Importer of Controlled Substances Registration: United States Pharmacopeial Convention, 75689-75690 [2015-30552]

Download as PDF 75689 Federal Register / Vol. 80, No. 232 / Thursday, December 3, 2015 / Notices comments on or objections to the issuance of the proposed registration in accordance with 21 CFR 1301.34(a) on or before January 4, 2016. Such persons may also file a written request for a hearing on the application pursuant to 21 CFR 1301.43 on or before January 4, 2016. Written comments should be sent to: Drug Enforcement Administration, Attention: DEA Federal Register Representative/OD/D, 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. ADDRESSES: The Attorney General has delegated her 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 1301.34(a), this is notice that on October 29, 2015, 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: SUPPLEMENTARY INFORMATION: Controlled substance Schedule Lhorne on DSK5TPTVN1PROD with NOTICES Methylphenidate (1724) ................ Fentanyl (9801) ............................ 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: November 27, 2015. Louis J. Milione, Deputy Assistant Administrator. DEPARTMENT OF JUSTICE DEPARTMENT OF JUSTICE Drug Enforcement Administration Drug Enforcement Administration [Docket No. DEA–392] [Docket No. DEA–392] Importer of Controlled Substances Registration: Fresenius Kabi USA, LLC ACTION: Fresenius Kabi USA, LLC applied to be registered as an importer of a certain basic class of controlled substance. The Drug Enforcement Administration (DEA) grants Fresenius Kabi USA, LLC registration as an importer of this controlled substance. SUMMARY: By notice dated September 16, 2015, and published in the Federal Register on September 23, 2015, 80 FR 57389 Fresenius Kabi USA, LLC, 3159 Staley Road, Grand Island, New York 14072 applied to be registered as an importer of a certain basic class of controlled substance. No comments or objections were submitted for this notice. The DEA has considered the factors in 21 U.S.C. 823, 952(a) and 958(a) and determined that the registration of Fresenius Kabi USA, LLC 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 the listed controlled substance for product development and preparation of stability batches. SUPPLEMENTARY INFORMATION: Dated: November 27, 2015. Louis J. Milione, Deputy Assistant Administrator. [FR Doc. 2015–30556 Filed 12–2–15; 8:45 am] [FR Doc. 2015–30555 Filed 12–2–15; 8:45 am] BILLING CODE 4410–09–P VerDate Sep<11>2014 15:11 Dec 02, 2015 ACTION: Notice of registration. BILLING CODE 4410–09–P Jkt 238001 PO 00000 Frm 00033 Fmt 4703 Sfmt 4703 Importer of Controlled Substances Registration: United States Pharmacopeial Convention Notice of registration. United States Pharmacopeial Convention applied to be registered as an importer of certain basic classes of controlled substances. The Drug Enforcement Administration (DEA) grants United States Pharmacopeial Convention registration as an importer of those controlled substances. SUPPLEMENTARY INFORMATION: By notice dated June 25, 2015, and published in the Federal Register on July 6, 2015, 80 FR 38466, 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 comments or objections were submitted for this notice. The 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: SUMMARY: Controlled substance 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) .................... E:\FR\FM\03DEN1.SGM 03DEN1 Schedule I I I I I I I I I I I I II 75690 Federal Register / Vol. 80, No. 232 / Thursday, December 3, 2015 / Notices Schedule Controlled substance Methamphetamine (1105) ............ Phenmetrazine (1631) .................. Methylphenidate (1724) ................ Amobarbital (2125) ....................... Pentobarbital (2270) ..................... Secobarbital (2315) ...................... Glutethimide (2550) ...................... Phencyclidine (7471) .................... 4-Anilino-N-phenethyl-4-piperidine (ANPP) (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) .......................... DEPARTMENT OF JUSTICE DEPARTMENT OF JUSTICE II II II II II II II II II Drug Enforcement Administration Drug Enforcement Administration [Docket No. DEA–392] [Docket No. DEA–392] Manufacturer of Controlled Substances Registration: Navinta, LLC ACTION: II II II II II II Lhorne on DSK5TPTVN1PROD with NOTICES 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. The company plans to import analytical reference standards for distribution to its customers for research and analytical purposes. Placement of these drug codes onto the company’s registration does not translate into automatic approval of subsequent permit applications to import