Bulk Manufacturer of Controlled Substances Application: Chattem Chemicals, Inc., 71929-71930 [2024-19779]
Download as PDF
<![CDATA[
71929
Federal Register / Vol. 89, No. 171 / Wednesday, September 4, 2024 / Notices
the issuance of the proposed registration
on or before October 4, 2024. Such
persons may also file a written request
for a hearing on the application on or
before October 4, 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. 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.
In
accordance with 21 CFR 1301.34(a), this
is notice that on July 3, 2024, Amneal
Complex Products Research LLC, 995
US Highway 202/206, Bridgewater, New
Jersey 08807–1291, applied to be
registered as an importer of the
following basic class(es) of controlled
substance(s):
SUPPLEMENTARY INFORMATION:
Controlled substance
Drug code
Methylphenidate .............................................................................................................................................................
Thebaine ........................................................................................................................................................................
The company plans to import the
listed controlled substances for internal
analytical testing 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 nonapproved finished dosage forms for
commercial sale.
Marsha L. Ikner,
Acting Deputy Assistant Administrator.
[FR Doc. 2024–19787 Filed 9–3–24; 8:45 am]
BILLING CODE P
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 July 19, 2024, Chattem
Chemicals, Inc. 3801 Saint Elmo
Avenue, Chattanooga, Tennessee
37409–1237, applied to be registered as
a bulk manufacturer of the following
basic class(es) of controlled
substance(s):
Drug Enforcement Administration
[Docket No. DEA–1417]
Bulk Manufacturer of Controlled
Substances Application: Chattem
Chemicals, Inc.
Drug Enforcement
Administration, Justice.
ACTION: Notice of application.
AGENCY:
Chattem Chemicals, Inc., 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 4, 2024. Such
persons may also file a written request
for a hearing on the application on or
before November 4, 2024.
ddrumheller on DSK120RN23PROD with NOTICES1
Controlled substance
Drug code
Gamma Hydroxybutyric Acid .........................................................................................................................................
Marihuana ......................................................................................................................................................................
Tetrahydrocannabinols ..................................................................................................................................................
4-Methoxyamphetamine ................................................................................................................................................
Dihydromorphine ............................................................................................................................................................
Amphetamine .................................................................................................................................................................
Methamphetamine .........................................................................................................................................................
Lisdexamfetamine ..........................................................................................................................................................
Methylphenidate .............................................................................................................................................................
Cocaine ..........................................................................................................................................................................
Codeine ..........................................................................................................................................................................
Dihydrocodeine ..............................................................................................................................................................
Oxycodone .....................................................................................................................................................................
Hydromorphone .............................................................................................................................................................
Ecgonine ........................................................................................................................................................................
VerDate Sep<11>2014
21:26 Sep 03, 2024
Jkt 262001
PO 00000
Frm 00052
Fmt 4703
Sfmt 4703
II
II
ADDRESSES:
DEPARTMENT OF JUSTICE
SUMMARY:
1724
9333
Schedule
E:\FR\FM\04SEN1.SGM
04SEN1
2010
7360
7370
7411
9145
1100
1105
1205
1724
9041
9050
9120
9143
9150
9180
Schedule
I
I
I
I
I
II
II
II
II
II
II
II
II
II
II
71930
Federal Register / Vol. 89, No. 171 / Wednesday, September 4, 2024 / Notices
Controlled substance
Drug code
Hydrocodone ..................................................................................................................................................................
Levorphanol ...................................................................................................................................................................
Methadone .....................................................................................................................................................................
Methadone intermediate ................................................................................................................................................
Morphine ........................................................................................................................................................................
Oripavine ........................................................................................................................................................................
Thebaine ........................................................................................................................................................................
Oxymorphone ................................................................................................................................................................
Noroxymorphone ...........................................................................................................................................................
Alfentanil ........................................................................................................................................................................
Remifentanil ...................................................................................................................................................................
Sufentanil .......................................................................................................................................................................
Tapentadol .....................................................................................................................................................................
Fentanyl .........................................................................................................................................................................
The company plans to bulk
manufacture the listed controlled
substances in bulk for distribution and
sale to its customers. In reference to
drug codes 7360 (Marihuana) and 7370
(Tetrahydrocannabinols), the company
plans to bulk manufacture these drugs
as a synthetic. 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
manufacturing of Food and Drug
Administration-approved or nonapproved finished dosage forms for
commercial sale.
Marsha L. Ikner,
Acting Deputy Assistant Administrator.
