Bulk Manufacturer of Controlled Substances Application: Euticals Inc., 45699-45700 [2020-16401]
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Federal Register / Vol. 85, No. 146 / Wednesday, July 29, 2020 / Notices
decisions require Applicant’s
unequivocal acceptance of
responsibility for his actions and a
demonstration that he will not engage in
future misconduct. ALRA Labs, Inc. v.
Drug Enf’t Admin., 54 F.3d 450, 452 (7th
Cir. 1995); Jayam Krishna-Iyer, M.D., 74
FR 459, 463 (2009) (collecting cases);
Jeffrey Stein, M.D., 84 FR 46968, 46972–
73 (2019). The Agency has decided that
the egregiousness and extent of the
misconduct are significant factors in
determining the appropriate sanction.
Garrett Howard Smith, M.D., 83 FR at
18910 (collecting cases). The Agency
has also considered the need to deter
similar acts by Applicant and by the
community of registrants. Id.
The extent of Applicant’s misconduct
proven by the record evidence is eight
felonies, six of which relate to
controlled substances and all of which
were affirmed on appeal, and the
unlawful dispensing of over 2,700
dosage units of controlled substances in
Schedules II, III, and IV. In addition, as
already discussed, Applicant’s
testimony was not always marked by
candor. Supra sections II.E. and III.D;
see also GX 3, at 3 (‘‘Individual I stated
that in or about 2011, . . . [Applicant]
instructed her to tell investigators that
he had written prescriptions for pain
medications for her, although this was
not true.’’).
While Applicant took responsibility
for some of his wrongdoing, he did not
take unequivocal responsibility for all of
it. First, despite the Fourth Circuit
Conviction Affirmance, Applicant
testified that he did not conspire to
distribute and dispense controlled
substances in violation of 21 U.S.C. 846.
Tr. 115 (denying that he ever unlawfully
directed employees to go to pharmacies
to pick up prescriptions and return
them to him); see also id. at 133–34.
Instead, he blamed his conspiracy
conviction on false testimony of his
former office manager. Id. at 116–17.
Second, concerning his convictions for
unlawfully dispensing controlled
substances, Applicant denied writing
prescriptions that did not have a
legitimate dental purpose. Id. at 116.
Instead, he testified that the
prescriptions were legitimate. He
explained that his ‘‘problem’’ was that
the prescriptions lacked proof of their
legitimacy in the form of proper
documentation. Id. at 117. Third, he
testified that it ‘‘would be wrong’’ for
someone to say that he intentionally
wrote or gave people prescriptions ‘‘for
other than a legitimate medical
purpose.’’ Id. at 121. Instead, he
attributed what courts and the VBD
determined were unlawful prescriptions
to his not being careful enough, his
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making a mistake, his stupidity, and his
being lax. Id. at 127–31.
As the Chief ALJ stated, ‘‘It would be
illogical for the Agency to entrust . . .
[Applicant] with the weighty
responsibilities of a DEA registrant
where he is unable to even accept the
proposition that he has engaged in the
misconduct that he was convicted of
and which was sustained by the . . .
[VBD].’’ RD, at 42. ‘‘[S]o long as . . .
Applicant adheres to his (almost
bizarre) state of denial regarding the
actual facts subsumed in his convictions
(and Board findings),’’ the Chief ALJ
continued, ‘‘it would be unreasonable to
believe that he will alter his conduct.’’
Id. Thus, as past Agency decisions make
clear that unequivocal acceptance of
responsibility is a prerequisite for the
forbearance of a sanction, Applicant’s
failure unequivocally to accept
responsibility means that he is not
eligible to avoid an unfavorable
disposition of his application under the
record facts in this case.28
Applicant testified that he is not
currently prescribing controlled
substances in his dental practice and
that he does not expect the income he
realizes from his practice to increase if
he had that authority. Tr. 46–48,113–14.
Instead, he stated, he would like
authority to prescribe Schedule V
controlled substances for the sake of his
patients’ comfort. Id. at 46–48; cf. supra
n.17 (summarizing Applicant’s
testimony that his not having
authorization to dispense controlled
substances has not dissuaded patients
from using his practice). Applicant does
not cite, and I am unaware of, any past
Agency decision that grants a
registration for the sake of patient
comfort when the applicant was
convicted of eight felonies and the
unlawful dispensing of over 2,700
controlled substance dosage units. I
decline to suggest, let alone establish,
such a path.
I agree with the Chief ALJ that
‘‘consideration of the egregiousness of
. . . [Applicant’s] transgressions
likewise does not support a sanction
less than an outright denial of . . .
[Applicant’s] application.’’ RD, at 43.
45699
The record in this case paints a picture of
a registrant out of control. He distributed and
dispensed drugs to himself and others with
no justifiable reason, tasked his employees
with taking controlled substance scrips to
pharmacies and filling them so that he could
dole them out to himself, friends, and other
non-patients, slapped a fentanyl patch on
himself in front of his staff, handed out
powerful controlled drugs to his love
interests, and prescribed scores of controlled
substances to multiple patients without a
legitimate medical purpose.
