Gregory D. Owens, D.D.S.; Suspension of Registration; Grant of Restricted Registration, 36751-36758 [E9-17681]
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Federal Register / Vol. 74, No. 141 / Friday, July 24, 2009 / Notices
Wholesale Distributors be, and it hereby
is, dismissed. This Order is effective
immediately.
Dated: July 16, 2009.
Michele M. Leonhart,
Deputy Administrator.
[FR Doc. E9–17688 Filed 7–23–09; 8:45 am]
BILLING CODE 4410–09–P
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. 06–77]
srobinson on DSKHWCL6B1PROD with NOTICES
Gregory D. Owens, D.D.S.; Suspension
of Registration; Grant of Restricted
Registration
On August 7, 2007, the Deputy
Assistant Administrator, Office of
Diversion Control, issued an Order to
Show Cause to Gregory D. Owens,
D.D.S. (Respondent), of Abingdon,
Virginia. The Show Cause Order
proposed the revocation of
Respondent’s DEA Certificate of
Registration as a practitioner on the
ground that his continued ‘‘registration
would be inconsistent with the public
interest, as that term is defined under 21
U.S.C. 823(f).’’ Show Cause Order at 1.
More specifically, the Show Cause
Order alleged that in 1986, when
Respondent moved his dental practice
from Tennessee to Virginia, he had
failed to obtain a new registration as
required by 21 U.S.C. 822. Id. The Order
further alleged that in 1992, Respondent
did not renew his State ‘‘controlled
dangerous substances license’’ and that
he only acquired the proper State and
Federal registrations in 1996 after a
Virginia Board of Dentistry (‘‘the
Board’’) inspection. Id. Relatedly, the
Order alleged that in 1996 and 1997,
Respondent had ‘‘continued to prescribe
controlled substances in violation of
law,’’ using his ‘‘long-expired DEA
Tennessee registration to facilitate this
illegal activity.’’ Id.
Next, the Show Cause Order alleged
that in both November 1997 and May
2000, the Board had placed
Respondent’s dental license on
probation and subjected him to certain
conditions. Id. at 1–2. The Order also
alleged that in August 2005, the State
Board had ‘‘issued an Order which
concluded that [Respondent] had
continuously demonstrated disregard
for the Board’s orders,’’ reprimanded
him, and continued him on probation.
Id. at 2.
Finally, the Show Cause Order alleged
that in October 1999, DEA had issued an
Order to Show Cause to revoke
Respondent’s registration, and that on
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August 2, 2002, my predecessor had
issued a Decision and Final Order
which granted Respondent a registration
which was ‘‘subject to restrictions and
conditions’’ including ‘‘recordkeeping
requirements.’’ Id. at 1. The Show Cause
Order further alleged that in November
2005, Respondent applied for a renewal
of his registration and that a compliance
review found ‘‘that in 2004 and 2005,
[Respondent had] failed to submit the
required controlled substance
recordkeeping information to DEA in
violation of the conditions of [the]
previously granted registration.’’ Id. at 2.
Respondent, through his counsel,
timely requested a hearing. The case
was assigned to a DEA Administrative
Law Judge (ALJ), who conducted a
hearing in Abingdon, Virginia, on June
27, 2007. At the hearing, both parties
called witnesses to testify and
introduced documentary evidence.
Following the hearing, both parties
submitted briefs containing proposed
findings of fact, conclusions of law, and
argument.
On March 6, 2009, the ALJ issued her
recommended decision (also ALJ).
Therein, the ALJ found that Respondent
had violated the terms of my
predecessor’s Final Order by failing to
file quarterly reports of the controlled
substances he dispensed between the
effective date of the Order (Sept. 3,
2002) and December 31, 2002, the date
stated as the expiration date on a
registration which was subsequently
issued to him several months after the
expiration date and which was the
result of a clerical error. ALJ at 37–39.
However, the ALJ further found that
Respondent’s failure to file the reports
after that date should be excused
because the Government did not clearly
communicate to him that this
registration was issued in error and that
a registration issued to him on
September 8, 2003 (which expired on
December 31, 2005) was the ‘‘newly
renewed registration’’ to which the
reporting requirement imposed by the
2002 Order applied. Id. at 39. However,
she also found that because Respondent
did not present evidence that he had
submitted the required drug activity
logs from August 2002 through
December 2002, Respondent’s ‘‘lack of
evidence proving good faith compliance
weigh[ed] against the Respondent’s
continued registration.’’ Id. at 40.
The ALJ also found that Respondent
had not complied with a second
requirement of the 2002 Order—that he
notify DEA within thirty days of any
action taken against his State ‘‘medical
license.’’ Id. at 40–41. According to the
ALJ, Respondent violated this provision
because he failed to report the 2005
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Board action which continued his
probation upon finding that he had
committed additional violations. Id. at
41. In so holding, the ALJ specifically
rejected Respondent’s contention that
because the 2002 Order had used the
term ‘‘medical license’’ rather than
‘‘dental license’’ in imposing the
condition, he had no obligation to report
the proceeding to DEA. Id.
While the ALJ found that the
Government had made out a prima facie
case to revoke Respondent’s registration,
she concluded that other factors
counseled against a revocation. Id. at 47.
More specifically, she noted that
Respondent treated ‘‘many patients from
underserved counties, and a substantial
portion of his patients have limited
incomes,’’ that there was no evidence of
diversion or irresponsible prescribing
practices on Respondent’s part, that
Respondent had instituted procedures
to ensure the accuracy of his dental
records, and that he had begun filing
drug activity reports with this Agency
following a 2006 inspection. Id. at 48.
The ALJ thus recommended the
revocation of Respondent’s registration
but that the revocation be stayed for
twelve months, and that ‘‘[d]uring
pendency of the stay, the Respondent
should be allowed to handle controlled
substances,’’ subject to certain
restrictions. Id.
Neither party filed exceptions to the
ALJ’s decision. Thereafter, the record
was forwarded to me for final agency
action.
Having considered the record as a
whole, I hereby issue this Decision and
Final Order. I adopt the ALJ’s findings
of fact and conclusions of law except as
noted below. While I accept
Respondent’s contention that the March
13, 2003 registration was the ‘‘newly
renewed registration’’ for purposes of
the 2002 Order, I note that Respondent
did not comply with the Order’s
requirement pertaining to the
submission of quarterly reports even
during period in which there is no
dispute that he was required to do so.
I also hold that Respondent violated the
2002 Order because he failed to report
the 2005 Board action to DEA. While I
agree that the record does not support
an outright revocation of his
registration, I conclude that
Respondent’s lengthy history of
regulatory troubles supports the
suspension of his registration as well as
the imposition of conditions on his new
registration. I make the following
findings.
Findings
Respondent graduated from the
Medical College of Virginia Dental
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School, now the Virginia
Commonwealth University Dental
School, in 1981. Tr. 151. Respondent is
licensed to practice dentistry in the
State of Virginia and practices in
Abingdon (Washington County),
Virginia. Id. at 150–52, 163. Respondent
performs root canals and tooth
extractions and often issues a
prescription for a controlled substance
to treat a patient’s post-operative pain.
Id. at 160.
Respondent’s last DEA Certificate of
Registration was issued on September 8,
2003, and had an expiration date of
December 31, 2005.1 RX 3; GX 1, at 1.
On or about November 21, 2005,
however, Respondent submitted a
renewal application. GX 2, at 1–2.
Accordingly, Respondent’s registration
has remained in effect throughout the
course of this proceeding.
While Respondent currently holds
both a DEA registration and a State
license, he is not a stranger to either
DEA or Board proceedings (nor to
Federal criminal proceedings either).
Indeed, Respondent has been
disciplined by the Virginia Board on
three occasions and has been the subject
of DEA proceedings on two occasions.
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The State Proceedings
The first of these proceedings began
in October 1997, when the Board’s
Executive Director gave notice and
ordered Respondent to appear at an
informal conference based in part on
allegations that an inspection of four of
his patient records had found that in
two of them, he had ‘‘failed to list drugs
prescribed, dispensed, administered and
the quantity.’’ GX 4, at 2. In the notice,
the Board also alleged that ‘‘on divers
occasions since March 31, 1986,
[Respondent] ha[s] prescribed various
1 Respondent previously held a DEA registration
which was issued on February 4, 1997, and which
expired on December 31, 1999. ALJ at 5. On October
1, 1999, the first DEA proceeding was initiated. RX
42, at 2. On November 8, 1999, Respondent filed
a renewal application, id. at 9, the effect of which
was to extend the expiration date of his registration
until the Agency issued its Decision and Final
Order resolving the first proceeding, which it did
on July 24, 2002. See Gregory D. Owens, 67 FR
50461, 50465 (2002) (RX 1, at 5).
On March 13, 2003, Respondent was issued a
new Certificate of Registration. RX 2. However, the
Certificate stated that it had expired on ‘‘12–31–
2002.’’ Id. According to the registration history, this
Certificate was issued in error. Tr. 85. However, the
fact that it was issued in error was not
communicated to Respondent. Id. at 85–86. It is not
clear whether Respondent filed a further
application to obtain the Certificate which was
issued on September 8, 2003.
It is also noted that registration certificate which
expired on December 31, 2005, did not contain any
indication that it was subject to restrictions. Tr. 53.
DEA does not, however, indicate on the face of a
certificate whether a registration is subject to
restrictions. Id. at 53–54.
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controlled substances for patients,
including but not limited to Demerol,
Percocet, Percodan, Endocet (all
Schedule II), and hydrocodone
(Schedule III), without a current DEA
number.’’ Id. The Board further alleged
that ‘‘from December 31, 1992 to July
1996, [Respondent had] issued said
prescriptions without having a current
Controlled Substance Registration
Certification.’’ Id. Finally, the Board
alleged that ‘‘[o]n or about June 30,
1997, in the United States District Court,
Abingdon, Virginia, [Respondent] w[as]
found guilty of one count of Failure to
report change of address to DEA, a
misdemeanor.’’ 2 GX 4, at 2. See also GX
14 (judgment finding that defendant had
pled guilty to violations of 21 U.S.C.
842(a)(5) & (c)(2), fining him $5000, and
sentencing him to two years of
supervised release).
On November 5, 1997, the Board
found the above allegations (as well as
others) proved. GX 5, at 2–3. The Board
imposed various sanctions including a
reprimand, subjected him to one
unannounced inspection annually, and
placed him on probation
indefinitely.3 Id. at 3.
On March 21, 2000, the State Board
commenced a second proceeding. This
proceeding was based, in part, on a
September 9, 1998 review of
Respondent’s drug inventory and
records which found that Respondent
had on hand two boxes, which had
originally contained twelve bottles each
of dihydrocodeine tablets but, at the
time of the inspection, held only eight
bottles each. GX 6, at 2. The Board
further alleged that Respondent had
‘‘failed to take a complete and accurate
biennial inventory of the schedule III
and V drugs maintained,’’ that he
‘‘failed to maintain a record of drugs
received to include the date of receipt,
the name and address from whom
received and the kind and quantity of
drugs received,’’ and that he had ‘‘failed
to maintain a record of drugs received
to include the date of receipt, the name
and address for which the drugs were
dispensed, and the kind and quantity of
drugs.’’ GX 6, at 2–3.4
On May 8, 2000, the Board found that
Respondent had violated certain terms
of its 1997 Order as well as various
provisions of the Virginia Code and the
Board of Dentistry Regulations. GX 7, at
1–2, 4. Pertinent to the Controlled
Substances Act, the Board specifically
found proved the allegations pertaining
to Respondent’s handling of the
dihydrocodeine tablets, including his
failure to take biennial inventories of
schedule III and V drugs, and to
maintain proper records of both the
drugs received and dispensed. Id. at 3.
The Order reprimanded Respondent and
continued his probation
‘‘INDEFINITELY,’’ subjected him to two
unannounced inspections annually and
a reporting requirement,5 and imposed
a monetary penalty of $ 5000. Id. at 4–
5 (emphasis in original).
On July 26, 2005, the Board
commenced a third proceeding. This
proceeding was initiated ‘‘to receive and
act upon [Respondent’s] petition for
termination of [his] probation, to review
[his] compliance with the terms and
conditions imposed on [his] license by
[the Board’s 2000 Order], and to receive
and act upon evidence that [he] may
have violated certain laws and
regulations governing the practice of
dentistry.’’ GX 8. More specifically, the
Board alleged that Respondent had been
delinquent in submitting multiple
reports, and that an unannounced
inspection on February 9, 2005 had
found that he ‘‘may have violated’’ State
law and regulations pertaining to the
practice of dentistry.6 Id. at 1–2.
On September 6, 2005, the Board
entered an Order which found each of
the allegations proved. GX 9, at 2–3. The
Order further found that Respondent
‘‘has continuously demonstrated
disregard for the Board’s Orders.’’ Id. at
3. The Board thus reprimanded
Respondent, levied an $11,000 penalty,
and denied Respondent’s request to
terminate his probation, which was
continued indefinitely.7 Id. at 3–4. The
Order provided that Respondent’s
probation ‘‘shall continue from the date
this Order is entered and shall continue
indefinitely.’’ Id. at 4.
