Bulk Manufacturer of Controlled Substances Application: Noramco Inc.

Federal Register, Volume 83 Issue 228 (Tuesday, November 27, 2018)

Federal Register Volume 83, Number 228 (Tuesday, November 27, 2018)

Notices

Page 60898

From the Federal Register Online via the Government Publishing Office www.gpo.gov

FR Doc No: 2018-25874

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DEPARTMENT OF JUSTICE

Drug Enforcement Administration

Docket No. DEA-392

Bulk Manufacturer of Controlled Substances Application: Noramco Inc.

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 on or before January 28, 2019.

ADDRESSES: Written comments should be sent to: Drug Enforcement Administration, Attention: DEA Federal Register Representative/DPW, 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 4, 2018, Noramco Inc., 1550 Olympic Dr. Athens, Georgia 30601 applied to be registered as a bulk manufacturer for the basic classes of controlled substances:

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Controlled substance Drug code Schedule

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Cathinone....................... 1235 I

Gamma Hydroxybutyric Acid....... 2010 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

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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: November 16, 2018.

John J. Martin,

Assistant Administrator.

FR Doc. 2018-25874 Filed 11-26-18; 8:45 am

BILLING CODE 4410-09-P

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