Bulk Manufacturer of Controlled Substances Application: Bulk Manufacturers of Marihuana: Irvine Labs, Inc., 10470-10471 [2020-03623]
Download as PDF
<![CDATA[
10470
Federal Register / Vol. 85, No. 36 / Monday, February 24, 2020 / Notices
Controlled substance
Drug code
Fentanyl related-compounds as defined in 21 CFR 1308.11(h) .....................................................................................
Phenmetrazine .................................................................................................................................................................
Methylphenidate ..............................................................................................................................................................
Amobarbital ......................................................................................................................................................................
Pentobarbital ....................................................................................................................................................................
Secobarbital .....................................................................................................................................................................
Glutethimide .....................................................................................................................................................................
Dronabinol in an oral solution in a drug product approved for marketing by the U.S. Food and Drug Administration
Nabilone ...........................................................................................................................................................................
1-Phenylcyclohexylamine ................................................................................................................................................
Phencyclidine ...................................................................................................................................................................
4-Anilino-N-phenethyl-4-piperidine (ANPP) .....................................................................................................................
Phenylacetone .................................................................................................................................................................
1-Piperidinocyclohexanecarbonitrile ................................................................................................................................
Alphaprodine ....................................................................................................................................................................
Anileridine ........................................................................................................................................................................
Coca Leaves ....................................................................................................................................................................
Cocaine ............................................................................................................................................................................
Etorphine HCl ..................................................................................................................................................................
Dihydrocodeine ................................................................................................................................................................
Diphenoxylate ..................................................................................................................................................................
Ecgonine ..........................................................................................................................................................................
Ethylmorphine ..................................................................................................................................................................
Levomethorphan ..............................................................................................................................................................
Levorphanol .....................................................................................................................................................................
Isomethadone ..................................................................................................................................................................
Meperidine .......................................................................................................................................................................
Meperidine intermediate-A ..............................................................................................................................................
Meperidine intermediate-B ..............................................................................................................................................
Meperidine intermediate-C ..............................................................................................................................................
Metazocine ......................................................................................................................................................................
Metopon ...........................................................................................................................................................................
Dextropropoxyphene, bulk (non-dosage forms) ..............................................................................................................
Dihydroetorphine .............................................................................................................................................................
Opium tincture .................................................................................................................................................................
Opium, powdered ............................................................................................................................................................
Opium, granulated ...........................................................................................................................................................
Phenazocine ....................................................................................................................................................................
Thiafentanil ......................................................................................................................................................................
Piminodine .......................................................................................................................................................................
Racemethorphan .............................................................................................................................................................
Racemorphan ..................................................................................................................................................................
Alfentanil ..........................................................................................................................................................................
Remifentanil .....................................................................................................................................................................
Sufentanil .........................................................................................................................................................................
Carfentanil .......................................................................................................................................................................
Tapentadol .......................................................................................................................................................................
Bezitramide ......................................................................................................................................................................
Moramide-intermediate ....................................................................................................................................................
The company plans to import small
quantities of the listed controlled
substances for the National Institute on
Drug Abuse for research activities. The
company plans to import analytical
reference standards for distribution to
its customers for research and analytical
purposes.
lotter on DSKBCFDHB2PROD with NOTICES
Dated: February 6, 2020.
William T. McDermott,
Assistant Administrator.
BILLING CODE 4410–09–P
18:30 Feb 21, 2020
Drug Enforcement Administration
[Docket No. DEA–588]
Jkt 250001
I
II
II
II
II
II
II
II
II
II
II
II
II
II
II
II
II
II
II
II
II
II
II
II
II
II
II
II
II
II
II
II
II
II
II
II
II
II
II
II
II
II
II
II
II
II
II
II
II
intends to promulgate regulations that
govern the program of growing
marihuana for scientific and medical
research under DEA registration.
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 April 24, 2020.
DATES:
Bulk Manufacturer of Controlled
Substances Application: Bulk
Manufacturers of Marihuana: Irvine
Labs, Inc.
ACTION:
[FR Doc. 2020–03619 Filed 2–21–20; 8:45 am]
VerDate Sep<11>2014
DEPARTMENT OF JUSTICE
9850
1631
1724
2125
2270
2315
2550
7365
7379
7460
7471
8333
8501
8603
9010
9020
9040
9041
9059
9120
9170
9180
9190
9210
9220
9226
9230
9232
9233
9234
9240
9260
9273
9334
9630
9639
9640
9715
9729
9730
9732
9733
9737
9739
9740
9743
9780
9800
9802
Schedule
Notice of application.
PO 00000
Frm 00073
Fmt 4703
Sfmt 4703
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–588 in all correspondence,
including attachments.
ADDRESSES:
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
SUMMARY:
E:\FR\FM\24FEN1.SGM
24FEN1
10471
Federal Register / Vol. 85, No. 36 / Monday, February 24, 2020 / Notices
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 May 30, 2019, Irvine Labs, Inc., 1864
Swan Circle, Costa Mesa, California
92626–4739 applied to be registered as
a bulk manufacturer of the following
basic class of controlled substances:
SUPPLEMENTARY INFORMATION:
Controlled
substance
Marihuana Extract ..
