Diversion Control Division, US Department of Justice, Drug Enforcement Administration

Importers Notice of Application - 2018

[Federal Register Volume 83, Number 129 (Thursday, July 5, 2018)]
[Notices]
[Page 31421]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-14396]


DEPARTMENT OF JUSTICE

Drug Enforcement Administration

[Docket No. DEA-392]

Importer of Controlled Substances Application: S & B Pharma, Inc.

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 on or before August 6, 2018. Such persons may also file a written request for a hearing on the application on or before August 6, 2018.

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 requests 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 June 6, 2018, S & B Pharma, Inc. DBA NORAC Pharma, 405 S Motor Avenue, Azusa, California 91702 applied to be registered as an importer of the following basic classes of controlled substances:

Controlled Substance Drug Code Schedule
4-Anilino-N-phenethyl-4-piperidine (ANPP) 8333 II
Tapentadol 9780 II

The company plans to import the controlled substances in bulk for the manufacture of other controlled substances for its customers. Tapentadol (9780) will be imported in Intermediate form to bulk manufacture Tapentadol for distribution to its customers. No other activity for these drug codes will be allowed.

Dated: June 26, 2018.

John J. Martin,
Assistant Administrator.

[FR Doc. 2018-14396 Filed 7-3-18; 8:45 am]

BILLING CODE 4410-09-P

NOTICE: This is an unofficial version. An official version of this publication may be obtained directly from the Government Publishing Office (GPO).

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U.S. DEPARTMENT OF JUSTICE  •  DRUG ENFORCEMENT ADMINISTRATION
Diversion Control Division  •  8701 Morrissette Drive  •  Springfield, VA 22152  •  1-800-882-9539

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