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

Manufacturers Notice of Application - 2018

[Federal Register Volume 83, Number 28 (Friday, February 9, 2018)]
[Notices]
[Page 5808]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-02645]


DEPARTMENT OF JUSTICE

Drug Enforcement Administration

[Docket No. DEA-392]

Bulk Manufacturer of Controlled Substances Application: Noramco, 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 April 10, 2018.

ADDRESSES: Written comments should be sent to: Drug Enforcement Administration, Attention: 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 1301.33(a), this is notice that on July 6, 2017, Noramco, Inc., 1440 Olympic Drive, Athens, Georgia 30601 applied to be registered as a bulk manufacturer for the basic classes of controlled substances:

Controlled Substance Drug Code Schedule
Cathinone 1235 I
Gamma Hydroxybutyric Acid 2010 I
Marihuana Extract 7350 I
Marihuana 7360 I
Tetrahydrocannabinols 7370 I
Codeine-N-oxide 9053 I
Dihydromorphine 9145 I
Hydromorphinol 9301 I
Morphine-N-oxide 9307 I
Amphetamine 1100 II
Lisdexamfetamine 1205 II
Methylphenidate 1724 II
Nabilone 7379 II
Codeine 9050 II
Dihydrocodeine 9120 II
Oxycodone 9143 II
Hydromorphone 9150 II
Hydrocodone 9193 II
Morphine 9300 II
Oripavine 9330 II
Thebaine 9333 II
Opium tincture 9630 II
Oxymorphone 9652 II
Noroxymorphone 9668 II
Alfentanil 9737 II
Sufentanil 9740 II
Carfentanil 9743 II
Tapentadol 9780 II
Fentanyl 9801 II

The company plans to manufacture bulk active pharmaceutical ingredients (APIs) and reference standards for distribution to their customers.

In reference to drug codes 7360 (marihuana) and 7370 (tetrahydrocannabinols), the company plans to bulk manufacture these drugs as synthetic. No other activities for these drug codes are authorized for this registration.

Dated: January 31, 2018.

Susan A. Gibson,
Deputy Assistant Administrator.

[FR Doc. 2018-02645 Filed 2-8-18; 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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