Importer of Controlled Substances Application: Globyz Pharma, LLC, 44405-44406 [2021-17181]
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44405
Federal Register / Vol. 86, No. 153 / Thursday, August 12, 2021 / Notices
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. DEA–865]
Bulk Manufacturer of Controlled
Substances Application: Bulk
Manufacturer of Marihuana: PA
Options for Wellness, Inc.
Drug Enforcement
Administration, Justice.
ACTION: Notice of application.
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
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.
SUMMARY:
Registered bulk manufacturers of
the affected basic class(es), and
applicants therefor, may file written
comments on or objections to the
issuance of the proposed registration on
or before October 12, 2021.
ADDRESSES: Written comments should
be sent to: Drug Enforcement
Administration, Attention: DEA Federal
Register Representative/DPW, 8701
Morrissette Drive, Springfield, Virginia
22152. To ensure proper handling of
comments, please reference Docket No.
DEA–865 in all correspondence,
including attachments.
SUPPLEMENTARY INFORMATION: 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
file written 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
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DATES:
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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
applicable laws, treaties, and
regulations and to ensure adequate
safeguards against diversion are in
place.
As this applicant has applied to
become registered as a bulk
manufacturer of marihuana, the
application will be evaluated under the
criteria of 21 U.S.C. 823(a). DEA will
conduct this evaluation in the manner
described in the rule published at 85 FR
82333 on December 18, 2020, and
reflected in DEA regulations at 21 CFR
part 1318.
In accordance with 21 CFR
1301.33(a), DEA is providing notice that
on May 26, 2021, PA Options for
Wellness, Inc., 4711 Queen Avenue,
Suite 201, Harrisburg, Pennsylvania
17109–3125, applied to be registered as
a bulk manufacturer of the following
basic class(es) of controlled substances:
Controlled substance
Marihuana Extract ...........
Marihuana ........................
Tetrahydrocannabinols ....
I
Drug
code
Schedule
7350
7360
7370
I
I
I
I
Brian S. Besser,
Acting Assistant Administrator.
[FR Doc. 2021–17171 Filed 8–11–21; 8:45 am]
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DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. DEA–878]
Importer of Controlled Substances
Application: Epic Pharma, LLC
Drug Enforcement
Administration, Justice.
ACTION: Notice of application.
Written comments should
be sent to: Drug Enforcement
Administration, Attention: DEA Federal
Register Representative/DPW, 8701
Morrissette Drive, Springfield, Virginia
22152. All requests for a hearing must
be sent to: Drug Enforcement
Administration, Attn: Administrator,
8701 Morrissette Drive, Springfield,
Virginia 22152. All requests for a
hearing should also 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.
SUPPLEMENTARY INFORMATION: In
accordance with 21 CFR 1301.34(a), this
is notice that on July 7, 2021, Epic
Pharma, LLC., 22715 North Conduit
Avenue, Laurelton, New York 11413,
applied to be registered as an importer
of the following basic class(es) of
controlled substance(s):
ADDRESSES:
Drug
code
Controlled substance
Methadone .....................
I
9250
Schedule
III
The company plans to import the
listed controlled substance for research
and development purposes.
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.
Brian S. Besser,
Acting Assistant Administrator.
[FR Doc. 2021–17182 Filed 8–11–21; 8:45 am]
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AGENCY:
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
Epic Pharma, 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 file written
comments on or objections to the
issuance of the proposed registration on
or before September 13, 2021. Such
persons may also file a written request
for a hearing on the application on or
before September 13, 2021.
SUMMARY:
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[Docket No. DEA–875]
Importer of Controlled Substances
Application: Globyz Pharma, LLC
Drug Enforcement
Administration, Justice.
ACTION: Notice of application.
AGENCY:
Globyz Pharma, 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.
SUMMARY:
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44406
Federal Register / Vol. 86, No. 153 / Thursday, August 12, 2021 / Notices
Registered bulk manufacturers of
the affected basic class(es), and
applicants therefore, may file written
comments on or objections to the
issuance of the proposed registration on
or before September 13, 2021. Such
persons may also file a written request
for a hearing on the application on or
before September 13, 2021.
DATES:
Written comments should
be sent to: Drug Enforcement
Administration, Attention: DEA Federal
Register Representative/DPW, 8701
Morrissette Drive, Springfield, Virginia
22152. All requests for a hearing must
be sent to: Drug Enforcement
Administration, Attn: Administrator,
8701 Morrissette Drive, Springfield,
Virginia 22152. All request for a hearing
should also 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.
ADDRESSES:
In
accordance with 21 CFR 1301.34(a), this
is notice that on May 7, 2021, Globyz
Pharma, LLC., 2101 Market Street, Suite
5, Upper Chichester, Pennsylvania
19061–4001, applied to be registered as
an importer of the following basic
class(es) of controlled substance(s):
SUPPLEMENTARY INFORMATION:
Drug
code
Controlled substance
Lisdexamfetamine .........
I
1205
Schedule
II
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The company plans to import finished
dosage unit products of
Lisdexamfetamine for the one time need
of analytical testing. No other activity
for this 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.
Brian S. Besser,
Acting Assistant Administrator.
Drug Enforcement Administration
[Docket No. DEA–881]
Drug Enforcement Administration
Notice of application.
