Importer of Controlled Substances Registration: Catalent Pharma Solutions, LLC, 8246-8247 [2016-03358]
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Federal Register / Vol. 81, No. 32 / Thursday, February 18, 2016 / Notices
[Docket No. DEA–392]
controlled substance in bulk from a
domestic source in order to manufacture
other controlled substances in bulk for
distribution to its customers.
Manufacturer of Controlled
Substances Registration: Euticals, Inc.
Dated: February 10, 2016.
Louis J. Milione,
Deputy Assistant Administrator.
DEPARTMENT OF JUSTICE
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
Drug Enforcement Administration
[Docket No. DEA–392]
Bulk Manufacturer of Controlled
Substances Application: Cedarburg
Pharmaceuticals, Inc.
ACTION:
ACTION:
Registered bulk manufacturers of
the affected basic class, and applicants
therefore, may file written comments on
or objections to the issuance of the
proposed registration in accordance
with 21 CFR 1301.33(a) on or before
April 18, 2016.
DATES:
Written comments should
be sent to: Drug Enforcement
Administration, Attention: DEA Federal
Register Representative/ODW, 8701
Morrissette Drive, Springfield, Virginia
22152.
ADDRESSES:
The
Attorney General has delegated her
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 Deputy Assistant
Administrator of the DEA Office of
Diversion Control (‘‘Deputy 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
November 4, 2015, Cedarburg
Pharmaceuticals, Inc., 870 Badger
Circle, Grafton, Wisconsin 53024
applied to be registered as a bulk
manufacturer of nabilone (7379), a basic
class of controlled substance listed in
schedule II.
The company plans to manufacturer
bulk active pharmaceutical ingredients
(API) for distribution to its customers.
mstockstill on DSK4VPTVN1PROD with NOTICES
Dated: February 10, 2016.
Louis J. Milione,
Deputy Assistant Administrator.
[FR Doc. 2016–03350 Filed 2–17–16; 8:45 am]
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Euticals, Inc. applied to be
registered as a manufacturer of certain
basic classes of controlled substances.
The Drug Enforcement Administration
(DEA) grants Euticals, Inc. registration
as a manufacturer of those controlled
substances.
SUPPLEMENTARY INFORMATION: By notice
dated September 16, 2015, and
published in the Federal Register on
September 23, 2015, 80 FR 57391,
Euticals, Inc., 2460 W. Bennett Street,
Springfield, Missouri 65807–1229
applied to be registered as a
manufacturer of certain basic classes of
controlled substances. No comments or
objections were submitted for this
notice.
The DEA has considered the factors in
21 U.S.C. 823(a) and determined that
the registration of Euticals, Inc. to
manufacture the basic classes of
controlled substances is consistent with
the public interest and with United
States obligations under international
treaties, conventions, or protocols in
effect on May 1, 1971. The DEA
investigated the company’s maintenance
of effective controls against diversion by
inspecting and testing the company’s
physical security systems, verifying the
company’s compliance with state and
local laws, and reviewing the company’s
background and history.
Therefore, pursuant to 21 U.S.C.
823(a), and in accordance with 21 CFR
1301.33, the above-named company is
granted registration as a bulk
manufacturer of the following basic
classes of controlled substances:
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SUMMARY:
Notice of application.
SUPPLEMENTARY INFORMATION:
[FR Doc. 2016–03355 Filed 2–17–16; 8:45 am]
Notice of registration.
Controlled substance
Gamma
Hydroxybutyric
Acid
(2010).
Amphetamine (1100) ....................
Lisdexamfetamine (1205) .............
Methylphenidate (1724) ................
Phenylacetone (8501) ..................
Methadone (9250) ........................
Methadone intermediate (9254) ...
Oripavine (9330) ...........................
Tapentadol (9780) ........................
Schedule
I
II
II
II
II
II
II
II
II
The company plans to manufacture
the listed controlled substances in bulk
for distribution and sale to its
customers.
In reference to oripavine (9330), the
company plans to acquire the listed
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DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. DEA–392]
Importer of Controlled Substances
Registration: Catalent Pharma
Solutions, LLC
ACTION:
Notice of registration.
Catalent Pharma Solutions,
LLC applied to be registered as an
importer of a certain basic class of
controlled substance. The Drug
Enforcement Administration (DEA)
grants Catalent Pharma Solutions, LLC
registration as an importer of this
controlled substance.
SUPPLEMENTARY INFORMATION: By notice
dated August 21, 2015, and published in
the Federal Register on August 31,
2015, 80 FR 52510, Catalent Pharma
Solutions, LLC, 3031 Red Lion Road,
Philadelphia, Pennsylvania 19114
applied to be registered as an importer
of a certain basic class of controlled
substance. No comments or objections
were submitted for this notice.