2 On or about January 30, 1997, in the United
States District Court, Abingdon, Virginia,
Respondent pled guilty to five (5) misdemeanor
counts of Failure to File Federal Tax Returns, and
was sentenced to five months of home detention
and fined $10,000. GX 13, at 1, 2 & 5.
3 The November 24, 1997 order was part of the
grounds of the prior DEA action. See RX 1, at 2; see
also Owens, 67 FR 50461, 50462.
4 The proceeding was also based on the results of
a September 8, 1999 inspection, which revealed
various deficiencies related to Respondent’s alleged
violation of the laws and regulations governing the
practice of dentistry. GX 6, at 1–2.
5 Respondent was required to submit quarterly
reports of his address and current employment as
part of this Order as well as the 1997 Order. See
GX 7, at 4.
6 More specifically, the Board alleged that
Respondent had ‘‘failed to consistently provide the
signature of the dentist completing laboratory work
order and the address of the dental practice,’’ and
that he had kept expired drugs (none of which are
controlled under Federal law) in his working stock.
GX 8, at 1–2.
7 Respondent was again required to submit
quarterly report noting his address and current
employment. GX 9, at 4.
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In October 2006, the Board conducted
an inspection of Respondent’s dental
practice and found no deficiencies. RX
13, at 5. Subsequently, in April 2007,
the Board notified Respondent that he
was in compliance with the Board’s
Order of September 6, 2005, and that no
action would be taken against his dental
license. RX 23.
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The First DEA Proceeding
On October 1, 1999, the Deputy
Assistant Administrator of the Office of
Diversion Control issued an Order to
Show Cause which sought the
revocation of Respondent’s registration
on the ground that Respondent had
committed various acts which rendered
his registration inconsistent with the
public interest. RX 1, at 1 (Gregory D.
Owens, 67 FR 50461 (2002)). More
specifically, the Show Cause Order
alleged that: (1) Between January 1990
and January 1997, Respondent had
prescribed approximately 8,600 dosages
units of controlled substances using his
DEA Registration number, which had
expired on August 5, 1986; (2)
Respondent had issued controlledsubstance prescriptions between May 1
and November 14, 1996, without
holding a valid State controlledsubstance registration; and (3)
Respondent had pled guilty to failing to
report his change of address to DEA. RX
42, at 2–3.
Following a hearing, on May 4, 2001,
the ALJ issued her recommended
decision. Id. at 1. Therein, the ALJ
found that between January 1990 and
January 1997, Respondent had issued
controlled-substance prescriptions
without a valid DEA registration; she
also found that from January 1993 until
July 1996, he had issued controlledsubstance prescriptions without a valid
State registration. Id. at 14–15. While in
the first proceeding Respondent testified
that he did not intend to violate Federal
law, the ALJ also found significant that
Respondent had prescribed Darvocet
(also a controlled substance) at the time
when his 1996 application was pending
but had yet to be renewed. Id. at 15. The
ALJ, however, recommended that my
predecessor consider ‘‘Respondent’s
acceptance of responsibility for past
offenses and rehabilitation when
deciding the likelihood that [his] future
conduct * * * will be consistent with
the public interest,’’ and that
Respondent be allowed ‘‘to demonstrate
that he can now handle the
responsibilities a DEA registrant.’’ Id. at
18. The ALJ thus recommended that my
predecessor grant Respondent a new
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registration subject to various
conditions.8 Id. at 19–20.
On July 24, 2002, the Deputy
Administrator issued his final decision
in the matter, which was effective no
later than September 3, 2002. See
Gregory D. Owens, 67 FR 50461, 50465
(2002). The Order granted Respondent’s
application for renewal of his
registration subject to the following
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 of
any action taken by any State upon his
medical license or upon his authorization to
handle controlled substances in 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.
Id. at 50464.
Respondent’s Compliance With the
2002 DEA Order
After receiving the ALJ’s
recommended decision (and before the
2002 Decision and Final Order was
issued), Respondent began filing
quarterly drug activity logs with the
Agency. Tr. 43 & 169; see also id. at 70–
71 (Respondent’s counsel asking DI
whether Respondent had started
sending in the drug logs following his
receipt of the ALJ’s decision). While not
part of the ALJ’s recommended sanction
(or subsequently required by the
Agency’s Final Order), Respondent
started using a carbon-copy prescription
pad and faxing prescriptions to
pharmacies so that the original
prescription could go in the patient file
and the carbon copy could be
maintained as a record to double-check
the drug activity log. Id. at 135 & 169.
8 My predecessor adopted the ALJ’s
recommended conditions nearly verbatim with the
exception of the first recommended condition
which was that Respondent take a course in the
identification and handling of controlled
substances. RX 42, at 19.
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However, following the issuance of
the Final Order, Respondent stopped
sending in the quarterly activity logs. Id.
at 42–43; 51. When asked by the
Government on cross-examination how
many quarterly reports he had sent to
DEA following the issuance of the Final
Order and the date he thought his
obligation to file the reports had ended,
Respondent testified that he did not
know and did not have that information
with him because he was ‘‘just prepared
to talk about 2004 and 2005.’’ Id. at 186.
On redirect examination, Respondent
further maintained that he was not
prepared to testify about what happened
in 2001 and 2002 because the
Government had not given him notice
that this would be at issue in the Show
Cause Order and other documents. Id. at
191.
Yet on direct examination,
Respondent had testified that when he
received the ALJ’s May 2001 decision,
he ‘‘began sending in our quarterly
reports.’’ Id. at 169.9 He also testified
that he believed—and had told the DI—
‘‘that the newly renewed registration
referred to in the DEA’s decision had
expired.’’ Id. at 162.
Regarding the 2002 Order’s
requirement that he notify the Agency
‘‘within 30 days’’ of ‘‘any action taken
by any State upon his medical license,’’
67 FR at 50464, Respondent testified
that he has never had a medical license
and that he has a dental license. Tr. 163
& 178. With respect to the 2005 State
Board proceeding, in which the Board
had reprimanded him, fined him,
rejected his petition to terminate and
continued him on probation,
Respondent maintained that the Board
had not taken action against his license
because there was no change in the
status of his license. Id. at 165.
Amplifying this testimony, Respondent
stated: ‘‘My license was under probation
and it did not change. Nothing changed
9 Respondent objected to the Government’s
questioning the DI regarding Respondent’s failure to
submit the drug logs in the years prior to 2004 and
2005 on the ground that neither the Show Cause
Order nor the Government’s pre-hearing statement
had disclosed that this would be at issue. Tr. 44–
46. Respondent, however, did not object when the
Government had previously asked the DI: ‘‘What log
of activities were received by DEA from
[Respondent] after the date of the issuance of this
order on August 2, 2002?’’ and the DI answered:
‘‘There were no activity logs or drug logs submitted
after August of 2002 until after we visited Dr.
Owens’ office in 2006.’’ Id. at 42–43. Notably, when
the DI continued with his answer and the
Government’s counsel interrupted him,
Respondent’s counsel did not object to the line of
questioning but only that ‘‘the witness be allowed
to complete his answer.’’ Id. at 43. The DI then
explained that in 2007, Respondent’s attorney had
‘‘submitted all the drug logs that were kept.’’ Id.
Respondent’s objection was untimely and was
properly overruled for this reason as well.
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on my license itself. I guess you could
split hairs.’’ Id. at 181. He also
maintained that his obligation to report
any Board actions against his license
had expired on December 31, 2002,
based on the expiration date of the
registration certificate, although he
acknowledge that ‘‘I don’t think it’s
quite as clear as on the other one.’’ Id.
at 188.
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The 2006 DEA Investigation
On November 21, 2005, Respondent
submitted an application to renew his
registration. GX 2, at 2. On January 19,
2006, two DEA DIs, who were
accompanied by a member of the
Virginia State Police, inspected
Respondent’s office and inquired as to
why Respondent had not submitted the
drug activity logs in 2004 and 2005. Tr.
23, 33–34. Respondent told the
investigators that ‘‘he wasn’t aware of
that’’ and showed them a copy of the
ALJ’s ruling. Id. at 65–66. The
investigators also determined that
Respondent did not have any Federally
controlled substances on the premises
and reviewed a drug log that he had
kept since September 18, 2005. Id. at
34–35; see also GX 10.
The DIs then looked at Respondent’s
appointment book and selected sixtyeight patient records to review to
determine whether the controlled
substances Respondent had prescribed
had been recorded in the drug log. Id.
at 38–39. According to the DI, there
were seven instances in which a
prescription which was recorded in a
patient file was not listed in the drug
log. Id. at 39, 60–61. The DI further
acknowledged that Respondent
consented to the inspection and was
cooperative, id. at 54–55, and that he
had no evidence that Respondent
engaged in the diversion of controlled
substances. Id. at 58.
The next day, Respondent had a
telephone conversation with one of the
DIs and asked him ‘‘exactly what was
the term of a newly renewed
registration.’’ Id. at 63. The DI did not
directly answer the question and instead
told Respondent that ‘‘we would take a
look at’’ the information that had been
obtained. Id. According to the DI, during
the conversation, Respondent told him
that he had found a letter which
explained what the requirements
were.10 Id. at 67. Respondent testified
that he ‘‘didn’t believe’’ that he was
required to submit records in 2004 and
2005 because he thought the ‘‘newly
renewed registration referred to in the
10 The
letter is not in the record.
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DEA’s decision had expired.’’ Id. at
161–62.
In his testimony, the DI further
testified that the Certificate of
Registration which was issued on March
13, 2003, and which had expired on
December 31, 2002, was not his new
registration, but rather ‘‘a continuation
of his previous registration.’’ Id. at 84.
He further maintained that this
registration certificate was issued in
error and pointed to an administrative
code, which indicated as much, on
Respondent’s registration history. Id. at
85; see also GX 15. However, the DI was
aware of no evidence that this
information had been communicated to
Respondent. Id. at 86.
On March 16, 2006, Respondent’s
counsel submitted the drug activity logs
from July 2002 through December 2005
to the DI. RX 22. In his letter forwarding
the logs, Respondent’s counsel
maintained that, based on the 2002
Order, Respondent ‘‘is under no duty to
provide these to the DEA.’’ 11 Id.
Relatedly, Respondent testified that he
submitted the drug activity logs out of
‘‘an abundance of caution’’ because it
was ‘‘difficult to know exactly what [he
was] supposed to do.’’ Tr. 183.
Respondent’s Evidence Regarding
Remedial Measures
On September 2, 2006, Respondent
entered into a consulting agreement
with a registered nurse, who was to
review his compliance with DEA
regulations on a monthly basis. RX 5, at
1, 5. Moreover, at the end of each
month, the consultant audits all the
patient charts that are listed in the drug
activity log. Tr. 106. The consultant also
goes through the appointment book and
randomly selects twenty-five patient
charts which she reviews to see if any
prescriptions were not entered into the
drug activity log. Id. The entries in the
drug activity log are also checked
against the patient charts for accuracy.
RX 6. The consultant then provides a
monthly report of both the drug activity
log audit and the random patient chart
11 Most of the logs pertaining to this period
(including those pertaining to the period between
the issuance of the 2002 Order and December 31,
2002) are not in evidence.
The ALJ found that these drug activity logs did
not meet the requirements of the 2002 Decision and
Order as they ‘‘failed to record when and the
amount of controlled substances that had last been
provided to the patient.’’ ALJ at 18 (citing Tr. 185;
RX 42, at 19; RX 1, at 4). It is noted that the Drug
Log for the period September 18, 2005, through
January 18, 2006, was frequently missing
information such as ‘‘the patient’s complaint,’’ as
well as the date the medicine was last prescribed
to the specific patient and the quantity. Compare
GX 10 with GX 3, at 6–7. Neither party, however,
submitted the drug logs for the period between the
issuance of the 2002 Order and December 31, 2002.
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audit. Tr. 106; RXs 7–13. According to
the consultant, Respondent’s
recordkeeping is now ‘‘well organized’’
and ‘‘efficient’’ and Respondent is
capable of providing ‘‘accurate’’ records
to this Agency.12 Tr. 113–14.
Discussion
Section 304(a) of the Controlled
Substances Act (CSA) provides that a
registration to ‘‘dispense a controlled
substance * * * may be suspended or
revoked by the Attorney General upon
a finding that the registrant * * * has
committed such acts as would render
his registration under section 823 of this
title inconsistent with the public
interest as determined under such
section.’’ 21 U.S.C. 824(a)(4). With
respect to a practitioner, the CSA
requires that the following factors be
considered in making the public interest
determination:
(1) The recommendation of the appropriate
State licensing board or professional
disciplinary authority.
(2) The applicant’s experience in
dispensing * * * 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.
21 U.S.C. 823(f).
These factors are considered in the
disjunctive; I ‘‘may rely on any one or
a combination of factors and may give
each factor the weight [I] deem[]
appropriate’’ in determining whether a
registration should be revoked and/or an
application should be denied. Robert A.
