[Federal Register Volume 83, Number 191 (Tuesday, October 2, 2018)]
[Notices]
[Page 49579]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-21351]


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DEPARTMENT OF JUSTICE

Drug Enforcement Administration

[Docket No. DEA-392]


Bulk Manufacturer of Controlled Substances Application: Cambrex 
Charles City

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 December 3, 2018.

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 June 
8, 2018, Cambrex Charles City, 1205 11th Street, Charles City, Iowa 
50616 applied to be registered as a bulk manufacturer of the basic 
classes of controlled substances:

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       Controlled substance             Drug code           Schedule
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Gamma Hydroxybutyric Acid.........  2010.............  I
Amphetamine.......................  1100.............  II
Lisdexamfetamine..................  1205.............  II
Methylphenidate...................  1724.............  II
4-Anilino-N-phenethyl-4-piperidine  8333.............  II
 (ANPP).
Phenylacetone.....................  8501.............  II
Cocaine...........................  9041.............  II
Codeine...........................  9050.............  II
Oxycodone.........................  9143.............  II
Hydromorphone.....................  9150.............  II
Hydrocodone.......................  9193.............  II
Morphine..........................  9300.............  II
Oripavine.........................  9330.............  II
Thebaine..........................  9333.............  II
Opium extracts....................  9610.............  II
Opium fluid extract...............  9620.............  II
Opium tincture....................  9630.............  II
Opium, powdered...................  9639.............  II
Oxymorphone.......................  9652.............  II
Noroxymorphone....................  9668.............  II
Fentanyl..........................  9801.............  II
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    The company plans to manufacture the listed controlled substances 
in bulk for conversion to other controlled substances and sale to its 
customers, for dosage form development, for clinical trials, and for 
use in stability qualification studies.

    Dated: September 20, 2018.
John J. Martin,
Assistant Administrator.
[FR Doc. 2018-21351 Filed 10-1-18; 8:45 am]
 BILLING CODE 4410-09-P