Id. In this context, specific and
general deterrence weigh in favor of
denying the application. I agree with the
Chief ALJ that ‘‘[t]o issue a registration
to this . . . [Applicant] would send a
message to the regulated community
that misconduct (even repeated serious,
intentional misconduct) will bear no
meaningful consequence, even after
state board findings and convictions,’’ if
the Applicant ‘‘deflects blame onto
others.’’ Id.
Given my decision that Applicant’s
application is not in the public interest,
I conclude that Applicant’s proposed
Corrective Action Plan provides no
basis for me to discontinue or defer this
proceeding.
Accordingly, I shall order the denial
of Applicant’s application.
Order
Pursuant to 28 CFR 0.100(b) and the
authority vested in me by 21 U.S.C.
823(f), I hereby deny the application
submitted by Hamada Makarita, D.D.S.,
Control No. W16093263C, seeking
registration in Virginia as a practitioner
in Schedule V, and any other pending
application submitted by Hamada
Makarita, D.D.S. for a DEA registration
in the Commonwealth of Virginia. This
Order is effective August 28, 2020
Timothy J. Shea,
Acting Administrator.
[FR Doc. 2020–16355 Filed 7–28–20; 8:45 am]
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DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. DEA–684]
testified about the changes he made
to his dental practice after his felony convictions
and the VBD Order. Those so-called ‘‘remedial
measures,’’ however, ‘‘bear no logical nexus to his
established misconduct’’ of misusing his controlled
substance privileges, as the Chief ALJ observed. RD,
at 41. While Applicant testified about the expensive
educational courses he took and the ‘‘measures
calculated to protect his scripts and prescribing
software from potential malfeasance of staff
members and burglars,’’ he introduced no remedial
measure ‘‘that might bear the capacity to protect
these powerful tools from his own future
malfeasance.’’ Id.
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Bulk Manufacturer of Controlled
Substances Application: Euticals Inc.
ACTION:
Notice of application.
Registered bulk manufacturers of
the affected basic class(es), and
applicants therefore, may file written
comments on or objections to the
issuance of the proposed registration on
or before September 28, 2020.
DATES:
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45700
Federal Register / Vol. 85, No. 146 / Wednesday, July 29, 2020 / Notices
Written comments should
be sent to: Drug Enforcement
Administration, Attention: DEA Federal
Register Representative/DPW, 8701
Morrissette Drive, Springfield, Virginia
22152.
SUPPLEMENTARY INFORMATION: In
accordance with 21 CFR 1301.33(a), this
is notice that on June 5, 2020, Euticals
Inc., 2460 W Bennett Street, Springfield,
Missouri 65807–1229, applied to be
registered as a bulk manufacturer of the
following basic class(es) of controlled
substances:
ADDRESSES:
Controlled substance
Gamma Hydroxybutyric
Acid.
Amphetamine ................
Lisdexamfetamine .........
Methylphenidate ............
Phenylacetone ...............
Methadone .....................
Methadone intermediate
Oripavine .......................
Tapentadol .....................
Drug
code
Schedule
Drug
code
Amphetamine ................
Tapentadol .....................
William T. McDermott,
Assistant Administrator.
[FR Doc. 2020–16397 Filed 7–28–20; 8:45 am]
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1100
1205
1724
8501
9250
9254
9330
9780
II
II
II
II
II
II
II
II
[OMB Number 1190–NEW]
Agency Information Collection
Activities; Proposed eCollection
eComments Requested; Generic
Clearance for Pilot and Field Studies
for Community Relations Service Data
Collection Activities
[FR Doc. 2020–16401 Filed 7–28–20; 8:45 am]
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DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. DEA–687]
Bulk Manufacturer of Controlled
Substances Application: Siegfried
USA, LLC
Notice of application.
Registered bulk manufacturers of
the affected basic class(es), and
applicants therefore, may file written
comments on or objections to the
issuance of the proposed registration on
or before September 28, 2020.
ADDRESSES: Written comments should
be sent to: Drug Enforcement
Administration, Attention: DEA Federal
Register Representative/DPW, 8701
Morrissette Drive, Springfield, Virginia
22152.
SUPPLEMENTARY INFORMATION: In
accordance with 21 CFR 1301.33(a), this
is notice that on May 21, 2020, Siegfried
USA, LLC, 33 Industrial Park Road,
Pennsville, New Jersey 08070–3244,
applied to be registered as a bulk
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II
II
The company plans to manufacture
the above-listed controlled substances
in bulk for sale to its customers.
DEPARTMENT OF JUSTICE
DATES:
Schedule
1100
9780
I
William T. McDermott,
Assistant Administrator.
VerDate Sep<11>2014
Controlled
substance
2010
The company plans to manufacture
the above-listed controlled substances
in bulk for distribution to its customers.
