Notice2022-11256
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
May 25, 2022
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
<html>
<head>
<title>Federal Register, Volume 87 Issue 101 (Wednesday, May 25, 2022)</title>
</head>
<body><pre>
[Federal Register Volume 87, Number 101 (Wednesday, May 25, 2022)]
[Notices]
[Page 31902]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2022-11256]
-----------------------------------------------------------------------
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. DEA-1010]
Bulk Manufacturer of Controlled Substances Application: PCI
Synthesis
AGENCY: Drug Enforcement Administration, Justice.
ACTION: Notice of application.
-----------------------------------------------------------------------
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
July 25, 2022. Such persons may also file a written request for a
hearing on the application on or before July 25, 2022.
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 April 1, 2022, PCI Synthesis, 9 Opportunity Way,
Newburyport, Massachusetts 01952-0195, applied to be registered as a
bulk manufacturer of the following basic class(es) of controlled
substance(s):
------------------------------------------------------------------------
Drug
Controlled substance code Schedule
------------------------------------------------------------------------
Amphetamine............................. 1100 II
Methamphetamine......................... 1105 II
------------------------------------------------------------------------
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.
Kristi N. O'Malley,
Assistant Administrator.
[FR Doc. 2022-11256 Filed 5-24-22; 8:45 am]
BILLING CODE 4410-09-P
</pre></body>
</html>Indexed from Federal Register on May 25, 2022.
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.