Notice2023-22627
Bulk Manufacturer of Controlled Substances Application: Chattem Chemicals, Inc.
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
October 13, 2023
Issuing agencies
Justice DepartmentDrug Enforcement Administration
Abstract
Chattem Chemicals, Inc., 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 88 Issue 197 (Friday, October 13, 2023)</title>
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[Federal Register Volume 88, Number 197 (Friday, October 13, 2023)]
[Notices]
[Pages 71021-71022]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2023-22627]
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DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. DEA-1280]
Bulk Manufacturer of Controlled Substances Application: Chattem
Chemicals, Inc.
AGENCY: Drug Enforcement Administration, Justice.
ACTION: Notice of application.
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SUMMARY: Chattem Chemicals, Inc., 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
December 12, 2023. Such persons may also file a written request for a
hearing on the application on or before December 12, 2023.
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 July 14, 2023, Chattem Chemicals, Inc. 3801 Saint
Elmo Avenue, Chattanooga, Tennessee 37409, applied to be registered as
a bulk manufacturer of the following basic class(es) of controlled
substance(s):
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Controlled substance Drug code Schedule
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Gamma Hydroxybutyric Acid.......... 2010 I
Marihuana.......................... 7360 I
Tetrahydrocannabinols.............. 7370 I
4-Methoxyamphetamine............... 7411 I
Dihydromorphine.................... 9145 I
Amphetamine........................ 1100 II
Methamphetamine.................... 1105 II
Lisdexamfetamine................... 1205 II
Methylphenidate.................... 1724 II
Cocaine............................ 9041 II
Codeine............................ 9050 II
Dihydrocodeine..................... 9120 II
Oxycodone.......................... 9143 II
Hydromorphone...................... 9150 II
Ecgonine........................... 9180 II
Hydrocodone........................ 9193 II
Levorphanol........................ 9220 II
Methadone.......................... 9250 II
Methadone intermediate............. 9254 II
Morphine........................... 9300 II
Oripavine.......................... 9330 II
Thebaine........................... 9333 II
Oxymorphone........................ 9652 II
Noroxymorphone..................... 9668 II
Alfentanil......................... 9737 II
Remifentanil....................... 9739 II
Sufentanil......................... 9740 II
Tapentadol......................... 9780 II
[[Page 71022]]
Fentanyl........................... 9801 II
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The company plans to bulk manufacture the listed controlled
substances in bulk for distribution and sale to its customers. In
reference to drug codes 7360 (Marihuana) and 7370
(Tetrahydrocannabinols), the company plans to bulk manufacture these
drugs as a synthetic. No other activities for these drug codes are
authorized for this registration.
Approval of permit applications will occur only when the
registrant's business activity is consistent with what is authorized
under 21 U.S.C. 952(a)(2). Authorization will not extend to the
manufacturing of Food and Drug Administration-approved or non-approved
finished dosage forms for commercial sale.
Claude Redd,
Acting Deputy Assistant Administrator.
[FR Doc. 2023-22627 Filed 10-12-23; 8:45 am]
BILLING CODE P
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</html>Indexed from Federal Register on October 13, 2023.
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