Margy Temponeras, M.D.; Decision and Order, 45675-45688 [2012-18749]
Download as PDF
tkelley on DSK3SPTVN1PROD with NOTICES
Federal Register / Vol. 77, No. 148 / Wednesday, August 1, 2012 / Notices
certifying or diagnosing a patient as
needing medical marijuana, but
acknowledged a lack of investigative
information that Respondent ‘‘ever
handed any marijuana to anybody for
cash.’’ (Tr. 77–78.) The weight of the
evidence demonstrates that
Respondent’s activities, as it relates to
marijuana, were primarily limited to
medical marijuana recommendations.
(See, e.g., Gov’t Ex. 2, at 3–4.)
Accordingly, I find that the
Government has not established by a
preponderance of the evidence that
Respondent ‘‘distributed marijuana[,]
* * * aided and abetted the distribution
of marijuana[,]’’ or engaged in other
related conduct. Cf. Marion ‘‘Molly’’ Fry,
M.D., 67 Fed. Reg. 78,015 (DEA 2002)
(the respondent’s registration not
revoked ‘‘‘merely because’ she
recommended marijuana to a patient
‘based on a sincere medical judgment’ ’’
but primarily because she distributed
marijuana and aided and abetted in
distribution of marijuana).
A remaining issue in this case is
whether Respondent has accepted
responsibility for his past misconduct,
and demonstrated that he will not
engage in future misconduct. The
Government argues that there ‘‘is
nothing in the record that evinces
Respondent’s acceptance of
responsibility * * *.’’ (Gov’t Br., at 18.)
The Government also notes that
Respondent lacked candor throughout
his testimony, simply claiming that he
was unaware of certain regulations or
attempting to justify his prescribing
practices by ‘‘fabricat[ing] a story
* * *.’’ (Id. at 18–19.) Respondent does
not specifically address acceptance of
responsibility in his post-hearing brief,
but he instead claims that the
Government did not meet its burden of
proof because he did not intentionally
violate any state or federal regulations,
and because ‘‘the government’s case
rests entirely upon a web of lies spun
by two undercover agents * * *.’’
(Resp’t Br., at 14–15.)
As discussed above, Respondent’s
testimony as a whole fails to adequately
accept responsibility for his past
misconduct, particularly with regard to
his prescribing practices to the UCs.
Under Agency precedent, in the absence
of a credible explanation by the
practitioner, as few as two incidents of
diversion are sufficient to revoke a
registration. Alan H. Olefsky, M.D., 57
FR 928, 929 (DEA 1992). Respondent’s
lack of credibility during numerous
material portions of his testimony
weighs heavily against a finding that
Respondent has accepted responsibility,
let alone demonstrated that he will not
engage in future misconduct. See Hoxie
VerDate Mar<15>2010
19:53 Jul 31, 2012
Jkt 226001
v. DEA, 419 F.3d 477, 483 (6th Cir.
2005) (DEA properly considers
physician’s candor, forthrightness in
assisting investigation, and admitting of
fault as important factors in determining
whether registration is consistent with
public interest).
I find by a preponderance of the
evidence that Respondent has not
accepted responsibility for his past
misconduct, nor has he credibly
demonstrated that he has learned from
his past mistakes and would properly
handle controlled substances in the
future. An ‘‘agency rationally may
conclude that past performance is the
best predictor of future performance.’’
Alra Labs, Inc. v. DEA, 54 F.3d 450, 452
(7th Cir. 1995). I find that Factor Five
weighs heavily in favor of a finding that
Respondent’s registration would be
inconsistent with the public interest.
VI. Conclusion and Recommendation
After balancing the foregoing public
interest factors, I find that the
Government has established by
substantial evidence a prima facie case
in support of revoking Respondent’s
DEA COR AE5382724, based on Factors
Two, Four and Five of 21 U.S.C. 823(f).
Once DEA has made its prima facie case
for revocation or denial, the burden
shifts to the respondent to show that,
given the totality of the facts and
circumstances in the record, revoking or
denying the registration would not be
appropriate. See Morall v. DEA, 412
F.3d 165, 174 (DC Cir. 2005);
Humphreys v. DEA, 96 F.3d 658, 661
(3d Cir. 1996); Shatz v. United States
Dep’t of Justice, 873 F.2d 1089, 1091
(8th Cir. 1989); Thomas E. Johnston, 45
Fed. Reg. 72, 311 (DEA 1980).
The record reveals that Respondent
has not sustained his burden in this
regard. In fact, as discussed above,
Respondent’s testimony in numerous
instances was not credible and reflected
an overall lack of admission of past
misconduct. Respondent’s testimony
was also effectively devoid of any
credible demonstration that he has
learned from his past mistakes and will
not engage in future misconduct. In
light of the foregoing, Respondent’s
evidence as a whole fails to sustain his
burden to accept responsibility for his
past misconduct and demonstrate that
he will not engage in future misconduct.
I recommend revocation of
Respondent’s DEA COR AE5382724 as a
practitioner, and denial of any pending
applications for renewal or
modification, on the grounds that
Respondent’s continued registration
would be fully inconsistent with the
public interest as that term is used in 21
U.S.C.§ 824(a)(4) and 823(f).
PO 00000
Frm 00101
Fmt 4703
Sfmt 4703
45675
Dated: April 5, 2012
s/Timothy D. Wing
Administrative Law Judge
[FR Doc. 2012–18747 Filed 7–31–12; 8:45 am]
BILLING CODE 4410–09–P
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. 11–57]
Margy Temponeras, M.D.; Decision and
Order
On December 15, 2011,
Administrative Law Judge (ALJ)
Timothy D. Wing issued the attached
recommended decision. Neither party
filed exceptions to the decision.
Having considered the entire record, I
have decided to adopt the ALJ’s
recommended rulings, factual findings,
and his legal conclusions, except as
discussed below.1 I further hold that the
record establishes that Respondent
engaged in acts which are sufficiently
egregious to warrant the revocation of
her registration and that she has not
rebutted this conclusion.2
1 All citations to the ALJ’s recommend decision
are to the slip opinion.
2 In discussing the public interest factors of 21
U.S.C. 823(f), the ALJ ‘‘conclude[d] that the
reference in 21 U.S.C. 823(f)(5) to ‘other conduct
which may threaten public health and safety’ would
as a matter of statutory interpretation logically
encompasses the factors listed in Section 824(a).’’
ALJ at 19 n.24 (citing Kuen H. Chen, M.D., 58 FR
65401, 65402 (1993)).
To be sure, the Agency decision in Chen stated
that ‘‘[t]he administrative law judge has concluded
here that the reference in 21 U.S.C. 823(f)(5) to
‘other conduct which may threaten the public
health and safety’ would as a matter of statutory
interpretation logically encompass the bases listed
in 21 U.S.C. 824(a).’’ 58 FR at 65402. However,
whether this constitutes a holding or merely
dictum, Chen is totally devoid of any indication
that the traditional tools of statutory construction
(i.e, text, structure, statutory purpose, and
legislative history) were employed in reaching this
conclusion. Indeed, while factor five focuses on
‘‘other conduct,’’ several of the grounds for
revocation are based on a registrant’s status and do
not require inquiry into the nature of the underlying
conduct. See 21 U.S.C. 824(a)(3) (authorizing
revocation where registrant ‘‘has had his State
license or registration suspended, revoked, or
denied by competent State authority and is no
longer authorized’’ to engage in controlled
substance activities or such sanction has been
recommended by competent state authority); id.
§ 824(a)(5) (authorizing revocation where registrant
has been excluded or is subject to exclusion from
participating in federal healthcare programs under
mandatory exclusion provisions). In addition,
construing factor five in this manner renders
superfluous factor one, which authorizes the
Agency to consider the recommendation of the state
licensing board or disciplinary authority, as well as
the provision of section 823(f) stating that the ‘‘[t]he
Attorney General shall register practitioners * * *
if the applicant is authorized to dispense * * *
controlled substances under the laws of the State
in which he practices.’’
E:\FR\FM\01AUN1.SGM
Continued
01AUN1
45676
Federal Register / Vol. 77, No. 148 / Wednesday, August 1, 2012 / Notices
The ALJ’s Footnote 9
tkelley on DSK3SPTVN1PROD with NOTICES
Among the allegations raised by the
Government were: (1) That Respondent
had failed to include required
information on various prescriptions
(such as a patient’s address) in violation
of 21 CFR 1306.05(a); (2) that she failed
to take initial and biennial inventories
of the controlled substances she
obtained and dispensed, in violation of
21 CFR 1304.11(b) & (c); and (3) that she
failed to properly complete various
order forms for schedule II controlled
substances (DEA Form 222), in violation
of 21 CFR 1305.13(e). ALJ Ex. 1, at 3
(Order to Show Cause). According to the
record, the prescriptions were seized
pursuant to a search warrant executed at
a local pharmacy. Tr. 53–55. As for the
inventories and DEA 222s, these were
apparently seized during the execution
of a search warrant at Respondent’s
registered location.
At the hearing, Respondent’s counsel
requested that the Government turn over
the prescriptions, see Tr. 124–25; some
fifty DEA Form 222s, see id. at 80–81,
353–54; and the daily inventories done
by the employees of Respondent’s
dispensary. Id. at 423. The Government
objected to each of these requests on the
ground that there is no right to
discovery in these proceedings. See id.
at 80, 128, 423. The ALJ denied each of
these requests, explaining in his opinion
that the requests were ‘‘untimely and
unsupported by applicable legal
Finally, it should be noted that since shortly after
the CSA’s enactment and years before section 823(f)
was amended to include the public interest factors,
DEA ‘‘has consistently held that where a
registration can be revoked under section 824, it
can, a fortiori, be denied under section 823 since
the law would not require an agency to indulge in
the useless act of granting a license on one day only
to withdraw it on the next.’’ Serling Drug Co. v.
Detroit Prescription Wholesaler, Inc., 40 FR 11918,
11919 (1975). See also John R. Amato, 40 FR 22852
(1975) (Denying application where practitioner’s
state license had been revoked, holding that section
823(f) ‘‘must logically give the Administrator the
authority to deny a registration if the practitioner
is not authorized by the State to dispense controlled
substances. * * * To hold otherwise would mean
that all applications would have to be granted only
to be revoked the next day under 21 U.S.C.
824(a)(3). This [A]gency has consistently held that
where a registration can be revoked under section
824, it can, a fortiori, be denied under section
823.’’).
Indeed, no court has ever questioned the
Agency’s longstanding and consistent interpretation
that it has authority to deny an application on any
of the grounds set forth in section 824(a). Cf.
National Muffler Dealers Assn., Inc., v. United
States, 440 U.S. 472,477 (2011) (‘‘A regulation may
have particular force if it is a substantially
contemporaneous construction of the statute by
those presumed to have been aware of
congressional intent.’’); EEOC v. Associated Dry
Goods Corp., 449 U.S. 590, 600 n.17 (1981) (‘‘a
contemporaneous construction deserves special
deference when it has remained consistent over a
long period of time’’).
VerDate Mar<15>2010
19:53 Jul 31, 2012
Jkt 226001
authority.’’ ALJ at 6 n.9 (citing Roy E.
Berkowitz, 74 FR 36,578, 36,760 (2009)
(holding that there is no ‘‘general right
to discovery under either the APA or
DEA regulations’’) (citing Nicholas A.
Sychak, d/b/a Medicap Pharmacy, 65
FR 75,959. 75,961 (2000))).
While I adopt the ALJ’s rulings, I do
so only because the requests were
untimely. In his Supplemental PreHearing Ruling, which was issued on
August 5, 2011, the ALJ made clear that
‘‘[a]ny requests for subpoenas by either
party are to be filed no later than 4:00
p.m. EDT on August 26, 2011.’’ ALJ Ex.
8, at 7. Respondent did not comply with
the ALJ’s order and instead waited until
the hearing to request the documents.
Respondent, however, had notice of the
Government’s intent to litigate these
issues from the outset of the proceeding;
thus, she cannot claim that she was
unaware until the hearing that she
would need the various documents to
respond to the allegations.3 Because
Respondent failed to timely request the
documents, the ALJ properly denied
those requests.4
3 Moreover, having reviewed the record, it
contains substantial evidence (as the ALJ found) to
support each of these allegations.
4 That there is no general right to discovery in
these proceedings would not have barred a timely
request for these documents. Respondent did not
seek broad-based discovery of whatever the
Government had obtained in the course of its
investigation, but rather, specific documents which
were clearly relevant and material to these three
allegations because they are the very basis for the
three allegations. Thus, if the requests had been
timely, this case would have been governed by the
principle that ‘‘[d]iscovery must be granted if in the
particular situation a refusal to do so would so
prejudice a party as to deny him due process.’’
McClellan v. Andrus, 606 F.2d 1278, 1286 (DC Cir.
1979) (noting that report was subject to discovery
in administrative proceeding because it was
potentially ‘‘uniquely relevant to appellant’s case’’
and ordering agency to turn over report to
administrative tribunal for in camera review to
determine relevancy and to allow Government to
assert any claim of privilege). See also Echostar
Communications Corp. v. FCC, 292 F.3d 749, 756
(DC Cir. 2002) (noting that ‘‘McClelland was
seeking a specific document ‘uniquely relevant to
[his] case’ ’’). See also 5 U.S.C. 555(d) (‘‘Agency
subpoenas authorized by law shall be issued to a
party on request and, when required by rules of
procedure, on a statement or showing of general
relevance and reasonable scope of the evidence
sought.’’). See also 21 U.S.C. 875 & 876.
As the Agency has previous noted, under
Goldberg v. Kelly, 397 U.S. 254, 270 (1970), ‘‘ ‘where
governmental action seriously injures an
individual, and the reasonableness of the action
depend on fact findings, the evidence used to prove
the Government’s case must be disclosed to the
individual so that he has an opportunity to show
that it is untrue.’ ’’ Beau Boshers, M.D., 76 FR
19401, 19403 (2011) (quoting 397 U.S. at 270).
Moreover, the Supreme Court has further explained
that ‘‘ ‘the Due Process Clause forbids an agency to
use evidence in a way that forecloses an
opportunity to offer a contrary presentation.’ ’’ Id.
(quoting Bowman Transp., Inc., v. Arkansas-Best
Freight System, Inc., 419 U.S. 281, 288 n.4 (1974)).
Where the Government alleges that one has failed
PO 00000
Frm 00102
Fmt 4703
Sfmt 4703
The ALJ’s Legal Conclusions Regarding
Respondent’s Operation of a
Dispensary
The gravamen of the Government’s
case was Respondent’s operation of a
dispensary, which in the Government’s
view was illegal because Respondent
dispensed thousands of controlled
substance prescriptions which were
issued by her father, who was not
registered at the location of
Respondent’s practice, and Respondent
does not hold a pharmacy registration
under the Controlled Substances Act.
See ALJ Ex. 1, at 1. The evidence
showed that beginning in either
November or December 2008,
Respondent began dispensing controlled
substances at her practice location and
that during the period in which it
operated, the dispensary filled 3,397
prescriptions for controlled substances
issued by her father, most of which were
for oxycodone, a schedule II narcotic,
and Xanax, a schedule IV
benzodiazepine. Tr. 210–11. In addition,
the evidence showed that the
prescriptions were filled and delivered
to the patients by employees who were
not licensed as pharmacists.
The ALJ concluded that Respondent
violated Ohio law because she was not
licensed as a Terminal Distributor of
Dangerous Drugs and did not fall within
the exemption provided under state law
for ‘‘a business practice with a sole
shareholder who is a licensed health
professional.’’ See ALJ at 21 (citing Ohio
Rev. Code Ann. § 4729.51(B)(1)(j)).5 The
ALJ based his reasoning in part on the
evidence showing ‘‘that Respondent
established, solely owned, and operated
two limited liability companies, Unique
Pain Management ([her] medical
practice) and Unique Relief ([her]
dispensary), both of which are located at
418 Center Street, Wheelersburg, Ohio,’’
and that the two entities were
‘‘physically separate’’ from each other,
although Respondent could observe the
dispensary through a system of security
cameras and a monitor she maintained
in her office. Id. The ALJ also noted that
the dispensary also filled ‘‘a significant
to properly maintain or complete required records,
it cannot seize those records and then refuse to turn
them over in response to a timely request for them.
5 The ALJ also noted that an Ohio Board of
Pharmacy guidance document, which interprets
this provision, states that ‘‘if the business practice
has a single prescriber * * * who is the sole
shareholder, member, or owner of the practice, then
this business practice is not required to be licensed
as a Terminal Distributor of Dangerous Drugs with
the Ohio Board of Pharmacy. Previously, this
exemption was only for a prescriber who practices
as a Sole Proprietor.’’ ALJ at 21 (quoting Ohio State
Board of Pharmacy, Licensing Issues For
Prescribers—Updated (July 2008)).
E:\FR\FM\01AUN1.SGM
01AUN1
Federal Register / Vol. 77, No. 148 / Wednesday, August 1, 2012 / Notices
portion’’ of the prescriptions issued by
Respondent’s father. Id. at 22.
Continuing, the ALJ reasoned that:
[t]o the extent Ohio law permits a sole
practitioner to dispense or personally furnish
controlled substances directly to a patient
without a Terminal Distributor license,
Respondent’s dispensing practices were well
outside of those parameters. Respondent
established a distinctly separate legal entity
to fill prescriptions that was physically
separate from Respondent’s medical office.
Furthermore, Respondent’s dispensary was
not limited to filling prescriptions issued
only by Respondent, but also routinely filled
prescriptions issued by Respondent’s father,
notwithstanding the fact that Respondent did
not have a Terminal Distributor license as
required by state law.
tkelley on DSK3SPTVN1PROD with NOTICES
Id. (citing Ohio Rev. Code Ann.
§§ 4729.51(B)(1)(j) & 4729.551).
However, I need not decide whether
under Ohio law, Respondent’s creation
of ‘‘a distinctly separately legal entity to
fill prescriptions,’’ id., required her to
hold a Terminal Distributor license,
because the Government did not raise
this issue in either the Order to Show
Cause or its pre-hearing statements. Nor
are the few fragments of testimony
regarding this license (which primarily
involved the Board of Pharmacy
Compliance Agent’s statements
regarding the reason for his February
2011 visit to the dispensary) sufficient
to conclude that the parties litigated the
issue by implied consent. Indeed, any
such conclusion is belied by the fact
that when Respondent’s counsel
attempted to question the Board’s
Compliance Agent about whether a
Board employee had told Respondent’s
staff that she did not need to have a
Terminal Distributor’s License, the
Government objected that the questions
were outside the scope of direct
examination as well as irrelevant and
the ALJ sustained the objections.6 Tr.
345–47.
Under these circumstances, it is clear
that the issue was not ‘‘fairly and fully
litigated at [the] hearing’’ and therefore
cannot be the basis for a sanction.
Yellow Freight System, Inc., v. Martin,
954 F.2d 353, 358 (6th Cir. 1992). As the
Sixth Circuit further explained:
6 Subsequently, Respondent succeeded in
eliciting testimony from one of her employees
regarding a phone conversation he had with an
employee of the pharmacy board regarding whether
she was required to have a Terminal Distributor’s
license. Tr. 567. However, given that the
Government had already argued that this line of
questioning was irrelevant, which it was in light of
the Government’s failure to disclose its intent to
litigate the issue in either the Show Cause Order or
its pre-hearing statement, I conclude that this
testimony is not enough to establish implied
consent and that the issue is not properly before the
Agency.
VerDate Mar<15>2010
19:53 Jul 31, 2012
Jkt 226001
45677
[A]n agency may not base its decision upon
an issue the parties tried inadvertently.
Implied consent is not established merely
because one party introduced evidence
relevant to an unpleaded issue and the
opposing party failed to object to its
introduction. It must appear that the parties
understood the evidence to be aimed at the
unpleaded issue.
professional practice where she
dispensed controlled substances.
Rather, Respondent violated the CSA
because she exceeded the authority
granted by her registration when she
dispensed controlled substance
prescriptions issued by her father
without holding a pharmacy
registration. Under 21 U.S.C. 822(b),
Id. (citing MBI Motor Co., Inc. v.
‘‘[p]ersons registered by the [Agency]
Lotus/East, Inc., 506 F.2d 709, 711 (6th
under this subchapter to * * * dispense
Cir. 1974)).
controlled substances * * * are
authorized to possess * * * or dispense
Moreover, ‘‘where the Government’s
such substances * * * to the extent
case ‘focus[es] on another issue and
authorized by their registration and in
[the] evidence of [an] uncharged
conformity with the other provisions of
violation [is] ‘‘at most incidental,’ ’’ the
this subchapter.’’ (emphasis added).
Government has not satisfied its
Under Federal law and DEA
constitutional obligation to provide a
regulations, a registered physician is
full and fair opportunity to litigate the
authorized to prescribe, administer or
issue and it cannot rely on the
‘‘dispense directly’’ to her patients in
incidental issue as a basis for imposing
a sanction.’’ CBS Wholesale Distributors, the course of professional practice. See
21 CFR 1306.11(b) (‘‘An individual
74 FR 36746, 36750 (2009) (quoting
practitioner may administer or dispense
Pergament United Sales, Inc., v. NLRB,
920 F.2d 130, 136 (2d Cir.1990) (quoting directly a controlled substance listed in
NLRB v. Majestic Weaving Co., 355 F.2d Schedule II in the course of his
professional practice without a
854, 861–62 (2d Cir. 1966))). Thus,
prescription. * * *’’); id. § 1306.21(b)
because the issue was not properly
(‘‘An individual practitioner may
raised and the evidence was at most
administer or dispense directly a
incidental, I reject the ALJ’s legal
controlled substance listed in Schedule
conclusion (and his discussion of Ohio
law) that Respondent violated Ohio law III, IV, or V in the course of his/her
professional practice without a
because she failed to obtain an Ohio
prescription * * *.’’). See also 21
Terminal Distributor’s license.
U.S.C. 829 (‘‘Except when dispensed
However, the ALJ also concluded that
directly by a practitioner, other than a
Respondent violated federal law
pharmacist, to an ultimate user, no
because she ‘‘dispensed or directed and
controlled substance in schedule II,
authorized the dispensing of controlled
which is a prescription drug under the
substances from an unregistered
Federal Food, Drug, and Cosmetic Act
location on numerous occasions
* * * may be dispensed without’’ a
between November 2008 and May
prescription); id. § 829(b) (schedule III &
2011.’’ ALJ at 24 (citing 21 U.S.C.
IV).
822(a)(2) & (e); id. § 841; 21 CFR
In addition, DEA regulations provide
1306.06). The ALJ offered no further
that ‘‘[a] prescription for a controlled
explanation for this conclusion. While I substance may only be filled by a
hold that the ALJ erred in concluding
pharmacist, acting in the usual course of
that she violated section 822(e), which
his professional practice and either
requires ‘‘[a] separate registration * * * registered individually or employed in a
at each principal place of business or
registered pharmacy, or registered
professional practice where the
institutional practitioner.’’ 21 CFR
applicant * * * dispenses controlled
1306.06. Accordingly, Respondent, who
substances,’’ 21 U.S.C. 822(e), the record did not hold a pharmacy registration,
clearly supports a finding that
exceeded the authority of her
Respondent’s dispensing activities
registration because she authorized her
violated the CSA.
employees to fill prescriptions issued by
The evidence of record shows that
her father.8 See 21 U.S.C. 822(b); id.
Respondent’s dispensary was located at § 841(a) (rendering unlawful the
the same address as her medical
knowing or intentional dispensing of a
practice. This was also the address at
controlled substance ‘‘[e]xcept as
which Respondent was registered with
authorized by this subchapter’’). And in
the Agency.7 See GX 1. Thus,
filling her father’s prescriptions, she
Respondent did not violate the
also violated 21 CFR 1306.06.
requirement that she obtain a separate
So too, Respondent violated Ohio law
registration for each principal place of
because she allowed unlicensed
7 There is no evidence that the dispensary had a
separate suite number as might be the case in a
large medical office building.
PO 00000
Frm 00103
Fmt 4703
Sfmt 4703
8 The evidence also showed that Respondent’s
father did not hold a registration at the address of
Respondent’s dispensary.
E:\FR\FM\01AUN1.SGM
01AUN1
45678
Federal Register / Vol. 77, No. 148 / Wednesday, August 1, 2012 / Notices
personnel to fill the prescriptions and
failed to personally furnish the
controlled substances to her
patients.9 See ALJ at 23–24. As the ALJ
found, Respondent used unlicensed
personnel to fill the prescriptions which
her dispensary delivered to her patients.
While Ohio law exempts ‘‘a prescriber,’’
which includes a physician who is
authorized to practice medicine and
prescribe drugs, see Ohio Rev. Code
Ann. § 4729.01(I), from the prohibition
against the unauthorized practice of
pharmacy under Ohio Rev. Code Ann.
§ 4729.28, the exemption requires that
the physician ‘‘personally furnish [ ]
the [prescriber’s] patients with drugs,
within the prescriber’s scope of
professional practice.’’ Id.
