Notice2022-04064
Bulk Manufacturer of Controlled Substances Application: Cedarburg Pharmaceuticals
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
February 25, 2022
Issuing agencies
Justice DepartmentDrug Enforcement Administration
Abstract
Cedarburg Pharmaceuticals has applied to be registered as a bulk manufacturer of basic class(es) of controlled substance(s). Refer to Supplemental Information listed below for further drug information.
Full Text
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<title>Federal Register, Volume 87 Issue 38 (Friday, February 25, 2022)</title>
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[Federal Register Volume 87, Number 38 (Friday, February 25, 2022)]
[Notices]
[Page 10820]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2022-04064]
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DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. DEA-974]
Bulk Manufacturer of Controlled Substances Application: Cedarburg
Pharmaceuticals
AGENCY: Drug Enforcement Administration, Justice.
ACTION: Notice of application.
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SUMMARY: Cedarburg Pharmaceuticals has applied to be registered as a
bulk manufacturer of basic class(es) of controlled substance(s). Refer
to Supplemental 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 April 26, 2022.
Such persons may also file a written request for a hearing on the
application on or before April 26, 2022.
ADDRESSES: DEA 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="http://www.regulations.gov">http://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="http://www.regulations.gov">http://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 August 27, 2021, Cedarburg Pharmaceuticals, 870
Badger Circle, Grafton, Wisconsin 53024-0000, 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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Lysergic Acid Diethylamide............. 7315 I
Tetrahydrocannabinols.................. 7370 I
4-Bromo-2,5-Dimethoxyphenethylamine.... 7392 I
3,4-Methylenediocyamphetamine.......... 7400 I
3.4-Methylenedioxymethamphetamine...... 7405 I
5-Methoxy-N-N-dimethltryptamine........ 7431 I
Dimethyltryptamine..................... 7435 I
Psilocybin............................. 7437 I
Psilocyn............................... 7438 I
Methylphenidate........................ 1724 II
Nabilone............................... 7379 II
4-Anilino-N-Phenethyl-4-Piperidine 8333 II
(ANPP).
Fentanyl............................... 9801 II
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The company plans to bulk manufacture the listed controlled
substances for the internal use intermediates or for sale to its
customers. In reference to the drug code 7370 (Tetrahydrocannabinols),
the company plans to bulk manufacture as synthetic. No other activity
for this drug code is authorized for this registration.
Matthew J. Strait,
Deputy Assistant Administrator.
[FR Doc. 2022-04064 Filed 2-24-22; 8:45 am]
BILLING CODE 4410-09-P
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</html>Indexed from Federal Register on February 25, 2022.
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.