Bulk Manufacturer of Controlled Substances Application: Eli-Elsohly Laboratories

Federal Register, Volume 83 Issue 239 (Thursday, December 13, 2018)

Federal Register Volume 83, Number 239 (Thursday, December 13, 2018)

Notices

Page 64159

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

FR Doc No: 2018-27029

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DEPARTMENT OF JUSTICE

Drug Enforcement Administration

Docket No. DEA-392

Bulk Manufacturer of Controlled Substances Application: Eli-

Elsohly Laboratories

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 February 11, 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 November 22, 2017, Eli-Elsohly Laboratories, Mahmoud A. Elsohly Ph.D., 5 Industrial Park Drive, Oxford, Mississippi 38655 applied to be registered as a bulk manufacturer of the following basic classes of controlled substances:

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Drug

Controlled substance code Schedule

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Marihuana Extract...................... 7350 I

Marihuana.............................. 7360 I

Tetrahydrocannabinols.................. 7370 I

Dihydromorphine........................ 9145 I

Amphetamine............................ 1100 II

Methamphetamine........................ 1105 II

Cocaine................................ 9041 II

Codeine................................ 9050 II

Dihydrocodeine......................... 9120 II

Oxycodone.............................. 9143 II

Hydromorphone.......................... 9150 II

Ecgonine............................... 9180 II

Hydrocodone............................ 9193 II

Morphine............................... 9300 II

Thebaine............................... 9333 II

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The company plans to manufacture the listed controlled substances for product development and reference standards. In reference to drug codes 7360 (marihuana) and 7370 (THC), the company plans to isolate these controlled substances from procured 7350 (marihuana extract). In reference to drug code 7360 (marihuana), no cultivation activities are authorized for this registration. No other activities for these drug codes are authorized for this registration.

Dated: December 3, 2018.

John J. Martin,

Assistant Administrator.

FR Doc. 2018-27029 Filed 12-12-18; 8:45 am

BILLING CODE 4410-09-P

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