§ 4729.29(A)(1).10 Moreover, ‘‘[w]hen a
prescriber personally furnishes drugs to
a patient pursuant to [the exemption],
the prescriber shall ensure that the
drugs are labeled and packaged in
accordance with state and federal drug
laws and any rules and regulations
adopted pursuant to those laws.’’ Id.
§ 4729.29(B).
Respondent did present evidence that
she had a security camera system and
monitor in her office which allowed her
to observe the operation of her
dispensary. See Resp. Br. 3 (citing Tr.
400). However, given that she was
actively seeing patients, her counsel’s
suggestion that she observed the
actually delivery of the drugs to the
patients, and thus was in compliance
with Ohio’s requirement that she
‘‘personally furnish’’ the drugs, is, as a
factual matter, ludicrous. I thus hold
that she violated Ohio law because she
did not personally furnish the
controlled substances to her patients.11
In her brief, Respondent further
claims that she ‘‘was ill-advised by
counsel’’ as to whether she needed a
pharmacy registration ‘‘and was
specifically told she was doing
everything correctly with respect to
operating the dispensary.’’ Resp. Br. 7.
Respondent then maintains that ‘‘[i]f a
tkelley on DSK3SPTVN1PROD with NOTICES
9 In
contrast to the issue of whether Respondent
was required to hold an Ohio Terminal Distributor’s
license, the Government provided notice of its
intent to litigate the issue of Respondent’s use of
unlicensed individuals to fill controlled substance
prescriptions. ALJ Ex. 5, at 5.
10 This citation, as well as the citation to section
4729.29(B), are to the provisions which were in
effect during the period at issue here.
11 As for the other violations, I agree with the
ALJ’s conclusions that Respondent failed to
properly complete DEA Form 222s for the schedule
II controlled substances she purchased, and that the
records were not kept separate from other records
as required by DEA regulations. See ALJ at 25–26
(citations omitted). I also agree with the ALJ’s
conclusion that Respondent failed to include
required information on some prescriptions. See
ALJ at 30 (citing GX 7).
VerDate Mar<15>2010
19:53 Jul 31, 2012
Jkt 226001
mistake was made it was not the
Respondent’s.’’ Id. While the ALJ
recounted the testimony of one
Respondent’s employees regarding the
purported legal advice she received, see
ALJ at 17 (citing Tr. 545, 559–60), he
did not address Respondent’s
contention.
I do and I reject the contention. Even
crediting the testimony of Respondent’s
employee that he had a discussion with
an attorney regarding the dispensary’s
compliance with DEA regulations and
was told that ‘‘we were doing it
perfectly,’’ Tr. 545, the employee’s
testimony was exceedingly vague as to
what issues were discussed and does
not establish that Respondent discussed
whether she needed to obtain a DEA
pharmacy registration because she was
filling the prescriptions issued by her
father. Thus, even were the Agency to
recognize a defense of good faith
reliance on legal advice, the defense
fails here because Respondent has not
established that there was a ‘‘full
disclosure of all pertinent facts’’ to the
attorney and that her reliance was ‘‘in
good faith.’’ United States v. Lindo, 18
F.3d 353, 356 (6th Cir.1994); see also
United States v. Painter, 314 F.2d 939,
943 (4th Cir. 1963). Indeed, the
contention is belied by the employee’s
testimony that he really ‘‘didn’t trust
some of the opinions [he] was getting
from’’ the attorney and that upon
looking at the DEA rules, he determined
that Respondent’s father had to be
registered at her clinic if narcotics were
stored there.12 Tr. 559–60. Moreover,
because Respondent invoked her Fifth
Amendment privilege and declined to
answer any questions (other than to
state her name and that she had a
registration as an individual
practitioner), she cannot establish that
she relied in good faith on the attorney’s
advice.
The Inventory Violations
The ALJ found that Respondent
violated DEA regulations requiring that
she take initial and biennial inventories.
ALJ at 27–29. While I agree that the
evidence establishes various violations,
I find much of the ALJ’s discussion of
the evidence and his reasoning
confusing.
The ALJ found that Respondent did
not have an initial inventory as required
by DEA regulations. See ALJ at 27
12 Having concluded that the Government did not
provide adequate notice of its intent to litigate the
issue of whether Respondent was required to hold
a Terminal Distributor’s license, it is unnecessary
to decide the issue of whether Respondent properly
relied on the statement of an Ohio Pharmacy Board
employee that Respondent did not need to hold this
license. Tr. 548.
PO 00000
Frm 00104
Fmt 4703
Sfmt 4703
(citing 21 CFR 1304.11(b) & (c)). While
I adopt this finding, I do so based solely
on the evidence that when the Board of
Pharmacy Compliance Agent conducted
his February 9, 2011 inspection,
Respondent’s dispensary manager stated
that ‘‘one had not been done.’’ Tr. 314.
Under Federal law, ‘‘every registrant
* * * shall * * * as soon * * * as
such registrant first engages in the
* * * dispensing of controlled
substances, and every second year
thereafter, make a complete and
accurate record of all stocks thereof on
hand.’’ 21 U.S.C. 827(a). Moreover,
under DEA regulations, ‘‘[i]n the event
a person commences business with no
controlled substances on hand, he/she
shall record this fact as the initial
inventory.’’ 21 CFR 1304.11(b). While
under DEA regulations, a registrant is
required to keep, and make available for
inspection, an inventory for only two
years, see 21 U.S.C. 827(b), a period
which, given the evidence that
Respondent opened the dispensary in
November or December 2008, would
have lapsed at the time of the February
2011 inspection, the statement of the
dispensary manager is sufficient to find
that this violation occurred.
Moreover, by the date of the February
2011 Pharmacy Board inspection,
Respondent was required to have
performed a biennial inventory. See id.
§ 827(a); 21 CFR 1304.11(c). However,
while Respondent had an ‘‘on-hand
inventory’’ that ‘‘was within the
computer itself,’’ Tr. 314, this did not
comply with DEA regulations which
require that an inventory ‘‘be
maintained in written, typewritten, or
printed form.’’ 21 CFR 1304.11(a). And
while there is evidence showing that
during the May 2011 search, documents
that were labeled as ‘‘biannual
inventories’’ were seized, the fact
remains that Respondent was required
to have on hand a proper biennial
inventory at the time of the February
2011 inspection.13
13 Had Respondent produced at the February
2011 inspection an inventory which complied with
21 CFR 1304.11(a) & (c), I would not place any
weight on the fact that the inventory was labeled
as a ‘‘biannual’’ rather than ‘‘biennial.’’
The ALJ further noted that it was ‘‘[o]f
significance, [that] no invoices, DEA Form 222s, or
dispensing logs were used to conduct the biennial
inventory.’’ ALJ at 28 (citing Tr. 480–82). However,
while the CSA requires that a registrant retain its
invoices, form 222s, as well as a dispensing log, for
at least two years, see 21 U.S.C. 827(b), taking an
inventory does not require doing anything more
than counting the drugs on hand and making a
record which includes the information required
under 21 CFR 1304.11(e).
The ALJ further concluded that ‘‘no compliant
* * *tory was * * *the May 17, 2011 search.’’ ALJ
at 28. However, the DI who seized the inventories
during the May 17, 2011 search did not offer any
E:\FR\FM\01AUN1.SGM
01AUN1
Federal Register / Vol. 77, No. 148 / Wednesday, August 1, 2012 / Notices
Conclusion
Having adopted the ALJ’s conclusion
(as modified herein) that Respondent
violated the CSA by dispensing
thousands of controlled substance
prescriptions issued by her father and
thus acted outside of the authority
granted by her registration, I conclude
that this conduct is egregious and
warrants the conclusion that she has
committed acts which render her
continued registration inconsistent with
the public interest and is sufficient by
itself to support the revocation of her
registration. See 21 U.S.C. 824(a)(4). The
additional violations established on this
record—her failure to have inventories,
failure to complete form 222s, failure to
include required information on
prescriptions, her commingling of
schedule II records with other records,
as well as her state law violations of
failing to personally furnish the drugs to
her patients—buttress this conclusion.
Because I further adopt the ALJ’s
findings that Respondent has presented
no evidence that she accepts
responsibility for her misconduct, I will
order that her registration be revoked
and that any pending application be
denied.14
tkelley on DSK3SPTVN1PROD with NOTICES
Order
Pursuant to the authority vested in me
by 21 U.S.C. 824(a)(4) and 28 CFR
0.100(b), I order that DEA Certificate of
Registration BT5598214, issued to
Margy Temponeras, M.D., be, and it
hereby is, revoked. I further order that
any pending application of Margy
Temponeras, M.D., to renew or modify
her registration, be, and it hereby is,
testimony that the inventories were not compliant
other than because they were not done within two
years of the opening of the dispensary. Tr. 84. The
ALJ further noted the testimony of one of
Respondent’s employees ‘‘that the process to
conduct a biennial inventory consisted of [her]
husband using a computer printout while she
physically counted the controlled substances,
adding that she did not ‘document anything’ from
the inventory.’’ ALJ at 28 (quoting 481–82).
It should be noted that even if the counts
matched the printout, at a minimum, the
inventories would have been required to document
whether they were done on the opening of business
or on the closing of business. See 21 CFR
1304.11(a). However, because the inventories were
not submitted into evidence, there is no basis for
concluding that they did not contain the required
information.
14 The ALJ noted that Respondent did not present
‘‘any evidence demonstrating that she will not
engage in future misconduct.’’ ALJ at 31. This is not
entirely accurate as the record suggests that
following the February 2011 visit of the Pharmacy
Board’s Compliance Agent, her employees did take
inventories. However, Respondent did not put on
any other evidence as to remedial measures and her
failure to testify warrants, as the ALJ held, the
adverse inference that she does not accept
responsibility for her misconduct. See id. (citing
cases).
VerDate Mar<15>2010
19:53 Jul 31, 2012
Jkt 226001
denied. This Order is effective August
31, 2012.
Dated: July 24, 2012.
Michele M. Leonhart,
Administrator.
D. Linden Barber, Esq. & Frank Mann, Esq.,
for the Government.
Bradley Davis Barbin, Esq., for the
Respondent.
Recommended Ruling, Findings of Fact,
Conclusions of Law and Decision of the
Administrative Law Judge
I. Introduction
Timothy D. Wing, Administrative Law
Judge. This proceeding is an
adjudication pursuant to the
Administrative Procedure Act (APA), 5
U.S.C. 551 et seq., to determine whether
the Drug Enforcement Administration
(DEA, Agency or Government) should
revoke a physician’s DEA Certificate of
Registration (COR) as a practitioner
pursuant to 21 U.S.C. 824(a)(4) and
deny, pursuant to 21 U.S.C. 823(f), any
pending applications for renewal or
modification thereof and any
application for a new COR. Without this
registration, Margy Temponeras, M.D.
(Respondent), of Wheelersburg, Ohio,
will be unable to lawfully prescribe,
dispense or otherwise handle controlled
substances in the course of her practice.
On May 16, 2011, the Administrator,
DEA, issued an Order to Show Cause
and Immediate Suspension of
Registration (OSC/IS), which was
personally served upon Respondent on
May 17, 2011.1 The OSC/IS immediately
suspended Respondent’s DEA COR as a
practitioner, and also provided notice to
Respondent of an opportunity to show
cause as to why the DEA should not
revoke Respondent’s COR, pursuant to
21 U.S.C. 824(a)(4), and deny, pursuant
to 21 U.S.C. 823(f), any pending
applications for renewal or modification
thereof and any applications for a new
COR, alleging that Respondent’s
continued registration is inconsistent
with the public interest as that term is
defined in 21 U.S.C. 823(f).
The OSC/IS alleged that Respondent
is registered as a practitioner authorized
to handle controlled substances in
Schedules II through V under DEA COR
BT5598214.
The OSC/IS further alleged in relevant
part: 2
That between approximately January
1, 2007 and November 3, 2009,
Respondent made approximately 3,397
unauthorized distributions of controlled
Exs. 1, 3.
Government represented prior to hearing
that it intended to proceed against Respondent only
with regard to allegations contained in numbered
paragraphs two, eight, nine, and ten of the OSC/IS.
PO 00000
1 ALJ
2 The
Frm 00105
Fmt 4703
Sfmt 4703
45679
substances. These distributions from
Respondent’s registered location were
purportedly based on prescriptions
issued by Dr. John Temponeras, who is
registered with DEA as a practitioner in
Portsmouth, Ohio. Respondent is not
registered with DEA as a pharmacy. All
in violation of 21 U.S.C. 841 and 21 CFR
1306.06;
That Respondent failed to take an
initial inventory and biennial
inventories of the controlled substances
in the dispensary that Respondent
operated in violation of 21 CFR
1304.11(b) and (c);
That Respondent failed to make and
keep complete and accurate records of
the receipt of controlled substances by,
among other things, failing to complete
DEA Form 222 with the amount and
date received of controlled substances
in violation of 21 CFR 1305.13(e); and
That Respondent frequently issued
prescriptions for controlled substances
that did not contain all of the
information required by 21 CFR
1306.05(a).3
Following prehearing procedures, a
hearing was held in Cincinnati, Ohio
between September 13, 2011, and
September 14, 2011, with the
Government and Respondent each
represented by counsel. Both parties
called witnesses to testify and both
introduced documentary evidence. After
the hearing, both parties filed proposed
findings of fact, conclusions of law, and
argument. All of the evidence and posthearing submissions have been
considered, and to the extent the
parties’ proposed findings of fact have
been adopted, they are substantively
incorporated into those set forth below.
II. Issue
Whether the record establishes that
Respondent’s DEA COR BT5598214 as a
practitioner should be revoked and any
pending applications for renewal or
modification of that registration should
be denied on the grounds that
Respondent’s continued registration
would be inconsistent with the public
interest as that term is used in 21 U.S.C.
824(a)(4) and 823(f).
III. Evidence and Incorporated
Findings of Fact 4
I find, by a preponderance of the
evidence, the following facts:
3 The section requires in relevant part that ‘‘[a]ll
prescriptions for controlled substances shall * * *
bear the full name and address of the patient * * *
[and] directions for use * * *.’’
4 In addition to the evidence discussed in this
Section, additional evidence and findings of fact are
discussed in later Sections of this Recommended
Decision.
E:\FR\FM\01AUN1.SGM
01AUN1
tkelley on DSK3SPTVN1PROD with NOTICES
45680
Federal Register / Vol. 77, No. 148 / Wednesday, August 1, 2012 / Notices
A. The Government’s Evidence
The Government’s evidence included
testimony from five witnesses:
Respondent; DEA Diversion Investigator
(DI) Christopher Kresnak (DI Kresnak);
DI Paula Albert (DI Albert); Ohio State
Board of Pharmacy Compliance Agent
Joseph Kinneer (Agent Kinneer); and DI
Stephanie Burkhart (DI Burkhart). In
addition to testimonial evidence, the
Government also introduced various
documentary exhibits, to include:
Respondent’s COR record; 5 three DEA
Form 222 purchaser records;6 copies of
prescriptions issued by Respondent
between August and November 2006; 7
and a document reflecting standard
procedures for Unique Pain
Management.8
Respondent was called to testify but
refused to answer any questions related
to the relevant allegations in the OSC/
IS by asserting her Fifth Amendment
privilege. (Tr. 35–36; 41–42.)
DI Kresnak testified in substance that
he has approximately eight years of
experience with DEA as a DI. (Tr.45.) DI
Kresnak testified that Respondent is
registered with DEA as a practitioner
under DEA COR BT5598214 with an
expiration date of November 30, 2012,
and a current status listed as ‘‘under
suspension.’’ (Tr. 47; Gov’t Ex. 1.) DI
Kresnak further testified that
Respondent has never held any other
type of DEA registration, including a
pharmacy registration. (Tr. 48.)
Respondent has never been registered
with the State of Ohio as a pharmacist
and has never held a pharmacy license
in Ohio. (Id.)
DI Kresnak next testified that
Respondent owns and operates two
limited liability companies–her medical
practice, Unique Pain Management, and
her dispensary, Unique Relief. (Tr. 48–
49.) Both of Respondent’s businesses are
located in the same building at 418
Center Street, Wheelersburg, Ohio. (Tr.
49.) DI Kresnak testified that he was
present inside both businesses on May
17, 2011, and he described the physical
layout of the location to include
Respondent’s office on the far left hand
corner from the entrance, with the
‘‘dispensary* * * on the right-hand
side of the building, * * *.’’ (Tr. 50–
51.) DI Kresnak testified that he
interviewed Respondent on that same
day, and in response to a question about
why the dispensary was operating,
Respondent ‘‘said words to the effect
that many of the local pharmacies
stopped filling for her prescriptions and
5 Gov’t
Ex. 1.
Ex. 6.
7 Gov’t Ex. 7.
8 Gov’t Ex. 8.
6 Gov’t
VerDate Mar<15>2010
19:53 Jul 31, 2012
Jkt 226001
that she wanted to provide a low-cost
convenience for her patients.’’ (Tr. 52.)
DI Kresnak also testified that pursuant
to a search warrant at Prime Pharmacy
Group d/b/a Medi-Mart Pharmacy, in
Portsmouth, Ohio, he obtained
prescriptions covering the time period
2005 to 2006 for Schedule III through V
controlled substances, and identified
twelve controlled substance
prescriptions issued by Respondent. (Tr.
53, 54–55.) The twelve prescriptions
related to more than one patient, but DI
Kresnak did not know how many
patients exactly, nor could he recall any
of the patients’ names.9 (Tr. 118, 188.)
DI Kresnak testified that of the twelve
prescriptions, only one was compliant
with DEA regulations. Eleven were
noncompliant because they lacked a
patient address. (Tr. 54; 123–24.)
DI Kresnak next explained that DEA
Form 222s are used by industry to order
Schedule II controlled substances, and
are issued to registrants by DEA. (Tr.
55.) DI Kresnak testified that a DEA
Form 222 contains, among other
information, the name and address of a
registrant, ‘‘what the registrant is
authorized to order,’’ and a serial
number. (Tr. 56.) A DEA Form 222
consists of three copies: the ‘‘brown
sheet,’’ which goes to the distributor; a
carbonated second ‘‘green’’ copy, which
also goes to the distributor; and a ‘‘blue’’
copy, which is maintained at the
registrant or practitioner’s registered
address when the registrant or
practitioner orders Schedule II
controlled substances. (Tr. 56–57.) DI
Kresnak further explained that the
distributor completes relevant
information on the Form 222 at time of
shipping, to include the National Drug
Code (NDC) and number of controlled
substances shipped. (Tr. 58.) The
distributor then sends the green
carbonated copy to the DEA office
where the distributor is located. (Tr. 58.)
9 None of the twelve prescriptions were produced
by the Government at hearing, and DI Kresnak was
uncertain if any of the twelve were the same as
those contained in Government Exhibit 7. (Tr. 118–
20.) Respondent requested production of the
records at hearing and the Government objected,
arguing in substance the lack of legal authority for
such a discovery request. I denied Respondent’s
discovery request since it was untimely and
unsupported by applicable legal authority. There is
no ‘‘general right to discovery under either the APA
or DEA regulations, but rather only a limited right
to receive in advance of hearing the documentary
evidence and summaries of the testimony which the
Government intends to rely upon.’’ Roy E.
Berkowitz, M.D., 74 FR 36,758, 36,760 (DEA 2009)
(citing Nicholas A. Sychak, d/b/a Medicap
Pharmacy, 65 FR 75,959, 75,961 (DEA 2000).
Respondent made various untimely requests for
discovery throughout hearing with regard to other
documents, such as original Form 222s, which were
denied for similar reasons.
PO 00000
Frm 00106
Fmt 4703
Sfmt 4703
DI Kresnak testified that he reviewed
approximately fifty DEA Form 222s
seized from Respondent’s dispensary,
and on approximately six to ten forms
he observed various discrepancies:
Many of them weren’t filled out properly,
missing information. Several of them didn’t
even indicate whether a shipment had been
received. One * * * just doesn’t reflect
anything. There were several, maybe seven
lines filled out on it and there’s nothing
indicating any product was received.
(Tr. 60.) DI Kresnak compared the green
copies of DEA Form 222s sent to DEA
by the distributor with those seized
from Respondent’s dispensary, and
testified that he recalled a specific
discrepancy:
I observed one particular 222 * * * where
the distributor indicated that they [sic] did
not fill the order. The blue copy of the 222,
which is found in the dispensary, which is
required by the Code to fill out how many
is [sic] received, indicated that there were 60
received. There were 60 ordered. The blue
copy was indicating 60 received, but the
distributor’s copy to DEA indicate[d] they
did not fill that order.
(Tr. 63.) DI Kresnak further testified that
he reviewed data from DEA’s
Automated Reports and Consolidated
Order System (ARCOS),10 which
confirmed that the information reflected
on the distributor’s DEA Form 222 was
accurate. (Tr. 63–64.)
DI Kresnak also testified about three
specific DEA Form 222s seized from
Respondent’s dispensary on May 17,
2011, which he found to be deficient.
(Tr. 64–65; Gov’t Ex. 6.) DI Kresnak
testified that one was deficient ‘‘[i]f
these drugs were received * * *
[because] a date received is omitted.’’
(Tr. 65; Gov’t Ex. 6, at 1.) A second form
is deficient because the ‘‘number of
packages received is omitted and the
date received is omitted.’’ (Tr. 66; Gov’t
Ex. 6, at 2.) A third form is deficient
because the ‘‘number of packages is
omitted on both items and the date
received.’’ (Tr. 66; Gov’t Ex. 3, at 3.) DI
Kresnak further testified somewhat
tepidly with regard to whether the
controlled substances were actually
shipped to Respondent, that he
‘‘believed they were’’ further explaining
that he believed ‘‘we found
10 ‘‘Registrants are also required to report records
of sales or acquisitions of controlled substances in
Schedules I and II, of narcotic controlled substances
listed in Schedules III, IV and V, and of
psychotropic controlled substances listed in
Schedules III and IV with the DEA’s Automation of
Reports and Consolidated Orders System (ARCOS).
21 CFR 1304.33(c); 21 U.S.C. [§ ] 827(d). These
reports must be filed every quarter not later than the
15th day of the month succeeding the quarter for
which it is submitted. 21 CFR 1304.33(b).’’ Easy
Returns Worldwide, Inc. v. United States, 266 F.
Supp. 2d 1014, 1016 (E.D. Mo. 2003).
E:\FR\FM\01AUN1.SGM
01AUN1
Federal Register / Vol. 77, No. 148 / Wednesday, August 1, 2012 / Notices
tkelley on DSK3SPTVN1PROD with NOTICES
documentation that these were shipped,
yes.’’ 11 (Tr. 82.)
DI Kresnak testified that during the
first two years that Respondent operated
her dispensary, the majority of
Respondent’s ordering was completed
through an electronic DEA controlled
substance ordering system (CSOS),
rather than using paper Form 222s. (Tr.
195–96.)12
DI Kresnak next testified that during
the search of Respondent’s dispensary,
documents related to inventories were
found, to include one marked opening
inventory, which ‘‘indicated that the
date that they opened the dispensary
there was a zero inventory.’’ (Tr. 83.)
‘‘No biennial inventory was ever
found.’’ (Tr. 84.) Rather, several
documents entitled ‘‘Biannual
Inventories’’ were found in a folder
marked ‘‘DEA inventories.’’ (Tr. 144.) DI
Kresnak testified that Respondent’s
dispensary opened ‘‘sometime in
November 2008, maybe December
2008.’’ (Tr. 99.) Although DI Kresnak
could not recall all of the details, he
testified that the inventories appeared to
be computer generated, listing the drugs
on the far left and dollar values in
another column. DI Kresnak did not
know what the dollar values
represented. He also testified that each
inventory was marked ‘‘biannual,’’
contained a date, and appeared to be
signed by Respondent. (Tr. 136–137.) DI
Kresnak testified that as a result of his
investigation he determined that ‘‘there
was one particular oxycodone product
that 100% was missing for the month of
April, 2011.’’ (Tr. 150.) DI Kresnak
further explained that he does not
‘‘recall the number of dosages * * *
missing * * * without referring to the
audit.’’ 13 (Tr. 153.) DI Kresnak testified
that he has not seen any inventories in
electronic format seized from
Respondent, but noted that he has not
as yet looked for any. (Tr. 173.)
DI Kresnak next testified that
Respondent and Respondent’s father,
Dr. John Temponeras, were the only
practitioners who issued prescriptions
for controlled substances in Schedules II
through V that were filled at
Respondent’s dispensary. (Tr. 101.) DI
Kresnak further testified that Dr. John
Temponeras had previously been a DEA
registrant with a registered location in
11 DI Kresnak’s testimony was further qualified by
his statement that ‘‘[w]e found invoices that reflect
some of these.’’ (Tr. 83.) Additionally, DI Kresnak
explained that ARCOS reports indicated shipments
of the relevant controlled substances to Respondent.
(Tr. 134–36.)
12 21 CFR1300.03. DI Kresnak explained that
CSOS is only for Schedule II controlled substances
and is ‘‘used to eliminate paper flow.’’ (Tr. 194.)
