Importer of Controlled Substances Application: United States Pharmacopeial Convention, 34694-34695 [2017-15693]

Download as PDF 34694 Federal Register / Vol. 82, No. 142 / Wednesday, July 26, 2017 / Notices Drug Enforcement Administration [Docket No. DEA–392] Importer of Controlled Substances Application: United States Pharmacopeial Convention ACTION: Written comments should be sent to: Drug Enforcement Administration, Attention: DEA Federal Register Representative/DRW, 8701 Morrissette Drive, Springfield, Virginia 22152. All requests for hearing must be sent to: Drug Enforcement Administration, Attn: Administrator, 8701 Morrissette Drive, Springfield, Virginia 22152. All request for hearing should also be sent to: (1) Drug Enforcement Administration, Attn: Hearing Clerk/LJ, 8701 Morrissette Drive, Springfield, Virginia 22152; and (2) Drug Enforcement Administration, Attn: DEA Federal Register Representative/DRW, 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 ADDRESSES: DEPARTMENT OF JUSTICE 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 August 25, 2017. Such persons may also file a written request for a hearing on the application pursuant to 21 CFR 1301.43 on or before August 25, 2017. DATES: (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 Assistant Administrator of the DEA Diversion Control Division (‘‘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 February 15, 2017, United States Pharmacopeial Convention, 12601 Twinbrook Parkway, Rockville, Maryland 20852 applied to be registered as an importer of the following basic classes of controlled substances: Controlled substance Drug code mstockstill on DSK30JT082PROD with NOTICES Cathinone ........................................................................................................................................................................ Methaqualone .................................................................................................................................................................. Lysergic acid diethylamide .............................................................................................................................................. Marihuana ........................................................................................................................................................................ Tetrahydrocannabinols .................................................................................................................................................... 4-Methyl-2,5-dimethoxyamphetamine ............................................................................................................................. 3,4-Methylenedioxyamphetamine .................................................................................................................................... 4-Methoxyamphetamine .................................................................................................................................................. Codeine-N-oxide .............................................................................................................................................................. Difenoxin .......................................................................................................................................................................... Heroin .............................................................................................................................................................................. Morphine-N-oxide ............................................................................................................................................................ Normethadone ................................................................................................................................................................. Methamphetamine ........................................................................................................................................................... Phenmetrazine ................................................................................................................................................................. Methylphenidate .............................................................................................................................................................. Amobarbital ...................................................................................................................................................................... Pentobarbital .................................................................................................................................................................... Secobarbital ..................................................................................................................................................................... Glutethimide ..................................................................................................................................................................... Phencyclidine ................................................................................................................................................................... 4-Anilino-N-phenethyl-4-piperidine (ANPP) ..................................................................................................................... Phenylacetone ................................................................................................................................................................. Alphaprodine .................................................................................................................................................................... Anileridine ........................................................................................................................................................................ Cocaine ............................................................................................................................................................................ Dihydrocodeine ................................................................................................................................................................ Diphenoxylate .................................................................................................................................................................. Levomethorphan .............................................................................................................................................................. Levorphanol ..................................................................................................................................................................... Meperidine ....................................................................................................................................................................... Dextropropoxyphene, bulk (non-dosage forms) .............................................................................................................. Thebaine .......................................................................................................................................................................... Noroxymorphone ............................................................................................................................................................. Alfentanil .......................................................................................................................................................................... Sufentanil ......................................................................................................................................................................... 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 VerDate Sep<11>2014 17:49 Jul 25, 2017 Jkt 241001 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 PO 00000 Frm 00072 Fmt 4703 Sfmt 4703 1235 2565 7315 7360 7370 7395 7400 7411 9053 9168 9200 9307 9635 1105 1631 1724 2125 2270 2315 2550 7471 8333 8501 9010 9020 9041 9120 9170 9210 9220 9230 9273 9333 9668 9737 9740 Schedule I 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 II II II II applications will occur only when the registrant’s business activity is consistent with what is authorized under 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. E:\FR\FM\26JYN1.SGM 26JYN1 34695 Federal Register / Vol. 82, No. 142 / Wednesday, July 26, 2017 / Notices Dated: July 20, 2017. Demetra Ashley, Acting Assistant Administrator. 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 September 25, 2017. ADDRESSES: Written comments should be sent to: Drug Enforcement Administration, Attention: DEA Federal Register Representative/DRW, 8701 Morrissette Drive, Springfield, Virginia 22152. [FR Doc. 2017–15693 Filed 7–25–17; 8:45 am] BILLING CODE 4410–09–P DEPARTMENT OF JUSTICE Drug Enforcement Administration [Docket No. DEA–392] ACTION: 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 SUPPLEMENTARY INFORMATION: Bulk Manufacturer of Controlled Substances Application: AMRI Rensselaer, Inc. Notice of application. Registered bulk manufacturers of the affected basic classes, and DATES: 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 Assistant Administrator of the DEA Diversion Control Division (‘‘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 March 30, 2017, AMRI Rensselaer, Inc., 33 Riverside Avenue, Rensselaer, New York 12144 applied to be registered as a bulk manufacturer of the following basic classes of controlled substances: Controlled substance Drug code Marihuana ........................................................................................................................................................................ Tetrahydrocannabinols .................................................................................................................................................... Amphetamine ................................................................................................................................................................... Lisdexamfetamine ............................................................................................................................................................ Methylphenidate .............................................................................................................................................................. Pentobarbital .................................................................................................................................................................... 4-Anilino-N-phenethyl-4-piperidine (ANPP) ..................................................................................................................... Codeine ........................................................................................................................................................................... Oxycodone ....................................................................................................................................................................... Hydromorphone ............................................................................................................................................................... Hydrocodone ................................................................................................................................................................... Meperidine ....................................................................................................................................................................... Morphine .......................................................................................................................................................................... Fentanyl ........................................................................................................................................................................... The company plans to manufacture bulk controlled substances for use in product development and for distribution to its customers. In reference to drug codes 7360 (marihuana) and 7370 (THC), the company plans to bulk manufacture these drugs as synthetics. No other activities for these drug codes are authorized for this registration. Dated: July 19, 2017. Demetra Ashley, Acting Assistant Administrator. [FR Doc. 2017–15688 Filed 7–25–17; 8:45 am] BILLING CODE 4410–09–P Drug Enforcement Administration [Docket No. DEA–392] Bulk Manufacturer of Controlled Substances Registration Notice of registration. Registrants listed below have applied for and been granted registration by the Drug Enforcement Administration (DEA) as bulk manufacturers of various classes of controlled substances. SUMMARY: Cedarburg Pharmaceuticals ...................................................................................... Siegfried USA, LLC ................................................................................................... Sigma Aldrich Research Biochemicals, Inc .............................................................. mstockstill on DSK30JT082PROD with NOTICES FR docket 82 FR 19083 ........................................... 82 FR 19084 ........................................... 82 FR 19085 ........................................... VerDate Sep<11>2014 17:49 Jul 25, 2017 Jkt 241001 I I II II II II II II II II II II II II The companies listed below applied to be registered as manufacturers of various basic classes of controlled substances. Information on previously published notices is listed in the table below. No comments or objections were submitted for these notices. Company The DEA has considered the factors in 21 U.S.C. 823(a) and determined that the registration of these registrants to manufacture the applicable basic classes of controlled substances is consistent with the public interest and with United States obligations under international 7360 7370 1100 1205 1724 2270 8333 9050 9143 9150 9193 9230 9300 9801 SUPPLEMENTARY INFORMATION: DEPARTMENT OF JUSTICE ACTION: Schedule treaties, conventions, or protocols in effect on May 1, 1971. The DEA investigated each of the company’s maintenance of effective controls against diversion by inspecting and testing each company’s physical security systems, verifying each PO 00000 Frm 00073 Fmt 4703 Sfmt 4703 Published April 25, 2017. April 25, 2017. April 25, 2017. company’s compliance with state and local laws, and reviewing each company’s background and history. Therefore, pursuant to 21 U.S.C. 823(a), and in accordance with 21 CFR 1301.33, the DEA has granted a E:\FR\FM\26JYN1.SGM 26JYN1

