Bulk Manufacturer of Controlled Substances Application: Insys Manufacturing LLC, 63221 [2016-22075]
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63221
Federal Register / Vol. 81, No. 178 / Wednesday, September 14, 2016 / Notices
Controlled substance
Schedule
Tetrahydrocannabinols (7370) .....................................................................................................................................................................
4-Methyl-2,5-dimethoxyamphetamine (7395) ..............................................................................................................................................
3,4-Methylenedioxyamphetamine (7400) ....................................................................................................................................................
Codeine-N-oxide (9053) ..............................................................................................................................................................................
Difenoxin (9168) ..........................................................................................................................................................................................
Heroin (9200) ...............................................................................................................................................................................................
Morphine-N-oxide (9307) .............................................................................................................................................................................
Norlevorphanol (9634) .................................................................................................................................................................................
Methamphetamine (1105) ...........................................................................................................................................................................
Phenmetrazine (1631) .................................................................................................................................................................................
Methylphenidate (1724) ...............................................................................................................................................................................
Amobarbital (2125) ......................................................................................................................................................................................
Pentobarbital (2270) ....................................................................................................................................................................................
Secobarbital (2315) .....................................................................................................................................................................................
Glutethimide (2550) .....................................................................................................................................................................................
Phencyclidine (7471) ...................................................................................................................................................................................
4-Anilino-N-phenethyl-4-piperidine (ANPP) (8333) .....................................................................................................................................
Phenylacetone (8501) .................................................................................................................................................................................
Alphaprodine (9010) ....................................................................................................................................................................................
Anileridine (9020) ........................................................................................................................................................................................
Cocaine (9041) ............................................................................................................................................................................................
Dihydrocodeine (9120) ................................................................................................................................................................................
Diphenoxylate (9170) ..................................................................................................................................................................................
Levomethorphan (9210) ..............................................................................................................................................................................
Levorphanol (9220) .....................................................................................................................................................................................
Meperidine (9230) .......................................................................................................................................................................................
Dextropropoxyphene, bulk (non-dosage forms) (9273) ..............................................................................................................................
Thebaine (9333) ..........................................................................................................................................................................................
Noroxymorphone (9668) ..............................................................................................................................................................................
Alfentanil (9737) ..........................................................................................................................................................................................
Sufentanil (9740) .........................................................................................................................................................................................
The company plans to import the
listed controlled substances in bulk
powder form from foreign sources for
the manufacture of analytical reference
standards for sale to their customers.
The company plans to import
analytical reference standards for
distribution to its customers for research
and analytical purposes. Placement of
these drug codes onto the company’s
registration does not translate into
automatic approval of subsequent
permit applications to import controlled
substances. Approval of permit
applications will occur only when the
registrant’s business activity is
consistent with what is authorized
under to 21 U.S.C. 952(a)(2).
Authorization will not extend to the
import of FDA approved or nonapproved finished dosage forms for
commercial sale.
asabaliauskas on DSK3SPTVN1PROD with NOTICES
Dated: September 7, 2016.
Louis J. Milione,
Deputy Assistant Administrator.
[FR Doc. 2016–22079 Filed 9–13–16; 8:45 am]
BILLING CODE 4410–09–P
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DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. DEA–392]
Bulk Manufacturer of Controlled
Substances Application: Insys
Manufacturing LLC
ACTION:
Notice of application.
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 November 14, 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 Administrator of
the Drug Enforcement Administration
(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
DATES:
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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 June
29, 2016, Insys Manufacturing LLC, 811
Paloma Drive, Suite C, Round Rock,
Texas 78665–2402 applied to be
registered as a bulk manufacturer the
following basic classes of controlled
substances:
Controlled substance
Marihuana (7360) .........................
Tetrahydrocannabinols (7370) .....
Schedule
I
I
The company plans to manufacture
bulk synthetic active pharmaceutical
ingredients (APIs) for product
development and distribution to its
customers. No other activity for these
drug codes are authorized for this
registration.
Dated: September 7, 2016.
Louis J. Milione,
Deputy Assistant Administrator.
[FR Doc. 2016–22075 Filed 9–13–16; 8:45 am]
BILLING CODE 4410–09–P
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]]>Agencies
[Federal Register Volume 81, Number 178 (Wednesday, September 14, 2016)]
[Notices]
[Page 63221]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-22075]
-----------------------------------------------------------------------
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. DEA-392]
Bulk Manufacturer of Controlled Substances Application: Insys
Manufacturing LLC
ACTION: Notice of application.
-----------------------------------------------------------------------
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 November 14, 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 Administrator of
the Drug Enforcement Administration (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 June
29, 2016, Insys Manufacturing LLC, 811 Paloma Drive, Suite C, Round
Rock, Texas 78665-2402 applied to be registered as a bulk manufacturer
the following basic classes of controlled substances:
------------------------------------------------------------------------
Controlled substance Schedule
------------------------------------------------------------------------
Marihuana (7360)........................... I
Tetrahydrocannabinols (7370)............... I
------------------------------------------------------------------------
The company plans to manufacture bulk synthetic active
pharmaceutical ingredients (APIs) for product development and
distribution to its customers. No other activity for these drug codes
are authorized for this registration.
Dated: September 7, 2016.
Louis J. Milione,
Deputy Assistant Administrator.
[FR Doc. 2016-22075 Filed 9-13-16; 8:45 am]
BILLING CODE 4410-09-P
