Bulk Manufacturer of Controlled Substances Application: Navinta LLC, 5498-5499 [2019-02877]
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Federal Register / Vol. 84, No. 35 / Thursday, February 21, 2019 / Notices
amozie on DSK3GDR082PROD with NOTICES1
entering into Stip. of Fact 4-21 the
Respondent accepted responsibility for
his recordkeeping violations that
occurred in his practice prior to
February 2014, as alleged in paragraph
4 of the OSC. FF 24. This limited
acceptance of responsibility is
outweighed by his numerous
prescribing and dispensing
transgressions, for which he has not
accepted responsibility.32 See Hatem M.
Ataya, M.D., 81 Fed. Reg. 8221, 8244
(2016) (‘‘[T]here are cases in which,
notwithstanding a finding that a
registrant has credibly accepted
responsibility, the misconduct is so
egregious and extensive that the
protection of the public interest
nonetheless warrants the revocation of a
registration or the denial of an
application.’’).
When considering whether the
Respondent’s continued registration is
consistent with the public interest, the
ALJ must consider both the
egregiousness of the registrant’s
violations and the DEA’s interest in
deterring future misconduct by both the
registrant as well as other registrants.
David A. Ruben, M.D., 78 Fed. Reg.
38363, 38364 (2013); see also Richard J.
Settles, D.O., 81 Fed. Reg. 64940, 64945
n.17 (2016) (‘‘In short, this is not a
contest in which score is kept; the
Agency is not required to mechanically
count up the factors and determine how
many favor the Government and how
many favor the registrant. Rather, it is
an inquiry which focuses on protecting
the public interest; what matters is the
seriousness of the registrant’s
misconduct.’’ (quoting Jayam KrishnaIyer, M.D., 74 Fed. Reg. 459, 462 (2009)).
While I do not believe that the
Respondent’s transgressions rise to the
level of intentional or knowing
diversion, I do find his multiple and
repeated recordkeeping and prescribing
violations to be sufficiently egregious to
warrant revocation.33 See Dewey C.
Administrator to draw an adverse inference from
[the Respondent’s] failure to testify’’). I note,
however, that even absent the adverse inference,
there is sufficient evidence to support the
conclusion that the Respondent has not accepted
responsibility for his improper prescribing and
dispensing of controlled substances.
32 Although the Respondent also stipulated to
many of the facts underlying the allegations contain
in paragraphs 7 and 9 of the OSC, those stipulations
do not admit to any misconduct. They just admit
to facts. The essence of the allegations contained in
paragraphs 7 and 9 of the OSC is that the
Respondent’s actions involving controlled
substances were outside the course of professional
practice and furthered no legitimate medical
purposes.
33 I acknowledge that the Respondent has taken
some remedial steps to reduce the likelihood that
his actions would result in future violations of the
CSA and/or its implementing regulations.
Nevertheless, a registrant does not accept
VerDate Sep<11>2014
19:03 Feb 20, 2019
Jkt 247001
MacKay, M.D., 75 Fed. Reg. 49956,
49974 n.35 (2010) (‘‘[U]nder the public
interest standard, DEA has authority to
consider those prescribing practices of a
physician, which, while not rising to the
level of intentional or knowing
misconduct, nonetheless create a
substantial risk of diversion.’’).
RECOMMENDATION
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. DEA–392]
Bulk Manufacturer of Controlled
Substances Application: Navinta LLC
ACTION:
The Government established that the
Respondent’s continued registration is
inconsistent with the public interest
because of his improper recordkeeping
and improper prescribing, and/or
dispensing, of controlled substances to
himself, his family, and his patients.
While the Respondent admitted to many
of the Government’s factual allegations,
he failed to fully accept responsibility
and acknowledge that his egregious
actions fell below the standard of care
in the State of Connecticut, and/or
lacked any legitimate medical purpose.
Accordingly, I RECOMMEND that the
Respondent’s DEA COR be REVOKED
and that any application for renewal of
his registration be DENIED.