13 No audit was produced at hearing.
VerDate Mar<15>2010
19:53 Jul 31, 2012
Jkt 226001
Portsmouth, Ohio. DI Kresnak
interviewed Dr. John Temponeras
regarding his application for a DEA
registration at Respondent’s Center
Street location in Wheelersburg, Ohio,
and learned ‘‘he had written
prescriptions [for controlled substances]
that were filled at the dispensary, and
he basically said he was needing a DEA
registration at that location because his
daughter said he needed one there.’’ (Tr.
102.)
DI Albert testified in substance that
she has eleven years of experience with
DEA as a diversion investigator. DI
Albert testified that she was present at
Respondent’s business location in
Wheelersburg, Ohio, on May 17, 2011,
assisting in the execution of a federal
search warrant and service of the OSC/
IS. (Tr. 202.) DI Albert described the
location as ‘‘a medical clinic and a—I
guess, a dispensary.’’ (Tr. 202.) By
dispensary, DI Albert testified that she
meant ‘‘[t]hey filled prescriptions and
dispense[d] medication to patients.’’
(Id.) The location was described as
having the doctor’s office on the left of
the building, and on the right after
passing through a door there was
another lobby and ‘‘[i]nside that lobby
there was a set of windows with thick
glass, and behind those windows were
[sic] the dispensary.’’ (Tr. 203.)
DI Albert further testified that Darryl
Leadingham (Mr. Leadingham) and Sue
Leadingham (Mrs. Leadingham) were
working in the dispensary on May 17,
2011. DI Albert interviewed Mr.
Leadingham regarding his
responsibilities in the pharmacy, and
learned that ‘‘he was responsible for the
computer system, the security system in
the whole building, the cameras. * * *
[H]e ordered the controlled substances
that were dispensed out of the
dispensary, and he also worked as far as
entering patient information into the
computer system, printing labels,
dispensing the controlled substances,
billing patients’ insurance, * * *.’’ (Tr.
203–04.) In terms of dispensing, Mr.
Leadingham indicated that patients
would bring a physical hard copy
prescription that either Respondent or
Respondent’s father had issued with an
original signature. The information was
entered in the computer system which
would generate three labels, the first for
the prescription bottle, second for the
original hard copy prescriptions, and
third on the outside bag containing all
of the bottles of medicine distributed.
(Tr. 208.)
DI Albert testified that Mrs.
Leadingham similarly stated that ‘‘she
was there to dispense the medication
and put the information, print the labels
and bill the insurance or accept cash.’’
PO 00000
Frm 00107
Fmt 4703
Sfmt 4703
45681
(Tr. 209.) DI Albert further testified that
both Mr. Leadingham and Mrs.
Leadingham stated during the May 17,
2011 interview:
Dr. John Temponeras had filled in and had
seen [Respondent’s] patients and that there
were prescriptions that patients brought to
the dispensary with [Dr. John Temponeras’]
name on them. And Darryl Leadingham told
me that at some point he figured out that it
was no longer—or that they shouldn’t be
doing that and that he had told [Respondent]
that her father needed to get his own DEA
registration for that location.
(Tr. 213.)
DI Albert testified that based on
information contained within the Ohio
Automated Rx Reporting System
(OARRS),14 the only prescriptions filled
at the dispensary were issued by
Respondent or Respondent’s father. (Tr.
209.) DI Albert testified that OARRS
data reflected that from November or
December 2008 until 2011,
Respondent’s dispensary filled
approximately 3,397 prescriptions
issued by Respondent’s father for
controlled substances, ‘‘mostly
oxycodone products and Xanax or the
Schedule IV.’’ (Tr. 210–11.) Regarding
prescriptions issued by Respondent, DI
Albert testified in April 2010 alone,
Respondent ‘‘filled 500 prescriptions at
her dispensary, which came out to—
after I compared that to other
pharmacies, it was over eighty-three
percent of her prescriptions were filled
by herself.’’ (Tr. 211.) DI Albert did not
know why eighty-three percent of the
patients chose to go to Respondent’s
dispensary and no cost analysis of
pharmacies in the region was conducted
by DI Albert. (Tr. 231.)
DI Albert next testified that as part of
her investigation of Respondent, she
reviewed ARCOS system data pertaining
to ‘‘all the oxycodone products
[Respondent] ordered’’ from the opening
of the dispensary in 2008 until her last
order in May 2011, finding a total of
‘‘approximately 1.6 million dosage
units’’ of oxycodone, a Schedule II
controlled substance. (Tr. 206–07.) DI
Albert testified that she recalled the
presence of various drugs at the
dispensary on May 17, 2011, described
as ‘‘mostly controlled substances,
oxycodone, OxyContin, benzos,[15]
Xanax, Valium.’’ (Tr. 204.) DI Albert
believed there may have been a small
quantity of hydrocodone and ‘‘a couple
14 DI Albert testified that OARRS is a prescription
monitoring system run by the Ohio Board of
Pharmacy based on information submitted by
pharmacies. (Tr. 209–10.) See also Ohio Admin.
Code R. 4729–37–03 (2011).
15 DI Albert explained her use of the term
‘‘benzos’’ was short-hand for benzodiazepines, a
Schedule IV controlled substance. (Tr. 205.)
E:\FR\FM\01AUN1.SGM
01AUN1
45682
Federal Register / Vol. 77, No. 148 / Wednesday, August 1, 2012 / Notices
of other Schedule II substances, such as
morphine.’’ (Tr. 204–05.)
DI Albert further testified that she has
reviewed the originals of the DEA Form
222s reflected in Government Exhibit 6,
which were seized from Respondent’s
dispensary on May 17, 2011, and did
not remove any attachments from the
originals nor was she aware of any other
DEA personnel removing attachments.
(Tr. 215.) DI Albert testified that she
reviewed and compared distributor
copies of the Form 222s with copies
retained by Respondent, and found
discrepancies between what the
distributors indicated they shipped and
what Respondent reported receiving.
(Tr. 216–17.) DI Albert elaborated:
I believe there were times where … on the
distributor’s copy, or the one that [the
distributor] provide[d] to DEA, it indicates
that they actually shipped a different
quantity or they voided out the line, where,
in fact, the copy that we found in the
dispensary will show that they received a
quantity and the distributor says that [the
distributor] voided it.
tkelley on DSK3SPTVN1PROD with NOTICES
(Tr. 218; Gov’t Ex. 6.)
Finally, DI Albert testified that she
reviewed various prescriptions for
controlled substances issued to Patient
[IM] by Respondent, dated between
August and November 2006, and
determined that the prescriptions were
missing the address of the patient, as
required by regulation. (Tr. 220–21,
249–50; Gov’t Ex. 7.)
Agent Kinneer testified that he has
been employed with the Ohio Board of
Pharmacy as a Compliance Agent for
approximately seventeen years.16 Agent
Kinneer further testified that he was
familiar with Respondent’s professional
practice, explaining that in December
2010, Respondent applied for a
Terminal Distributor license,17 which
would allow for the purchase of
prescription drugs and controlled
substances. (Tr. 301–02.)
Agent Kinneer next testified that
based on Respondent’s application for a
Terminal Distributor license, he
conducted an inspection of
Respondent’s location on February 9,
2011. (Tr. 303.) As a result of the
inspection, Agent Kinneer determined
that the dispensary was operated by Mr.
Leadingham, who had been introduced
as the dispensary manager. (Tr. 307.)
Agent Kinneer further determined that
16 Agent Kinneer’s duties include inspection of
entities licensed by the Ohio Board of Pharmacy, to
include physicians, pharmacies, pharmacists,
dentists, and paramedics. Agent Kinneer’s duties
further include investigation of drug diversion. (Tr.
300.)
17 The license was for Respondent’s dispensary,
Unique Relief, located within the same building as
Respondent’s medical practice. (Tr. 308.)
VerDate Mar<15>2010
19:53 Jul 31, 2012
Jkt 226001
for the past two years, Respondent had
no role in the physical delivery of
controlled substances to her patients.
(Tr. 307, 334.)
Agent Kinneer explained that during
his inspection, he observed a dispensing
practice that failed to properly
document the filling of prescriptions.
‘‘What would happen is, you had one
prescription that had all three labels on
it * * * [a]nd then the other two had no
labels at all. So there was no way to
document that those prescriptions had
actually been filled.’’ (Tr. 313.)
Agent Kinneer testified that he
requested an opening inventory and
none was produced. Instead, Mr.
Leadingham stated that ‘‘one had not
been done.’’ (Tr. 314.) Mr. Leadingham
was also unable to produce a biennial
inventory. (Tr. 315.) Agent Kinneer
further testified that he conducted a
series of audits of individual drugs
using a running inventory from the
computer in Respondent’s dispensary.
(Tr. 316–17.) He determined a slight
overage for two controlled substances
and a shortage of two other controlled
substances. (Tr. 317.) Agent Kinneer
testified that ‘‘our demonstration was to
show Mr. Leadingham that you cannot
rely on a running inventory. There
actually needs to be a hard copy. And
the purpose of it was to show that those
things can be off.’’ (Tr. 317.) The
running audit also revealed that ‘‘[t]here
was drugs [sic] that were dead on.’’ (Tr.
318.) Agent Kinneer further testified
that there was no way to tell whether
Respondent’s dispensary had significant
shortages or overages, since the absence
of a starting point for the audit
precluded a true inventory of controlled
substances within Respondent’s
dispensary.
Remember, this [running inventory] was
just a tool to show Darryl Leadingham and
Sue Leadingham that they cannot rely on the
running inventory as a true inventory, that
they needed an opening inventory as well as
their DEA inventory. In order for me to do
an audit I need a starting point. And that’s
what I am trying to express to them.
(Tr. 373–75.)
Agent Kinneer also reviewed DEA
Form 222s during his inspection,
specifically requesting the production of
‘‘their blue copy where they actually
receipted the medication.’’ (Tr. 318.)
Based on a review of a two to three inch
stack of DEA Form 222s on the counter
at the dispensary, Agent Kinneer
testified that none had been
‘‘receipted,’’ explaining that none ‘‘had
a date or quantity on a filled-out line for
those individual drugs that had been
ordered and received.’’ (Tr. 319, 362–
63.) A review of DEA Form 222s kept in
PO 00000
Frm 00108
Fmt 4703
Sfmt 4703
a vault within the dispensary also
revealed that none had been receipted.18
Agent Kinneer testified that Mr.
Leadingham was unaware of the
requirement to do so, instead indicating
‘‘that he had been trained just to * * *
do the invoices * * * [and]
documenting it in the computer that
they had received them.’’ (Tr. 320.)
Agent Kinneer further testified that he
did not recall seeing invoices attached
to the DEA Form 222s that he looked at,
noting that it did not matter since that
is not the requirement. (Tr. 320–21.)
Agent Kinneer does not recall seeing
staple marks on the DEA Form 222s that
he reviewed, but explained he was not
looking for staple marks. (Tr. 348.)
Agent Kinneer testified that
controlled substances were ordered by
the dispensary manager, Mr.
Leadingham, using Respondent’s DEA
registration, but there was no indication
that Respondent was active or
accountable for the accuracy and
completeness of the dispensary’s
records. (Tr. 321–22.) Agent Kinneer
further testified that at the completion
of the inspection, he informed Mr.
Leadingham that ‘‘from what we were
witnessing he was running a pharmacy,
which was illegal.’’ (Tr. 323.) Agent
Kinneer testified that Respondent’s
dispensary was not registered with the
Ohio Board of Pharmacy as a pharmacy,
nor were any personnel working in the
dispensary licensed as pharmacists in
Ohio. (Tr. 324–25.)
DI Burkhart was called in rebuttal by
the Government, and testified in
substance that she participated in the
execution of a federal search warrant at
Respondent’s location on May 17, 2011,
to include seizing the blue copies of
DEA Form 222s. (Tr. 600–01.)
Specifically, DI Burkhart testified that
she seized and reviewed approximately
fifty DEA Form 222s and only two blue
copies had an invoice stapled to the
back of them. (Tr. 601.) The fifty seized
DEA Form 222s included the three
reflected in Government Exhibit 6,
which did not have any documents or
invoices stapled to them at the time they
were seized. (Id.) DI Burkhart further
testified that she seized the DEA Form
222s from within the dispensary vault
and in other places in the dispensary.
(Tr. 607–08.)
I find the foregoing witness testimony
fully credible in that each of the
witnesses presented testimony that was
internally consistent and evidenced a
18 Agent Kinneer testified that his inspection did
not focus on how many dispensary orders were
electronic as compared with orders using handwritten Form 222’s with an accompanying blue
copy. ‘‘We were solely looking at the blue copies.’’
(Tr. 360.)
E:\FR\FM\01AUN1.SGM
01AUN1
Federal Register / Vol. 77, No. 148 / Wednesday, August 1, 2012 / Notices
tkelley on DSK3SPTVN1PROD with NOTICES
reasonable level of memory for past
events. Each witness presented
testimony in a professional manner and
the material portions of the testimony
were consistent with other credible
evidence of record, as discussed more
fully below.
C. Respondent’s Evidence
Respondent’s evidence included
testimony from two witnesses: Mrs.
Leadingham and Mr. Leadingham.
Respondent also introduced a letter
dated April 27, 2010, from the Director
of the Ohio Department of Health.19
Mrs. Leadingham testified in substance
as to her background and experience, to
include having worked for
approximately five years at an assisted
living center before beginning work in
Respondent’s dispensary in or about
November 2008. (Tr. 385, 390.) Prior to
working for Respondent, Mrs.
Leadingham had no prior working
experience dispensing drugs at a
pharmacy. (Tr. 457.) Mrs. Leadingham
testified that when hired in November
2008, she worked for Ken Days (Mr.
Days) in Respondent’s dispensary. (Tr.
390–91.) Mrs. Leadingham described
her duties to include counting pills,
labeling medicine bottles, helping with
inventory, filing, and handling invoices
and DEA Form 222s. (Tr. 391.) Mrs.
Leadingham further testified that she
loved working for Respondent, who she
described as caring and ‘‘the best
employer I have ever had.’’ (Id.) Mrs.
Leadingham explained that
Respondent’s dispensary operated like a
pharmacy to include the use of
pharmacy software called Rx30, as well
as printed prescriptions, labeled drugs,
and the filling of prescriptions, all
consistent with that of a pharmacy. (Tr.
473.) Mrs. Leadingham testified that the
dispensary filled controlled substance
prescriptions for Respondent and
Respondent’s father, on a regular basis
between 2008 and late 2010, when
Respondent’s father stopped issuing
prescriptions. (Tr. 485.)
Mrs. Leadingham next testified that
Respondent’s role in the dispensary
included stopping by every morning
and evening to answer questions or
discuss issues. (Tr. 400.) ‘‘She had a
monitor in her office that she watched
us the whole time we were at work. She
could see everything we did at any
given time.’’ (Id.) Mrs. Leadingham later
contradicted this testimony, admitting
that Respondent could not watch the
dispensary while she was examining
patients throughout the day. (Tr. 478.)
No monitors were present in patient
19 Resp’t Ex. 6. This was the only exhibit offered
by Respondent at hearing.
VerDate Mar<15>2010
19:53 Jul 31, 2012
Jkt 226001
examination rooms. (Tr. 469.) Mrs.
Leadingham further testified to the
physical layout of the dispensary, to
include security measures. (Tr. 403–04.)
Mrs. Leadingham testified that the
dispensary kept detailed daily
inventories, and also completed a
biennial inventory every two years that
was kept ‘‘in a file in the vault.’’ (Tr.
407.) Other than working from a
computerized printout, Mrs.
Leadingham testified that she did not
document anything from the biennial
inventory. (Tr. 481–82.) Mrs.
Leadingham further testified that she
believes the physical copy of the
inventory was seized by DEA on May
17, 2011, since the folder was gone from
the dispensary after that date. (Tr. 408,
412.)
Mrs. Leadingham testified that she
worked in Respondent’s dispensary
until April 2009, when she was fired
along with Mr. Leadingham. (Tr. 419.)
Mrs. Leadingham testified that she
returned to work at Respondent’s
dispensary on July 1, 2009, along with
Mr. Leadingham, explaining the
circumstances of why Respondent asked
them to return to work:
[Respondent] was very, very concerned
with the way the dispensary was being run.
She was allowed no access to the dispensary
itself in these two months that we were gone.
When we got back, I know we got a lot of
complaints from the patients that there was
pills missing, they weren’t treated well,
* * *.’’
(Tr. 421.) Mrs. Leadingham further
testified that upon her return to
Respondent’s dispensary in July 2009
she observed pills that had been put in
unmarked vials, to include some pills
that appeared to have been crushed. (Tr.
427.)
Mrs. Leadingham also testified as to
her understanding and practice with
regard to DEA Form 222s, stating in
substance that she always stapled the
invoices for incoming controlled
substances to the Form 222. (Tr. 428.)
Mrs. Leadingham further testified that
most controlled substance orders were
placed electronically, but approximately
fifty paper copies of DEA Form 222s
would have been present in the
dispensary within folders identified by
suppliers. (Tr. 440–41.) Prior to
February 2010, the dispensary practice
was not to put the date and amount of
controlled substances received on DEA
Form 222s, but rather to staple the
invoice for controlled substances to the
form. (Tr. 462–63.) Mrs. Leadingham
testified that following the Ohio
Pharmacy Board inspection of the
dispensary in February 2011, she
personally wrote the amount and date
PO 00000
Frm 00109
Fmt 4703
Sfmt 4703
45683
received on DEA Form 222s. (Tr. 464–
65.)
Mrs. Leadingham next testified to
completing pill counts within the
dispensary to ensure that the numbers
on hand matched the computer records,
and does not recall any significant
discrepancies of greater than one
percent. (Tr. 446.) Mrs. Leadingham
further testified that Respondent has
been present in the dispensary on at
least one occasion and counted
medications which were matched with
inventories. Additionally, Respondent
received daily inventories from the
dispensary. (Tr. 453–54.)
Mrs. Leadingham was called by
Respondent in rebuttal, and testified in
substance that she had separated
existing DEA Form 222s from the
invoices two to three weeks prior to
May 16, 2011, in order to prepare copies
for submission to the Ohio Medical
Board. (Tr. 629.) Mrs. Leadingham
further testified that during the week
prior to May 16, 2011, she stapled the
DEA Form 222s and invoices together
again, and filed them in the dispensary
vault. (Tr. 631.)
Mr. Leadingham testified in substance
as to his background and experience, to
include work in Respondent’s
dispensary, Unique Relief, beginning in
November 2008. (Tr. 513.) Unique Relief
was a separately operated business from
Respondent’s medical practice, Unique
Pain Management. (Tr. 572.) The
dispensary’s sole purpose was to fill
prescriptions issued by Respondent and
Respondent’s father. (Tr. 572–73.) Mr.
Leadingham testified that he worked as
the manager of the dispensary, to
include pricing, printing labels for
prescriptions, and ordering. (Id.) Mr.
Leadingham testified that he received
no training prior to dispensing
controlled substances from
Respondent’s dispensary, other than to
travel to an existing pharmacy to
observe a pharmacist for approximately
two hours. (Tr. 576, 580.) Mr.
Leadingham explained that he worked
for Mr. Days and Respondent,
describing his relationship with Mr.
Days as ‘‘very contentious’’ because Mr.
Days kept telling Mr. Leadingham what
to tell Respondent to do, which Mr.
Leadingham would not. (Tr. 514–15.) In
April 2009, Mr. Leadingham and Mrs.
Leadingham were fired by Mr. Days. (Tr.
517.)
Mr. Leadingham testified that he
returned to work for Respondent in July
2009, after the departure of Mr. Days.
(Tr. 520.) Upon return, Mr. Leadingham
testified that he completed an inventory,
which was placed in a folder and ‘‘we
had written on it that it was for a DEA
biennial.’’ (Id.) A similar inventory was
E:\FR\FM\01AUN1.SGM
01AUN1
45684
Federal Register / Vol. 77, No. 148 / Wednesday, August 1, 2012 / Notices
done in February 2011, and marked
‘‘DEA Biannual Report.’’ (Tr. 521.) Mr.
Leadingham testified that the two files
were present in the dispensary on May
17, 2011, but following that date
‘‘[t]here was no paperwork left in the
vault.’’ (Tr. 522.) Mr. Leadingham
testified that between July 2009 and
May 17, 2011, there were never any
large amounts of drugs missing, and
with regard to oxycodones, Mr.
Leadingham did not believe variances
existed of ‘‘even one-tenth of a percent.’’
(Tr. 561.)
Mr. Leadingham testified that with
regard to his compliance with federal
regulations for the operation of
Respondent’s dispensary, he received
legal advice that ‘‘we were doing it
perfectly.’’ (Tr. 545.) Mr. Leadingham
further testified that he later questioned
the legal advice he was getting with
regard to filling prescriptions issued by
Respondent’s father and looked up the
DEA rules ‘‘that stated there had to be
a DEA license address for the [d]octor at
that address, with that address, if there
was a Schedule II narcotics there.’’ (Tr.
559–60.) Mr. Leadingham testified that
he provided a printout of the rules to
Respondent, who then applied to DEA
for a license for her father at
Respondent’s address. (Tr. 560.) Mr.
Leadingham testified, however, that he
did not see the DEA regulation that DEA
Form 222s had to be kept separate from
all other records, and the dispensary
was ‘‘[a]pparently not’’ complying with
that regulation. (Tr. 568.)
Respondent’s witnesses presented
their testimony in a professional and
serious manner, but as more fully
explained in the discussion section
below, I find it only partially credible in
several material respects.
IV. Discussion
tkelley on DSK3SPTVN1PROD with NOTICES
A. The Applicable Statutory and
Regulatory Provisions
The Controlled Substances Act (CSA)
provides that any person who dispenses
(including prescribing) a controlled
substance must obtain a registration
issued by the DEA in accordance with
applicable rules and regulations.20 ‘‘A
prescription for a controlled substance
to be effective must be issued for a
legitimate medical purpose by an
individual practitioner acting in the
usual course of his professional
practice. The responsibility for the
proper prescribing and dispensing of
controlled substances is upon the
prescribing practitioner’’ with a
corresponding responsibility on the
20 21
U.S.C. 802(10), 822(a)(2).
VerDate Mar<15>2010
19:53 Jul 31, 2012
Jkt 226001
pharmacist who fills the prescription.21
It is unlawful for any person to possess
a controlled substance unless that
substance was obtained pursuant to a
valid prescription from a practitioner
acting in the course of their professional
practice.22 It is also unlawful to refuse
or negligently fail to make, keep or
furnish required records.23
B. The Public Interest Standard
The CSA, at 21 U.S.C. 824(a)(4),
provides, insofar as pertinent to this
proceeding, that the Administrator may
revoke a DEA COR if she finds that the
continued registration would be
inconsistent with the public interest as
that term is used in 21 U.S.C. 823(f).
Pursuant to 21 U.S.C. 823(f), the
Administrator may deny an application
for a DEA COR if she determines that
such registration would be inconsistent
with the public interest. In determining
the public interest, the Administrator is
required to consider the following
factors:
(1) The recommendation of the
appropriate state licensing board or
professional disciplinary authority.
(2) The applicant’s experience in
dispensing or conducting research with
respect to controlled substances.
(3) The applicant’s conviction record
under federal or state laws relating to
the manufacture, distribution or
dispensing of controlled substances.
(4) Compliance with applicable state,
federal or local laws relating to
controlled substances.
(5) Such other conduct which may
threaten the public health and safety.24
As a threshold matter, the factors
specified in Section 823(f) are to be
considered in the disjunctive: The
Administrator may properly rely on any
one or a combination of those factors,
and give each factor the weight she
deems appropriate, in determining
whether a registration should be
revoked or an application for
registration denied. See David H. Gillis,
M.D., 58 FR 37,507, 37,508 (DEA 1993);
see also D & S Sales, 71 FR 37,607,
37,610 (DEA 2006); Joy’s Ideas, 70 FR
33,195, 33,197 (DEA 2005); Henry J.
Schwarz, Jr., M.D., 54 FR 16,422, 16,424
(DEA 1989). Application of the public
interest factors requires an
individualized determination and
CFR 1306.04(a).
22 21 U.S.C. 844(a).
23 21 U.S.C. 842(a)(5).
24 In addition, I conclude that the reference in 21
U.S.C. 823(f)(5) to ‘‘other conduct which may
threaten the public health and safety’’ would as a
matter of statutory interpretation logically
encompass the factors listed in Section 824(a). See
Kuen H. Chen, M.D., 58 FR 65,401, 65,402 (DEA
1993).
PO 00000
21 21
Frm 00110
Fmt 4703
Sfmt 4703
assessment of prescribing and recordkeeping practices that are ‘‘tethered
securely to state law * * * and federal
regulations.’’ Volkman v. DEA, 567 F.3d
215, 223 (6th Cir. 2009). Additionally,
in an action to revoke a registrant’s
COR, the DEA has the burden of proving
that the requirements for revocation are
satisfied.25 The burden of proof shifts to
the respondent once the Government
has made its prima facie case.26
C. The Factors to Be Considered
Factors 1 and 3: The Recommendation
of the Appropriate State Licensing
Board or Professional Disciplinary
Authority and Conviction Record Under
Federal or State Laws Relating to the
Manufacture, Distribution or Dispensing
of Controlled Substances
In this case, regarding Factor One, it
is undisputed that Respondent currently
holds a valid, unrestricted medical
license in Ohio. Although not
dispositive, Respondent’s possession of
a valid unrestricted medical license in
Ohio weighs against a finding that
Respondent’s registration would be
inconsistent with the public interest.
