83 FR 5274 - Bulk Manufacturer of Controlled Substances Application: Patheon Pharmaceuticals, Inc.

DEPARTMENT OF JUSTICE
Drug Enforcement Administration

Federal Register Volume 83, Issue 25 (February 6, 2018)

[Federal Register Volume 83, Number 25 (Tuesday, February 6, 2018)]
[Notices]
[Page 5274]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2018-02345]


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DEPARTMENT OF JUSTICE

Drug Enforcement Administration

[Docket No. DEA-392]


Bulk Manufacturer of Controlled Substances Application: Patheon 
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 in accordance with 21 CFR 
1301.33(a) on or before April 9, 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 revocation of registration) has been redelegated 
to the Deputy Assistant Administrator of the DEA Office of Diversion 
Control (``Deputy 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 
December 11, 2017, Patheon Pharmaceuticals, Inc., 2110 E Galbraith 
Road, Cincinnati, OH 45237 applied for renewal of their registration as 
a bulk manufacturer of the Schedule I control substance Gamma 
Hydroxybutyric Acid (2010) the basic class of controlled substances.
    The Gama Hydroxybutyric Acid will be produced during the process of 
converting gamma-butyrolactone (GBL) into a new product for 
development. The company plans to manufacture the above listed 
controlled substance as Active Pharmaceutical Ingredient (API) that 
will be further synthesized into dosage forms of a new product.
    No other activities for this drug code are authorized for this 
registration.

    Dated: January 30, 2018.
Susan A. Gibson,
Deputy Assistant Administrator.
[FR Doc. 2018-02345 Filed 2-5-18; 8:45 am]
 BILLING CODE 4410-09-P