Notice of application.
Registered bulk manufacturers of
the affected basic classes, and
applicants therefore, may file written
comments on or objections to the
issuance of the proposed registration on
or before April 22, 2019.
DATES:
Written comments should
be sent to: Drug Enforcement
Administration, Attention: DEA Federal
Register Representative/DPW, 8701
Morrissette Drive, Springfield, Virginia
22152.
ADDRESSES:
The
Attorney General has delegated his
authority under the Controlled
Substances Act to the Administrator of
the Drug Enforcement Administration
Dated: May 25, 2017
(DEA), 28 CFR 0.100(b). Authority to
exercise all necessary functions with
s/Charles Wm. Dorman
respect to the promulgation and
U.S. Administrative Law Judge
implementation of 21 CFR part 1301,
incident to the registration of
CERTIFICATE OF SERVICE
manufacturers, distributors, dispensers,
This is to certify that the undersigned, importers, and exporters of controlled
on May 25, 2017, caused a copy of the
substances (other than final orders in
foregoing to be transmitted via facsimile connection with suspension, denial, or
and placed in interoffice mail addressed revocation of registration) has been
to Paul A. Dean, Esq., Office of Chief
delegated to the Assistant Administrator
Counsel, Drug Enforcement
of the DEA Diversion Control Division
Administration, 8701 Morrissette Drive, (‘‘Assistant Administrator’’) pursuant to
section 7 of 28 CFR part 0, appendix to
Springfield, VA 22152; facsimile (202)
subpart R.
307–4946, and a copy to be transmitted
via facsimile and mailed, postage
In accordance with 21 CFR
prepaid, to counsel for the Respondent,
1301.33(a), this is notice that on
Ronald W. Chapman, II, Esq. and Robert September 13, 2018, Navinta, LLC.,
J. Andretz, Esq., 1441 West Long Lake
1499 Lower Ferry Road, Ewing, New
Road, Suite 310, Troy, Michigan 48098;
Jersey 08618–1414 applied to be
facsimile (248) 644–6324.
registered as a bulk manufacturer of the
lllllllllllllllllll following basic classes of controlled
substances:
Rhonda L. Gore
Secretary to Judge Charles Wm. Dorman
Office of Administrative Law Judges
SUPPLEMENTARY INFORMATION:
Controlled substance
Drug
code
Schedule
[FR Doc. 2019–02865 Filed 2–20–19; 8:45 am]
BILLING CODE 4410–09–P
responsibility for its actions simply by taking
remedial measures. Holiday CVS, L.L.C., d/b/a CVS/
Pharmacy Nos. 219 & 5195, 77 Fed. Reg. 62316,
62346 (2012). Further, where a registrant has not
accepted responsibility it is not necessary to
consider evidence of the registrant’s remedial
measures. Jones Total Health Care Pharmacy, L.L.C.
& SND Health Care, L.L.C., 81 Fed. Reg. 79188,
79202–03 (2016).
PO 00000
Frm 00095
Fmt 4703
Sfmt 4703
Pentobarbital ............
4-Anilino-Nphenethyl-4-piperidine (ANPP).
Levorphanol ..............
Remifentanil ..............
Fentanyl ....................
2270
8333
II
II
9220
9739
9801
II
II
II
The company plans to manufacture
the listed controlled substances in bulk
for sale to its customers.
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5499
Federal Register / Vol. 84, No. 35 / Thursday, February 21, 2019 / Notices
Dated: February 11, 2019.
John J. Martin,
Assistant Administrator.
Controlled substance
[FR Doc. 2019–02877 Filed 2–20–19; 8:45 am]
BILLING CODE 4410–09–P
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. DEA–392]
Bulk Manufacturer of Controlled
Substances Application: Noramco, Inc.
ACTION:
Notice of application.
Registered bulk manufacturers of
the affected basic classes, and
applicants therefore, may file written
comments on or objections to the
issuance of the proposed registration on
or before April 22, 2019.
