James Clopton, M.D.; Decision and Order, 2475-2478 [2014-00524]
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BILLING CODE 4410–15–P
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
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James Clopton, M.D.; Decision and
Order
On March 22, 2012, the Deputy
Assistant Administrator, Office of
Diversion Control, Drug Enforcement
Administration, issued an Order to
Show Cause to James Clopton, M.D.
(hereinafter, Applicant), of El Dorado
Hills, California. GX 2. The Show Cause
Order proposed the denial of
Applicant’s application for a DEA
Certificate of Registration as a
practitioner, on the ground that his
registration would be inconsistent with
the public interest. Id. (citing 21 U.S.C.
823(f)).
The Show Cause Order alleged that on
May 22, 2009 and July 8, 2009,
Applicant ‘‘illegally distributed
OxyContin, a schedule II controlled
substance,’’ to an undercover law
enforcement officer, ‘‘for other than a
legitimate medical purpose and outside
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the usual course of professional
practice.’’ Id. (citing 21 U.S.C.
841(a)(1)). Specifically, the Show Cause
Order alleged that Applicant failed to
conduct a physical examination prior to
prescribing the controlled substances to
the undercover officer. Id.
Next, the Show Cause Order alleged
that on February 10, 2010, Applicant
illegally distributed Norco, a schedule
III hydrocodone combination product,
and Xanax, a schedule IV controlled
substance, to the same undercover
officer under similar circumstances. Id.
at 2. Finally, the Show Cause Order
alleged that Applicant ‘‘failed to
maintain an inventory of controlled
substances, records of receipt of
controlled substances, failed to retain
copy 3 of DEA form 222, and failed to
maintain dispensing records.’’ Id. (citing
21 CFR 1304.11, 1304.22, 1305.17).
The Show Cause Order also notified
Applicant of his right to request a
hearing on the allegations or to submit
a written statement regarding the
allegations while waiving his right to a
hearing. Id. at 2. However, the Order
then notified Applicant that ‘‘[s]hould
[he] fail to respond to this official
correspondence by exercising [his]
rights . . . [his] application shall be
deemed withdrawn pursuant to 21 CFR
§ 1301.16(b).’’ Id.
On April 2, 2012, the Government
personally served the Show Cause Order
on Respondent. Request for Final
Agency Action, Attachment 2, at 5.
Thereafter, Applicant neither filed a
request for a hearing nor submitted a
written statement in lieu of a hearing.
Request for Final Agency Action, at 2.
On November 5, 2012, the
Government forwarded a Request for
Final Agency Action to this Office. Id.
at 1. Therein, the Government noted
that since the date of service of the
Show Cause Order, Applicant had not
requested a hearing. Id. at 2. The
Government thus contended that
Applicant had waived his right to a
hearing and requested the issuance of a
final order denying the application. Id.
at 2–9.
On review, the Administrator found
that the Government had failed to
provide fair notice to Applicant
regarding the consequences of his
failure to request a hearing or to submit
a written statement in lieu of a hearing.
Order, at 1. Specifically, the
Administrator found that the
Government had not notified Applicant
that the consequence of failing to
request a hearing or to submit a written
statement ‘‘would be that it would then
seek a final order denying his
application.’’ Id. at 2. Rather, the
Administrator found that the
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Government ‘‘specifically notified
Applicant that the only consequence of
his failure to request a hearing or to
submit a written statement in lieu of a
hearing would be that his application
would be deemed withdrawn.’’ Id.
(citing 21 CFR 1301.16(b)).1 The
Administrator further explained that
‘‘were a final order issued denying the
application, Applicant would be
required to disclose the existence of
such an order on any subsequent
application, under the threat of criminal
prosecution if he failed to do so.’’ Id. at
2–3. Finally, the Administrator
explained that the findings of the final
order ‘‘would be entitled to preclusive
effect in a subsequent DEA proceeding.’’
Id. at 3 (citing Jose G. Zavaleta, 78 FR
27431, 27434 (2013)).
Accordingly, the Administrator
instructed the Government that if it
intended to seek a final order denying
the application, it must serve a
corrected Show Cause Order, which
‘‘properly notifie[d] Applicant of the
consequences of failing to either request
a hearing or submit a written statement
in lieu of a hearing.’’ Id. The
Administrator further directed the
Government to notify her Office, within
thirty days, if it intended to do so. Id.
The Government subsequently complied
with the Order. Second Request for
Final Agency Action, Attachment 2, at
1.
On July 29, 2013, the Deputy
Assistant Administrator issued a new
Show Cause Order, which re-alleged the
charges of the previous Show Cause
Order. The second Show Cause Order
again advised Applicant that he had the
right to request a hearing or to submit
a written statement while waiving his
right to a hearing and the procedure for
electing either option. Most importantly,
the Order properly advised Applicant
that ‘‘[s]hould you decline to file a
request for a hearing . . . you shall be
deemed to have waived the right to a
1 This regulation provides, in relevant part, that
‘‘[a]fter an application has been accept for filing
. . . the failure of the applicant to respond to
official correspondence regarding the application,
when sent by registered or certified mail, return
receipt requested, shall be deemed to be a
withdrawal of the application.’’ 21 CFR 1301.16(b).
In her Order, the Administrator explained that once
the Government files an Order Show Cause, the
consequence of an applicant’s or registrant’s failure
to respond to the Order is specifically addressed by
21 CFR 1301.43(d), which provides that if ‘‘[i]f any
person entitled to a hearing . . . fails to file a
request for a hearing . . . such person shall be
deemed to have waived the opportunity for a
hearing . . . unless such person shows good cause
for such failure.’’ See also 21 CFR 1301.43(e) (‘‘If
all persons entitled to a hearing . . . are deemed
to waive their opportunity for the hearing . . . the
Administrator may cancel the hearing, if scheduled,
and issue his/her final order pursuant to § 1301.46
without a hearing.’’).
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hearing and the Administrator may . . .
issue a final order in this matter without
a hearing based upon the evidence
presented to her.’’ Show Cause Order
(II), at 2 (citing 21 CFR 1301.43(d) & (e);
id. § 1301.46). On August 23, 2013, the
Show Cause Order was personally
served on Applicant by the lead
Diversion Investigator. Second Request
for Final Agency Action, Attachment 4.
On October 2, 2013, the Government
submitted a Second Request for Final
Agency Action. Therein, the
Government noted that since the date of
service of the Second Show Cause
Order, Applicant had not requested a
hearing. Id. at 2. The Government thus
contends that Applicant has waived his
right to a hearing and requests the
issuance of a final order denying the
application. Id.
