Notice2022-17175
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
August 10, 2022
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 87 Issue 153 (Wednesday, August 10, 2022)</title>
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[Federal Register Volume 87, Number 153 (Wednesday, August 10, 2022)]
[Notices]
[Pages 48692-48693]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2022-17175]
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DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. DEA-1048]
Bulk Manufacturer of Controlled Substances Application: Cambrex
Charles City
AGENCY: Drug Enforcement Administration, Justice.
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 submit electronic comments on or
objections to the issuance of the proposed registration on or before
October 11, 2022. Such persons may also file a written request for a
hearing on the application on or before October 11, 2022.
ADDRESSES: The Drug Enforcement Administration requires that all
comments be submitted electronically through the Federal eRulemaking
Portal, which provides the ability to type short comments directly into
the comment field on the web page or attach a file for lengthier
comments. Please go to <a href="https://www.regulations.gov">https://www.regulations.gov</a> and follow the
online instructions at that site for submitting comments. Upon
submission of your comment, you will receive a Comment Tracking Number.
Please be aware that submitted comments are not instantaneously
available for public view on <a href="https://www.regulations.gov">https://www.regulations.gov</a>. If you have
received a Comment Tracking Number, your comment has been successfully
submitted and there is no need to resubmit the same comment.
SUPPLEMENTARY INFORMATION: In accordance with 21 CFR 1301.33(a), this
is notice that on May 9, 2022, 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- 8333 II
piperidine).
Phenylacetone.......................... 8501 II
Codeine................................ 9050 II
Oxycodone.............................. 9143 II
Hydromorphone.......................... 9150 II
Hydrocodone............................ 9193 II
Methadone.............................. 9250 II
Morphine............................... 9300 II
Oripavine.............................. 9330 II
[[Page 48693]]
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 sales to its
customers for dosage form development, clinical trials and use in
stability qualification studies.
In reference to drug codes 7360 (Marihuana), and 7370
(Tetrahydrocannabinols), the company plans to bulk manufacture these
drugs as synthetic. No other activities for these drug codes are
authorized for this registration.
Kristi O'Malley,
Assistant Administrator.
[FR Doc. 2022-17175 Filed 8-9-22; 8:45 am]
BILLING CODE P
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</html>Indexed from Federal Register on August 10, 2022.
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