Importer of Controlled Substances Registration: United States Pharmacopeial Convention, 8902-8903 [2015-03481]

Download as PDF 8902 Federal Register / Vol. 80, No. 33 / Thursday, February 19, 2015 / Notices Dated: February 11, 2015. Joseph T. Rannazzisi, Deputy Assistant Administrator. Controlled substance Amphetamine (1100) .................... Methylphenidate (1724) ................ Codeine (9050) ............................. Oxycodone (9143) ........................ Diphenoxylate (9170) ................... Hydrocodone (9193) ..................... Meperidine (9230) ........................ Methadone (9250) ........................ Methadone intermediate (9254) ... Morphine (9300) ........................... Thebaine (9333) ........................... [FR Doc. 2015–03489 Filed 2–18–15; 8:45 am] BILLING CODE 4410–09–P DEPARTMENT OF JUSTICE Drug Enforcement Administration [Docket No. DEA–392] Bulk Manufacturer of Controlled Substances Application: Johnson Matthey, Inc. 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 April 20, 2015. 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, dispensers, importers, and exporters 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 part 0, appendix to subpart R. In accordance with 21 CFR 1301.33(a), this is notice that on September 3, 2014, Johnson Matthey, Inc., Pharmaceuticals Materials, 900 River Road, Conshohocken, Pennsylvania 19428, applied to be registered as a bulk manufacturer of the following basic classes of controlled substances: emcdonald on DSK67QTVN1PROD with NOTICES DATES: Controlled substance Gamma (2010). Hydroxybutyric VerDate Sep<11>2014 Schedule Acid 16:58 Feb 18, 2015 I Jkt 235001 Schedule 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. The Thebaine (9333) will be used to manufacture other controlled substances for sale in bulk to its customers. Dated: February 11, 2015. Joseph T. Rannazzisi, Deputy Assistant Administrator. BILLING CODE 4410–09–P DEPARTMENT OF JUSTICE Drug Enforcement Administration [Docket No. DEA–392] Importer of Controlled Substances Application: Mylan Technologies, Inc. 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 1301.34(a) on or before March 23, 2015. Such persons may also file a written request for a hearing on the application pursuant to 21 CFR 1301.43 on or before March 23, 2015. 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 DATES: PO 00000 Frm 00060 Fmt 4703 Sfmt 4703 Controlled substance Methylphenidate (1724) ................ Fentanyl (9801) ............................ [FR Doc. 2015–03491 Filed 2–18–15; 8:45 am] ACTION: manufacturers, distributors, dispensers, importers, and exporters 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 part 0, appendix to subpart R. In accordance with 21 CFR 1301.34(a), this is notice that on November 13, 2014, Mylan Technologies, Inc., 110 Lake Street, Saint Albans, Vermont 05478, applied to be registered as an importer of the following basic classes of controlled substances: Schedule II II The company plans to import the listed controlled substances in finished dosage form (FDF) from foreign sources for analytical testing and clinical trials in which the foreign FDF will be compared to the company’s own domestically-manufactured FDF. This analysis is required to allow the company to export domesticallymanufactured FDF to foreign markets. Dated: February 11, 2015. Joseph T. Rannazzisi, Deputy Assistant Administrator. [FR Doc. 2015–03493 Filed 2–18–15; 8:45 am] BILLING CODE 4410–09–P DEPARTMENT OF JUSTICE Drug Enforcement Administration [Docket No. DEA–392] Importer of Controlled Substances Registration: United States Pharmacopeial Convention ACTION: Notice of registration. United States Pharmacopeial Convention applied to be registered as an importer of certain basic classes of controlled substances. The DEA grants United States Pharmacopeial Convention registration as an importer of those controlled substances. SUPPLEMENTARY INFORMATION: By notice dated August 11, 2014, and published in the Federal Register on August 20, 2014, 79 FR 49341, United States Pharmacopeial Convention, 12601 Twinbrook Parkway, Rockville, Maryland 20852, applied to be registered as an importer of certain basic classes of controlled substances. No SUMMARY: E:\FR\FM\19FEN1.SGM 19FEN1 8903 Federal Register / Vol. 80, No. 33 / Thursday, February 19, 2015 / Notices comments or objections were submitted to 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 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. 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 the basic classes of controlled substances listed: Controlled substance Schedule Cathinone (1235) .......................... Methaqualone (2565) ................... Lysergic acid diethylamide (7315) Marihuana (7360) ......................... Tetrahydrocannabinols (7370) ..... 4-Methyl-2,5dimethoxyamphetamine (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) .................... I I I I I I I I I I I I II II II II II II II II II Controlled substance 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) ................... 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) .......................... Schedule II II II II II II II II II II II II II II II II II II II II II 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. Dated: February 11, 2015. Joseph T. Rannazzisi, Deputy Assistant Administrator. [FR Doc. 2015–03481 Filed 2–18–15; 8:45 am] BILLING CODE 4410–09–P DEPARTMENT OF JUSTICE Drug Enforcement Administration [Docket No. DEA–392] Importer of Controlled Substances Registration: Research Triangle Institute ACTION: Notice of registration. Research Triangle Institute applied to be registered as an importer of certain basic classes of controlled substances. The DEA grants Research Triangle Institute registration as an importer of the controlled substance. SUMMARY: By notice dated July 2, 2014, and published in the Federal Register on July 11, 2014, 79 FR 40160, Research Triangle Institute, Kenneth S. Rehder, Ph.D., Hermann Building East Institute Drive, P.O. Box 12194, Research Triangle Park, North Carolina 27709, applied to be registered as an importer of certain basic classes of controlled substances. No comments or objections were submitted for this notice. Comments and requests for hearings on applications to import narcotic raw material are not appropriate. 72 FR 3417 (January 25, 2007). 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 Research Triangle Institute 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. 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 the basic classes of controlled substances: SUPPLEMENTARY INFORMATION: emcdonald on DSK67QTVN1PROD with NOTICES Controlled substance Schedule AM-2201 (7201) ........................................................................................................................................................................................... AM-694 (7694) ............................................................................................................................................................................................. JWH-018 (7118) .......................................................................................................................................................................................... JWH-073 (7173) .......................................................................................................................................................................................... JWH-200 (7200) .......................................................................................................................................................................................... JWH-250 (6250) .......................................................................................................................................................................................... JWH-019 (7019) .......................................................................................................................................................................................... JWH-081(7081) ........................................................................................................................................................................................... SR-19 and RCS-4 (7104) ............................................................................................................................................................................ JWH-122 (7122) .......................................................................................................................................................................................... JWH-203 (7203) .......................................................................................................................................................................................... JWH-398 (7398) .......................................................................................................................................................................................... 1-(1-Phenylcyclohexyl)pyrrolidine (7458) .................................................................................................................................................... 1-[1-(2-Thienyl)cyclohexyl]piperidine (7470) ............................................................................................................................................... 1-[1-(2-Thienyl)cyclohexyl]pyrrolidine (7473) .............................................................................................................................................. 1-Methyl-4-phenyl-4-propionoxypiperidine (9661) ....................................................................................................................................... 1-(2-Phenylethyl)-4-phenyl-4-acetoxypiperidine (9663) .............................................................................................................................. VerDate Sep<11>2014 16:58 Feb 18, 2015 Jkt 235001 PO 00000 Frm 00061 Fmt 4703 Sfmt 4703 E:\FR\FM\19FEN1.SGM 19FEN1 I I I I I I I I I I I I I I I I I