Based on the Government’s
submission, I find that since the date of
service of the Second Order to Show
Cause, neither Applicant, nor anyone
purporting to represent him, has either
requested a hearing on the allegations or
submitted a written statement in lieu of
a hearing. See 21 CFR 1301.43(a) & (c).
Accordingly, I find that Applicant has
waived his right to a hearing or to
submit a written statement. Id.
§ 1301.43(c) & (d). I therefore issue this
Decision and Final Order based on the
Investigative Record submitted by the
Government. Id. § 1301.43(e). I make the
following findings of fact.
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Findings
Applicant is a psychiatrist, who
previously held DEA Certificate of
Registration BC2559219, which
authorized him to dispense controlled
substances, as a practitioner, in
schedules II–V. GX 1, at 4. On January
26, 2011, Applicant surrendered this
registration for cause, ‘‘after which date
no controlled substances could be
obtained, stored, administered,
prescribed, or dispensed under’’ his
registration. Id. at 1. However, on June
8, 2011, Applicant submitted an
application for a new registration. Id. at
3.
In February 2009, DEA first became
interested in Applicant after a Diversion
Investigator (DI) received a letter from a
pharmacist in Cameron Park, California.
GX 3, at 1; GX 6. In the letter, the
pharmacist expressed her ‘‘concerns
about [Applicant’s] prescribing’’
practices. GX 6. Specifically, the
pharmacist opined that Applicant was
writing methadone prescriptions to treat
drug withdrawal, that he was
prescribing excessive amounts of
methadone, and that in 2007, one of his
patients died from a drug overdose. Id.
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Subsequently, the DI teamed up with
the West El Dorado Narcotics
Enforcement Team to conduct several
undercover operations involving
Applicant. GX 3, at 1. Specifically, on
May 22, 2009, July 8, 2009, and
February 10, 2010, the team conducted
three undercover visits, during which a
West El Dorado Detective, using the
alias of ‘‘Tony Cruz,’’ visited Applicant
for the purpose of obtaining controlled
substances. Id.
On May 22, 2009, the Detective
arrived at Applicant’s medical clinic
and paid $250 before seeing him. GX 4,
at 2. Upon meeting Applicant, the
Detective told him that he was taking
‘‘Oxy,’’ but because his wallet had been
stolen he had borrowed some pills from
a friend. Id. at 3–4. The following
exchange ensued:
Applicant: What’s the medical problem?
Det: Um you know I started a while ago
and you know.
Applicant: Ok, so you are trying to get off
of them at this point?
Id. at 4.
Applicant then recognized that the
Detective’s use of OxyContin was
‘‘recreational’’ and that ‘‘there’s not a
medical problem.’’ Id. at 4–5. The
Detective further told Applicant that he
‘‘liked to stay more on the right side you
know I mean I like to have a
prescription instead of hitting somebody
up.’’ Id. at 10.
Applicant then stated: ‘‘You see, the
only problem is unless we have an
actual pain diagnosis psychiatrists can’t
write for it. So have you ever been
diagnosed with a disk problem or
anything?’’ Id. The Detective replied: ‘‘I
mean um if I just gotta say I got
something.’’ Id. Applicant then stated
‘‘ok[,] what I can do is probably write it
for a couple of months,’’ but then
warned that ‘‘after that it’s got to be
more of a primary care or the urgent
care because you know again without
the pain diagnosis that’s where we get
nailed.’’ Id. at 10–11.
Applicant did not perform a physical
examination during the visit, which
lasted thirteen minutes. Nonetheless,
Applicant issued the Detective a
prescription for 120 tablets of
OxyContin 80mg. GX 5, at 1. On the
prescription, Applicant wrote: ‘‘Dx
722.1.’’ Id. According to the DI, this is
an insurance code ‘‘describing
displacement of thoracic or lumbar
invertebral [sic] disc without
myelopathy.’’ GX 4, at 13.
On July 8, 2009, the Detective
returned to Applicant’s clinic. Id.
During the visit, Applicant asked the
Detective what kind of pain he felt, and
if it was back pain. Id. at 14. The
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Detective answered, ‘‘um, that’s what
you uh told me you put on there
before.’’ Id. Applicant replied, ‘‘Ok. Ok.
Good luck.’’ Id.
Applicant’s interaction with the
Detective lasted all of two minutes,
during which Applicant did not perform
a physical examination. GX 4, at 14–15.
He did, however, issue to the Detective
another prescription for 120 tablets of
OxyContin 80mg. GX 5.
On February 10, 2010, the Detective
returned again to Applicant’s clinic. Id.
at 15. Upon meeting Applicant, the
Detective again asked for ‘‘Oxy.’’ Id. at
16. However, Applicant stated that
‘‘they won’t let us,’’ and added that
‘‘[t]he Drug Enforcement Agency has
basically told physicians that if you
don’t give a physical exam you can’t
prescribe opiates.’’ Id. at 16–17.
Applicant then stated that
‘‘[p]sychiatrists don’t do physical exams
and so [we are] specifically forbidden
from doing that.’’ Id. at 17. Applicant
added that ‘‘they will not let us do . . .
the Schedule II’s like the Oxy [and] the
Percocet . . . they will let us do the
Schedule III’s which are the Norcos.’’ Id.
After Applicant discussed with the
Detective where he could get Schedule
II drugs, the Detective asked if he would
‘‘still be able to’’ get Norcos.2 Id. at 18.
Applicant replied, ‘‘I can write Norco,
yeah.’’ Id.
Applicant then asked ‘‘[i]s this for
your back?’’ Id. The Detective answered:
‘‘You know yeah that’s well last time
you told me to it was my back yeah.’’
Id. Continuing, Applicant asked, ‘‘[i]s it
more help out your mood or what’s it
do for you?’’ Id. The Detective answered
that he did ‘‘concrete all day long’’ and
was ‘‘working with people and stuff like
that,’’ and that after coming home, the
drug ‘‘helps [to] unwind.’’ Id. To this,
Applicant stated: ‘‘Ok[,] that one they’ll
let us do.’’ Id.
Next, the Detective asked if Applicant
had ‘‘anything that will help sleep’’;
Applicant replied in the affirmative. Id.
The Detective then said that someone
had told him about a drug that was
‘‘spelt weird,’’ and that he couldn’t
remember the drug’s name but that it
‘‘had two X’s.’’ Applicant then said
‘‘Xanax?’’ and the Detective agreed. Id.