ADDRESSES: Written comments should
be sent to: Drug Enforcement
Administration, Attention: DEA Federal
Register Representative/DPW, 8701
Morrissette Drive, Springfield, Virginia
22152.
SUPPLEMENTARY INFORMATION: The
Attorney General has delegated his
authority under the Controlled
Substances Act to the Administrator of
the Drug Enforcement Administration
(DEA), 28 CFR 0.100(b). Authority to
exercise all necessary functions with
respect to the promulgation and
implementation of 21 CFR part 1301,
incident to the registration of
manufacturers, distributors, dispensers,
importers, and exporters of controlled
substances (other than final orders in
connection with suspension, denial, or
revocation of registration) has been
redelegated to the Assistant
Administrator of the DEA Diversion
Control Division (‘‘Assistant
Administrator’’) pursuant to section 7 of
28 CFR part 0, appendix to subpart R.
In accordance with 21 CFR
1301.33(a), this is notice that on October
30, 2018, Noramco, Inc., 500 Swedes
Landing Road, Wilmington, Delaware
19801 applied to be registered as a bulk
manufacturer of the following basic
classes of controlled substances:
DATES:
amozie on DSK3GDR082PROD with NOTICES1
Controlled substance
Marihuana .................
Tetrahydrocannabinols.
Codeine-N-oxide .......
Dihydromorphine ......
Hydromorphinol ........
Morphine-N-oxide .....
Amphetamine ...........
VerDate Sep<11>2014
Drug
code
Schedule
7360
7370
I
I
9053
9145
9301
9307
1100
I
I
I
I
II
17:08 Feb 20, 2019
Jkt 247001
Drug
code
Methylphenidate .......
Nabilone ...................
Phenylacetone ..........
Codeine ....................
Dihydrocodeine .........
Oxycodone ...............
Hydromorphone ........
Hydrocodone ............
Morphine ...................
Oripavine ..................
Thebaine ...................
Opium extracts .........
Opium fluid extract ...
Opium tincture ..........
Opium, powdered .....
Opium, granulated ....
Oxymorphone ...........
Noroxymorphone ......
Tapentadol ................
1724
7379
8501
9050
9120
9143
9150
9193
9300
9330
9333
9610
9620
9630
9639
9640
9652
9668
9780
Schedule
II
II
II
II
II
II
II
II
II
II
II
II
II
II
II
II
II
II
II
The company plans to manufacture
bulk active pharmaceutical ingredients
(APIs) and reference standards for
distribution to their customers.
In reference to drug codes 7360
(marihuana) and 7370
(tetrahydrocannabinols), the company
plans to bulk manufacture these drugs
as synthetics. No other activities for
these drug codes are authorized for this
registration.
authority under the Controlled
Substances Act to the Administrator of
the Drug Enforcement Administration
(DEA), 28 CFR 0.100(b). Authority to
exercise all necessary functions with
respect to the promulgation and
implementation of 21 CFR part 1301,
incident to the registration of
manufacturers, distributors, dispensers,
importers, and exporters of controlled
substances (other than final orders in
connection with suspension, denial, or
revocation of registration) has been
redelegated to the Assistant
Administrator of the DEA Diversion
Control Division (‘‘Assistant
Administrator’’) pursuant to section 7 of
28 CFR part 0, appendix to subpart R.
In accordance with 21 CFR
1301.34(a), this is notice that on
December 7, 2018, Stepan Company,
100 W Hunter Ave, Maywood, New
Jersey 07607, re-applied to be registered
as a bulk manufacturer of the following
basic classes of controlled substances.
Controlled substance
Drug
code
Cocaine ....................
Ecgonine ...................
9041
9180
Schedule
II
II
Dated: February 11, 2019.
John J. Martin,
Assistant Administrator.
The company plans to manufacture
the listed controlled substances in bulk
for distribution to its customers.
[FR Doc. 2019–02883 Filed 2–20–19; 8:45 am]
Dated: February 11, 2019.
