Bulk Manufacturer of Controlled Substances Application: Royal Emerald Pharmaceuticals, 13892 [2025-05279]
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13892
Federal Register / Vol. 90, No. 58 / Thursday, March 27, 2025 / Notices
Controlled Substance
Schedule
Opium, raw ......................................................................................................................................................................
Opium extracts ................................................................................................................................................................
Opium fluid extract ..........................................................................................................................................................
Opium tincture .................................................................................................................................................................
Opium, powdered ............................................................................................................................................................
Opium, granulated ...........................................................................................................................................................
Levo-alphacetylmethadol .................................................................................................................................................
Opium poppy ...................................................................................................................................................................
Oxymorphone ..................................................................................................................................................................
Noroxymorphone .............................................................................................................................................................
Poppy Straw Concentrate ...............................................................................................................................................
Phenazocine ....................................................................................................................................................................
Thiafentanil ......................................................................................................................................................................
Piminodine .......................................................................................................................................................................
Racemethorphan .............................................................................................................................................................
Racemorphan ..................................................................................................................................................................
Alfentanil ..........................................................................................................................................................................
Remifentanil .....................................................................................................................................................................
Sufentanil .........................................................................................................................................................................
Carfentanil .......................................................................................................................................................................
Tapentadol .......................................................................................................................................................................
Bezitramide ......................................................................................................................................................................
Fentanyl ...........................................................................................................................................................................
Moramide-intermediate ....................................................................................................................................................
9600
9610
9620
9630
9639
9640
9648
9650
9652
9668
9670
9715
9729
9730
9732
9733
9737
9739
9740
9743
9780
9800
9801
9802
II
II
II
II
II
II
II
II
II
II
II
II
II
II
II
II
II
II
II
II
II
II
II
II
The company plans to import the
listed controlled substances for the use
in the manufacture of exempted
certified reference materials. 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 nonapproved finished dosage forms for
commercial sale.
Controlled substance
Drug
code
Schedule
Marihuana Extract .............
Marihuana .........................
Tetrahydrocannabinols .....
7350
7360
7370
I
I
I
Matthew Strait,
Deputy Assistant Administrator.
[FR Doc. 2025–05282 Filed 3–26–25; 8:45 am]
BILLING CODE P
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. DEA–1521]
Bulk Manufacturer of Controlled
Substances Application: Royal
Emerald Pharmaceuticals
Drug Enforcement
Administration, Justice.
ACTION: Notice of application.
AGENCY:
lotter on DSK11XQN23PROD with NOTICES1
Drug Code
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.
SUMMARY:
VerDate Sep<11>2014
17:43 Mar 26, 2025
Jkt 265001
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.
DATES:
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.
ADDRESSES:
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):
SUPPLEMENTARY INFORMATION:
PO 00000
Frm 00041
Fmt 4703
Sfmt 4703
I
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
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
Thomas Andr’e Endicott, D.D.S.;
Decision and Order
On March 26, 2024, the Drug
Enforcement Administration (DEA or
Government) issued an Order to Show
Cause (OSC) to Thomas Andr’e
Endicott, D.D.S., of Salt Lake City, Utah
(Registrant). Request for Final Agency
Action (RFAA), Exhibit (RFAAX) 1, at 1,
3. The OSC proposed the revocation of
Registrant’s Certificate of Registration
No. FE3865029, alleging that
Registrant’s registration should be
revoked because Registrant is ‘‘currently
without authority to handle controlled
E:\FR\FM\27MRN1.SGM
27MRN1
]]>Agencies
[Federal Register Volume 90, Number 58 (Thursday, March 27, 2025)]
[Notices]
[Page 13892]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2025-05279]
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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 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 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):
------------------------------------------------------------------------
Drug
Controlled substance code Schedule
------------------------------------------------------------------------
Marihuana Extract....................... 7350 I
Marihuana............................... 7360 I
Tetrahydrocannabinols................... 7370 I
------------------------------------------------------------------------
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
