80 FR 75690 - Importer of Controlled Substances Registration: Akorn, Inc.

DEPARTMENT OF JUSTICE
Drug Enforcement Administration

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

Page Range		75690-75690
FR Document		2015-30559

Akorn, Inc. applied to be registered as an importer of a certain basic class of controlled substance. The Drug Enforcement Administration (DEA) grants Akorn, Inc. 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 75690]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2015-30559]


-----------------------------------------------------------------------

DEPARTMENT OF JUSTICE

Drug Enforcement Administration

[Docket No. DEA-392]


Importer of Controlled Substances Registration: Akorn, Inc.

ACTION: Notice of registration.

-----------------------------------------------------------------------

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

SUPPLEMENTARY INFORMATION: 
    By notice dated September 1, 2015, and published in the Federal 
Register on September 9, 2015, 80 FR 54327 Akorn, Inc., 1222 W. Grand 
Avenue, Decatur, Illinois 62522 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 Akorn, Inc. 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 remifentanil in dosage form for 
distribution.

    Dated: November 23, 2015.
Louis J. Milione,
Deputy Assistant Administrator.
[FR Doc. 2015-30559 Filed 12-2-15; 8:45 am]
BILLING CODE 4410-09-P

75690 Federal Register / Vol. 80, No. 232 / Thursday, December 3, 2015 / Notices

Controlled substance Schedule DEPARTMENT OF JUSTICE DEPARTMENT OF JUSTICE

Methamphetamine (1105) ............ II Drug Enforcement Administration Drug Enforcement Administration
Phenmetrazine (1631) .................. II
[Docket No. DEA–392]
Methylphenidate (1724) ................ II [Docket No. DEA–392]
Amobarbital (2125) ....................... II Manufacturer of Controlled
Pentobarbital (2270) ..................... II Substances Registration: Navinta, LLC Importer of Controlled Substances
Secobarbital (2315) ...................... II Registration: Akorn, Inc.
Glutethimide (2550) ...................... II ACTION: Notice of registration.
Phencyclidine (7471) .................... II
SUMMARY: Navinta, LLC applied to be ACTION: Notice of registration.
4-Anilino-N-phenethyl-4-piperidine II
(ANPP) (8333). registered as a manufacturer of certain
Phenylacetone (8501) .................. II basic classes of controlled substances. SUMMARY: Akorn, Inc. applied to be
Alphaprodine (9010) ..................... II The Drug Enforcement Administration registered as an importer of a certain
Anileridine (9020) ......................... II (DEA) grants Navinta, LLC registration basic class of controlled substance. The
Cocaine (9041) ............................. II as a manufacturer of those controlled Drug Enforcement Administration
Codeine (9050) ............................. II substances. (DEA) grants Akorn, Inc. registration as
Dihydrocodeine (9120) ................. II SUPPLEMENTARY INFORMATION: By notice an importer of this controlled substance.
Oxycodone (9143) ........................ II dated June 25, 2015, and published in SUPPLEMENTARY INFORMATION:
Hydromorphone (9150) ................ II the Federal Register on July 6, 2015, 80
Diphenoxylate (9170) ................... II FR 38471, Navinta, LLC, 1499 Lower By notice dated September 1, 2015,
Hydrocodone (9193) ..................... II Ferry Road, Ewing, New Jersey 08618– and published in the Federal Register
Levomethorphan (9210) ............... II 1414 applied to be registered as a on September 9, 2015, 80 FR 54327
Levorphanol (9220) ...................... II manufacturer of certain basic classes of Akorn, Inc., 1222 W. Grand Avenue,
Meperidine (9230) ........................ II controlled substances. No comments or Decatur, Illinois 62522 applied to be
Methadone (9250) ........................ II objections were submitted for this registered as an importer of a certain
Dextropropoxyphene, bulk (non- II notice. basic class of controlled substance. No
dosage forms) (9273). The DEA has considered the factors in comments or objections were submitted
Morphine (9300) ........................... II 21 U.S.C. 823(a) and determined that for this notice.
Thebaine (9333) ........................... II the registration of Navinta, LLC to
Oxymorphone (9652) ................... II manufacture the basic classes of The DEA has considered the factors in
Noroxymorphone (9668) .............. II controlled substances is consistent with 21 U.S.C. 823, 952(a) and 958(a) and
Alfentanil (9737) ........................... II the public interest and with United determined that the registration of
Sufentanil (9740) .......................... II States obligations under international Akorn, Inc. to import the basic class of
treaties, conventions, or protocols in controlled substance is consistent with
The company plans to import the effect on May 1, 1971. The DEA the public interest and with United
listed controlled substances in bulk investigated the company’s maintenance States obligations under international
powder form from foreign sources for of effective controls against diversion by treaties, conventions, or protocols in
the manufacture of analytical reference inspecting and testing the company’s effect on May 1, 1971. The DEA
standards for sale to their customers. physical security systems, verifying the investigated the company’s maintenance
company’s compliance with state and of effective controls against diversion by
The company plans to import
local laws, and reviewing the company’s inspecting and testing the company’s
analytical reference standards for background and history.
distribution to its customers for research physical security systems, verifying the
Therefore, pursuant to 21 U.S.C. company’s compliance with state and
and analytical purposes. Placement of 823(a), and in accordance with 21 CFR
these drug codes onto the company’s local laws, and reviewing the company’s
1301.33, the above-named company is background and history.
registration does not translate into granted registration as a bulk
automatic approval of subsequent manufacturer of the following basic Therefore, pursuant to 21 U.S.C.
permit applications to import controlled classes of controlled substances: 952(a) and 958(a), and in accordance
substances. Approval of permit with 21 CFR 1301.34, the above-named
applications will occur only when the Controlled substance Schedule company is granted registration as an
registrant’s business activity is importer of remifentanil (9739), a basic
4-Anilino-N-phenethyl-4-piperidine II class of controlled substance listed in
consistent with what is authorized (ANPP) (8333).
under to 21 U.S.C 952(a)(2). Fentanyl (9801) ............................ II
schedule II.
Authorization will not extend to the The company plans to import
import of FDA approved or non- The company plans initially to remifentanil in dosage form for
approved finished dosage forms for manufacture API quantities of the listed distribution.
commercial sale. controlled substances for validation
Dated: November 23, 2015.
Dated: November 23, 2015. purposes and FDA approval, then
eventually upon FDA approval to Louis J. Milione,
Louis J. Milione, Deputy Assistant Administrator.
produce commercial size batches for
Deputy Assistant Administrator. distribution to dosage form [FR Doc. 2015–30559 Filed 12–2–15; 8:45 am]
Lhorne on DSK5TPTVN1PROD with NOTICES

[FR Doc. 2015–30552 Filed 12–2–15; 8:45 am] manufacturers. BILLING CODE 4410–09–P
BILLING CODE 4410–09–P Dated: November 23, 2015.
Louis J. Milione,
Deputy Assistant Administrator.
[FR Doc. 2015–30558 Filed 12–2–15; 8:45 am]
BILLING CODE 4410–09–P

VerDate Sep<11>2014 15:11 Dec 02, 2015 Jkt 238001 PO 00000 Frm 00034 Fmt 4703 Sfmt 9990 E:\FR\FM\03DEN1.SGM 03DEN1

Document Created: 2015-12-14 13:51:35
Document Modified: 2015-12-14 13:51:35

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 75690

80 FR 75690 - Importer of Controlled Substances Registration: Akorn, Inc.

DEPARTMENT OF JUSTICEDrug Enforcement Administration

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

DEPARTMENT OF JUSTICE
Drug Enforcement Administration