Applicant issued to the Detective two
prescriptions: One for 120 tablets of
Norco 10/325mg and one for 30 tablets
of Xanax 1mg. GX 5, at 3–4. Applicant’s
interaction with the Detective lasted
three minutes, during which Applicant
again failed to perform a physical exam.
GX 4, at 15–18.
2 Norco (hydrocodone/acetaminophen) is a
schedule III narcotic. See 21 CFR 1308.13(e)(1).
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On January 25, 2011, DEA
Investigators, including the DI, executed
a federal search warrant at Applicant’s
clinic. GX 3, at 2. During the execution
of the warrant, Applicant admitted to
the DI ‘‘that he did not maintain any
records of acquisition or dispensation’’
of controlled substances and that he
‘‘did not document the dispensation in
the patient’s chart.’’ Id. He also admitted
that he ‘‘frequently would not perform
physical examinations on patients.’’ Id.
During the search, DEA seized various
schedule IV controlled substances
including alprazolam (Xanax), zolpidem
(Ambien), and eszopiclone (Lunesta).
GX 7; see 21 CFR 1308. 14(c). That same
day, Applicant surrendered his DEA
Certificate of Registration. GX 3.
Discussion
Section 303(f) of the Controlled
Substances Act (CSA) provides that an
application for a practitioner’s
registration may be denied ‘‘if the
Attorney General determines that the
issuance of such registration . . . would
be inconsistent with the public
interest.’’ 21 U.S.C. 823(f). In making
this determination, Congress directed
that the following factors be considered:
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(1) The recommendation of the appropriate
State licensing board or professional
disciplinary authority.
(2) The applicant’s experience in
dispensing . . . controlled substances.
(3) The applicant’s conviction record under
Federal or State laws relating to the
manufacture, distribution, or dispensing of
controlled substances.
(4) Compliance with applicable State,
Federal, or local laws relating to controlled
substances.
(5) Such other conduct which may threaten
the public health and safety.
Id.
‘‘These factors are . . . considered in
the disjunctive.’’ Robert A. Leslie, M.D.,
68 FR 15227, 15230 (2003). I ‘‘may rely
on any one or a combination of factors
and may give each factor the weight
. . . [I] deem [ ] appropriate in
determining whether . . . an
application for registration [should be]
denied.’’ Id.; see also Kevin Dennis,
M.D., 78 FR 52787, 52794 (2013);
MacKay v. DEA, 664 F.3d 808, 816 (10th
Cir. 2011).
The Government has the burden of
proving, by substantial evidence, that
the requirements for a denial of an
application, pursuant to 21 U.S.C.
823(f), are met. 21 CFR 1301.44(e). This
is so even in a non-contested case.
Gabriel Sanchez, M.D., 78 FR 59060,
59063 (2013). Having considered all of
the factors,3 I conclude that the
3 The record contains no evidence regarding any
recommendation of the state licensing board or
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Government’s evidence with respect to
factors two and four establishes, prima
facie, that the issuance of a DEA
certificate of registration to Applicant
‘‘would be inconsistent with the public
interest.’’ See 21 U.S.C. 823(f).
Factors Two and Four—The Applicant’s
Experience in Dispensing Controlled
Substances and Compliance With
Applicable Laws Related to Controlled
Substances
Under a longstanding Agency
regulation, ‘‘[a] prescription for a
controlled substance [is not] effective
[unless it is] issued for a legitimate
medical purpose by an individual
practitioner acting in the usual course of
[his] professional practice.’’ 21 CFR
1306.04(a). This regulation further
provides that ‘‘an order purporting to be
a prescription issued not in the usual
course of professional treatment . . . is
not a prescription within the meaning
and intent of [21 U.S.C. 829] and . . .
the person issuing it, shall be subject to
the penalties provided for violations of
the provisions of law relating to
controlled substances.’’ Id.
As the Supreme Court recently
explained, ‘‘the prescription
requirement . . . ensures patients use
controlled substances under the
supervision of a doctor so as to prevent
addiction and recreational abuse. As a
corollary, [it] also bars doctors from
peddling to patients who crave the
drugs for those prohibited uses.’’
Gonzales v. Oregon, 546 U.S. 243, 274
(2006) (citing United States v. Moore,
423 U.S. 122, 135, 143 (1975)); United
States v. Alerre, 430 F.3d 681, 691 (4th
Cir. 2005), cert. denied, 547 U.S. 1113
(2006) (holding that the CSA’s
prescription requirement stands as a
proscription against doctors acting not
‘‘as a healer[,] but as a seller of wares.’’).
Under the CSA, it is fundamental that
a practitioner establish and maintain a
legitimate doctor-patient relationship in
professional disciplinary authority, or any other
evidence as to the status of Applicant’s state
license. See 21 U.S.C. 823(f)(1). However, even
assuming that Applicant currently possesses state
authority to dispense controlled substances and
thus meets this requirement for obtaining a
practitioner’s registration, see id. sections 802(21)
and 823(f), this is only one of the five factors which
the Agency considers in making the public interest
determination and is therefore not dispositive. See
Joseph Gaudio, 74 FR 10083, 10090 n.25 (2009);
Mortimer B. Levin, 55 FR 8209, 8210 (1990).
There is also no evidence in the record that
Applicant has been convicted of an offense related
to the manufacture, distribution or dispensing of
controlled substances. See 21 U.S.C. 823(f)(3).
However, as the Agency has held, there are a
number of reasons why a person who has
committed misconduct may not have been
convicted, let alone prosecuted for such an offense.
Accordingly, the absence of such a conviction is not
dispositive.
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order to act ‘‘in the usual course of . . .
professional practice’’ and to issue a
prescription for a ‘‘legitimate medical
purpose.’’ Paul H. Volkman, 73 FR
30629, 30642 (2008), pet. for rev.
denied, 567 F.3d 215, 223–24 (6th Cir.
2009). The CSA generally looks to state
law and state medical practice standards
to determine whether a legitimate
doctor-patient relationship has been
established. Id.
Under California law, a physician
‘‘may prescribe for, or dispense or
administer to, a person under his or her
treatment for a medical condition . . .
prescription controlled substances for
the treatment of pain or a condition
causing pain.’’ Cal. Bus. & Prof. Code
section 2241.5(a). However, under
California law, in order to legally
prescribe a controlled substance, a
physician must conduct an ‘‘appropriate
prior examination.’’ Cal. Bus. & Prof.
Code section 2242(a) (‘‘Prescribing,
dispensing, or furnishing dangerous
drugs . . . without an appropriate prior
examination and a medical indication,
constitutes unprofessional conduct.’’);
see also People v. Gandotra, 14 Cal.
