Importer of Controlled Substances Application: Aurobindo Pharma USA, Inc., 50903 [2021-19631]
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50903
Federal Register / Vol. 86, No. 174 / Monday, September 13, 2021 / Notices
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 July 1, 2021, Amethyst Exploration,
LLC., 4210 Jewell Road, Sparta, Georgia
31087, applied to be registered as a bulk
manufacturer of the following basic
class(es) of controlled substances:
Drug
code
Controlled substance
Marihuana Extract .........
Marihuana ......................
Tetrahydrocannabinols ..
I
7350
7360
7370
Schedule
I
I
I
I
Brian S. Besser,
Acting Assistant Administrator.
[FR Doc. 2021–19629 Filed 9–10–21; 8:45 am]
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DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. DEA–899]
lotter on DSK11XQN23PROD with NOTICES1
I
I
I
II
II
II
II
II
II
II
The company plans to manufacture
the listed controlled substances for
product development and reference
standards. In reference to drug codes
7360 (Marihuana) and 7370
(Tetrahydrocannabinols), the company
plans to isolate these controlled
substances from procured 7350
(Marihuana Extract). In reference to
drug code 7360, no cultivation activities
are authorized for this registration. In
reference to drug code 9333 (Thebaine),
the company plans to manufacture a
Thebaine derivative. No other activities
for these drug codes are authorized for
this registration.
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
Eli-Elsohly Laboratories 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 file written
comments on or objections to the
issuance of the proposed registration on
or before November 12, 2021. Such
persons may also file a written request
for a hearing on the application on or
before November 12, 2021.
Jkt 253001
7350
7360
7370
1100
1105
9041
9050
9120
9180
9333
Schedule
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Drug Enforcement
Administration, Justice.
ACTION: Notice of application.
17:39 Sep 10, 2021
Marihuana Extract .........
Marihuana ......................
Tetrahydrocannabinols ..
Amphetamine ................
Methamphetamine .........
Cocaine .........................
Codeine .........................
Dihydrocodeine ..............
Ecgonine ........................
Thebaine ........................
Drug
code
[FR Doc. 2021–19679 Filed 9–10–21; 8:45 am]
AGENCY:
VerDate Sep<11>2014
Controlled substances
Brian S. Bresser,
Acting Assistant Administrator.
Bulk Manufacturer of Controlled
Substances Application: Eli-Elsohly
Laboratories
SUMMARY:
Written comments should
be sent to: Drug Enforcement
Administration, Attention: DEA Federal
Register Representative/DPW, 8701
Morrissette Drive, Springfield, Virginia
22152.
SUPPLEMENTARY INFORMATION: In
accordance with 21 CFR 1301.33(a), this
is notice that on August 5, 2021, EliElsohly Laboratories, 5 Industrial Park
Drive, Oxford, Mississippi 38655,
applied to be registered as an bulk
manufacturer of the following basic
class(es) of controlled substance(s):
ADDRESSES:
[Docket No. DEA–897]
Importer of Controlled Substances
Application: Aurobindo Pharma USA,
Inc.
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 October 13, 2021. Such
persons may also file a written request
for a hearing on the application on or
before October 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 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 20, 2021,
Aurobindo Pharma USA, Inc., 6
Wheeling Road, Dayton, New Jersey
08810–1526, applied to be registered as
an importer of the following basic
class(es) of controlled substance(s):
SUPPLEMENTARY INFORMATION:
Drug
code
Controlled substance
Remifentanil ...................
I
9739
Brian S. Besser,
Acting Assistant Administrator.
Aurobindo Pharma USA, 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.
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SUMMARY:
PO 00000
Frm 00033
Fmt 4703
Sfmt 9990
III
The company plans to import
Remifentanil (9739) in bulk form for
research and development. 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.
Drug Enforcement
Administration, Justice.
ACTION: Notice of application.
AGENCY:
Schedule
[FR Doc. 2021–19631 Filed 9–10–21; 8:45 am]
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[Federal Register Volume 86, Number 174 (Monday, September 13, 2021)]
[Notices]
[Page 50903]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-19631]
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DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. DEA-897]
Importer of Controlled Substances Application: Aurobindo Pharma
USA, Inc.
AGENCY: Drug Enforcement Administration, Justice.
ACTION: Notice of application.
-----------------------------------------------------------------------
SUMMARY: Aurobindo Pharma USA, 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 file written comments on or objections to
the issuance of the proposed registration on or before October 13,
2021. Such persons may also file a written request for a hearing on the
application on or before October 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
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 20, 2021, Aurobindo Pharma USA, Inc., 6 Wheeling
Road, Dayton, New Jersey 08810-1526, applied to be registered as an
importer of the following basic class(es) of controlled substance(s):
------------------------------------------------------------------------
Drug
Controlled substance code Schedule
------------------------------------------------------------------------
Remifentanil........................... 9739 II
------------------------------------------------------------------------
The company plans to import Remifentanil (9739) in bulk form for
research and development. 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 non-approved finished
dosage forms for commercial sale.
Brian S. Besser,
Acting Assistant Administrator.
[FR Doc. 2021-19631 Filed 9-10-21; 8:45 am]
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