Importer of Controlled Substances, Notice of Registration, Myoderm, 5498 [2013-01540]

Download as PDF 5498 Federal Register / Vol. 78, No. 17 / Friday, January 25, 2013 / Notices DEPARTMENT OF JUSTICE Drug Enforcement Administration Importer of Controlled Substances; Notice of Registration; R & D Systems, Inc. By Notice dated August 17, 2012, and published in the Federal Register on August 20, 2012, 77 FR 50162, R & D Systems, Inc., 614 McKinley Place NE., Minneapolis, Minnesota 55413, made application to the Drug Enforcement Administration (DEA) to be registered as an importer of the following basic classes of controlled substances: Drug Schedule mstockstill on DSK4VPTVN1PROD with 1-Pentyl-3-(1-naphthoyl)indole (7118). 5-(1,1-Dimethylheptyl)-2-[(1R,3S)3- hydroxycyclohexyl]- phenol (7297). Marihuana (7360) ......................... Tetrahydrocannabinols (7370) ..... 4-Bromo-2,5dimethoxyamphetamine (7391). 3,4Methylenedioxymethamphetamine (7405). Dimethyltryptamine (7435) ........... Amphetamine (1100) .................... Methylphenidate (1724) ................ Phencyclidine (7471) .................... Cocaine (9041) ............................. Oxycodone (9143) ........................ Thebaine (9333) ........................... Fentanyl (9801) ............................ I 18:39 Jan 24, 2013 I I I I [FR Doc. 2013–01554 Filed 1–24–13; 8:45 am] BILLING CODE 4410–09–P DEPARTMENT OF JUSTICE Drug Enforcement Administration Importer of Controlled Substances, Notice of Registration, Myoderm Drug I II II II II II II II Jkt 229001 Dated: January 15, 2013. Joseph T. Rannazzisi, Deputy Assistant Administrator, Office of Diversion Control, Drug Enforcement Administration. By Notice dated June 28, 2012, and published in the Federal Register on July 5, 2012, 77 FR 39741, Myoderm, 48 East Main Street, Norristown, Pennsylvania 19401, made application to the Drug Enforcement Administration (DEA) to be registered as an importer of the following basic classes of controlled substances: I The company plans to import the listed controlled substances in dosage form to distribute to researchers. In reference to drug codes 7360 and 7370, the company plans to import a synthetic cannabidiol and a synthetic Tetrahydrocannabinol. No other activity for this drug code is authorized for this registration. No comments or objections have been received. DEA has considered the factors in 21 U.S.C. 823(a) and 952(a), and determined that the registration of R & D Systems, Inc., to import 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, at this time. DEA has investigated R & D Systems, Inc., to ensure that the company’s registration is consistent with the public interest. The investigation has included inspection and testing of the company’s physical security systems, verification of the company’s compliance with state and local laws, and a review of the company’s background and history. Therefore, pursuant to 21 U.S.C. 952(a) and 958(a), and in accordance VerDate Mar<15>2010 with 21 CFR § 1301.34, the above named company is granted registration as an importer of the basic classes of controlled substances listed. Schedule Amphetamine (1100) .................... Lisdexamfetamine (1205) ............. Methylphenidate (1724) ................ Pentobarbital (2270) ..................... Nabilone (7379) ............................ Codeine (9050) ............................. Oxycodone (9143) ........................ Hydromorphone (9150) ................ Hydrocodone (9193) ..................... Levomethorphan (9210) ............... Meperidine (9230) ........................ Methadone (9250) ........................ Methadone intermediate (9254) ... Morphine (9300) ........................... Oxymorphone (9652) ................... Fentanyl (9801) ............................ II II II II II II II II II II II II II II II II The company plans to import the listed controlled substances in finished dosage form for clinical trials, and research. The import of the above listed basic classes of controlled substances is granted only for analytical testing and clinical trials. This authorization does not extend to the import of a finished FDA approved or non-approved dosage form for commercial distribution in the United States. No comments or objections have been received. DEA has considered the factors in 21 U.S.C. 823(a) and 952(a), and determined that the registration of Myoderm, to import 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, at this time. DEA PO 00000 Frm 00092 Fmt 4703 Sfmt 4703 has investigated Myoderm, to ensure that the company’s registration is consistent with the public interest. The investigation has included inspection and testing of the company’s physical security systems, verification of the company’s compliance with state and local laws, and a review of 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 the basic classes of controlled substances listed. Dated: January 15, 2013. Joseph T. Rannazzisi, Deputy Assistant Administrator, Office of Diversion Control, Drug Enforcement Administration. [FR Doc. 2013–01540 Filed 1–24–13; 8:45 am] BILLING CODE 4410–09–P DEPARTMENT OF JUSTICE Drug Enforcement Administration Importer of Controlled Substances; Notice of Registration; Chattem Chemicals, Inc. By Notice dated June 28, 2012, and published in the Federal Register on July 6, 2012, 77 FR 40086, Chattem Chemicals, Inc., 3801 St. Elmo Avenue, Chattanooga, Tennessee 37409, made application by renewal to the Drug Enforcement Administration (DEA) to be registered as an importer of the following basic classes of controlled substances: Drug Methamphetamine (1105) ............ 4-Anilino-N-phenethyl-4-piperidine (8333). Phenylacetone (8501) .................. Opium, raw (9600) ....................... Poppy Straw Concentrate (9670) Tapentadol (9780) ........................ Schedule II II II II II II The company plans to import the listed controlled substances to manufacture bulk controlled substances for sale to its customers. The company plans to import an intermediate form of Tapentadol (9780), to bulk manufacture Tapentadol for distribution to its customers. Comments and requests for hearing on applications to import narcotic raw material are not appropriate, 72 FR 3417(2007). Regarding all other basic classes of controlled substances, no comments or objections have been received. DEA has considered the factors in 21 U.S.C. 823(a) and 952(a), and determined that E:\FR\FM\25JAN1.SGM 25JAN1

