Importer of Controlled Substances Registration, 60898-60899 [2018-25863]
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60898
Federal Register / Vol. 83, No. 228 / Tuesday, November 27, 2018 / Notices
The company plans to import the listed
controlled substances for analytical
research, testing and clinical trials.
Dated: November 16, 2018.
John J. Martin,
Assistant Administrator.
[FR Doc. 2018–25869 Filed 11–26–18; 8:45 am]
BILLING CODE 4410–09–P
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
The
Attorney General has delegated his
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
SUPPLEMENTARY INFORMATION:
[Docket No. DEA–392]
Bulk Manufacturer of Controlled
Substances Application: Noramco Inc.
ACTION:
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 January 28, 2019.
ADDRESSES: Written comments should
be sent to: Drug Enforcement
Administration, Attention: DEA Federal
Register Representative/DPW, 8701
Morrissette Drive, Springfield, Virginia
22152.
DATES:
Notice of application.
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 Assistant
Administrator of the DEA Diversion
Control Division (‘‘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 4,
2018, Noramco Inc., 1550 Olympic Dr.
Athens, Georgia 30601 applied to be
registered as a bulk manufacturer for the
basic classes of controlled substances:
Controlled substance
Drug code
amozie on DSK3GDR082PROD with NOTICES1
Cathinone ................................................................................................................................................................
Gamma Hydroxybutyric Acid ...................................................................................................................................
Marihuana ................................................................................................................................................................
Tetrahydrocannabinols ............................................................................................................................................
Codeine-N-oxide ......................................................................................................................................................
Dihydromorphine .....................................................................................................................................................
Hydromorphinol .......................................................................................................................................................
Morphine-N-oxide ....................................................................................................................................................
Amphetamine ..........................................................................................................................................................
Lisdexamfetamine ...................................................................................................................................................
Methylphenidate ......................................................................................................................................................
Nabilone ..................................................................................................................................................................
Codeine ...................................................................................................................................................................
Dihydrocodeine ........................................................................................................................................................
Oxycodone ..............................................................................................................................................................
Hydromorphone .......................................................................................................................................................
Hydrocodone ...........................................................................................................................................................
Morphine ..................................................................................................................................................................
Oripavine .................................................................................................................................................................
Thebaine ..................................................................................................................................................................
Opium tincture .........................................................................................................................................................
Oxymorphone ..........................................................................................................................................................
Noroxymorphone .....................................................................................................................................................
Alfentanil ..................................................................................................................................................................
Sufentanil .................................................................................................................................................................
Carfentanil ...............................................................................................................................................................
Tapentadol ...............................................................................................................................................................
Fentanyl ...................................................................................................................................................................
The company plans to manufacture
bulk active pharmaceutical ingredients
(APIs) and reference standards for
distribution to their customers.
In reference to drug codes 7360
(marihuana) and 7370
(tetrahydrocannabinols), the company
plans to bulk manufacture these drugs
as synthetic. No other activities for these
drug codes are authorized for this
registration.
Dated: November 16, 2018.
John J. Martin,
Assistant Administrator.
[FR Doc. 2018–25874 Filed 11–26–18; 8:45 am]
BILLING CODE 4410–09–P
Jkt 247001
The registrant listed below
has applied for and has been granted
registration by the Drug Enforcement
Administration (DEA) as an importer of
schedule I or II controlled substances.
The
company listed below applied to be
registered as an importer of various
basic classes of controlled substances.
Information on the previously published
notice is listed in the table below. No
comments or objections were submitted
and no requests for a hearing were
submitted for this notice.
SUPPLEMENTARY INFORMATION:
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. DEA–392]
ACTION:
17:45 Nov 26, 2018
I
I
I
I
I
I
I
I
II
II
II
II
II
II
II
II
II
II
II
II
II
II
II
II
II
II
II
II
SUMMARY:
Importer of Controlled Substances
Registration
VerDate Sep<11>2014
1235
2010
7360
7370
9053
9145
9301
9307
1100
1205
1724
7379
9050
9120
9143
9150
9193
9300
9330
9333
9630
9652
9668
9737
9740
9743
9780
9801
Schedule
PO 00000
Notice of registration.
Frm 00078
Fmt 4703
Sfmt 4703
E:\FR\FM\27NON1.SGM
27NON1
60899
Federal Register / Vol. 83, No. 228 / Tuesday, November 27, 2018 / Notices
Company
FR Docket
Alcami Carolinas Corporation .............................................
83 FR 46758 ......................................................................
The DEA has considered the factors in
21 U.S.C. 823, 952(a) and 958(a) and
determined that the registration of the
listed registrant to import the applicable
basic classes of schedule I 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
the company’s 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.