Rptr. 2d 896, 899–900 (Cal. Ct. App.
1992) (‘‘A prescription for a controlled
substance shall only be issued for a
legitimate medical purpose by an
individual practitioner acting in the
usual course of his or her professional
practice.’’) (quoting Cal. Health & Safety
Code section 11153(a)).
Here, the Government has presented
evidence that on multiple occasions,
Applicant acted outside of the usual
course of professional practice and
lacked a legitimate medical purpose
when he prescribed highly abused
controlled substances including
OxyContin (oxycodone), hydrocodone,
and alprazolam to the Detective,
without conducting a prior physical
examination as required by state law.
See 21 CFR 1306.04(a). More
specifically, the evidence shows that
Applicant did not perform a physical
examination of the Detective at any of
the visits and that the Detective did not
even complain of any symptoms that
would warrant medical treatment, let
alone the issuance of controlled
substance prescriptions. Indeed,
Respondent issued prescriptions to the
Detective notwithstanding that he
clearly knew that the latter (in his
undercover persona) was seeking drugs
to abuse them.
As found above, during his first visit,
the Detective openly stated that he had
borrowed some pills from a friend and
Applicant acknowledged that the
Detective’s use of OxyContin was
‘‘recreational’’ and that ‘‘there’s not a
medical problem.’’ Moreover, after the
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Detective stated that he would like to
get ‘‘a prescription instead of hitting
somebody up,’’ Applicant
acknowledged that ‘‘the only problem is
unless we have an actual pain diagnosis
psychiatrists can’t write for it’’ and then
asked the Detective if he had ‘‘ever been
diagnosed with a disk problem or
anything?’’ GX 4, at 10. Even then, the
Detective did not identify any pain
problem, and said: ‘‘I mean . . . if I just
gotta say I got something.’’ Id. Applicant
thus clearly knew that the Detective did
not have a legitimate pain condition.
Moreover, Applicant did not perform
a physical exam at either the Detective’s
second or third visit, each of which
lasted two to three minutes. Indeed, at
the second visit, Applicant merely
asked ‘‘what kind of pain is it? Is it back
pain or?’’ to which the Detective
replied: ‘‘That’s what you . . . told me
you put on there before.’’ Id. at 14. Here
again, Applicant issued the Detective an
additional prescription for OxyContin
and did so notwithstanding that he
knew that the Detective did not have
any pain.
So too, at the Detective’s third visit,
Applicant’s inquiry into the former’s
need for controlled substances involved
him asking, ‘‘[i]s this for your back?’’
with the Detective answering: ‘‘You
know yeah that’s well last time you told
me to it was my back yeah.’’ Id. at 18.
Applicant then asked ‘‘[i]s it more help
out your mood or what’s it do for you?’’
to which the Detective answered that he
did ‘‘concrete all day long’’ and was
‘‘working with people and stuff like
that,’’ and that after coming home, ‘‘it
helps unwind.’’ Respondent then stated:
‘‘Ok that one they’ll let us do.’’ Id.
Applicant then agreed to write the
Detective a prescription for Norco, a
schedule III combination drug which
contains hydrocodone. Id. Moreover, he
also wrote the Detective a prescription
for Xanax based solely on the
Detective’s asking him if he had
anything for sleep and did not ask him
a single question about his sleep
patterns. Id.
As the evidence shows, at each of the
above visits, Applicant knew that the
Detective was not seeking the drugs for
the purpose of treating a legitimate
medical condition, but rather, for the
purpose of abusing them. He also did
not perform a physical examination.
Applicant nonetheless issued the four
prescriptions to the Detective. Given the
evidence, expert testimony is not
necessary to conclude that Applicant
acted outside of the usual course of
professional practice and lacked a
legitimate medical purpose in issuing
each of the four prescriptions. 21 CFR
1306.04(a); see also T.J. McNichol, 77
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FR 57133, 57147–48 (2012), pet. for rev.
denied McNichol v. DEA, No. 12–15292,
Slip. Op. at 4 (11th Cir. Oct. 17, 2013).
Indeed, these were outright drug
deals. See Moore, 423 U.S. at 142–43
(noting that evidence established that
physician ‘‘exceeded the bounds of
professional practice,’’ when, inter alia,
‘‘he gave inadequate physical
examinations or none at all’’ and
ignored signs of diversion); Cal. Bus. &
Prof. Code section 2242(a) (requiring a
‘‘prior examination’’ before prescribing
medication); Gabriel Sanchez, M.D., 78
FR 59060, 59063–64 (2013) (finding that
a doctor acted outside the usual course
of professional practice by not
conducting an adequate physical
examination before prescribing
controlled substances). These findings
alone support the conclusion that
granting Applicant’s application for a
new registration ‘‘would be inconsistent
with the public interest.’’ 21 U.S.C.
823(f).
While these findings provide reason
alone to deny his application, the
evidence further shows that Applicant
violated several recordkeeping
requirements. See Volkman, 73 FR at
30644 (‘‘Recordkeeping is one of the
CSA’s central features; a registrant’s
accurate and diligent adherence to this
obligation is absolutely essential to
protect against the diversion of
controlled substances.’’). As found
above, at the time of the search,
Respondent possessed various
controlled substances including Ambien
(zolpidem), Lunesta (eszopiclone), and
Xanax (alprazolam). Applicant,
however, admitted to the DI that he ‘‘did
not maintain any records of acquisition
or dispensation’’ of controlled
substances and that he ‘‘did not
document the dispensation in the
patient’s chart.’’ GX 3, at 2.
Under the CSA, a ‘‘registered
individual practitioner is required to
maintain records of controlled
substances in Schedules II–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.’’ Richard A. Herbert, 76 FR
53942, 53958 (2011) (citing 21 CFR
1304.03(b), 1304.22(c)); see also 21
U.S.C. 827(a) & (c). Thus, by his own
admission, Applicant violated federal
law by failing to maintain CSA-required
records. See Volkman, 73 FR at 30644);
see also Cal. Bus. & Prof. Code section
2241.5(c)(5) (subjecting physician to
discipline for failing to ‘‘keep complete
and accurate records of purchases and
disposals of . . . controlled substances
scheduled in the federal Comprehensive
Drug Abuse Prevention and Control Act
PO 00000
Frm 00072
Fmt 4703
Sfmt 4703
of 1970’’). This finding provides an
additional basis for denying Applicant’s
application.
I therefore conclude that the
Government has met its prima facie
burden of showing that the issuance of
a registration to Applicant ‘‘would be
inconsistent with the public interest.’’
