Deputy Administrator must also consider the 
Respondent's acceptance of responsibility for past offenses and 
rehabilitation efforts when deciding the likelihood that the 
Respondent's future conduct with respect to his DEA registration will 
be consistent with the public interest as defined by 21 U.S.C. 823(f). 
See e.g., Michael Alan Patterson, M.D., 65 FR 5,682 (2000).
    In the instant case, the Deputy Administrator concurs with Judge 
Randall's conclusion that the Respondent should be allowed the 
opportunity to demonstrate that he can now handle the responsibilities 
of a DEA registrant. The Deputy Administrator further concurs with 
Judge Randall's determination that the public interest would best be 
served by monitoring the Respondent's handling of controlled substances 
during this registration period. Therefore, like Judge Randall, the 
Deputy Administrator concludes that granting the Respondent a 
registration, with restrictions, ``will allow the Respondent to 
demonstrate that he can responsibly handle controlled substances in his 
[dental] practice, yet simultaneously protect the public by providing a 
mechanism for rapid detection of any improper activity related to 
controlled substances.'' Michael J. Septer, D.O., 61 FR 53,762, 53,765 
(1996) (citing Steven M. Gardner, M.D., 51 FR 12,576 (1986)).
    Therefore, the Respondent's application shall be granted, pursuant 
to the following restrictions and conditions:
    (1) During the duration of the newly renewed registration, the 
Respondent must provide the local DEA office with a log of activities 
on a quarterly basis that shall state: (1) The date that a controlled 
substance prescription was written, or such substance was administered; 
(2) the name of the patient for whom the prescription was written, or 
to whom the substance was administered; (3) the patient's complaint; 
(4) the name, dosage, and quantity of the substance prescribed, 
dispensed, or administered; and (5) the date that the medication was 
last prescribed, dispensed, or administered to that patient, as well as 
the amount last provided to that patient. If no controlled substances 
are prescribed, administered, or dispensed during a given quarter, the 
Respondent shall indicate that fact in writing, in lieu of submission 
of the log.
    (2) Within 30 days of the event, the Respondent must inform the 
local DEA office of any action taken by any state upon his medical 
license or upon his authorization to handle controlled substances 
within that state.
    (3) Should the Respondent change employment during this 
registration period, he shall immediately notify the local DEA office 
that is monitoring his log of activities.
    Accordingly, the Deputy Administrator of the Drug Enforcement 
Administration, pursuant to the

[[Page 50465]]

authority vested in him by 21 U.S.C. 823 and 824 and 28 CFR 0.100(b) 
and 0.104, hereby orders that the application for renewal of his 
registration submitted by Gregory D. Owens, D.D.S., be, and it hereby 
is, granted subject to the above described restrictions. This order is 
effective upon the issuance of the DEA Certificate of Registration, but 
no later than September 3, 2002.

    Dated: July 24, 2002.
John B. Brown, III,
Deputy Administrator.
[FR Doc. 02-19530 Filed 8-01-02; 8:45 am]
BILLING CODE 4410-09-M