952(a) and 958(a), and in accordance
with 21 CFR 1301.34, the DEA has
granted a registration as an importer for
schedule I controlled substances to the
above listed company.
Dated: November 16, 2018.
John J. Martin,
Assistant Administrator.
[FR Doc. 2018–25863 Filed 11–26–18; 8:45 am]
BILLING CODE 4410–09–P
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. DEA–392]
Importer of Controlled Substances
Application: GE Healthcare
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 on
or before December 27, 2018. Such
persons may also file a written request
for a hearing on the application on or
before December 27, 2018.
ADDRESSES: Written comments should
be sent to: Drug Enforcement
Administration, Attention: DEA Federal
Register Representative/DPW, 8701
Morrissette Drive, Springfield, Virginia
22152. All requests for hearing must be
sent to: Drug Enforcement
amozie on DSK3GDR082PROD with NOTICES1
DATES:
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/OALJ, 8701 Morrissette
Drive, Springfield, Virginia 22152; and
(2) Drug Enforcement Administration,
Attn: DEA Federal Register
Representative/DPW, 8701 Morrissette
Drive, Springfield, Virginia 22152.
SUPPLEMENTARY INFORMATION: The
Attorney General has delegated his
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 Assistant
Administrator of the DEA Diversion
Control Division (‘‘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
September 5, 2018, GE Healthcare, 3350
North Ridge Avenue, Arlington Heights,
Illinois 60004, applied to be registered
as an importer of cocaine (9041), a basic
class of controlled substance listed in
schedule II.
The company plans to import small
quantities of Ioflupane, in the form of
three separate analogues of cocaine, to
validate production and quality control
systems, for a reference standard, and
for producing material for a future
investigational new drug (IND)
submission. Supplies of this particular
controlled substance are not available in
the form needed within the current
domestic supply of the United States.
Dated: November 16, 2018.
John J. Martin,
Assistant Administrator.
[FR Doc. 2018–25864 Filed 11–26–18; 8:45 am]
Published
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 on
or before January 28, 2019.
DATES:
Written comments should
be sent to: Drug Enforcement
Administration, Attention: DEA Federal
Register Representative/DPW, 8701
Morrissette Drive, Springfield, Virginia
22152.
ADDRESSES:
The
Attorney General has delegated his
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
delegated to the Assistant Administrator
of the DEA Diversion Control Division
(‘‘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 October
4, 2018, Insys Manufacturing, LLC, 811
Paloma Drive, Suite C, Round Rock,
Texas 78665, applied to be registered as
a bulk manufacturer of the following
basic classes of controlled substances:
SUPPLEMENTARY INFORMATION:
BILLING CODE 4410–09–P
Controlled substance
Drug code
Marihuana ................................................................................................................................................................
Tetrahydrocannabinols ............................................................................................................................................
VerDate Sep<11>2014
17:45 Nov 26, 2018
Jkt 247001
September 14, 2018.
PO 00000
Frm 00079
Fmt 4703
Sfmt 4703
E:\FR\FM\27NON1.SGM
27NON1
7360
7370
Schedule
I
I
]]>Agencies
[Federal Register Volume 83, Number 228 (Tuesday, November 27, 2018)]
[Notices]
[Pages 60898-60899]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-25863]
-----------------------------------------------------------------------
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. DEA-392]
Importer of Controlled Substances Registration
ACTION: Notice of registration.
-----------------------------------------------------------------------
SUMMARY: The registrant listed below has applied for and has been
granted registration by the Drug Enforcement Administration (DEA) as an
importer of schedule I or II controlled substances.
SUPPLEMENTARY INFORMATION: The company listed below applied to be
registered as an importer of various basic classes of controlled
substances. Information on the previously published notice is listed in
the table below. No comments or objections were submitted and no
requests for a hearing were submitted for this notice.
[[Page 60899]]
----------------------------------------------------------------------------------------------------------------
Company FR Docket Published
----------------------------------------------------------------------------------------------------------------
Alcami Carolinas Corporation............ 83 FR 46758................ September 14, 2018.
----------------------------------------------------------------------------------------------------------------
The DEA has considered the factors in 21 U.S.C. 823, 952(a) and
958(a) and determined that the registration of the listed registrant to
import the applicable basic classes of schedule I 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 the company's
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. 952(a) and 958(a), and in
accordance with 21 CFR 1301.34, the DEA has granted a registration as
an importer for schedule I controlled substances to the above listed
company.
Dated: November 16, 2018.
John J. Martin,
Assistant Administrator.
[FR Doc. 2018-25863 Filed 11-26-18; 8:45 am]
BILLING CODE 4410-09-P
