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

Agencies

• Drug Enforcement Administration
• Department of Justice

[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