80 FR 75689 - Importer of Controlled Substances Registration: Fresenius Kabi USA, LLC

DEPARTMENT OF JUSTICE
Drug Enforcement Administration

Federal Register Volume 80, Issue 232 (December 3, 2015)

Page Range		75689-75689
FR Document		2015-30556

Fresenius Kabi USA, LLC applied to be registered as an importer of a certain basic class of controlled substance. The Drug Enforcement Administration (DEA) grants Fresenius Kabi USA, LLC registration as an importer of this controlled substance.

Federal Register, Volume 80 Issue 232 (Thursday, December 3, 2015)

[Federal Register Volume 80, Number 232 (Thursday, December 3, 2015)]
[Notices]
[Page 75689]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2015-30556]


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DEPARTMENT OF JUSTICE

Drug Enforcement Administration

[Docket No. DEA-392]


Importer of Controlled Substances Registration: Fresenius Kabi 
USA, LLC

ACTION: Notice of registration.

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SUMMARY: Fresenius Kabi USA, LLC applied to be registered as an 
importer of a certain basic class of controlled substance. The Drug 
Enforcement Administration (DEA) grants Fresenius Kabi USA, LLC 
registration as an importer of this controlled substance.

SUPPLEMENTARY INFORMATION: By notice dated September 16, 2015, and 
published in the Federal Register on September 23, 2015, 80 FR 57389 
Fresenius Kabi USA, LLC, 3159 Staley Road, Grand Island, New York 14072 
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 Fresenius Kabi USA, 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 remifentanil (9739), a basic class of 
controlled substance listed in schedule II.
    The company plans to import the listed controlled substance for 
product development and preparation of stability batches.

    Dated: November 27, 2015.
Louis J. Milione,
Deputy Assistant Administrator.
[FR Doc. 2015-30556 Filed 12-2-15; 8:45 am]
BILLING CODE 4410-09-P

