FR Doc E9-17681[Federal Register: July 24, 2009 (Volume 74,
Number 141)] [Notices] [Page 36751-36758] From the Federal
Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr24jy09-134]
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.
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\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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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).
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\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.
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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.
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\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.
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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\
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\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.
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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).
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\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.
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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.
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\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.
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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.
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\7\ Respondent was again required to submit quarterly
report noting his address and current employment. GX 9, at 4.
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[[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.
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\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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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.
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\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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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.
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\10\ The letter is not in the record.
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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.
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\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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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.
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\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.
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\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\
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\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.
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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\
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\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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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.
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\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
NOTICE: This is an
unofficial version. An official version of these publications may be obtained
directly from the Government Printing Office (GPO).