[Federal Register Volume 87, Number 101 (Wednesday, May 25, 2022)]
[Notices]
[Page 31909]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-11257]


-----------------------------------------------------------------------

DEPARTMENT OF JUSTICE

Drug Enforcement Administration

[Docket No. DEA-1011]


Bulk Manufacturer of Controlled Substances Application: Royal 
Emerald Pharmaceuticals

AGENCY: Drug Enforcement Administration, Justice.

ACTION: Notice of application.

-----------------------------------------------------------------------

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 
July 25, 2022. Such persons may also file a written request for a 
hearing on the application on or before July 25, 2022.

ADDRESSES: The Drug Enforcement Administration (DEA) 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 March 25, 2022, Royal Emerald Pharmaceuticals, 14011 
Palm Drive, Desert Hot Springs, California 92240-6845, applied to be 
registered as a bulk manufacturer of the following basic class(es) of 
controlled substance(s):

------------------------------------------------------------------------
                                           Drug
          Controlled  substance            code          Schedule
------------------------------------------------------------------------
Marihuana Extract.......................    7350  I
Marihuana...............................    7360  I
Tetrahydrocannabinols...................    7370  I
------------------------------------------------------------------------

    The company plans to bulk manufacture the listed controlled 
substances to provide Marihuana (Cannabis) as botanical raw material 
and/or active pharmaceutical ingredients (API) to DEA research 
registrants and manufacturers. No other activities for these drug codes 
are authorized for this registration.

Kristi N. O'Malley,
Assistant Administrator.
[FR Doc. 2022-11257 Filed 5-24-22; 8:45 am]
BILLING CODE P