Importer of Controlled Substances Registration: Akorn, Inc., 75690 [2015-30559]

Download as PDF 75690 Federal Register / Vol. 80, No. 232 / Thursday, December 3, 2015 / Notices Schedule Controlled substance Methamphetamine (1105) ............ Phenmetrazine (1631) .................. Methylphenidate (1724) ................ Amobarbital (2125) ....................... Pentobarbital (2270) ..................... Secobarbital (2315) ...................... Glutethimide (2550) ...................... Phencyclidine (7471) .................... 4-Anilino-N-phenethyl-4-piperidine (ANPP) (8333). Phenylacetone (8501) .................. Alphaprodine (9010) ..................... Anileridine (9020) ......................... Cocaine (9041) ............................. Codeine (9050) ............................. Dihydrocodeine (9120) ................. Oxycodone (9143) ........................ Hydromorphone (9150) ................ Diphenoxylate (9170) ................... Hydrocodone (9193) ..................... Levomethorphan (9210) ............... Levorphanol (9220) ...................... Meperidine (9230) ........................ Methadone (9250) ........................ Dextropropoxyphene, bulk (nondosage forms) (9273). Morphine (9300) ........................... Thebaine (9333) ........................... Oxymorphone (9652) ................... Noroxymorphone (9668) .............. Alfentanil (9737) ........................... Sufentanil (9740) .......................... DEPARTMENT OF JUSTICE DEPARTMENT OF JUSTICE II II II II II II II II II Drug Enforcement Administration Drug Enforcement Administration [Docket No. DEA–392] [Docket No. DEA–392] Manufacturer of Controlled Substances Registration: Navinta, LLC ACTION: II II II II II II Lhorne on DSK5TPTVN1PROD with NOTICES The company plans to import the listed controlled substances in bulk powder form from foreign sources for the manufacture of analytical reference standards for sale to their customers. The company plans to import analytical reference standards for distribution to its customers for research and analytical purposes. Placement of these drug codes onto the company’s registration does not translate into automatic approval of subsequent permit applications to import controlled substances. Approval of permit applications will occur only when the 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. [FR Doc. 2015–30552 Filed 12–2–15; 8:45 am] BILLING CODE 4410–09–P Navinta, LLC applied to be registered as a manufacturer of certain basic classes of controlled substances. The Drug Enforcement Administration (DEA) grants Navinta, LLC registration as a manufacturer of those controlled substances. SUPPLEMENTARY INFORMATION: By notice dated June 25, 2015, and published in the Federal Register on July 6, 2015, 80 FR 38471, Navinta, LLC, 1499 Lower Ferry Road, Ewing, New Jersey 08618– 1414 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 Navinta, LLC 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: SUMMARY: II II II II II II II II II II II II II II II Dated: November 23, 2015. Louis J. Milione, Deputy Assistant Administrator. Notice of registration. Controlled substance 4-Anilino-N-phenethyl-4-piperidine (ANPP) (8333). Fentanyl (9801) ............................ Schedule II II The company plans initially to manufacture API quantities of the listed controlled substances for validation purposes and FDA approval, then eventually upon FDA approval to produce commercial size batches for distribution to dosage form manufacturers. Importer of Controlled Substances Registration: Akorn, Inc. ACTION: Notice of registration. 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. SUMMARY: 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 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

Agencies

[Federal Register Volume 80, Number 232 (Thursday, December 3, 2015)]
[Notices]
[Page 75690]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-30559]


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DEPARTMENT OF JUSTICE

Drug Enforcement Administration

[Docket No. DEA-392]


Importer of Controlled Substances Registration: Akorn, Inc.

ACTION: Notice of registration.

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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

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