See Robert A. Leslie, M.D., 68 FR 15,227,
15,230 (DEA 2003) (state license is a
necessary, but not a sufficient condition
for registration, and therefore, this factor
is not dispositive).
Regarding Factor Three, there is no
evidence that Respondent has ever been
convicted under any federal or state law
relating to the manufacture, distribution
or dispensing of controlled substances.
I therefore find that this factor, although
not dispositive, see Leslie, 68 FR at
15,230, weighs against a finding that
Respondent’s registration would be
inconsistent with the public interest.
Factors 2 and 4: Respondent’s
Experience in Handling Controlled
Substances and Compliance with
Applicable State, Federal or Local Laws
Relating to Controlled Substances
In this case, there is indeed evidence
that Respondent has failed to remain in
compliance with applicable federal and
state law relating to controlled
substances, and that her past experience
in handling controlled substances and
compliance with applicable laws is
inconsistent with the public interest.
1. Respondent’s Dispensing Practices
Federal law requires every person
who dispenses (including prescribing)
any controlled substance to obtain a
registration from the Attorney
25 See
21 CFR 1301.44(e).
Medicine Shoppe—Jonesborough, 73 FR
364,380 (DEA 2008); see also Thomas E. Johnston,
45 FR 72,311, 72,311 (DEA 1980).
26 See
E:\FR\FM\01AUN1.SGM
01AUN1
Federal Register / Vol. 77, No. 148 / Wednesday, August 1, 2012 / Notices
General.27 Additionally, a separate
registration must be obtained for each
principal place of practice where a
registrant dispenses controlled
substances and a registrant must report
any change of address by applying to
modify her registration, which shall be
treated as an application for
registration.28 The Code of Federal
Regulations delineates the procedures a
registrant must follow to request a
change in registered address.29 Federal
regulations also mandate that a
‘‘prescription for a controlled substance
may only be filled by a pharmacist,
acting in the usual course of his
professional practice and either
registered individually or employed in a
registered pharmacy, a registered central
fill pharmacy, or registered institutional
practitioner.’’ 30
Ohio law requires ‘‘[e]ach person
* * * who sells dangerous drugs [31] at
retail for delivery or distribution to
persons residing in this state, shall be
licensed as a terminal distributor of
dangerous drugs pursuant to sections
4729.54 and 4729.55 of the Revised
Code.’’ Ohio Rev. Code Ann. § 4729.551
(2011). It further requires that to operate
a pharmacy, a ‘‘person not a pharmacist,
who owns, manages, or conducts a
pharmacy, shall employ a pharmacist to
be in full and actual charge of such
pharmacy, * * * .’’ Ohio Rev. Code
Ann. § 4729.27 (2011).
Various provisions of Ohio law
authorize a licensed health professional,
including a physician,32 to prescribe,
administer, or personally furnish
controlled substances to a patient, or
‘‘[c]ause * * * controlled substances to
be administered under the prescriber’s
direction and supervision.’’ Ohio Rev.
Code Ann. § 3719.06 (2011).33
Furthermore, Ohio law exempts, under
defined circumstances, a business
practice with a sole shareholder who is
a licensed health professional from the
requirement of obtaining a terminal
distributor license. Ohio Rev. Code Ann.
§ 4729.51 (B)(1)(j) (2011) (effective
September 2008). The parameters of this
exemption are set forth in a guidance
document published by the Ohio State
Board of Pharmacy:
[S]ection 4729.51(B)(1)(j) which will now
allow registered wholesale distributors of
27 21
U.S.C. 822(a)(2).
U.S.C. 822(e), 827(g); 21 CFR 1301.51.
29 See 21 CFR 1301.51.
30 21 CFR 1306.06
31 Dangerous drugs under Ohio law includes any
‘‘drug that may be dispensed only upon a
prescription.’’ Ohio Rev. Code Ann. § 4729.01(F)
(2011).
32 Ohio Rev. Code Ann. § 4729.01(I)(4) (2011).
33 See also Ohio Rev. Code Ann. §§ 4729.29,
4729.291 (2011).
tkelley on DSK3SPTVN1PROD with NOTICES
28 21
VerDate Mar<15>2010
19:53 Jul 31, 2012
Jkt 226001
dangerous drugs to sell dangerous drugs to a
business practice that is a corporation,
limited liability company, or professional
association if the business practice has a
SOLE SHAREHOLDER who is a licensed
health professional authorized to prescribe
drugs (prescriber) and is authorized to
provide the professional services being
offered by the practice.
This means that if the business practice has
a single prescriber (M.D. * * *) who is the
sole shareholder, member, or owner of the
practice, then this business practice is not
required to be licensed as a Terminal
Distributor of Dangerous Drugs with the Ohio
Board of Pharmacy. Previously, this
exemption was only for a prescriber who
practiced as a Sole Proprietor.
(Emphasis in original).34
The credible evidence at hearing
demonstrated that Respondent
established, solely owned, and operated
two limited liability companies, Unique
Pain Management (medical practice)
and Unique Relief (dispensary), both of
which are located at 418 Center Street,
Wheelersburg, Ohio. (Tr. 48–49, 302–
03.) Respondent’s medical practice,
which included her office and patient
examination rooms, was physically
separate from the dispensary, although
a system of security cameras allowed
some level of observing the dispensary
operation by Respondent from a monitor
located in her medical practice office.
(Tr. 400.) The dispensary filled
prescriptions issued by Respondent, as
well as by Respondent’s father, Dr. John
Temponeras. The evidence of record
reflects that between November 2008
and May 2011, a total of approximately
1.6 million dosage units of oxycodone,
a Schedule II controlled substance, were
ordered by Respondent, among other
controlled substances. (Tr. 206–07.) The
evidence further reflects that
Respondent’s father issued a large
number of prescriptions for controlled
substances while working at
Respondent’s medical practice at least
one day a week from 2008 until late
2010, a significant portion of which
were filled at Respondent’s dispensary.
(Tr. 181, 484–87.) Respondent’s father
was registered with DEA as an
individual practitioner in Portsmouth,
Ohio, but was not registered at
Respondent’s practice location. (Tr.
214.)
To the extent Ohio law permits a sole
practitioner to dispense or personally
furnish controlled substances directly to
a patient without a Terminal Distributor
license, Respondent’s dispensing
practices were well outside of those
parameters. Respondent established a
34 Ohio State Board of Pharmacy, Licensing Issues
for Prescribers (Updated July 2008), https://
www.pharmacy.ohio.gov/
Licensing_Issues_for_Prescribers_07252008.pdf.
PO 00000
Frm 00111
Fmt 4703
Sfmt 4703
45685
distinctly separate legal entity to fill
prescriptions that was physically
separate from Respondent’s medical
office. Furthermore, Respondent’s
dispensary was not limited to filling
prescriptions issued only by
Respondent, but also routinely filled
prescriptions issued by Respondent’s
father, notwithstanding the fact that
Respondent did not have a Terminal
Distributor license as required by state
law. Compare Ohio Rev. Code Ann.
§ 4729.551, with § 4729.51(B)(1)(j)
(2011). Respondent’s dispensary was
not registered with DEA as a pharmacy
and none of the dispensary employees
was licensed in Ohio as a pharmacist, as
required by state and federal law.35 (Tr.
103–04.)
In addition to the foregoing violations,
Respondent also failed to directly
monitor or supervise the dispensing
activities of her employees, none of
whom were licensed, trained, or
qualified to handle and dispense
controlled substances in Ohio. Rather,
Respondent’s employees operated in
large measure as an independent
pharmacy filling prescriptions for
Respondent and Respondent’s father.
The weight of the evidence
demonstrated that Respondent and her
father were not personally
administering, dispensing, or furnishing
controlled substances to their patients,
but rather issued prescriptions for
patients to be filled either at
Respondent’s dispensary or at other
pharmacies. (Tr. 210–11.) The fact that
patients had the option to fill
prescriptions at other locations, which
occurred to some extent, is inconsistent
with personally administering or
furnishing controlled substances.36
While the majority of prescriptions
issued by Respondent or her father were
filled at Respondent’s dispensary, there
is no credible evidence of record that
Respondent or her father had any
personal role or supervision of that
process. Instead, the process was left to
Respondent’s employees, who were
unlicensed, untrained, and unqualified
to handle or distribute controlled
substances.
I do not find the testimonial evidence
with regard to cameras in the dispensary
and a monitor within Respondent’s
office credible insofar as establishing,
consistent with Ohio law, that
Respondent effectively supervised her
employees dispensing or furnishing of
35 21 CFR 1306.06 (2011); Ohio Rev. Code Ann.
§ 4729.27 (2011).
36 A sampling of data for a one month time period
in April 2010 revealed that Respondent filled
approximately eighty-three percent of her
prescriptions, with the remainder filled at other
pharmacies. (Tr. 211.)
E:\FR\FM\01AUN1.SGM
01AUN1
tkelley on DSK3SPTVN1PROD with NOTICES
45686
Federal Register / Vol. 77, No. 148 / Wednesday, August 1, 2012 / Notices
controlled substances. For example,
Mrs. Leadingham testified that
Respondent could not monitor the
dispensary while treating patients in the
examination rooms, nor did the screen
on the monitor allow for the reading of
labels on prescription bottles. (Tr. 471,
478.) The evidence of record establishes
at most a system of cameras that was
designed for security of the premises,
rather than Respondent’s direct
supervision of the dispensing or
furnishing of controlled substances.
Moreover, Mrs. Leadingham testified
that upon her return to work at
Respondent’s dispensary in July 2009,
Respondent was very concerned with
the way the dispensary had been run, to
include complaints from patients and
missing pills. (Tr. 421.) Respondent
‘‘was allowed no access to the
dispensary itself in these two months
that we were gone.’’ (Id.) The fact that
Respondent continued to operate a
dispensary from April to July 2009, with
admittedly no access at all, is fully
consistent with other credible evidence
of record, to include testimony by Agent
Kinneer, that Respondent had for
significant periods of time essentially no
role in the physical delivery of
controlled substances to her patients.
(Tr. 307.)
Respondent also offered at hearing
one documentary exhibit, namely a
letter from the Ohio Department of
Health, dated April 27, 2010, which
apparently was in reply to a document
submitted by Respondent entitled:
‘‘Policy and Procedure for Initial Intake,
Screening, Verification of Identity and
Medical Records, Monthly Processing of
Patient.’’ (Resp’t Ex. 6; Gov’t Ex. 8.) The
reply letter in relevant part
complimented Respondent and her staff
‘‘on your thoroughness and intense
efforts for security in preventing
prescription drug abuse.’’ (Id.) For
purposes of this recommended decision,
I have given this letter little weight.
While the document facially confirms
that Respondent had a written policy
related to prevention of drug abuse, it
does not address or rebut the specific
evidence of Respondent’s
noncompliance with various provisions
of state and federal law related to her
handling of controlled substances
alleged in the OSC/IS. Additionally,
there is no credible evidence of record
to suggest that the Ohio Department of
Health, through Alvin D. Jackson,
Director, was aware in April 2010 of the
evidence of Respondent’s specific
misconduct which forms the basis of the
instant proceeding, a significant portion
of which became known to state and
federal authorities after April 2010.
VerDate Mar<15>2010
19:53 Jul 31, 2012
Jkt 226001
I find by a preponderance of the
evidence that Respondent dispensed or
directed and authorized the dispensing
of controlled substances from an
unregistered location on numerous
occasions between November 2008 and
May 2011, in violation of 21 U.S.C. 841
and 822(a)(2) and (e), as well as 21 CFR
1306.06.37 I further find that
Respondent’s dispensing practices and
lack of supervision of employees during
that time period violated applicable
state law. Ohio Rev. Code Ann.
§§ 4729.551, 4729.27, and 3719.06
(2011).
2. Respondent’s Record-Keeping
Practices
Pursuant to 21 CFR 1304.03(b),
1304.21(a), 1304.22(a)(2)(iv),
1304.22(a)(2)(ix) and 1304.22(c), a
registered individual practitioner is
required to maintain records of
controlled substances in Schedules II
through V that are dispensed and
received, including the number of
dosage units, the date of receipt or
disposal and the name, address and
registration number of the distributor. It
is unlawful to refuse or negligently fail
to make, keep or furnish required
records.38 DEA regulations require that
‘‘each registered individual practitioner
required to keep records’’ shall maintain
inventories and records of Schedule II
controlled substances ‘‘separately from
all of the records of the registrant;’’
inventories and records of Schedule III
through V controlled substances ‘‘shall
be maintained either separately from all
other records of the registrant or in such
form that the information required is
readily retrievable from the ordinary
business records of the registrant.’’ 39
DEA registrants are required to maintain
‘‘a complete and accurate record of all
controlled substances on hand * * *
.’’ 40 They must ‘‘take a new inventory
* * * at least every two years.’’ 41 The
inventory ‘‘must be kept by the
registrant and be available[] for at least
2 years’’ from the date of its creation.42
‘‘The inventory may be taken either as
of opening of business or as of the close
37 The OSC/IS alleged misconduct beginning on
January 1, 2007, but the undisputed evidence of
record established that Respondent opened her
dispensary in or about November 2008, and no
other relevant evidence was offered by the
Government pertaining to ‘‘unauthorized
distributions of controlled substances’’ by
Respondent prior to that date. See ALJ Ex. 1, at 1.
38 21 U.S.C. 842(a)(5).
39 21 CFR 1304.04(g), (f)(2).
40 21 CFR 1304.11(a).
41 21 CFR 1304.11(c); see also 21 CFR 1304.04(a)
(‘‘every inventory * * * must be kept by the
registrant and be available * * * for at least two
years from the date of such inventory’’).
42 21 CFR 1304.04(a).
PO 00000
Frm 00112
Fmt 4703
Sfmt 4703
of business on the inventory date and it
shall be indicated on the inventory.’’ 43
Under longstanding Agency
precedent, ‘‘the failure to comply with
record keeping requirements is a basis
for revoking a registration.’’ Alexander
Drug Co., 66 FR 18,299, 18,303 (DEA
2001) (citing Singer-Andreini Pharmacy,
Inc., 63 FR 4,668 (DEA 1998); Arthur
Sklar, d/b/a King Pharmacy, 54 FR
34,623 (DEA 1989); Summer Grove
Pharmacy, 54 FR 28,522 (DEA 1989);
and The Boro Pharmacy and Bell
Apothecary, 53 FR 15,151 (DEA 1988)).
The CSA’s emphasis on record-keeping
constitutes ‘‘ ‘an attempt to regulate
closely the distribution of certain
substances determined by Congress to
pose dangers, if freely available, to the
public at large.’ ’’ United States v.
Poulin, 926 F. Supp. 246, 250 (D. Mass.
1996) (quoting United States v. Averi,
715 F. Supp. 1508, 1510 (M.D. Ala.
1989)).
One mandatory record-keeping
vehicle is DEA Form 222, the ‘‘official
triplicate order form[] used by
physicians to order scheduled
narcotics’’ and other controlled
substances.44 A menu of federal
regulations specifies procedures relating
to DEA Form 222, such as obtaining, 21
CFR 1305.11, executing, § 1305.12,
filling, § 1305.13, and endorsing DEA
Form 222, § 1305.14, among other
procedures.45 In addition, 21 CFR
1305.03 requires that a DEA Form 222
be used for each distribution of a
controlled substance listed in Schedules
I or II, and Section 1305.17 provides
that these order forms must be
maintained separately from all other
records and that they ‘‘are required to be
kept available for inspection for a period
of 2 years.’’
The evidence at hearing reflected
numerous record-keeping violations by
Respondent. The evidence credibly
reflects that Respondent did not
properly prepare or maintain DEA Form
222s as required by law. The evidence
also demonstrated with regard to
Respondent’s dispensary, that Schedule
II controlled substance records were
improperly commingled with other
controlled substance records, contrary
to 21 CFR 1304.04.
Respondent’s evidence did not deny
the record-keeping violations with
regard to DEA Form 222 alleged by the
Government in the OSC/IS.
Respondent’s witnesses admitted that
paper copies of DEA Form 222 were not
properly maintained with required
43 21
CFR 1304.11(a).
L. Dougherty, Jr., M.D., 60 FR 55,047,
55,048 (DEA 1995).
45 See, e.g., 21 CFR 1305.15–.19.
44 Robert
E:\FR\FM\01AUN1.SGM
01AUN1
tkelley on DSK3SPTVN1PROD with NOTICES
Federal Register / Vol. 77, No. 148 / Wednesday, August 1, 2012 / Notices
information, or in separate locations
from other records. Rather, the
testimony focused on whether the
improperly completed DEA Form 222s
had distributor invoices stapled to them
in an apparent attempt to comply with
the substance and spirit of the
applicable DEA regulations.
As a factual matter, the testimony
from Respondent’s witnesses that
invoices were routinely stapled to DEA
Form 222s was directly contradicted by
physical evidence at hearing, namely
three purchaser copies of Form 222
seized from Respondent’s dispensary on
May 17, 2011, none of which was
accompanied by an invoice. (Tr. 64–65;
Gov’t Ex. 6.) Additionally, all of the
Government witnesses were consistent
in describing the absence of stapled
invoices in the vast majority of DEA
Form 222s observed and seized from
Respondent’s dispensary.
Agent Kinneer credibly testified that
during his February 9, 2011 inspection
of Respondent’s dispensary he reviewed
a two to three inch stack of Form 222s
on the dispensary counter with no
attached invoices, noting that ‘‘none of
them had a date or quantity on a filledout line for those individual drugs that
had been ordered and received.’’ (Tr.
319.) Agent Kinneer also testified that
he reviewed a box kept in the
dispensary vault with folders full of
blue Form 222s, and none of them had
the requisite receipt information, to
include date or quantity received. (Tr.
319–20.) With regard to attached
invoices, Agent Kinneer testified that he
did not go through all of the forms in
the box, but none of those he recalls
reviewing had an invoice attached. (Tr.
320.)
Consistent with Agent Kinneer’s
testimony, DI Burkhart credibly testified
that she participated in the execution of
a federal search warrant at Respondent’s
dispensary on May 17, 2011, resulting
in the seizure of approximately fifty
blue purchaser copies of DEA Form 222,
among other items. (Tr. 600–01.) Of the
fifty, only two had an invoice stapled to
the back of them. (Tr. 601.)
In light of the foregoing testimony
credibly demonstrating that on February
9, 2011, and May 17, 2011, the vast
majority of DEA Form 222s present in
Respondent’s dispensary did not have
accompanying invoices attached, I do
not find credible the testimony of
Respondent’s witnesses to the contrary.
Even if there had been credible evidence
offered to establish that Respondent
routinely attached invoices to DEA
Form 222s, such evidence would ‘‘not
obsolve [a registrant] from its obligation
to adhere to the law.’’ Alexander Drug
Co., 66 FR at 18,303.
VerDate Mar<15>2010
19:53 Jul 31, 2012
Jkt 226001
The efficacy of the closed system of
distribution for controlled substances and
certain chemicals mandated by Congress
through the Controlled Substances Act
depends upon strict adherence by all
registrants to all record keeping requirements
including those set forth at 21 U.S.C. [§§ ]
827, 828, 829, and 830, and all implementing
regulations found in Title 21 Code of Federal
Regulations, as well as all applicable state
laws and regulations.
(Id.)
The evidence at hearing also
demonstrated that Respondent did not
take an initial inventory or biennial
inventories, contrary to applicable
regulations. 21 CFR 1304.11(b) and (c).
Agent Kinneer credibly testified that
during his February 9, 2011 inspection,
he requested an opening inventory but
was informed by Mr. Leadingham that
‘‘one had not been done.’’ (Tr. 314.) Nor
was a biennial inventory produced
during the inspection. DI Kresnak
credibly testified that as a result of the
May 2011 search of Respondent’s
dispensary, documents related to
inventories were found, none of which
reflected a ‘‘biennial inventory.’’ For
example, there is evidence of record that
documents were seized from
Respondent’s dispensary reflecting
‘‘biannual inventories,’’ and one marked
‘‘opening inventory’’ which ‘‘indicated
that the date that they opened the
dispensary there was a zero inventory.’’
(Tr. 83.)
Respondent’s evidence with regard to
inventories centered primarily on
testimony by Respondent’s dispensary
employees that frequently during
‘‘down time’’ they would count on-hand
drugs, including controlled substances,
to ensure a match with computer
records. Mrs. Leadingham testified that
the dispensary kept detailed daily
inventories, and completed a biennial
inventory every two years, which was
kept in the dispensary vault. (Tr. 407.)
Later contradicting that testimony, Mrs.
Leadingham testified that the process to
conduct a biennial inventory consisted
of Mr. Leadingham using a computer
printout while she physically counted
the controlled substances, adding that
she did not ‘‘document anything’’ from
the inventory. (Tr. 481–82.) The lack of
documentation undermines the
credibility of Mrs. Leadingham’s
assertions that detailed inventories were
kept. Of significance, no invoices, DEA
Form 222s, or dispensing logs were used
to conduct the biennial inventory. (Tr.
480–82.) Nor is there any credible
evidence that Respondent participated
in the inventory process in any
meaningful way to ensure an accurate
inventory was taken and proper records
PO 00000
Frm 00113
Fmt 4703
Sfmt 4703
45687
maintained.46 Instead, the credible
evidence of record reflects that
Respondent delegated that task to
employees who were neither trained nor
properly supervised to perform the task.
The evidence at hearing
unequivocally demonstrates that
Respondent’s employees, however wellintentioned, lacked the qualifications,
training, or supervision to conduct an
appropriate initial or biennial inventory,
as required by applicable law and
regulation. The fact that no compliant
initial or biennial inventory was
produced by Respondent or her
employees during the February 9, 2011
inspection, nor seized during the May
17, 2011 search, amply demonstrates
Respondent’s blatant non-compliance
with this important record-keeping
requirement. As Agent Kinneer
succinctly testified, a ‘‘running
inventory’’ is no substitute for a true
inventory, since in ‘‘order for me to do
an audit I need a starting point.’’ (Tr.
373–74.) There is no evidence that such
a starting point existed within
Respondent’s dispensary records, nor
any other compliant inventory records.
Contrary to Respondent’s assertion
that the foregoing represents ‘‘highly
technical paperwork errors,’’ (Resp’t Br.
At 7), the failure by Respondent to
properly maintain required records
prevented investigators, as well as
Respondent, from determining whether
Respondent’s dispensary had significant
shortages or overages. (See, e.g., Tr.
375.) The sheer volume of controlled
substances handled by Respondent,
which between November 2008 and
May 2011, totaled approximately 1.6
million dosage units of the Schedule II
controlled substance oxycodone alone,
demonstrates that overages or shortages
had the potential to be quantitatively
significant. (See Tr. 375.) Nor was the
risk of diversion purely speculative with
regard to Respondent’s dispensary
given, for example, the testimony by
Mrs. Leadingham that during May and
June 2009, Respondent was not allowed
access to her own dispensary. (Tr. 421.)
Additionally, Mrs. Leadingham testified
that when she returned to work in
Respondent’s dispensary in July 2009,
she observed crushed pills and pills in
unmarked vials, and received
complaints from customers of missing
pills. (Tr. 421, 427.) Rather than being
technical paperwork errors, I find
46 I have carefully considered and reject as not
credible testimony by Respondent’s employees that
Respondent actively participated or supervised the
inventory process. (See, e.g., Tr. 453–54.) Even if
such testimony was found to be credible, the
methodology used to conduct the inventory, with
or without the Respondent, was clearly contrary to
law.
E:\FR\FM\01AUN1.SGM
01AUN1
45688
Federal Register / Vol. 77, No. 148 / Wednesday, August 1, 2012 / Notices
tkelley on DSK3SPTVN1PROD with NOTICES
Respondent’s blatant disregard for
fundamental record-keeping
requirements, among other violations, to
be significantly at odds with the public
interest.
Accordingly I find by a
preponderance of the evidence that
Respondent unlawfully failed to make,
keep or furnish required records relating
to her handling of controlled
substances, during the time period from
November 2008 to May 2011, in
violation of applicable federal law.47
3. Respondent’s Issuance of
Prescriptions Without Required
Information
Pursuant to 21 CFR 1306.05(a), ‘‘[a]ll
prescriptions for controlled substances
shall * * * bear the full name and
address of the patient * * * [and]
directions for use * * *.’’ The evidence
of record included approximately
eleven prescriptions issued by
Respondent for various controlled
substances to a single patient covering
the time period August to November
2006. (Tr. 219–20; Gov’t Ex. 7.) Each of
the eleven prescriptions was deficient
by failing to include the patient’s
address. (Tr. 220–21; see Gov’t Ex. 7.)
Additionally, the Government
introduced testimony by DI Kresnak that
he reviewed approximately twelve
prescriptions seized from a Portsmouth,
Ohio pharmacy that Respondent had
issued for controlled substances to more
than one patient between 2005 and
2006. Of the twelve reviewed, DI
Kresnak testified that eleven lacked a
patient address. (Tr. 53–55, 123–24.)