The DEA has considered the factors in
21 U.S.C. 823, 952(a) and 958(a) and
determined that the registration of
Catalent Pharma Solutions, LLC to
import the basic class of controlled
substance is consistent with the public
interest and with United States
obligations under international treaties,
conventions, or protocols in effect on
May 1, 1971. The DEA investigated the
company’s maintenance of effective
controls against diversion by inspecting
and testing the company’s physical
security systems, verifying the
company’s compliance with state and
local laws, and reviewing the company’s
background and history.
Therefore, pursuant to 21 U.S.C.
952(a) and 958(a), and in accordance
with 21 CFR 1301.34, the above-named
company is granted registration as an
importer of hydromorphone (9150), a
basic class of controlled substance listed
in schedule II.
The company plans to import the
above listed controlled substance for a
clinical trial study. Approval of permit
applications will occur only when the
SUMMARY:
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Federal Register / Vol. 81, No. 32 / Thursday, February 18, 2016 / Notices
importer of butylone (7541), a basic
class of controlled substance listed in
schedule I.
The company plans to import the
above listed controlled substance for
analytical research and testing of
equipment. This authorization does not
extend to the import of a finished FDA
approved or non-approved dosage form
for commercial sale.
registrant’s business activity is
consistent with what is authorized
under to 21 U.S.C. 952(a)(2).
Authorization will not extend to the
import of FDA approved or nonapproved finished dosage forms for
commercial sale.
Dated: February 10, 2016.
Louis J. Milione,
Deputy Assistant Administrator.
Dated: February 10, 2016.
Louis J. Milione,
Deputy Assistant Administrator.
[FR Doc. 2016–03358 Filed 2–17–16; 8:45 am]
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[FR Doc. 2016–03353 Filed 2–17–16; 8:45 am]
DEPARTMENT OF JUSTICE
BILLING CODE 4410–09–P
Drug Enforcement Administration
[Docket No. DEA–392]
DEPARTMENT OF JUSTICE
Importer of Controlled Substances
Registration: Sigma Aldrich
International GMBH-Sigma Aldrich Co.
LLC
Drug Enforcement Administration
ACTION:
Notice of registration.
Sigma Aldrich International
GMBH-Sigma Aldrich Co. LLC applied
to be registered as an importer of a basic
class of controlled substance. The Drug
Enforcement Administration (DEA)
grants Sigma Aldrich International
GMBH-Sigma Aldrich Co. LLC
registration as an importer of this
controlled substance.
SUPPLEMENTARY INFORMATION: By notice
dated October 13, 2015, and published
in the Federal Register on October 21,
2015, 80 FR 63839, Sigma Aldrich
International GMBH-Sigma Aldrich Co.
LLC, 3500 Dekalb Street, Saint Louis,
Missouri 63118 applied to be registered
as an importer of a certain basic class of
controlled substance. No comments or
objections were submitted for this
notice.
The DEA has considered the factors in
21 U.S.C. 823, 952(a) and 958(a) and
determined that the registration of
Sigma Aldrich International GMBHSigma Aldrich Co. LLC, to import the
basic class of controlled substance is
consistent with the public interest and
with United States obligations under
international treaties, conventions, or
protocols in effect on May 1, 1971. The
DEA investigated the company’s
maintenance of effective controls
against diversion by inspecting and
testing the company’s physical security
systems, verifying the company’s
compliance with state and local laws,
and reviewing the company’s
background and history.
Therefore, pursuant to 21 U.S.C.
952(a) and 958(a), and in accordance
with 21 CFR 1301.34, the above-named
company is granted registration as an
mstockstill on DSK4VPTVN1PROD with NOTICES
SUMMARY:
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[Docket No. 15–1]
Arvinder Singh, M.D.; Decision and
Order
On October 16, 2014, the Deputy
Assistant Administrator, Office of
Diversion Control, issued an Order to
Show Cause to Arvinder Singh, M.D.
(Respondent), of Clifton Park, New
York. ALJ Ex. 1. The Show Cause Order
proposed the denial of Respondent’s
application for a DEA Certificate of
Registration as a practitioner on three
grounds.
First, the Show Cause Order alleged
that on August 4, 2003, Respondent,
following a jury trial, was convicted on
16 counts of health care fraud in
violation of 18 U.S.C. 1347, one count
of conspiracy to distribute controlled
substances in violation of 21 U.S.C. 846,
and 24 counts of unlawful distribution
of controlled substances in violations of
21 U.S.C. 841(a)(1) and 18 U.S.C. 2. Id.
at 1–2. (citing 21 U.S.C. 824(a)(2)).
Second, the Show Cause Order
alleged that Respondent’s convictions
for violating the Controlled Substances
Act ‘‘were based on a scheme in which
[he] left pre-signed but otherwise blank
prescriptions for [his] nursing staff to
fill in and issue Schedule II controlled
substances prescriptions to patients
when neither [he] nor any other
physician saw the patient at the time
such prescriptions were issued.’’ Id. at
2. The Show Cause Order alleged that
Respondent’s scheme also violated 21
CFR 1306.04(a) and 1306.05(a), and that
this conduct constituted acts
inconsistent with the public interest. Id.
