Importer of Controlled Substances Application: Myonex Inc., 17627-17628 [2023-05913]
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17627
Federal Register / Vol. 88, No. 56 / Thursday, March 23, 2023 / Notices
Controlled substance
Drug code
Phenazocine ..........................................................................................................................................................................
Thiafentanil ............................................................................................................................................................................
Piminodine .............................................................................................................................................................................
Racemethorphan ...................................................................................................................................................................
Racemorphan ........................................................................................................................................................................
Alfentanil ................................................................................................................................................................................
Remifentanil ...........................................................................................................................................................................
Sufentanil ...............................................................................................................................................................................
Carfentanil .............................................................................................................................................................................
Tapentadol .............................................................................................................................................................................
Bezitramide ............................................................................................................................................................................
Fentanyl .................................................................................................................................................................................
Moramide-intermediate ..........................................................................................................................................................
The company plans to import
analytical reference standards for
distribution to its customers for research
and analytics purposes. Placement of
these drug codes onto the company’s
registration does not translate into
automatic approval of subsequent
permit applications to import controlled
substances. Approval of permit
applications will occur only when the
registrant’s business activity is
consistent with what is authorized in 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.
Matthew Strait,
Deputy Assistant Administrator.
[FR Doc. 2023–05916 Filed 3–22–23; 8:45 am]
BILLING CODE P
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. DEA–1169]
Importer of Controlled Substances
Application: Purisys, LLC
Drug Enforcement
Administration, Justice.
ACTION: Notice of application.
AGENCY:
Purisys, LLC 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, 2023. Such
persons may also file a written request
for a hearing on the application on or
before April 24, 2023.
ADDRESSES: The Drug Enforcement
Administration requires that all
ddrumheller on DSK120RN23PROD with NOTICES1
SUMMARY:
VerDate Sep<11>2014
19:23 Mar 22, 2023
Jkt 259001
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 15, 2023,
Purisys, LLC, 1550 Olympic Drive,
Athens, Georgia 30601–1602, applied to
be registered as an importer of the
following basic class(es) of controlled
substance(s):
Controlled substance
Marihuana Extract ...........
Marihuana ........................
Tetrahydrocannabinols ....
Nabilone ..........................
Phenylacetone .................
Ecgonine ..........................
Levorphanol .....................
Thebaine ..........................
Opium, raw ......................
Opium, powdered ............
Opium, granulated ...........
PO 00000
Frm 00112
Fmt 4703
Noroxymorphone .............
Poppy Straw Concentrate
Tapentadol ......................
II
II
II
II
II
II
II
II
II
II
II
II
II
Drug
code
Schedule
9668
9670
9780
II
II
II
The company plans to import Opium,
Raw (9600), Opium, Powered (9639) and
Opium, Granulated (9640) to
manufacture an Active Pharmaceutical
Ingredient (API) only for distribution to
its customers. The company plans to
import Phenylacetone (8501) and Poppy
Straw Concentrate (9670), to bulk
manufacture other Controlled
substances for distribution to its
customers. The company plans to
import impurities of buprenorphine that
have been determined by DEA to be
captured under Thebaine (9333). In
reference to Marihuana Extract (7350),
Marihuana (7360) and
Tetrahydrocannabinols (7370) the
company plans to import as synthetic.
No other activity for these drug codes is
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.
Matthew Strait,
Deputy Assistant Administrator.
[FR Doc. 2023–05939 Filed 3–22–23; 8:45 am]
BILLING CODE P
Drug
code
Schedule
7350
7360
7370
7379
8501
9180
9220
9333
9600
9639
9640
I
I
I
II
II
II
II
II
II
II
II
Sfmt 4703
Controlled substance
9715
9729
9730
9732
9733
9737
9739
9740
9743
9780
9800
9801
9802
Schedule
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. DEA–1145]
Importer of Controlled Substances
Application: Myonex Inc.
Drug Enforcement
Administration, Justice.
AGENCY:
E:\FR\FM\23MRN1.SGM
23MRN1
17628
ACTION:
Federal Register / Vol. 88, No. 56 / Thursday, March 23, 2023 / Notices
Notice of application.
Controlled substance
Myonex Inc. 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.
SUMMARY:
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, 2023. Such
persons may also file a written request
for a hearing on the application on or
before April 24, 2023.
