2019-04030. Bulk Manufacturer of Controlled Substances Application: S&B Pharma Inc.  

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    ACTION:

    Notice of application.

    DATES:

    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 May 6, 2019.

    ADDRESSES:

    Written comments should be sent to: Drug Enforcement Administration, Attention: DEA Federal Register Representative/DPW, 8701 Morrissette Drive, Springfield, Virginia 22152.

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    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 February 28, 2017, S&B Pharma Inc., 405 South Motor Avenue, Azusa, California 91702-3232 applied to be registered as a bulk manufacturer of the following basic classes of controlled substances:

    Controlled substanceDrug codeSchedule
    Marihuana7360I
    Tetrahydrocannabinols7370I
    Amphetamine1100II
    Methamphetamine1105II
    Lisdexamfetamine1205II
    Methylphenidate1724II
    Pentobarbital2270II
    4-Anilino-N-phenethyl-4-piperidine (ANPP)8333II
    Tapentadol9780II
    Fentanyl9801II

    The company plans to manufacture the listed controlled substances in bulk for use in product development and for commercial sales to its customers. In reference to drug codes 7360 (marihuana) and 7370 (THC), the company plans to bulk manufacture both as synthetic substances. No other activity for these drug codes is authorized for this registration.

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    Dated: February 18, 2019.

    John J. Martin,

    Assistant Administrator.

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    [FR Doc. 2019-04030 Filed 3-5-19; 8:45 am]

    BILLING CODE 4410-09-P

Document Information

Published:
03/06/2019
Department:
Justice Department
Agency:
Drug Enforcement Administration
EntryType:
Notice
Action:
Notice of application.
Document Number:
2019-04030
Dates:
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 May 6, 2019.
Pages:
8116-8116 (1 pages)
Docket Numbers:
Docket No. DEA-392
SectionNoes:
PDF File:
2019-04030.pdf