Notice2022-04803
Importer of Controlled Substances Application: 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 8, 2022
Issuing agencies
Justice DepartmentDrug Enforcement Administration
Abstract
ANI Pharmaceuticals Inc. has applied to be registered as an importer 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 45 (Tuesday, March 8, 2022)</title>
</head>
<body><pre>
[Federal Register Volume 87, Number 45 (Tuesday, March 8, 2022)]
[Notices]
[Page 12982]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2022-04803]
-----------------------------------------------------------------------
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. DEA-961]
Importer of Controlled Substances Application: ANI
Pharmaceuticals Inc.
AGENCY: Drug Enforcement Administration, Justice.
ACTION: Notice of application.
-----------------------------------------------------------------------
SUMMARY: ANI Pharmaceuticals Inc. has applied to be registered as an
importer 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
April 7, 2022. Such persons may also file a written request for a
hearing on the application on or before April 7, 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. All requests for a hearing must be sent to:
(1) Drug Enforcement Administration, Attn: Hearing Clerk/OALJ, 8701
Morrissette Drive, Springfield, Virginia 22152; and (2) Drug
Enforcement Administration, Attn: DEA Federal Register Representative/
DPW, 8701 Morrissette Drive, Springfield, Virginia 22152. All requests
for a hearing should also be sent to: Drug Enforcement Administration,
Attn: Administrator, 8701 Morrissette Drive, Springfield, Virginia
22152.
SUPPLEMENTARY INFORMATION: In accordance with 21 CFR 1301.34(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 an
importer of the following basic class(es) of controlled substance(s):
------------------------------------------------------------------------
Drug
Controlled substance code Schedule
------------------------------------------------------------------------
Psilocybin............................. 7437 I
Levorphanol............................ 9220 II
------------------------------------------------------------------------
The substance Levorphanol (9220) will be used to manufacture the
Food and Drug Administration-approved dosage forms for distribution in
the United States. The substance Psilocybin (7437) will be used to
support formulation development and clinical trial research. No other
activity for these drug codes are authorized for this registration.
Approval of permit applications will occur only when the
registrant's business activity is consistent with what is authorized
under 21 U.S.C. 952(a)(2).
Authorization will not extend to the import of Food Drug
Administration-approved or non-approved finished dosage forms for
commercial sale.
Matthew J. Strait,
Deputy Assistant Administrator.
[FR Doc. 2022-04803 Filed 3-7-22; 8:45 am]
BILLING CODE P
</pre></body>
</html>Indexed from Federal Register on March 8, 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.