Notice2025-15279
Bulk Manufacturer of Controlled Substances Application: Benuvia Operations, LLC
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 12, 2025
Issuing agencies
Justice DepartmentDrug Enforcement Administration
Abstract
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.
Full Text
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<title>Federal Register, Volume 90 Issue 153 (Tuesday, August 12, 2025)</title>
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[Federal Register Volume 90, Number 153 (Tuesday, August 12, 2025)]
[Notices]
[Pages 38799-38800]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2025-15279]
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DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. DEA-1584]
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
October 14, 2025. Such persons may also file a written request for a
hearing on the application on or before October 14, 2025.
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 June 13, 2025, 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-diisopropyltryptamine. 7439 I
Amphetamine......................... 1100 II
Lisdexamfetamine.................... 1205 II
Remifentanil........................ 9739 II
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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.
Justin Wood,
Acting Deputy Assistant Administrator.
[FR Doc. 2025-15279 Filed 8-11-25; 8:45 am]
BILLING CODE P
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</html>Indexed from Federal Register on August 12, 2025.
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