Notice2024-04747
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
March 6, 2024
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 89 Issue 45 (Wednesday, March 6, 2024)</title>
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[Federal Register Volume 89, Number 45 (Wednesday, March 6, 2024)]
[Notices]
[Pages 16030-16031]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2024-04747]
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DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. DEA-1328]
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
May 6, 2024. Such persons may also file a written request for a hearing
on the application on or before May 6, 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
[[Page 16031]]
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, 2024, Sterling Pharma USA LLC., 10001
Sheldon Drive, Suite 101, Cary, North Carolina 27513, 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 manufacture the above-listed controlled
substance(s) to support clinical trials. No other activities for these
drug codes are authorized for this registration.
Marsha Ikner,
Acting Deputy Assistant Administrator.
[FR Doc. 2024-04747 Filed 3-5-24; 8:45 am]
BILLING CODE P
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</html>Indexed from Federal Register on March 6, 2024.
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