Bulk Manufacturer of Controlled Substances Application: Eli-Elsohly Laboratories, 76152 [2024-21060]
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76152
Federal Register / Vol. 89, No. 180 / Tuesday, September 17, 2024 / Notices
Drug
code
Controlled substance
Thebaine ......................................................................................................................................................................................
Dihydroetorphine .........................................................................................................................................................................
Levo-alphacetylmethadol .............................................................................................................................................................
Oxymorphone ..............................................................................................................................................................................
Noroxymorphone .........................................................................................................................................................................
Phenazocine ................................................................................................................................................................................
Thiafentanil ..................................................................................................................................................................................
Piminodine ...................................................................................................................................................................................
Racemethorphan .........................................................................................................................................................................
Racemorphan ..............................................................................................................................................................................
Alfentanil ......................................................................................................................................................................................
Remifentanil .................................................................................................................................................................................
Sufentanil .....................................................................................................................................................................................
Carfentanil ...................................................................................................................................................................................
Tapentadol ...................................................................................................................................................................................
Bezitramide ..................................................................................................................................................................................
Fentanyl .......................................................................................................................................................................................
Moramide-intermediate ................................................................................................................................................................
The company plans to bulk
manufacture the listed controlled
substances for distribution to its
customers. In reference to dug codes
7360 (Marihuana), and 7370
(Tetrahydrocannabinols), the company
plans to bulk manufacture these drugs
as synthetic. No other activities for these
drug codes are authorized for this
registration.
Marsha L. Ikner,
Acting Deputy Assistant Administrator.
[FR Doc. 2024–21062 Filed 9–16–24; 8:45 am]
BILLING CODE 4410–09–P
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. DEA–1432]
Bulk Manufacturer of Controlled
Substances Application: Eli-Elsohly
Laboratories
Drug Enforcement
Administration, Justice.
ACTION: Notice of application.
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 August 16, 2024, EliElsohly Laboratories, 5 Industrial Park
Drive, Oxford, Mississippi 38655–5343,
applied to be registered as a bulk
manufacturer of the following basic
class(es) of controlled substance(s):
AGENCY:
Eli-Elsohly Laboratories 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 November 18, 2024. Such
persons may also file a written request
for a hearing on the application on or
before November 18, 2024.
ADDRESSES: The Drug Enforcement
Administration requires that all
comments be submitted electronically
SUMMARY:
ddrumheller on DSK120RN23PROD with NOTICES1
Controlled substance
VerDate Sep<11>2014
17:12 Sep 16, 2024
Jkt 262001
Marihuana Extract ..........
Marihuana .......................
Tetrahydrocannabinols ...
Dihydromorphine ............
Amphetamine .................
Methamphetamine ..........
Cocaine ..........................
Codeine ..........................
Dihydrocodeine ...............
Oxycodone .....................
Ecgonine .........................
Thebaine .........................
Drug
code
Schedule
7350
7360
7370
9145
1100
1105
9041
9050
9120
9143
9180
9333
I
I
I
I
II
II
II
II
II
II
II
II
The company plans to manufacture
the listed controlled substances for
product development reference
standards. In reference to drug codes
7360 (Marihuana), and 7370
(Tetrahydrocannabinols), the company
plans to isolate these controlled
PO 00000
Frm 00088
Fmt 4703
Sfmt 4703
9333
9334
9648
9652
9668
9715
9729
9730
9732
9733
9737
9739
9740
9743
9780
9800
9801
9802
Schedule
II
II
II
II
II
II
II
II
II
II
II
II
II
II
II
II
II
II
substances from procured 7350
(Marihuana Extract). In reference to
drug code 7360, no cultivation activities
are authorized for this registration.
In reference to drug code 9333
(Thebaine), the company plans to
manufacture a Thebaine derivative. No
other activities for these drug codes are
authorized for this registration.
Marsha L. Ikner,
Acting Deputy Assistant Administrator.
[FR Doc. 2024–21060 Filed 9–16–24; 8:45 am]
BILLING CODE P
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. 23–53]
George D. Gowder, III, M.D.; Decision
and Order
On July 18, 2023, the Drug
Enforcement Administration (DEA or
Government) issued an Order to Show
Cause (OSC) to George Gowder, III,
M.D., of Blairsville, Georgia
(Respondent). OSC, at 1, 3. The OSC
proposed the denial of Respondent’s
application for a DEA Certificate of
Registration (registration), Control No.
W22147308C, alleging that Respondent
has been convicted of a felony relating
to Federal controlled substance laws,
and that he has been excluded from
participation in Medicare, Medicaid,
and all Federal health care programs. Id.
at 1–2 (citing 21 U.S.C. 823(g)(1),
824(a)(2), 824(a)(5)).
A hearing was held before DEA
Administrative Law Judge Teresa A.
Wallbaum (ALJ), who, on December 1,
2023, issued her Recommended Rulings,
Findings of Fact, Conclusions of Law,
and Decision (Recommended Decision
or RD). The RD recommended that
E:\FR\FM\17SEN1.SGM
17SEN1
]]>Agencies
[Federal Register Volume 89, Number 180 (Tuesday, September 17, 2024)]
[Notices]
[Page 76152]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-21060]
-----------------------------------------------------------------------
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. DEA-1432]
Bulk Manufacturer of Controlled Substances Application: Eli-
Elsohly Laboratories
AGENCY: Drug Enforcement Administration, Justice.
ACTION: Notice of application.
-----------------------------------------------------------------------
SUMMARY: Eli-Elsohly Laboratories 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
November 18, 2024. Such persons may also file a written request for a
hearing on the application on or before November 18, 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 August 16, 2024, Eli-Elsohly Laboratories, 5
Industrial Park Drive, Oxford, Mississippi 38655-5343, 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
Dihydromorphine........................ 9145 I
Amphetamine............................ 1100 II
Methamphetamine........................ 1105 II
Cocaine................................ 9041 II
Codeine................................ 9050 II
Dihydrocodeine......................... 9120 II
Oxycodone.............................. 9143 II
Ecgonine............................... 9180 II
Thebaine............................... 9333 II
------------------------------------------------------------------------
The company plans to manufacture the listed controlled substances
for product development reference standards. In reference to drug codes
7360 (Marihuana), and 7370 (Tetrahydrocannabinols), the company plans
to isolate these controlled substances from procured 7350 (Marihuana
Extract). In reference to drug code 7360, no cultivation activities are
authorized for this registration.
In reference to drug code 9333 (Thebaine), the company plans to
manufacture a Thebaine derivative. No other activities for these drug
codes are authorized for this registration.
Marsha L. Ikner,
Acting Deputy Assistant Administrator.
[FR Doc. 2024-21060 Filed 9-16-24; 8:45 am]
BILLING CODE P
