Notice2025-03061
Importer of Controlled Substances Application: Catalent Pharma Solutions, LLC
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
February 26, 2025
Issuing agencies
Justice DepartmentDrug Enforcement Administration
Abstract
Catalent Pharma Solutions, LLC 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
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<title>Federal Register, Volume 90 Issue 37 (Wednesday, February 26, 2025)</title>
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[Federal Register Volume 90, Number 37 (Wednesday, February 26, 2025)]
[Notices]
[Pages 10731-10732]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2025-03061]
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DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. DEA-1503]
Importer of Controlled Substances Application: Catalent Pharma
Solutions, LLC
AGENCY: Drug Enforcement Administration, Justice.
ACTION: Notice of application.
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SUMMARY: Catalent Pharma Solutions, LLC 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
March 28, 2025. Such persons may also file a written request for a
hearing on the application on or before March 28, 2025.
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 November 19, 2024, Catalent Pharma Solutions, LLC,
3031 Red Lion Road, Philadelphia, Pennsylvania 19114-1123, 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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Ibogaine........................... 7260 I
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The company plans to import the listed controlled substance as
finished dosage unit products for clinical trials, research, and
analytical activities. No other activity for this drug code is
authorized for this registration.
Approval of permit applications will occur only when the
registrant's business activity is consistent with what
[[Page 10732]]
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. 2025-03061 Filed 2-25-25; 8:45 am]
BILLING CODE P
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</html>Indexed from Federal Register on February 26, 2025.
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.