[Federal Register Volume 88, Number 64 (Tuesday, April 4, 2023)]
[Notices]
[Page 19989]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-06949]


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DEPARTMENT OF JUSTICE

Drug Enforcement Administration

[Docket No. DEA-1178]


Importer of Controlled Substances Application: ANI 
Pharmaceuticals, Inc.

AGENCY: Drug Enforcement Administration, Justice.

ACTION: Notice of application.

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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 
May 4, 2023. Such persons may also file a written request for a hearing 
on the application on or before May 4, 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 https://www.regulations.gov 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 https://www.regulations.gov. 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 March 3, 2023, 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):

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       Controlled substance             Drug code           Schedule
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Psilocybin........................               7437  I
Levorphanol.......................               9220  II
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    Psilocybin (7437) will be imported to support research, formulation 
development, and clinical trials of an experimental drug product for 
the United States market. Levorphanol (9220) will be imported as bulk 
active pharmaceutical ingredient (API) to support the manufacturing of 
Food and Drug Administration-approved dosage forms for distribution in 
the United States. No other activities 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 and Drug Administration-approved or non-approved finished 
dosage forms for commercial sale.

Matthew Strait,
Deputy Assistant Administrator.
[FR Doc. 2023-06949 Filed 4-3-23; 8:45 am]
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