21 U.S.C. 823(f). Because Applicant
neither requested a hearing nor
submitted a written statement regarding
the allegations of the Order to Show
Cause, there is no evidence to the
contrary. Patrick K. Chau, 77 FR 36003,
36008 (2012). Accordingly, I will order
that Applicant’s application be denied.
Order
Pursuant to the authority vested in me
by 21 U.S.C. 823(f), as well as 28 CFR
0.100(b) and 0.104, I hereby order that
the application of James Clopton, M.D.,
for a DEA Certificate of Registration be,
and it hereby is, denied. This order is
effective immediately.
Dated: January 6, 2014.
Thomas M. Harrigan,
Deputy Administrator.
[FR Doc. 2014–00524 Filed 1–13–14; 8:45 am]
BILLING CODE 4410–09–P
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E:\FR\FM\14JAN1.SGM
14JAN1
Agencies
[Federal Register Volume 79, Number 9 (Tuesday, January 14, 2014)]
[Notices]
[Pages 2475-2478]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-00524]
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DEPARTMENT OF JUSTICE
Drug Enforcement Administration
James Clopton, M.D.; Decision and Order
On March 22, 2012, the Deputy Assistant Administrator, Office of
Diversion Control, Drug Enforcement Administration, issued an Order to
Show Cause to James Clopton, M.D. (hereinafter, Applicant), of El
Dorado Hills, California. GX 2. The Show Cause Order proposed the
denial of Applicant's application for a DEA Certificate of Registration
as a practitioner, on the ground that his registration would be
inconsistent with the public interest. Id. (citing 21 U.S.C. 823(f)).
The Show Cause Order alleged that on May 22, 2009 and July 8, 2009,
Applicant ``illegally distributed OxyContin, a schedule II controlled
substance,'' to an undercover law enforcement officer, ``for other than
a legitimate medical purpose and outside the usual course of
professional practice.'' Id. (citing 21 U.S.C. 841(a)(1)).
Specifically, the Show Cause Order alleged that Applicant failed to
conduct a physical examination prior to prescribing the controlled
substances to the undercover officer. Id.
Next, the Show Cause Order alleged that on February 10, 2010,
Applicant illegally distributed Norco, a schedule III hydrocodone
combination product, and Xanax, a schedule IV controlled substance, to
the same undercover officer under similar circumstances. Id. at 2.
Finally, the Show Cause Order alleged that Applicant ``failed to
maintain an inventory of controlled substances, records of receipt of
controlled substances, failed to retain copy 3 of DEA form 222, and
failed to maintain dispensing records.'' Id. (citing 21 CFR 1304.11,
1304.22, 1305.17).
The Show Cause Order also notified Applicant of his right to
request a hearing on the allegations or to submit a written statement
regarding the allegations while waiving his right to a hearing. Id. at
2. However, the Order then notified Applicant that ``[s]hould [he] fail
to respond to this official correspondence by exercising [his] rights .
. . [his] application shall be deemed withdrawn pursuant to 21 CFR
Sec. 1301.16(b).'' Id.
On April 2, 2012, the Government personally served the Show Cause
Order on Respondent. Request for Final Agency Action, Attachment 2, at
5. Thereafter, Applicant neither filed a request for a hearing nor
submitted a written statement in lieu of a hearing. Request for Final
Agency Action, at 2.
On November 5, 2012, the Government forwarded a Request for Final
Agency Action to this Office. Id. at 1. Therein, the Government noted
that since the date of service of the Show Cause Order, Applicant had
not requested a hearing. Id. at 2. The Government thus contended that
Applicant had waived his right to a hearing and requested the issuance
of a final order denying the application. Id. at 2-9.
On review, the Administrator found that the Government had failed
to provide fair notice to Applicant regarding the consequences of his
failure to request a hearing or to submit a written statement in lieu
of a hearing. Order, at 1. Specifically, the Administrator found that
the Government had not notified Applicant that the consequence of
failing to request a hearing or to submit a written statement ``would
be that it would then seek a final order denying his application.'' Id.
at 2. Rather, the Administrator found that the Government
``specifically notified Applicant that the only consequence of his
failure to request a hearing or to submit a written statement in lieu
of a hearing would be that his application would be deemed withdrawn.''
Id. (citing 21 CFR 1301.16(b)).\1\ The Administrator further explained
that ``were a final order issued denying the application, Applicant
would be required to disclose the existence of such an order on any
subsequent application, under the threat of criminal prosecution if he
failed to do so.'' Id. at 2-3. Finally, the Administrator explained
that the findings of the final order ``would be entitled to preclusive
effect in a subsequent DEA proceeding.'' Id. at 3 (citing Jose G.
Zavaleta, 78 FR 27431, 27434 (2013)).
---------------------------------------------------------------------------
\1\ This regulation provides, in relevant part, that ``[a]fter
an application has been accept for filing . . . the failure of the
applicant to respond to official correspondence regarding the
application, when sent by registered or certified mail, return
receipt requested, shall be deemed to be a withdrawal of the
application.'' 21 CFR 1301.16(b). In her Order, the Administrator
explained that once the Government files an Order Show Cause, the
consequence of an applicant's or registrant's failure to respond to
the Order is specifically addressed by 21 CFR 1301.43(d), which
provides that if ``[i]f any person entitled to a hearing . . . fails
to file a request for a hearing . . . such person shall be deemed to
have waived the opportunity for a hearing . . . unless such person
shows good cause for such failure.'' See also 21 CFR 1301.43(e)
(``If all persons entitled to a hearing . . . are deemed to waive
their opportunity for the hearing . . . the Administrator may cancel
the hearing, if scheduled, and issue his/her final order pursuant to
Sec. 1301.46 without a hearing.'').
---------------------------------------------------------------------------
Accordingly, the Administrator instructed the Government that if it
intended to seek a final order denying the application, it must serve a
corrected Show Cause Order, which ``properly notifie[d] Applicant of
the consequences of failing to either request a hearing or submit a
written statement in lieu of a hearing.'' Id. The Administrator further
directed the Government to notify her Office, within thirty days, if it
intended to do so. Id. The Government subsequently complied with the
Order. Second Request for Final Agency Action, Attachment 2, at 1.
On July 29, 2013, the Deputy Assistant Administrator issued a new
Show Cause Order, which re-alleged the charges of the previous Show
Cause Order. The second Show Cause Order again advised Applicant that
he had the right to request a hearing or to submit a written statement
while waiving his right to a hearing and the procedure for electing
either option. Most importantly, the Order properly advised Applicant
that ``[s]hould you decline to file a request for a hearing . . . you
shall be deemed to have waived the right to a
[[Page 2476]]
hearing and the Administrator may . . . issue a final order in this
matter without a hearing based upon the evidence presented to her.''