[Docket No. DEA–882]
Cambrex High Point, Inc., has
applied to be registered as an importer
of basic class(es) of controlled
substance(s). Refer to Supplemental
Information listed below for further
drug information.
Importer of Controlled Substances
Application: MP Pharma Services
Registered bulk manufacturers of
the affected basic class(es), and
applicants therefore, may file written
comments on or objections to the
issuance of the proposed registration on
or before September 13, 2021. Such
persons may also file a written request
for a hearing on the application on or
before September 13, 2021.
SUMMARY:
SUMMARY:
DATES:
Written comments should
be sent to: Drug Enforcement
Administration, Attention: DEA Federal
Register Representative/DPW, 8701
Morrissette Drive, Springfield, Virginia
22152. All requests for a hearing must
be sent to: Drug Enforcement
Administration, Attn: Administrator,
8701 Morrissette Drive, Springfield,
Virginia 22152. All requests for a
hearing should also 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.
ADDRESSES:
In
accordance with 21 CFR 1301.34(a), this
is notice that on July 9, 2021, Cambrex
High Point, Inc., 4180 Mendenhall Oaks
Parkway, High Point, North Carolina
27265–8017, applied to renew as an
importer of the following basic class(es)
of controlled substance(s):
SUPPLEMENTARY INFORMATION:
Drug
code
Controlled substance
Poppy Straw Concentrate.
Schedule
9670
I
II
I
The company plans to import Poppy
Straw Concentrate to develop its own
portfolio of generic products. Approval
of permit applications will occur only
when the registrant’s business activity is
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DEPARTMENT OF JUSTICE
Drug Enforcement
Administration, Justice.
AGENCY:
ACTION:
Brian S. Besser,
Acting Assistant Administrator.
[FR Doc. 2021–17185 Filed 8–11–21; 8:45 am]
Importer of Controlled Substances
Application: Cambrex High Point, Inc.
[FR Doc. 2021–17181 Filed 8–11–21; 8:45 am]
VerDate Sep<11>2014
consistent with what is authorized
under 21 U.S.C. 952(a)(2).
DEPARTMENT OF JUSTICE
PO 00000
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Fmt 4703
Sfmt 4703
Drug Enforcement
Administration, Justice.
ACTION: Notice of application.
AGENCY:
MP Pharma Services has
applied to be registered as an importer
of basic class(es) of controlled
substance(s). Refer to Supplemental
Information listed below for further
drug information.
DATES: Registered bulk manufacturers of
the affected basic class(es), and
applicants therefore, may file written
comments on or objections to the
issuance of the proposed registration on
or before September 13, 2021. Such
persons may also file a written request
for a hearing on the application on or
before September 13, 2021.
ADDRESSES: Written comments should
be sent to: Drug Enforcement
Administration, Attention: DEA Federal
Register Representative/DPW, 8701
Morrissette Drive, Springfield, Virginia
22152. All requests for a hearing must
be sent to: Drug Enforcement
Administration, Attn: Administrator,
8701 Morrissette Drive, Springfield,
Virginia 22152. All request for a hearing
should also 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.
SUPPLEMENTARY INFORMATION: In
accordance with 21 CFR 1301.34(a), this
is notice that on June 30, 2021, MP
Pharma Services, 4222 Emperor
Boulevard, Suite 320, Durham, North
Carolina 27703–9455, applied to be
registered as an importer of the
following basic class(es) of controlled
substance(s):
Drug
code
Controlled substance
5-Methoxy-N-NDimethyltryptamine.
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Schedule
7431
I
I
I
]]>Agencies
[Federal Register Volume 86, Number 153 (Thursday, August 12, 2021)]
[Notices]
[Pages 44405-44406]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-17181]
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DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. DEA-875]
Importer of Controlled Substances Application: Globyz Pharma, LLC
AGENCY: Drug Enforcement Administration, Justice.
ACTION: Notice of application.
-----------------------------------------------------------------------
SUMMARY: Globyz Pharma, 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.
[[Page 44406]]
DATES: Registered bulk manufacturers of the affected basic class(es),
and applicants therefore, may file written comments on or objections to
the issuance of the proposed registration on or before September 13,
2021. Such persons may also file a written request for a hearing on the
application on or before September 13, 2021.
ADDRESSES: Written comments should be sent to: Drug Enforcement
Administration, Attention: DEA Federal Register Representative/DPW,
8701 Morrissette Drive, Springfield, Virginia 22152. All requests for a
hearing must be sent to: Drug Enforcement Administration, Attn:
Administrator, 8701 Morrissette Drive, Springfield, Virginia 22152. All
request for a hearing should also 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.
SUPPLEMENTARY INFORMATION: In accordance with 21 CFR 1301.34(a), this
is notice that on May 7, 2021, Globyz Pharma, LLC., 2101 Market Street,
Suite 5, Upper Chichester, Pennsylvania 19061-4001, applied to be
registered as an importer of the following basic class(es) of
controlled substance(s):
------------------------------------------------------------------------
Drug
Controlled substance code Schedule
------------------------------------------------------------------------
Lisdexamfetamine....................... 1205 I
------------------------------------------------------------------------
The company plans to import finished dosage unit products of
Lisdexamfetamine for the one time need of analytical testing. No other
activity for this 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 non-approved finished
dosage forms for commercial sale.
Brian S. Besser,
Acting Assistant Administrator.
[FR Doc. 2021-17181 Filed 8-11-21; 8:45 am]
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