Notice2026-02230
Bulk Manufacturer of Controlled Substances Application: Sterling Pharma USA 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 4, 2026
Issuing agencies
Justice DepartmentDrug Enforcement Administration
Abstract
Sterling Pharma USA LLC has applied to be registered as a bulk manufacturer 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 91 Issue 23 (Wednesday, February 4, 2026)</title>
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[Federal Register Volume 91, Number 23 (Wednesday, February 4, 2026)]
[Notices]
[Page 5111]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2026-02230]
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DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. DEA-1655]
Bulk Manufacturer of Controlled Substances Application: Sterling
Pharma USA LLC
AGENCY: Drug Enforcement Administration, Justice.
ACTION: Notice of application.
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SUMMARY: Sterling Pharma USA LLC has applied to be registered as a bulk
manufacturer 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
April 6, 2026. Such persons may also file a written request for a
hearing on the application on or before April 6, 2026.
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.
SUPPLEMENTARY INFORMATION: In accordance with 21 CFR 1301.33(a), this
is notice that on January 9, 2026, Sterling Pharma USA LLC, 1001
Sheldon Drive, Suite 101, Cary, North Carolina 27513-2078, applied to
be registered as a bulk manufacturer of the following basic class(es)
of controlled substance(s):
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Drug
Controlled substance code Schedule
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Tetrahydrocannabinols.................. 7370 I
5-Methoxy-N-N-dimethyltryptamine....... 7431 I
Dimethyltryptamine..................... 7435 I
Psilocybin............................. 7437 I
Psilocyn............................... 7438 I
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The company plans to bulk manufacture the listed controlled
substances to support internal research and for sale to its customers
for pre-clinical trial studies. No other activities for these drug
codes are authorized for this registration.
Thomas Prevoznik,
Deputy Assistant Administrator.
[FR Doc. 2026-02230 Filed 2-3-26; 8:45 am]
BILLING CODE 4410-09-P
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</html>Indexed from Federal Register on February 4, 2026.
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.