Show Cause Order (II), at 2 (citing 21 CFR 1301.43(d) & (e); id. Sec.
1301.46). On August 23, 2013, the Show Cause Order was personally
served on Applicant by the lead Diversion Investigator. Second Request
for Final Agency Action, Attachment 4.
On October 2, 2013, the Government submitted a Second Request for
Final Agency Action. Therein, the Government noted that since the date
of service of the Second Show Cause Order, Applicant had not requested
a hearing. Id. at 2. The Government thus contends that Applicant has
waived his right to a hearing and requests the issuance of a final
order denying the application. Id.
Based on the Government's submission, I find that since the date of
service of the Second Order to Show Cause, neither Applicant, nor
anyone purporting to represent him, has either requested a hearing on
the allegations or submitted a written statement in lieu of a hearing.
See 21 CFR 1301.43(a) & (c). Accordingly, I find that Applicant has
waived his right to a hearing or to submit a written statement. Id.
Sec. 1301.43(c) & (d). I therefore issue this Decision and Final Order
based on the Investigative Record submitted by the Government. Id.
Sec. 1301.43(e). I make the following findings of fact.
Findings
Applicant is a psychiatrist, who previously held DEA Certificate of
Registration BC2559219, which authorized him to dispense controlled
substances, as a practitioner, in schedules II-V. GX 1, at 4. On
January 26, 2011, Applicant surrendered this registration for cause,
``after which date no controlled substances could be obtained, stored,
administered, prescribed, or dispensed under'' his registration. Id. at
1. However, on June 8, 2011, Applicant submitted an application for a
new registration. Id. at 3.
In February 2009, DEA first became interested in Applicant after a
Diversion Investigator (DI) received a letter from a pharmacist in
Cameron Park, California. GX 3, at 1; GX 6. In the letter, the
pharmacist expressed her ``concerns about [Applicant's] prescribing''
practices. GX 6. Specifically, the pharmacist opined that Applicant was
writing methadone prescriptions to treat drug withdrawal, that he was
prescribing excessive amounts of methadone, and that in 2007, one of
his patients died from a drug overdose. Id.
Subsequently, the DI teamed up with the West El Dorado Narcotics
Enforcement Team to conduct several undercover operations involving
Applicant. GX 3, at 1. Specifically, on May 22, 2009, July 8, 2009, and
February 10, 2010, the team conducted three undercover visits, during
which a West El Dorado Detective, using the alias of ``Tony Cruz,''
visited Applicant for the purpose of obtaining controlled substances.
Id.
On May 22, 2009, the Detective arrived at Applicant's medical
clinic and paid $250 before seeing him. GX 4, at 2. Upon meeting
Applicant, the Detective told him that he was taking ``Oxy,'' but
because his wallet had been stolen he had borrowed some pills from a
friend. Id. at 3-4. The following exchange ensued:
Applicant: What's the medical problem?
Det: Um you know I started a while ago and you know.
Applicant: Ok, so you are trying to get off of them at this
point?
Id. at 4.
Applicant then recognized that the Detective's use of OxyContin was
``recreational'' and that ``there's not a medical problem.'' Id. at 4-
5. The Detective further told Applicant that he ``liked to stay more on
the right side you know I mean I like to have a prescription instead of
hitting somebody up.'' Id. at 10.
Applicant then stated: ``You see, the only problem is unless we
have an actual pain diagnosis psychiatrists can't write for it. So have
you ever been diagnosed with a disk problem or anything?'' Id. The
Detective replied: ``I mean um if I just gotta say I got something.''
Id. Applicant then stated ``ok[,] what I can do is probably write it
for a couple of months,'' but then warned that ``after that it's got to
be more of a primary care or the urgent care because you know again
without the pain diagnosis that's where we get nailed.'' Id. at 10-11.
Applicant did not perform a physical examination during the visit,
which lasted thirteen minutes. Nonetheless, Applicant issued the
Detective a prescription for 120 tablets of OxyContin 80mg. GX 5, at 1.
On the prescription, Applicant wrote: ``Dx 722.1.'' Id. According to
the DI, this is an insurance code ``describing displacement of thoracic
or lumbar invertebral [sic] disc without myelopathy.'' GX 4, at 13.
On July 8, 2009, the Detective returned to Applicant's clinic. Id.
During the visit, Applicant asked the Detective what kind of pain he
felt, and if it was back pain. Id. at 14. The Detective answered, ``um,
that's what you uh told me you put on there before.'' Id. Applicant
replied, ``Ok. Ok. Good luck.'' Id.
Applicant's interaction with the Detective lasted all of two
minutes, during which Applicant did not perform a physical examination.
GX 4, at 14-15. He did, however, issue to the Detective another
prescription for 120 tablets of OxyContin 80mg. GX 5.
On February 10, 2010, the Detective returned again to Applicant's
clinic. Id. at 15. Upon meeting Applicant, the Detective again asked
for ``Oxy.'' Id. at 16. However, Applicant stated that ``they won't let
us,'' and added that ``[t]he Drug Enforcement Agency has basically told
physicians that if you don't give a physical exam you can't prescribe
opiates.'' Id. at 16-17. Applicant then stated that ``[p]sychiatrists
don't do physical exams and so [we are] specifically forbidden from
doing that.'' Id. at 17. Applicant added that ``they will not let us do
. . . the Schedule II's like the Oxy [and] the Percocet . . . they will
let us do the Schedule III's which are the Norcos.'' Id.
After Applicant discussed with the Detective where he could get
Schedule II drugs, the Detective asked if he would ``still be able to''
get Norcos.\2\ Id. at 18. Applicant replied, ``I can write Norco,
yeah.'' Id.
---------------------------------------------------------------------------
\2\ Norco (hydrocodone/acetaminophen) is a schedule III
narcotic. See 21 CFR 1308.13(e)(1).
---------------------------------------------------------------------------
Applicant then asked ``[i]s this for your back?'' Id. The Detective
answered: ``You know yeah that's well last time you told me to it was
my back yeah.'' Id. Continuing, Applicant asked, ``[i]s it more help
out your mood or what's it do for you?'' Id. The Detective answered
that he did ``concrete all day long'' and was ``working with people and
stuff like that,'' and that after coming home, the drug ``helps [to]
unwind.'' Id. To this, Applicant stated: ``Ok[,] that one they'll let
us do.'' Id.
