Bulk Manufacturer of Controlled Substances Application: Apertus Pharmaceuticals, 32321-32322 [2014-12972]

Download as PDF 32321 Federal Register / Vol. 79, No. 107 / Wednesday, June 4, 2014 / Notices DEPARTMENT OF JUSTICE DEPARTMENT OF JUSTICE Drug Enforcement Administration Drug Enforcement Administration Dated: May 28, 2014. Joseph T. Rannazzisi, Deputy Assistant Administrator. [Docket No. DEA–392] [Docket No. DEA–392] [FR Doc. 2014–12956 Filed 6–3–14; 8:45 am] Bulk Manufacturer of Controlled Substances Application: Lin Zhi International, Inc Bulk Manufacturer of Controlled Substances Application: Boehringer Ingelheim Chemical, Inc. BILLING CODE 4410–09–P ACTION: ACTION: Notice of application. 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 August 4, 2014. ADDRESSES: Written comments should be sent to: Drug Enforcement Administration, Attention: DEA Federal Register Representative/ODW, 8701 Morrissette Drive, Springfield, Virginia 22152. DATES: 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 sec. 7(g) of 28 CFR part 0, subpart R, App. In accordance with 21 CFR 1301.33(a), this is notice that on March 27, 2014, Lin Zhi International, Inc., 670 Almanor Avenue, Sunnyvale, California 94085, applied to be registered as a bulk manufacturer of the following basic classes of controlled substances: SUPPLEMENTARY INFORMATION: Controlled substance tkelley on DSK3SPTVN1PROD with NOTICES II II II II II Dated: May 28, 2014. Joseph T. Rannazzisi, Deputy Assistant Administrator. [FR Doc. 2014–12967 Filed 6–3–14; 8:45 am] BILLING CODE 4410–09–P VerDate Mar<15>2010 16:05 Jun 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 August 4, 2014. ADDRESSES: Written comments should be sent to: Drug Enforcement Administration, Attention: DEA Federal Register Representative/ODW, 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 sec. 7(g) of 28 CFR part 0, subpart R, App. In accordance with 21 CFR 1301.33(a), this is notice that on May 2, 2014, Boehringer Ingelheim Chemical, Inc., 2820 N. Normandy Drive, Petersburg, Virginia 23805–9372, applied to be registered as a bulk manufacturer of the following basic classes of controlled substances: Jkt 232001 Controlled substance Amphetamine (1100) .................... Methylphenidate (1724) ................ Methadone (9250) ........................ Methadone Intermediate (9254) ... The company plans to manufacture the listed controlled substances as bulk reagents for use in drug abuse testing. Drug Enforcement Administration DATES: Schedule Cocaine (9041) ............................. Oxycodone (9143) ........................ Hydrocodone (9193) ..................... Methadone (9250) ........................ Morphine (9300) ........................... Notice of application. Schedule II II II II The company plans to manufacture the listed controlled substances in bulk for sale to its customers for formulation into finished pharmaceuticals. In reference to Methadone Intermediate (9254), the company plans to produce Methadone HCL active pharmaceutical ingredients (APIs) for sale to its customers. PO 00000 Frm 00109 Fmt 4703 Sfmt 4703 DEPARTMENT OF JUSTICE [Docket No. DEA–392] Bulk Manufacturer of Controlled Substances Application: Apertus Pharmaceuticals ACTION: Notice of application. 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 August 4, 2014. ADDRESSES: Written comments should be sent to: Drug Enforcement Administration, Attention: DEA Federal Register Representative/ODW, 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 sec. 7(g) of 28 CFR part 0, subpart R, App. In accordance with 21 CFR 1301.33(a), this is notice that on March 20, 2014, Apertus Pharmaceuticals, 331 Concort Drive, St. Louis, Missouri 63011, applied to be registered as a bulk manufacturer of the following basic classes of narcotic or nonnarcotic controlled substances: DATES: Controlled substance Alfentanil (9737) ........................... Remifentanil (9739) ...................... Sufentanil (9740) .......................... Fentanyl (9801) ............................ Schedule II II II II The company plans to manufacture small quantities of the listed controlled E:\FR\FM\04JNN1.SGM 04JNN1 32322 Federal Register / Vol. 79, No. 107 / Wednesday, June 4, 2014 / Notices substances to make reference standards for distribution to their customers. Dated: May 28, 2014. Joseph T. Rannazzisi, Deputy Assistant Administrator. [FR Doc. 2014–12972 Filed 6–3–14; 8:45 am] BILLING CODE 4410–09–P DEPARTMENT OF JUSTICE (‘‘Deputy Assistant Administrator’’) pursuant to sec. 7(g) of 28 CFR part 0, subpart R, App. In accordance with 21 CFR 1301.33(a), this is notice that on March 27, 2014, Austin Pharma, LLC., 811 Paloma Drive, Suite C, Round Rock, Texas 78665–2402, applied to be registered as a bulk manufacturer of the following basic classes of controlled substances: Drug Enforcement Administration Controlled substance Schedule [Docket No. DEA–392] Marihuana (7360) ......................... Tetrahydrocannabinols (7370) ..... Bulk Manufacturer of Controlled Substances Application: AUSTIN PHARMA, LLC ACTION: Notice of application. 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 August 4, 2014. ADDRESSES: Written comments should be to: Drug Enforcement Administration, Attention: DEA Federal Register Representative/ODW, 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 DATES: I I The company plans to manufacture bulk synthetic active pharmaceutical ingredients (APIs) for distribution and new product development to its customers. The company plans to bulk manufacture a synthetic tetrahydrocannabinol. In reference to drug code 7360, the company plans to manufacture a synthetic cannabinol in bulk for sale to its customers. The controlled substance will be further synthesized to bulk manufacture a synthetic tetrahydrocannabinol (7370). No other activity for this drug code is authorized for this registration. Dated: May 28, 2014. Joseph T. Rannazzisi, Deputy Assistant Administrator. [FR Doc. 2014–12944 Filed 6–3–14; 8:45 am] BILLING CODE 4410–09–P DEPARTMENT OF JUSTICE Drug Enforcement Administration [Docket No. DEA–392] Manufacturer of Controlled Substances Registration: Cayman Chemical Company ACTION: Cayman Chemical Company applied to be registered as a manufacturer of certain basic classes of narcotic or non-narcotic controlled substances. The DEA grants Cayman Chemical Company registration as a manufacturer of those controlled substances. SUMMARY: By notice dated December 31, 2013, and published in the Federal Register on January 10, 2014, 79 FR 1889, Cayman Chemical Company, 1180 East Ellsworth Road, Ann Arbor, Michigan 48108, applied to be registered as a manufacturer of certain basic classes of narcotic or non-narcotic controlled substances. The Drug Enforcement Administration (DEA) has considered the factors in 21 U.S.C. 823(a) and determined that the registration of Cayman Chemical Company 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, verified the company’s compliance with state and local laws, and reviewed 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 basic classes of narcotic or non-narcotic controlled substances listed: SUPPLEMENTARY INFORMATION: Notice of registration. tkelley on DSK3SPTVN1PROD with NOTICES Controlled substance Schedule Cathinone (1235) ......................................................................................................................................................................................... Methcathinone (1237) .................................................................................................................................................................................. 4-Methyl-N-methylcathinone (1248) ............................................................................................................................................................ N-Ethylamphetamine (1475) ........................................................................................................................................................................ N,N-Dimethylamphetamine (1480) .............................................................................................................................................................. Aminorex (1585) .......................................................................................................................................................................................... 4-Methylaminorex (cis isomer) (1590) ......................................................................................................................................................... Gamma Hydroxybutyric Acid (2010) ........................................................................................................................................................... JWH-250 (6250) .......................................................................................................................................................................................... SR-18 also known as RCS-8 (7008) ........................................................................................................................................................... XLR11 (7011) .............................................................................................................................................................................................. JWH-019 (7019) .......................................................................................................................................................................................... AKB48 (7048) .............................................................................................................................................................................................. JWH-081 (7081) .......................................................................................................................................................................................... SR-19 also known as RCS-4 (7104) ........................................................................................................................................................... 1-Pentyl-3-(1-naphthoyl)indole (7118) ......................................................................................................................................................... JWH-122 (7122) .......................................................................................................................................................................................... VerDate Mar<15>2010 16:05 Jun 03, 2014 Jkt 232001 PO 00000 Frm 00110 Fmt 4703 Sfmt 4703 E:\FR\FM\04JNN1.SGM 04JNN1 I I I I I I I I I I I I I I I I I

