Notice2022-05323
Bulk Manufacturer of Controlled Substances: ANI Pharmaceuticals, Inc.
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
March 14, 2022
Issuing agencies
Justice DepartmentDrug Enforcement Administration
Abstract
ANI Pharmaceuticals, Inc., has applied to be registered as a bulk manufacturer of basic class(es) of controlled substance(s). Refer to Supplemental Information listed below for further drug information.
Full Text
<html>
<head>
<title>Federal Register, Volume 87 Issue 49 (Monday, March 14, 2022)</title>
</head>
<body><pre>
[Federal Register Volume 87, Number 49 (Monday, March 14, 2022)]
[Notices]
[Page 14290]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2022-05323]
-----------------------------------------------------------------------
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. DEA-978]
Bulk Manufacturer of Controlled Substances: ANI Pharmaceuticals,
Inc.
AGENCY: Drug Enforcement Administration, Justice.
ACTION: Notice of application.
-----------------------------------------------------------------------
SUMMARY: ANI Pharmaceuticals, Inc., has applied to be registered as a
bulk manufacturer of basic class(es) of controlled substance(s). Refer
to Supplemental 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
May 13, 2022. Such persons may also file a written request for a
hearing on the application on or before May 13, 2022.
ADDRESSES: The DEA 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 January 6, 2022, ANI Pharmaceuticals, Inc., 70 Lake
Drive, East Windsor, New Jersey 08520, applied to be registered as a
bulk manufacturer of the following basic class(es) of controlled
substance(s):
------------------------------------------------------------------------
Drug
Controlled substance code Schedule
------------------------------------------------------------------------
Psilocybin............................. 7437 I
Psilocyn............................... 7438 I
Levorphanol............................ 9220 II
------------------------------------------------------------------------
The company plans to bulk manufacture the listed controlled
substances for the internal use or for sale to its customers. No other
activities for these drug codes are authorized for this registration.
Matthew J. Strait,
Deputy Assistant Administrator.
[FR Doc. 2022-05323 Filed 3-11-22; 8:45 am]
BILLING CODE P
</pre></body>
</html>Indexed from Federal Register on March 14, 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.