Leslie, 68 FR 15227, 15230 (2003).
Moreover, case law establishes that I am
‘‘not required to make findings as to all
the factors.’’ Hoxie v. DEA, 419 F.3d
477, 482 (6th Cir. 2005); see also Morall
v. DEA, 412 F.3d 165, 173–74 (D.C. Cir.
2005).13
12 Respondent offered into evidence affidavits of
three other dentists, who variously declared that he
is ‘‘an asset to the dental community in the
Abingdon, Virginia area,’’ ‘‘an excellent asset to the
dental and general community,’’ and an ‘‘excellent
dentist who uses good dental techniques.’’ RXs 15–
17.
Respondent also put on extensive evidence
regarding the socioeconomic status of his patients
and the shortage of dentists in the area where he
practices. However, for reasons discussed below, I
conclude that it is not necessary to engage in factfinding on these issues.
13 DEA has the burden of proving that the
requirements for revocation are met. 21 CFR
1301.44(e). However, if the Government makes out
a prima facie case, the burden shifts to the
Respondent to demonstrate that the continuation of
his registration is consistent with the public
interest.
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Factor One: The Recommendation of
the State Licensing Board
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As found above, Respondent had been
the subject of three separate State board
proceedings and been disciplined on
each occasion. Moreover, the first two
proceedings involved violations which
did not simply involve violations of
State rules pertaining to the practice of
dentistry but also violations of the CSA
and DEA’s regulations.
The ALJ noted that in the 2002
Decision and Order, the Agency had
concurred with her conclusion that
because the Board had not restricted
Respondent’s ability to handle
controlled substances, this
‘‘demonstrate[d] that the Board does not
believe Respondent poses a danger to
the public health and safety, to the
extent that he cannot be trusted with the
serious responsibilities of practicing
dentistry and handling controlled
substances.’’ ALJ at 34–35 (quoting
Owens, 67 FR at 50463). Remarking on
the 2005 Board proceeding and the
April 2007 Board letter which closed
the case, the ALJ found it ‘‘significant
that in all orders, the Board chose not
to restrict Respondent’s handling of
controlled substances,’’ and that this
factor ‘‘weighs in favor of continuing the
Respondent’s DEA Certificate of
Registration.’’ Id. at 35–36.
While DEA has frequently considered
State board proceedings which do not
result in a revocation or suspension
under this factor, the Agency
‘‘maintains a separate oversight
responsibility with respect to the
handling of controlled substances and
has a statutory obligation to make its
independent determination’’ as to
whether the continuation of an existing
registration is in the public interest.
Mortimer B. Levin, 55 FR 8209, 8210
(1990); see also Jayam Krishna-Iyer, 74
FR 459, 462 (2009).14 Accordingly,
while I concur in the ALJ’s conclusion
regarding this factor, I give it only
nominal weight in the public interest
inquiry. See Martha Hernandez, 62 FR
61145, 61147 (1997) (finding that State
board decisions are relevant, although
not dispositive, on the issue of granting
or denying a DEA application).
14 As
my predecessor noted in the 2002 Decision
and Order, the various orders issued in the State
board proceedings are not in any sense an ‘‘official
recommendation regarding this proceeding’s
outcome.’’ 67 FR at 50463. Moreover, a State board
may apply a different standard than the public
interest standard applicable under the CSA and
thus consider factors which DEA does not consider
relevant. Thus, I give this factor only nominal
weight.
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Factors Two and Four: Applicant’s
Experience in Dispensing Controlled
Substances and Compliance With
Applicable State, Federal or Local Law
The record in this matter establishes
a pattern of Respondent’s noncompliance with the requirements of
both State and Federal Law relating to
controlled substances. More
specifically, for at least seven years,
Respondent violated Federal law by
issuing prescriptions for both schedule
II and III controlled substance based on
an expired registration.15 See 21 U.S.C.
822(a)(2); see also 21 U.S.C. 843(a)(2).
He also violated Virginia law, which at
the time required that he also hold a
State registration, for more than three
years.
Subsequently, the Virginia Board
found that Respondent was in violation
of various State rules because he had on
hand a stock of schedule III controlled
substances and was not taking
inventories and maintaining both
receiving and dispensing records.16
Moreover, the findings of the Board
establish that Respondent could not
account for eight bottles of
dihydrocodeine, a schedule III
controlled substance.17 GX 7, at 3.
The central issue in this case was,
however, Respondent’s compliance with
the terms of this Agency’s 2002 Order.
More specifically, the Government
contended that Respondent had failed to
comply with the requirements that he
submit drug activity logs each quarter
and notify DEA of any action taken
against his ‘‘medical license.’’
With respect to the first issue,
Respondent raises several contentions.
First, he argues that his rights under the
Due Process Clause and the
Administrative Procedure Act were
violated because the Government was
allowed to introduce evidence regarding
his compliance with the 2002 Order
pertaining to years which were not
alleged in the Show Cause Order (which
alleged that he had not complied during
the years 2004 and 2005) or in the
Government’s Pre-Hearing Statement.
Resp. Br. at 21. Respondent also argues
that ‘‘he had no notice to prepare for or
to rebut the testimony as to the years
before 2004.’’ Id. Relatedly, Respondent
contends that ‘‘[o]ver [his] objection, the
15 I further note Respondent’s misdemeanor
conviction for failing to notify DEA of his address
change. See 21 U.S.C. 823(f)(3).
16 Under DEA regulations, ‘‘[a] registered
individual practitioner is required to keep records
* * * of controlled substances in Schedules II, III,
IV, and V which are dispensed, other than by
prescribing or administering in the lawful course of
professional practice.’’ 21 CFR 1304.03(b).
17 It is unclear, however, how many tablets were
in each bottle.
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ALJ allowed the Government to inquire
into [his] reporting before 2004.’’ Id. at
25.
Respondent did not, however, timely
object to the Government’s questioning
the DI as to what logs have been
received after the issuance of the Order
on August 2, 2002. Tr. 42–43. Indeed,
Respondent’s counsel objected that the
Government had not allowed the DI to
complete his answer. Id. at 43. Nor did
Respondent object to the Government’s
subsequent question as to what logs he
had submitted prior to the issuance of
the 2002 Order. Id. Rather, Respondent
did not object until after the
Government had asked several
additional questions. Id. at 43–44. I thus
conclude that Respondent waived his
objection to the admission of this
evidence.18
Finally, even if it was error for the
ALJ to allow the Government to pursue
this line of questioning, the error was
not prejudicial. See 5 U.S.C. 706.
Notably, on direct examination,
Respondent testified that after receiving
the ALJ’s recommended decision, which
was issued in May 2001, ‘‘[W]e began
sending in our quarterly reports.’’ Tr.
168–69. Thus, Respondent went into
areas that pre-dated the time-frame
referenced in the Show Cause Order and
Government’s Pre-Hearing Statement.
Moreover, on direct examination,
Respondent maintained that he was not
required to file the reports because he
believed ‘‘that the newly renewed
registration referred to in the [2002]
decision had expired.’’ Id. at 162. Given
his testimony that he had started
sending in the reports after receiving the
ALJ’s May 2001 decision and that he
believed his obligation ended based on
the expiration of the erroneously issued
registration, the contention that his
compliance during the four-month
period in which it is undisputed that he
was required to submit the reports is not
properly at issue, amounts to trying to
have his cake and eat it too.19
I am also unpersuaded by
Respondent’s contention that he was
‘‘not prepared to testify about what
happened in 2001 and 2002’’ because
18 Moreover, on cross-examination Respondent’s
Counsel asked the DI whether Respondent had
started sending in the drug logs following his
receipt of the ALJ’s Decision. Tr. 70–71.
19 Furthermore, while the ALJ denied
Respondent’s request for a continuance to gather
the evidence that would show that the logs were
sent in during the period between the issuance of
the 2002 Order and December 2002, the ALJ made
clear that Respondent could renew his request at
‘‘the conclusion of the presentation of [the]
evidence’’ and noted that the record could be left
open for this purpose. Tr. 48–49. Respondent did
not, however, request that the record be left open
or submit any such reports.
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the Government failed to give notice. Tr.
191. Respondent’s testimony that he
started sending in the reports after
receiving the ALJ’s May 2001 decision
demonstrates that he was obviously
prepared to discuss what happened in
2001 and 2002. I therefore reject
Respondent’s contention that his rights
under the Due Process Clause and APA
were violated because the Government
introduced evidence regarding his noncompliance with the Order.
As found above, the record establishes
that Respondent did not submit any
drug activity logs as required by the
2002 Decision and Final Order. I
conclude, however, that Respondent
cannot be deemed to have violated the
terms of the Order subsequent to
December 31, 2002.
The Order expressly stated that it was
granting Respondent’s renewal
application and that it was effective ‘‘no
later than September 3, 2002.’’ GX 3, at
7. Thus, while the certificate issued on
March 13, 2003, indicated that it had
expired on December 31, 2002, and the
evidence indicates that it was issued in
error, the registration could be
reasonably interpreted as having granted
authority to Respondent for the period
between September 3 and December 31,
2002.20
Throughout this proceeding, the
Government has contended that
Respondent’s obligation to submit the
quarterly drug activity logs did not end
with the expiration date indicated on
this registration. The Government
further contends that the actual
registration the 2002 Order referred to
was that which issued on September 8,
2003, and which expired on December
31, 2005.
It is acknowledged that my
predecessor likely used the phrase—
‘‘[d]uring the duration of the newly
renewed registration’’—intending that
the first condition would last for the
period of a full registration. Under
DEA’s regulations, a practitioner’s
registration is typically valid for thirtysix months, see 21 CFR 1301.13(d)), and
not for only four months.
The Government ignores, however,
that Due Process requires that when the
Agency imposes conditions on a
registration, those conditions must be
‘‘sufficiently clear to inform’’ a
registrant as to ‘‘what conduct will
result in’’ a violation. United States v.
Ashland, Inc., 356 F.3d 871, 874 (8th
20 Under the APA, Respondent’s November 1999
renewal application provided authority only ‘‘until
the application ha[d] finally been finally
determined by the agency.’’ 5 U.S.C. 558(c). The
final determination on this application was the
2002 Decision and Final Order which granted the
application.
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Cir. 2004) (citing United States v.
Guagliardo, 278 F.3d 868, 872 (9th Cir.
2002)). Relatedly, the Government
ignores that it never informed
Respondent that the March 13, 2003
registration was issued by mistake. It
also ignores that it was not until more
than three years later that it informed
Respondent of its view that the
September 8, 2003 registration was ‘‘the
newly renewed registration’’ which
governed the duration of his obligation
to file the drug activity logs.
Respondent therefore cannot be held
to have violated the 2002 Order because
he failed to file the drug activity logs
after December 31, 2002. Respondent
did, however, violate the Order because
he did not file the logs even during the
period when it was clear that he was
required to do so.
As found above, the record also
establishes that Respondent did not
report the 2005 Board proceeding to the
Agency. Respondent offers three
arguments in response. First, relying on
the 2002 Order’s mistaken reference to
‘‘any action taken * * * upon his
medical license,’’ 21 he contends that he
‘‘has never held a medical license,’’ and
that ‘‘[t]he [S]tate of Virginia has never
taken any action against [his] nonexistent medical license.’’ Resp. Br. at
21.
The argument is too clever by half.
Precisely because Respondent has never
held a medical license, and the prior
DEA proceeding discussed an action by
the State Board of Dentistry which
imposed conditions on his dental
license, see RX 42, at 13–14,
Respondent had ample reason to know
that the 2002 Order had mistakenly
referred to his ‘‘medical license’’ and
that the purpose of the condition was to
require him to report any action taken
upon his dental license.
Next, Respondent contends that the
2005 Board action ‘‘occurred long after
[his] duty to report to the DEA lapsed.’’
Resp. Br. at 21. However, in contrast to
the other two conditions it imposed, the
2002 Order did not limit the duration
that this condition would be in effect.
See GX 3, at 6–7. This is hardly
surprising given that at the time the
Order was issued, the State Board had
placed him on probation
‘‘INDEFINITELY’’ and had imposed
various conditions. See GX 7, at 4–5.
Nor is it surprising given Respondent
history of non-compliance with the
Board’s orders. Most significantly, the
2002 DEA Order was ‘‘sufficiently clear
21 See also RX 42, at 19 (ALJ’ s recommended
sanction that ‘‘Respondent must inform the DEA of
any action taken by any State upon his medical
license’’).
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to inform’’ Respondent as to his
obligation to report the 2005 Board
action. Ashland, 356 F.3d at 874.
Finally, Respondent maintains that he
had no obligation to report the 2005
Board action because the Board ‘‘took
no action against [his] dental license’’
and ‘‘[h]e remained on probation
throughout the relevant period.’’ Resp.
Br. at 21. In the 2005 proceeding,
however, the Board (in addition to
reprimanding and fining him), rejected
Respondent’s petition to terminate his
probation, and again, continued his
probation ‘‘indefinitely.’’ GX 9, at 3.
