Notice2022-26913
Bulk Manufacturer of Controlled Substances Application: Sterling Pharma USA, 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
December 12, 2022
Issuing agencies
Justice DepartmentDrug Enforcement Administration
Abstract
Sterling Pharma USA, 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
<html>
<head>
<title>Federal Register, Volume 87 Issue 237 (Monday, December 12, 2022)</title>
</head>
<body><pre>
[Federal Register Volume 87, Number 237 (Monday, December 12, 2022)]
[Notices]
[Pages 76083-76084]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2022-26913]
=======================================================================
-----------------------------------------------------------------------
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. DEA-1112]
Bulk Manufacturer of Controlled Substances Application: Sterling
Pharma USA, LLC
AGENCY: Drug Enforcement Administration, Justice.
ACTION: Notice of application.
-----------------------------------------------------------------------
SUMMARY: Sterling Pharma USA, 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
February 10, 2023. Such persons may also file a written request for a
hearing on the application on or before February 10, 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
[[Page 76084]]
<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 October 7, 2022, Sterling Pharma USA, LLC, 1001
Sheldon Drive, Suite 101, Cary, North Carolina 27513-2078, applied to
be registered as a bulk manufacturer of the following basic class(es)
of controlled substance(s):
------------------------------------------------------------------------
Drug
Controlled substance code Schedule
------------------------------------------------------------------------
5-Methoxy-N-N-dimethyltryptamine........ 7431 I
Psilocybin.............................. 7437 I
Psilocyn................................ 7438 I
------------------------------------------------------------------------
The company plans to manufacture the above-listed controlled
substances as clinical trials. No other activities for these drug codes
are authorized for this registration.
Matthew Strait,
Deputy Assistant Administrator.
[FR Doc. 2022-26913 Filed 12-9-22; 8:45 am]
BILLING CODE P
</pre></body>
</html>Indexed from Federal Register on December 12, 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.