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Bulk Manufacturer of Controlled Substances Application: S&B Pharma LLC DBA Norac Pharma

S&B Pharma LLC DBA Norac Pharma has applied to be registered as a bulk manufacturer of basic class(es) of controlled substance(s). Refer to Supplementary Information listed belo...

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Department of Justice
Drug Enforcement Administration
  1. [Docket No. DEA-1385]

AGENCY:

Drug Enforcement Administration, Justice.

ACTION:

Notice of application.

SUMMARY:

S&B Pharma LLC DBA Norac Pharma 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 September 6, 2024. Such persons may also file a written request for a hearing on the application on or before September 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 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 April 30, 2024, S&B Pharma LLC DBA Norac Pharma, 405 South Motor Avenue, Azusa, California 91702, applied to be registered as a bulk manufacturer of the following basic class(es) of controlled substance(s): ( printed page 55986)

Controlled substance Drug code Schedule
Gamma Hydroxybutyric Acid 2010 I

The company plans to manufacture the above listed controlled substance for internal research and for development purposes as part of the process in seeking Food and Drug Administration approval prior to distribution to customers. No other activity for this drug code is authorized for this registration.

Marsha L. Ikner,

Acting Deputy Assistant Administrator.

[FR Doc. 2024-14910 Filed 7-5-24; 8:45 am]

BILLING CODE P

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89 FR 55985

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“Bulk Manufacturer of Controlled Substances Application: S&B Pharma LLC DBA Norac Pharma,” thefederalregister.org (July 8, 2024), https://thefederalregister.org/documents/2024-14910/bulk-manufacturer-of-controlled-substances-application-s-and-b-pharma-llc-dba-norac-pharma.