No other activities for these drug codes
are authorized for this registration.
ACTION:
manufacturer of the following basic
class(es) of controlled substances:
Community Relations Service,
Department of Justice.
ACTION: 30-Day notice.
AGENCY:
The Department of Justice
(DOJ), Community Relations Service
(CRS), intends to request approval from
the Office of Management and Budget
(OMB) for a generic information
collection clearance that will allow CRS
to conduct a variety of participant
feedback studies. CRS will submit the
request for review and approval in
accordance with the Paperwork
Reduction Act of 1995. Over the next
three years, CRS anticipates collecting
program impact evaluation data for
reassessing ongoing programs across
several areas within community
outreach. The purpose of these
collections is to gather feedback from
participants who attended CRS
programs and to use that information to
measure the impact of the programs.
This work may entail redesigning and/
or modifying existing programs based
upon received feedback. CRS envisions
using surveys, interviews, and other
electronic data collection instruments.
DATES: Comments are encouraged and
will be accepted for 60 days until
September 28, 2020.
ADDRESSES: Written comments and
recommendations for the proposed
information collection should be sent
within 30 days of publication of this
notice to www.reginfo.gov/public/do/
PRAMain. Find this particular
information collection by selecting
‘‘Currently under 30-day Review—Open
SUMMARY:
PO 00000
Frm 00127
Fmt 4703
Sfmt 4703
for Public Comments’’ or by using the
search function.
SUPPLEMENTARY INFORMATION: Written
comments and suggestions from the
public and affected agencies concerning
the proposed collection of information
are encouraged. Your comments should
address one or more of the following
four points:
—Evaluate whether the proposed
collection of information is necessary
for the proper performance of the
functions of the Community Relations
Service, including whether the
information will have practical utility.
—Evaluate the accuracy of the agency’s
estimate of the burden of the
proposed collection of information,
including the validity of the
methodology and assumptions used.
—Evaluate whether (and if so, how) the
quality, utility, and clarity of the
information to be collected can be
enhanced.
—Minimize the burden of the collection
of information on those who are to
respond, including using appropriate
automated, electronic, mechanical, or
other technological collection
techniques or other forms of
information technology, e.g.,
permitting electronic submission of
responses.
Overview of This Information
Collection
(1) Type of Information Collection:
New Generic Information Collection
Request.
(2) The Title of the Form/Collection:
Generic Clearance for Community
Relations Service Program Impact
Evaluations.
(3) The agency form number, if any,
and the applicable component of the
Department sponsoring the collection:
Form numbers not available for generic
clearance. The applicable component
within the Department of Justice is the
Community Relations Service.
(4) Affected public who will be asked
or required to respond, as well as a brief
abstract: Participants of CRS programs
in relevant jurisdictional fields;
individuals; facilitators; state and local
law enforcement, government officials,
faith leaders, and community leaders;
students; school administrators; and
representatives of advocacy
organizations.
(5) An estimate of the total number of
respondents and the amount of time
estimated for an average respondent to
respond: We estimate that
approximately 80–90 respondents will
be involved in program impact
evaluations conducted under this
clearance over the requested 3-year
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]]>Agencies
[Federal Register Volume 85, Number 146 (Wednesday, July 29, 2020)]
[Notices]
[Pages 45699-45700]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-16401]
-----------------------------------------------------------------------
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. DEA-684]
Bulk Manufacturer of Controlled Substances Application: Euticals
Inc.
ACTION: Notice of application.
-----------------------------------------------------------------------
DATES: Registered bulk manufacturers of the affected basic class(es),
and applicants therefore, may file written comments on or objections to
the issuance of the proposed registration on or before September 28,
2020.
[[Page 45700]]
ADDRESSES: Written comments should be sent to: Drug Enforcement
Administration, Attention: DEA Federal Register Representative/DPW,
8701 Morrissette Drive, Springfield, Virginia 22152.
SUPPLEMENTARY INFORMATION: In accordance with 21 CFR 1301.33(a), this
is notice that on June 5, 2020, Euticals Inc., 2460 W Bennett Street,
Springfield, Missouri 65807-1229, applied to be registered as a bulk
manufacturer of the following basic class(es) of controlled substances:
------------------------------------------------------------------------
Drug
Controlled substance code Schedule
------------------------------------------------------------------------
Gamma Hydroxybutyric Acid.............. 2010 I
Amphetamine............................ 1100 II
Lisdexamfetamine....................... 1205 II
Methylphenidate........................ 1724 II
Phenylacetone.......................... 8501 II
Methadone.............................. 9250 II
Methadone intermediate................. 9254 II
Oripavine.............................. 9330 II
Tapentadol............................. 9780 II
------------------------------------------------------------------------
The company plans to manufacture the above-listed controlled
substances in bulk for distribution to its customers. No other
activities for these drug codes are authorized for this registration.
William T. McDermott,
Assistant Administrator.
[FR Doc. 2020-16401 Filed 7-28-20; 8:45 am]
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