Notice2025-13454
Bulk Manufacturer of Controlled Substances Application: AMPAC Fine Chemicals 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
July 17, 2025
Issuing agencies
Justice DepartmentDrug Enforcement Administration
Abstract
AMPAC Fine Chemicals 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 135 (Thursday, July 17, 2025)</title>
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[Federal Register Volume 90, Number 135 (Thursday, July 17, 2025)]
[Notices]
[Page 33397]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2025-13454]
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DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. DEA-1565]
Bulk Manufacturer of Controlled Substances Application: AMPAC
Fine Chemicals LLC
AGENCY: Drug Enforcement Administration, Justice.
ACTION: Notice of application.
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SUMMARY: AMPAC Fine Chemicals 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
September 15, 2025. Such persons may also file a written request for a
hearing on the application on or before September 15, 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 May 22, 2025, AMPAC Fine Chemicals LLC, Highway 50
and Hazel Avenue, Rancho Cordova, California 95670, 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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Norlevorphanol.................. 9634 I
Amphetamine..................... 1100 II
Lisdexamfetamine................ 1205 II
Methylphenidate................. 1724 II
Levomethorphan.................. 9210 II
Levorphanol..................... 9220 II
Thebaine........................ 9333 II
Remifentanil.................... 9739 II
Tapentadol...................... 9780 II
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The company plans to bulk manufacture the listed controlled
substances for use as intermediates, impurity testing, and distribution
to its customers. No other activities for these drug codes are
authorized for this registration.
Justin Wood,
Acting Deputy Assistant Administrator.
[FR Doc. 2025-13454 Filed 7-16-25; 8:45 am]
BILLING CODE 4410-09-P
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</html>Indexed from Federal Register on July 17, 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.