Bulk Manufacturer of Controlled Substances Application: Insys Therapeutics, Inc., 9220 [2016-03855]
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Federal Register / Vol. 81, No. 36 / Wednesday, February 24, 2016 / Notices
Controlled substance
Schedule
Marihuana (7360) .........................
Tetrahydrocannabinols (7370) .....
4-Anilino-N-phenethyl-4-piperidine
(ANPP) (8333).
Remifentanil (9739) ......................
Fentanyl (9801) ............................
I
I
II
II
II
The company plans to manufacture
the above-listed controlled substances
in bulk for distribution to its customers.
In reference to drug code 7360,
marihuana, the company plans to bulk
manufacture cannabidiol as a synthetic
intermediate. This controlled substance
will be further synthesized to bulk
manufacture a synthetic
tetrahydrocannabinols (7370). No other
activity for this drug code is authorized
for this registration.
Dated: February 16, 2016.
Louis J. Milione,
Deputy Assistant Administrator.
[FR Doc. 2016–03853 Filed 2–23–16; 8:45 am]
BILLING CODE 4410–09–P
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. DEA–392]
Manufacturer of Controlled
Substances Registration: Chemtos,
LLC
ACTION:
Notice of registration.
Chemtos, LLC applied to be
registered as a manufacturer of certain
basic classes of controlled substances.
The Drug Enforcement Administration
(DEA) grants Chemtos, LLC registration
as a manufacturer of those controlled
substances.
SUPPLEMENTARY INFORMATION: By notice
dated September 16, 2015, and
published in the Federal Register on
September 23, 2015, 80 FR 57389,
Chemtos, LLC, 14101 W. Highway 290,
Building 2000B, Austin, Texas 78737–
9331 applied to be registered as a
manufacturer of certain basic classes of
controlled substances. No comments or
objections were submitted for this
notice.
The DEA has considered the factors in
21 U.S.C. 823(a) and determined that
the registration of Chemtos, LLC to
manufacture the basic classes of
controlled substances is consistent with
the public interest and with United
States obligations under international
treaties, conventions, or protocols in
effect on May 1, 1971. The DEA
investigated the company’s maintenance
of effective controls against diversion by
inspecting and testing the company’s
mstockstill on DSK4VPTVN1PROD with NOTICES
SUMMARY:
VerDate Sep<11>2014
17:59 Feb 23, 2016
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physical security systems, verifying the
company’s compliance with state and
local laws, and reviewing the company’s
background and history.
Therefore, pursuant to 21 U.S.C.
823(a), and in accordance with 21 CFR
1301.33, the above-named company is
granted registration as a bulk
manufacturer of the following basic
classes of controlled substances:
Controlled substance
Marihuana (7360) .........................
Amphetamine (1100) ....................
Methamphetamine (1105) ............
Lisdexamfetamine (1205) .............
Methylphenidate (1724) ................
Nabilone (7379) ............................
Phenylacetone (8501) ..................
Cocaine (9041) .............................
Codeine (9050) .............................
Etorphine HCI (9059) ...................
Dihydrocodeine (9120) .................
Oxycodone (9143) ........................
Hydromorphone (9150) ................
Ecgonine (9180) ...........................
Ethylmorphine (9190) ...................
Hydrocodone (9193) .....................
Levomethorphan (9210) ...............
Levorphanol (9220) ......................
Isomethadone (9226) ...................
Meperidine (9230) ........................
Meperidine intermediate–A (9232)
Meperidine intermediate–B (9233)
Meperidine intermediate–C (9234)
Methadone (9250) ........................
Methadone intermediate (9254) ...
Morphine (9300) ...........................
Thebaine (9333) ...........................
Dihydroetorphine (9334) ...............
Levo-alphacetylmethadol (9648) ..
Oxymorphone (9652) ...................
Racemethorphan (9732) ..............
Racemorphan (9733) ...................
Schedule
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
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The company plans to manufacture
small quantities of the listed controlled
substances in bulk for distribution to its
customers for use as reference
standards.
Dated: February 16, 2016.
Louis J. Milione,
Deputy Assistant Administrator.
The Attorney General has
delegated her authority under the
Controlled Substances Act to the
Administrator of the Drug Enforcement
Administration (DEA).
SUMMARY:
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 in
accordance with 21 CFR 1301.33(a) on
or before April 25, 2016.
DATES:
Written comments should
be sent to: Drug Enforcement
Administration, Attention: DEA Federal
Register Representative/ODW, 8701
Morrissette Drive, Springfield, Virginia
22152.
