Importer of Controlled Substances; Notice of Registration; United States Pharmacopeial Convention, 54913-54914 [2013-21742]

Download as PDF 54913 Federal Register / Vol. 78, No. 173 / Friday, September 6, 2013 / Notices Commission may also be obtained by accessing its internet server (http:// www.usitc.gov). The public record for these investigations may be viewed on the Commission’s electronic docket (EDIS) at http://edis.usitc.gov. Authority: These investigations are being terminated under authority of title VII of the Tariff Act of 1930; this notice is published pursuant to section 201.10 of the Commission’s rules (19 CFR 201.10). By order of the Commission. Issued: September 3, 2013. Lisa R. Barton, Acting Secretary to the Commission. [FR Doc. 2013–21725 Filed 9–5–13; 8:45 am] BILLING CODE 7020–02–P DEPARTMENT OF JUSTICE Drug Enforcement Administration Importer of Controlled Substances; Notice of Application; Clinical Supplies Management, Inc. Pursuant to Title 21 Code of Federal Regulations 1301.34 (a), this is notice that on July 22, 2013, Clinical Supplies Management, Inc., 342 42nd Street South, Fargo, North Dakota 58103, made application by renewal to the Drug Enforcement Administration (DEA) to be registered as an importer of Sufentanil (9740), a basic class of controlled substance listed in schedule II. The company plans to import the listed controlled substance with the sole purpose of packaging, labeling, and distributing to customers which are qualified clinical sites, conducting FDAapproved clinical trials. Any bulk manufacturer who is presently, or is applying to be, registered with D listed in schedule II, which falls under the authority of section 1002(a)(2)(B) of the Act 21 U.S.C. 952 (a)(2)(B) may, in the circumstances set forth in 21 U.S.C. 958(i), file comments or objections to the issuance of the proposed registration and may, at the same time, file a written request for a hearing on such application pursuant to 21 CFR 1301.43, and in such form as prescribed by 21 CFR 1316.47. Any such written comments or objections should be addressed, in quintuplicate, to the Drug Enforcement Administration, Office of Diversion Control, Federal Register Representative (ODL), 8701 Morrissette Drive, Springfield, Virginia 22152; and must be filed no later than October 7, 2013. This procedure is to be conducted simultaneously with, and independent of, the procedures described in 21 CFR § 1301.34(b), (c), (d), (e), and (f). As noted in a previous notice published in the Federal Register on September 23, 1975, 40 FR 43745–46, all applicants for registration to import a basic class of any controlled substance in schedules I or II are, and will continue to be, required to demonstrate to the Deputy Assistant Administrator, Office of Diversion Control, Drug Enforcement Administration, that the requirements for such registration pursuant to 21 U.S.C. 958(a); 21 U.S.C. 823(a); and 21 CFR 1301.34(b), (c), (d), (e), and (f) are satisfied. Dated: August 29, 2013. Joseph T. Rannazzisi, Deputy Assistant Administrator, Office of Diversion Control, Drug Enforcement Administration. [FR Doc. 2013–21735 Filed 9–5–13; 8:45 am] BILLING CODE 4410–09–P DEPARTMENT OF JUSTICE Drug Enforcement Administration Importer of Controlled Substances; Notice of Registration; United States Pharmacopeial Convention By Notice dated May 22, 2013, and published in the Federal Register on May 30, 2013, 78 FR 32457, United States Pharmacopeial Convention, 12601 Twinbrook Parkway, Rockville, Maryland 20852, made application by renewal to the Drug Enforcement Administration (DEA) to be registered as an importer of the following basic classes of controlled substances: mstockstill on DSK4VPTVN1PROD with NOTICES Drug Schedule Cathinone (1235) ......................................................................................................................................................................................... Methaqualone (2565) .................................................................................................................................................................................. Lysergic acid diethylamide (7315) ............................................................................................................................................................... Marihuana (7360) ........................................................................................................................................................................................ Tetrahydrocannabinols (7370) ..................................................................................................................................................................... 4-Methyl-2,5-dimethoxyamphetamine (7395) .............................................................................................................................................. 3,4-Methylenedioxyamphetamine (7400) .................................................................................................................................................... Codeine-N-oxide (9053) .............................................................................................................................................................................. Difenoxin (9168) .......................................................................................................................................................................................... Heroin (9200) ............................................................................................................................................................................................... Morphine-N-oxide (9307) ............................................................................................................................................................................. Norlevorphanol (9634) ................................................................................................................................................................................. Amphetamine (1100) ................................................................................................................................................................................... Methamphetamine (1105) ........................................................................................................................................................................... Phenmetrazine (1631) ................................................................................................................................................................................. Methylphenidate (1724) ............................................................................................................................................................................... Amobarbital (2125) ...................................................................................................................................................................................... Pentobarbital (2270) .................................................................................................................................................................................... Secobarbital (2315) ..................................................................................................................................................................................... Glutethimide (2550) ..................................................................................................................................................................................... Phencyclidine (7471) ................................................................................................................................................................................... 