Bulk Manufacturer of Controlled Substances Application: S&B Pharma, Inc., 64563-64564 [2019-25402]
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64563
Federal Register / Vol. 84, No. 226 / Friday, November 22, 2019 / Notices
2028 applied to be registered as an
importer of the following basic classes
of controlled substances:
Controlled substance
Drug code
Schedule
Remifentanil .............................................................................................................................................................
9739
II
Dated: October 23, 2019.
William T. McDermott,
Assistant Administrator.
[FR Doc. 2019–25403 Filed 11–21–19; 8:45 am]
BILLING CODE 4410–09–P
[FR Doc. 2019–25404 Filed 11–21–19; 8:45 am]
BILLING CODE 4410–09–P
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
In
accordance with 21 CFR 1301.34(a), this
is notice that on July 15, 2019, GE
Healthcare, 3350 North Ridge Avenue,
Arlington Heights, Illinois 60004–1412
applied to be registered as an importer
of the following basic class of controlled
substance:
SUPPLEMENTARY INFORMATION:
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. DEA–538]
Importer of Controlled Substances
Application: GE Healthcare
ACTION:
Dated: November 7, 2019.
William T. McDermott,
Assistant Administrator.
Virginia 22152. All requests for a
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.
The company plans to import the
listed controlled substance for bulk
manufacture.
[Docket No. DEA–529]
Bulk Manufacturer of Controlled
Substances Application: Patheon API
Manufacturing, 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 on
or before January 21, 2020.
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.
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 23, 2019. Such
persons may also file a written request
for a hearing on the application on or
before December 23, 2019.
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 a hearing must
be sent to: Drug Enforcement
Administration, Attn: Administrator,
8701 Morrissette Drive, Springfield,
DATES:
Controlled
substance
Drug code
Cocaine .....
Schedule
9041
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.
In
accordance with 21 CFR 1301.33(a), this
is notice that on March 15, 2019,
Patheon API Manufacturing, Inc., 309
Delaware Street, Greenville, South
Carolina 29605 applied to be registered
as a bulk manufacturer of the following
basic classes of controlled substances:
SUPPLEMENTARY INFORMATION:
Controlled substance
Drug code
Thebaine ..................................................................................................................................................................
Noroxymorphone .....................................................................................................................................................
Gamma Hydroxybutyric Acid ...................................................................................................................................
Alpha-methyltryptamine ...........................................................................................................................................
khammond on DSKJM1Z7X2PROD with NOTICES
The company plans to bulk
manufacture the listed controlled
substances as an Active Pharmaceutical
Ingredient for supply to its customers.
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. DEA–545]
[FR Doc. 2019–25401 Filed 11–21–19; 8:45 am]
Bulk Manufacturer of Controlled
Substances Application: S&B Pharma,
Inc.
ACTION:
BILLING CODE 4410–09–P
Notice of application.
Registered bulk manufacturers of
the affected basic classes, and
DATES:
16:57 Nov 21, 2019
9333
9668
2010
7432
II
II
I
I
applicants therefore, may file written
comments on or objections to the
issuance of the proposed on or before
January 21, 2020.
Written comments should
be sent to: Drug Enforcement
Administration, Attention: DEA Federal
Register Representative/DPW, 8701
Morrissette Drive, Springfield, Virginia
22152.
ADDRESSES:
Dated: November 5, 2019.
William T. McDermott,
Assistant Administrator.
VerDate Sep<11>2014
Schedule
Jkt 250001
PO 00000
Frm 00111
Fmt 4703
Sfmt 4703
In
accordance with 21 CFR 1301.33(a), this
SUPPLEMENTARY INFORMATION:
E:\FR\FM\22NON1.SGM
22NON1
64564
Federal Register / Vol. 84, No. 226 / Friday, November 22, 2019 / Notices
is notice that on October 4, 2019, S &
B Pharma, Inc., DBA Norac Pharma, 405
South Motor Avenue, Azusa, California
91702–3232 applied to be registered as
a bulk manufacturer of the following
basic classes of controlled substances:
Controlled substance
Drug code
Gamma Hydroxybutyric Acid ...................................................................................................................................
Telrahydrocannabinois .............................................................................................................................................
Amphetamine ...........................................................................................................................................................
Methamphetamine ...................................................................................................................................................
Lisdexamfetamine ....................................................................................................................................................
Methylphenidate .......................................................................................................................................................
Pentobarbital ............................................................................................................................................................
4-Anilino-N-phenethyl-4-piperidine (ANPP) .............................................................................................................
Tapentadol ...............................................................................................................................................................
Fentanyl ...................................................................................................................................................................
The company plans to manufacture
the listed controlled substances in bulk
for use in product development and for
commercial sales to its customers. In
reference to drug code 7360 (marihuana)
and 7370 (tetrahydrocannabinois), the
company plans to bulk manufacture
both as synthetic substances. No other
activity for these dug codes is
authorized for this registration.
Dated: November 5, 2019.
William T. McDermott,
Assistant Administrator.