Agencies

[Federal Register Volume 80, Number 33 (Thursday, February 19, 2015)]
[Notices]
[Pages 8902-8903]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2015-03481]


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DEPARTMENT OF JUSTICE

Drug Enforcement Administration

[Docket No. DEA-392]


Importer of Controlled Substances Registration: United States 
Pharmacopeial Convention

ACTION: Notice of registration.

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

SUMMARY: United States Pharmacopeial Convention applied to be 
registered as an importer of certain basic classes of controlled 
substances. The DEA grants United States Pharmacopeial Convention 
registration as an importer of those controlled substances.

SUPPLEMENTARY INFORMATION: By notice dated August 11, 2014, and 
published in the Federal Register on August 20, 2014, 79 FR 49341, 
United States Pharmacopeial Convention, 12601 Twinbrook Parkway, 
Rockville, Maryland 20852, applied to be registered as an importer of 
certain basic classes of controlled substances. No

[[Page 8903]]

comments or objections were submitted to 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 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. 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 the basic classes of controlled 
substances listed:

------------------------------------------------------------------------
            Controlled substance                       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
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
Noroxymorphone (9668)......................  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.

    Dated: February 11, 2015.
Joseph T. Rannazzisi,
Deputy Assistant Administrator.
[FR Doc. 2015-03481 Filed 2-18-15; 8:45 am]
BILLING CODE 4410-09-P

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