controlled substances. Approval of permit applications will occur only when the registrant’s business activity is consistent with what is authorized under to 21 U.S.C 952(a)(2). Authorization will not extend to the import of FDA approved or nonapproved finished dosage forms for commercial sale. [FR Doc. 2015–30552 Filed 12–2–15; 8:45 am] BILLING CODE 4410–09–P Navinta, LLC applied to be registered as a manufacturer of certain basic classes of controlled substances. The Drug Enforcement Administration (DEA) grants Navinta, LLC registration as a manufacturer of those controlled substances. SUPPLEMENTARY INFORMATION: By notice dated June 25, 2015, and published in the Federal Register on July 6, 2015, 80 FR 38471, Navinta, LLC, 1499 Lower Ferry Road, Ewing, New Jersey 08618– 1414 applied to be registered as a manufacturer of certain basic classes of controlled substances. No comments or objections were submitted for this notice. The DEA has considered the factors in 21 U.S.C. 823(a) and determined that the registration of Navinta, LLC 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, 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. 823(a), and in accordance with 21 CFR 1301.33, the above-named company is granted registration as a bulk manufacturer of the following basic classes of controlled substances: SUMMARY: II II II II II II II II II II II II II II II Dated: November 23, 2015. Louis J. Milione, Deputy Assistant Administrator. Notice of registration. Controlled substance 4-Anilino-N-phenethyl-4-piperidine (ANPP) (8333). Fentanyl (9801) ............................ Schedule II II The company plans initially to manufacture API quantities of the listed controlled substances for validation purposes and FDA approval, then eventually upon FDA approval to produce commercial size batches for distribution to dosage form manufacturers. Importer of Controlled Substances Registration: Akorn, Inc. ACTION: Notice of registration. Akorn, Inc. applied to be registered as an importer of a certain basic class of controlled substance. The Drug Enforcement Administration (DEA) grants Akorn, Inc. registration as an importer of this controlled substance. SUMMARY: SUPPLEMENTARY INFORMATION: By notice dated September 1, 2015, and published in the Federal Register on September 9, 2015, 80 FR 54327 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 submitted for this notice. The 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 dosage form for distribution. Dated: November 23, 2015. Louis J. Milione, Deputy Assistant Administrator. [FR Doc. 2015–30559 Filed 12–2–15; 8:45 am] BILLING CODE 4410–09–P Dated: November 23, 2015. Louis J. Milione, Deputy Assistant Administrator. [FR Doc. 2015–30558 Filed 12–2–15; 8:45 am] BILLING CODE 4410–09–P VerDate Sep<11>2014 15:11 Dec 02, 2015 Jkt 238001 PO 00000 Frm 00034 Fmt 4703 Sfmt 9990 E:\FR\FM\03DEN1.SGM 03DEN1

Agencies

[Federal Register Volume 80, Number 232 (Thursday, December 3, 2015)]
[Notices]
[Pages 75689-75690]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-30552]


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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.

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

SUPPLEMENTARY INFORMATION: By notice dated June 25, 2015, and published 
in the Federal Register on July 6, 2015, 80 FR 38466, 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 comments or objections were submitted for 
this notice.
    The 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:

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

[[Page 75690]]

 
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 (ANPP)    II
 (8333).
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 the listed controlled substances in 
bulk powder form from foreign sources for the manufacture of analytical 
reference standards for sale to their customers.
    The company plans to import analytical reference standards for 
distribution to its customers for research and analytical purposes. 
Placement of these drug codes onto the company's registration does not 
translate into automatic approval of subsequent permit applications to 
import controlled substances. Approval of permit applications will 
occur only when the registrant's business activity is consistent with 
what is authorized under to 21 U.S.C 952(a)(2). Authorization will not 
extend to the import of FDA approved or non-approved finished dosage 
forms for commercial sale.

    Dated: November 23, 2015.
Louis J. Milione,
Deputy Assistant Administrator.
[FR Doc. 2015-30552 Filed 12-2-15; 8:45 am]
BILLING CODE 4410-09-P

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