[FR Doc. 2019–25402 Filed 11–21–19; 8:45 am]
BILLING CODE 4410–09–P
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. DEA–549]
Importer of Controlled Substances
Application: Mylan Technologies 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 on
or before December 23, 2019. Such
persons may also file a written request
for a hearing on the application on or
before December 23, 2019.
ADDRESSES: Written comments should
be sent to: Drug Enforcement
Administration, Attention: DEA Federal
Register Representative/DPW, 8701
DATES:
In
accordance with 21 CFR 1301.34(a), this
is notice that on October 16, 2019,
Mylan Technologies Inc., 110 Lake
Street, Saint Albans, Vermont 054780
applied to be registered as an importer
of the following basic classes of
controlled substances:
Drug code
khammond on DSKJM1Z7X2PROD with NOTICES
DEPARTMENT OF JUSTICE
Dated: November 8, 2019.
William T. McDermott,
Assistant Administrator.
DATES:
[FR Doc. 2019–25405 Filed 11–21–19; 8:45 am]
BILLING CODE 4410–09–P
Jkt 250001
Drug Enforcement Administration
[Docket No. DEA–540]
Bulk Manufacturer of Controlled
Substances Application: Chattem
Chemicals
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 21, 2020.
PO 00000
Frm 00112
Fmt 4703
1724
9801
In
accordance with 21 CFR 1301.33(a), this
is notice that on May 17, 2019, Chattem
Chemicals, 3801 Saint Elmo Avenue,
Chattanooga, Tennessee 37409 applied
to be registered as a bulk manufacturer
of the following basic classes of
controlled substances:
SUPPLEMENTARY INFORMATION:
Drug code
Sfmt 4703
II
II
Written comments should
be sent to: Drug Enforcement
Administration, Attention: DEA Federal
Register Representative/DPW, 8701
Morrissette Drive, Springfield, Virginia
22152.
Gamma Hydroxybutyric Acid ...................................................................................................................................
Marihuana ................................................................................................................................................................
Tetrahydrocannabinols ............................................................................................................................................
16:57 Nov 21, 2019
Schedule
ADDRESSES:
Controlled substance
VerDate Sep<11>2014
I
I
II
II
II
II
II
II
II
II
SUPPLEMENTARY INFORMATION:
Methylphenidate .......................................................................................................................................................
Fentanyl ...................................................................................................................................................................
ACTION:
7360
7370
1100
1105
1205
1724
2270
8333
9780
9801
Morrissette Drive, Springfield, Virginia
22152. All requests for a hearing must
be sent to: Drug Enforcement
Administration, Attn: Administrator,
8701 Morrissette Drive, Springfield,
Virginia 22152. All requests for a
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.
Controlled substance
The company plans to import the
listed controlled substances in finished
dosage form (FDF) from foreign sources
for analytical testing and clinical trials
in which the foreign FDF will be
compared to the company’s own
domestically-manufactured FDF. This
analysis is required to allow the
company to export domestically
manufactured FDF to foreign markets.
Schedule
E:\FR\FM\22NON1.SGM
22NON1
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7360
7370
Schedule
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]]>Agencies
[Federal Register Volume 84, Number 226 (Friday, November 22, 2019)]
[Notices]
[Pages 64563-64564]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-25402]
-----------------------------------------------------------------------
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. DEA-545]
Bulk Manufacturer of Controlled Substances Application: S&B
Pharma, Inc.
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 on or before January 21, 2020.
ADDRESSES: Written comments should be sent to: Drug Enforcement
Administration, Attention: DEA Federal Register Representative/DPW,
8701 Morrissette Drive, Springfield, Virginia 22152.
SUPPLEMENTARY INFORMATION: In accordance with 21 CFR 1301.33(a), this
[[Page 64564]]
is notice that on October 4, 2019, S & B Pharma, Inc., DBA Norac
Pharma, 405 South Motor Avenue, Azusa, California 91702-3232 applied to
be registered as a bulk manufacturer of the following basic classes of
controlled substances:
------------------------------------------------------------------------
Controlled substance Drug code Schedule
------------------------------------------------------------------------
Gamma Hydroxybutyric Acid............... 7360 I
Telrahydrocannabinois................... 7370 I
Amphetamine............................. 1100 II
Methamphetamine......................... 1105 II
Lisdexamfetamine........................ 1205 II
Methylphenidate......................... 1724 II
Pentobarbital........................... 2270 II
4-Anilino-N-phenethyl-4-piperidine 8333 II
(ANPP).................................
Tapentadol.............................. 9780 II
Fentanyl................................ 9801 II
------------------------------------------------------------------------
The company plans to manufacture the listed controlled substances
in bulk for use in product development and for commercial sales to its
customers. In reference to drug code 7360 (marihuana) and 7370
(tetrahydrocannabinois), the company plans to bulk manufacture both as
synthetic substances. No other activity for these dug codes is
authorized for this registration.
Dated: November 5, 2019.
William T. McDermott,
Assistant Administrator.
[FR Doc. 2019-25402 Filed 11-21-19; 8:45 am]
BILLING CODE 4410-09-P
