Notice2025-21177

Importer of Controlled Substances Application: Halo Pharmaceutical 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
November 26, 2025

Issuing agencies

Justice DepartmentDrug Enforcement Administration

Abstract

Halo Pharmaceutical 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

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<title>Federal Register, Volume 90 Issue 226 (Wednesday, November 26, 2025)</title>
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[Federal Register Volume 90, Number 226 (Wednesday, November 26, 2025)]
[Notices]
[Pages 54369-54370]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2025-21177]


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DEPARTMENT OF JUSTICE

Drug Enforcement Administration

[Docket No. DEA-1620]


Importer of Controlled Substances Application: Halo 
Pharmaceutical Inc.

AGENCY: Drug Enforcement Administration, Justice.

ACTION: Notice of application.

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SUMMARY: Halo Pharmaceutical 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 
December 26, 2025. Such persons may also file a written request for a 
hearing on the application on or before December 26, 2025.

ADDRESSES: The Drug Enforcement Administration requires that all 
comments be submitted electronically through the Federal eRulemaking 
Portal,

[[Page 54370]]

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 September 29, 2025, Halo Pharmaceutical Inc., 30 
North Jefferson Road, Whippany, New Jersey 07981-1030, 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
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    The company plans to import the listed controlled substance to 
support formulation development and use in clinical trials. 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 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.

Justin Wood,
Acting Deputy Assistant Administrator.
[FR Doc. 2025-21177 Filed 11-25-25; 8:45 am]
BILLING CODE P


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Indexed from Federal Register on November 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.