John J. Martin,
Assistant Administrator.
BILLING CODE 4410–09–P
[FR Doc. 2019–02878 Filed 2–20–19; 8:45 am]
DEPARTMENT OF JUSTICE
BILLING CODE 4410–09–P
Drug Enforcement Administration
[Docket No. DEA–392]
DEPARTMENT OF JUSTICE
Bulk Manufacturer of Controlled
Substances Application: Stepan
Company
Drug Enforcement Administration
ACTION:
Notice of application.
Registered bulk manufacturers of
the affected basic classes, and
applicants therefore, may file written
comments on or objections to the
issuance of the proposed registration on
or before March 25, 2019. Such persons
may also file a written request for a
hearing on the application on or before
March 25, 2019.
ADDRESSES: Written comments should
be sent to: Drug Enforcement
Administration, Attention: DEA Federal
Register Representative/DPW, 8701
Morrissette Drive, Springfield, Virginia
22152.
SUPPLEMENTARY INFORMATION: The
Attorney General has delegated his
DATES:
PO 00000
Frm 00096
Fmt 4703
Sfmt 4703
[Docket No. DEA–392]
Bulk Manufacturer of Controlled
Substances Registration
ACTION:
Notice of registration.
The registrant listed below
has applied for and been granted
registration by the Drug Enforcement
Administration (DEA) as a bulk
manufacturer of various classes of
schedule I and II controlled substances.
SUPPLEMENTARY INFORMATION: The
company listed below applied to be
registered as a bulk manufacturer of
various basic classes of controlled
substances. Information on a previously
published notice is listed below. No
comments or objections were submitted
for the notice.
SUMMARY:
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]]>Agencies
[Federal Register Volume 84, Number 35 (Thursday, February 21, 2019)]
[Notices]
[Pages 5498-5499]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-02877]
-----------------------------------------------------------------------
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. DEA-392]
Bulk Manufacturer of Controlled Substances Application: Navinta
LLC
ACTION: Notice of application.
-----------------------------------------------------------------------
DATES: Registered bulk manufacturers of the affected basic classes, and
applicants therefore, may file written comments on or objections to the
issuance of the proposed registration on or before April 22, 2019.
ADDRESSES: Written comments should be sent to: Drug Enforcement
Administration, Attention: DEA Federal Register Representative/DPW,
8701 Morrissette Drive, Springfield, Virginia 22152.
SUPPLEMENTARY INFORMATION: The Attorney General has delegated his
authority under the Controlled Substances Act to the Administrator of
the Drug Enforcement Administration (DEA), 28 CFR 0.100(b). Authority
to exercise all necessary functions with respect to the promulgation
and implementation of 21 CFR part 1301, incident to the registration of
manufacturers, distributors, dispensers, importers, and exporters of
controlled substances (other than final orders in connection with
suspension, denial, or revocation of registration) has been delegated
to the Assistant Administrator of the DEA Diversion Control Division
(``Assistant Administrator'') pursuant to section 7 of 28 CFR part 0,
appendix to subpart R.
In accordance with 21 CFR 1301.33(a), this is notice that on
September 13, 2018, Navinta, LLC., 1499 Lower Ferry Road, Ewing, New
Jersey 08618-1414 applied to be registered as a bulk manufacturer of
the following basic classes of controlled substances:
------------------------------------------------------------------------
Controlled substance Drug code Schedule
------------------------------------------------------------------------
Pentobarbital......................... 2270 II
4-Anilino-N-phenethyl-4-piperidine 8333 II
(ANPP).
Levorphanol........................... 9220 II
Remifentanil.......................... 9739 II
Fentanyl.............................. 9801 II
------------------------------------------------------------------------
The company plans to manufacture the listed controlled substances
in bulk for sale to its customers.
[[Page 5499]]
Dated: February 11, 2019.
John J. Martin,
Assistant Administrator.
[FR Doc. 2019-02877 Filed 2-20-19; 8:45 am]
BILLING CODE 4410-09-P
