AGENCY:
Drug Enforcement Administration, Justice.
ACTION:
Notice of application.
SUMMARY:
Noramco Inc has applied to be registered as a bulk manufacturer of basic class(es) of controlled substance(s). Refer to Supplemental 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 April 6, 2021. Such persons may also file a written request for a hearing on the application on or before April 6, 2021.
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 November 3, 2020, Noramco Inc, 1550 Olympic Drive, Athens Georgia 30601, applied to be registered as an bulk manufacturer of the following basic class(es) of controlled substance(s):
Controlled substance | Drug code | Schedule |
---|---|---|
Gamma Hydroxybutyric Acid | 2010 | I |
Marihuana Extract | 7350 | I |
Marihuana | 7360 | I |
Tetrahydrocannabinols | 7370 | I |
Codeine-N-oxide | 9053 | I |
Dihydromorphine | 9145 | I |
Hydromorphinol | 9301 | I |
Nabilone | 7379 | II |
Codeine | 9050 | II |
Dihydrocodeine | 9120 | II |
Oxycodone | 9143 | II |
Hydromorphone | 9150 | II |
Hydrocodone | 9193 | II |
Levorphanol | 9220 | II |
Morphine | 9300 | II |
The company plans to manufacture bulk active pharmaceutical ingredients (API) and reference standards for distribution to their customers.
In reference to drug codes 7350 (Marihuana Extract), 7360 (Marihuana), and 7370 (Tetrahydrocannabinols), the company plans to bulk manufacture these drugs as synthetics. No other activities for these drugs are authorized for this registration.
William T. McDermott,
Assistant Administrator.
[FR Doc. 2021-02454 Filed 2-4-21; 8:45 am]
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