4-Anilino-N-phenethyl-4-piperidine (8333) ................................................................................................................................................... Phenylacetone (8501) ................................................................................................................................................................................. Alphaprodine (9010) .................................................................................................................................................................................... Anileridine (9020) ........................................................................................................................................................................................ Cocaine (9041) ............................................................................................................................................................................................ Codeine (9050) ............................................................................................................................................................................................ Dihydrocodeine (9120) ................................................................................................................................................................................ Oxycodone (9143) ....................................................................................................................................................................................... Hydromorphone (9150) ............................................................................................................................................................................... Diphenoxylate (9170) .................................................................................................................................................................................. VerDate Mar<15>2010 18:05 Sep 05, 2013 Jkt 229001 PO 00000 Frm 00052 Fmt 4703 Sfmt 4703 E:\FR\FM\06SEN1.SGM 06SEN1 I I I I I I I I I I I I II II II II II II II II II II II II II II II II II II II 54914 Federal Register / Vol. 78, No. 173 / Friday, September 6, 2013 / Notices Drug Schedule Hydrocodone (9193) .................................................................................................................................................................................... Levomethorphan (9210) .............................................................................................................................................................................. Levorphanol (9220) ..................................................................................................................................................................................... Meperidine (9230) ....................................................................................................................................................................................... Methadone (9250) ....................................................................................................................................................................................... Dextropropoxyphene, bulk (non-dosage forms) (9273) .............................................................................................................................. Morphine (9300) .......................................................................................................................................................................................... Thebaine (9333) .......................................................................................................................................................................................... Oxymorphone (9652) ................................................................................................................................................................................... Alfentanil (9737) .......................................................................................................................................................................................... Sufentanil (9740) ......................................................................................................................................................................................... The company plans to import reference standards for sale to researchers and analytical labs. 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. 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 United States Pharmacopeial Convention 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. DEA has investigated United States Pharmacopeial Convention 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: August 29, 2013. Joseph T. Rannazzisi, Deputy Assistant Administrator, Office of Diversion Control, Drug Enforcement Administration. [FR Doc. 2013–21742 Filed 9–5–13; 8:45 am] BILLING CODE 4410–09–P DEPARTMENT OF JUSTICE Drug Enforcement Administration Importer of Controlled Substances; Notice of Registration; GE Healthcare By Notice dated June 7, 2013, and published in the Federal Register on June 18, 2013, 78 FR 36594, GE Healthcare, 3350 North Ridge Avenue, Arlington Heights, Illinois 60004–1412, made application by renewal to the Drug Enforcement Administration (DEA) to be registered as an importer of Cocaine (9041), a basic class of controlled substance listed in schedule II. The company plans to import small quantities of ioflupane, in the form of three separate analogues of Cocaine, to validate production and quality control systems, for a reference standard, and for producing material for a future investigational new drug (IND) submission. 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 GE Healthcare 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. DEA has investigated GE Healthcare 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 class of controlled substance listed. Dated: August 29, 2013. Joseph T. Rannazzisi, Deputy Assistant Administrator, Office of Diversion Control, Drug Enforcement Administration. [FR Doc. 2013–21743 Filed 9–5–13; 8:45 am] BILLING CODE 4410–09–P DEPARTMENT OF JUSTICE Drug Enforcement Administration Importer of Controlled Substances; Notice of Registration; Lipomed, Inc. By Notice dated June 7, 2013, and published in the Federal Register on June 18, 2013, 78 FR 36591, Lipomed, Inc., One Broadway, Cambridge, Massachusetts 02142, made application by renewal to the Drug Enforcement Administration (DEA) to be registered as an importer of the following basic classes of controlled substances: mstockstill on DSK4VPTVN1PROD with NOTICES Drug Schedule Cathinone (1235) ......................................................................................................................................................................................... Methcathinone (1237) .................................................................................................................................................................................. 4-Mephedrone (1248) .................................................................................................................................................................................. N-Ethylamphetamine (1475) ........................................................................................................................................................................ N,N-Dimethylamphetamine (1480) .............................................................................................................................................................. Fenethylline (1503) ...................................................................................................................................................................................... Aminorex (1585) .......................................................................................................................................................................................... 4-Methylaminorex (cis isomer) (1590) ......................................................................................................................................................... Gamma Hydroxybutyric Acid (2010) ........................................................................................................................................................... Methaqualone (2565) .................................................................................................................................................................................. VerDate Mar<15>2010 18:05 Sep 05, 2013 Jkt 229001 PO 00000 Frm 00053 Fmt 4703 II II II II II II II II II II II Sfmt 4703 E:\FR\FM\06SEN1.SGM 06SEN1 I I I I I I I I I I