Next, the Detective asked if Applicant had ``anything that will
help sleep''; Applicant replied in the affirmative. Id. The Detective
then said that someone had told him about a drug that was ``spelt
weird,'' and that he couldn't remember the drug's name but that it
``had two X's.'' Applicant then said ``Xanax?'' and the Detective
agreed. Id.
Applicant issued to the Detective two prescriptions: One for 120
tablets of Norco 10/325mg and one for 30 tablets of Xanax 1mg. GX 5, at
3-4. Applicant's interaction with the Detective lasted three minutes,
during which Applicant again failed to perform a physical exam. GX 4,
at 15-18.
[[Page 2477]]
On January 25, 2011, DEA Investigators, including the DI, executed
a federal search warrant at Applicant's clinic. GX 3, at 2. During the
execution of the warrant, Applicant admitted to the DI ``that he did
not maintain any records of acquisition or dispensation'' of controlled
substances and that he ``did not document the dispensation in the
patient's chart.'' Id. He also admitted that he ``frequently would not
perform physical examinations on patients.'' Id.
During the search, DEA seized various schedule IV controlled
substances including alprazolam (Xanax), zolpidem (Ambien), and
eszopiclone (Lunesta). GX 7; see 21 CFR 1308. 14(c). That same day,
Applicant surrendered his DEA Certificate of Registration. GX 3.
Discussion
Section 303(f) of the Controlled Substances Act (CSA) provides that
an application for a practitioner's registration may be denied ``if the
Attorney General determines that the issuance of such registration . .
. would be inconsistent with the public interest.'' 21 U.S.C. 823(f).
In making this determination, Congress directed that the following
factors be considered:
(1) The recommendation of the appropriate State licensing board
or professional disciplinary authority.
(2) The applicant's experience in dispensing . . . 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.
Id.
``These factors are . . . considered in the disjunctive.'' Robert
A. Leslie, M.D., 68 FR 15227, 15230 (2003). I ``may rely on any one or
a combination of factors and may give each factor the weight . . . [I]
deem [ ] appropriate in determining whether . . . an application for
registration [should be] denied.'' Id.; see also Kevin Dennis, M.D., 78
FR 52787, 52794 (2013); MacKay v. DEA, 664 F.3d 808, 816 (10th Cir.
2011).
The Government has the burden of proving, by substantial evidence,
that the requirements for a denial of an application, pursuant to 21
U.S.C. 823(f), are met. 21 CFR 1301.44(e). This is so even in a non-
contested case. Gabriel Sanchez, M.D., 78 FR 59060, 59063 (2013).
Having considered all of the factors,\3\ I conclude that the
Government's evidence with respect to factors two and four establishes,
prima facie, that the issuance of a DEA certificate of registration to
Applicant ``would be inconsistent with the public interest.'' See 21
U.S.C. 823(f).
---------------------------------------------------------------------------
\3\ The record contains no evidence regarding any recommendation
of the state licensing board or professional disciplinary authority,
or any other evidence as to the status of Applicant's state license.
See 21 U.S.C. 823(f)(1). However, even assuming that Applicant
currently possesses state authority to dispense controlled
substances and thus meets this requirement for obtaining a
practitioner's registration, see id. sections 802(21) and 823(f),
this is only one of the five factors which the Agency considers in
making the public interest determination and is therefore not
dispositive. See Joseph Gaudio, 74 FR 10083, 10090 n.25 (2009);
Mortimer B. Levin, 55 FR 8209, 8210 (1990).
There is also no evidence in the record that Applicant has been
convicted of an offense related to the manufacture, distribution or
dispensing of controlled substances. See 21 U.S.C. 823(f)(3).
However, as the Agency has held, there are a number of reasons why a
person who has committed misconduct may not have been convicted, let
alone prosecuted for such an offense. Accordingly, the absence of
such a conviction is not dispositive.
---------------------------------------------------------------------------
Factors Two and Four--The Applicant's Experience in Dispensing
Controlled Substances and Compliance With Applicable Laws Related to
Controlled Substances
Under a longstanding Agency regulation, ``[a] prescription for a
controlled substance [is not] effective [unless it is] issued for a
legitimate medical purpose by an individual practitioner acting in the
usual course of [his] professional practice.'' 21 CFR 1306.04(a). This
regulation further provides that ``an order purporting to be a
prescription issued not in the usual course of professional treatment .
. . is not a prescription within the meaning and intent of [21 U.S.C.
829] and . . . the person issuing it, shall be subject to the penalties
provided for violations of the provisions of law relating to controlled
substances.'' Id.
As the Supreme Court recently explained, ``the prescription
requirement . . . ensures patients use controlled substances under the
supervision of a doctor so as to prevent addiction and recreational
abuse. As a corollary, [it] also bars doctors from peddling to patients
who crave the drugs for those prohibited uses.'' Gonzales v. Oregon,
546 U.S. 243, 274 (2006) (citing United States v. Moore, 423 U.S. 122,
135, 143 (1975)); United States v. Alerre, 430 F.3d 681, 691 (4th Cir.
2005), cert. denied, 547 U.S. 1113 (2006) (holding that the CSA's
prescription requirement stands as a proscription against doctors
acting not ``as a healer[,] but as a seller of wares.'').
Under the CSA, it is fundamental that a practitioner establish and
maintain a legitimate doctor-patient relationship in order to act ``in
the usual course of . . . professional practice'' and to issue a
prescription for a ``legitimate medical purpose.'' Paul H. Volkman, 73
FR 30629, 30642 (2008), pet. for rev. denied, 567 F.3d 215, 223-24 (6th
Cir. 2009). The CSA generally looks to state law and state medical
practice standards to determine whether a legitimate doctor-patient
relationship has been established. Id.
Under California law, a physician ``may prescribe for, or dispense
or administer to, a person under his or her treatment for a medical
condition . . . prescription controlled substances for the treatment of
pain or a condition causing pain.'' Cal. Bus. & Prof. Code section
2241.5(a). However, under California law, in order to legally prescribe
a controlled substance, a physician must conduct an ``appropriate prior
examination.'' Cal. Bus. & Prof. Code section 2242(a) (``Prescribing,
dispensing, or furnishing dangerous drugs . . . without an appropriate
prior examination and a medical indication, constitutes unprofessional
conduct.''); see also People v. Gandotra, 14 Cal. Rptr. 2d 896, 899-900
(Cal. Ct. App. 1992) (``A prescription for a controlled substance shall
only be issued for a legitimate medical purpose by an individual
practitioner acting in the usual course of his or her professional
practice.'') (quoting Cal. Health & Safety Code section 11153(a)).
