Notice2024-14910
Bulk Manufacturer of Controlled Substances Application: S&B Pharma LLC DBA Norac Pharma
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 8, 2024
Issuing agencies
Justice DepartmentDrug Enforcement Administration
Abstract
S&B Pharma LLC DBA Norac Pharma 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 89 Issue 130 (Monday, July 8, 2024)</title>
</head>
<body><pre>
[Federal Register Volume 89, Number 130 (Monday, July 8, 2024)]
[Notices]
[Pages 55985-55986]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2024-14910]
-----------------------------------------------------------------------
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. DEA-1385]
Bulk Manufacturer of Controlled Substances Application: S&B
Pharma LLC DBA Norac Pharma
AGENCY: Drug Enforcement Administration, Justice.
ACTION: Notice of application.
-----------------------------------------------------------------------
SUMMARY: S&B Pharma LLC DBA Norac Pharma 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 6, 2024. Such persons may also file a written request for a
hearing on the application on or before September 6, 2024.
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 30, 2024, S&B Pharma LLC DBA Norac Pharma, 405
South Motor Avenue, Azusa, California 91702, applied to be registered
as a bulk manufacturer of the following basic class(es) of controlled
substance(s):
[[Page 55986]]
------------------------------------------------------------------------
Controlled substance Drug code Schedule
------------------------------------------------------------------------
Gamma Hydroxybutyric Acid........... 2010 I
------------------------------------------------------------------------
The company plans to manufacture the above listed controlled
substance for internal research and for development purposes as part of
the process in seeking Food and Drug Administration approval prior to
distribution to customers. No other activity for this drug code is
authorized for this registration.
Marsha L. Ikner,
Acting Deputy Assistant Administrator.
[FR Doc. 2024-14910 Filed 7-5-24; 8:45 am]
BILLING CODE P
</pre></body>
</html>Indexed from Federal Register on July 8, 2024.
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.