Notice2023-19989
Bulk Manufacturer of Controlled Substances Application: PCI Synthesis
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
September 15, 2023
Issuing agencies
Justice DepartmentDrug Enforcement Administration
Abstract
PCI Synthesis 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 88 Issue 178 (Friday, September 15, 2023)</title>
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[Federal Register Volume 88, Number 178 (Friday, September 15, 2023)]
[Notices]
[Pages 63622-63623]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2023-19989]
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DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. DEA-1248]
Bulk Manufacturer of Controlled Substances Application: PCI
Synthesis
AGENCY: Drug Enforcement Administration, Justice.
ACTION: Notice of application.
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SUMMARY: PCI Synthesis 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 14, 2023. Such persons may also file a written request for a
hearing on the application on or before November 14, 2023.
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 30, 2023, PCI Synthesis, 9 Opportunity Way,
Newburyport, Massachusetts 01950-0195, applied to be registered as a
bulk manufacturer of the following basic class(es) of controlled
substance(s):
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Drug
Controlled substance code Schedule
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Amphetamine............................ 1100 II
[[Page 63623]]
Methamphetamine........................ 1105 II
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The company plans to develop manufacturing processes, conduct
analytical method validation and conduct bulk product stability
studies. No other activities for these drug codes are authorized for
this registration.
Claude Redd,
Acting Deputy Assistant Administrator.
[FR Doc. 2023-19989 Filed 9-14-23; 8:45 am]
BILLING CODE P
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</html>Indexed from Federal Register on September 15, 2023.
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