Moreover, the Board stated that
‘‘[v]iolation of this Order may constitute
grounds for suspension or revocation of
[Respondent’s] license.’’ Id. at 4. The
Board’s Order thus clearly constituted
‘‘action taken by any State upon his
* * * license.’’ GX 3, at 7.
I therefore conclude that Respondent
violated the terms of the Agency’s 2002
Order by failing to report the 2005
Board action as well as by his failure to
file the quarterly drug activity logs
during the period between the issuance
of the Order and December 31, 2002.
These failures alone establish that
Respondent has committed acts which
‘‘render his registration * * *
inconsistent with the public interest’’
and which support the suspension or
revocation of his registration. 21 U.S.C.
824(a). Moreover, even though
Respondent’s misconduct, which was
the subject of the 2002 Order, occurred
some time ago, it buttresses this
conclusion. See 21 U.S.C. 823(f)(2)
(directing the Attorney General to
consider the registrant’s experience in
dispensing controlled substances).
Factor Five—Such Other Conduct
Which May Threaten Public Health and
Safety
Under this factor, the ALJ made
extensive findings regarding the
shortage of dentists in the region where
Respondent practices and the
percentage of his patients who come
from underserved areas. The ALJ further
noted that in Pettigrew Rexall Drugs, 64
FR 8855 (1999), a case involving a
pharmacy, the Agency had considered
that the ‘‘pharmacy was located in an
underserved community’’ and that this
was a factor that ‘‘impacted the public
interest.’’ ALJ at 46 (citing 64 FR at
8860). The ALJ then reasoned that even
though Respondent is not ‘‘physically
located in an underserved community
* * * the focus should be on who is
actually being served by the practice.’’
Id. Because Respondent has 561 patients
from underserved counties, and many of
these patients have limited incomes, the
ALJ concluded that this factor weighs
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against the imposition of either a
suspension or revocation of his
registration. Id. at 48.
DEA has never applied this rule in a
subsequent case, and I conclude that it
would be ill-advised to extend it to the
case of a prescribing practitioner. The
public interest standard of 21 U.S.C.
823(f) is not a freewheeling inquiry but
is guided by the five specific factors
which Congress directed the Attorney
General to consider; consideration of the
socioeconomic status of a practitioner’s
patient population is not mandated by
the text of either 21 U.S.C. 823(f) or
824(a)(4), which focus primarily on the
acts committed by a practitioner.
Moreover, where, as here, the
Government has made out a prima facie
case that a practitioner has committed
acts which render his registration
inconsistent with the public interest, the
relevant inquiry is (and the Agency’s
longstanding rule has been to examine)
whether the practitioner has put
forward ‘‘sufficient mitigating evidence
to assure the Administrator that he can
be entrusted with the responsibility
carried by such a registration.’’ Medicine
Shoppe-Jonesborough, 73 FR 364, 387
(2008) (citing cases). As noted in
numerous cases, this inquiry looks to
whether the registrant has accepted
responsibility for his misconduct and
undertaken corrective measures to
prevent the re-occurrence of similar
acts. Whether a practitioner treats
patients who come from a medically
underserved community or who have
limited incomes has no bearing on
whether he has accepted responsibility
and undertaken adequate corrective
measures.
Finally, contrary to the ALJ’s
understanding, extending the holding of
Rexall Pettigrew would likely cause
greater harm to the public interest. The
diversion of prescription drugs has
become an increasingly serious societal
problem, which is particularly
significant in poorer communities
whether they are located in rural or
urban areas. See, e.g., George C. Aycock,
74 FR 17529, 17544 n.33 (2009);
Laurence T. McKinney, 73 FR 43260
(2008); Paul H. Volkman, 73 FR 30630
(2008); Medicine Shoppe-Jonesborough,
73 FR at 363. See also U.S. General
Accounting Office, PRESCRIPTION
DRUGS: OxyContin Abuse and
Diversion and Efforts to Address the
Problem 31–32 (Dec. 2003) (noting that
‘‘the Appalachian region, which
encompasses parts of Kentucky,
Tennessee, Virginia, and West Virginia,
has been severely affected by
prescription drug abuse, particularly
pain relievers * * * for many years’’).
The residents of this Nation’s poorer
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areas are as deserving of protection from
diverters as are the citizens of its
wealthier communities, and there is no
legitimate reason why practitioners
should be treated any differently
because of where they practice or the
socioeconomic status of their patients.22
I thus conclude that this factor does not
support the continuation of
Respondent’s registration.
Sanction
Where, as here, the Government has
made out a prima facie case that a
practitioner has committed acts which
render his registration inconsistent with
the public interest, the practitioner must
put forward ‘‘sufficient mitigating
evidence to assure the Administrator
that he can be entrusted with the
responsibility carried by such a
registration.’’ Medicine ShoppeJonesborough, 73 FR 364, 387 (2008)
(citing cases). As noted in numerous
cases, this inquiry looks to whether the
registrant has accepted responsibility for
his misconduct and undertaken
corrective measures to prevent reoccurrence of similar acts.
As found above, Respondent violated
the terms of the restricted registration
which the Agency granted him by
failing to submit a quarterly drug
activity log during the four- month
period over which there is no dispute
that he was required to submit the log.
Moreover, Respondent failed to report
the 2005 Board Action. When coupled
22 It is acknowledged that there is no evidence
that Respondent has diverted controlled substances.
However, in assessing what sanction to impose, the
Agency already considers the extent and
egregiousness of a practitioner’s misconduct.
Accordingly, it is not clear what principle exists for
determining when evidence that a practitioner
treats underserved patients should be considered
and when it should not be.
Beyond this, the ALJ’s reasoning suggests how
unworkable applying this standard would be. As
she explained: ‘‘the focus should not simply be on
whether a dental practice is physically located in
an underserved community; this is simply too
narrow a view. Rather, the focus should be on who
is actually being served by the practice.’’ ALJ at 46.
The ALJ then noted that 561 of his patients
(notably, only about ten percent of his patients)
were from underserved areas, and that a majority
of his patients have limited finances.
The ALJ’s reasoning begs the question of how
many patients from underserved areas would a
practitioner have to treat to claim the benefit of the
rule. As for her reliance on the fact that a majority
of Respondent’s patients have limited incomes,
determining what constitutes a patient with a
limited income or finances and how many patients
(or what percentage of patients) a practitioner must
have to claim entitlement to this rule, would inject
a new level of complexity into already complex
proceedings and take the Agency far afield of the
purpose of the CSA’s registration provisions, which
is to prevent diversion. Finally, while I decline to
extend the Pettigrew rule to prescribing
practitioners, I further note that Respondent offered
no evidence that he charges his patients who have
‘‘limited finances’’ lower fees for his services.
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with the acts which gave rise to the
2002 Order, Respondent has
demonstrated a disturbing record of
non-compliance with both State and
Agency requirements.
Respondent’s evidence regarding his
acceptance of responsibility is
equivocal. While it appears that
Respondent started sending in drug logs
upon receipt of the ALJ’s 2001 decision,
he offered no explanation as to why he
stopped upon receiving the 2002 Order.
Moreover, while I acknowledge that a
registrant can in good faith dispute
whether a regulatory provision requires
certain action, Respondent’s arguments
with respect to his failure to report the
2005 Board action (e.g., that the Order
did not apply to him because he has a
dental license and that the State took no
action against him when it rejected his
petition to terminate and continued his
probation) were generally disingenuous.
I acknowledge that Respondent also
instituted corrective measures to
improve his documentation of his
prescribing practices, including bringing
in a consultant to audit his records.23 I
also note that there is no evidence that
Respondent has prescribed controlled
substances without ‘‘a legitimate
medical purpose.’’ 21 CFR 1306.04(a). I
therefore conclude that the record as a
whole does not support the revocation
of Respondent’s registration.
However, Respondent has a lengthy
history of non-compliance with both
DEA and State requirements and did not
appreciate the forbearance which this
Agency exercised in the 2002 Order.
Moreover, in light of the wording of the
2002 Order and the circumstances
surrounding the issuance of the
registration certificate in March 2003,
Respondent has not been required to
comply with the intended requirements
of that Order. I therefore conclude that
Respondent should be granted a new
registration subject to the following
conditions.
(A) Respondent shall submit to the local
DEA office, a drug activity log on a quarterly
basis, no later than twenty (20) days from the
last day of the quarter which shall be March
31, June 30, September 30, and December 31
of each calendar year. Each log must contain
23 In setting this sanction, I place no weight on
the DI’s testimony that during the 2006 inspection,
he found seven discrepancies between the drug
activity logs and Respondent’s patient records
because the discrepancies did not involve the
period in which it is clear that Respondent had an
obligation to maintain the logs. I also place no
weight on Respondent’s evidence regarding the
drug logs he eventually submitted for the period in
which the requirement clearly applied. Even were
I to ignore that the logs were submitted years late,
because Respondent did not submit copies of these
documents for the record, it is unclear whether they
contained all of the information required by the
2002 Order.
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the following: (1) The date that a controlled
substance was administered, or dispensed
(whether by prescription or actual delivery of
the drug); (2) the name of the patient to
whom a controlled substance was
administered or dispensed (whether by
prescription or actual delivery); (3) the
patient’s dental complaint; (4) the name,
dosage, and quantity of the substance
prescribed, dispensed or administered; and
(5) the date that the medication was
previously prescribed, dispensed or
administered to that patient if the medication
was prescribed, dispensed or administered in
the last year, as well as the amount last
provided to that patient. If no controlled
substances are prescribed, administered, or
dispensed during a given quarter,
Respondent shall submit a letter to the DEA
office indicating that there was no activity to
report during the quarter.
(B) Within 15 days of the event,
Respondent shall inform the local DEA office
of any proceeding initiated against him by a
State licensing board, whether the board
regulates his professional practice or his
authority to prescribe controlled substances.
In addition, within 15 days of the event,
Respondent shall inform the local DEA office
of any interim or final order of a State
licensing board which imposes a sanction,
whether the sanction be a reprimand, a fine,
a civil penalty, a probationary period, a
rejection of a petition for termination of
probation, an imposition of a condition, a
suspension, or a revocation of any State
professional license or authority to prescribe
a controlled substance.
(C) In the event that Respondent changes
employment during this three-year period, he
shall immediately notify the local DEA office
that is monitoring his drug activity logs.
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To ensure that there is no confusion
as to the duration of these conditions,
all three conditions shall remain in
effect for a period of three years from
the date of this Order’s publication in
the Federal Register.
Moreover, because Respondent has
not previously appreciated the
seriousness of these proceedings and his
obligation to comply with the CSA, the
Agency’s rules, and the conditions
imposed pursuant to the 2002 Order, I
further conclude that a period of
outright suspension of his registration is
warranted. Accordingly, while I grant
Respondent a new registration, said
registration will be suspended outright
for a period of three months.
Order
Pursuant to the authority vested in me
by 21 U.S.C. 823 and 824, as well as 28
CFR 0.100(b) and 0.104, I hereby order
that the application of Gregory D.
Owens, D.D.S., to renew his DEA
Certificate of Registration, be, and it
hereby is, granted subject to the
conditions set forth above. I further
order that the DEA Certificate of
Registration issued to Gregory D.
Owens, be, and it hereby is, suspended
VerDate Nov<24>2008
18:55 Jul 23, 2009
Jkt 217001
for a period of three months from the
effective date of this Order. This Order
is effective August 24, 2009.
Dated: July 16, 2009.
Michele M. Leonhart,
Deputy Administrator.
[FR Doc. E9–17681 Filed 7–23–09; 8:45 am]
BILLING CODE 4410–09–P
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. 08–59]
Roy E. Berkowitz, M.D.; Revocation of
Registration
On August 26, 2008, the Deputy
Assistant Administrator, Office of
Diversion Control, Drug Enforcement
Administration, issued an Order to
Show Cause to Roy E. Berkowitz, M.D.
(Respondent), of Slidell, Louisiana. The
Show Cause Order proposed the
revocation of Respondent’s DEA
Certificate of Registration, BB0492912,
as a practitioner, and the denial of any
pending applications to renew or
modify his registration, on the grounds
that Respondent does ‘‘not have
authority to prescribe controlled
substances in the State of Louisiana,’’
and that his ‘‘continued registration is
inconsistent with the public interest.’’
Show Cause Order at 1.
More specifically, the Show Cause
Order alleged that as a result of
prescriptions for controlled substances
which Respondent issued in 2006 and
2007 that were inconsistent with State
rules and regulations, Respondent
entered into a Consent Order with the
Louisiana State Board of Medical
Examiners, which ‘‘strips [Respondent]
of authority to handle controlled
substances in the State of Louisiana, the
state in which [he is] registered with
DEA.’’ Id.
Respondent requested a hearing on
the allegations, and the matter was
assigned to an Administrative Law
Judge (ALJ), who commenced prehearing procedures. Thereafter, the
Government moved for summary
disposition on the ground that
Respondent ‘‘currently lacks authority
to handle controlled substances in the
State of Louisiana—his state of
registration.’’ Gov. Mot. at 1.
In support of its motion, the
Government attached a declaration of a
DEA Diversion Investigator (DI).
