Notice2021-13252
Bulk Manufacturer of Controlled Substances Application: Cambrex Charles City
Primary source
Metadata and text below are from the Federal Register, a public-domain U.S. government work. Always verify the official published version before relying on it for any legal matter.
Published
June 24, 2021
Issuing agencies
Justice DepartmentDrug Enforcement Administration
Abstract
Cambrex Charles City has applied to be registered as a bulk manufacturer of basic class(es) of controlled substance(s). Refer to Supplementary Information listed below for further drug information.
Full Text
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<title>Federal Register, Volume 86 Issue 119 (Thursday, June 24, 2021)</title>
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[Federal Register Volume 86, Number 119 (Thursday, June 24, 2021)]
[Notices]
[Pages 33358-33359]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2021-13252]
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DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. DEA-857]
Bulk Manufacturer of Controlled Substances Application: Cambrex
Charles City
AGENCY: Drug Enforcement Administration, Justice.
[[Page 33359]]
ACTION: Notice of application.
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SUMMARY: Cambrex Charles City has applied to be registered as a bulk
manufacturer of basic class(es) of controlled substance(s). Refer to
Supplementary Information listed below for further drug information.
DATES: Registered bulk manufacturers of the affected basic class(es),
and applicants therefore, may file written comments on or objections to
the issuance of the proposed registration on or before August 23, 2021.
Such persons may also file a written request for a hearing on the
application on or before August 23, 2021.
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 6, 2021, Cambrex Charles City, 1205 11th Street,
Charles City, Iowa 50616-3466, applied to be registered as a bulk
manufacturer of the following basic class(es) of controlled
substance(s):
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Drug
Controlled substance code Schedule
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Gamma Hydroxybutyric Acid........................... 2010 I
Tetrahydrocannabinols............................... 7370 I
Amphetamine......................................... 1100 II
Lisdexamfetamine.................................... 1205 II
Methylphenidate..................................... 1724 II
ANPP (4-Anilino-N-phenethyl-4-piperidine)........... 8333 II
Phenylacetone....................................... 8501 II
Codeine............................................. 9050 II
Oxycodone........................................... 9143 II
Hydromorphone....................................... 9150 II
Hydrocodone......................................... 9193 II
Methadone........................................... 9250 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 above-listed controlled
substances in bulk for conversion to other controlled substances and
sales to its customers for dosage form development, clinical trials and
use in stability qualification studies. In reference to drug code 7370
(Tetrahydrocannabinols), the company plans to bulk manufacture this
drug as synthetic. No other activities for these drug codes are
authorized for this registration.
William T. McDermott,
Assistant Administrator.
[FR Doc. 2021-13252 Filed 6-23-21; 8:45 am]
BILLING CODE P
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</html>Indexed from Federal Register on June 24, 2021.
This is legal information, not legal advice. Laws vary by jurisdiction and change frequently. Always verify current law with official sources and consult a licensed attorney in your jurisdiction for advice on your specific situation.