Bulk Manufacturer of Controlled Substances Application: Patheon API Manufacturing, Inc., 33911-33912 [2023-11163]
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33911
Federal Register / Vol. 88, No. 101 / Thursday, May 25, 2023 / Notices
Controlled substance
Drug code
3, 4-Methylenedioxyamphetamine .........................................................................................................................................
3, 4-Methylenedioxymethamphetamine .................................................................................................................................
5-Methoxy-N-N-dimethyltryptamine .......................................................................................................................................
Dimethyltryptamine ................................................................................................................................................................
Psilocybin ...............................................................................................................................................................................
Psilocyn .................................................................................................................................................................................
5-Methoxy-N, N-diisopropyltryptamine ..................................................................................................................................
The company plans to bulk
manufacture the listed controlled
substances for the internal use
intermediates or for sale to its
customers. In reference to dug codes
7370 (Tetrahydrocannabinols), the
company plans to bulk manufacture this
drug as synthetic. No other activities for
these drug codes are authorized for this
registration.
Matthew Strait,
Deputy Assistant Administrator.
[FR Doc. 2023–11158 Filed 5–24–23; 8:45 am]
BILLING CODE P
Controlled substance
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
Lysergic acid
diethylamide.
Mescaline ........................
Peyote .............................
Diethyltryptamine .............
Dimethyltryptamine ..........
Psilocybin ........................
Psilocyn ...........................
[Docket No. DEA–1206]
Bulk Manufacturer of Controlled
Substances Application: Irvine Labs,
Inc.
Drug Enforcement
Administration, Justice.
ACTION: Notice of application.
AGENCY:
Irvine Labs, 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 July 24, 2023. Such persons
may also file a written request for a
hearing on the application on or before
July 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
lotter on DSK11XQN23PROD with NOTICES1
SUMMARY:
VerDate Sep<11>2014
18:04 May 24, 2023
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 April 5, 2023, Irvine
Labs, Inc., 7305 Murdy Drive, Hunting
Beach, California 92647–3533, applied
to be registered as a bulk manufacturer
of the following basic class(es) of
controlled substance(s):
Jkt 259001
Drug
code
Schedule
7315
I
7381
7415
7434
7435
7437
7438
I
I
I
I
I
I
The company plans to bulk
manufacture the listed controlled
substances to support their internal
research, clinical trials, and analytical
purposes as well as to distribute to their
customers. No other activities for these
drug codes are authorized for this
registration.
Matthew Strait,
Deputy Assistant Administrator.
[FR Doc. 2023–11178 Filed 5–24–23; 8:45 am]
BILLING CODE P
DEPARTMENT OF JUSTICE
7400
7405
7431
7435
7437
7438
7439
Schedule
I
I
I
I
I
I
I
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 July 24, 2023. Such persons
may also file a written request for a
hearing on the application on or before
July 24, 2023.
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 March 31, 2023,
Patheon API Manufacturing, Inc., 309
Delaware Street, Greenville, South
Carolina 29605–5420, applied to be
registered as a bulk manufacturer of the
following basic class(es) of controlled
substance(s):
SUPPLEMENTARY INFORMATION:
Drug Enforcement Administration
Controlled substance
[Docket No. DEA–1191]
Bulk Manufacturer of Controlled
Substances Application: Patheon API
Manufacturing, Inc.
Drug Enforcement
Administration, Justice.
ACTION: Notice of application.
Dimethyltryptamine ..........
Psilocybin ........................
Psilocyn ...........................
Drug
code
Schedule
7435
7437
7438
I
I
I
AGENCY:
Patheon API Manufacturing,
Inc. has applied to be registered as a
bulk manufacturer of basic class(es) of
controlled substance(s). Refer to
SUMMARY:
PO 00000
Frm 00052
Fmt 4703
Sfmt 4703
The company plans to bulk
manufacture the listed controlled
substances as an Active Pharmaceutical
Ingredient (API) for distribution to its
customers. No other activities for these
E:\FR\FM\25MYN1.SGM
25MYN1
33912
Federal Register / Vol. 88, No. 101 / Thursday, May 25, 2023 / Notices
8701 Morrissette Drive, Springfield,
Virginia 22152.
