Notice2025-07278
Importer of Controlled Substances Application: Skalar Pharma 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
April 28, 2025
Issuing agencies
Justice DepartmentDrug Enforcement Administration
Abstract
Skalar Pharma 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
<html>
<head>
<title>Federal Register, Volume 90 Issue 80 (Monday, April 28, 2025)</title>
</head>
<body><pre>
[Federal Register Volume 90, Number 80 (Monday, April 28, 2025)]
[Notices]
[Page 17615]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2025-07278]
=======================================================================
-----------------------------------------------------------------------
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. DEA-1535]
Importer of Controlled Substances Application: Skalar Pharma LLC
AGENCY: Drug Enforcement Administration, Justice.
ACTION: Notice of application.
-----------------------------------------------------------------------
SUMMARY: Skalar Pharma 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
May 28, 2025. Such persons may also file a written request for a
hearing on the application on or before May 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 February 26, 2025, Skalar Pharma LLC, SR 53 KM 82
Guayama, Guayama, Puerto Rico 00785, applied to be registered as an
importer of the following basic class(es) of controlled substance(s):
------------------------------------------------------------------------
Drug
Controlled substance code Schedule
------------------------------------------------------------------------
Phenylacetone.......................... 8501 II
------------------------------------------------------------------------
The company plans to import the listed controlled substance to be
used in the manufacturing process for other controlled substances. 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.
Matthew Strait,
Deputy Assistant Administrator.
[FR Doc. 2025-07278 Filed 4-25-25; 8:45 am]
BILLING CODE 4410-09-P
</pre></body>
</html>Indexed from Federal Register on April 28, 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.