Agencies

[Federal Register Volume 82, Number 142 (Wednesday, July 26, 2017)]
[Notices]
[Pages 34694-34695]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-15693]



[[Page 34694]]

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DEPARTMENT OF JUSTICE

Drug Enforcement Administration

[Docket No. DEA-392]


Importer of Controlled Substances Application: United States 
Pharmacopeial Convention

ACTION: Notice of application.

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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 
1301.34(a) on or before August 25, 2017. Such persons may also file a 
written request for a hearing on the application pursuant to 21 CFR 
1301.43 on or before August 25, 2017.

ADDRESSES: Written comments should be sent to: Drug Enforcement 
Administration, Attention: DEA Federal Register Representative/DRW, 
8701 Morrissette Drive, Springfield, Virginia 22152. All requests for 
hearing must be sent to: Drug Enforcement Administration, Attn: 
Administrator, 8701 Morrissette Drive, Springfield, Virginia 22152. All 
request for hearing should also be sent to: (1) Drug Enforcement 
Administration, Attn: Hearing Clerk/LJ, 8701 Morrissette Drive, 
Springfield, Virginia 22152; and (2) Drug Enforcement Administration, 
Attn: DEA Federal Register Representative/DRW, 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 Assistant Administrator of the DEA Diversion Control Division 
(``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 
February 15, 2017, United States Pharmacopeial Convention, 12601 
Twinbrook Parkway, Rockville, Maryland 20852 applied to be registered 
as an importer of the following basic classes of controlled substances:

------------------------------------------------------------------------
        Controlled substance             Drug code         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
4-Methoxyamphetamine................            7411  I
Codeine-N-oxide.....................            9053  I
Difenoxin...........................            9168  I
Heroin..............................            9200  I
Morphine-N-oxide....................            9307  I
Normethadone........................            9635  I
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
 (ANPP).
Phenylacetone.......................            8501  II
Alphaprodine........................            9010  II
Anileridine.........................            9020  II
Cocaine.............................            9041  II
Dihydrocodeine......................            9120  II
Diphenoxylate.......................            9170  II
Levomethorphan......................            9210  II
Levorphanol.........................            9220  II
Meperidine..........................            9230  II
Dextropropoxyphene, bulk (non-dosage            9273  II
 forms).
Thebaine............................            9333  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 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.


[[Page 34695]]


    Dated: July 20, 2017.
Demetra Ashley,
Acting Assistant Administrator.
[FR Doc. 2017-15693 Filed 7-25-17; 8:45 am]
 BILLING CODE 4410-09-P