None of these prescriptions were
introduced by the Government at
hearing, and DI Kresnak was uncertain
if any of the prescriptions he recalled
reviewing from the Portsmouth, Ohio
pharmacy were the same as those
identified in Government Exhibit 7. Nor
could DI Kresnak recall any of the
patient names from memory without
reviewing copies of the prescriptions.48
(Tr. 118.) In light of this testimony, I
give little overall weight to the
testimony offered by the Government
with regard to the eleven prescriptions
seized from the Portsmouth, Ohio
pharmacy, since those prescriptions
may or may not be the same as those
contained within Government Exhibit 7.
‘‘Speculation is, of course, no substitute
for evidence, and a decision based on
speculation is not supported by
substantial evidence.’’ White ex rel.
47 See 21 U.S.C. 827(a), 842(a)(5); 13 CFR 1304.11
(b) and (c), 1305.13(e).
48 The Government did not seek to refresh DI
Kresnak’s recollection with any documents, nor
were the prescriptions at issue introduced at
hearing. See supra note 9.
VerDate Mar<15>2010
19:53 Jul 31, 2012
Jkt 226001
Smith v. Apfel, 167 F.3d 369, 375 (7th
Cir. 1999) (citing Erhardt v. Sec’y, DHS,
969 F.2d 534, 538 (7th Cir. 1992)).
Accordingly, I find by a
preponderance of the evidence that
Respondent issued approximately
eleven prescriptions between August
and November 2006 for controlled
substances without providing a patient
address, in violation of applicable
federal regulations.
All of the above findings regarding
Respondent’s violation of applicable
law and regulation as it pertains to her
prescribing practices, record-keeping,
and dispensing from an unregistered
location weigh heavily against a finding
under Factors Two and Four of 21
U.S.C. 823(f) that Respondent’s
continued registration would be
consistent with the public interest.
Factor 5: Such Other Conduct Which
May Threaten the Public Health and
Safety
Under Factor Five, the Administrator
is authorized to consider ‘‘other conduct
which may threaten the public health
and safety.’’ 5 U.S.C. 823(f)(5). The
Agency has accordingly held that
‘‘where a registrant has committed acts
inconsistent with the public interest, the
registrant must accept responsibility for
his or her actions and demonstrate that
he or she will not engage in future
misconduct. Patrick W. Stodola, 74 FR
20,727, 20,734 (DEA 2009).49 A
‘‘[r]espondent’s lack of candor and
inconsistent explanations’’ may serve as
a basis for denial of a registration. John
Stanford Noell, M.D., 59 FR 47,359,
47,361 (DEA 1994).
In this case Respondent was called by
the Government to testify, but refused to
answer questions by invoking her Fifth
Amendment privilege. ‘‘It is well
established that the Agency may draw
an adverse inference from a
respondent’s failure ‘to testify in
response to probative evidence offered
against’ [her].’’ Surinder Dang, M.D., 76
FR 51,417, 51,422 (DEA 2011) (citing
Baxter v. Palmigiano, 425 U.S. 308, 318
(1976)). I find it appropriate on the facts
of this case to draw an adverse inference
against Respondent where the
Government presented evidence of
misconduct involving Respondent’s
prescribing, dispensing, and recordkeeping practices, yet Respondent failed
to testify and respond to this evidence.
Additionally, Respondent presented no
evidence of acceptance of responsibility
for past misconduct, nor any evidence
49 See also Hoxie v. DEA, 419 F.3d 477, 484 (6th
Cir. 2005) (decision to revoke registration
‘‘consistent with the DEA’s view of the importance
of physician candor and cooperation’’).
PO 00000
Frm 00114
Fmt 4703
Sfmt 4703
demonstrating that she will not engage
in future misconduct, which weighs
heavily against a finding under Factor
Five of 21 U.S.C. 823(f) that
Respondent’s continued registration
would be consistent with the public
interest.
V. Conclusion and Recommendation
After balancing the foregoing public
interest factors, I find that the
Government has established by
substantial evidence a prima facie case
in support of revoking Respondent’s
DEA COR BT5598214, based on Factors
Two, Four and Five of 21 U.S.C. 823(f).
Once DEA has made its prima facie case
for revocation or denial, the burden
shifts to the respondent to show that,
given the totality of the facts and
circumstances in the record, revoking or
denying the registration would not be
appropriate. See Morall v. DEA, 412
F.3d 165, 174 (D.C. Cir. 2005);
Humphreys v. DEA, 96 F.3d 658, 661
(3d Cir. 1996); Shatz v. United States
Dep’t of Justice, 873 F.2d 1089, 1091
(8th Cir. 1989); Thomas E. Johnston, 45
FR 72,311 (DEA 1980). The record
reveals that Respondent has not
sustained her burden in this regard. In
light of the foregoing, Respondent’s
evidence as a whole fails to sustain her
burden to accept responsibility for her
misconduct and demonstrate that she
will not engage in future misconduct.
I recommend revocation of
Respondent’s DEA COR BT5598214 as a
practitioner, and denial of any pending
applications for renewal or
modification, on the grounds that
Respondent’s continued registration
would be fully inconsistent with the
public interest as that term is used in 21
U.S.C. 824(a)(4) and 823(f).
Dated: December 15, 2011.
Timothy D. Wing,
Administrative Law Judge.
[FR Doc. 2012–18749 Filed 7–31–12; 8:45 am]
BILLING CODE 4410–09–P
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. DEA–364]
Electronic Prescriptions for Controlled
Substances Notice of Approved
Certification Process
Drug Enforcement
Administration (DEA), Department of
Justice.
ACTION: Notice.
AGENCY:
DEA is announcing a new
DEA-approved certification process for
Electronic Prescriptions for Controlled
SUMMARY:
E:\FR\FM\01AUN1.SGM
01AUN1
Agencies
[Federal Register Volume 77, Number 148 (Wednesday, August 1, 2012)]
[Notices]
[Pages 45675-45688]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-18749]
-----------------------------------------------------------------------
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. 11-57]
Margy Temponeras, M.D.; Decision and Order
On December 15, 2011, Administrative Law Judge (ALJ) Timothy D.
Wing issued the attached recommended decision. Neither party filed
exceptions to the decision.
Having considered the entire record, I have decided to adopt the
ALJ's recommended rulings, factual findings, and his legal conclusions,
except as discussed below.\1\ I further hold that the record
establishes that Respondent engaged in acts which are sufficiently
egregious to warrant the revocation of her registration and that she
has not rebutted this conclusion.\2\
---------------------------------------------------------------------------
\1\ All citations to the ALJ's recommend decision are to the
slip opinion.
\2\ In discussing the public interest factors of 21 U.S.C.
823(f), the ALJ ``conclude[d] that the reference in 21 U.S.C.
823(f)(5) to `other conduct which may threaten public health and
safety' would as a matter of statutory interpretation logically
encompasses the factors listed in Section 824(a).'' ALJ at 19 n.24
(citing Kuen H. Chen, M.D., 58 FR 65401, 65402 (1993)).
To be sure, the Agency decision in Chen stated that ``[t]he
administrative law judge has concluded here that the reference in 21
U.S.C. 823(f)(5) to `other conduct which may threaten the public
health and safety' would as a matter of statutory interpretation
logically encompass the bases listed in 21 U.S.C. 824(a).'' 58 FR at
65402. However, whether this constitutes a holding or merely dictum,
Chen is totally devoid of any indication that the traditional tools
of statutory construction (i.e, text, structure, statutory purpose,
and legislative history) were employed in reaching this conclusion.
Indeed, while factor five focuses on ``other conduct,'' several of
the grounds for revocation are based on a registrant's status and do
not require inquiry into the nature of the underlying conduct. See
21 U.S.C. 824(a)(3) (authorizing revocation where registrant ``has
had his State license or registration suspended, revoked, or denied
by competent State authority and is no longer authorized'' to engage
in controlled substance activities or such sanction has been
recommended by competent state authority); id. Sec. 824(a)(5)
(authorizing revocation where registrant has been excluded or is
subject to exclusion from participating in federal healthcare
programs under mandatory exclusion provisions). In addition,
construing factor five in this manner renders superfluous factor
one, which authorizes the Agency to consider the recommendation of
the state licensing board or disciplinary authority, as well as the
provision of section 823(f) stating that the ``[t]he Attorney
General shall register practitioners * * * if the applicant is
authorized to dispense * * * controlled substances under the laws of
the State in which he practices.''
Finally, it should be noted that since shortly after the CSA's
enactment and years before section 823(f) was amended to include the
public interest factors, DEA ``has consistently held that where a
registration can be revoked under section 824, it can, a fortiori,
be denied under section 823 since the law would not require an
agency to indulge in the useless act of granting a license on one
day only to withdraw it on the next.'' Serling Drug Co. v. Detroit
Prescription Wholesaler, Inc., 40 FR 11918, 11919 (1975). See also
John R. Amato, 40 FR 22852 (1975) (Denying application where
practitioner's state license had been revoked, holding that section
823(f) ``must logically give the Administrator the authority to deny
a registration if the practitioner is not authorized by the State to
dispense controlled substances. * * * To hold otherwise would mean
that all applications would have to be granted only to be revoked
the next day under 21 U.S.C. 824(a)(3). This [A]gency has
consistently held that where a registration can be revoked under
section 824, it can, a fortiori, be denied under section 823.'').
Indeed, no court has ever questioned the Agency's longstanding
and consistent interpretation that it has authority to deny an
application on any of the grounds set forth in section 824(a). Cf.
National Muffler Dealers Assn., Inc., v. United States, 440 U.S.
472,477 (2011) (``A regulation may have particular force if it is a
substantially contemporaneous construction of the statute by those
presumed to have been aware of congressional intent.''); EEOC v.
Associated Dry Goods Corp., 449 U.S. 590, 600 n.17 (1981) (``a
contemporaneous construction deserves special deference when it has
remained consistent over a long period of time'').
---------------------------------------------------------------------------
[[Page 45676]]
The ALJ's Footnote 9
Among the allegations raised by the Government were: (1) That
Respondent had failed to include required information on various
prescriptions (such as a patient's address) in violation of 21 CFR
1306.05(a); (2) that she failed to take initial and biennial
inventories of the controlled substances she obtained and dispensed, in
violation of 21 CFR 1304.11(b) & (c); and (3) that she failed to
properly complete various order forms for schedule II controlled
substances (DEA Form 222), in violation of 21 CFR 1305.13(e). ALJ Ex.
1, at 3 (Order to Show Cause). According to the record, the
prescriptions were seized pursuant to a search warrant executed at a
local pharmacy. Tr. 53-55. As for the inventories and DEA 222s, these
were apparently seized during the execution of a search warrant at
Respondent's registered location.
At the hearing, Respondent's counsel requested that the Government
turn over the prescriptions, see Tr. 124-25; some fifty DEA Form 222s,
see id. at 80-81, 353-54; and the daily inventories done by the
employees of Respondent's dispensary. Id. at 423. The Government
objected to each of these requests on the ground that there is no right
to discovery in these proceedings. See id. at 80, 128, 423. The ALJ
denied each of these requests, explaining in his opinion that the
requests were ``untimely and unsupported by applicable legal
authority.'' ALJ at 6 n.9 (citing Roy E. Berkowitz, 74 FR 36,578,
36,760 (2009) (holding that there is no ``general right to discovery
under either the APA or DEA regulations'') (citing Nicholas A. Sychak,
d/b/a Medicap Pharmacy, 65 FR 75,959. 75,961 (2000))).
While I adopt the ALJ's rulings, I do so only because the requests
were untimely. In his Supplemental Pre-Hearing Ruling, which was issued
on August 5, 2011, the ALJ made clear that ``[a]ny requests for
subpoenas by either party are to be filed no later than 4:00 p.m. EDT
on August 26, 2011.'' ALJ Ex. 8, at 7. Respondent did not comply with
the ALJ's order and instead waited until the hearing to request the
documents. Respondent, however, had notice of the Government's intent
to litigate these issues from the outset of the proceeding; thus, she
cannot claim that she was unaware until the hearing that she would need
the various documents to respond to the allegations.\3\ Because
Respondent failed to timely request the documents, the ALJ properly
denied those requests.\4\
---------------------------------------------------------------------------
\3\ Moreover, having reviewed the record, it contains
substantial evidence (as the ALJ found) to support each of these
allegations.
\4\ That there is no general right to discovery in these
proceedings would not have barred a timely request for these
documents. Respondent did not seek broad-based discovery of whatever
the Government had obtained in the course of its investigation, but
rather, specific documents which were clearly relevant and material
to these three allegations because they are the very basis for the
three allegations. Thus, if the requests had been timely, this case
would have been governed by the principle that ``[d]iscovery must be
granted if in the particular situation a refusal to do so would so
prejudice a party as to deny him due process.'' McClellan v. Andrus,
606 F.2d 1278, 1286 (DC Cir. 1979) (noting that report was subject
to discovery in administrative proceeding because it was potentially
``uniquely relevant to appellant's case'' and ordering agency to
turn over report to administrative tribunal for in camera review to
determine relevancy and to allow Government to assert any claim of
privilege). See also Echostar Communications Corp. v. FCC, 292 F.3d
749, 756 (DC Cir. 2002) (noting that ``McClelland was seeking a
specific document `uniquely relevant to [his] case' ''). See also 5
U.S.C. 555(d) (``Agency subpoenas authorized by law shall be issued
to a party on request and, when required by rules of procedure, on a
statement or showing of general relevance and reasonable scope of
the evidence sought.''). See also 21 U.S.C. 875 & 876.
As the Agency has previous noted, under Goldberg v. Kelly, 397
U.S. 254, 270 (1970), `` `where governmental action seriously
injures an individual, and the reasonableness of the action depend
on fact findings, the evidence used to prove the Government's case
must be disclosed to the individual so that he has an opportunity to
show that it is untrue.' '' Beau Boshers, M.D., 76 FR 19401, 19403
(2011) (quoting 397 U.S. at 270). Moreover, the Supreme Court has
further explained that `` `the Due Process Clause forbids an agency
to use evidence in a way that forecloses an opportunity to offer a
contrary presentation.' '' Id. (quoting Bowman Transp., Inc., v.
Arkansas-Best Freight System, Inc., 419 U.S. 281, 288 n.4 (1974)).
Where the Government alleges that one has failed to properly
maintain or complete required records, it cannot seize those records
and then refuse to turn them over in response to a timely request
for them.
---------------------------------------------------------------------------
The ALJ's Legal Conclusions Regarding Respondent's Operation of a
Dispensary
The gravamen of the Government's case was Respondent's operation of
a dispensary, which in the Government's view was illegal because
Respondent dispensed thousands of controlled substance prescriptions
which were issued by her father, who was not registered at the location
of Respondent's practice, and Respondent does not hold a pharmacy
registration under the Controlled Substances Act. See ALJ Ex. 1, at 1.
The evidence showed that beginning in either November or December 2008,
Respondent began dispensing controlled substances at her practice
location and that during the period in which it operated, the
dispensary filled 3,397 prescriptions for controlled substances issued
by her father, most of which were for oxycodone, a schedule II
narcotic, and Xanax, a schedule IV benzodiazepine. Tr. 210-11. In
addition, the evidence showed that the prescriptions were filled and
delivered to the patients by employees who were not licensed as
pharmacists.
The ALJ concluded that Respondent violated Ohio law because she was
not licensed as a Terminal Distributor of Dangerous Drugs and did not
fall within the exemption provided under state law for ``a business
practice with a sole shareholder who is a licensed health
professional.'' See ALJ at 21 (citing Ohio Rev. Code Ann. Sec.
4729.51(B)(1)(j)).\5\ The ALJ based his reasoning in part on the
evidence showing ``that Respondent established, solely owned, and
operated two limited liability companies, Unique Pain Management ([her]
medical practice) and Unique Relief ([her] dispensary), both of which
are located at 418 Center Street, Wheelersburg, Ohio,'' and that the
two entities were ``physically separate'' from each other, although
Respondent could observe the dispensary through a system of security
cameras and a monitor she maintained in her office. Id. The ALJ also
noted that the dispensary also filled ``a significant
[[Page 45677]]
portion'' of the prescriptions issued by Respondent's father. Id. at
22.
\5\ The ALJ also noted that an Ohio Board of Pharmacy guidance
document, which interprets this provision, states that ``if the
business practice has a single prescriber * * * who is the sole
shareholder, member, or owner of the practice, then this business
practice is not required to be licensed as a Terminal Distributor of
Dangerous Drugs with the Ohio Board of Pharmacy. Previously, this
exemption was only for a prescriber who practices as a Sole
Proprietor.'' ALJ at 21 (quoting Ohio State Board of Pharmacy,
Licensing Issues For Prescribers--Updated (July 2008)).
---------------------------------------------------------------------------
Continuing, the ALJ reasoned that:
[t]o the extent Ohio law permits a sole practitioner to dispense
or personally furnish controlled substances directly to a patient
without a Terminal Distributor license, Respondent's dispensing
practices were well outside of those parameters. Respondent
established a distinctly separate legal entity to fill prescriptions
that was physically separate from Respondent's medical office.
Furthermore, Respondent's dispensary was not limited to filling
prescriptions issued only by Respondent, but also routinely filled
prescriptions issued by Respondent's father, notwithstanding the
fact that Respondent did not have a Terminal Distributor license as
required by state law.
Id. (citing Ohio Rev. Code Ann. Sec. Sec. 4729.51(B)(1)(j) &
4729.551).
However, I need not decide whether under Ohio law, Respondent's
creation of ``a distinctly separately legal entity to fill
prescriptions,'' id., required her to hold a Terminal Distributor
license, because the Government did not raise this issue in either the
Order to Show Cause or its pre-hearing statements. Nor are the few
fragments of testimony regarding this license (which primarily involved
the Board of Pharmacy Compliance Agent's statements regarding the
reason for his February 2011 visit to the dispensary) sufficient to
conclude that the parties litigated the issue by implied consent.
Indeed, any such conclusion is belied by the fact that when
Respondent's counsel attempted to question the Board's Compliance Agent
about whether a Board employee had told Respondent's staff that she did
not need to have a Terminal Distributor's License, the Government
objected that the questions were outside the scope of direct
examination as well as irrelevant and the ALJ sustained the
objections.\6\ Tr. 345-47.
---------------------------------------------------------------------------
\6\ Subsequently, Respondent succeeded in eliciting testimony
from one of her employees regarding a phone conversation he had with
an employee of the pharmacy board regarding whether she was required
to have a Terminal Distributor's license. Tr. 567. However, given
that the Government had already argued that this line of questioning
was irrelevant, which it was in light of the Government's failure to
disclose its intent to litigate the issue in either the Show Cause
Order or its pre-hearing statement, I conclude that this testimony
is not enough to establish implied consent and that the issue is not
properly before the Agency.
---------------------------------------------------------------------------
Under these circumstances, it is clear that the issue was not
``fairly and fully litigated at [the] hearing'' and therefore cannot be
the basis for a sanction. Yellow Freight System, Inc., v. Martin, 954
F.2d 353, 358 (6th Cir. 1992). As the Sixth Circuit further explained:
[A]n agency may not base its decision upon an issue the parties
tried inadvertently. Implied consent is not established merely
because one party introduced evidence relevant to an unpleaded issue
and the opposing party failed to object to its introduction. It must
appear that the parties understood the evidence to be aimed at the
unpleaded issue.
Id. (citing MBI Motor Co., Inc. v. Lotus/East, Inc., 506 F.2d 709,
711 (6th Cir. 1974)).
Moreover, ``where the Government's case `focus[es] on another issue
and [the] evidence of [an] uncharged violation [is] ``at most
incidental,' '' the Government has not satisfied its constitutional
obligation to provide a full and fair opportunity to litigate the issue
and it cannot rely on the incidental issue as a basis for imposing a
sanction.'' CBS Wholesale Distributors, 74 FR 36746, 36750 (2009)
(quoting Pergament United Sales, Inc., v. NLRB, 920 F.2d 130, 136 (2d
Cir.1990) (quoting NLRB v. Majestic Weaving Co., 355 F.2d 854, 861-62
(2d Cir. 1966))). Thus, because the issue was not properly raised and
the evidence was at most incidental, I reject the ALJ's legal
conclusion (and his discussion of Ohio law) that Respondent violated
Ohio law because she failed to obtain an Ohio Terminal Distributor's
license.
However, the ALJ also concluded that Respondent violated federal
law because she ``dispensed or directed and authorized the dispensing
of controlled substances from an unregistered location on numerous
occasions between November 2008 and May 2011.'' ALJ at 24 (citing 21
U.S.C. 822(a)(2) & (e); id. Sec. 841; 21 CFR 1306.06). The ALJ
offered no further explanation for this conclusion. While I hold that
the ALJ erred in concluding that she violated section 822(e), which
requires ``[a] separate registration * * * at each principal place of
business or professional practice where the applicant * * * dispenses
controlled substances,'' 21 U.S.C. 822(e), the record clearly supports
a finding that Respondent's dispensing activities violated the CSA.
The evidence of record shows that Respondent's dispensary was
located at the same address as her medical practice. This was also the
address at which Respondent was registered with the Agency.\7\ See GX
1. Thus, Respondent did not violate the requirement that she obtain a
separate registration for each principal place of professional practice
where she dispensed controlled substances.
---------------------------------------------------------------------------
\7\ There is no evidence that the dispensary had a separate
suite number as might be the case in a large medical office
building.
---------------------------------------------------------------------------
Rather, Respondent violated the CSA because she exceeded the
authority granted by her registration when she dispensed controlled
substance prescriptions issued by her father without holding a pharmacy
registration. Under 21 U.S.C. 822(b), ``[p]ersons registered by the
[Agency] under this subchapter to * * * dispense controlled substances
* * * are authorized to possess * * * or dispense such substances * * *
to the extent authorized by their registration and in conformity with
the other provisions of this subchapter.'' (emphasis added).
Under Federal law and DEA regulations, a registered physician is
authorized to prescribe, administer or ``dispense directly'' to her
patients in the course of professional practice. See 21 CFR 1306.11(b)
(``An individual practitioner may administer or dispense directly a
controlled substance listed in Schedule II in the course of his
professional practice without a prescription. * * *''); id. Sec.
1306.21(b) (``An individual practitioner may administer or dispense
directly a controlled substance listed in Schedule III, IV, or V in the
course of his/her professional practice without a prescription * *
*.''). See also 21 U.S.C. 829 (``Except when dispensed directly by a
practitioner, other than a pharmacist, to an ultimate user, no
controlled substance in schedule II, which is a prescription drug under
the Federal Food, Drug, and Cosmetic Act * * * may be dispensed
without'' a prescription); id. Sec. 829(b) (schedule III & IV).
In addition, DEA regulations provide that ``[a] prescription for a
controlled substance may only be filled by a pharmacist, acting in the
usual course of his professional practice and either registered
individually or employed in a registered pharmacy, or registered
institutional practitioner.'' 21 CFR 1306.06. Accordingly, Respondent,
who did not hold a pharmacy registration, exceeded the authority of her
registration because she authorized her employees to fill prescriptions
issued by her father.\8\ See 21 U.S.C. 822(b); id. Sec. 841(a)
(rendering unlawful the knowing or intentional dispensing of a
controlled substance ``[e]xcept as authorized by this subchapter'').
And in filling her father's prescriptions, she also violated 21 CFR
1306.06.
---------------------------------------------------------------------------
\8\ The evidence also showed that Respondent's father did not
hold a registration at the address of Respondent's dispensary.
---------------------------------------------------------------------------
So too, Respondent violated Ohio law because she allowed unlicensed
[[Page 45678]]
personnel to fill the prescriptions and failed to personally furnish
the controlled substances to her patients.\9\ See ALJ at 23-24. As the
ALJ found, Respondent used unlicensed personnel to fill the
prescriptions which her dispensary delivered to her patients. While
Ohio law exempts ``a prescriber,'' which includes a physician who is
authorized to practice medicine and prescribe drugs, see Ohio Rev. Code
Ann. Sec. 4729.01(I), from the prohibition against the unauthorized
practice of pharmacy under Ohio Rev. Code Ann. Sec. 4729.28, the
exemption requires that the physician ``personally furnish [ ] the
[prescriber's] patients with drugs, within the prescriber's scope of
professional practice.'' Id. Sec. 4729.29(A)(1).\10\ Moreover,
``[w]hen a prescriber personally furnishes drugs to a patient pursuant
to [the exemption], the prescriber shall ensure that the drugs are
labeled and packaged in accordance with state and federal drug laws and
any rules and regulations adopted pursuant to those laws.'' Id. Sec.
4729.29(B).
---------------------------------------------------------------------------
\9\ In contrast to the issue of whether Respondent was required
to hold an Ohio Terminal Distributor's license, the Government
provided notice of its intent to litigate the issue of Respondent's
use of unlicensed individuals to fill controlled substance
prescriptions. ALJ Ex. 5, at 5.
\10\ This citation, as well as the citation to section
4729.29(B), are to the provisions which were in effect during the
period at issue here.