Therein, the DI stated that on October
15, 2008, she had queried the Louisiana
State Board of Pharmacy’s Web site to
determine Respondent’s license status,
and found that ‘‘the Controlled
PO 00000
Frm 00110
Fmt 4703
Sfmt 4703
Dangerous Substance license #33853 of
Roy E. Berkowitz, M.D. was delinquent,
having expired on September 25, 2008.’’
Id. at Appendix I.
The ALJ allowed the Respondent to
file a response to the motion through
October 30, 2008. Moreover, on October
29, 2008, the ALJ granted Respondent
an extension of the due date until
November 6, 2008, on which date
Respondent filed his response.
Therein, Respondent noted that while
the Show Cause Order had relied on the
State Board’s Consent Order, the motion
for summary disposition relied on a
‘‘declaration * * * asserting that a
license issued by the Louisiana Board of
Pharmacy to [Respondent] expired on
September 25, 2008.’’ Resp. at 1.
Respondent maintained that the
Government was improperly changing
its theory of the case, and argued that
‘‘[t]he DEA without leave to amend the
Order to Show Cause has sought to
change the underlying basis of the
case.’’ 1 Id. at 2–3.
Next, Respondent argued that the
Agency lacks authority to revoke his
registration because in his view, 21
U.S.C. 824(a)(3) requires both a
suspension, denial or revocation of the
state license or registration, and that the
practitioner no longer be authorized by
state law to handle controlled
substances. Id. at 3–4. In support of his
contention, Respondent attached his
declaration in which he stated that he
submitted his application for renewal of
his Louisiana Controlled Dangerous
Substance License in July 2008, and that
he was ‘‘advised by the Louisiana Board
of Pharmacy that this agency was unable
to process’’ his application. Id., Ex. A at
1. The declaration further asserted that
the Louisiana Board of Pharmacy ‘‘did
not enter an order’’ denying, suspending
or revoking Respondent’s application.
Id. at 1–2. Thus, Respondent argued that
the Government’s motion should be
denied ‘‘[b]ased upon a failure to
establish the elements required under
21 U.S.C. 824(a)(3) and 21 U.S.C.
824(a)(4).’’ Resp. at 5.
On January 27, 2009, the ALJ issued
her Opinion and Recommended
1 Respondent also invoked the ‘‘mend the hold
doctrine,’’ an obscure common law rule which
prohibits a party to a contract from changing its
position on the contract’s meaning during the
course of litigation over it. Id. at 3 (citing Utica Mut.
Ins. Co. v. Vigo Coal Co., Inc., 393 F.3d 707, 716
(7th Cir. 2004)). Specifically, Respondent
contended that the Government’s reliance on the
expiration of Respondent’s lack of a state controlled
substance license was ‘‘analogous to an attempt to
mend the hold,’’ presumably because the Show
Cause Order had cited the consent agreement rather
than the expiration. Id. at 3 (citation omitted).
Respondent did not renew this argument in his
exceptions, and in any event, the analogy is
misplaced.
E:\FR\FM\24JYN1.SGM
24JYN1
Agencies
[Federal Register Volume 74, Number 141 (Friday, July 24, 2009)]
[Notices]
[Pages 36751-36758]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E9-17681]
-----------------------------------------------------------------------
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. 06-77]
Gregory D. Owens, D.D.S.; Suspension of Registration; Grant of
Restricted Registration
On August 7, 2007, the Deputy Assistant Administrator, Office of
Diversion Control, issued an Order to Show Cause to Gregory D. Owens,
D.D.S. (Respondent), of Abingdon, Virginia. The Show Cause Order
proposed the revocation of Respondent's DEA Certificate of Registration
as a practitioner on the ground that his continued ``registration would
be inconsistent with the public interest, as that term is defined under
21 U.S.C. 823(f).'' Show Cause Order at 1.
More specifically, the Show Cause Order alleged that in 1986, when
Respondent moved his dental practice from Tennessee to Virginia, he had
failed to obtain a new registration as required by 21 U.S.C. 822. Id.
The Order further alleged that in 1992, Respondent did not renew his
State ``controlled dangerous substances license'' and that he only
acquired the proper State and Federal registrations in 1996 after a
Virginia Board of Dentistry (``the Board'') inspection. Id. Relatedly,
the Order alleged that in 1996 and 1997, Respondent had ``continued to
prescribe controlled substances in violation of law,'' using his
``long-expired DEA Tennessee registration to facilitate this illegal
activity.'' Id.
Next, the Show Cause Order alleged that in both November 1997 and
May 2000, the Board had placed Respondent's dental license on probation
and subjected him to certain conditions. Id. at 1-2. The Order also
alleged that in August 2005, the State Board had ``issued an Order
which concluded that [Respondent] had continuously demonstrated
disregard for the Board's orders,'' reprimanded him, and continued him
on probation. Id. at 2.
Finally, the Show Cause Order alleged that in October 1999, DEA had
issued an Order to Show Cause to revoke Respondent's registration, and
that on August 2, 2002, my predecessor had issued a Decision and Final
Order which granted Respondent a registration which was ``subject to
restrictions and conditions'' including ``recordkeeping requirements.''
Id. at 1. The Show Cause Order further alleged that in November 2005,
Respondent applied for a renewal of his registration and that a
compliance review found ``that in 2004 and 2005, [Respondent had]
failed to submit the required controlled substance recordkeeping
information to DEA in violation of the conditions of [the] previously
granted registration.'' Id. at 2.
Respondent, through his counsel, timely requested a hearing. The
case was assigned to a DEA Administrative Law Judge (ALJ), who
conducted a hearing in Abingdon, Virginia, on June 27, 2007. At the
hearing, both parties called witnesses to testify and introduced
documentary evidence. Following the hearing, both parties submitted
briefs containing proposed findings of fact, conclusions of law, and
argument.
On March 6, 2009, the ALJ issued her recommended decision (also
ALJ). Therein, the ALJ found that Respondent had violated the terms of
my predecessor's Final Order by failing to file quarterly reports of
the controlled substances he dispensed between the effective date of
the Order (Sept. 3, 2002) and December 31, 2002, the date stated as the
expiration date on a registration which was subsequently issued to him
several months after the expiration date and which was the result of a
clerical error. ALJ at 37-39. However, the ALJ further found that
Respondent's failure to file the reports after that date should be
excused because the Government did not clearly communicate to him that
this registration was issued in error and that a registration issued to
him on September 8, 2003 (which expired on December 31, 2005) was the
``newly renewed registration'' to which the reporting requirement
imposed by the 2002 Order applied. Id. at 39. However, she also found
that because Respondent did not present evidence that he had submitted
the required drug activity logs from August 2002 through December 2002,
Respondent's ``lack of evidence proving good faith compliance weigh[ed]
against the Respondent's continued registration.'' Id. at 40.
The ALJ also found that Respondent had not complied with a second
requirement of the 2002 Order--that he notify DEA within thirty days of
any action taken against his State ``medical license.'' Id. at 40-41.
According to the ALJ, Respondent violated this provision because he
failed to report the 2005 Board action which continued his probation
upon finding that he had committed additional violations. Id. at 41. In
so holding, the ALJ specifically rejected Respondent's contention that
because the 2002 Order had used the term ``medical license'' rather
than ``dental license'' in imposing the condition, he had no obligation
to report the proceeding to DEA. Id.
While the ALJ found that the Government had made out a prima facie
case to revoke Respondent's registration, she concluded that other
factors counseled against a revocation. Id. at 47. More specifically,
she noted that Respondent treated ``many patients from underserved
counties, and a substantial portion of his patients have limited
incomes,'' that there was no evidence of diversion or irresponsible
prescribing practices on Respondent's part, that Respondent had
instituted procedures to ensure the accuracy of his dental records, and
that he had begun filing drug activity reports with this Agency
following a 2006 inspection. Id. at 48. The ALJ thus recommended the
revocation of Respondent's registration but that the revocation be
stayed for twelve months, and that ``[d]uring pendency of the stay, the
Respondent should be allowed to handle controlled substances,'' subject
to certain restrictions. Id.
Neither party filed exceptions to the ALJ's decision. Thereafter,
the record was forwarded to me for final agency action.
Having considered the record as a whole, I hereby issue this
Decision and Final Order. I adopt the ALJ's findings of fact and
conclusions of law except as noted below. While I accept Respondent's
contention that the March 13, 2003 registration was the ``newly renewed
registration'' for purposes of the 2002 Order, I note that Respondent
did not comply with the Order's requirement pertaining to the
submission of quarterly reports even during period in which there is no
dispute that he was required to do so. I also hold that Respondent
violated the 2002 Order because he failed to report the 2005 Board
action to DEA. While I agree that the record does not support an
outright revocation of his registration, I conclude that Respondent's
lengthy history of regulatory troubles supports the suspension of his
registration as well as the imposition of conditions on his new
registration. I make the following findings.
Findings
Respondent graduated from the Medical College of Virginia Dental
[[Page 36752]]
School, now the Virginia Commonwealth University Dental School, in
1981. Tr. 151. Respondent is licensed to practice dentistry in the
State of Virginia and practices in Abingdon (Washington County),
Virginia. Id. at 150-52, 163. Respondent performs root canals and tooth
extractions and often issues a prescription for a controlled substance
to treat a patient's post-operative pain. Id. at 160.
Respondent's last DEA Certificate of Registration was issued on
September 8, 2003, and had an expiration date of December 31, 2005.\1\
RX 3; GX 1, at 1. On or about November 21, 2005, however, Respondent
submitted a renewal application. GX 2, at 1-2. Accordingly,
Respondent's registration has remained in effect throughout the course
of this proceeding.
---------------------------------------------------------------------------
\1\ Respondent previously held a DEA registration which was
issued on February 4, 1997, and which expired on December 31, 1999.
ALJ at 5. On October 1, 1999, the first DEA proceeding was
initiated. RX 42, at 2. On November 8, 1999, Respondent filed a
renewal application, id. at 9, the effect of which was to extend the
expiration date of his registration until the Agency issued its
Decision and Final Order resolving the first proceeding, which it
did on July 24, 2002. See Gregory D. Owens, 67 FR 50461, 50465
(2002) (RX 1, at 5).
On March 13, 2003, Respondent was issued a new Certificate of
Registration. RX 2. However, the Certificate stated that it had
expired on ``12-31-2002.'' Id. According to the registration
history, this Certificate was issued in error. Tr. 85. However, the
fact that it was issued in error was not communicated to Respondent.
Id. at 85-86. It is not clear whether Respondent filed a further
application to obtain the Certificate which was issued on September
8, 2003.
It is also noted that registration certificate which expired on
December 31, 2005, did not contain any indication that it was
subject to restrictions. Tr. 53. DEA does not, however, indicate on
the face of a certificate whether a registration is subject to
restrictions. Id. at 53-54.
---------------------------------------------------------------------------
While Respondent currently holds both a DEA registration and a
State license, he is not a stranger to either DEA or Board proceedings
(nor to Federal criminal proceedings either). Indeed, Respondent has
been disciplined by the Virginia Board on three occasions and has been
the subject of DEA proceedings on two occasions.
The State Proceedings
The first of these proceedings began in October 1997, when the
Board's Executive Director gave notice and ordered Respondent to appear
at an informal conference based in part on allegations that an
inspection of four of his patient records had found that in two of
them, he had ``failed to list drugs prescribed, dispensed, administered
and the quantity.'' GX 4, at 2. In the notice, the Board also alleged
that ``on divers occasions since March 31, 1986, [Respondent] ha[s]
prescribed various controlled substances for patients, including but
not limited to Demerol, Percocet, Percodan, Endocet (all Schedule II),
and hydrocodone (Schedule III), without a current DEA number.'' Id. The
Board further alleged that ``from December 31, 1992 to July 1996,
[Respondent had] issued said prescriptions without having a current
Controlled Substance Registration Certification.'' Id. Finally, the
Board alleged that ``[o]n or about June 30, 1997, in the United States
District Court, Abingdon, Virginia, [Respondent] w[as] found guilty of
one count of Failure to report change of address to DEA, a
misdemeanor.'' \2\ GX 4, at 2. See also GX 14 (judgment finding that
defendant had pled guilty to violations of 21 U.S.C. 842(a)(5) &
(c)(2), fining him $5000, and sentencing him to two years of supervised
release).
---------------------------------------------------------------------------
\2\ On or about January 30, 1997, in the United States District
Court, Abingdon, Virginia, Respondent pled guilty to five (5)
misdemeanor counts of Failure to File Federal Tax Returns, and was
sentenced to five months of home detention and fined $10,000. GX 13,
at 1, 2 & 5.
---------------------------------------------------------------------------
On November 5, 1997, the Board found the above allegations (as well
as others) proved. GX 5, at 2-3. The Board imposed various sanctions
including a reprimand, subjected him to one unannounced inspection
annually, and placed him on probation indefinitely.\3\ Id. at 3.
---------------------------------------------------------------------------
\3\ The November 24, 1997 order was part of the grounds of the
prior DEA action. See RX 1, at 2; see also Owens, 67 FR 50461,
50462.
