[Federal Register Volume 89, Number 171 (Wednesday, September 4, 2024)]
[Notices]
[Pages 71927-71928]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-19795]


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DEPARTMENT OF JUSTICE

Drug Enforcement Administration

[Docket No. DEA-1408]


Bulk Manufacturer of Controlled Substances Application: Benuvia 
Operations, LLC

AGENCY: Drug Enforcement Administration, Justice.

ACTION: Notice of application.

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SUMMARY: Benuvia Operations, LLC 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 
November 4, 2024. Such persons may also file a written request for a 
hearing on the application on or before November 4, 2024.

ADDRESSES: The Drug Enforcement Administration requires that all

[[Page 71928]]

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 June 7, 2024, Benuvia Operations, LLC, 3950 North 
Mays Street, Round Rock, Texas 78665, 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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Ibogaine..........................            7260  I
Marihuana Extract.................            7350  I
Tetrahydrocannabinols.............            7370  I
Mescaline.........................            7381  I
3,4-Methylenedioxyamphetamine.....            7400  I
3,4-Methylenedioxymethamphetamine.            7405  I
5-Methoxy-N-N-dimethyltryptamine..            7431  I
Dimethyltryptamine................            7435  I
Psilocybin........................            7437  I
Psilocyn..........................            7438  I
5-Methoxy-N,N-                                7439  I
 diisopropyltryptamine.
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    The company plans to bulk manufacture the listed controlled 
substances for internal research and dosage formulation development. No 
other activities for these drug codes are authorized for this 
registration.

Marsha L. Ikner,
Acting Deputy Assistant Administrator.
[FR Doc. 2024-19795 Filed 9-3-24; 8:45 am]
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