---------------------------------------------------------------------------
Respondent did present evidence that she had a security camera
system and monitor in her office which allowed her to observe the
operation of her dispensary. See Resp. Br. 3 (citing Tr. 400). However,
given that she was actively seeing patients, her counsel's suggestion
that she observed the actually delivery of the drugs to the patients,
and thus was in compliance with Ohio's requirement that she
``personally furnish'' the drugs, is, as a factual matter, ludicrous. I
thus hold that she violated Ohio law because she did not personally
furnish the controlled substances to her patients.\11\
---------------------------------------------------------------------------
\11\ As for the other violations, I agree with the ALJ's
conclusions that Respondent failed to properly complete DEA Form
222s for the schedule II controlled substances she purchased, and
that the records were not kept separate from other records as
required by DEA regulations. See ALJ at 25-26 (citations omitted). I
also agree with the ALJ's conclusion that Respondent failed to
include required information on some prescriptions. See ALJ at 30
(citing GX 7).
---------------------------------------------------------------------------
In her brief, Respondent further claims that she ``was ill-advised
by counsel'' as to whether she needed a pharmacy registration ``and was
specifically told she was doing everything correctly with respect to
operating the dispensary.'' Resp. Br. 7. Respondent then maintains that
``[i]f a mistake was made it was not the Respondent's.'' Id. While the
ALJ recounted the testimony of one Respondent's employees regarding the
purported legal advice she received, see ALJ at 17 (citing Tr. 545,
559-60), he did not address Respondent's contention.
I do and I reject the contention. Even crediting the testimony of
Respondent's employee that he had a discussion with an attorney
regarding the dispensary's compliance with DEA regulations and was told
that ``we were doing it perfectly,'' Tr. 545, the employee's testimony
was exceedingly vague as to what issues were discussed and does not
establish that Respondent discussed whether she needed to obtain a DEA
pharmacy registration because she was filling the prescriptions issued
by her father. Thus, even were the Agency to recognize a defense of
good faith reliance on legal advice, the defense fails here because
Respondent has not established that there was a ``full disclosure of
all pertinent facts'' to the attorney and that her reliance was ``in
good faith.'' United States v. Lindo, 18 F.3d 353, 356 (6th Cir.1994);
see also United States v. Painter, 314 F.2d 939, 943 (4th Cir. 1963).
Indeed, the contention is belied by the employee's testimony that he
really ``didn't trust some of the opinions [he] was getting from'' the
attorney and that upon looking at the DEA rules, he determined that
Respondent's father had to be registered at her clinic if narcotics
were stored there.\12\ Tr. 559-60. Moreover, because Respondent invoked
her Fifth Amendment privilege and declined to answer any questions
(other than to state her name and that she had a registration as an
individual practitioner), she cannot establish that she relied in good
faith on the attorney's advice.
---------------------------------------------------------------------------
\12\ Having concluded that the Government did not provide
adequate notice of its intent to litigate the issue of whether
Respondent was required to hold a Terminal Distributor's license, it
is unnecessary to decide the issue of whether Respondent properly
relied on the statement of an Ohio Pharmacy Board employee that
Respondent did not need to hold this license. Tr. 548.
---------------------------------------------------------------------------
The Inventory Violations
The ALJ found that Respondent violated DEA regulations requiring
that she take initial and biennial inventories. ALJ at 27-29. While I
agree that the evidence establishes various violations, I find much of
the ALJ's discussion of the evidence and his reasoning confusing.
The ALJ found that Respondent did not have an initial inventory as
required by DEA regulations. See ALJ at 27 (citing 21 CFR 1304.11(b) &
(c)). While I adopt this finding, I do so based solely on the evidence
that when the Board of Pharmacy Compliance Agent conducted his February
9, 2011 inspection, Respondent's dispensary manager stated that ``one
had not been done.'' Tr. 314. Under Federal law, ``every registrant * *
* shall * * * as soon * * * as such registrant first engages in the * *
* dispensing of controlled substances, and every second year
thereafter, make a complete and accurate record of all stocks thereof
on hand.'' 21 U.S.C. 827(a). Moreover, under DEA regulations, ``[i]n
the event a person commences business with no controlled substances on
hand, he/she shall record this fact as the initial inventory.'' 21 CFR
1304.11(b). While under DEA regulations, a registrant is required to
keep, and make available for inspection, an inventory for only two
years, see 21 U.S.C. 827(b), a period which, given the evidence that
Respondent opened the dispensary in November or December 2008, would
have lapsed at the time of the February 2011 inspection, the statement
of the dispensary manager is sufficient to find that this violation
occurred.
Moreover, by the date of the February 2011 Pharmacy Board
inspection, Respondent was required to have performed a biennial
inventory. See id. Sec. 827(a); 21 CFR 1304.11(c). However, while
Respondent had an ``on-hand inventory'' that ``was within the computer
itself,'' Tr. 314, this did not comply with DEA regulations which
require that an inventory ``be maintained in written, typewritten, or
printed form.'' 21 CFR 1304.11(a). And while there is evidence showing
that during the May 2011 search, documents that were labeled as
``biannual inventories'' were seized, the fact remains that Respondent
was required to have on hand a proper biennial inventory at the time of
the February 2011 inspection.\13\
---------------------------------------------------------------------------
\13\ Had Respondent produced at the February 2011 inspection an
inventory which complied with 21 CFR 1304.11(a) & (c), I would not
place any weight on the fact that the inventory was labeled as a
``biannual'' rather than ``biennial.''
The ALJ further noted that it was ``[o]f significance, [that]
no invoices, DEA Form 222s, or dispensing logs were used to conduct
the biennial inventory.'' ALJ at 28 (citing Tr. 480-82). However,
while the CSA requires that a registrant retain its invoices, form
222s, as well as a dispensing log, for at least two years, see 21
U.S.C. 827(b), taking an inventory does not require doing anything
more than counting the drugs on hand and making a record which
includes the information required under 21 CFR 1304.11(e).
The ALJ further concluded that ``no compliant * * *tory was * *
*the May 17, 2011 search.'' ALJ at 28. However, the DI who seized
the inventories during the May 17, 2011 search did not offer any
testimony that the inventories were not compliant other than because
they were not done within two years of the opening of the
dispensary. Tr. 84. The ALJ further noted the testimony of one of
Respondent's employees ``that the process to conduct a biennial
inventory consisted of [her] husband using a computer printout while
she physically counted the controlled substances, adding that she
did not `document anything' from the inventory.'' ALJ at 28 (quoting
481-82).
It should be noted that even if the counts matched the
printout, at a minimum, the inventories would have been required to
document whether they were done on the opening of business or on the
closing of business. See 21 CFR 1304.11(a). However, because the
inventories were not submitted into evidence, there is no basis for
concluding that they did not contain the required information.
---------------------------------------------------------------------------
[[Page 45679]]
Conclusion
Having adopted the ALJ's conclusion (as modified herein) that
Respondent violated the CSA by dispensing thousands of controlled
substance prescriptions issued by her father and thus acted outside of
the authority granted by her registration, I conclude that this conduct
is egregious and warrants the conclusion that she has committed acts
which render her continued registration inconsistent with the public
interest and is sufficient by itself to support the revocation of her
registration. See 21 U.S.C. 824(a)(4). The additional violations
established on this record--her failure to have inventories, failure to
complete form 222s, failure to include required information on
prescriptions, her commingling of schedule II records with other
records, as well as her state law violations of failing to personally
furnish the drugs to her patients--buttress this conclusion. Because I
further adopt the ALJ's findings that Respondent has presented no
evidence that she accepts responsibility for her misconduct, I will
order that her registration be revoked and that any pending application
be denied.\14\
---------------------------------------------------------------------------
\14\ The ALJ noted that Respondent did not present ``any
evidence demonstrating that she will not engage in future
misconduct.'' ALJ at 31. This is not entirely accurate as the record
suggests that following the February 2011 visit of the Pharmacy
Board's Compliance Agent, her employees did take inventories.
However, Respondent did not put on any other evidence as to remedial
measures and her failure to testify warrants, as the ALJ held, the
adverse inference that she does not accept responsibility for her
misconduct. See id. (citing cases).
---------------------------------------------------------------------------
Order
Pursuant to the authority vested in me by 21 U.S.C. 824(a)(4) and
28 CFR 0.100(b), I order that DEA Certificate of Registration
BT5598214, issued to Margy Temponeras, M.D., be, and it hereby is,
revoked. I further order that any pending application of Margy
Temponeras, M.D., to renew or modify her registration, be, and it
hereby is, denied. This Order is effective August 31, 2012.
Dated: July 24, 2012.
Michele M. Leonhart,
Administrator.
D. Linden Barber, Esq. & Frank Mann, Esq., for the Government.
Bradley Davis Barbin, Esq., for the Respondent.
Recommended Ruling, Findings of Fact, Conclusions of Law and Decision
of the Administrative Law Judge
I. Introduction
Timothy D. Wing, Administrative Law Judge. This proceeding is an
adjudication pursuant to the Administrative Procedure Act (APA), 5
U.S.C. 551 et seq., to determine whether the Drug Enforcement
Administration (DEA, Agency or Government) should revoke a physician's
DEA Certificate of Registration (COR) as a practitioner pursuant to 21
U.S.C. 824(a)(4) and deny, pursuant to 21 U.S.C. 823(f), any pending
applications for renewal or modification thereof and any application
for a new COR. Without this registration, Margy Temponeras, M.D.
(Respondent), of Wheelersburg, Ohio, will be unable to lawfully
prescribe, dispense or otherwise handle controlled substances in the
course of her practice.
On May 16, 2011, the Administrator, DEA, issued an Order to Show
Cause and Immediate Suspension of Registration (OSC/IS), which was
personally served upon Respondent on May 17, 2011.\1\ The OSC/IS
immediately suspended Respondent's DEA COR as a practitioner, and also
provided notice to Respondent of an opportunity to show cause as to why
the DEA should not revoke Respondent's COR, pursuant to 21 U.S.C.
824(a)(4), and deny, pursuant to 21 U.S.C. 823(f), any pending
applications for renewal or modification thereof and any applications
for a new COR, alleging that Respondent's continued registration is
inconsistent with the public interest as that term is defined in 21
U.S.C. 823(f).
---------------------------------------------------------------------------
\1\ ALJ Exs. 1, 3.
---------------------------------------------------------------------------
The OSC/IS alleged that Respondent is registered as a practitioner
authorized to handle controlled substances in Schedules II through V
under DEA COR BT5598214.
The OSC/IS further alleged in relevant part: \2\
---------------------------------------------------------------------------
\2\ The Government represented prior to hearing that it intended
to proceed against Respondent only with regard to allegations
contained in numbered paragraphs two, eight, nine, and ten of the
OSC/IS.
---------------------------------------------------------------------------
That between approximately January 1, 2007 and November 3, 2009,
Respondent made approximately 3,397 unauthorized distributions of
controlled substances. These distributions from Respondent's registered
location were purportedly based on prescriptions issued by Dr. John
Temponeras, who is registered with DEA as a practitioner in Portsmouth,
Ohio. Respondent is not registered with DEA as a pharmacy. All in
violation of 21 U.S.C. 841 and 21 CFR 1306.06;
That Respondent failed to take an initial inventory and biennial
inventories of the controlled substances in the dispensary that
Respondent operated in violation of 21 CFR 1304.11(b) and (c);
That Respondent failed to make and keep complete and accurate
records of the receipt of controlled substances by, among other things,
failing to complete DEA Form 222 with the amount and date received of
controlled substances in violation of 21 CFR 1305.13(e); and
That Respondent frequently issued prescriptions for controlled
substances that did not contain all of the information required by 21
CFR 1306.05(a).\3\
---------------------------------------------------------------------------
\3\ The section requires in relevant part that ``[a]ll
prescriptions for controlled substances shall * * * bear the full
name and address of the patient * * * [and] directions for use * *
*.''
---------------------------------------------------------------------------
Following prehearing procedures, a hearing was held in Cincinnati,
Ohio between September 13, 2011, and September 14, 2011, with the
Government and Respondent each represented by counsel. Both parties
called witnesses to testify and both introduced documentary evidence.
After the hearing, both parties filed proposed findings of fact,
conclusions of law, and argument. All of the evidence and post-hearing
submissions have been considered, and to the extent the parties'
proposed findings of fact have been adopted, they are substantively
incorporated into those set forth below.
II. Issue
Whether the record establishes that Respondent's DEA COR BT5598214
as a practitioner should be revoked and any pending applications for
renewal or modification of that registration should be denied on the
grounds that Respondent's continued registration would be inconsistent
with the public interest as that term is used in 21 U.S.C. 824(a)(4)
and 823(f).
III. Evidence and Incorporated Findings of Fact \4\
---------------------------------------------------------------------------
\4\ In addition to the evidence discussed in this Section,
additional evidence and findings of fact are discussed in later
Sections of this Recommended Decision.
---------------------------------------------------------------------------
I find, by a preponderance of the evidence, the following facts:
[[Page 45680]]
A. The Government's Evidence
The Government's evidence included testimony from five witnesses:
Respondent; DEA Diversion Investigator (DI) Christopher Kresnak (DI
Kresnak); DI Paula Albert (DI Albert); Ohio State Board of Pharmacy
Compliance Agent Joseph Kinneer (Agent Kinneer); and DI Stephanie
Burkhart (DI Burkhart). In addition to testimonial evidence, the
Government also introduced various documentary exhibits, to include:
Respondent's COR record; \5\ three DEA Form 222 purchaser records;\6\
copies of prescriptions issued by Respondent between August and
November 2006; \7\ and a document reflecting standard procedures for
Unique Pain Management.\8\
---------------------------------------------------------------------------
\5\ Gov't Ex. 1.
\6\ Gov't Ex. 6.
\7\ Gov't Ex. 7.
\8\ Gov't Ex. 8.
---------------------------------------------------------------------------
Respondent was called to testify but refused to answer any
questions related to the relevant allegations in the OSC/IS by
asserting her Fifth Amendment privilege. (Tr. 35-36; 41-42.)
DI Kresnak testified in substance that he has approximately eight
years of experience with DEA as a DI. (Tr.45.) DI Kresnak testified
that Respondent is registered with DEA as a practitioner under DEA COR
BT5598214 with an expiration date of November 30, 2012, and a current
status listed as ``under suspension.'' (Tr. 47; Gov't Ex. 1.) DI
Kresnak further testified that Respondent has never held any other type
of DEA registration, including a pharmacy registration. (Tr. 48.)
Respondent has never been registered with the State of Ohio as a
pharmacist and has never held a pharmacy license in Ohio. (Id.)
DI Kresnak next testified that Respondent owns and operates two
limited liability companies-her medical practice, Unique Pain
Management, and her dispensary, Unique Relief. (Tr. 48-49.) Both of
Respondent's businesses are located in the same building at 418 Center
Street, Wheelersburg, Ohio. (Tr. 49.) DI Kresnak testified that he was
present inside both businesses on May 17, 2011, and he described the
physical layout of the location to include Respondent's office on the
far left hand corner from the entrance, with the ``dispensary* * * on
the right-hand side of the building, * * *.'' (Tr. 50-51.) DI Kresnak
testified that he interviewed Respondent on that same day, and in
response to a question about why the dispensary was operating,
Respondent ``said words to the effect that many of the local pharmacies
stopped filling for her prescriptions and that she wanted to provide a
low-cost convenience for her patients.'' (Tr. 52.)
DI Kresnak also testified that pursuant to a search warrant at
Prime Pharmacy Group d/b/a Medi-Mart Pharmacy, in Portsmouth, Ohio, he
obtained prescriptions covering the time period 2005 to 2006 for
Schedule III through V controlled substances, and identified twelve
controlled substance prescriptions issued by Respondent. (Tr. 53, 54-
55.) The twelve prescriptions related to more than one patient, but DI
Kresnak did not know how many patients exactly, nor could he recall any
of the patients' names.\9\ (Tr. 118, 188.) DI Kresnak testified that of
the twelve prescriptions, only one was compliant with DEA regulations.
Eleven were noncompliant because they lacked a patient address. (Tr.
54; 123-24.)
---------------------------------------------------------------------------
\9\ None of the twelve prescriptions were produced by the
Government at hearing, and DI Kresnak was uncertain if any of the
twelve were the same as those contained in Government Exhibit 7.
(Tr. 118-20.) Respondent requested production of the records at
hearing and the Government objected, arguing in substance the lack
of legal authority for such a discovery request. I denied
Respondent's discovery request since it was untimely and unsupported
by applicable legal authority. There is no ``general right to
discovery under either the APA or DEA regulations, but rather only a
limited right to receive in advance of hearing the documentary
evidence and summaries of the testimony which the Government intends
to rely upon.'' Roy E. Berkowitz, M.D., 74 FR 36,758, 36,760 (DEA
2009) (citing Nicholas A. Sychak, d/b/a Medicap Pharmacy, 65 FR
75,959, 75,961 (DEA 2000). Respondent made various untimely requests
for discovery throughout hearing with regard to other documents,
such as original Form 222s, which were denied for similar reasons.
---------------------------------------------------------------------------
DI Kresnak next explained that DEA Form 222s are used by industry
to order Schedule II controlled substances, and are issued to
registrants by DEA. (Tr. 55.) DI Kresnak testified that a DEA Form 222
contains, among other information, the name and address of a
registrant, ``what the registrant is authorized to order,'' and a
serial number. (Tr. 56.) A DEA Form 222 consists of three copies: the
``brown sheet,'' which goes to the distributor; a carbonated second
``green'' copy, which also goes to the distributor; and a ``blue''
copy, which is maintained at the registrant or practitioner's
registered address when the registrant or practitioner orders Schedule
II controlled substances. (Tr. 56-57.) DI Kresnak further explained
that the distributor completes relevant information on the Form 222 at
time of shipping, to include the National Drug Code (NDC) and number of
controlled substances shipped. (Tr. 58.) The distributor then sends the
green carbonated copy to the DEA office where the distributor is
located. (Tr. 58.)
DI Kresnak testified that he reviewed approximately fifty DEA Form
222s seized from Respondent's dispensary, and on approximately six to
ten forms he observed various discrepancies:
Many of them weren't filled out properly, missing information.
Several of them didn't even indicate whether a shipment had been
received. One * * * just doesn't reflect anything. There were
several, maybe seven lines filled out on it and there's nothing
indicating any product was received.
(Tr. 60.) DI Kresnak compared the green copies of DEA Form 222s sent to
DEA by the distributor with those seized from Respondent's dispensary,
and testified that he recalled a specific discrepancy:
I observed one particular 222 * * * where the distributor
indicated that they [sic] did not fill the order. The blue copy of
the 222, which is found in the dispensary, which is required by the
Code to fill out how many is [sic] received, indicated that there
were 60 received. There were 60 ordered. The blue copy was
indicating 60 received, but the distributor's copy to DEA
indicate[d] they did not fill that order.
(Tr. 63.) DI Kresnak further testified that he reviewed data from DEA's
Automated Reports and Consolidated Order System (ARCOS),\10\ which
confirmed that the information reflected on the distributor's DEA Form
222 was accurate. (Tr. 63-64.)
---------------------------------------------------------------------------
\10\ ``Registrants are also required to report records of sales
or acquisitions of controlled substances in Schedules I and II, of
narcotic controlled substances listed in Schedules III, IV and V,
and of psychotropic controlled substances listed in Schedules III
and IV with the DEA's Automation of Reports and Consolidated Orders
System (ARCOS). 21 CFR 1304.33(c); 21 U.S.C. [Sec. ] 827(d). These
reports must be filed every quarter not later than the 15th day of
the month succeeding the quarter for which it is submitted. 21 CFR
1304.33(b).'' Easy Returns Worldwide, Inc. v. United States, 266 F.
Supp. 2d 1014, 1016 (E.D. Mo. 2003).
DI Kresnak also testified about three specific DEA Form 222s seized
from Respondent's dispensary on May 17, 2011, which he found to be
deficient. (Tr. 64-65; Gov't Ex. 6.) DI Kresnak testified that one was
deficient ``[i]f these drugs were received * * * [because] a date
received is omitted.'' (Tr. 65; Gov't Ex. 6, at 1.) A second form is
deficient because the ``number of packages received is omitted and the
date received is omitted.'' (Tr. 66; Gov't Ex. 6, at 2.) A third form
is deficient because the ``number of packages is omitted on both items
and the date received.'' (Tr. 66; Gov't Ex. 3, at 3.) DI Kresnak
further testified somewhat tepidly with regard to whether the
controlled substances were actually shipped to Respondent, that he
``believed they were'' further explaining that he believed ``we found
[[Page 45681]]
documentation that these were shipped, yes.'' \11\ (Tr. 82.)
---------------------------------------------------------------------------
\11\ DI Kresnak's testimony was further qualified by his
statement that ``[w]e found invoices that reflect some of these.''
(Tr. 83.) Additionally, DI Kresnak explained that ARCOS reports
indicated shipments of the relevant controlled substances to
Respondent. (Tr. 134-36.)
DI Kresnak testified that during the first two years that
Respondent operated her dispensary, the majority of Respondent's
ordering was completed through an electronic DEA controlled substance
ordering system (CSOS), rather than using paper Form 222s. (Tr. 195-
96.)\12\
---------------------------------------------------------------------------
\12\ 21 CFR1300.03. DI Kresnak explained that CSOS is only for
Schedule II controlled substances and is ``used to eliminate paper
flow.'' (Tr. 194.)
---------------------------------------------------------------------------
DI Kresnak next testified that during the search of Respondent's
dispensary, documents related to inventories were found, to include one
marked opening inventory, which ``indicated that the date that they
opened the dispensary there was a zero inventory.'' (Tr. 83.) ``No
biennial inventory was ever found.'' (Tr. 84.) Rather, several
documents entitled ``Biannual Inventories'' were found in a folder
marked ``DEA inventories.'' (Tr. 144.) DI Kresnak testified that
Respondent's dispensary opened ``sometime in November 2008, maybe
December 2008.'' (Tr. 99.) Although DI Kresnak could not recall all of
the details, he testified that the inventories appeared to be computer
generated, listing the drugs on the far left and dollar values in
another column. DI Kresnak did not know what the dollar values
represented. He also testified that each inventory was marked
``biannual,'' contained a date, and appeared to be signed by
Respondent. (Tr. 136-137.) DI Kresnak testified that as a result of his
investigation he determined that ``there was one particular oxycodone
product that 100% was missing for the month of April, 2011.'' (Tr.
150.) DI Kresnak further explained that he does not ``recall the number
of dosages * * * missing * * * without referring to the audit.'' \13\
(Tr. 153.) DI Kresnak testified that he has not seen any inventories in
electronic format seized from Respondent, but noted that he has not as
yet looked for any. (Tr. 173.)
---------------------------------------------------------------------------
\13\ No audit was produced at hearing.
---------------------------------------------------------------------------
DI Kresnak next testified that Respondent and Respondent's father,
Dr. John Temponeras, were the only practitioners who issued
prescriptions for controlled substances in Schedules II through V that
were filled at Respondent's dispensary. (Tr. 101.) DI Kresnak further
testified that Dr. John Temponeras had previously been a DEA registrant
with a registered location in Portsmouth, Ohio. DI Kresnak interviewed
Dr. John Temponeras regarding his application for a DEA registration at
Respondent's Center Street location in Wheelersburg, Ohio, and learned
``he had written prescriptions [for controlled substances] that were
filled at the dispensary, and he basically said he was needing a DEA
registration at that location because his daughter said he needed one
there.'' (Tr. 102.)
DI Albert testified in substance that she has eleven years of
experience with DEA as a diversion investigator. DI Albert testified
that she was present at Respondent's business location in Wheelersburg,
Ohio, on May 17, 2011, assisting in the execution of a federal search
warrant and service of the OSC/IS. (Tr. 202.) DI Albert described the
location as ``a medical clinic and a--I guess, a dispensary.'' (Tr.
202.) By dispensary, DI Albert testified that she meant ``[t]hey filled
prescriptions and dispense[d] medication to patients.'' (Id.) The
location was described as having the doctor's office on the left of the
building, and on the right after passing through a door there was
another lobby and ``[i]nside that lobby there was a set of windows with
thick glass, and behind those windows were [sic] the dispensary.'' (Tr.
203.)
DI Albert further testified that Darryl Leadingham (Mr. Leadingham)
and Sue Leadingham (Mrs. Leadingham) were working in the dispensary on
May 17, 2011. DI Albert interviewed Mr. Leadingham regarding his
responsibilities in the pharmacy, and learned that ``he was responsible
for the computer system, the security system in the whole building, the
cameras. * * * [H]e ordered the controlled substances that were
dispensed out of the dispensary, and he also worked as far as entering
patient information into the computer system, printing labels,
dispensing the controlled substances, billing patients' insurance, * *
*.'' (Tr. 203-04.) In terms of dispensing, Mr. Leadingham indicated
that patients would bring a physical hard copy prescription that either
Respondent or Respondent's father had issued with an original
signature. The information was entered in the computer system which
would generate three labels, the first for the prescription bottle,
second for the original hard copy prescriptions, and third on the
outside bag containing all of the bottles of medicine distributed. (Tr.
208.)
