Notice2025-07280

Bulk Manufacturer of Controlled Substances Application: Pisgah Laboratories 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
April 28, 2025

Issuing agencies

Justice DepartmentDrug Enforcement Administration

Abstract

Pisgah Laboratories 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 80 (Monday, April 28, 2025)</title>
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[Federal Register Volume 90, Number 80 (Monday, April 28, 2025)]
[Notices]
[Pages 17620-17621]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2025-07280]


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DEPARTMENT OF JUSTICE

Drug Enforcement Administration

[Docket No. DEA-1534]


Bulk Manufacturer of Controlled Substances Application: Pisgah 
Laboratories Inc

AGENCY: Drug Enforcement Administration, Justice.

ACTION: Notice of application.

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SUMMARY: Pisgah Laboratories 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 
June 27, 2025. Such persons may also file a written request for a 
hearing on the application on or before June 27, 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 March 5, 2025, Pisgah Laboratories Inc, 3222 Old 
Hendersonville Highway, Pisgah Forest, North Carolina 28768, 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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4-Bromo-2,5-dimethoxyphenethylamine...         7392  I
Methylone (3,4-Methylenedioxy-N-               7540  I
 methylcathinone).
Amphetamine...........................         1100  II
Lisdexamfetamine......................         1205  II
Methylphenidate.......................         1724  II
Diphenoxylate.........................         9170  II
Meperidine............................         9230  II
Methadone.............................         9250  II
Tapentadol............................         9780  II
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[[Page 17621]]

    The company plans to bulk manufacture the above-listed controlled 
substances in bulk for internal research purposes and distribution to 
its customers. No other activities for these drug codes are authorized 
for this registration.

Matthew Strait,
Deputy Assistant Administrator.
[FR Doc. 2025-07280 Filed 4-25-25; 8:45 am]
BILLING CODE P


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Indexed from Federal Register on April 28, 2025.

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.