Importer of Controlled Substances Application: United States Pharmacopeial Convention, 63220-63221 [2016-22079]
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63220
Federal Register / Vol. 81, No. 178 / Wednesday, September 14, 2016 / Notices
Company
FR Docket
Sigma Aldrich Research Biochemicals, Inc .............................................................................
81 FR 38217 ..........................
The DEA has considered the factors in
21 U.S.C. 823(a) and determined that
the registration of these registrants to
manufacture the applicable 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 each of the company’s
maintenance of effective controls
against diversion by inspecting and
testing each company’s physical
security systems, verifying each
company’s compliance with state and
local laws, and reviewing each
company’s background and history.
Therefore, pursuant to 21 U.S.C.
823(a), and in accordance with 21 CFR
1301.33, the DEA has granted
registration as a bulk manufacturer to
the above listed persons.
Dated: September 7, 2016.
Louis J. Milione,
Deputy Assistant Administrator.
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 July 27,
2016, Halo Pharmaceutical, Inc., 30
North Jefferson Road, Whippany, New
Jersey 07981 applied to be registered as
a bulk manufacturer of the following
basic classes of controlled substances:
Controlled substance
[FR Doc. 2016–22082 Filed 9–13–16; 8:45 am]
BILLING CODE 4410–09–P
Dihydromorphine (9145) ...............
Hydromorphone (9150) ................
DEPARTMENT OF JUSTICE
I
II
The company plans to manufacture
Hydromorphone (9150) for distribution
to its customers. Dihydromorphine
(9145) is an intermediate in the
manufacture of Hydromorphone and is
not for commercial distribution.
Drug Enforcement Administration
[Docket No. DEA–392]
Bulk Manufacturer of Controlled
Substances Application: Halo
Pharmaceutical, Inc.
ACTION:
Schedule
Dated: September 7, 2016.
Louis J. Milione,
Deputy Assistant Administrator.
Notice of application.
[FR Doc. 2016–22074 Filed 9–13–16; 8:45 am]
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.
asabaliauskas on DSK3SPTVN1PROD with NOTICES
DATES:
The
Attorney General has delegated her
SUPPLEMENTARY INFORMATION:
BILLING CODE 4410–09–P
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. DEA–392]
Importer of Controlled Substances
Application: United States
Pharmacopeial Convention
ACTION:
Notice of application.
Registered bulk manufacturers of
the affected basic classes, and
DATES:
Published
June 13, 2016.
applicants therefore, may file written
comments on or objections to the
issuance of the proposed registration in
accordance with 21 CFR 1301.34(a) on
or before October 14, 2016. Such
persons may also file a written request
for a hearing on the application
pursuant to 21 CFR 1301.43 on or before
October 14, 2016.
Written comments should
be sent to: Drug Enforcement
Administration, Attention: DEA Federal
Register Representative/ODW, 8701
Morrissette Drive, Springfield, Virginia
22152. All requests for hearing must be
sent to: Drug Enforcement
Administration, Attn: Administrator,
8701 Morrissette Drive, Springfield,
Virginia 22152. All requests for hearing
should also be sent to: (1) Drug
Enforcement Administration, Attn:
Hearing Clerk/LJ, 8701 Morrissette
Drive, Springfield, Virginia 22152; and
(2) Drug Enforcement Administration,
Attn: 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 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
1301.34(a), this is notice that on
February 26, 2016, United States
Pharmacopeial Convention, 12601
Twinbrook Parkway, Rockville,
Maryland 20852 applied to be registered
as an importer of the following basic
classes of controlled substances:
SUPPLEMENTARY INFORMATION:
Controlled substance
Schedule
Cathinone (1235) .........................................................................................................................................................................................
Methaqualone (2565) ..................................................................................................................................................................................
Lysergic acid diethylamide (7315) ...............................................................................................................................................................
Marihuana (7360) ........................................................................................................................................................................................
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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
VerDate Sep<11>2014
20:55 Sep 13, 2016
Jkt 238001
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]
[Pages 63220-63221]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-22079]
-----------------------------------------------------------------------
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. DEA-392]
Importer of Controlled Substances Application: United States
Pharmacopeial Convention
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
1301.34(a) on or before October 14, 2016. Such persons may also file a
written request for a hearing on the application pursuant to 21 CFR
1301.43 on or before October 14, 2016.
ADDRESSES: Written comments should be sent to: Drug Enforcement
Administration, Attention: DEA Federal Register Representative/ODW,
8701 Morrissette Drive, Springfield, Virginia 22152. All requests for
hearing must be sent to: Drug Enforcement Administration, Attn:
Administrator, 8701 Morrissette Drive, Springfield, Virginia 22152. All
requests for hearing should also be sent to: (1) Drug Enforcement
Administration, Attn: Hearing Clerk/LJ, 8701 Morrissette Drive,
Springfield, Virginia 22152; and (2) Drug Enforcement Administration,
Attn: 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 1301.34(a), this is notice that on
February 26, 2016, United States Pharmacopeial Convention, 12601
Twinbrook Parkway, Rockville, Maryland 20852 applied to be registered
as an importer of the following basic classes of controlled substances:
------------------------------------------------------------------------
Controlled substance Schedule
------------------------------------------------------------------------
Cathinone (1235)............................ I
Methaqualone (2565)......................... I
Lysergic acid diethylamide (7315)........... I
Marihuana (7360)............................ I
[[Page 63221]]
Tetrahydrocannabinols (7370)................ I
4-Methyl-2,5-dimethoxyamphetamine (7395).... I
3,4-Methylenedioxyamphetamine (7400)........ I
Codeine-N-oxide (9053)...................... I
Difenoxin (9168)............................ I
Heroin (9200)............................... I
Morphine-N-oxide (9307)..................... I
Norlevorphanol (9634)....................... I
Methamphetamine (1105)...................... II
Phenmetrazine (1631)........................ II
Methylphenidate (1724)...................... II
Amobarbital (2125).......................... II
Pentobarbital (2270)........................ II
Secobarbital (2315)......................... II
Glutethimide (2550)......................... II
Phencyclidine (7471)........................ II
4-Anilino-N-phenethyl-4-piperidine (ANPP) II
(8333).
Phenylacetone (8501)........................ II
Alphaprodine (9010)......................... II
Anileridine (9020).......................... II
Cocaine (9041).............................. II
Dihydrocodeine (9120)....................... II
Diphenoxylate (9170)........................ II
Levomethorphan (9210)....................... II
Levorphanol (9220).......................... II
Meperidine (9230)........................... II
Dextropropoxyphene, bulk (non-dosage forms) II
(9273).
Thebaine (9333)............................. II
Noroxymorphone (9668)....................... II
Alfentanil (9737)........................... II
Sufentanil (9740)........................... II
------------------------------------------------------------------------
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 non-approved finished dosage
forms for commercial sale.
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
