2022-21934. Bulk Manufacturer of Controlled Substances Application: Curia New York, Inc.  

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    AGENCY:

    Drug Enforcement Administration, Justice.

    ACTION:

    Notice of application.

    SUMMARY:

    Curia New York, Inc., 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 submit electronic comments on or objections to the issuance of the proposed registration on or before December 12, 2022. Such persons may also file a written request for a hearing on the application on or before December 12, 2022.

    ADDRESSES:

    The Drug Enforcement Administration requires that all comments be submitted electronically through the Federal eRulemaking Portal, which provides the ability to type short comments directly into the comment field on the web page or attach a file for lengthier comments. Please go to https://www.regulations.gov and follow the online instructions at that site for submitting comments. Upon submission of your comment, you will receive a Comment Tracking Number. Please be aware that submitted comments are not instantaneously available for public view on https://www.regulations.gov. If you have received a Comment Tracking Number, your comment has been successfully submitted and there is no need to resubmit the same comment.

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    SUPPLEMENTARY INFORMATION:

    In accordance with 21 CFR 1301.33(a), this is notice that on July 18, 2022, Curia New York, Inc., 33 Riverside Avenue, Rensselaer, New York 12144-2951, applied to be registered as a bulk manufacturer of the following basic class(es) of controlled substance(s):

    Controlled substanceDrug codeSchedule
    Marihuana7360I
    Tetrahydrocannabinols7370I
    Amphetamine1100II
    Lisdexamfetamine1205II
    Pentobarbital2270II
    4-Anilino-N-phenethyl-4-piperidine (ANPP)8333II
    Codeine9050II
    Oxycodone9143II
    Hydromorphone9150II
    Hydrocodone9193II
    Meperidine9230II
    Morphine9300II
    Fentanyl9801II

    The company plans to manufacture the above controlled substances as bulk active pharmaceutical ingredients (API) for use in product development and for distribution to its customers. In reference to drug 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.

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    Kristi O'Malley,

    Assistant Administrator.

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    [FR Doc. 2022-21934 Filed 10-7-22; 8:45 am]

    BILLING CODE 4410-09-P

Document Information

Published:
10/11/2022
Department:
Drug Enforcement Administration
Entry Type:
Notice
Action:
Notice of application.
Document Number:
2022-21934
Dates:
Registered bulk manufacturers of the affected basic class(es), and applicants therefore, may submit electronic comments on or objections to the issuance of the proposed registration on or before December 12, 2022. Such persons may also file a written request for a hearing on the application on or before December 12, 2022.
Pages:
61367-61367 (1 pages)
Docket Numbers:
Docket No. DEA-1081
PDF File:
2022-21934.pdf
Supporting Documents:
» Bulk Manufacturer Application - Curia New York (2022-21934) - DEA1081