83 FR 58596 - Bulk Manufacturer of Controlled Substances Application: Patheon API Manufacturing, Inc.

DEPARTMENT OF JUSTICE
Drug Enforcement Administration

Federal Register Volume 83, Issue 224 (November 20, 2018)

[Federal Register Volume 83, Number 224 (Tuesday, November 20, 2018)]
[Notices]
[Page 58596]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2018-25228]


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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 January 22, 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 26, 2018, Patheon API Manufacturing, Inc., 309 Delaware St., 
Greenville, South Carolina 29605 applied to be registered as a bulk 
manufacturer for the basic classes of controlled substances:

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         Controlled substance            Drug 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 an Active Pharmaceutical Ingredient (API) for supply to 
its customers.

    Dated: November 2, 2018.
John J. Martin,
Assistant Administrator.
[FR Doc. 2018-25228 Filed 11-19-18; 8:45 am]
 BILLING CODE 4410-09-P