Bulk Manufacturer of Controlled Substances Application: Specgx LLC, 43570-43571 [2017-19786]
Download as PDF
<![CDATA[
43570
Federal Register / Vol. 82, No. 179 / Monday, September 18, 2017 / Notices
Controlled substance
Gamma Hydroxybutyric Acid ...
Marihuana Extract ....................
Marihuana ................................
Drug
code
2010
7350
7360
Schedule
Drug Enforcement Administration
I
I
I
[Docket No. DEA–392]
The company plans to import finished
dosage unit products containing gammahydroxybutryic acid and cannabis
extracts for clinical trial studies.
These cannabis extracts compounds
are listed under drug code 7350. No
other activity for these drug codes is
authorized for this registration.
Approval of permit applications will
occur only when the registrant’s
business activity is consistent with what
is authorized under 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.
Dated: September 11, 2017.
Demetra Ashley,
Acting Assistant Administrator.
[FR Doc. 2017–19833 Filed 9–15–17; 8:45 am]
BILLING CODE 4410–09–P
DEPARTMENT OF JUSTICE
Bulk Manufacturer of Controlled
Substances Application: Specgx 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 17, 2017.
ADDRESSES: Written comments should
be sent to: Drug Enforcement
Administration, Attention: DEA Federal
Register Representative/DRW, 8701
Morrissette Drive, Springfield, Virginia
22152.
SUPPLEMENTARY INFORMATION: The
Attorney General has delegated his
authority under the Controlled
Substances Act to the Administrator of
DATES:
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
1301.33(a), this is notice that on August
9, 2017, Specgx LLC, 3600 North
Second Street, Saint Louis, Missouri
63147 applied to be registered as a bulk
manufacturer of the following basic
classes of controlled substances:
sradovich on DSKBBY8HB2PROD with NOTICES
Controlled substance
Drug code
Gamma Hydroxybutyric Acid ...........................................................................................................................................
Tetrahydrocannabinols ....................................................................................................................................................
Codeine-N-oxide ..............................................................................................................................................................
Dihydromorphine .............................................................................................................................................................
Difenoxin ..........................................................................................................................................................................
Morphine-N-oxide ............................................................................................................................................................
Normorphine ....................................................................................................................................................................
Norlevorphanol ................................................................................................................................................................
Acetyl Fentanyl (N-(1-phenethylpiperidin-4-yl)-N-phenylacetamide) ...............................................................................
Butyryl Fentanyl ...............................................................................................................................................................
Amphetamine ...................................................................................................................................................................
Methamphetamine ...........................................................................................................................................................
Lisdexamfetamine ............................................................................................................................................................
Methylphenidate ..............................................................................................................................................................
Nabilone ...........................................................................................................................................................................
4-Anilino-N-phenethyl-4-piperidine (ANPP) .....................................................................................................................
Codeine ...........................................................................................................................................................................
Dihydrocodeine ................................................................................................................................................................
Oxycodone .......................................................................................................................................................................
Hydromorphone ...............................................................................................................................................................
Diphenoxylate ..................................................................................................................................................................
Ecgonine ..........................................................................................................................................................................
Hydrocodone ...................................................................................................................................................................
Levorphanol .....................................................................................................................................................................
Meperidine .......................................................................................................................................................................
Methadone .......................................................................................................................................................................
Methadone intermediate ..................................................................................................................................................
Dextropropoxyphene, bulk (non-dosage forms) ..............................................................................................................
Morphine ..........................................................................................................................................................................
Oripavine .........................................................................................................................................................................
Thebaine ..........................................................................................................................................................................
Opium tincture .................................................................................................................................................................
Opium, powdered ............................................................................................................................................................
Oxymorphone ..................................................................................................................................................................
Noroxymorphone .............................................................................................................................................................
Alfentanil ..........................................................................................................................................................................
Remifentanil .....................................................................................................................................................................
Sufentanil .........................................................................................................................................................................
Tapentadol .......................................................................................................................................................................
Fentanyl ...........................................................................................................................................................................
VerDate Sep<11>2014
16:54 Sep 15, 2017
Jkt 241001
PO 00000
Frm 00057
Fmt 4703
Sfmt 4703
E:\FR\FM\18SEN1.SGM
18SEN1
2010
7370
9053
9145
9168
9307
9313
9634
9821
9822
1100
1105
1205
1724
7379
8333
9050
9120
9143
9150
9170
9180
9193
9220
9230
9250
9254
9273
9300
9330
9333
9630
9639
9652
9668
9737
9739
9740
9780
9801
Schedule
I
I
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
II
II
II
II
II
II
II
II
II
II
43571
Federal Register / Vol. 82, No. 179 / Monday, September 18, 2017 / Notices
The company plans to manufacture
bulk active pharmaceutical ingredients
(APIs) for distribution to its customers.
Dated: September 13, 2017
Demetra Ashley,
Acting Assistant Administrator.
[FR Doc. 2017–19786 Filed 9–15–17; 8:45 am]
BILLING CODE 4410–09–P
Drug Enforcement Administration
Marihuana .......................
Phenylacetone ................
Coca Leaves ..................
Opium, raw .....................
Poppy Straw Concentrate.
[Docket No. DEA–392]
Importer of Controlled Substances
Application: Specgx LLC
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 1301.34(a) on
or before October 18, 2017. Such
persons may also file a written request
for a hearing on the application
pursuant to 21 CFR 1301.43 on or before
October 18, 2017.
