Importer of Controlled Substances Application: S&B Pharma LLC DBA Norac Pharma, 13746 [2024-03718]
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13746
Federal Register / Vol. 89, No. 37 / Friday, February 23, 2024 / Notices
8701 Morrissette Drive, Springfield,
Virginia 22152.
SUPPLEMENTARY INFORMATION: In
accordance with 21 CFR 1301.34(a), this
is notice that on January 10, 2024, S&B
Pharma LLC DBA Norac Pharma, 405
South Motor Avenue, Azusa, California
91702, applied to be registered as an
importer of the following basic class(es)
of controlled substance(s):
approved finished dosage forms for
commercial sale.
Marsha Ikner,
Acting Deputy Assistant Administrator.
[FR Doc. 2024–03683 Filed 2–22–24; 8:45 am]
BILLING CODE P
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
Drug
code
Controlled substance
[Docket No. DEA–1326]
4-Anilino-N-phenethyl-4piperidine (ANPP).
Tapentadol .....................
Importer of Controlled Substances
Application: S&B Pharma LLC DBA
Norac Pharma
Drug Enforcement
Administration, Justice.
ACTION: Notice of application.
AGENCY:
S&B Pharma LLC DBA Norac
Pharma 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 March 25, 2024. Such
persons may also file a written request
for a hearing on the application on or
before March 25, 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,
ddrumheller on DSK120RN23PROD with NOTICES1
SUMMARY:
VerDate Sep<11>2014
17:19 Feb 22, 2024
Jkt 262001
I
Schedule
8333
II
9780
III
The company plans to import
intermediate forms of Tapentadol (9780)
for further manufacturing prior to
distribution to its customers. The
company plans to import ANNP (8333)
to bulk manufacture other controlled
substances for distribution to its
customers. 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. 2024–03718 Filed 2–22–24; 8:45 am]
BILLING CODE P
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. DEA–1319]
Bulk Manufacturer of Controlled
Substances Application: Patheon API
Services Inc.
Drug Enforcement
Administration, Justice.
ACTION: Notice of application.
for a hearing on the application on or
before April 23, 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 December 21, 2023,
Patheon API Services Inc., 101
Technology Place, Florence, South
Carolina 29501, applied to be registered
as a bulk manufacturer of the following
basic class(es) of controlled
substance(s):
Controlled substance
Dimethyltryptamine ........
Psilocybin ......................
Psilocyn .........................
Amphetamine ................
Methadone .....................
Drug
code
7435
7437
7438
1100
9250
Schedule
I
I
I
II
II
The company plans to bulk
manufacture the above controlled
substances to support customers’
clinical trials. No other activities for
these drug codes are authorized for this
registration.
Marsha Ikner,
Acting Deputy Assistant Administrator.
[FR Doc. 2024–03686 Filed 2–22–24; 8:45 am]
BILLING CODE P
AGENCY:
DEPARTMENT OF JUSTICE
Patheon API Services 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 April 23, 2024. Such
persons may also file a written request
SUMMARY:
PO 00000
Frm 00068
Fmt 4703
Sfmt 4703
Drug Enforcement Administration
[Docket No. DEA–1325]
Importer of Controlled Substances
Application: Pfizer, Inc.
Drug Enforcement
Administration, Justice.
ACTION: Notice of application.
AGENCY:
Pfizer, Inc. has applied to be
registered as an importer of basic
class(es) of controlled substance(s).
Refer to Supplementary Information
SUMMARY:
E:\FR\FM\23FEN1.SGM
23FEN1
]]>Agencies
[Federal Register Volume 89, Number 37 (Friday, February 23, 2024)]
[Notices]
[Page 13746]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-03718]
-----------------------------------------------------------------------
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. DEA-1326]
Importer of Controlled Substances Application: S&B Pharma LLC DBA
Norac Pharma
AGENCY: Drug Enforcement Administration, Justice.
ACTION: Notice of application.
-----------------------------------------------------------------------
SUMMARY: S&B Pharma LLC DBA Norac Pharma 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
March 25, 2024. Such persons may also file a written request for a
hearing on the application on or before March 25, 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.
SUPPLEMENTARY INFORMATION: In accordance with 21 CFR 1301.34(a), this
is notice that on January 10, 2024, S&B Pharma LLC DBA Norac Pharma,
405 South Motor Avenue, Azusa, California 91702, applied to be
registered as an importer of the following basic class(es) of
controlled substance(s):
------------------------------------------------------------------------
Drug
Controlled substance code Schedule
------------------------------------------------------------------------
4-Anilino-N-phenethyl-4-piperidine 8333 II
(ANPP).
Tapentadol............................. 9780 II
------------------------------------------------------------------------
The company plans to import intermediate forms of Tapentadol (9780)
for further manufacturing prior to distribution to its customers. The
company plans to import ANNP (8333) to bulk manufacture other
controlled substances for distribution to its customers. 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.
Marsha Ikner,
Acting Deputy Assistant Administrator.
[FR Doc. 2024-03718 Filed 2-22-24; 8:45 am]
BILLING CODE P
