Bulk Manufacturer of Controlled Substances Application: AMPAC Fine Chemicals Virginia LLC, 63619 [2023-20003]
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63619
Federal Register / Vol. 88, No. 178 / Friday, September 15, 2023 / Notices
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 July 27, 2023,
AndersonBrecon, Inc. DBA PCI Pharma
Services, 4545 Assembly Drive,
Rockford, Illinois 61109–3081, applied
to be registered as an importer of the
following basic class(es) of controlled
substance(s):
Controlled substance
Dimethyltryptamine ..........
Drug
code
Schedule
7435
I
The company plans to import the
listed controlled substances for clinical
trials. No other activity for this drug
code 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.
for a hearing on the application on or
before November 14, 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 May 2, 2023, AMPAC
Fine Chemicals Virginia LLC., 2820
North Normandy Drive, Petersburg,
Virginia 23805–2380, applied to be
registered as a bulk manufacturer of the
following basic class(es) of controlled
substance(s):
Controlled substance
Methylphenidate ...........
Levomethorphan ...........
Levorphanol ..................
Morphine .......................
Thebaine .......................
Noroxymorphone ..........
Tapentadol ....................
Claude Redd,
Acting Deputy Assistant Administrator.
[FR Doc. 2023–19988 Filed 9–14–23; 8:45 am]
BILLING CODE 4410–09–P
Drug
code
1724
9210
9220
9300
9333
9668
9780
Schedule
II
II
II
II
II
II
II
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. DEA–1264]
Bulk Manufacturer of Controlled
Substances Application: AMPAC Fine
Chemicals Virginia LLC
The company plans to bulk
manufacture the above listed controlled
substances for the internal use as
intermediates or for distribution to its
customers. No other activities for these
drug codes are authorized for this
registration.
Claude Redd,
Acting Deputy Assistant Administrator.
Drug Enforcement
Administration, Justice.
ACTION: Notice of application.
AGENCY:
[FR Doc. 2023–20003 Filed 9–14–23; 8:45 am]
BILLING CODE P
AMPAC Fine Chemicals
Virginia 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 November 14, 2023. Such
persons may also file a written request
ddrumheller on DSK120RN23PROD with NOTICES1
SUMMARY:
VerDate Sep<11>2014
17:05 Sep 14, 2023
Jkt 259001
Olon Ricerca Bioscience, 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 October 16, 2023. Such
persons may also file a written request
for a hearing on the application on or
before October 16, 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 July 11, 2023, Olon
Ricerca Bioscience, LLC, 7528 Auburn
Road, Concord Township, Ohio 44077–
9176, applied to be registered as an
importer of the following basic class(es)
of controlled substance(s):
SUMMARY:
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
Controlled substance
Drug
Code
Schedule
[Docket No. DEA–1260]
Phenylacetone .................
Importer of Controlled Substances
Application: Olon Ricerca Bioscience,
LLC
The company plans to import the
listed controlled substance to
manufacture into other controlled
substances which will be distributed to
its customers. No other activities for this
drug code is authorized for this
registration.
Drug Enforcement
Administration, Justice.
ACTION: Notice of application.
AGENCY:
PO 00000
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II
]]>Agencies
[Federal Register Volume 88, Number 178 (Friday, September 15, 2023)]
[Notices]
[Page 63619]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-20003]
-----------------------------------------------------------------------
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. DEA-1264]
Bulk Manufacturer of Controlled Substances Application: AMPAC
Fine Chemicals Virginia LLC
AGENCY: Drug Enforcement Administration, Justice.
ACTION: Notice of application.
-----------------------------------------------------------------------
SUMMARY: AMPAC Fine Chemicals Virginia 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
November 14, 2023. Such persons may also file a written request for a
hearing on the application on or before November 14, 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 May 2, 2023, AMPAC Fine Chemicals Virginia LLC., 2820
North Normandy Drive, Petersburg, Virginia 23805-2380, applied to be
registered as a bulk manufacturer of the following basic class(es) of
controlled substance(s):
------------------------------------------------------------------------
Drug
Controlled substance code Schedule
------------------------------------------------------------------------
Methylphenidate........................ 1724 II
Levomethorphan......................... 9210 II
Levorphanol............................ 9220 II
Morphine............................... 9300 II
Thebaine............................... 9333 II
Noroxymorphone......................... 9668 II
Tapentadol............................. 9780 II
------------------------------------------------------------------------
The company plans to bulk manufacture the above listed controlled
substances for the internal use as intermediates or for distribution to
its customers. No other activities for these drug codes are authorized
for this registration.
Claude Redd,
Acting Deputy Assistant Administrator.
[FR Doc. 2023-20003 Filed 9-14-23; 8:45 am]
BILLING CODE P
