Bulk Manufacturer of Controlled Substances Application: Noramco, Inc.
Department of Justice Drug Enforcement Administration [Docket No. DEA-392] ACTION: Notice of application. DATES: Registered bulk manufacturers of the affected basic classes, and...
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 22, 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 October 30, 2018, Noramco, Inc., 500 Swedes Landing Road, Wilmington, Delaware 19801 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 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 synthetics. No other activities for these drug codes are authorized for this registration.