---------------------------------------------------------------------------
On March 21, 2000, the State Board commenced a second proceeding.
This proceeding was based, in part, on a September 9, 1998 review of
Respondent's drug inventory and records which found that Respondent had
on hand two boxes, which had originally contained twelve bottles each
of dihydrocodeine tablets but, at the time of the inspection, held only
eight bottles each. GX 6, at 2. The Board further alleged that
Respondent had ``failed to take a complete and accurate biennial
inventory of the schedule III and V drugs maintained,'' that he
``failed to maintain a record of drugs received to include the date of
receipt, the name and address from whom received and the kind and
quantity of drugs received,'' and that he had ``failed to maintain a
record of drugs received to include the date of receipt, the name and
address for which the drugs were dispensed, and the kind and quantity
of drugs.'' GX 6, at 2-3.\4\
---------------------------------------------------------------------------
\4\ The proceeding was also based on the results of a September
8, 1999 inspection, which revealed various deficiencies related to
Respondent's alleged violation of the laws and regulations governing
the practice of dentistry. GX 6, at 1-2.
---------------------------------------------------------------------------
On May 8, 2000, the Board found that Respondent had violated
certain terms of its 1997 Order as well as various provisions of the
Virginia Code and the Board of Dentistry Regulations. GX 7, at 1-2, 4.
Pertinent to the Controlled Substances Act, the Board specifically
found proved the allegations pertaining to Respondent's handling of the
dihydrocodeine tablets, including his failure to take biennial
inventories of schedule III and V drugs, and to maintain proper records
of both the drugs received and dispensed. Id. at 3. The Order
reprimanded Respondent and continued his probation ``INDEFINITELY,''
subjected him to two unannounced inspections annually and a reporting
requirement,\5\ and imposed a monetary penalty of $ 5000. Id. at 4-5
(emphasis in original).
---------------------------------------------------------------------------
\5\ Respondent was required to submit quarterly reports of his
address and current employment as part of this Order as well as the
1997 Order. See GX 7, at 4.
---------------------------------------------------------------------------
On July 26, 2005, the Board commenced a third proceeding. This
proceeding was initiated ``to receive and act upon [Respondent's]
petition for termination of [his] probation, to review [his] compliance
with the terms and conditions imposed on [his] license by [the Board's
2000 Order], and to receive and act upon evidence that [he] may have
violated certain laws and regulations governing the practice of
dentistry.'' GX 8. More specifically, the Board alleged that Respondent
had been delinquent in submitting multiple reports, and that an
unannounced inspection on February 9, 2005 had found that he ``may have
violated'' State law and regulations pertaining to the practice of
dentistry.\6\ Id. at 1-2.
---------------------------------------------------------------------------
\6\ More specifically, the Board alleged that Respondent had
``failed to consistently provide the signature of the dentist
completing laboratory work order and the address of the dental
practice,'' and that he had kept expired drugs (none of which are
controlled under Federal law) in his working stock. GX 8, at 1-2.
---------------------------------------------------------------------------
On September 6, 2005, the Board entered an Order which found each
of the allegations proved. GX 9, at 2-3. The Order further found that
Respondent ``has continuously demonstrated disregard for the Board's
Orders.'' Id. at 3. The Board thus reprimanded Respondent, levied an
$11,000 penalty, and denied Respondent's request to terminate his
probation, which was continued indefinitely.\7\ Id. at 3-4. The Order
provided that Respondent's probation ``shall continue from the date
this Order is entered and shall continue indefinitely.'' Id. at 4.
---------------------------------------------------------------------------
\7\ Respondent was again required to submit quarterly report
noting his address and current employment. GX 9, at 4.
---------------------------------------------------------------------------
[[Page 36753]]
In October 2006, the Board conducted an inspection of Respondent's
dental practice and found no deficiencies. RX 13, at 5. Subsequently,
in April 2007, the Board notified Respondent that he was in compliance
with the Board's Order of September 6, 2005, and that no action would
be taken against his dental license. RX 23.
The First DEA Proceeding
On October 1, 1999, the Deputy Assistant Administrator of the
Office of Diversion Control issued an Order to Show Cause which sought
the revocation of Respondent's registration on the ground that
Respondent had committed various acts which rendered his registration
inconsistent with the public interest. RX 1, at 1 (Gregory D. Owens, 67
FR 50461 (2002)). More specifically, the Show Cause Order alleged that:
(1) Between January 1990 and January 1997, Respondent had prescribed
approximately 8,600 dosages units of controlled substances using his
DEA Registration number, which had expired on August 5, 1986; (2)
Respondent had issued controlled-substance prescriptions between May 1
and November 14, 1996, without holding a valid State controlled-
substance registration; and (3) Respondent had pled guilty to failing
to report his change of address to DEA. RX 42, at 2-3.
Following a hearing, on May 4, 2001, the ALJ issued her recommended
decision. Id. at 1. Therein, the ALJ found that between January 1990
and January 1997, Respondent had issued controlled-substance
prescriptions without a valid DEA registration; she also found that
from January 1993 until July 1996, he had issued controlled-substance
prescriptions without a valid State registration. Id. at 14-15. While
in the first proceeding Respondent testified that he did not intend to
violate Federal law, the ALJ also found significant that Respondent had
prescribed Darvocet (also a controlled substance) at the time when his
1996 application was pending but had yet to be renewed. Id. at 15. The
ALJ, however, recommended that my predecessor consider ``Respondent's
acceptance of responsibility for past offenses and rehabilitation when
deciding the likelihood that [his] future conduct * * * will be
consistent with the public interest,'' and that Respondent be allowed
``to demonstrate that he can now handle the responsibilities a DEA
registrant.'' Id. at 18. The ALJ thus recommended that my predecessor
grant Respondent a new registration subject to various conditions.\8\
Id. at 19-20.
---------------------------------------------------------------------------
\8\ My predecessor adopted the ALJ's recommended conditions
nearly verbatim with the exception of the first recommended
condition which was that Respondent take a course in the
identification and handling of controlled substances. RX 42, at 19.
---------------------------------------------------------------------------
On July 24, 2002, the Deputy Administrator issued his final
decision in the matter, which was effective no later than September 3,
2002. See Gregory D. Owens, 67 FR 50461, 50465 (2002). The Order
granted Respondent's application for renewal of his registration
subject to the following 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 of any action taken by any State upon his medical license
or upon his authorization to handle controlled substances in 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.
Id. at 50464.
Respondent's Compliance With the 2002 DEA Order
After receiving the ALJ's recommended decision (and before the 2002
Decision and Final Order was issued), Respondent began filing quarterly
drug activity logs with the Agency. Tr. 43 & 169; see also id. at 70-71
(Respondent's counsel asking DI whether Respondent had started sending
in the drug logs following his receipt of the ALJ's decision). While
not part of the ALJ's recommended sanction (or subsequently required by
the Agency's Final Order), Respondent started using a carbon-copy
prescription pad and faxing prescriptions to pharmacies so that the
original prescription could go in the patient file and the carbon copy
could be maintained as a record to double-check the drug activity log.
Id. at 135 & 169.
However, following the issuance of the Final Order, Respondent
stopped sending in the quarterly activity logs. Id. at 42-43; 51. When
asked by the Government on cross-examination how many quarterly reports
he had sent to DEA following the issuance of the Final Order and the
date he thought his obligation to file the reports had ended,
Respondent testified that he did not know and did not have that
information with him because he was ``just prepared to talk about 2004
and 2005.'' Id. at 186. On redirect examination, Respondent further
maintained that he was not prepared to testify about what happened in
2001 and 2002 because the Government had not given him notice that this
would be at issue in the Show Cause Order and other documents. Id. at
191.
Yet on direct examination, Respondent had testified that when he
received the ALJ's May 2001 decision, he ``began sending in our
quarterly reports.'' Id. at 169.\9\ He also testified that he
believed--and had told the DI--``that the newly renewed registration
referred to in the DEA's decision had expired.'' Id. at 162.
---------------------------------------------------------------------------
\9\ Respondent objected to the Government's questioning the DI
regarding Respondent's failure to submit the drug logs in the years
prior to 2004 and 2005 on the ground that neither the Show Cause
Order nor the Government's pre-hearing statement had disclosed that
this would be at issue. Tr. 44-46. Respondent, however, did not
object when the Government had previously asked the DI: ``What log
of activities were received by DEA from [Respondent] after the date
of the issuance of this order on August 2, 2002?'' and the DI
answered: ``There were no activity logs or drug logs submitted after
August of 2002 until after we visited Dr. Owens' office in 2006.''
Id. at 42-43. Notably, when the DI continued with his answer and the
Government's counsel interrupted him, Respondent's counsel did not
object to the line of questioning but only that ``the witness be
allowed to complete his answer.'' Id. at 43. The DI then explained
that in 2007, Respondent's attorney had ``submitted all the drug
logs that were kept.'' Id.
Respondent's objection was untimely and was properly overruled
for this reason as well.
---------------------------------------------------------------------------
Regarding the 2002 Order's requirement that he notify the Agency
``within 30 days'' of ``any action taken by any State upon his medical
license,'' 67 FR at 50464, Respondent testified that he has never had a
medical license and that he has a dental license. Tr. 163 & 178. With
respect to the 2005 State Board proceeding, in which the Board had
reprimanded him, fined him, rejected his petition to terminate and
continued him on probation, Respondent maintained that the Board had
not taken action against his license because there was no change in the
status of his license. Id. at 165. Amplifying this testimony,
Respondent stated: ``My license was under probation and it did not
change. Nothing changed
[[Page 36754]]
on my license itself. I guess you could split hairs.'' Id. at 181. He
also maintained that his obligation to report any Board actions against
his license had expired on December 31, 2002, based on the expiration
date of the registration certificate, although he acknowledge that ``I
don't think it's quite as clear as on the other one.'' Id. at 188.
The 2006 DEA Investigation
On November 21, 2005, Respondent submitted an application to renew
his registration. GX 2, at 2. On January 19, 2006, two DEA DIs, who
were accompanied by a member of the Virginia State Police, inspected
Respondent's office and inquired as to why Respondent had not submitted
the drug activity logs in 2004 and 2005. Tr. 23, 33-34. Respondent told
the investigators that ``he wasn't aware of that'' and showed them a
copy of the ALJ's ruling. Id. at 65-66. The investigators also
determined that Respondent did not have any Federally controlled
substances on the premises and reviewed a drug log that he had kept
since September 18, 2005. Id. at 34-35; see also GX 10.
The DIs then looked at Respondent's appointment book and selected
sixty-eight patient records to review to determine whether the
controlled substances Respondent had prescribed had been recorded in
the drug log. Id. at 38-39. According to the DI, there were seven
instances in which a prescription which was recorded in a patient file
was not listed in the drug log. Id. at 39, 60-61. The DI further
acknowledged that Respondent consented to the inspection and was
cooperative, id. at 54-55, and that he had no evidence that Respondent
engaged in the diversion of controlled substances. Id. at 58.
The next day, Respondent had a telephone conversation with one of
the DIs and asked him ``exactly what was the term of a newly renewed
registration.'' Id. at 63. The DI did not directly answer the question
and instead told Respondent that ``we would take a look at'' the
information that had been obtained. Id. According to the DI, during the
conversation, Respondent told him that he had found a letter which
explained what the requirements were.\10\ Id. at 67. Respondent
testified that he ``didn't believe'' that he was required to submit
records in 2004 and 2005 because he thought the ``newly renewed
registration referred to in the DEA's decision had expired.'' Id. at
161-62.
---------------------------------------------------------------------------
\10\ The letter is not in the record.
---------------------------------------------------------------------------
In his testimony, the DI further testified that the Certificate of
Registration which was issued on March 13, 2003, and which had expired
on December 31, 2002, was not his new registration, but rather ``a
continuation of his previous registration.'' Id. at 84. He further
maintained that this registration certificate was issued in error and
pointed to an administrative code, which indicated as much, on
Respondent's registration history. Id. at 85; see also GX 15. However,
the DI was aware of no evidence that this information had been
communicated to Respondent. Id. at 86.
On March 16, 2006, Respondent's counsel submitted the drug activity
logs from July 2002 through December 2005 to the DI. RX 22. In his
letter forwarding the logs, Respondent's counsel maintained that, based
on the 2002 Order, Respondent ``is under no duty to provide these to
the DEA.'' \11\ Id. Relatedly, Respondent testified that he submitted
the drug activity logs out of ``an abundance of caution'' because it
was ``difficult to know exactly what [he was] supposed to do.'' Tr.
183.
---------------------------------------------------------------------------
\11\ Most of the logs pertaining to this period (including those
pertaining to the period between the issuance of the 2002 Order and
December 31, 2002) are not in evidence.