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 December 21, 2022,
Myonex Inc.. 100 Progress Drive,
Horsham, Pennsylvania 19044, applied
to be registered as an importer of the
following basic class(es) of controlled
substance(s):
ddrumheller on DSK120RN23PROD with NOTICES1
DATES:
Controlled substance
Amphetamine ..................
Lisdexamfetamine ...........
Methylphenidate ..............
Nabilone ..........................
Oxycodone ......................
Hydromorphone ...............
Hydrocodone ...................
VerDate Sep<11>2014
Drug
code
Schedule
1100
1205
1724
7379
9143
9150
9193
II
II
II
II
II
II
II
19:23 Mar 22, 2023
Jkt 259001
Morphine ..........................
Oxymorphone ..................
Fentanyl ...........................
Drug
code
Schedule
9300
9652
9801
II
II
II
The company plans to import the
listed controlled substances in dosage
form for clinical trials, research, and
analytical 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.
Matthew Strait,
Deputy Assistant Administrator.
[FR Doc. 2023–05913 Filed 3–22–23; 8:45 am]
BILLING CODE P
DEPARTMENT OF JUSTICE
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 January 10, 2023,
Scottsdale Research Institute, 5436 East
Tapekim Road, Cave Creek, Arizona
85331, applied to be registered as a bulk
manufacturer of the following basic
class(es) of controlled substance(s):
Controlled substance
Psilocybin .......................
Psilocyn ..........................
Drug
code
Schedule
7437
7438
I
I
The company plans to bulk
manufacture the listed controlled
substances for internal research and
analytical development purposes. No
other activities for these drug codes are
authorized for this registration.
Drug Enforcement Administration
Matthew Strait,
Deputy Assistant Administrator.
[Docket No. DEA–1162]
[FR Doc. 2023–05921 Filed 3–22–23; 8:45 am]
BILLING CODE P
Bulk Manufacturer of Controlled
Substances Application: Scottsdale
Research Institute
Drug Enforcement
Administration, Justice.
ACTION: Notice of application.
AGENCY:
Drug Enforcement Administration
[Docket No. DEA–1163]
Scottsdale Research Institute,
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 22, 2023. Such persons
may also file a written request for a
hearing on the application on or before
May 22, 2023.
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
SUMMARY:
PO 00000
Frm 00113
Fmt 4703
Sfmt 4703
DEPARTMENT OF JUSTICE
Bulk Manufacturer of Controlled
Substances Application: Sigma Aldrich
Research Biochemicals, Inc.
Drug Enforcement
Administration, Justice.
ACTION: Notice of application.
AGENCY:
Sigma Aldrich Research
Biochemicals, 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 May 22, 2023. Such persons
may also file a written request for a
hearing on the application on or before
May 22, 2023.
ADDRESSES: The Drug Enforcement
Administration requires that all
comments be submitted electronically
through the Federal eRulemaking Portal,
SUMMARY:
E:\FR\FM\23MRN1.SGM
23MRN1
Agencies
[Federal Register Volume 88, Number 56 (Thursday, March 23, 2023)]
[Notices]
[Pages 17627-17628]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-05913]
-----------------------------------------------------------------------
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. DEA-1145]
Importer of Controlled Substances Application: Myonex Inc.
AGENCY: Drug Enforcement Administration, Justice.
[[Page 17628]]
ACTION: Notice of application.
-----------------------------------------------------------------------
SUMMARY: Myonex Inc. 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, 2023. Such persons may also file a written request for a
hearing on the application on or before April 24, 2023.
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 December 21, 2022, Myonex Inc.. 100 Progress Drive,
Horsham, Pennsylvania 19044, applied to be registered as an importer of
the following basic class(es) of controlled substance(s):
------------------------------------------------------------------------
Drug
Controlled substance code Schedule
------------------------------------------------------------------------
Amphetamine............................. 1100 II
Lisdexamfetamine........................ 1205 II
Methylphenidate......................... 1724 II
Nabilone................................ 7379 II
Oxycodone............................... 9143 II
Hydromorphone........................... 9150 II
Hydrocodone............................. 9193 II
Morphine................................ 9300 II
Oxymorphone............................. 9652 II
Fentanyl................................ 9801 II
------------------------------------------------------------------------
The company plans to import the listed controlled substances in
dosage form for clinical trials, research, and analytical 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. 2023-05913 Filed 3-22-23; 8:45 am]
BILLING CODE P