Here, the Government has presented evidence that on multiple
occasions, Applicant acted outside of the usual course of professional
practice and lacked a legitimate medical purpose when he prescribed
highly abused controlled substances including OxyContin (oxycodone),
hydrocodone, and alprazolam to the Detective, without conducting a
prior physical examination as required by state law. See 21 CFR
1306.04(a). More specifically, the evidence shows that Applicant did
not perform a physical examination of the Detective at any of the
visits and that the Detective did not even complain of any symptoms
that would warrant medical treatment, let alone the issuance of
controlled substance prescriptions. Indeed, Respondent issued
prescriptions to the Detective notwithstanding that he clearly knew
that the latter (in his undercover persona) was seeking drugs to abuse
them.
As found above, during his first visit, the Detective openly stated
that he had borrowed some pills from a friend and Applicant
acknowledged that the Detective's use of OxyContin was ``recreational''
and that ``there's not a medical problem.'' Moreover, after the
[[Page 2478]]
Detective stated that he would like to get ``a prescription instead of
hitting somebody up,'' Applicant acknowledged that ``the only problem
is unless we have an actual pain diagnosis psychiatrists can't write
for it'' and then asked the Detective if he had ``ever been diagnosed
with a disk problem or anything?'' GX 4, at 10. Even then, the
Detective did not identify any pain problem, and said: ``I mean . . .
if I just gotta say I got something.'' Id. Applicant thus clearly knew
that the Detective did not have a legitimate pain condition.
Moreover, Applicant did not perform a physical exam at either the
Detective's second or third visit, each of which lasted two to three
minutes. Indeed, at the second visit, Applicant merely asked ``what
kind of pain is it? Is it back pain or?'' to which the Detective
replied: ``That's what you . . . told me you put on there before.'' Id.
at 14. Here again, Applicant issued the Detective an additional
prescription for OxyContin and did so notwithstanding that he knew that
the Detective did not have any pain.
So too, at the Detective's third visit, Applicant's inquiry into
the former's need for controlled substances involved him asking, ``[i]s
this for your back?'' with the Detective answering: ``You know yeah
that's well last time you told me to it was my back yeah.'' Id. at 18.
Applicant then asked ``[i]s it more help out your mood or what's it do
for you?'' to which the Detective answered that he did ``concrete all
day long'' and was ``working with people and stuff like that,'' and
that after coming home, ``it helps unwind.'' Respondent then stated:
``Ok that one they'll let us do.'' Id. Applicant then agreed to write
the Detective a prescription for Norco, a schedule III combination drug
which contains hydrocodone. Id. Moreover, he also wrote the Detective a
prescription for Xanax based solely on the Detective's asking him if he
had anything for sleep and did not ask him a single question about his
sleep patterns. Id.
As the evidence shows, at each of the above visits, Applicant knew
that the Detective was not seeking the drugs for the purpose of
treating a legitimate medical condition, but rather, for the purpose of
abusing them. He also did not perform a physical examination. Applicant
nonetheless issued the four prescriptions to the Detective. Given the
evidence, expert testimony is not necessary to conclude that Applicant
acted outside of the usual course of professional practice and lacked a
legitimate medical purpose in issuing each of the four prescriptions.
21 CFR 1306.04(a); see also T.J. McNichol, 77 FR 57133, 57147-48
(2012), pet. for rev. denied McNichol v. DEA, No. 12-15292, Slip. Op.
at 4 (11th Cir. Oct. 17, 2013).
Indeed, these were outright drug deals. See Moore, 423 U.S. at 142-
43 (noting that evidence established that physician ``exceeded the
bounds of professional practice,'' when, inter alia, ``he gave
inadequate physical examinations or none at all'' and ignored signs of
diversion); Cal. Bus. & Prof. Code section 2242(a) (requiring a ``prior
examination'' before prescribing medication); Gabriel Sanchez, M.D., 78
FR 59060, 59063-64 (2013) (finding that a doctor acted outside the
usual course of professional practice by not conducting an adequate
physical examination before prescribing controlled substances). These
findings alone support the conclusion that granting Applicant's
application for a new registration ``would be inconsistent with the
public interest.'' 21 U.S.C. 823(f).
While these findings provide reason alone to deny his application,
the evidence further shows that Applicant violated several
recordkeeping requirements. See Volkman, 73 FR at 30644
(``Recordkeeping is one of the CSA's central features; a registrant's
accurate and diligent adherence to this obligation is absolutely
essential to protect against the diversion of controlled
substances.''). As found above, at the time of the search, Respondent
possessed various controlled substances including Ambien (zolpidem),
Lunesta (eszopiclone), and Xanax (alprazolam). Applicant, however,
admitted to the DI that he ``did not maintain any records of
acquisition or dispensation'' of controlled substances and that he
``did not document the dispensation in the patient's chart.'' GX 3, at
2.
Under the CSA, a ``registered individual practitioner is required
to maintain records of controlled substances in Schedules II-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.'' Richard A. Herbert, 76 FR 53942, 53958 (2011)
(citing 21 CFR 1304.03(b), 1304.22(c)); see also 21 U.S.C. 827(a) &
(c). Thus, by his own admission, Applicant violated federal law by
failing to maintain CSA-required records. See Volkman, 73 FR at 30644);
see also Cal. Bus. & Prof. Code section 2241.5(c)(5) (subjecting
physician to discipline for failing to ``keep complete and accurate
records of purchases and disposals of . . . controlled substances
scheduled in the federal Comprehensive Drug Abuse Prevention and
Control Act of 1970''). This finding provides an additional basis for
denying Applicant's application.
I therefore conclude that the Government has met its prima facie
burden of showing that the issuance of a registration to Applicant
``would be inconsistent with the public interest.'' 21 U.S.C. 823(f).
Because Applicant neither requested a hearing nor submitted a written
statement regarding the allegations of the Order to Show Cause, there
is no evidence to the contrary. Patrick K. Chau, 77 FR 36003, 36008
(2012). Accordingly, I will order that Applicant's application be
denied.
Order
Pursuant to the authority vested in me by 21 U.S.C. 823(f), as well
as 28 CFR 0.100(b) and 0.104, I hereby order that the application of
James Clopton, M.D., for a DEA Certificate of Registration be, and it
hereby is, denied. This order is effective immediately.
Dated: January 6, 2014.
Thomas M. Harrigan,
Deputy Administrator.
[FR Doc. 2014-00524 Filed 1-13-14; 8:45 am]
BILLING CODE 4410-09-P