Bulk Manufacturer of Controlled Substances Application: Purisys, LLC, 20697-20698 [2024-06185]
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20697
Federal Register / Vol. 89, No. 58 / Monday, March 25, 2024 / Notices
listed below for further drug
information.
In
accordance with 21 CFR 1301.34(a), this
is notice that on January 22, 2024,
Hybrid Pharma, 1015 West Newport
Center Drive, Suite 106A, Deerfield
Beach, Florida 33442–7707, applied to
be registered as an importer of the
following basic class(es) of controlled
substance(s):
SUPPLEMENTARY 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 April 24, 2024. Such
persons may also file a written request
for a hearing on the application on or
before April 24, 2024.
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. 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.
ADDRESSES:
Drug
code
Controlled substance
Dimethyltryptamine ..........
I
7435
Schedule
II
The company plans to import the
listed controlled substance for the
compounding of dosage units to be used
in clinical trials. 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 Ikner,
Acting Deputy Assistant Administrator.
[FR Doc. 2024–06188 Filed 3–22–24; 8:45 am]
BILLING CODE P
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. DEA–1342]
Bulk Manufacturer of Controlled
Substances Application: Purisys, LLC
Drug Enforcement
Administration, Justice.
AGENCY:
ACTION:
Notice of application.
Purisys, LLC 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 24, 2024. Such persons
may also file a written request for a
hearing on the application on or before
May 24, 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 February 8, 2024,
Purisys, LLC, 1550 Olympic Drive,
Athens, Georgia 30601–1602, applied to
be registered as a bulk manufacturer of
the following basic class(es) of
controlled substance(s):
SUMMARY:
khammond on DSKJM1Z7X2PROD with NOTICES
Controlled substance
Drug code
Cathinone ...............................................................................................................................................................................
Gamma Hydroxybutyric Acid ..................................................................................................................................................
Ibogaine ..................................................................................................................................................................................
Lysergic acid diethylamide .....................................................................................................................................................
Marihuana Extract ..................................................................................................................................................................
Marihuana ...............................................................................................................................................................................
Tetrahydrocannabinols ...........................................................................................................................................................
Mescaline ...............................................................................................................................................................................
2,5-Dimethoxyamphetamine ...................................................................................................................................................
3,4-Methylenedioxyamphetamine ...........................................................................................................................................
3,4-Methylenedioxy-N-ethylamphetamine ..............................................................................................................................
3,4-Methylenedioxymethamphetamine ...................................................................................................................................
5-Methoxy-N,N-dimethyltryptamine ........................................................................................................................................
Diethyltryptamine ....................................................................................................................................................................
Dimethyltryptamine .................................................................................................................................................................
Psilocybin ...............................................................................................................................................................................
Psilocyn ..................................................................................................................................................................................
5-Methyoxy-N,N-diisopropyltryptamine ...................................................................................................................................
Methylone (3,4-Methylenedioxy-N-methylcathinone) .............................................................................................................
Codeine-N-oxide .....................................................................................................................................................................
Dihydromorphine ....................................................................................................................................................................
Heroin .....................................................................................................................................................................................
VerDate Sep<11>2014
18:08 Mar 22, 2024
Jkt 262001
PO 00000
Frm 00069
Fmt 4703
Sfmt 4703
E:\FR\FM\25MRN1.SGM
25MRN1
1235
2010
7260
7315
7350
7360
7370
7381
7396
7400
7404
7405
7431
7434
7435
7437
7438
7439
7540
9053
9145
9200
Schedule
I
I
I
I
I
I
I
I
I
I
I
I
I
I
I
I
I
I
I
I
I
I
20698
Federal Register / Vol. 89, No. 58 / Monday, March 25, 2024 / Notices
Controlled substance
Drug code
Hydromorphinol ......................................................................................................................................................................
Morphine-N-oxide ...................................................................................................................................................................
Normorphine ...........................................................................................................................................................................
Norlevorphanol .......................................................................................................................................................................
Amphetamine .........................................................................................................................................................................
Lisdexamfetamine ..................................................................................................................................................................
Methylphenidate .....................................................................................................................................................................
Pentobarbital ..........................................................................................................................................................................
Nabilone .................................................................................................................................................................................
Cocaine ..................................................................................................................................................................................
Codeine ..................................................................................................................................................................................
Dihydrocodeine .......................................................................................................................................................................
Oxycodone .............................................................................................................................................................................
Hydromorphone ......................................................................................................................................................................
Ecgonine .................................................................................................................................................................................
Hydrocodone ..........................................................................................................................................................................
Levorphanol ............................................................................................................................................................................
Meperidine ..............................................................................................................................................................................
Meperidine intermediate-A .....................................................................................................................................................
Meperidine intermediate-B .....................................................................................................................................................
Meperidine intermediate-C .....................................................................................................................................................
Methadone intermediate .........................................................................................................................................................
Methadone intermediate .........................................................................................................................................................
Morphine .................................................................................................................................................................................
Oripavine ................................................................................................................................................................................
Thebaine .................................................................................................................................................................................
Opium tincture ........................................................................................................................................................................
Opium, powdered ...................................................................................................................................................................
Opium, granulated ..................................................................................................................................................................
Oxymorphone .........................................................................................................................................................................
Noroxymorphone ....................................................................................................................................................................
Alfentanil .................................................................................................................................................................................
Sufentanil ................................................................................................................................................................................
Carfentanil ..............................................................................................................................................................................
Tapentadol ..............................................................................................................................................................................
Fentanyl ..................................................................................................................................................................................
The company plans to bulk
manufacture the listed controlled
substances for the production of active
pharmaceutical ingredients (API) and
analytical reference standards for sale to
its customers. The company plans to
manufacture the above listed controlled
substances as clinical trial and starting
materials to make compounds for
distribution to its customers. No other
activities for these drug codes are
authorized for this registration.