Agencies

[Federal Register Volume 78, Number 173 (Friday, September 6, 2013)]
[Notices]
[Pages 54913-54914]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-21742]


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DEPARTMENT OF JUSTICE

Drug Enforcement Administration


Importer of Controlled Substances; Notice of Registration; United 
States Pharmacopeial Convention

    By Notice dated May 22, 2013, and published in the Federal Register 
on May 30, 2013, 78 FR 32457, United States Pharmacopeial Convention, 
12601 Twinbrook Parkway, Rockville, Maryland 20852, 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                               Schedule
------------------------------------------------------------------------
Cathinone (1235)............................  I
Methaqualone (2565).........................  I
Lysergic acid diethylamide (7315)...........  I
Marihuana (7360)............................  I
Tetrahydrocannabinols (7370)................  I
4-Methyl-2,5-dimethoxyamphetamine (7395)....  I
3,4-Methylenedioxyamphetamine (7400)........  I
Codeine-N-oxide (9053)......................  I
Difenoxin (9168)............................  I
Heroin (9200)...............................  I
Morphine-N-oxide (9307).....................  I
Norlevorphanol (9634).......................  I
Amphetamine (1100)..........................  II
Methamphetamine (1105)......................  II
Phenmetrazine (1631)........................  II
Methylphenidate (1724)......................  II
Amobarbital (2125)..........................  II
Pentobarbital (2270)........................  II
Secobarbital (2315).........................  II
Glutethimide (2550).........................  II
Phencyclidine (7471)........................  II
4-Anilino-N-phenethyl-4-piperidine (8333)...  II
Phenylacetone (8501)........................  II
Alphaprodine (9010).........................  II
Anileridine (9020)..........................  II
Cocaine (9041)..............................  II
Codeine (9050)..............................  II
Dihydrocodeine (9120).......................  II
Oxycodone (9143)............................  II
Hydromorphone (9150)........................  II
Diphenoxylate (9170)........................  II

[[Page 54914]]

 
Hydrocodone (9193)..........................  II
Levomethorphan (9210).......................  II
Levorphanol (9220)..........................  II
Meperidine (9230)...........................  II
Methadone (9250)............................  II
Dextropropoxyphene, bulk (non-dosage forms)   II
 (9273).
Morphine (9300).............................  II
Thebaine (9333).............................  II
Oxymorphone (9652)..........................  II
Alfentanil (9737)...........................  II
Sufentanil (9740)...........................  II
------------------------------------------------------------------------

    The company plans to import reference standards for sale to 
researchers and analytical labs.
    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.
    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 United States Pharmacopeial Convention 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. DEA has 
investigated United States Pharmacopeial Convention 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 Sec.  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: August 29, 2013.
Joseph T. Rannazzisi,
Deputy Assistant Administrator, Office of Diversion Control, Drug 
Enforcement Administration.
[FR Doc. 2013-21742 Filed 9-5-13; 8:45 am]
BILLING CODE 4410-09-P