Importer of Controlled Substances Application: Noramco Inc.
Federal Register, Volume 83 Issue 239 (Thursday, December 13, 2018)
Federal Register Volume 83, Number 239 (Thursday, December 13, 2018)
Notices
Pages 64159-64160
From the Federal Register Online via the Government Publishing Office www.gpo.gov
FR Doc No: 2018-27037
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DEPARTMENT OF JUSTICE
Drug Enforcement Administration
Docket No. DEA-392
Importer 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 14, 2019. Such persons may also file a written request for a hearing on the application on or before January 14, 2019.
ADDRESSES: Written comments should be sent to: Drug Enforcement Administration, Attention: DEA Federal Register Representative/DPW, 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/OALJ, 8701 Morrissette Drive, Springfield, Virginia 22152; and (2) Drug Enforcement Administration, Attn: DEA Federal Register Representative/DPW, 8701 Morrissette Drive, Springfield, Virginia 22152.
Page 64160
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 August 14, 2018, Noramco Inc., 500 Swedes Landing Road, Wilmington, Delaware 19801-4417 applied to be registered as an importer of the following basic classes of controlled substances:
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Drug
Controlled substance code Schedule
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Marihuana.............................. 7360 I
Tetrahydrocannabinols.................. 7370 I
Nabilone............................... 7379 II
Phenylacetone.......................... 8501 II
Opium, raw............................. 9600 II
Poppy Straw Concentrate................ 9670 II
Tapentadol............................. 9780 II
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The company plans to import phenylacetone (8501), and poppy straw concentrate (9670) to bulk manufacture other controlled substances for distribution to its customers. In reference to drug codes 7360 (marihuana) and 7370 (THC), the company plans to import a synthetic cannabidiol and a synthetic tetrahydrocannabinol. No other activity for these drug codes is authorized for this registration. 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.
Dated: December 3, 2018.
John J. Martin,
Assistant Administrator.
FR Doc. 2018-27037 Filed 12-12-18; 8:45 am
BILLING CODE 4410-09-P
