Bulk Manufacturer of Controlled Substances Application: Bulk Manufacturers of Marihuana: Royal Emerald Pharmaceuticals Research and Development, 71001 [2019-27783]
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71001
Federal Register / Vol. 84, No. 247 / Thursday, December 26, 2019 / Notices
Registered bulk manufacturers of
the affected basic classes, and
applicants therefore, may file written
comments on or objections to the
issuance of the proposed registration on
or before February 24, 2020.
ADDRESSES: 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 October 25, 2019,
Kinetochem LLC, 111 W Cooperative
Way, Suite 310–B, Georgetown, Texas
78626 applied to be registered as a bulk
manufacturer of the following basic
classes of controlled substances:
DATES:
Controlled
substance
Drug code
Marihuana ...............
Tetrahydrocannabinols.
7360
7370
Schedule
I
I
The company plans to synthetically
manufacture drug codes 7360
(marihuana) and 7370
(tetrahydrocannabinols), in bulk for
distribution and sale to its customers.
No other activities for these drug codes
are authorized for this registration.
Dated: December 6, 2019.
William T. McDermott,
Assistant Administrator.
[FR Doc. 2019–27784 Filed 12–23–19; 8:45 am]
BILLING CODE 4410–09–P
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. DEA–559]
Bulk Manufacturer of Controlled
Substances Application: Bulk
Manufacturers of Marihuana: Royal
Emerald Pharmaceuticals Research
and Development
ACTION:
Notice of application.
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 classes of
controlled substances listed in schedule
I. Prior to making decisions on this and
other pending applications, DEA
intends to promulgate regulations that
govern the program of growing
marihuana for scientific and medical
research under DEA registration.
DATES: Registered bulk manufacturers of
the affected basic classes, and
khammond on DSKJM1Z7X2PROD with NOTICES
SUMMARY:
VerDate Sep<11>2014
16:53 Dec 23, 2019
Jkt 250001
applicants therefore, may file written
comments on or objections to the
issuance of the proposed registration on
or before February 24, 2020.
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–559 in all correspondence,
including attachments.
ADDRESSES:
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
classes, and applicants therefore, 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 its 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
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) as described
in 84 FR 44920, published on August
27, 2019.
In accordance with 21 CFR
1301.33(a), DEA is providing notice that
on September 24, 2019, Royal Emerald
Pharmaceuticals Research and
Development, 7220 Trade Street, Suite
340, San Diego, California 92121–2324
applied to be registered as a bulk
manufacturer of the following basic
classes of controlled substances:
SUPPLEMENTARY INFORMATION:
PO 00000
Frm 00074
Fmt 4703
Sfmt 4703
Controlled
substance
Drug code
Marihuana Extract
Marihuana .............
Tetrahydrocannabinols ....................
Schedule
7350
7360
1
I
7370
I
The applicant noticed above applied
to become registered with DEA to grow
marihuana as a bulk manufacturer
subsequent to a 2016 DEA policy
statement that provided information on
how it intended to expand the number
of registrations, and described in general
terms the way it would oversee those
additional growers. Before DEA
completes the evaluation and
registration process for applicants to
grow marihuana, DEA intends to
propose regulations in the near future
that would supersede the 2016 policy
statement and govern persons seeking to
become registered with DEA to grow
marihuana as bulk manufacturers,
consistent with applicable law, as
described in 84 FR 44920.
Dated: December 6, 2019.
William T. McDermott,
Assistant Administrator.
[FR Doc. 2019–27783 Filed 12–23–19; 8:45 am]
BILLING CODE 4410–09–P
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. DEA–563]
Bulk Manufacturer of Controlled
Substances Application: Bulk
Manufacturers of Marihuana:
Agronomed Pharmaceuticals
ACTION:
Notice of application.
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 classes of
controlled substances listed in schedule
I. Prior to making decisions on this and
other pending applications, DEA
intends to promulgate regulations that
govern the program of growing
marihuana for scientific and medical
research under DEA registration.
DATES: Registered bulk manufacturers of
the affected basic classes, and
applicants therefor, may file written
comments on or objections to the
issuance of the proposed registration on
or before February 24, 2020.
ADDRESSES: Written comments should
be sent to: Drug Enforcement
Administration, Attention: DEA Federal
Register Representative/DPW 8701
Morrissette Drive, Springfield, Virginia
SUMMARY:
E:\FR\FM\26DEN1.SGM
26DEN1
]]>Agencies
[Federal Register Volume 84, Number 247 (Thursday, December 26, 2019)]
[Notices]
[Page 71001]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-27783]
-----------------------------------------------------------------------
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. DEA-559]
Bulk Manufacturer of Controlled Substances Application: Bulk
Manufacturers of Marihuana: Royal Emerald Pharmaceuticals Research and
Development
ACTION: Notice of application.
-----------------------------------------------------------------------
SUMMARY: 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 classes of controlled
substances listed in schedule I. Prior to making decisions on this and
other pending applications, DEA intends to promulgate regulations that
govern the program of growing marihuana for scientific and medical
research under DEA registration.
DATES: Registered bulk manufacturers of the affected basic classes, and
applicants therefore, may file written comments on or objections to the
issuance of the proposed registration on or before February 24, 2020.
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-559 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 classes, and applicants therefore, 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 its 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 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) as described in 84 FR 44920, published on
August 27, 2019.
In accordance with 21 CFR 1301.33(a), DEA is providing notice that
on September 24, 2019, Royal Emerald Pharmaceuticals Research and
Development, 7220 Trade Street, Suite 340, San Diego, California 92121-
2324 applied to be registered as a bulk manufacturer of the following
basic classes of controlled substances:
------------------------------------------------------------------------
Controlled substance Drug code Schedule
------------------------------------------------------------------------
Marihuana Extract............................... 7350 1
Marihuana....................................... 7360 I
Tetrahydrocannabinols........................... 7370 I
------------------------------------------------------------------------
The applicant noticed above applied to become registered with DEA
to grow marihuana as a bulk manufacturer subsequent to a 2016 DEA
policy statement that provided information on how it intended to expand
the number of registrations, and described in general terms the way it
would oversee those additional growers. Before DEA completes the
evaluation and registration process for applicants to grow marihuana,
DEA intends to propose regulations in the near future that would
supersede the 2016 policy statement and govern persons seeking to
become registered with DEA to grow marihuana as bulk manufacturers,
consistent with applicable law, as described in 84 FR 44920.
Dated: December 6, 2019.
William T. McDermott,
Assistant Administrator.
[FR Doc. 2019-27783 Filed 12-23-19; 8:45 am]
BILLING CODE 4410-09-P