The ALJ found that these drug activity logs did not meet the
requirements of the 2002 Decision and Order as they ``failed to
record when and the amount of controlled substances that had last
been provided to the patient.'' ALJ at 18 (citing Tr. 185; RX 42, at
19; RX 1, at 4). It is noted that the Drug Log for the period
September 18, 2005, through January 18, 2006, was frequently missing
information such as ``the patient's complaint,'' as well as the date
the medicine was last prescribed to the specific patient and the
quantity. Compare GX 10 with GX 3, at 6-7. Neither party, however,
submitted the drug logs for the period between the issuance of the
2002 Order and December 31, 2002.
---------------------------------------------------------------------------
Respondent's Evidence Regarding Remedial Measures
On September 2, 2006, Respondent entered into a consulting
agreement with a registered nurse, who was to review his compliance
with DEA regulations on a monthly basis. RX 5, at 1, 5. Moreover, at
the end of each month, the consultant audits all the patient charts
that are listed in the drug activity log. Tr. 106. The consultant also
goes through the appointment book and randomly selects twenty-five
patient charts which she reviews to see if any prescriptions were not
entered into the drug activity log. Id. The entries in the drug
activity log are also checked against the patient charts for accuracy.
RX 6. The consultant then provides a monthly report of both the drug
activity log audit and the random patient chart audit. Tr. 106; RXs 7-
13. According to the consultant, Respondent's recordkeeping is now
``well organized'' and ``efficient'' and Respondent is capable of
providing ``accurate'' records to this Agency.\12\ Tr. 113-14.
---------------------------------------------------------------------------
\12\ Respondent offered into evidence affidavits of three other
dentists, who variously declared that he is ``an asset to the dental
community in the Abingdon, Virginia area,'' ``an excellent asset to
the dental and general community,'' and an ``excellent dentist who
uses good dental techniques.'' RXs 15-17.
Respondent also put on extensive evidence regarding the
socioeconomic status of his patients and the shortage of dentists in
the area where he practices. However, for reasons discussed below, I
conclude that it is not necessary to engage in fact-finding on these
issues.
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Discussion
Section 304(a) of the Controlled Substances Act (CSA) provides that
a registration to ``dispense a controlled substance * * * may be
suspended or revoked by the Attorney General upon a finding that the
registrant * * * has committed such acts as would render his
registration under section 823 of this title inconsistent with the
public interest as determined under such section.'' 21 U.S.C.
824(a)(4). With respect to a practitioner, the CSA requires that the
following factors be considered in making the public interest
determination:
(1) The recommendation of the appropriate State licensing board
or professional disciplinary authority.
(2) The applicant's experience in dispensing * * * 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.
21 U.S.C. 823(f).
These factors are considered in the disjunctive; I ``may rely on
any one or a combination of factors and may give each factor the weight
[I] deem[] appropriate'' in determining whether a registration should
be revoked and/or an application should be denied. Robert A. Leslie, 68
FR 15227, 15230 (2003). Moreover, case law establishes that I am ``not
required to make findings as to all the factors.'' Hoxie v. DEA, 419
F.3d 477, 482 (6th\\ Cir. 2005); see also Morall v. DEA, 412 F.3d 165,
173-74 (D.C. Cir. 2005).\13\
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\13\ DEA has the burden of proving that the requirements for
revocation are met. 21 CFR 1301.44(e). However, if the Government
makes out a prima facie case, the burden shifts to the Respondent to
demonstrate that the continuation of his registration is consistent
with the public interest.
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[[Page 36755]]
Factor One: The Recommendation of the State Licensing Board
As found above, Respondent had been the subject of three separate
State board proceedings and been disciplined on each occasion.
Moreover, the first two proceedings involved violations which did not
simply involve violations of State rules pertaining to the practice of
dentistry but also violations of the CSA and DEA's regulations.
The ALJ noted that in the 2002 Decision and Order, the Agency had
concurred with her conclusion that because the Board had not restricted
Respondent's ability to handle controlled substances, this
``demonstrate[d] that the Board does not believe Respondent poses a
danger to the public health and safety, to the extent that he cannot be
trusted with the serious responsibilities of practicing dentistry and
handling controlled substances.'' ALJ at 34-35 (quoting Owens, 67 FR at
50463). Remarking on the 2005 Board proceeding and the April 2007 Board
letter which closed the case, the ALJ found it ``significant that in
all orders, the Board chose not to restrict Respondent's handling of
controlled substances,'' and that this factor ``weighs in favor of
continuing the Respondent's DEA Certificate of Registration.'' Id. at
35-36.
While DEA has frequently considered State board proceedings which
do not result in a revocation or suspension under this factor, the
Agency ``maintains a separate oversight responsibility with respect to
the handling of controlled substances and has a statutory obligation to
make its independent determination'' as to whether the continuation of
an existing registration is in the public interest. Mortimer B. Levin,
55 FR 8209, 8210 (1990); see also Jayam Krishna-Iyer, 74 FR 459, 462
(2009).\14\ Accordingly, while I concur in the ALJ's conclusion
regarding this factor, I give it only nominal weight in the public
interest inquiry. See Martha Hernandez, 62 FR 61145, 61147 (1997)
(finding that State board decisions are relevant, although not
dispositive, on the issue of granting or denying a DEA application).
---------------------------------------------------------------------------
\14\ As my predecessor noted in the 2002 Decision and Order, the
various orders issued in the State board proceedings are not in any
sense an ``official recommendation regarding this proceeding's
outcome.'' 67 FR at 50463. Moreover, a State board may apply a
different standard than the public interest standard applicable
under the CSA and thus consider factors which DEA does not consider
relevant. Thus, I give this factor only nominal weight.
---------------------------------------------------------------------------
Factors Two and Four: Applicant's Experience in Dispensing Controlled
Substances and Compliance With Applicable State, Federal or Local Law
The record in this matter establishes a pattern of Respondent's
non-compliance with the requirements of both State and Federal Law
relating to controlled substances. More specifically, for at least
seven years, Respondent violated Federal law by issuing prescriptions
for both schedule II and III controlled substance based on an expired
registration.\15\ See 21 U.S.C. 822(a)(2); see also 21 U.S.C.
843(a)(2). He also violated Virginia law, which at the time required
that he also hold a State registration, for more than three years.
---------------------------------------------------------------------------
\15\ I further note Respondent's misdemeanor conviction for
failing to notify DEA of his address change. See 21 U.S.C.
823(f)(3).
---------------------------------------------------------------------------
Subsequently, the Virginia Board found that Respondent was in
violation of various State rules because he had on hand a stock of
schedule III controlled substances and was not taking inventories and
maintaining both receiving and dispensing records.\16\ Moreover, the
findings of the Board establish that Respondent could not account for
eight bottles of dihydrocodeine, a schedule III controlled
substance.\17\ GX 7, at 3.
---------------------------------------------------------------------------
\16\ Under DEA regulations, ``[a] registered individual
practitioner is required to keep records * * * of controlled
substances in Schedules II, III, IV, and V which are dispensed,
other than by prescribing or administering in the lawful course of
professional practice.'' 21 CFR 1304.03(b).
\17\ It is unclear, however, how many tablets were in each
bottle.
---------------------------------------------------------------------------
The central issue in this case was, however, Respondent's
compliance with the terms of this Agency's 2002 Order. More
specifically, the Government contended that Respondent had failed to
comply with the requirements that he submit drug activity logs each
quarter and notify DEA of any action taken against his ``medical
license.''
With respect to the first issue, Respondent raises several
contentions. First, he argues that his rights under the Due Process
Clause and the Administrative Procedure Act were violated because the
Government was allowed to introduce evidence regarding his compliance
with the 2002 Order pertaining to years which were not alleged in the
Show Cause Order (which alleged that he had not complied during the
years 2004 and 2005) or in the Government's Pre-Hearing Statement.
Resp. Br. at 21. Respondent also argues that ``he had no notice to
prepare for or to rebut the testimony as to the years before 2004.''
Id. Relatedly, Respondent contends that ``[o]ver [his] objection, the
ALJ allowed the Government to inquire into [his] reporting before
2004.'' Id. at 25.
Respondent did not, however, timely object to the Government's
questioning the DI as to what logs have been received after the
issuance of the Order on August 2, 2002. Tr. 42-43. Indeed,
Respondent's counsel objected that the Government had not allowed the
DI to complete his answer. Id. at 43. Nor did Respondent object to the
Government's subsequent question as to what logs he had submitted prior
to the issuance of the 2002 Order. Id. Rather, Respondent did not
object until after the Government had asked several additional
questions. Id. at 43-44. I thus conclude that Respondent waived his
objection to the admission of this evidence.\18\
---------------------------------------------------------------------------
\18\ Moreover, on cross-examination Respondent's Counsel asked
the DI whether Respondent had started sending in the drug logs
following his receipt of the ALJ's Decision. Tr. 70-71.
---------------------------------------------------------------------------
Finally, even if it was error for the ALJ to allow the Government
to pursue this line of questioning, the error was not prejudicial. See
5 U.S.C. 706. Notably, on direct examination, Respondent testified that
after receiving the ALJ's recommended decision, which was issued in May
2001, ``[W]e began sending in our quarterly reports.'' Tr. 168-69.
Thus, Respondent went into areas that pre-dated the time-frame
referenced in the Show Cause Order and Government's Pre-Hearing
Statement. Moreover, on direct examination, Respondent maintained that
he was not required to file the reports because he believed ``that the
newly renewed registration referred to in the [2002] decision had
expired.'' Id. at 162. Given his testimony that he had started sending
in the reports after receiving the ALJ's May 2001 decision and that he
believed his obligation ended based on the expiration of the
erroneously issued registration, the contention that his compliance
during the four-month period in which it is undisputed that he was
required to submit the reports is not properly at issue, amounts to
trying to have his cake and eat it too.\19\
---------------------------------------------------------------------------
\19\ Furthermore, while the ALJ denied Respondent's request for
a continuance to gather the evidence that would show that the logs
were sent in during the period between the issuance of the 2002
Order and December 2002, the ALJ made clear that Respondent could
renew his request at ``the conclusion of the presentation of [the]
evidence'' and noted that the record could be left open for this
purpose. Tr. 48-49. Respondent did not, however, request that the
record be left open or submit any such reports.
---------------------------------------------------------------------------
I am also unpersuaded by Respondent's contention that he was ``not
prepared to testify about what happened in 2001 and 2002'' because
[[Page 36756]]
the Government failed to give notice. Tr. 191. Respondent's testimony
that he started sending in the reports after receiving the ALJ's May
2001 decision demonstrates that he was obviously prepared to discuss
what happened in 2001 and 2002. I therefore reject Respondent's
contention that his rights under the Due Process Clause and APA were
violated because the Government introduced evidence regarding his non-
compliance with the Order.
As found above, the record establishes that Respondent did not
submit any drug activity logs as required by the 2002 Decision and
Final Order. I conclude, however, that Respondent cannot be deemed to
have violated the terms of the Order subsequent to December 31, 2002.
The Order expressly stated that it was granting Respondent's
renewal application and that it was effective ``no later than September
3, 2002.'' GX 3, at 7. Thus, while the certificate issued on March 13,
2003, indicated that it had expired on December 31, 2002, and the
evidence indicates that it was issued in error, the registration could
be reasonably interpreted as having granted authority to Respondent for
the period between September 3 and December 31, 2002.\20\
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\20\ Under the APA, Respondent's November 1999 renewal
application provided authority only ``until the application ha[d]
finally been finally determined by the agency.'' 5 U.S.C. 558(c).
The final determination on this application was the 2002 Decision
and Final Order which granted the application.
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Throughout this proceeding, the Government has contended that
Respondent's obligation to submit the quarterly drug activity logs did
not end with the expiration date indicated on this registration. The
Government further contends that the actual registration the 2002 Order
referred to was that which issued on September 8, 2003, and which
expired on December 31, 2005.
It is acknowledged that my predecessor likely used the phrase--
``[d]uring the duration of the newly renewed registration''--intending
that the first condition would last for the period of a full
registration. Under DEA's regulations, a practitioner's registration is
typically valid for thirty-six months, see 21 CFR 1301.13(d)), and not
for only four months.
The Government ignores, however, that Due Process requires that
when the Agency imposes conditions on a registration, those conditions
must be ``sufficiently clear to inform'' a registrant as to ``what
conduct will result in'' a violation. United States v. Ashland, Inc.,
356 F.3d 871, 874 (8th Cir. 2004) (citing United States v. Guagliardo,
278 F.3d 868, 872 (9th Cir. 2002)). Relatedly, the Government ignores
that it never informed Respondent that the March 13, 2003 registration
was issued by mistake. It also ignores that it was not until more than
three years later that it informed Respondent of its view that the
September 8, 2003 registration was ``the newly renewed registration''
which governed the duration of his obligation to file the drug activity
logs.
Respondent therefore cannot be held to have violated the 2002 Order
because he failed to file the drug activity logs after December 31,
2002. Respondent did, however, violate the Order because he did not
file the logs even during the period when it was clear that he was
required to do so.
As found above, the record also establishes that Respondent did not
report the 2005 Board proceeding to the Agency. Respondent offers three
arguments in response. First, relying on the 2002 Order's mistaken
reference to ``any action taken * * * upon his medical license,'' \21\
he contends that he ``has never held a medical license,'' and that
``[t]he [S]tate of Virginia has never taken any action against [his]
non-existent medical license.'' Resp. Br. at 21.
