[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