Marsha Ikner,
Acting Deputy Assistant Administrator.
[FR Doc. 2024–06185 Filed 3–22–24; 8:45 am]
BILLING CODE P
DEPARTMENT OF JUSTICE
khammond on DSKJM1Z7X2PROD with NOTICES
Drug Enforcement Administration
[Docket No. DEA–1335]
Importer of Controlled Substances
Application: Stepan Company
Drug Enforcement
Administration, Justice.
AGENCY:
ACTION:
Notice of application.
VerDate Sep<11>2014
18:08 Mar 22, 2024
Jkt 262001
Stepan Company 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 April 24, 2024. Such
persons may also file a written request
for a hearing on the application on or
before April 24, 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
SUMMARY:
PO 00000
Frm 00070
Fmt 4703
Sfmt 4703
9301
9307
9313
9634
1100
1205
1724
2270
7379
9041
9050
9120
9143
9150
9180
9193
9220
9230
9232
9233
9234
9250
9254
9300
9330
9333
9630
9639
9640
9652
9668
9737
9740
9743
9780
9801
Schedule
I
I
I
I
II
II
II
II
II
II
II
II
II
II
II
II
II
II
II
II
II
II
II
II
II
II
II
II
II
II
II
II
II
II
II
II
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 January 26, 2024,
Stepan Company, 100 West Hunter
Avenue, Maywood, New Jersey 07607–
1021, applied to be registered as an
importer of the following basic class(es)
of controlled substance(s):
SUPPLEMENTARY INFORMATION:
Drug
code
Controlled substance
Coca Leaves ...................
E:\FR\FM\25MRN1.SGM
25MRN1
I
9040
Schedule
III
]]>Agencies
[Federal Register Volume 89, Number 58 (Monday, March 25, 2024)]
[Notices]
[Pages 20697-20698]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-06185]
-----------------------------------------------------------------------
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. DEA-1342]
Bulk Manufacturer of Controlled Substances Application: Purisys,
LLC
AGENCY: Drug Enforcement Administration, Justice.
ACTION: Notice of application.
-----------------------------------------------------------------------
SUMMARY: Purisys, LLC 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 24, 2024. Such persons may also file a written request for a
hearing on the application on or before May 24, 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 February 8, 2024, Purisys, LLC, 1550 Olympic Drive,
Athens, Georgia 30601-1602, applied to be registered as a bulk
manufacturer of the following basic class(es) of controlled
substance(s):
------------------------------------------------------------------------
Controlled substance Drug code Schedule
------------------------------------------------------------------------
Cathinone................................... 1235 I
Gamma Hydroxybutyric Acid................... 2010 I
Ibogaine.................................... 7260 I
Lysergic acid diethylamide.................. 7315 I
Marihuana Extract........................... 7350 I
Marihuana................................... 7360 I
Tetrahydrocannabinols....................... 7370 I
Mescaline................................... 7381 I
2,5-Dimethoxyamphetamine.................... 7396 I
3,4-Methylenedioxyamphetamine............... 7400 I
3,4-Methylenedioxy-N-ethylamphetamine....... 7404 I
3,4-Methylenedioxymethamphetamine........... 7405 I
5-Methoxy-N,N-dimethyltryptamine............ 7431 I
Diethyltryptamine........................... 7434 I
Dimethyltryptamine.......................... 7435 I
Psilocybin.................................. 7437 I
Psilocyn.................................... 7438 I
5-Methyoxy-N,N-diisopropyltryptamine........ 7439 I
Methylone (3,4-Methylenedioxy-N- 7540 I
methylcathinone).
Codeine-N-oxide............................. 9053 I
Dihydromorphine............................. 9145 I
Heroin...................................... 9200 I
[[Page 20698]]
Hydromorphinol.............................. 9301 I
Morphine-N-oxide............................ 9307 I
Normorphine................................. 9313 I
Norlevorphanol.............................. 9634 I
Amphetamine................................. 1100 II
Lisdexamfetamine............................ 1205 II
Methylphenidate............................. 1724 II
Pentobarbital............................... 2270 II
Nabilone.................................... 7379 II
Cocaine..................................... 9041 II
Codeine..................................... 9050 II
Dihydrocodeine.............................. 9120 II
Oxycodone................................... 9143 II
Hydromorphone............................... 9150 II
Ecgonine.................................... 9180 II
Hydrocodone................................. 9193 II
Levorphanol................................. 9220 II
Meperidine.................................. 9230 II
Meperidine intermediate-A................... 9232 II
Meperidine intermediate-B................... 9233 II
Meperidine intermediate-C................... 9234 II
Methadone intermediate...................... 9250 II
Methadone intermediate...................... 9254 II
Morphine.................................... 9300 II
Oripavine................................... 9330 II
Thebaine.................................... 9333 II
Opium tincture.............................. 9630 II
Opium, powdered............................. 9639 II
Opium, granulated........................... 9640 II
Oxymorphone................................. 9652 II
Noroxymorphone.............................. 9668 II
Alfentanil.................................. 9737 II
Sufentanil.................................. 9740 II
Carfentanil................................. 9743 II
Tapentadol.................................. 9780 II
Fentanyl.................................... 9801 II
------------------------------------------------------------------------
The company plans to bulk manufacture the listed controlled
substances for the production of active pharmaceutical ingredients
(API) and analytical reference standards for sale to its customers. The
company plans to manufacture the above listed controlled substances as
clinical trial and starting materials to make compounds for
distribution to its customers. No other activities for these drug codes
are authorized for this registration.
Marsha Ikner,
Acting Deputy Assistant Administrator.
[FR Doc. 2024-06185 Filed 3-22-24; 8:45 am]
BILLING CODE P
