Importer of Controlled Substances Application: Catalent Pharma Solutions, LLC, 36945-36946 [2019-16166]
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36945
Federal Register / Vol. 84, No. 146 / Tuesday, July 30, 2019 / Notices
Controlled substance
Drug code
Metazocine .....................................................................................................................................................................
Methadone .....................................................................................................................................................................
Methadone intermediate ................................................................................................................................................
Metopon .........................................................................................................................................................................
Dextropropoxyphene, bulk (non-dosage forms) ............................................................................................................
Morphine ........................................................................................................................................................................
Oripavine ........................................................................................................................................................................
Thebaine ........................................................................................................................................................................
Dihydroetorphine ............................................................................................................................................................
Opium, raw ....................................................................................................................................................................
Opium extracts ...............................................................................................................................................................
Opium fluid extract .........................................................................................................................................................
Opium tincture ...............................................................................................................................................................
Opium, powdered ..........................................................................................................................................................
Opium, granulated .........................................................................................................................................................
Levo-alphacetylmethadol ...............................................................................................................................................
Opium poppy .................................................................................................................................................................
Oxymorphone ................................................................................................................................................................
Poppy Straw Concentrate ..............................................................................................................................................
Phenazocine ..................................................................................................................................................................
Piminodine .....................................................................................................................................................................
Racemethorphan ...........................................................................................................................................................
Racemorphan ................................................................................................................................................................
Alfentanil ........................................................................................................................................................................
Remifentanil ...................................................................................................................................................................
Sufentanil .......................................................................................................................................................................
Carfentanil ......................................................................................................................................................................
Tapentadol .....................................................................................................................................................................
Bezitramide ....................................................................................................................................................................
Fentanyl .........................................................................................................................................................................
Moramide-intermediate ..................................................................................................................................................
The company plans to import small
quantities of the listed controlled
substances for the National Institute on
Drug Abuse (NIDA) for research
activities. The company plans to import
analytical reference standards for
distribution to its customers for research
and analytical purposes.
Dated: July 16, 2019.
John J. Martin,
Assistant Administrator.
[FR Doc. 2019–16167 Filed 7–29–19; 8:45 am]
BILLING CODE 4410–09–P
DEPARTMENT OF JUSTICE
In
accordance with 21 CFR 1301.34(a), this
is notice that on May 15, 2019, Cambrex
Charles City, 1205 11th Street, Charles
City, Iowa 50616 applied to be
registered as an importer of the
following basic classes of controlled
substances:
SUPPLEMENTARY INFORMATION:
Drug Enforcement Administration
[Docket No. DEA–392]
Importer of Controlled Substances
Application: Cambrex Charles City
ACTION:
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,
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.
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 August 29, 2019. Such persons
may also file a written request for a
hearing on the application on or before
August 29, 2019.
ADDRESSES: Written comments should
be sent to: Drug Enforcement
jspears on DSK3GMQ082PROD with NOTICES
DATES:
VerDate Sep<11>2014
16:42 Jul 29, 2019
Jkt 247001
Drug
code
Controlled substance
4-Anilino-N-phenethyl-4-piperidine (ANPP).
Phenylacetone ......................
Coca Leaves .........................
Opium, raw ...........................
Poppy Straw Concentrate .....
Schedule
8333
II
8501
9040
9600
9670
II
II
II
II
The company plans to import the
listed controlled substances for internal
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9254
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9273
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9648
9650
9652
9670
9715
9730
9732
9733
9737
9739
9740
9743
9780
9800
9801
9802
Schedule
II
II
II
II
II
II
II
II
II
II
II
II
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II
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use, and to manufacture bulk
intermediates for sale to its customers.
Dated: July 16, 2019.
John J. Martin,
Assistant Administrator.