Agencies

[Federal Register Volume 78, Number 17 (Friday, January 25, 2013)]
[Notices]
[Page 5498]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-01540]


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DEPARTMENT OF JUSTICE

Drug Enforcement Administration


Importer of Controlled Substances, Notice of Registration, 
Myoderm

    By Notice dated June 28, 2012, and published in the Federal 
Register on July 5, 2012, 77 FR 39741, Myoderm, 48 East Main Street, 
Norristown, Pennsylvania 19401, made application to the Drug 
Enforcement Administration (DEA) to be registered as an importer of the 
following basic classes of controlled substances:

------------------------------------------------------------------------
                    Drug                               Schedule
------------------------------------------------------------------------
Amphetamine (1100).........................  II
Lisdexamfetamine (1205)....................  II
Methylphenidate (1724).....................  II
Pentobarbital (2270).......................  II
Nabilone (7379)............................  II
Codeine (9050).............................  II
Oxycodone (9143)...........................  II
Hydromorphone (9150).......................  II
Hydrocodone (9193).........................  II
Levomethorphan (9210)......................  II
Meperidine (9230)..........................  II
Methadone (9250)...........................  II
Methadone intermediate (9254)..............  II
Morphine (9300)............................  II
Oxymorphone (9652).........................  II
Fentanyl (9801)............................  II
------------------------------------------------------------------------

    The company plans to import the listed controlled substances in 
finished dosage form for clinical trials, and research.
    The import of the above listed basic classes of controlled 
substances is granted only for analytical testing and clinical trials. 
This authorization does not extend to the import of a finished FDA 
approved or non-approved dosage form for commercial distribution in the 
United States.
    No comments or objections have been received. DEA has considered 
the factors in 21 U.S.C. 823(a) and 952(a), and determined that the 
registration of Myoderm, to import 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, at this time. DEA has investigated 
Myoderm, to ensure that the company's registration is consistent with 
the public interest. The investigation has included inspection and 
testing of the company's physical security systems, verification of the 
company's compliance with state and local laws, and a review of 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 the basic 
classes of controlled substances listed.

    Dated: January 15, 2013.
 Joseph T. Rannazzisi,
 Deputy Assistant Administrator, Office of Diversion Control, Drug 
Enforcement Administration.
[FR Doc. 2013-01540 Filed 1-24-13; 8:45 am]
BILLING CODE 4410-09-P