ADDRESSES: Written comments should
be sent to: Drug Enforcement
Administration, Attention: DEA Federal
Register Representative/DRW, 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 request 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/DRW, 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
sradovich on DSKBBY8HB2PROD with NOTICES
DATES:
VerDate Sep<11>2014
16:54 Sep 15, 2017
Drug
code
Controlled substance
DEPARTMENT OF JUSTICE
ACTION:
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 August
9, 2017, Specgx LLC, 3600 North
Second Street, Saint Louis, Missouri
63147 applied to be registered as an
importer of the following basic classes
of controlled substances:
Jkt 241001
Schedule
7360
8501
9040
9600
9670
I
II
II
II
II
The company plans to import the
listed controlled substances to bulk
manufacture into Active Pharmaceutical
Ingredients for distribution to its
customers. In reference to drug code
7360 (marihuana) the company plans to
import a synthetic cannabidiol. No other
activity for this drug code is authorized
for this registration. 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 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 11, 2017.
Demetra Ashley,
Acting Assistant Administrator.
[FR Doc. 2017–19784 Filed 9–15–17; 8:45 am]
BILLING CODE 4410–09–P
Register Representative/DRW, 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
1301.33(a), this is notice that on July 11,
2017, Halo Pharmaceutical, Inc., 30
North Jefferson Road, Whippany, New
Jersey 07981 applied to be registered as
a bulk manufacturer the following basic
classes of controlled substances:
Controlled substance
Dihydromorphine ..........
Hydromorphone ............
Drug
code
9145
9150
Schedule
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.
Dated: September 11, 2017.
Demetra Ashley,
Acting Assistant Administrator.
[FR Doc. 2017–19834 Filed 9–15–17; 8:45 am]
BILLING CODE P
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
DEPARTMENT OF JUSTICE
[Docket No. DEA–392]
Drug Enforcement Administration
Bulk Manufacturer of Controlled
Substances Application: Halo
Pharmaceutical, Inc.
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 17, 2017.
ADDRESSES: Written comments should
be sent to: Drug Enforcement
Administration, Attention: DEA Federal
DATES:
PO 00000
Frm 00058
Fmt 4703
Sfmt 4703
[Docket No. DEA–392]
Importer of Controlled Substances
Application: Unither 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 1301.34(a) on
or before October 18, 2017. Such
persons may also file a written request
DATES:
E:\FR\FM\18SEN1.SGM
18SEN1
]]>Agencies
[Federal Register Volume 82, Number 179 (Monday, September 18, 2017)]
[Notices]
[Pages 43570-43571]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-19786]
-----------------------------------------------------------------------
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. DEA-392]
Bulk Manufacturer of Controlled Substances Application: Specgx
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 17, 2017.
ADDRESSES: Written comments should be sent to: Drug Enforcement
Administration, Attention: DEA Federal Register Representative/DRW,
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 1301.33(a), this is notice that on August
9, 2017, Specgx LLC, 3600 North Second Street, Saint Louis, Missouri
63147 applied to be registered as a bulk manufacturer of the following
basic classes of controlled substances:
------------------------------------------------------------------------
Controlled substance Drug code Schedule
------------------------------------------------------------------------
Gamma Hydroxybutyric Acid.......... 2010 I
Tetrahydrocannabinols.............. 7370 I
Codeine-N-oxide.................... 9053 I
Dihydromorphine.................... 9145 I
Difenoxin.......................... 9168 I
Morphine-N-oxide................... 9307 I
Normorphine........................ 9313 I
Norlevorphanol..................... 9634 I
Acetyl Fentanyl (N-(1- 9821 I
phenethylpiperidin-4-yl)-N-
phenylacetamide).
Butyryl Fentanyl................... 9822 I
Amphetamine........................ 1100 II
Methamphetamine.................... 1105 II
Lisdexamfetamine................... 1205 II
Methylphenidate.................... 1724 II
Nabilone........................... 7379 II
4-Anilino-N-phenethyl-4-piperidine 8333 II
(ANPP).
Codeine............................ 9050 II
Dihydrocodeine..................... 9120 II
Oxycodone.......................... 9143 II
Hydromorphone...................... 9150 II
Diphenoxylate...................... 9170 II
Ecgonine........................... 9180 II
Hydrocodone........................ 9193 II
Levorphanol........................ 9220 II
Meperidine......................... 9230 II
Methadone.......................... 9250 II
Methadone intermediate............. 9254 II
Dextropropoxyphene, bulk (non- 9273 II
dosage forms).
Morphine........................... 9300 II
Oripavine.......................... 9330 II
Thebaine........................... 9333 II
Opium tincture..................... 9630 II
Opium, powdered.................... 9639 II
Oxymorphone........................ 9652 II
Noroxymorphone..................... 9668 II
Alfentanil......................... 9737 II
Remifentanil....................... 9739 II
Sufentanil......................... 9740 II
Tapentadol......................... 9780 II
Fentanyl........................... 9801 II
------------------------------------------------------------------------
[[Page 43571]]
The company plans to manufacture bulk active pharmaceutical
ingredients (APIs) for distribution to its customers.
Dated: September 13, 2017
Demetra Ashley,
Acting Assistant Administrator.
[FR Doc. 2017-19786 Filed 9-15-17; 8:45 am]
BILLING CODE 4410-09-P