(citing 21 U.S.C. 824(a)(4) and 823(f)).
Third, the Show Cause Order alleged
that on May 8, 2004, the U.S.
Department of Health and Human
Services (HHS) excluded Respondent
from participation in federal health care
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8247
programs for a period of 15 years based
on his convictions for Health Care Fraud
and for violating the Controlled
Substances Act. Id. The Government
further alleged that because ‘‘the
amount of the financial loss’’ was in
excess of $5,000; the time period of
Respondent’s illegal activity exceeded
more than one year; and Respondent
had been convicted of the CSA
violations; HHS imposed a 15-year
exclusion, which was three times the
minimum exclusion period. Id. (citing
21 U.S.C. 824(a)(5)).
Following service of the Show Cause
Order, Respondent requested a hearing
on the allegations. The matter was
placed on the docket of the Office of
Administrative Law Judges and assigned
to Chief Administrative Law Judge
(hereinafter, CALJ) John J. Mulrooney,
II. Following pre-hearing procedures,
the CALJ conducted a hearing at which
both parties introduced documentary
evidence and called witnesses to testify.
Thereafter, both parties submitted briefs
containing their proposed findings of
fact, conclusions of law, and arguments
regarding the ultimate disposition of
this matter.
On February 10, 2015, the CALJ
issued his Recommended Decision.
Therein, the CALJ found that the
Government had established a prima
facie case to deny Respondent’s
application for registration as a
practitioner on multiple grounds.1 R.D.
at 37.
These included that Respondent had
been convicted of twenty-four counts of
1 Pursuant to 21 U.S.C. 823(f), ‘‘[t]he Attorney
General may deny an application for [a
practitioner’s] registration . . . if [she] determines
that the issuance of such registration . . . would be
inconsistent with the public interest.’’ In making
this determination, section 823(f) directs the
Agency 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 . . .
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. § 823(f).
‘‘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 a registration should be revoked. Id.; see
also MacKay v. DEA, 664 F.3d 808, 816 (10th Cir.
2011); Volkman v. DEA, 567 F.3d 215, 222 (6th Cir.
2009); Hoxie v. DEA, 419 F.3d 477, 482 (6th Cir.
2005). Moreover, while I am required to consider
each of the factors, I ‘‘need not make explicit
findings as to each one.’’ MacKay, 664 F.3d at 816
(quoting Volkman, 567 F.3d at 222 (quoting Hoxie,
419 F.3d at 482)).
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]]>Agencies
[Federal Register Volume 81, Number 32 (Thursday, February 18, 2016)]
[Notices]
[Pages 8246-8247]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-03358]
-----------------------------------------------------------------------
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. DEA-392]
Importer of Controlled Substances Registration: Catalent Pharma
Solutions, LLC
ACTION: Notice of registration.
-----------------------------------------------------------------------
SUMMARY: Catalent Pharma Solutions, LLC applied to be registered as an
importer of a certain basic class of controlled substance. The Drug
Enforcement Administration (DEA) grants Catalent Pharma Solutions, LLC
registration as an importer of this controlled substance.
SUPPLEMENTARY INFORMATION: By notice dated August 21, 2015, and
published in the Federal Register on August 31, 2015, 80 FR 52510,
Catalent Pharma Solutions, LLC, 3031 Red Lion Road, Philadelphia,
Pennsylvania 19114 applied to be registered as an importer of a certain
basic class of controlled substance. No comments or objections were
submitted for this notice.
The DEA has considered the factors in 21 U.S.C. 823, 952(a) and
958(a) and determined that the registration of Catalent Pharma
Solutions, LLC to import the basic class of controlled substance is
consistent with the public interest and with United States obligations
under international treaties, conventions, or protocols in effect on
May 1, 1971. The DEA investigated the company's maintenance of
effective controls against diversion by inspecting and testing the
company's physical security systems, verifying the company's compliance
with state and local laws, and reviewing the company's background and
history.
Therefore, pursuant to 21 U.S.C. 952(a) and 958(a), and in
accordance with 21 CFR 1301.34, the above-named company is granted
registration as an importer of hydromorphone (9150), a basic class of
controlled substance listed in schedule II.
The company plans to import the above listed controlled substance
for a clinical trial study. Approval of permit applications will occur
only when the
[[Page 8247]]
registrant's business activity is consistent with what is authorized
under to 21 U.S.C. 952(a)(2). Authorization will not extend to the
import of FDA approved or non-approved finished dosage forms for
commercial sale.
Dated: February 10, 2016.
Louis J. Milione,
Deputy Assistant Administrator.
[FR Doc. 2016-03358 Filed 2-17-16; 8:45 am]
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