83 FR 22516 - Bulk Manufacturer of Controlled Substances Application: Patheon API Manufacturing, Inc.

DEPARTMENT OF JUSTICE
Drug Enforcement Administration

Federal Register Volume 83, Issue 94 (May 15, 2018)

[Federal Register Volume 83, Number 94 (Tuesday, May 15, 2018)]
[Notices]
[Pages 22516-22517]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2018-10303]


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DEPARTMENT OF JUSTICE

Drug Enforcement Administration

[Docket No. DEA-392]


Bulk Manufacturer of Controlled Substances Application: Patheon 
API Manufacturing, 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 July 16, 2018.

ADDRESSES: Written comments should be sent to: Drug Enforcement 
Administration, Attention: DEA Federal Register Representative/DRW, 
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

[[Page 22517]]

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 April 
5, 2017, Patheon API Manufacturing, Inc., 309 Delaware Street, Building 
1106, Greenville, South Carolina 29605 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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Thebaine...............................    9333  II
Noroxymorphone.........................    9668  II
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    The company plans to manufacture the above-listed controlled 
substances as Active Pharmaceutical Ingredient (API) for supply to its 
customers.

    Dated: May 1, 2018.
 Susan A. Gibson,
Deputy Assistant Administrator.
[FR Doc. 2018-10303 Filed 5-14-18; 8:45 am]
 BILLING CODE 4410-09-P