Notice2025-05279

Bulk Manufacturer of Controlled Substances Application: Royal Emerald Pharmaceuticals

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 27, 2025

Issuing agencies

Justice DepartmentDrug Enforcement Administration

Abstract

Royal Emerald Pharmaceuticals 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 90 Issue 58 (Thursday, March 27, 2025)</title>
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[Federal Register Volume 90, Number 58 (Thursday, March 27, 2025)]
[Notices]
[Page 13892]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2025-05279]


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DEPARTMENT OF JUSTICE

Drug Enforcement Administration

[Docket No. DEA-1521]


Bulk Manufacturer of Controlled Substances Application: Royal 
Emerald Pharmaceuticals

AGENCY: Drug Enforcement Administration, Justice.

ACTION: Notice of application.

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SUMMARY: Royal Emerald Pharmaceuticals 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 27, 2025. Such persons may also file a written request for a 
hearing on the application on or before May 27, 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.

SUPPLEMENTARY INFORMATION: In accordance with 21 CFR 1301.33(a), this 
is notice that on February 25, 2025, Royal Emerald Pharmaceuticals, 
14011 Palm Drive, Building B, Desert Hot Springs, California 92240-
6845, 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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Marihuana Extract.......................   7350  I
Marihuana...............................   7360  I
Tetrahydrocannabinols...................   7370  I
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    The company plans to bulk manufacture the listed controlled 
substance to provide Marihuana (Cannabis) as botanical raw material 
and/or active pharmaceutical ingredients (API) to Drug Enforcement 
Administration-registered researchers and manufacturers. No other 
activities for these drug codes are authorized for this registration.

Matthew Strait,
Deputy Assistant Administrator.
[FR Doc. 2025-05279 Filed 3-26-25; 8:45 am]
BILLING CODE P


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Indexed from Federal Register on March 27, 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.