[Federal Register Volume 88, Number 178 (Friday, September 15, 2023)]
[Notices]
[Pages 63622-63623]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[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 https://www.regulations.gov 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 https://www.regulations.gov. 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