86 FR 223 pg. 66589 - Bulk Manufacturer of Controlled Substances Application: Noramco
Type: NOTICEVolume: 86Number: 223Page: 66589
Page: 66589Docket number: [Docket No. DEA-925]
FR document: [FR Doc. 2021-25578 Filed 11-22-21; 8:45 am]
Agency: Justice Department
Sub Agency: Drug Enforcement Administration
Official PDF Version: PDF Version
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DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. DEA-925]
Bulk Manufacturer of Controlled Substances Application: Noramco
AGENCY:
Drug Enforcement Administration, Justice.
ACTION:
Notice of application.
SUMMARY:
Noramco, has applied to be registered as a bulk manufacturer of basic class(es) of controlled substance(s). Refer to Supplementary Information listed below for further drug information.
DATES:
Registered bulk manufacturers of the affected basic class(es), and applicants therefore, may file written comments on or objections to the issuance of the proposed registration on or before January 24, 2022. Such persons may also file a written request for a hearing on the application on or before January 24, 2022.
ADDRESSES:
Written comments should be sent to: Drug Enforcement Administration, Attention: DEA Federal Register Representative/DPW, 8701 Morrissette Drive, Springfield, Virginia 22152.
SUPPLEMENTARY INFORMATION:
In accordance with 21 CFR 1301.33(a), this is notice that on October 19, 2021, Noramco, 500 Swedes Landing Road, Wilmington, Delaware 19801-4417, applied to be registered as a bulk manufacturer of the following basic class(es) of controlled substance(s):
| Controlled substance | Drug code | Schedule |
|---|---|---|
| Marihuana | 7360 | I |
| Tetrahydrocannabinols | 7370 | I |
| Dihydromorphine | 9145 | I |
| Hydromorphinol | 9301 | 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 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 bulk manufacture the listed controlled substances as an Active Pharmaceutical Ingredient (API) for supply to its customers. In reference to dug 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.
Brian S. Besser,
Acting Assistant Administrator.
[FR Doc. 2021-25578 Filed 11-22-21; 8:45 am]
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