DI Albert testified that Mrs. Leadingham similarly stated that
``she was there to dispense the medication and put the information,
print the labels and bill the insurance or accept cash.'' (Tr. 209.) DI
Albert further testified that both Mr. Leadingham and Mrs. Leadingham
stated during the May 17, 2011 interview:
Dr. John Temponeras had filled in and had seen [Respondent's]
patients and that there were prescriptions that patients brought to
the dispensary with [Dr. John Temponeras'] name on them. And Darryl
Leadingham told me that at some point he figured out that it was no
longer--or that they shouldn't be doing that and that he had told
[Respondent] that her father needed to get his own DEA registration
for that location.
(Tr. 213.)
DI Albert testified that based on information contained within the
Ohio Automated Rx Reporting System (OARRS),\14\ the only prescriptions
filled at the dispensary were issued by Respondent or Respondent's
father. (Tr. 209.) DI Albert testified that OARRS data reflected that
from November or December 2008 until 2011, Respondent's dispensary
filled approximately 3,397 prescriptions issued by Respondent's father
for controlled substances, ``mostly oxycodone products and Xanax or the
Schedule IV.'' (Tr. 210-11.) Regarding prescriptions issued by
Respondent, DI Albert testified in April 2010 alone, Respondent
``filled 500 prescriptions at her dispensary, which came out to--after
I compared that to other pharmacies, it was over eighty-three percent
of her prescriptions were filled by herself.'' (Tr. 211.) DI Albert did
not know why eighty-three percent of the patients chose to go to
Respondent's dispensary and no cost analysis of pharmacies in the
region was conducted by DI Albert. (Tr. 231.)
---------------------------------------------------------------------------
\14\ DI Albert testified that OARRS is a prescription monitoring
system run by the Ohio Board of Pharmacy based on information
submitted by pharmacies. (Tr. 209-10.) See also Ohio Admin. Code R.
4729-37-03 (2011).
---------------------------------------------------------------------------
DI Albert next testified that as part of her investigation of
Respondent, she reviewed ARCOS system data pertaining to ``all the
oxycodone products [Respondent] ordered'' from the opening of the
dispensary in 2008 until her last order in May 2011, finding a total of
``approximately 1.6 million dosage units'' of oxycodone, a Schedule II
controlled substance. (Tr. 206-07.) DI Albert testified that she
recalled the presence of various drugs at the dispensary on May 17,
2011, described as ``mostly controlled substances, oxycodone,
OxyContin, benzos,\[15]\ Xanax, Valium.'' (Tr. 204.) DI Albert believed
there may have been a small quantity of hydrocodone and ``a couple
[[Page 45682]]
of other Schedule II substances, such as morphine.'' (Tr. 204-05.)
---------------------------------------------------------------------------
\15\ DI Albert explained her use of the term ``benzos'' was
short-hand for benzodiazepines, a Schedule IV controlled substance.
(Tr. 205.)
---------------------------------------------------------------------------
DI Albert further testified that she has reviewed the originals of
the DEA Form 222s reflected in Government Exhibit 6, which were seized
from Respondent's dispensary on May 17, 2011, and did not remove any
attachments from the originals nor was she aware of any other DEA
personnel removing attachments. (Tr. 215.) DI Albert testified that she
reviewed and compared distributor copies of the Form 222s with copies
retained by Respondent, and found discrepancies between what the
distributors indicated they shipped and what Respondent reported
receiving. (Tr. 216-17.) DI Albert elaborated:
I believe there were times where [hellip] on the distributor's
copy, or the one that [the distributor] provide[d] to DEA, it
indicates that they actually shipped a different quantity or they
voided out the line, where, in fact, the copy that we found in the
dispensary will show that they received a quantity and the
distributor says that [the distributor] voided it.
(Tr. 218; Gov't Ex. 6.)
Finally, DI Albert testified that she reviewed various
prescriptions for controlled substances issued to Patient [IM] by
Respondent, dated between August and November 2006, and determined that
the prescriptions were missing the address of the patient, as required
by regulation. (Tr. 220-21, 249-50; Gov't Ex. 7.)
Agent Kinneer testified that he has been employed with the Ohio
Board of Pharmacy as a Compliance Agent for approximately seventeen
years.\16\ Agent Kinneer further testified that he was familiar with
Respondent's professional practice, explaining that in December 2010,
Respondent applied for a Terminal Distributor license,\17\ which would
allow for the purchase of prescription drugs and controlled substances.
(Tr. 301-02.)
---------------------------------------------------------------------------
\16\ Agent Kinneer's duties include inspection of entities
licensed by the Ohio Board of Pharmacy, to include physicians,
pharmacies, pharmacists, dentists, and paramedics. Agent Kinneer's
duties further include investigation of drug diversion. (Tr. 300.)
\17\ The license was for Respondent's dispensary, Unique Relief,
located within the same building as Respondent's medical practice.
(Tr. 308.)
---------------------------------------------------------------------------
Agent Kinneer next testified that based on Respondent's application
for a Terminal Distributor license, he conducted an inspection of
Respondent's location on February 9, 2011. (Tr. 303.) As a result of
the inspection, Agent Kinneer determined that the dispensary was
operated by Mr. Leadingham, who had been introduced as the dispensary
manager. (Tr. 307.) Agent Kinneer further determined that for the past
two years, Respondent had no role in the physical delivery of
controlled substances to her patients. (Tr. 307, 334.)
Agent Kinneer explained that during his inspection, he observed a
dispensing practice that failed to properly document the filling of
prescriptions. ``What would happen is, you had one prescription that
had all three labels on it * * * [a]nd then the other two had no labels
at all. So there was no way to document that those prescriptions had
actually been filled.'' (Tr. 313.)
Agent Kinneer testified that he requested an opening inventory and
none was produced. Instead, Mr. Leadingham stated that ``one had not
been done.'' (Tr. 314.) Mr. Leadingham was also unable to produce a
biennial inventory. (Tr. 315.) Agent Kinneer further testified that he
conducted a series of audits of individual drugs using a running
inventory from the computer in Respondent's dispensary. (Tr. 316-17.)
He determined a slight overage for two controlled substances and a
shortage of two other controlled substances. (Tr. 317.) Agent Kinneer
testified that ``our demonstration was to show Mr. Leadingham that you
cannot rely on a running inventory. There actually needs to be a hard
copy. And the purpose of it was to show that those things can be off.''
(Tr. 317.) The running audit also revealed that ``[t]here was drugs
[sic] that were dead on.'' (Tr. 318.) Agent Kinneer further testified
that there was no way to tell whether Respondent's dispensary had
significant shortages or overages, since the absence of a starting
point for the audit precluded a true inventory of controlled substances
within Respondent's dispensary.
Remember, this [running inventory] was just a tool to show
Darryl Leadingham and Sue Leadingham that they cannot rely on the
running inventory as a true inventory, that they needed an opening
inventory as well as their DEA inventory. In order for me to do an
audit I need a starting point. And that's what I am trying to
express to them.
(Tr. 373-75.)
Agent Kinneer also reviewed DEA Form 222s during his inspection,
specifically requesting the production of ``their blue copy where they
actually receipted the medication.'' (Tr. 318.) Based on a review of a
two to three inch stack of DEA Form 222s on the counter at the
dispensary, Agent Kinneer testified that none had been ``receipted,''
explaining that none ``had a date or quantity on a filled-out line for
those individual drugs that had been ordered and received.'' (Tr. 319,
362-63.) A review of DEA Form 222s kept in a vault within the
dispensary also revealed that none had been receipted.\18\ Agent
Kinneer testified that Mr. Leadingham was unaware of the requirement to
do so, instead indicating ``that he had been trained just to * * * do
the invoices * * * [and] documenting it in the computer that they had
received them.'' (Tr. 320.) Agent Kinneer further testified that he did
not recall seeing invoices attached to the DEA Form 222s that he looked
at, noting that it did not matter since that is not the requirement.
(Tr. 320-21.) Agent Kinneer does not recall seeing staple marks on the
DEA Form 222s that he reviewed, but explained he was not looking for
staple marks. (Tr. 348.)
---------------------------------------------------------------------------
\18\ Agent Kinneer testified that his inspection did not focus
on how many dispensary orders were electronic as compared with
orders using hand-written Form 222's with an accompanying blue copy.
``We were solely looking at the blue copies.'' (Tr. 360.)
---------------------------------------------------------------------------
Agent Kinneer testified that controlled substances were ordered by
the dispensary manager, Mr. Leadingham, using Respondent's DEA
registration, but there was no indication that Respondent was active or
accountable for the accuracy and completeness of the dispensary's
records. (Tr. 321-22.) Agent Kinneer further testified that at the
completion of the inspection, he informed Mr. Leadingham that ``from
what we were witnessing he was running a pharmacy, which was illegal.''
(Tr. 323.) Agent Kinneer testified that Respondent's dispensary was not
registered with the Ohio Board of Pharmacy as a pharmacy, nor were any
personnel working in the dispensary licensed as pharmacists in Ohio.
(Tr. 324-25.)
DI Burkhart was called in rebuttal by the Government, and testified
in substance that she participated in the execution of a federal search
warrant at Respondent's location on May 17, 2011, to include seizing
the blue copies of DEA Form 222s. (Tr. 600-01.) Specifically, DI
Burkhart testified that she seized and reviewed approximately fifty DEA
Form 222s and only two blue copies had an invoice stapled to the back
of them. (Tr. 601.) The fifty seized DEA Form 222s included the three
reflected in Government Exhibit 6, which did not have any documents or
invoices stapled to them at the time they were seized. (Id.) DI
Burkhart further testified that she seized the DEA Form 222s from
within the dispensary vault and in other places in the dispensary. (Tr.
607-08.)
I find the foregoing witness testimony fully credible in that each
of the witnesses presented testimony that was internally consistent and
evidenced a
[[Page 45683]]
reasonable level of memory for past events. Each witness presented
testimony in a professional manner and the material portions of the
testimony were consistent with other credible evidence of record, as
discussed more fully below.
C. Respondent's Evidence
Respondent's evidence included testimony from two witnesses: Mrs.
Leadingham and Mr. Leadingham. Respondent also introduced a letter
dated April 27, 2010, from the Director of the Ohio Department of
Health.\19\ Mrs. Leadingham testified in substance as to her background
and experience, to include having worked for approximately five years
at an assisted living center before beginning work in Respondent's
dispensary in or about November 2008. (Tr. 385, 390.) Prior to working
for Respondent, Mrs. Leadingham had no prior working experience
dispensing drugs at a pharmacy. (Tr. 457.) Mrs. Leadingham testified
that when hired in November 2008, she worked for Ken Days (Mr. Days) in
Respondent's dispensary. (Tr. 390-91.) Mrs. Leadingham described her
duties to include counting pills, labeling medicine bottles, helping
with inventory, filing, and handling invoices and DEA Form 222s. (Tr.
391.) Mrs. Leadingham further testified that she loved working for
Respondent, who she described as caring and ``the best employer I have
ever had.'' (Id.) Mrs. Leadingham explained that Respondent's
dispensary operated like a pharmacy to include the use of pharmacy
software called Rx30, as well as printed prescriptions, labeled drugs,
and the filling of prescriptions, all consistent with that of a
pharmacy. (Tr. 473.) Mrs. Leadingham testified that the dispensary
filled controlled substance prescriptions for Respondent and
Respondent's father, on a regular basis between 2008 and late 2010,
when Respondent's father stopped issuing prescriptions. (Tr. 485.)
---------------------------------------------------------------------------
\19\ Resp't Ex. 6. This was the only exhibit offered by
Respondent at hearing.
---------------------------------------------------------------------------
Mrs. Leadingham next testified that Respondent's role in the
dispensary included stopping by every morning and evening to answer
questions or discuss issues. (Tr. 400.) ``She had a monitor in her
office that she watched us the whole time we were at work. She could
see everything we did at any given time.'' (Id.) Mrs. Leadingham later
contradicted this testimony, admitting that Respondent could not watch
the dispensary while she was examining patients throughout the day.
(Tr. 478.) No monitors were present in patient examination rooms. (Tr.
469.) Mrs. Leadingham further testified to the physical layout of the
dispensary, to include security measures. (Tr. 403-04.)
Mrs. Leadingham testified that the dispensary kept detailed daily
inventories, and also completed a biennial inventory every two years
that was kept ``in a file in the vault.'' (Tr. 407.) Other than working
from a computerized printout, Mrs. Leadingham testified that she did
not document anything from the biennial inventory. (Tr. 481-82.) Mrs.
Leadingham further testified that she believes the physical copy of the
inventory was seized by DEA on May 17, 2011, since the folder was gone
from the dispensary after that date. (Tr. 408, 412.)
Mrs. Leadingham testified that she worked in Respondent's
dispensary until April 2009, when she was fired along with Mr.
Leadingham. (Tr. 419.) Mrs. Leadingham testified that she returned to
work at Respondent's dispensary on July 1, 2009, along with Mr.
Leadingham, explaining the circumstances of why Respondent asked them
to return to work:
[Respondent] was very, very concerned with the way the
dispensary was being run. She was allowed no access to the
dispensary itself in these two months that we were gone. When we got
back, I know we got a lot of complaints from the patients that there
was pills missing, they weren't treated well, * * *.''
(Tr. 421.) Mrs. Leadingham further testified that upon her return to
Respondent's dispensary in July 2009 she observed pills that had been
put in unmarked vials, to include some pills that appeared to have been
crushed. (Tr. 427.)
Mrs. Leadingham also testified as to her understanding and practice
with regard to DEA Form 222s, stating in substance that she always
stapled the invoices for incoming controlled substances to the Form
222. (Tr. 428.) Mrs. Leadingham further testified that most controlled
substance orders were placed electronically, but approximately fifty
paper copies of DEA Form 222s would have been present in the dispensary
within folders identified by suppliers. (Tr. 440-41.) Prior to February
2010, the dispensary practice was not to put the date and amount of
controlled substances received on DEA Form 222s, but rather to staple
the invoice for controlled substances to the form. (Tr. 462-63.) Mrs.
Leadingham testified that following the Ohio Pharmacy Board inspection
of the dispensary in February 2011, she personally wrote the amount and
date received on DEA Form 222s. (Tr. 464-65.)
Mrs. Leadingham next testified to completing pill counts within the
dispensary to ensure that the numbers on hand matched the computer
records, and does not recall any significant discrepancies of greater
than one percent. (Tr. 446.) Mrs. Leadingham further testified that
Respondent has been present in the dispensary on at least one occasion
and counted medications which were matched with inventories.
Additionally, Respondent received daily inventories from the
dispensary. (Tr. 453-54.)
Mrs. Leadingham was called by Respondent in rebuttal, and testified
in substance that she had separated existing DEA Form 222s from the
invoices two to three weeks prior to May 16, 2011, in order to prepare
copies for submission to the Ohio Medical Board. (Tr. 629.) Mrs.
Leadingham further testified that during the week prior to May 16,
2011, she stapled the DEA Form 222s and invoices together again, and
filed them in the dispensary vault. (Tr. 631.)
Mr. Leadingham testified in substance as to his background and
experience, to include work in Respondent's dispensary, Unique Relief,
beginning in November 2008. (Tr. 513.) Unique Relief was a separately
operated business from Respondent's medical practice, Unique Pain
Management. (Tr. 572.) The dispensary's sole purpose was to fill
prescriptions issued by Respondent and Respondent's father. (Tr. 572-
73.) Mr. Leadingham testified that he worked as the manager of the
dispensary, to include pricing, printing labels for prescriptions, and
ordering. (Id.) Mr. Leadingham testified that he received no training
prior to dispensing controlled substances from Respondent's dispensary,
other than to travel to an existing pharmacy to observe a pharmacist
for approximately two hours. (Tr. 576, 580.) Mr. Leadingham explained
that he worked for Mr. Days and Respondent, describing his relationship
with Mr. Days as ``very contentious'' because Mr. Days kept telling Mr.
Leadingham what to tell Respondent to do, which Mr. Leadingham would
not. (Tr. 514-15.) In April 2009, Mr. Leadingham and Mrs. Leadingham
were fired by Mr. Days. (Tr. 517.)
Mr. Leadingham testified that he returned to work for Respondent in
July 2009, after the departure of Mr. Days. (Tr. 520.) Upon return, Mr.
Leadingham testified that he completed an inventory, which was placed
in a folder and ``we had written on it that it was for a DEA
biennial.'' (Id.) A similar inventory was
[[Page 45684]]
done in February 2011, and marked ``DEA Biannual Report.'' (Tr. 521.)
Mr. Leadingham testified that the two files were present in the
dispensary on May 17, 2011, but following that date ``[t]here was no
paperwork left in the vault.'' (Tr. 522.) Mr. Leadingham testified that
between July 2009 and May 17, 2011, there were never any large amounts
of drugs missing, and with regard to oxycodones, Mr. Leadingham did not
believe variances existed of ``even one-tenth of a percent.'' (Tr.
561.)
Mr. Leadingham testified that with regard to his compliance with
federal regulations for the operation of Respondent's dispensary, he
received legal advice that ``we were doing it perfectly.'' (Tr. 545.)
Mr. Leadingham further testified that he later questioned the legal
advice he was getting with regard to filling prescriptions issued by
Respondent's father and looked up the DEA rules ``that stated there had
to be a DEA license address for the [d]octor at that address, with that
address, if there was a Schedule II narcotics there.'' (Tr. 559-60.)
Mr. Leadingham testified that he provided a printout of the rules to
Respondent, who then applied to DEA for a license for her father at
Respondent's address. (Tr. 560.) Mr. Leadingham testified, however,
that he did not see the DEA regulation that DEA Form 222s had to be
kept separate from all other records, and the dispensary was
``[a]pparently not'' complying with that regulation. (Tr. 568.)
Respondent's witnesses presented their testimony in a professional
and serious manner, but as more fully explained in the discussion
section below, I find it only partially credible in several material
respects.
IV. Discussion
A. The Applicable Statutory and Regulatory Provisions
The Controlled Substances Act (CSA) provides that any person who
dispenses (including prescribing) a controlled substance must obtain a
registration issued by the DEA in accordance with applicable rules and
regulations.\20\ ``A prescription for a controlled substance to be
effective must be issued for a legitimate medical purpose by an
individual practitioner acting in the usual course of his professional
practice. The responsibility for the proper prescribing and dispensing
of controlled substances is upon the prescribing practitioner'' with a
corresponding responsibility on the pharmacist who fills the
prescription.\21\ It is unlawful for any person to possess a controlled
substance unless that substance was obtained pursuant to a valid
prescription from a practitioner acting in the course of their
professional practice.\22\ It is also unlawful to refuse or negligently
fail to make, keep or furnish required records.\23\
---------------------------------------------------------------------------
\20\ 21 U.S.C. 802(10), 822(a)(2).
\21\ 21 CFR 1306.04(a).
\22\ 21 U.S.C. 844(a).
\23\ 21 U.S.C. 842(a)(5).
---------------------------------------------------------------------------
B. The Public Interest Standard
The CSA, at 21 U.S.C. 824(a)(4), provides, insofar as pertinent to
this proceeding, that the Administrator may revoke a DEA COR if she
finds that the continued registration would be inconsistent with the
public interest as that term is used in 21 U.S.C. 823(f). Pursuant to
21 U.S.C. 823(f), the Administrator may deny an application for a DEA
COR if she determines that such registration would be inconsistent with
the public interest. In determining the public interest, the
Administrator is required to consider the following factors:
(1) The recommendation of the appropriate state licensing board or
professional disciplinary authority.
(2) The applicant's experience in dispensing or conducting research
with respect to controlled substances.
(3) The applicant's conviction record under federal or state laws
relating to the manufacture, distribution or dispensing of controlled
substances.
(4) Compliance with applicable state, federal or local laws
relating to controlled substances.
(5) Such other conduct which may threaten the public health and
safety.\24\
---------------------------------------------------------------------------
\24\ In addition, I conclude that the reference in 21 U.S.C.
823(f)(5) to ``other conduct which may threaten the public health
and safety'' would as a matter of statutory interpretation logically
encompass the factors listed in Section 824(a). See Kuen H. Chen,
M.D., 58 FR 65,401, 65,402 (DEA 1993).
---------------------------------------------------------------------------
As a threshold matter, the factors specified in Section 823(f) are
to be considered in the disjunctive: The Administrator may properly
rely on any one or a combination of those factors, and give each factor
the weight she deems appropriate, in determining whether a registration
should be revoked or an application for registration denied. See David
H. Gillis, M.D., 58 FR 37,507, 37,508 (DEA 1993); see also D & S Sales,
71 FR 37,607, 37,610 (DEA 2006); Joy's Ideas, 70 FR 33,195, 33,197 (DEA
2005); Henry J. Schwarz, Jr., M.D., 54 FR 16,422, 16,424 (DEA 1989).
Application of the public interest factors requires an individualized
determination and assessment of prescribing and record-keeping
practices that are ``tethered securely to state law * * * and federal
regulations.'' Volkman v. DEA, 567 F.3d 215, 223 (6th Cir. 2009).
Additionally, in an action to revoke a registrant's COR, the DEA has
the burden of proving that the requirements for revocation are
satisfied.\25\ The burden of proof shifts to the respondent once the
Government has made its prima facie case.\26\
---------------------------------------------------------------------------
\25\ See 21 CFR 1301.44(e).
\26\ See Medicine Shoppe--Jonesborough, 73 FR 364,380 (DEA
2008); see also Thomas E. Johnston, 45 FR 72,311, 72,311 (DEA 1980).
---------------------------------------------------------------------------
C. The Factors to Be Considered
Factors 1 and 3: The Recommendation of the Appropriate State Licensing
Board or Professional Disciplinary Authority and Conviction Record
Under Federal or State Laws Relating to the Manufacture, Distribution
or Dispensing of Controlled Substances
In this case, regarding Factor One, it is undisputed that
Respondent currently holds a valid, unrestricted medical license in
Ohio. Although not dispositive, Respondent's possession of a valid
unrestricted medical license in Ohio weighs against a finding that
Respondent's registration would be inconsistent with the public
interest. See Robert A. Leslie, M.D., 68 FR 15,227, 15,230 (DEA 2003)
(state license is a necessary, but not a sufficient condition for
registration, and therefore, this factor is not dispositive).
Regarding Factor Three, there is no evidence that Respondent has
ever been convicted under any federal or state law relating to the
manufacture, distribution or dispensing of controlled substances. I
therefore find that this factor, although not dispositive, see Leslie,
68 FR at 15,230, weighs against a finding that Respondent's
registration would be inconsistent with the public interest.
Factors 2 and 4: Respondent's Experience in Handling Controlled
Substances and Compliance with Applicable State, Federal or Local Laws
Relating to Controlled Substances
In this case, there is indeed evidence that Respondent has failed
to remain in compliance with applicable federal and state law relating
to controlled substances, and that her past experience in handling
controlled substances and compliance with applicable laws is
inconsistent with the public interest.
1. Respondent's Dispensing Practices
Federal law requires every person who dispenses (including
prescribing) any controlled substance to obtain a registration from the
Attorney
[[Page 45685]]
General.\27\ Additionally, a separate registration must be obtained for
each principal place of practice where a registrant dispenses
controlled substances and a registrant must report any change of
address by applying to modify her registration, which shall be treated
as an application for registration.\28\ The Code of Federal Regulations
delineates the procedures a registrant must follow to request a change
in registered address.\29\ Federal regulations also mandate that a
``prescription for a controlled substance may only be filled by a
pharmacist, acting in the usual course of his professional practice and
either registered individually or employed in a registered pharmacy, a
registered central fill pharmacy, or registered institutional
practitioner.'' \30\
---------------------------------------------------------------------------
\27\ 21 U.S.C. 822(a)(2).
\28\ 21 U.S.C. 822(e), 827(g); 21 CFR 1301.51.
\29\ See 21 CFR 1301.51.
\30\ 21 CFR 1306.06
---------------------------------------------------------------------------
Ohio law requires ``[e]ach person * * * who sells dangerous drugs
[31] at retail for delivery or distribution to persons
residing in this state, shall be licensed as a terminal distributor of
dangerous drugs pursuant to sections 4729.54 and 4729.55 of the Revised
Code.'' Ohio Rev. Code Ann. Sec. 4729.551 (2011). It further requires
that to operate a pharmacy, a ``person not a pharmacist, who owns,
manages, or conducts a pharmacy, shall employ a pharmacist to be in
full and actual charge of such pharmacy, * * * .'' Ohio Rev. Code Ann.
Sec. 4729.27 (2011).
---------------------------------------------------------------------------
\31\ Dangerous drugs under Ohio law includes any ``drug that may
be dispensed only upon a prescription.'' Ohio Rev. Code Ann. Sec.
4729.01(F) (2011).
---------------------------------------------------------------------------
Various provisions of Ohio law authorize a licensed health
professional, including a physician,\32\ to prescribe, administer, or
personally furnish controlled substances to a patient, or ``[c]ause * *
* controlled substances to be administered under the prescriber's
direction and supervision.'' Ohio Rev. Code Ann. Sec. 3719.06
(2011).\33\ Furthermore, Ohio law exempts, under defined circumstances,
a business practice with a sole shareholder who is a licensed health
professional from the requirement of obtaining a terminal distributor
license. Ohio Rev. Code Ann. Sec. 4729.51 (B)(1)(j) (2011) (effective
September 2008). The parameters of this exemption are set forth in a
guidance document published by the Ohio State Board of Pharmacy:
---------------------------------------------------------------------------
\32\ Ohio Rev. Code Ann. Sec. 4729.01(I)(4) (2011).