---------------------------------------------------------------------------
\21\ See also RX 42, at 19 (ALJ' s recommended sanction that
``Respondent must inform the DEA of any action taken by any State
upon his medical license'').
---------------------------------------------------------------------------
The argument is too clever by half. Precisely because Respondent
has never held a medical license, and the prior DEA proceeding
discussed an action by the State Board of Dentistry which imposed
conditions on his dental license, see RX 42, at 13-14, Respondent had
ample reason to know that the 2002 Order had mistakenly referred to his
``medical license'' and that the purpose of the condition was to
require him to report any action taken upon his dental license.
Next, Respondent contends that the 2005 Board action ``occurred
long after [his] duty to report to the DEA lapsed.'' Resp. Br. at 21.
However, in contrast to the other two conditions it imposed, the 2002
Order did not limit the duration that this condition would be in
effect. See GX 3, at 6-7. This is hardly surprising given that at the
time the Order was issued, the State Board had placed him on probation
``INDEFINITELY'' and had imposed various conditions. See GX 7, at 4-5.
Nor is it surprising given Respondent history of non-compliance with
the Board's orders. Most significantly, the 2002 DEA Order was
``sufficiently clear to inform'' Respondent as to his obligation to
report the 2005 Board action. Ashland, 356 F.3d at 874.
Finally, Respondent maintains that he had no obligation to report
the 2005 Board action because the Board ``took no action against [his]
dental license'' and ``[h]e remained on probation throughout the
relevant period.'' Resp. Br. at 21. In the 2005 proceeding, however,
the Board (in addition to reprimanding and fining him), rejected
Respondent's petition to terminate his probation, and again, continued
his probation ``indefinitely.'' GX 9, at 3. Moreover, the Board stated
that ``[v]iolation of this Order may constitute grounds for suspension
or revocation of [Respondent's] license.'' Id. at 4. The Board's Order
thus clearly constituted ``action taken by any State upon his * * *
license.'' GX 3, at 7.
I therefore conclude that Respondent violated the terms of the
Agency's 2002 Order by failing to report the 2005 Board action as well
as by his failure to file the quarterly drug activity logs during the
period between the issuance of the Order and December 31, 2002. These
failures alone establish that Respondent has committed acts which
``render his registration * * * inconsistent with the public interest''
and which support the suspension or revocation of his registration. 21
U.S.C. 824(a). Moreover, even though Respondent's misconduct, which was
the subject of the 2002 Order, occurred some time ago, it buttresses
this conclusion. See 21 U.S.C. 823(f)(2) (directing the Attorney
General to consider the registrant's experience in dispensing
controlled substances).
Factor Five--Such Other Conduct Which May Threaten Public Health and
Safety
Under this factor, the ALJ made extensive findings regarding the
shortage of dentists in the region where Respondent practices and the
percentage of his patients who come from underserved areas. The ALJ
further noted that in Pettigrew Rexall Drugs, 64 FR 8855 (1999), a case
involving a pharmacy, the Agency had considered that the ``pharmacy was
located in an underserved community'' and that this was a factor that
``impacted the public interest.'' ALJ at 46 (citing 64 FR at 8860). The
ALJ then reasoned that even though Respondent is not ``physically
located in an underserved community * * * the focus should be on who is
actually being served by the practice.'' Id. Because Respondent has 561
patients from underserved counties, and many of these patients have
limited incomes, the ALJ concluded that this factor weighs
[[Page 36757]]
against the imposition of either a suspension or revocation of his
registration. Id. at 48.
DEA has never applied this rule in a subsequent case, and I
conclude that it would be ill-advised to extend it to the case of a
prescribing practitioner. The public interest standard of 21 U.S.C.
823(f) is not a freewheeling inquiry but is guided by the five specific
factors which Congress directed the Attorney General to consider;
consideration of the socioeconomic status of a practitioner's patient
population is not mandated by the text of either 21 U.S.C. 823(f) or
824(a)(4), which focus primarily on the acts committed by a
practitioner.
Moreover, where, as here, the Government has made out a prima facie
case that a practitioner has committed acts which render his
registration inconsistent with the public interest, the relevant
inquiry is (and the Agency's longstanding rule has been to examine)
whether the practitioner has put forward ``sufficient mitigating
evidence to assure the Administrator that he can be entrusted with the
responsibility carried by such a registration.'' Medicine Shoppe-
Jonesborough, 73 FR 364, 387 (2008) (citing cases). As noted in
numerous cases, this inquiry looks to whether the registrant has
accepted responsibility for his misconduct and undertaken corrective
measures to prevent the re-occurrence of similar acts. Whether a
practitioner treats patients who come from a medically underserved
community or who have limited incomes has no bearing on whether he has
accepted responsibility and undertaken adequate corrective measures.
Finally, contrary to the ALJ's understanding, extending the holding
of Rexall Pettigrew would likely cause greater harm to the public
interest. The diversion of prescription drugs has become an
increasingly serious societal problem, which is particularly
significant in poorer communities whether they are located in rural or
urban areas. See, e.g., George C. Aycock, 74 FR 17529, 17544 n.33
(2009); Laurence T. McKinney, 73 FR 43260 (2008); Paul H. Volkman, 73
FR 30630 (2008); Medicine Shoppe-Jonesborough, 73 FR at 363. See also
U.S. General Accounting Office, PRESCRIPTION DRUGS: OxyContin Abuse and
Diversion and Efforts to Address the Problem 31-32 (Dec. 2003) (noting
that ``the Appalachian region, which encompasses parts of Kentucky,
Tennessee, Virginia, and West Virginia, has been severely affected by
prescription drug abuse, particularly pain relievers * * * for many
years''). The residents of this Nation's poorer areas are as deserving
of protection from diverters as are the citizens of its wealthier
communities, and there is no legitimate reason why practitioners should
be treated any differently because of where they practice or the
socioeconomic status of their patients.\22\ I thus conclude that this
factor does not support the continuation of Respondent's registration.
---------------------------------------------------------------------------
\22\ It is acknowledged that there is no evidence that
Respondent has diverted controlled substances. However, in assessing
what sanction to impose, the Agency already considers the extent and
egregiousness of a practitioner's misconduct. Accordingly, it is not
clear what principle exists for determining when evidence that a
practitioner treats underserved patients should be considered and
when it should not be.
Beyond this, the ALJ's reasoning suggests how unworkable
applying this standard would be. As she explained: ``the focus
should not simply be on whether a dental practice is physically
located in an underserved community; this is simply too narrow a
view. Rather, the focus should be on who is actually being served by
the practice.'' ALJ at 46. The ALJ then noted that 561 of his
patients (notably, only about ten percent of his patients) were from
underserved areas, and that a majority of his patients have limited
finances.
The ALJ's reasoning begs the question of how many patients from
underserved areas would a practitioner have to treat to claim the
benefit of the rule. As for her reliance on the fact that a majority
of Respondent's patients have limited incomes, determining what
constitutes a patient with a limited income or finances and how many
patients (or what percentage of patients) a practitioner must have
to claim entitlement to this rule, would inject a new level of
complexity into already complex proceedings and take the Agency far
afield of the purpose of the CSA's registration provisions, which is
to prevent diversion. Finally, while I decline to extend the
Pettigrew rule to prescribing practitioners, I further note that
Respondent offered no evidence that he charges his patients who have
``limited finances'' lower fees for his services.
---------------------------------------------------------------------------
Sanction
Where, as here, the Government has made out a prima facie case that
a practitioner has committed acts which render his registration
inconsistent with the public interest, the practitioner must put
forward ``sufficient mitigating evidence to assure the Administrator
that he can be entrusted with the responsibility carried by such a
registration.'' Medicine Shoppe-Jonesborough, 73 FR 364, 387 (2008)
(citing cases). As noted in numerous cases, this inquiry looks to
whether the registrant has accepted responsibility for his misconduct
and undertaken corrective measures to prevent re-occurrence of similar
acts.
As found above, Respondent violated the terms of the restricted
registration which the Agency granted him by failing to submit a
quarterly drug activity log during the four- month period over which
there is no dispute that he was required to submit the log. Moreover,
Respondent failed to report the 2005 Board Action. When coupled with
the acts which gave rise to the 2002 Order, Respondent has demonstrated
a disturbing record of non-compliance with both State and Agency
requirements.
Respondent's evidence regarding his acceptance of responsibility is
equivocal. While it appears that Respondent started sending in drug
logs upon receipt of the ALJ's 2001 decision, he offered no explanation
as to why he stopped upon receiving the 2002 Order. Moreover, while I
acknowledge that a registrant can in good faith dispute whether a
regulatory provision requires certain action, Respondent's arguments
with respect to his failure to report the 2005 Board action (e.g., that
the Order did not apply to him because he has a dental license and that
the State took no action against him when it rejected his petition to
terminate and continued his probation) were generally disingenuous.
I acknowledge that Respondent also instituted corrective measures
to improve his documentation of his prescribing practices, including
bringing in a consultant to audit his records.\23\ I also note that
there is no evidence that Respondent has prescribed controlled
substances without ``a legitimate medical purpose.'' 21 CFR 1306.04(a).
I therefore conclude that the record as a whole does not support the
revocation of Respondent's registration.
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\23\ In setting this sanction, I place no weight on the DI's
testimony that during the 2006 inspection, he found seven
discrepancies between the drug activity logs and Respondent's
patient records because the discrepancies did not involve the period
in which it is clear that Respondent had an obligation to maintain
the logs. I also place no weight on Respondent's evidence regarding
the drug logs he eventually submitted for the period in which the
requirement clearly applied. Even were I to ignore that the logs
were submitted years late, because Respondent did not submit copies
of these documents for the record, it is unclear whether they
contained all of the information required by the 2002 Order.
---------------------------------------------------------------------------
However, Respondent has a lengthy history of non-compliance with
both DEA and State requirements and did not appreciate the forbearance
which this Agency exercised in the 2002 Order. Moreover, in light of
the wording of the 2002 Order and the circumstances surrounding the
issuance of the registration certificate in March 2003, Respondent has
not been required to comply with the intended requirements of that
Order. I therefore conclude that Respondent should be granted a new
registration subject to the following conditions.
(A) Respondent shall submit to the local DEA office, a drug
activity log on a quarterly basis, no later than twenty (20) days
from the last day of the quarter which shall be March 31, June 30,
September 30, and December 31 of each calendar year. Each log must
contain
[[Page 36758]]
the following: (1) The date that a controlled substance was
administered, or dispensed (whether by prescription or actual
delivery of the drug); (2) the name of the patient to whom a
controlled substance was administered or dispensed (whether by
prescription or actual delivery); (3) the patient's dental
complaint; (4) the name, dosage, and quantity of the substance
prescribed, dispensed or administered; and (5) the date that the
medication was previously prescribed, dispensed or administered to
that patient if the medication was prescribed, dispensed or
administered in the last year, as well as the amount last provided
to that patient. If no controlled substances are prescribed,
administered, or dispensed during a given quarter, Respondent shall
submit a letter to the DEA office indicating that there was no
activity to report during the quarter.
(B) Within 15 days of the event, Respondent shall inform the
local DEA office of any proceeding initiated against him by a State
licensing board, whether the board regulates his professional
practice or his authority to prescribe controlled substances. In
addition, within 15 days of the event, Respondent shall inform the
local DEA office of any interim or final order of a State licensing
board which imposes a sanction, whether the sanction be a reprimand,
a fine, a civil penalty, a probationary period, a rejection of a
petition for termination of probation, an imposition of a condition,
a suspension, or a revocation of any State professional license or
authority to prescribe a controlled substance.
(C) In the event that Respondent changes employment during this
three-year period, he shall immediately notify the local DEA office
that is monitoring his drug activity logs.
To ensure that there is no confusion as to the duration of these
conditions, all three conditions shall remain in effect for a period of
three years from the date of this Order's publication in the Federal
Register.
Moreover, because Respondent has not previously appreciated the
seriousness of these proceedings and his obligation to comply with the
CSA, the Agency's rules, and the conditions imposed pursuant to the
2002 Order, I further conclude that a period of outright suspension of
his registration is warranted. Accordingly, while I grant Respondent a
new registration, said registration will be suspended outright for a
period of three months.
Order
Pursuant to the authority vested in me by 21 U.S.C. 823 and 824, as
well as 28 CFR 0.100(b) and 0.104, I hereby order that the application
of Gregory D. Owens, D.D.S., to renew his DEA Certificate of
Registration, be, and it hereby is, granted subject to the conditions
set forth above. I further order that the DEA Certificate of
Registration issued to Gregory D. Owens, be, and it hereby is,
suspended for a period of three months from the effective date of this
Order. This Order is effective August 24, 2009.
Dated: July 16, 2009.
Michele M. Leonhart,
Deputy Administrator.
[FR Doc. E9-17681 Filed 7-23-09; 8:45 am]
BILLING CODE 4410-09-P