84 FR 8114 - Bulk Manufacturer of Controlled Substances Application: Patheon Pharmaceuticals, Inc.

[Federal Register Volume 84, Number 44 (Wednesday, March 6, 2019)]
[Notices]
[Page 8114]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2019-04029]


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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 on or before April 5, 2019. Such 
persons may also file a written request for a hearing on the 
application on or before April 5, 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 1301.34(a), this is notice that on 
December 24, 2018, Patheon Pharmaceuticals, Inc., 2110 E Galbraith 
Road, Cincinnati, Ohio 45237, has re-applied to be registered as a bulk 
manufacturer of the Schedule I controlled substance Gamma 
Hydroxybutyric Acid (2010), a basic class of controlled substance.
    The Gamma 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: February 18, 2019.
 John J. Martin,
Assistant Administrator.
[FR Doc. 2019-04029 Filed 3-5-19; 8:45 am]
BILLING CODE 4410-09-P