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Importers Notice of Application - 2017

[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]


DEPARTMENT OF JUSTICE

Drug Enforcement Administration

[Docket No. DEA-392]

Importer of Controlled Substances Application: United States Pharmacopeial Convention

ACTION: Notice of application.


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 (ANPP) 8333 II
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 forms) 9273 II
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

 

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