[FR Doc. 2024–19779 Filed 9–3–24; 8:45 am]
ddrumheller on DSK120RN23PROD with NOTICES1
BILLING CODE 4410–09–P
9193
9220
9250
9254
9300
9330
9333
9652
9668
9737
9739
9740
9780
9801
Schedule
II
II
II
II
II
II
II
II
II
II
II
II
II
II
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 July 17, 2024,
Biopharmaceutical Research Company,
11045 Commercial Parkway, Castroville,
California 95012–3209, applied to be
registered as a bulk manufacturer of the
following basic class(es) of controlled
substance(s):
ADDRESSES:
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. DEA–1418]
Bulk Manufacturer of Controlled
Substances Application:
Biopharmaceutical Research Company
Drug Enforcement
Administration, Justice.
ACTION: Notice of application.
AGENCY:
Biopharmaceutical Research
Company 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 4, 2024. Such
persons may also file a written request
for a hearing on the application on or
before November 4, 2024.
SUMMARY:
Controlled substance
Drug code
Schedule
Marihuana Extract ...........................................................................................................................................................
Marihuana ........................................................................................................................................................................
Tetrahydrocannabinols ....................................................................................................................................................
7350
7360
7370
I
I
I
The company plans to bulk
manufacture the listed controlled
substances to provided Pharmaceuticalgrade marihuana in order to facilitate
research in a manner that complies with
local, state, and federal regulations. No
other activities for these drug codes are
authorized for this registration.
DEPARTMENT OF JUSTICE
Marsha L. Ikner,
Acting Deputy Assistant Administrator.
AGENCY:
[FR Doc. 2024–19783 Filed 9–3–24; 8:45 am]
[Docket No. DEA–1411]
Bulk Manufacturer of Controlled
Substances Application: Cambridge
Isotope Laboratories, Inc.
Drug Enforcement
Administration, Justice.
ACTION: Notice of application.
Cambridge Isotope
Laboratories, Inc has applied to be
SUMMARY:
BILLING CODE P
VerDate Sep<11>2014
Drug Enforcement Administration
21:26 Sep 03, 2024
Jkt 262001
PO 00000
Frm 00053
Fmt 4703
Sfmt 4703
registered as a bulk manufacturer of
basic class(es) of controlled
substance(s). Refer to Supplementary
Information listed below for further
drug information.
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 4, 2024. Such
persons may also file a written request
for a hearing on the application on or
before November 4, 2024.
DATES:
E:\FR\FM\04SEN1.SGM
04SEN1
]]>Agencies
[Federal Register Volume 89, Number 171 (Wednesday, September 4, 2024)]
[Notices]
[Pages 71929-71930]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-19779]
-----------------------------------------------------------------------
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. DEA-1417]
Bulk Manufacturer of Controlled Substances Application: Chattem
Chemicals, Inc.
AGENCY: Drug Enforcement Administration, Justice.
ACTION: Notice of application.
-----------------------------------------------------------------------
SUMMARY: Chattem Chemicals, Inc., 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 4, 2024. Such persons may also file a written request for a
hearing on the application on or before November 4, 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 July 19, 2024, Chattem Chemicals, Inc. 3801 Saint
Elmo Avenue, Chattanooga, Tennessee 37409-1237, applied to be
registered as a bulk manufacturer of the following basic class(es) of
controlled substance(s):
------------------------------------------------------------------------
Controlled substance Drug code Schedule
------------------------------------------------------------------------
Gamma Hydroxybutyric Acid........... 2010 I
Marihuana........................... 7360 I
Tetrahydrocannabinols............... 7370 I
4-Methoxyamphetamine................ 7411 I
Dihydromorphine..................... 9145 I
Amphetamine......................... 1100 II
Methamphetamine..................... 1105 II
Lisdexamfetamine.................... 1205 II
Methylphenidate..................... 1724 II
Cocaine............................. 9041 II
Codeine............................. 9050 II
Dihydrocodeine...................... 9120 II
Oxycodone........................... 9143 II
Hydromorphone....................... 9150 II
Ecgonine............................ 9180 II
[[Page 71930]]
Hydrocodone......................... 9193 II
Levorphanol......................... 9220 II
Methadone........................... 9250 II
Methadone intermediate.............. 9254 II
Morphine............................ 9300 II
Oripavine........................... 9330 II
Thebaine............................ 9333 II
Oxymorphone......................... 9652 II
Noroxymorphone...................... 9668 II
Alfentanil.......................... 9737 II
Remifentanil........................ 9739 II
Sufentanil.......................... 9740 II
Tapentadol.......................... 9780 II
Fentanyl............................ 9801 II
------------------------------------------------------------------------
The company plans to bulk manufacture the listed controlled
substances in bulk for distribution and sale to its customers. In
reference to drug codes 7360 (Marihuana) and 7370
(Tetrahydrocannabinols), the company plans to bulk manufacture these
drugs as a synthetic. 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
manufacturing of Food and Drug Administration-approved or non-approved
finished dosage forms for commercial sale.
Marsha L. Ikner,
Acting Deputy Assistant Administrator.
[FR Doc. 2024-19779 Filed 9-3-24; 8:45 am]
BILLING CODE 4410-09-P
