Bulk Manufacturer of Controlled Substances Application: Pisgah Laboratories Inc., 37246 [2024-09810]
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37246
Federal Register / Vol. 89, No. 88 / Monday, May 6, 2024 / Notices
By order of the Commission.
Pisgah Laboratories 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 5, 2024. Such persons
may also file a written request for a
hearing on the application on or before
July 5, 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
SUMMARY:
Issued: April 30, 2024.
Lisa Barton,
Secretary to the Commission.
[FR Doc. 2024–09746 Filed 5–3–24; 8:45 am]
BILLING CODE 7020–02–P
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. DEA–1360]
Bulk Manufacturer of Controlled
Substances Application: Pisgah
Laboratories Inc.
Drug Enforcement
Administration, Justice.
ACTION: Notice of application.
AGENCY:
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 15, 2024, Pisgah
Laboratories Inc., 3222 Old
Hendersonville Highway, Pisgah Forest,
North Carolina 28768, applied to be
registered as a bulk manufacturer of the
following basic class(es) of controlled
substance(s):
Controlled substance
Drug code
4-Bromo-2,5-dimethoxyphenethylamine ..............................................................................................................................
Methylone (3,4-Methylenedioxy-N-methylcathinone) ..........................................................................................................
Amphetamine .......................................................................................................................................................................
Lisdexamfetamine ................................................................................................................................................................
Methylphenidate ..................................................................................................................................................................
Diphenoxylate ......................................................................................................................................................................
Meperidine ...........................................................................................................................................................................
Methadone ...........................................................................................................................................................................
Tapentadol ...........................................................................................................................................................................
The company plans to bulk
manufacture the above-listed controlled
substances in bulk for internal research
purposes and distribution to its
customers. No other activities for these
drug codes are authorized for this
registration.
Marsha Ikner,
Acting Deputy Assistant Administrator.
[FR Doc. 2024–09810 Filed 5–3–24; 8:45 am]
BILLING CODE P
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. 1354]
Bulk Manufacturer of Controlled
Substances Application: Bulk
Manufacturer of Marihuana: Entheogen
Pharmaceuticals Inc
Drug Enforcement
Administration, Justice.
ACTION: Notice of application.
ddrumheller on DSK120RN23PROD with NOTICES1
AGENCY:
The Drug Enforcement
Administration (DEA) is providing
notice of an application it has received
from an entity applying to be registered
to manufacture in bulk basic class(es) of
controlled substances listed in schedule
SUMMARY:
VerDate Sep<11>2014
18:02 May 03, 2024
Jkt 262001
I. DEA intends to evaluate this and other
pending applications according to its
regulations governing the program of
growing marihuana for scientific and
medical research under DEA
registration.
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 5, 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.’’
DATES:
PO 00000
Frm 00087
Fmt 4703
Sfmt 4703
7392
7540
1100
1205
1724
9170
9230
9250
9780
Schedule
I
I
II
II
II
II
II
II
II
The
Controlled Substances Act (CSA)
prohibits the cultivation and
distribution of marihuana except by
persons who are registered under the
CSA to do so for lawful purposes. In
accordance with the purposes specified
in 21 CFR 1301.33(a), DEA is providing
notice that the entity identified below
has applied for registration as a bulk
manufacturer of schedule I controlled
substances. In response, registered bulk
manufacturers of the affected basic
class(es), and applicants therefor, may
submit electronic comments on or
objections of the requested registration,
as provided in this notice. This notice
does not constitute any evaluation or
determination of the merits of the
application submitted.
The applicant plans to manufacture
bulk active pharmaceutical ingredients
(APIs) for product development and
distribution to DEA registered
researchers. If the application for
registration is granted, the registrant
would not be authorized to conduct
other activity under this registration
aside from those coincident activities
specifically authorized by DEA
regulations. DEA will evaluate the
application for registration as a bulk
manufacturer for compliance with all
SUPPLEMENTARY INFORMATION:
E:\FR\FM\06MYN1.SGM
06MYN1
]]>Agencies
[Federal Register Volume 89, Number 88 (Monday, May 6, 2024)]
[Notices]
[Page 37246]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-09810]
=======================================================================
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DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. DEA-1360]
Bulk Manufacturer of Controlled Substances Application: Pisgah
Laboratories Inc.
AGENCY: Drug Enforcement Administration, Justice.
ACTION: Notice of application.
-----------------------------------------------------------------------
SUMMARY: Pisgah Laboratories 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 5, 2024. Such persons may also file a written request for a
hearing on the application on or before July 5, 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 March 15, 2024, Pisgah Laboratories Inc., 3222 Old
Hendersonville Highway, Pisgah Forest, North Carolina 28768, applied to
be registered as a bulk manufacturer of the following basic class(es)
of controlled substance(s):
------------------------------------------------------------------------
Controlled substance Drug code Schedule
------------------------------------------------------------------------
4-Bromo-2,5-dimethoxyphenethylamine........ 7392 I
Methylone (3,4-Methylenedioxy-N- 7540 I
methylcathinone).
Amphetamine................................ 1100 II
Lisdexamfetamine........................... 1205 II
Methylphenidate............................ 1724 II
Diphenoxylate.............................. 9170 II
Meperidine................................. 9230 II
Methadone.................................. 9250 II
Tapentadol................................. 9780 II
------------------------------------------------------------------------
The company plans to bulk manufacture the above-listed controlled
substances in bulk for internal research purposes and distribution to
its customers. No other activities for these drug codes are authorized
for this registration.
Marsha Ikner,
Acting Deputy Assistant Administrator.
[FR Doc. 2024-09810 Filed 5-3-24; 8:45 am]
BILLING CODE P
