83 FR 55205 - Bulk Manufacturer of Controlled Substances Application: Janssen Pharmaceuticals, Inc.

DEPARTMENT OF JUSTICE
Drug Enforcement Administration

Federal Register Volume 83, Issue 213 (November 2, 2018)

[Federal Register Volume 83, Number 213 (Friday, November 2, 2018)]
[Notices]
[Pages 55205-55206]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2018-24006]


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DEPARTMENT OF JUSTICE

Drug Enforcement Administration

[Docket No. DEA-392]


Bulk Manufacturer of Controlled Substances Application: Janssen 
Pharmaceuticals, Inc.

ACTION: Notice of application.

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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 January 2, 2019.

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

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 
September 13, 2018, Janssen Pharmaceuticals, Inc., Buildings 1-5 & 7-
14, 1440 Olympic Drive, Athens, Georgia 30601 applied to be registered 
as a bulk manufacturer of the following basic classes of controlled 
substances:

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                                           Drug
          Controlled substance             code          Schedule
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Methylphenidate.........................   1724  II
Hydromorphone...........................   9150  II
Hydrocodone.............................   9193  II
Oripavine...............................   9330  II
Thebaine................................   9333  II
Tapentadol..............................   9780  II
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[[Page 55206]]

    The company plans to manufacture the above-listed controlled 
substances in bulk for distribution to its customers.

    Dated: October 24, 2018.
John J. Martin,
Assistant Administrator.
[FR Doc. 2018-24006 Filed 11-1-18; 8:45 am]
 BILLING CODE 4410-09-P