Bulk Manufacturer of Controlled Substances Application: Noramco, Inc.

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Federal RegisterAug 29, 2017
82 Fed. Reg. 41055 (Aug. 29, 2017)

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 in accordance with 21 CFR 1301.33(a) on or before October 30, 2017.

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., 500 Swedes Landing Road, Wilmington, Delaware 19801-4417 applied to be registered as a bulk manufacturer of the following basic classes of controlled substances:

Controlled substance Drug code Schedule
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
Methylphenidate 1724 II
Nabilone 7379 II
Phenylacetone 8501 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 extracts 9610 II
Opium fluid extract 9620 II
Opium tincture 9630 II
Opium, powdered 9639 II
Opium, granulated 9640 II
Oxymorphone 9652 II
Noroxymorphone 9668 II
Tapentadol 9780 II

The company plans to manufacture the above-listed controlled substances in bulk for distribution to its customers. In reference to drug code 7360, the company plans to manufacture a synthetic version of cannabidiol in bulk for sale to its customers, who are final dosage form manufacturers. No other activity for this drug code is authorized for this registration.

Dated: August 21, 2017.

Demetra Ashley,

Acting Assistant Administrator.

[FR Doc. 2017-18315 Filed 8-28-17; 8:45 am]

BILLING CODE 4410-09-P