Bulk Manufacturer of Controlled Substances Application: Patheon Pharmaceuticals, Inc., 10471 [2020-03617]
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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
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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
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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
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]]>Agencies
[Federal Register Volume 85, Number 36 (Monday, February 24, 2020)]
[Notices]
[Page 10471]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-03617]
-----------------------------------------------------------------------
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. DEA-585]
Bulk Manufacturer of Controlled Substances Application: Patheon
Pharmaceuticals, Inc.
ACTION: Notice of application.
-----------------------------------------------------------------------
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 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.
SUPPLEMENTARY INFORMATION: 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:
------------------------------------------------------------------------
Drug
Controlled substance code Schedule
------------------------------------------------------------------------
Gamma Hydroxybutyric Acid.............. 2010 I
------------------------------------------------------------------------
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.
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