SUPPLEMENTARY INFORMATION: In
accordance with 21 CFR 1301.34(a), this
is notice that on April 25, 2023,
Galephar Pharmaceutical Research, Inc.,
100 Carr 198 Industrial Park, Juncos,
Puerto Rico 00777–3873, applied to be
registered as an importer of the
following basic class(es) of controlled
substance(s):
drug codes are authorized for this
registration.
Matthew Strait,
Deputy Assistant Administrator.
[FR Doc. 2023–11163 Filed 5–24–23; 8:45 am]
BILLING CODE P
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. DEA–1201]
Controlled substance
Importer of Controlled Substances
Application: Galephar Pharmaceuticals
Research, Inc.
Drug Enforcement
Administration, Justice.
ACTION: Notice of application.
AGENCY:
Galephar Pharmaceuticals
Research, 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 June 26, 2023. Such
persons may also file a written request
for a hearing on the application on or
before June 26, 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,
lotter on DSK11XQN23PROD with NOTICES1
SUMMARY:
VerDate Sep<11>2014
18:04 May 24, 2023
Jkt 259001
Morphine ..........................
Drug
code
Schedule
9300
II
The company plans to import the
listed controlled substance for analytical
purpose only. 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. 2023–11176 Filed 5–24–23; 8:45 am]
BILLING CODE P
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. DEA–1199]
Importer of Controlled Substances
Application: Usona Institute
Drug Enforcement
Administration, Justice.
ACTION: Notice of application.
AGENCY:
Usona Institute 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 June 26, 2023. Such
persons may also file a written request
for a hearing on the application on or
before June 26, 2023.
ADDRESSES: The Drug Enforcement
Administration requires that all
comments be submitted electronically
through the Federal eRulemaking Portal,
DATES:
PO 00000
Frm 00053
Fmt 4703
Sfmt 9990
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 April 20, 2023, Usona
Institute, 2780 Woods Hollow Road,
Room 2412, Fitchburg, Wisconsin
53711–5370, applied to be registered as
an importer of the following basic
class(es) of controlled substance(s):
SUPPLEMENTARY INFORMATION:
Controlled substance
5-Methoxy-N–Ndimethyltryptamine.
Dimethyltryptamine ..........
Psilocybin ........................
Psilocyn ...........................
Drug
code
Schedule
7431
I
7435
7437
7438
I
I
I
The institute plans to import the
listed controlled substances to be used
for research and analytical purposes.
The materials will not be used for
clinical trials or bulk manufacture. 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. 2023–11174 Filed 5–24–23; 8:45 am]
BILLING CODE P
E:\FR\FM\25MYN1.SGM
25MYN1
]]>Agencies
[Federal Register Volume 88, Number 101 (Thursday, May 25, 2023)]
[Notices]
[Pages 33911-33912]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-11163]
-----------------------------------------------------------------------
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. DEA-1191]
Bulk Manufacturer of Controlled Substances Application: Patheon
API Manufacturing, Inc.
AGENCY: Drug Enforcement Administration, Justice.
ACTION: Notice of application.
-----------------------------------------------------------------------
SUMMARY: Patheon API Manufacturing, 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
July 24, 2023. Such persons may also file a written request for a
hearing on the application on or before July 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.
SUPPLEMENTARY INFORMATION: In accordance with 21 CFR 1301.33(a), this
is notice that on March 31, 2023, Patheon API Manufacturing, Inc., 309
Delaware Street, Greenville, South Carolina 29605-5420, applied to be
registered as a bulk manufacturer of the following basic class(es) of
controlled substance(s):
------------------------------------------------------------------------
Drug
Controlled substance code Schedule
------------------------------------------------------------------------
Dimethyltryptamine...................... 7435 I
Psilocybin.............................. 7437 I
Psilocyn................................ 7438 I
------------------------------------------------------------------------
The company plans to bulk manufacture the listed controlled
substances as an Active Pharmaceutical Ingredient (API) for
distribution to its customers. No other activities for these
[[Page 33912]]
drug codes are authorized for this registration.
Matthew Strait,
Deputy Assistant Administrator.
[FR Doc. 2023-11163 Filed 5-24-23; 8:45 am]
BILLING CODE P
