AGENCY:
Drug Enforcement Administration, Justice.
ACTION:
Notice of application.
SUMMARY:
Noramco Coventry LLC has applied to be registered as an importer 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 March 28, 2022. Such persons may also file a written request for a hearing on the application on or before March 28, 2022.
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 a hearing must be sent to: Drug Enforcement Administration, Attn: Administrator, 8701 Morrissette Drive, Springfield, Virginia 22152. All request for a 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.
SUPPLEMENTARY INFORMATION:
In accordance with 21 CFR 1301.34(a), this is notice that on September 29, 2021, Noramco Coventry LLC, 498 Washington Street, Coventry, Rhode Island 02816, applied to be registered as an importer of the following basic class(es) of controlled substance(s):
Controlled substance | Drug code | Schedule |
---|---|---|
Tetrahydrocannabinols | 7370 | I |
Methylphenidate | 1724 | II |
Oxycodone | 9143 | II |
Hydromorphone | 9150 | II |
Hydrocodone | 9193 | II |
Morphine | 9300 | II |
Opium, raw | 9600 | II |
Oxymorphone | 9652 | II |
Poppy Straw Concentrate | 9670 | II |
The company plans to import Opium, raw (9600), and Poppy Straw Concentrate (9670) in order to bulk manufacture-controlled substances in Active Pharmaceutical Ingredient (API) form. The company will use the imported narcotic raw materials in ancillary activities including process development and analytical studies. Noramco does not anticipate redistributing the imported narcotic raw materials domestically to other registered bulk manufacturers. The company plans to import the other listed controlled substances for internal reference standards use only. No other activity for these drug codes is authorized for this registration.
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 Food and Drug Administration-approved or non-approved finished dosage forms for commercial sale.
Matthew J. Strait,
Deputy Assistant Administrator.
[FR Doc. 2022-03902 Filed 2-23-22; 8:45 am]
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