[Federal Register Volume 88, Number 197 (Friday, October 13, 2023)]
[Notices]
[Pages 71021-71022]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[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 https://www.regulations.gov 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 https://www.regulations.gov. 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]
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