\33\ See also Ohio Rev. Code Ann. Sec. Sec. 4729.29, 4729.291
(2011).
[S]ection 4729.51(B)(1)(j) which will now allow registered
wholesale distributors of dangerous drugs to sell dangerous drugs to
a business practice that is a corporation, limited liability
company, or professional association if the business practice has a
SOLE SHAREHOLDER who is a licensed health professional authorized to
prescribe drugs (prescriber) and is authorized to provide the
professional services being offered by the practice.
This means that if the business practice has a single prescriber
(M.D. * * *) who is the sole shareholder, member, or owner of the
practice, then this business practice is not required to be licensed
as a Terminal Distributor of Dangerous Drugs with the Ohio Board of
Pharmacy. Previously, this exemption was only for a prescriber who
practiced as a Sole Proprietor.
(Emphasis in original).\34\
---------------------------------------------------------------------------
\34\ Ohio State Board of Pharmacy, Licensing Issues for
Prescribers (Updated July 2008), https://www.pharmacy.ohio.gov/Licensing_Issues_for_Prescribers_07252008.pdf.
The credible evidence at hearing demonstrated that Respondent
established, solely owned, and operated two limited liability
companies, Unique Pain Management (medical practice) and Unique Relief
(dispensary), both of which are located at 418 Center Street,
Wheelersburg, Ohio. (Tr. 48-49, 302-03.) Respondent's medical practice,
which included her office and patient examination rooms, was physically
separate from the dispensary, although a system of security cameras
allowed some level of observing the dispensary operation by Respondent
from a monitor located in her medical practice office. (Tr. 400.) The
dispensary filled prescriptions issued by Respondent, as well as by
Respondent's father, Dr. John Temponeras. The evidence of record
reflects that between November 2008 and May 2011, a total of
approximately 1.6 million dosage units of oxycodone, a Schedule II
controlled substance, were ordered by Respondent, among other
controlled substances. (Tr. 206-07.) The evidence further reflects that
Respondent's father issued a large number of prescriptions for
controlled substances while working at Respondent's medical practice at
least one day a week from 2008 until late 2010, a significant portion
of which were filled at Respondent's dispensary. (Tr. 181, 484-87.)
Respondent's father was registered with DEA as an individual
practitioner in Portsmouth, Ohio, but was not registered at
Respondent's practice location. (Tr. 214.)
To the extent Ohio law permits a sole practitioner to dispense or
personally furnish controlled substances directly to a patient without
a Terminal Distributor license, Respondent's dispensing practices were
well outside of those parameters. Respondent established a distinctly
separate legal entity to fill prescriptions that was physically
separate from Respondent's medical office. Furthermore, Respondent's
dispensary was not limited to filling prescriptions issued only by
Respondent, but also routinely filled prescriptions issued by
Respondent's father, notwithstanding the fact that Respondent did not
have a Terminal Distributor license as required by state law. Compare
Ohio Rev. Code Ann. Sec. 4729.551, with Sec. 4729.51(B)(1)(j) (2011).
Respondent's dispensary was not registered with DEA as a pharmacy and
none of the dispensary employees was licensed in Ohio as a pharmacist,
as required by state and federal law.\35\ (Tr. 103-04.)
---------------------------------------------------------------------------
\35\ 21 CFR 1306.06 (2011); Ohio Rev. Code Ann. Sec. 4729.27
(2011).
---------------------------------------------------------------------------
In addition to the foregoing violations, Respondent also failed to
directly monitor or supervise the dispensing activities of her
employees, none of whom were licensed, trained, or qualified to handle
and dispense controlled substances in Ohio. Rather, Respondent's
employees operated in large measure as an independent pharmacy filling
prescriptions for Respondent and Respondent's father. The weight of the
evidence demonstrated that Respondent and her father were not
personally administering, dispensing, or furnishing controlled
substances to their patients, but rather issued prescriptions for
patients to be filled either at Respondent's dispensary or at other
pharmacies. (Tr. 210-11.) The fact that patients had the option to fill
prescriptions at other locations, which occurred to some extent, is
inconsistent with personally administering or furnishing controlled
substances.\36\ While the majority of prescriptions issued by
Respondent or her father were filled at Respondent's dispensary, there
is no credible evidence of record that Respondent or her father had any
personal role or supervision of that process. Instead, the process was
left to Respondent's employees, who were unlicensed, untrained, and
unqualified to handle or distribute controlled substances.
---------------------------------------------------------------------------
\36\ A sampling of data for a one month time period in April
2010 revealed that Respondent filled approximately eighty-three
percent of her prescriptions, with the remainder filled at other
pharmacies. (Tr. 211.)
---------------------------------------------------------------------------
I do not find the testimonial evidence with regard to cameras in
the dispensary and a monitor within Respondent's office credible
insofar as establishing, consistent with Ohio law, that Respondent
effectively supervised her employees dispensing or furnishing of
[[Page 45686]]
controlled substances. For example, Mrs. Leadingham testified that
Respondent could not monitor the dispensary while treating patients in
the examination rooms, nor did the screen on the monitor allow for the
reading of labels on prescription bottles. (Tr. 471, 478.) The evidence
of record establishes at most a system of cameras that was designed for
security of the premises, rather than Respondent's direct supervision
of the dispensing or furnishing of controlled substances. Moreover,
Mrs. Leadingham testified that upon her return to work at Respondent's
dispensary in July 2009, Respondent was very concerned with the way the
dispensary had been run, to include complaints from patients and
missing pills. (Tr. 421.) Respondent ``was allowed no access to the
dispensary itself in these two months that we were gone.'' (Id.) The
fact that Respondent continued to operate a dispensary from April to
July 2009, with admittedly no access at all, is fully consistent with
other credible evidence of record, to include testimony by Agent
Kinneer, that Respondent had for significant periods of time
essentially no role in the physical delivery of controlled substances
to her patients. (Tr. 307.)
Respondent also offered at hearing one documentary exhibit, namely
a letter from the Ohio Department of Health, dated April 27, 2010,
which apparently was in reply to a document submitted by Respondent
entitled: ``Policy and Procedure for Initial Intake, Screening,
Verification of Identity and Medical Records, Monthly Processing of
Patient.'' (Resp't Ex. 6; Gov't Ex. 8.) The reply letter in relevant
part complimented Respondent and her staff ``on your thoroughness and
intense efforts for security in preventing prescription drug abuse.''
(Id.) For purposes of this recommended decision, I have given this
letter little weight. While the document facially confirms that
Respondent had a written policy related to prevention of drug abuse, it
does not address or rebut the specific evidence of Respondent's
noncompliance with various provisions of state and federal law related
to her handling of controlled substances alleged in the OSC/IS.
Additionally, there is no credible evidence of record to suggest that
the Ohio Department of Health, through Alvin D. Jackson, Director, was
aware in April 2010 of the evidence of Respondent's specific misconduct
which forms the basis of the instant proceeding, a significant portion
of which became known to state and federal authorities after April
2010.
I find by a preponderance of the evidence that Respondent dispensed
or directed and authorized the dispensing of controlled substances from
an unregistered location on numerous occasions between November 2008
and May 2011, in violation of 21 U.S.C. 841 and 822(a)(2) and (e), as
well as 21 CFR 1306.06.\37\ I further find that Respondent's dispensing
practices and lack of supervision of employees during that time period
violated applicable state law. Ohio Rev. Code Ann. Sec. Sec. 4729.551,
4729.27, and 3719.06 (2011).
---------------------------------------------------------------------------
\37\ The OSC/IS alleged misconduct beginning on January 1, 2007,
but the undisputed evidence of record established that Respondent
opened her dispensary in or about November 2008, and no other
relevant evidence was offered by the Government pertaining to
``unauthorized distributions of controlled substances'' by
Respondent prior to that date. See ALJ Ex. 1, at 1.
---------------------------------------------------------------------------
2. Respondent's Record-Keeping Practices
Pursuant to 21 CFR 1304.03(b), 1304.21(a), 1304.22(a)(2)(iv),
1304.22(a)(2)(ix) and 1304.22(c), a registered individual practitioner
is required to maintain records of controlled substances in Schedules
II through V that are dispensed and received, including the number of
dosage units, the date of receipt or disposal and the name, address and
registration number of the distributor. It is unlawful to refuse or
negligently fail to make, keep or furnish required records.\38\ DEA
regulations require that ``each registered individual practitioner
required to keep records'' shall maintain inventories and records of
Schedule II controlled substances ``separately from all of the records
of the registrant;'' inventories and records of Schedule III through V
controlled substances ``shall be maintained either separately from all
other records of the registrant or in such form that the information
required is readily retrievable from the ordinary business records of
the registrant.'' \39\ DEA registrants are required to maintain ``a
complete and accurate record of all controlled substances on hand * * *
.'' \40\ They must ``take a new inventory * * * at least every two
years.'' \41\ The inventory ``must be kept by the registrant and be
available[] for at least 2 years'' from the date of its creation.\42\
``The inventory may be taken either as of opening of business or as of
the close of business on the inventory date and it shall be indicated
on the inventory.'' \43\
---------------------------------------------------------------------------
\38\ 21 U.S.C. 842(a)(5).
\39\ 21 CFR 1304.04(g), (f)(2).
\40\ 21 CFR 1304.11(a).
\41\ 21 CFR 1304.11(c); see also 21 CFR 1304.04(a) (``every
inventory * * * must be kept by the registrant and be available * *
* for at least two years from the date of such inventory'').
\42\ 21 CFR 1304.04(a).
\43\ 21 CFR 1304.11(a).
---------------------------------------------------------------------------
Under longstanding Agency precedent, ``the failure to comply with
record keeping requirements is a basis for revoking a registration.''
Alexander Drug Co., 66 FR 18,299, 18,303 (DEA 2001) (citing Singer-
Andreini Pharmacy, Inc., 63 FR 4,668 (DEA 1998); Arthur Sklar, d/b/a
King Pharmacy, 54 FR 34,623 (DEA 1989); Summer Grove Pharmacy, 54 FR
28,522 (DEA 1989); and The Boro Pharmacy and Bell Apothecary, 53 FR
15,151 (DEA 1988)). The CSA's emphasis on record-keeping constitutes ``
`an attempt to regulate closely the distribution of certain substances
determined by Congress to pose dangers, if freely available, to the
public at large.' '' United States v. Poulin, 926 F. Supp. 246, 250 (D.
Mass. 1996) (quoting United States v. Averi, 715 F. Supp. 1508, 1510
(M.D. Ala. 1989)).
One mandatory record-keeping vehicle is DEA Form 222, the
``official triplicate order form[] used by physicians to order
scheduled narcotics'' and other controlled substances.\44\ A menu of
federal regulations specifies procedures relating to DEA Form 222, such
as obtaining, 21 CFR 1305.11, executing, Sec. 1305.12, filling, Sec.
1305.13, and endorsing DEA Form 222, Sec. 1305.14, among other
procedures.\45\ In addition, 21 CFR 1305.03 requires that a DEA Form
222 be used for each distribution of a controlled substance listed in
Schedules I or II, and Section 1305.17 provides that these order forms
must be maintained separately from all other records and that they
``are required to be kept available for inspection for a period of 2
years.''
---------------------------------------------------------------------------
\44\ Robert L. Dougherty, Jr., M.D., 60 FR 55,047, 55,048 (DEA
1995).
\45\ See, e.g., 21 CFR 1305.15-.19.
---------------------------------------------------------------------------
The evidence at hearing reflected numerous record-keeping
violations by Respondent. The evidence credibly reflects that
Respondent did not properly prepare or maintain DEA Form 222s as
required by law. The evidence also demonstrated with regard to
Respondent's dispensary, that Schedule II controlled substance records
were improperly commingled with other controlled substance records,
contrary to 21 CFR 1304.04.
Respondent's evidence did not deny the record-keeping violations
with regard to DEA Form 222 alleged by the Government in the OSC/IS.
Respondent's witnesses admitted that paper copies of DEA Form 222 were
not properly maintained with required
[[Page 45687]]
information, or in separate locations from other records. Rather, the
testimony focused on whether the improperly completed DEA Form 222s had
distributor invoices stapled to them in an apparent attempt to comply
with the substance and spirit of the applicable DEA regulations.
As a factual matter, the testimony from Respondent's witnesses that
invoices were routinely stapled to DEA Form 222s was directly
contradicted by physical evidence at hearing, namely three purchaser
copies of Form 222 seized from Respondent's dispensary on May 17, 2011,
none of which was accompanied by an invoice. (Tr. 64-65; Gov't Ex. 6.)
Additionally, all of the Government witnesses were consistent in
describing the absence of stapled invoices in the vast majority of DEA
Form 222s observed and seized from Respondent's dispensary.
Agent Kinneer credibly testified that during his February 9, 2011
inspection of Respondent's dispensary he reviewed a two to three inch
stack of Form 222s on the dispensary counter with no attached invoices,
noting that ``none of them had a date or quantity on a filled-out line
for those individual drugs that had been ordered and received.'' (Tr.
319.) Agent Kinneer also testified that he reviewed a box kept in the
dispensary vault with folders full of blue Form 222s, and none of them
had the requisite receipt information, to include date or quantity
received. (Tr. 319-20.) With regard to attached invoices, Agent Kinneer
testified that he did not go through all of the forms in the box, but
none of those he recalls reviewing had an invoice attached. (Tr. 320.)
Consistent with Agent Kinneer's testimony, DI Burkhart credibly
testified that she participated in the execution of a federal search
warrant at Respondent's dispensary on May 17, 2011, resulting in the
seizure of approximately fifty blue purchaser copies of DEA Form 222,
among other items. (Tr. 600-01.) Of the fifty, only two had an invoice
stapled to the back of them. (Tr. 601.)
In light of the foregoing testimony credibly demonstrating that on
February 9, 2011, and May 17, 2011, the vast majority of DEA Form 222s
present in Respondent's dispensary did not have accompanying invoices
attached, I do not find credible the testimony of Respondent's
witnesses to the contrary. Even if there had been credible evidence
offered to establish that Respondent routinely attached invoices to DEA
Form 222s, such evidence would ``not obsolve [a registrant] from its
obligation to adhere to the law.'' Alexander Drug Co., 66 FR at 18,303.
The efficacy of the closed system of distribution for controlled
substances and certain chemicals mandated by Congress through the
Controlled Substances Act depends upon strict adherence by all
registrants to all record keeping requirements including those set
forth at 21 U.S.C. [Sec. Sec. ] 827, 828, 829, and 830, and all
implementing regulations found in Title 21 Code of Federal
Regulations, as well as all applicable state laws and regulations.
(Id.)
The evidence at hearing also demonstrated that Respondent did not
take an initial inventory or biennial inventories, contrary to
applicable regulations. 21 CFR 1304.11(b) and (c). Agent Kinneer
credibly testified that during his February 9, 2011 inspection, he
requested an opening inventory but was informed by Mr. Leadingham that
``one had not been done.'' (Tr. 314.) Nor was a biennial inventory
produced during the inspection. DI Kresnak credibly testified that as a
result of the May 2011 search of Respondent's dispensary, documents
related to inventories were found, none of which reflected a ``biennial
inventory.'' For example, there is evidence of record that documents
were seized from Respondent's dispensary reflecting ``biannual
inventories,'' and one marked ``opening inventory'' which ``indicated
that the date that they opened the dispensary there was a zero
inventory.'' (Tr. 83.)
Respondent's evidence with regard to inventories centered primarily
on testimony by Respondent's dispensary employees that frequently
during ``down time'' they would count on-hand drugs, including
controlled substances, to ensure a match with computer records. Mrs.
Leadingham testified that the dispensary kept detailed daily
inventories, and completed a biennial inventory every two years, which
was kept in the dispensary vault. (Tr. 407.) Later contradicting that
testimony, Mrs. Leadingham testified that the process to conduct a
biennial inventory consisted of Mr. Leadingham using a computer
printout while she physically counted the controlled substances, adding
that she did not ``document anything'' from the inventory. (Tr. 481-
82.) The lack of documentation undermines the credibility of Mrs.
Leadingham's assertions that detailed inventories were kept. Of
significance, no invoices, DEA Form 222s, or dispensing logs were used
to conduct the biennial inventory. (Tr. 480-82.) Nor is there any
credible evidence that Respondent participated in the inventory process
in any meaningful way to ensure an accurate inventory was taken and
proper records maintained.\46\ Instead, the credible evidence of record
reflects that Respondent delegated that task to employees who were
neither trained nor properly supervised to perform the task.
---------------------------------------------------------------------------
\46\ I have carefully considered and reject as not credible
testimony by Respondent's employees that Respondent actively
participated or supervised the inventory process. (See, e.g., Tr.
453-54.) Even if such testimony was found to be credible, the
methodology used to conduct the inventory, with or without the
Respondent, was clearly contrary to law.
---------------------------------------------------------------------------
The evidence at hearing unequivocally demonstrates that
Respondent's employees, however well-intentioned, lacked the
qualifications, training, or supervision to conduct an appropriate
initial or biennial inventory, as required by applicable law and
regulation. The fact that no compliant initial or biennial inventory
was produced by Respondent or her employees during the February 9, 2011
inspection, nor seized during the May 17, 2011 search, amply
demonstrates Respondent's blatant non-compliance with this important
record-keeping requirement. As Agent Kinneer succinctly testified, a
``running inventory'' is no substitute for a true inventory, since in
``order for me to do an audit I need a starting point.'' (Tr. 373-74.)
There is no evidence that such a starting point existed within
Respondent's dispensary records, nor any other compliant inventory
records.
Contrary to Respondent's assertion that the foregoing represents
``highly technical paperwork errors,'' (Resp't Br. At 7), the failure
by Respondent to properly maintain required records prevented
investigators, as well as Respondent, from determining whether
Respondent's dispensary had significant shortages or overages. (See,
e.g., Tr. 375.) The sheer volume of controlled substances handled by
Respondent, which between November 2008 and May 2011, totaled
approximately 1.6 million dosage units of the Schedule II controlled
substance oxycodone alone, demonstrates that overages or shortages had
the potential to be quantitatively significant. (See Tr. 375.) Nor was
the risk of diversion purely speculative with regard to Respondent's
dispensary given, for example, the testimony by Mrs. Leadingham that
during May and June 2009, Respondent was not allowed access to her own
dispensary. (Tr. 421.) Additionally, Mrs. Leadingham testified that
when she returned to work in Respondent's dispensary in July 2009, she
observed crushed pills and pills in unmarked vials, and received
complaints from customers of missing pills. (Tr. 421, 427.) Rather than
being technical paperwork errors, I find
[[Page 45688]]
Respondent's blatant disregard for fundamental record-keeping
requirements, among other violations, to be significantly at odds with
the public interest.
Accordingly I find by a preponderance of the evidence that
Respondent unlawfully failed to make, keep or furnish required records
relating to her handling of controlled substances, during the time
period from November 2008 to May 2011, in violation of applicable
federal law.\47\
---------------------------------------------------------------------------
\47\ See 21 U.S.C. 827(a), 842(a)(5); 13 CFR 1304.11 (b) and
(c), 1305.13(e).
---------------------------------------------------------------------------
3. Respondent's Issuance of Prescriptions Without Required Information
Pursuant to 21 CFR 1306.05(a), ``[a]ll prescriptions for controlled
substances shall * * * bear the full name and address of the patient *
* * [and] directions for use * * *.'' The evidence of record included
approximately eleven prescriptions issued by Respondent for various
controlled substances to a single patient covering the time period
August to November 2006. (Tr. 219-20; Gov't Ex. 7.) Each of the eleven
prescriptions was deficient by failing to include the patient's
address. (Tr. 220-21; see Gov't Ex. 7.)
Additionally, the Government introduced testimony by DI Kresnak
that he reviewed approximately twelve prescriptions seized from a
Portsmouth, Ohio pharmacy that Respondent had issued for controlled
substances to more than one patient between 2005 and 2006. Of the
twelve reviewed, DI Kresnak testified that eleven lacked a patient
address. (Tr. 53-55, 123-24.) None of these prescriptions were
introduced by the Government at hearing, and DI Kresnak was uncertain
if any of the prescriptions he recalled reviewing from the Portsmouth,
Ohio pharmacy were the same as those identified in Government Exhibit
7. Nor could DI Kresnak recall any of the patient names from memory
without reviewing copies of the prescriptions.\48\ (Tr. 118.) In light
of this testimony, I give little overall weight to the testimony
offered by the Government with regard to the eleven prescriptions
seized from the Portsmouth, Ohio pharmacy, since those prescriptions
may or may not be the same as those contained within Government Exhibit
7. ``Speculation is, of course, no substitute for evidence, and a
decision based on speculation is not supported by substantial
evidence.'' White ex rel. Smith v. Apfel, 167 F.3d 369, 375 (7th Cir.
1999) (citing Erhardt v. Sec'y, DHS, 969 F.2d 534, 538 (7th Cir.
1992)).
---------------------------------------------------------------------------
\48\ The Government did not seek to refresh DI Kresnak's
recollection with any documents, nor were the prescriptions at issue
introduced at hearing. See supra note 9.
---------------------------------------------------------------------------
Accordingly, I find by a preponderance of the evidence that
Respondent issued approximately eleven prescriptions between August and
November 2006 for controlled substances without providing a patient
address, in violation of applicable federal regulations.
All of the above findings regarding Respondent's violation of
applicable law and regulation as it pertains to her prescribing
practices, record-keeping, and dispensing from an unregistered location
weigh heavily against a finding under Factors Two and Four of 21 U.S.C.
823(f) that Respondent's continued registration would be consistent
with the public interest.
Factor 5: Such Other Conduct Which May Threaten the Public Health and
Safety
Under Factor Five, the Administrator is authorized to consider
``other conduct which may threaten the public health and safety.'' 5
U.S.C. 823(f)(5). The Agency has accordingly held that ``where a
registrant has committed acts inconsistent with the public interest,
the registrant must accept responsibility for his or her actions and
demonstrate that he or she will not engage in future misconduct.
Patrick W. Stodola, 74 FR 20,727, 20,734 (DEA 2009).\49\ A
``[r]espondent's lack of candor and inconsistent explanations'' may
serve as a basis for denial of a registration. John Stanford Noell,
M.D., 59 FR 47,359, 47,361 (DEA 1994).
---------------------------------------------------------------------------
\49\ See also Hoxie v. DEA, 419 F.3d 477, 484 (6th Cir. 2005)
(decision to revoke registration ``consistent with the DEA's view of
the importance of physician candor and cooperation'').
---------------------------------------------------------------------------
In this case Respondent was called by the Government to testify,
but refused to answer questions by invoking her Fifth Amendment
privilege. ``It is well established that the Agency may draw an adverse
inference from a respondent's failure `to testify in response to
probative evidence offered against' [her].'' Surinder Dang, M.D., 76 FR
51,417, 51,422 (DEA 2011) (citing Baxter v. Palmigiano, 425 U.S. 308,
318 (1976)). I find it appropriate on the facts of this case to draw an
adverse inference against Respondent where the Government presented
evidence of misconduct involving Respondent's prescribing, dispensing,
and record-keeping practices, yet Respondent failed to testify and
respond to this evidence. Additionally, Respondent presented no
evidence of acceptance of responsibility for past misconduct, nor any
evidence demonstrating that she will not engage in future misconduct,
which weighs heavily against a finding under Factor Five of 21 U.S.C.
823(f) that Respondent's continued registration would be consistent
with the public interest.
V. Conclusion and Recommendation
After balancing the foregoing public interest factors, I find that
the Government has established by substantial evidence a prima facie
case in support of revoking Respondent's DEA COR BT5598214, based on
Factors Two, Four and Five of 21 U.S.C. 823(f). Once DEA has made its
prima facie case for revocation or denial, the burden shifts to the
respondent to show that, given the totality of the facts and
circumstances in the record, revoking or denying the registration would
not be appropriate. See Morall v. DEA, 412 F.3d 165, 174 (D.C. Cir.
2005); Humphreys v. DEA, 96 F.3d 658, 661 (3d Cir. 1996); Shatz v.
United States Dep't of Justice, 873 F.2d 1089, 1091 (8th Cir. 1989);
Thomas E. Johnston, 45 FR 72,311 (DEA 1980). The record reveals that
Respondent has not sustained her burden in this regard. In light of the
foregoing, Respondent's evidence as a whole fails to sustain her burden
to accept responsibility for her misconduct and demonstrate that she
will not engage in future misconduct.
I recommend revocation of Respondent's DEA COR BT5598214 as a
practitioner, and denial of any pending applications for renewal or
modification, on the grounds that Respondent's continued registration
would be fully inconsistent with the public interest as that term is
used in 21 U.S.C. 824(a)(4) and 823(f).
Dated: December 15, 2011.
Timothy D. Wing,
Administrative Law Judge.
[FR Doc. 2012-18749 Filed 7-31-12; 8:45 am]
BILLING CODE 4410-09-P