Agencies

[Federal Register Volume 79, Number 107 (Wednesday, June 4, 2014)]
[Notices]
[Pages 32321-32322]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-12972]


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

DEPARTMENT OF JUSTICE

Drug Enforcement Administration

[Docket No. DEA-392]


Bulk Manufacturer of Controlled Substances Application: Apertus 
Pharmaceuticals

ACTION: Notice of application.

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

DATES: 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 August 4, 2014.

ADDRESSES: Written comments should be sent to: Drug Enforcement 
Administration, Attention: DEA Federal Register Representative/ODW, 
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 sec. 7(g) of 28 CFR 
part 0, subpart R, App.
    In accordance with 21 CFR 1301.33(a), this is notice that on March 
20, 2014, Apertus Pharmaceuticals, 331 Concort Drive, St. Louis, 
Missouri 63011, applied to be registered as a bulk manufacturer of the 
following basic classes of narcotic or nonnarcotic controlled 
substances:

------------------------------------------------------------------------
            Controlled substance                       Schedule
------------------------------------------------------------------------
Alfentanil (9737)..........................  II
Remifentanil (9739)........................  II
Sufentanil (9740)..........................  II
Fentanyl (9801)............................  II
------------------------------------------------------------------------

    The company plans to manufacture small quantities of the listed 
controlled

[[Page 32322]]

substances to make reference standards for distribution to their 
customers.

    Dated: May 28, 2014.
Joseph T. Rannazzisi,
Deputy Assistant Administrator.
[FR Doc. 2014-12972 Filed 6-3-14; 8:45 am]
BILLING CODE 4410-09-P

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