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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</html>Indexed from Federal Register on April 28, 2025.
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