[Federal Register Volume 90, Number 79 (Friday, April 25, 2025)]
[Notices]
[Page 17450]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2025-07155]
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DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. DEA-1523]
Importer 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
an importer 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 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. All
requests for a hearing must be sent to: (1) Drug Enforcement
Administration, Attn: Hearing Clerk/OALJ, 8701 Morrissette Drive,
Springfield, Virginia 22152; and (2) Drug Enforcement Administration,
Attn: DEA Federal Register Representative/DPW, 8701 Morrissette Drive,
Springfield, Virginia 22152. All requests for a hearing should also be
sent to: Drug Enforcement Administration, Attn: Administrator, 8701
Morrissette Drive, Springfield, Virginia 22152.
SUPPLEMENTARY INFORMATION: In accordance with 21 CFR 1301.34(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 an importer 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 import immature plants to use as starting/raw
materials to continue cultivation of Marihuana under their Bulk
Manufacturing registration. All products and materials will be
developed as botanical raw materials or Active Pharmaceutical
Ingredients for Drug Enforcement Administration-approved legitimate
medical, scientific, research, and/or industrial purposes. No other
activities for these drug codes are authorized for this registration.
Approval of permit applications will occur only when the
registrant's business activity is consistent with what is authorized
under 21 U.S.C. 952(a)(2). Authorization will not extend to the import
of Food and Drug Administration-approved or non-approved finished
dosage forms for commercial sale.
Matthew Strait,
Deputy Assistant Administrator.
[FR Doc. 2025-07155 Filed 4-24-25; 8:45 am]
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