Federal Register / Vol. 80, No. 232 / Thursday, December 3, 2015 / Notices 75689

comments on or objections to the DEPARTMENT OF JUSTICE DEPARTMENT OF JUSTICE
issuance of the proposed registration in
accordance with 21 CFR 1301.34(a) on Drug Enforcement Administration Drug Enforcement Administration
or before January 4, 2016. Such persons [Docket No. DEA–392]
may also file a written request for a [Docket No. DEA–392]
hearing on the application pursuant to Importer of Controlled Substances
21 CFR 1301.43 on or before January 4, Importer of Controlled Substances Registration: United States
2016. Registration: Fresenius Kabi USA, LLC Pharmacopeial Convention
ADDRESSES: Written comments should
ACTION: Notice of registration. ACTION: Notice of registration.
be sent to: Drug Enforcement
Administration, Attention: DEA Federal SUMMARY: United States Pharmacopeial
Register Representative/OD/D, 8701 SUMMARY: Fresenius Kabi USA, LLC Convention applied to be registered as
Morrissette Drive, Springfield, Virginia applied to be registered as an importer an importer of certain basic classes of
22152. Request for hearings should be of a certain basic class of controlled controlled substances. The Drug
sent to: Drug Enforcement substance. The Drug Enforcement Enforcement Administration (DEA)
Administration, Attention: Hearing Administration (DEA) grants Fresenius grants United States Pharmacopeial
Clerk/LJ, 8701 Morrissette Drive, Kabi USA, LLC registration as an Convention registration as an importer
Springfield, Virginia 22152. importer of this controlled substance. of those controlled substances.
SUPPLEMENTARY INFORMATION: The SUPPLEMENTARY INFORMATION: By notice SUPPLEMENTARY INFORMATION: By notice
Attorney General has delegated her dated September 16, 2015, and dated June 25, 2015, and published in
authority under the Controlled published in the Federal Register on the Federal Register on July 6, 2015, 80
Substances Act to the Administrator of September 23, 2015, 80 FR 57389 FR 38466, United States Pharmacopeial
the Drug Enforcement Administration Fresenius Kabi USA, LLC, 3159 Staley Convention, 12601 Twinbrook Parkway,
(DEA), 28 CFR 0.100(b). Authority to Road, Grand Island, New York 14072 Rockville, Maryland 20852 applied to be
exercise all necessary functions with registered as an importer of certain basic
applied to be registered as an importer
respect to the promulgation and classes of controlled substances. No
of a certain basic class of controlled
implementation of 21 CFR part 1301, comments or objections were submitted
substance. No comments or objections
incident to the registration of for this notice.
were submitted for this notice. The DEA has considered the factors in
manufacturers, distributors, dispensers,
importers, and exporters of controlled The DEA has considered the factors in 21 U.S.C. 823, 952(a) and 958(a) and
substances (other than final orders in 21 U.S.C. 823, 952(a) and 958(a) and determined that the registration of
connection with suspension, denial, or determined that the registration of United States Pharmacopeial
revocation of registration) has been Fresenius Kabi USA, LLC to import the Convention to import the basic classes
redelegated to the Deputy Assistant basic class of controlled substance is of controlled substances is consistent
Administrator of the DEA Office of consistent with the public interest and with the public interest and with United
Diversion Control (‘‘Deputy Assistant with United States obligations under States obligations under international
Administrator’’) pursuant to section 7 of international treaties, conventions, or treaties, conventions, or protocols in
28 CFR part 0, appendix to subpart R. protocols in effect on May 1, 1971. The effect on May 1, 1971. The DEA
In accordance with 21 CFR DEA investigated the company’s investigated the company’s maintenance
1301.34(a), this is notice that on October maintenance of effective controls of effective controls against diversion by
29, 2015, Mylan Technologies, Inc., 110 against diversion by inspecting and inspecting and testing the company’s
Lake Street, Saint Albans, Vermont testing the company’s physical security physical security systems, verifying the
05478 applied to be registered as an systems, verifying the company’s company’s compliance with state and
importer of the following basic classes local laws, and reviewing the company’s
compliance with state and local laws,
of controlled substances: background and history.
and reviewing the company’s
Therefore, pursuant to 21 U.S.C.
background and history.
Controlled substance Schedule 952(a) and 958(a), and in accordance
Therefore, pursuant to 21 U.S.C. with 21 CFR 1301.34, the above-named
Methylphenidate (1724) ................ II 952(a) and 958(a), and in accordance company is granted registration as an
Fentanyl (9801) ............................ II with 21 CFR 1301.34, the above-named importer of the basic classes of
company is granted registration as an controlled substances:
The company plans to import the importer of remifentanil (9739), a basic
class of controlled substance listed in Controlled substance Schedule
listed controlled substances in finished
dosage form (FDF) from foreign sources schedule II.
Cathinone (1235) .......................... I
for analytical testing and clinical trials The company plans to import the Methaqualone (2565) ................... I
in which the foreign FDF will be listed controlled substance for product Lysergic acid diethylamide (7315) I
compared to the company’s own development and preparation of Marihuana (7360) ......................... I
domestically-manufactured FDF. This stability batches. Tetrahydrocannabinols (7370) ..... I
analysis is required to allow the 4-Methyl-2,5- I
Dated: November 27, 2015. dimethoxyamphetamine (7395).
company to export domestically-
Lhorne on DSK5TPTVN1PROD with NOTICES

Louis J. Milione, 3,4-Methylenedioxyamphetamine I
manufactured FDF to foreign markets.
(7400).
Deputy Assistant Administrator.
Dated: November 27, 2015. Codeine-N-oxide (9053) ............... I
[FR Doc. 2015–30556 Filed 12–2–15; 8:45 am] Difenoxin (9168) ........................... I
Louis J. Milione,
BILLING CODE 4410–09–P Heroin (9200) ............................... I
Deputy Assistant Administrator.
Morphine-N-oxide (9307) ............. I
[FR Doc. 2015–30555 Filed 12–2–15; 8:45 am] Norlevorphanol (9634) .................. I
BILLING CODE 4410–09–P Amphetamine (1100) .................... II

VerDate Sep<11>2014 15:11 Dec 02, 2015 Jkt 238001 PO 00000 Frm 00033 Fmt 4703 Sfmt 4703 E:\FR\FM\03DEN1.SGM 03DEN1

Document Created: 2015-12-14 13:51:47
Document Modified: 2015-12-14 13:51:47

Category		Regulatory Information
Collection		Federal Register
sudoc Class		AE 2.7: GS 4.107: AE 2.106:
Publisher		Office of the Federal Register, National Archives and Records Administration
Section		Notices
Action		Notice of registration.
FR Citation		80 FR 75689

80 FR 75689 - Importer of Controlled Substances Registration: Fresenius Kabi USA, LLC

DEPARTMENT OF JUSTICEDrug Enforcement Administration

Federal Register Volume 80, Issue 232 (December 3, 2015)

DEPARTMENT OF JUSTICE
Drug Enforcement Administration