Marihuana ...............
Tetrahydrocannabinols.
Drug code
7350
7360
7370
Schedule
I
I
I
The applicant noticed above applied
to become registered with DEA to grow
marihuana as 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: February 3, 2020.
William T. McDermott,
Assistant Administrator.
Gamma Hydroxybutyric
Acid.
lotter on DSKBCFDHB2PROD with NOTICES
Jkt 250001
2010
I
I
I
Dated: January 31, 2020.
William T. McDermott,
Assistant Administrator.
[FR Doc. 2020–03617 Filed 2–21–20; 8:45 am]
BILLING CODE 4410–09–P
[FR Doc. 2020–03623 Filed 2–21–20; 8:45 am]
BILLING CODE 4410–09–P
DEPARTMENT OF JUSTICE
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
Drug Enforcement Administration
[Docket No. DEA–595]
[Docket No. DEA–585]
Bulk Manufacturer of Controlled
Substances Application: Patheon
Pharmaceuticals, Inc.
ACTION:
Bulk Manufacturer of Controlled
Substances Application: Chemtos,
LLC
ACTION:
Notice of application.
Notice of application.
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 April 24, 2020.
ADDRESSES: Written comments should
be sent to: Drug Enforcement
Administration, Attention: DEA Federal
Register Representative/DPW, 8701
Morrissette Drive, Springfield, Virginia
22152.
DATES:
In
accordance with 21 CFR 1301.33(a), this
is notice that on December 23, 2019,
Patheon Pharmaceuticals, Inc., 2100 E
Galbraith Road, Cincinnati, Ohio
45237–1625 applied to be registered as
a bulk manufacturer of the following
basic class(es) of controlled substance:
SUPPLEMENTARY INFORMATION:
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 April 24, 2020.
DATES:
Written comments should
be sent to: Drug Enforcement
Administration, Attention: DEA Federal
Register Representative/DPW, 8701
Morrissette Drive, Springfield, Virginia
22152.
ADDRESSES:
In
accordance with 21 CFR 1301.33(a), this
is notice that on January 9, 2020,
Chemtos, LLC, 16713 Picadilly Court,
Round Rock, Texas 78664–8544 applied
to be registered as a bulk manufacturer
of the following basic classes of
controlled substances:
SUPPLEMENTARY INFORMATION:
Drug
code
3-Fluoro-N-methylcathinone (3–FMC) .....................................................................................................................................
Cathinone ................................................................................................................................................................................
Methcathinone .........................................................................................................................................................................
4-Fluoro-N-methylcathinone (4–FMC) .....................................................................................................................................
Pentedrone (a-methylaminovalerophenone) ...........................................................................................................................
Mephedrone (4-Methyl-N-methylcathinone) ............................................................................................................................
4-Methyl-N-ethylcathinone (4–MEC) .......................................................................................................................................
18:30 Feb 21, 2020
Schedule
The Gamma Hydroxbutyric Acid will
be produced during the process of
converting gamma-butyrolactone into a
new product for development. The
company plans to manufacture the
above-listed controlled substance as
Active Pharmaceutical Ingredient (API)
that will be further synthesized into
dosage forms of a new product. No other
activities for this drug code are
authorized for this registration.
Controlled substance
VerDate Sep<11>2014
Drug
code
Controlled substance
PO 00000
Frm 00074
Fmt 4703
Sfmt 4703
E:\FR\FM\24FEN1.SGM
24FEN1
1233
1235
1237
1238
1246
1248
1249
Schedule
I
I
I
I
I
I
I
]]>Agencies
[Federal Register Volume 85, Number 36 (Monday, February 24, 2020)]
[Notices]
[Pages 10470-10471]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-03623]
-----------------------------------------------------------------------
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. DEA-588]
Bulk Manufacturer of Controlled Substances Application: Bulk
Manufacturers of Marihuana: Irvine Labs, Inc.
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 April 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-588 in all
correspondence, including attachments.
[[Page 10471]]
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 May 30, 2019, Irvine Labs, Inc., 1864 Swan Circle, Costa Mesa,
California 92626-4739 applied to be registered as a bulk manufacturer
of the following basic class of controlled substances:
------------------------------------------------------------------------
Controlled substance Drug code Schedule
------------------------------------------------------------------------
Marihuana Extract.................... 7350 I
Marihuana............................ 7360 I
Tetrahydrocannabinols................ 7370 I
------------------------------------------------------------------------
The applicant noticed above applied to become registered with DEA
to grow marihuana as 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: February 3, 2020.
William T. McDermott,
Assistant Administrator.
[FR Doc. 2020-03623 Filed 2-21-20; 8:45 am]
BILLING CODE 4410-09-P