ADDRESSES:
The
Attorney General has delegated her
authority under the Controlled
Substances Act to the DEA, 28 CFR
0.100(b). Authority to exercise all
necessary functions with respect to the
promulgation and implementation of 21
CFR part 1301, incident to the
registration of manufacturers,
distributors, dispensers, importers, and
exporters of controlled substances (other
than final orders in connection with
suspension, denial, or revocation of
registration) has been redelegated to the
Deputy Assistant Administrator of the
DEA Office of Diversion Control
(‘‘Deputy Assistant Administrator’’)
pursuant to section 7 of 28 CFR part 0,
appendix to subpart R.
In accordance with 21 CFR
1301.33(a), this is notice that on
November 12, 2015, Insys Therapeutics,
Inc., 2700 Oakmont, Round Rock, Texas
78665 applied to be registered as a bulk
manufacturer of the following basic
classes of controlled substances:
SUPPLEMENTARY INFORMATION:
Controlled substance
Marihuana (7360) .........................
Tetrahydrocannabinols (7370) .....
Schedule
I
I
[FR Doc. 2016–03856 Filed 2–23–16; 8:45 am]
BILLING CODE 4410–09–P
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. DEA–392]
Bulk Manufacturer of Controlled
Substances Application: Insys
Therapeutics, Inc.
Drug Enforcement
Administration, Justice.
ACTION: Notice of application.
AGENCY:
PO 00000
Frm 00060
Fmt 4703
Sfmt 9990
The company plans to manufacture
the above-listed controlled substances
in bulk for distribution to its customers.
In reference to drug codes 7360,
marihuana, and 7370,
tetrahydrocannabinols, the company
plans to bulk manufacture both as
synthetic substances. No other activity
for these drug codes is authorized for
this registration.
Dated: February 16, 2016.
Louis J. Milione,
Deputy Assistant Administrator.
[FR Doc. 2016–03855 Filed 2–23–16; 8:45 am]
BILLING CODE 4410–09–P
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[Federal Register Volume 81, Number 36 (Wednesday, February 24, 2016)]
[Notices]
[Page 9220]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-03855]
-----------------------------------------------------------------------
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. DEA-392]
Bulk Manufacturer of Controlled Substances Application: Insys
Therapeutics, Inc.
AGENCY: Drug Enforcement Administration, Justice.
ACTION: Notice of application.
-----------------------------------------------------------------------
SUMMARY: The Attorney General has delegated her authority under the
Controlled Substances Act to the Administrator of the Drug Enforcement
Administration (DEA).
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 in accordance with 21 CFR
1301.33(a) on or before April 25, 2016.
ADDRESSES: Written comments should be sent to: Drug Enforcement
Administration, Attention: DEA Federal Register Representative/ODW,
8701 Morrissette Drive, Springfield, Virginia 22152.
SUPPLEMENTARY INFORMATION: The Attorney General has delegated her
authority under the Controlled Substances Act to the DEA, 28 CFR
0.100(b). Authority to exercise all necessary functions with respect to
the promulgation and implementation of 21 CFR part 1301, incident to
the registration of manufacturers, distributors, dispensers, importers,
and exporters of controlled substances (other than final orders in
connection with suspension, denial, or revocation of registration) has
been redelegated to the Deputy Assistant Administrator of the DEA
Office of Diversion Control (``Deputy Assistant Administrator'')
pursuant to section 7 of 28 CFR part 0, appendix to subpart R.
In accordance with 21 CFR 1301.33(a), this is notice that on
November 12, 2015, Insys Therapeutics, Inc., 2700 Oakmont, Round Rock,
Texas 78665 applied to be registered as a bulk manufacturer of the
following basic classes of controlled substances:
------------------------------------------------------------------------
Controlled substance Schedule
------------------------------------------------------------------------
Marihuana (7360)........................... I
Tetrahydrocannabinols (7370)............... I
------------------------------------------------------------------------
The company plans to manufacture the above-listed controlled
substances in bulk for distribution to its customers. In reference to
drug codes 7360, marihuana, and 7370, tetrahydrocannabinols, the
company plans to bulk manufacture both as synthetic substances. No
other activity for these drug codes is authorized for this
registration.
Dated: February 16, 2016.
Louis J. Milione,
Deputy Assistant Administrator.
[FR Doc. 2016-03855 Filed 2-23-16; 8:45 am]
BILLING CODE 4410-09-P
