[Federal Register Volume 89, Number 45 (Wednesday, March 6, 2024)]
[Notices]
[Pages 16030-16031]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[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 https://www.regulations.gov 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 https://www.regulations.gov. 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]
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