Importer of Controlled Substances Registration: Akorn, Inc., 52764 [2014-21063]

Download as PDF 52764 Federal Register / Vol. 79, No. 171 / Thursday, September 4, 2014 / Notices DEPARTMENT OF JUSTICE DEPARTMENT OF JUSTICE Drug Enforcement Administration Drug Enforcement Administration Controlled substance [Docket No. DEA–392] [Docket No. DEA–392] Bulk Manufacturer of Controlled Substances Application: Chattem Chemicals, Inc. Importer of Controlled Substances Registration: Akorn, Inc. ACTION: ACTION: Notice of registration. Akorn, Inc., applied to be registered as an importer of a certain basic class of controlled substance. The DEA grants Akorn, Inc., registration as an importer of this controlled substance. SUMMARY: By notice dated May 28, 2014, and published in the Federal Register on June 4, 2014, 79 FR 32317, 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 reviewed for this notice. The Drug Enforcement Administration (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 bulk for use in dosage form manufacturing. SUPPLEMENTARY INFORMATION: mstockstill on DSK4VPTVN1PROD with NOTICES [FR Doc. 2014–21063 Filed 9–3–14; 8:45 am] BILLING CODE 4410–09–P 18:14 Sep 03, 2014 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 in accordance with 21 CFR 1301.33(a) on or before November 3, 2014. ADDRESSES: Written comments should be sent to: Drug Enforcement Administration, Attention: DEA Federal Register Representative/ODW, 8701 Morrissette Drive, Springfield, Virginia 22152. Request for hearings should be sent to: Drug Enforcement Administration, Attention: Hearing Clerk/LJ, 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, and dispensers 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 pt. 0, subpt. R, App. In accordance with 21 CFR 1301.33(a), this is notice that on June 23, 2014, Chattem Chemicals, Inc., 3801 St. Elmo Avenue, Chattanooga, Tennessee 37409, applied to be registered as a bulk manufacturer of the following basic classes of controlled substances: DATES: Controlled substance Dated: August 27, 2014. Joseph T. Rannazzisi, Deputy Assistant Administrator. VerDate Mar<15>2010 Notice of application. Jkt 232001 Gamma Hydroxybutyric Acid (2010). 4-Methoxyamphetamine (7411) ... Dihydromorphine (9145) ............... Amphetamine (1100) .................... Lisdexamfetamine (1205) ............. Methylphenidate (1724) ................ Pentobarbital (2270) ..................... Codeine (9050) ............................. Dihydrocodeine (9120) ................. Oxycodone (9143) ........................ PO 00000 Frm 00140 Fmt 4703 Sfmt 4703 Schedule I I I II II II II II II II Hydromorphone (9150) ................ Hydrocodone (9193) ..................... Meperidine (9230) ........................ Meperidine intermediate-A (9232) Meperidine intermediate-B (9233) Meperidine intermediate-C (9234) Methadone (9250) ........................ Methadone intermediate (9254) ... Morphine (9300) ........................... Oripavine (9330) ........................... Thebaine (9333) ........................... Opium tincture (9630) .................. Opium, powdered (9639) ............. Opium, granulated (9640) ............ Oxymorphone (9652) ................... Noroxymorphone (9668) .............. Alfentanil (9737) ........................... Remifentanil (9739) ...................... Sufentanil (9740) .......................... Tapentadol (9780) ........................ Fentanyl (9801) ............................ 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 the listed controlled substances in bulk for distribution and sale to its customers. Regarding (9640) the company plans to manufacture another controlled substance for sale to its customers. Dated: August 27, 2014. Joseph T. Rannazzisi, Deputy Assistant Administrator. [FR Doc. 2014–21062 Filed 9–3–14; 8:45 am] BILLING CODE 4410–09–P DEPARTMENT OF JUSTICE Drug Enforcement Administration [Docket No. DEA–392] Manufacturer of Controlled Substances Registration: Organix, Inc. ACTION: Notice of registration. Organix, Inc. applied to be registered as a manufacturer of certain basic classes of narcotic and nonnarcotic controlled substances. The DEA grants Organix, Inc. registration as a manufacturer of those controlled substances. SUMMARY: By notice dated April 21, 2014, and published in the Federal Register on April 28, 2014, 79 FR 23376, Organix, Inc., 240 Salem Street, Woburn, Massachusetts 01801, applied to be registered as a manufacturer of certain basic classes of controlled substances. No comments or objections have been received. The Drug Enforcement Administration (DEA) has considered the factors in 21 U.S.C. 823(a) and determined that the registration of Organix, Inc. to manufacture the basic classes of controlled substances is SUPPLEMENTARY INFORMATION: E:\FR\FM\04SEN1.SGM 04SEN1

Agencies

[Federal Register Volume 79, Number 171 (Thursday, September 4, 2014)]
[Notices]
[Page 52764]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-21063]



[[Page 52764]]

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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 DEA grants Akorn, 
Inc., registration as an importer of this controlled substance.

SUPPLEMENTARY INFORMATION: By notice dated May 28, 2014, and published 
in the Federal Register on June 4, 2014, 79 FR 32317, 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 reviewed for this notice.
    The Drug Enforcement Administration (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 bulk for use in dosage 
form manufacturing.

    Dated: August 27, 2014.
Joseph T. Rannazzisi,
Deputy Assistant Administrator.
[FR Doc. 2014-21063 Filed 9-3-14; 8:45 am]
BILLING CODE 4410-09-P