Notice2024-11794
Importer of Controlled Substances Application: ANI Pharmaceuticals Inc.
Primary source
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Published
May 30, 2024
Issuing agencies
Justice DepartmentDrug Enforcement Administration
Abstract
ANI Pharmaceuticals Inc., 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
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<title>Federal Register, Volume 89 Issue 105 (Thursday, May 30, 2024)</title>
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[Federal Register Volume 89, Number 105 (Thursday, May 30, 2024)]
[Notices]
[Pages 46906-46907]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2024-11794]
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DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. DEA-1373]
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., 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
July 1, 2024. Such persons may also file a written request for a
hearing on the application on or before July 1, 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. 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 April 9, 2024, ANI Pharmaceuticals Inc., 70 Lake
Drive, East Windsor, New Jersey 08520-5321, applied to be registered as
an importer of the following basic class(es) of controlled
substance(s):
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Drug
Controlled substance code Schedule
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Psilocybin.............................. 7437 I
Levorphanol............................. 9220 II
Tapentadol.............................. 9780 II
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Psilocybin (7437) will be imported for use in dosage form
development leading to use in clinical trials. Levorphanol (9220) will
be imported for distribution to customers. Tapentadol (9780) will be
used to import small quantities for internal research and reference
standards purposes. 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-
[[Page 46907]]
approved finished dosage forms for commercial sale.
Marsha L. Ikner,
Acting Deputy Assistant Administrator.
[FR Doc. 2024-11794 Filed 5-29-24; 8:45 am]
BILLING CODE 4410-09-P
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</html>Indexed from Federal Register on May 30, 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.