Diversion Control Division, US Department of Justice, Drug Enforcement Administration

Manufacturers Notice of Application - 2019

[Federal Register Volume 84, Number 218 (Tuesday, November 12, 2019)]
[Notices]
[Page 61074]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-24543]


DEPARTMENT OF JUSTICE

Drug Enforcement Administration

[Docket No. DEA-539]

Bulk Manufacturer of Controlled Substances Application: Cambrex Charles City

ACTION: Notice of application.


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 13, 2020.

ADDRESSES: Written comments should be sent to: Drug Enforcement Administration, Attention: DEA Federal Register Representative/DPW, 8701 Morrissette Drive, Springfield, Virginia 22152.

SUPPLEMENTARY INFORMATION: In accordance with 21 CFR 1301.33(a), this is notice that on May 15, 2019, Cambrex Charles City, 1205 11th Street, Charles City, Iowa 50616-3466 applied to be registered as a bulk manufacturer of the following basic classes of controlled substances:

Controlled Substance Drug Code Schedule
Gamma Hydroxybutyric Acid 2010 I
Amphetamine 1100 II
Lisdexamfetamine 1205 II
Methylphenidate 1724 II
ANPP (4-Anilino-N-phenethyl-4-piperidine) 8333 II
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

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: October 30, 2019.

William T. McDermott,
Assistant Administrator.

[FR Doc. 2019-24543 Filed 11-8-19; 8:45 am]

BILLING CODE 4410-09-P

NOTICE: This is an unofficial version. An official version of this publication may be obtained directly from the Government Publishing Office (GPO).

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U.S. DEPARTMENT OF JUSTICE  •  DRUG ENFORCEMENT ADMINISTRATION
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