[FR Doc. 2019–16174 Filed 7–29–19; 8:45 am]
BILLING CODE 4410–09–P
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. DEA–392]
Importer of Controlled Substances
Application: Catalent Pharma
Solutions, 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 August 29, 2019. Such persons
may also file a written request for a
hearing on the application on or before
August 29, 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
DATES:
E:\FR\FM\30JYN1.SGM
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36946
Federal Register / Vol. 84, No. 146 / Tuesday, July 30, 2019 / Notices
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.
In
accordance with 21 CFR 1301.34(a), this
is notice that on May 31, 2019, Catalent
Pharma Solutions, LLC, 3031 Red Lion
Road, Philadelphia, Pennsylvania 19114
applied to be registered as an importer
of the following basic class of controlled
substance:
SUPPLEMENTARY INFORMATION:
Controlled substance
Gamma Hydroxybutyric Acid.
Drug
code
Schedule
2010
I
The company plans to import finished
dosage unit products containing gamma-
hydroxybutyric acid for clinical trials,
research, and analytical activities.
Dated: July 16, 2019.
John J. Martin,
Assistant Administrator.
[FR Doc. 2019–16166 Filed 7–29–19; 8:45 am]
BILLING CODE 4410–09–P
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. DEA–392]
Importer of Controlled Substances
Application: Xcelience
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 August 29, 2019. Such persons
may also file a written request for a
hearing on the application on or before
August 29, 2019.
DATES:
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,
Virginia 22152. All request 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.
ADDRESSES:
SUPPLEMENTARY INFORMATION:
In accordance with 21 CFR
1301.34(a), this is notice that on May 2,
2019, Xcelience, 4901 West Grace
Street, Tampa, Florida 33607, applied to
be registered as an importer of the
following basic class of controlled
substance:
Controlled substance
Drug code
Amphetamine .........................................................................................................................................................
The company plans to import the
listed controlled substance in finished
dosage form for clinical trials, research
and analytical purposes.
Dated: July 16, 2019.
John J. Martin,
Assistant Administrator.
[FR Doc. 2019–16168 Filed 7–29–19; 8:45 am]
BILLING CODE 4410–09–P
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 August 29, 2019. Such persons
may also file a written request for a
hearing on the application on or before
August 29, 2019.
DATES:
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,
Virginia 22152. All requests for a
hearing should also be sent to: (1) Drug
Enforcement Administration, Attn:
ADDRESSES:
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. DEA–392]
Importer of Controlled Substances
Application: Nostrum Laboratories,
Inc.
ACTION:
Notice of application.
1100
SUPPLEMENTARY INFORMATION:
In accordance with 21 CFR
1301.34(a), this is notice that on March
13, 2019, Nostrum Laboratories, Inc.,
705 East Mulberry Street, Bryan, Ohio
43506 applied to be registered as an
importer of the following basic class of
controlled substance:
Drug code
jspears on DSK3GMQ082PROD with NOTICES
Marihuana Extract ..................................................................................................................................................
Marihuana ..............................................................................................................................................................
VerDate Sep<11>2014
16:42 Jul 29, 2019
Jkt 247001
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.
PO 00000
Frm 00063
Fmt 4703
II
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 for research
and new drug development. Approval of
permit applications will occur only
when the registrant’s business activity is
Schedule
Sfmt 9990
7350
7360
Schedule
I
I
Dated: July 16, 2019.
John J. Martin,
Assistant Administrator.
[FR Doc. 2019–16173 Filed 7–29–19; 8:45 am]
BILLING CODE 4410–09–P
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]]>Agencies
[Federal Register Volume 84, Number 146 (Tuesday, July 30, 2019)]
[Notices]
[Pages 36945-36946]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-16166]
-----------------------------------------------------------------------
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. DEA-392]
Importer of Controlled Substances Application: Catalent Pharma
Solutions, 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 on or before August 29, 2019.
Such persons may also file a written request for a hearing on the
application on or before August 29, 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
[[Page 36946]]
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.
SUPPLEMENTARY INFORMATION: In accordance with 21 CFR 1301.34(a), this
is notice that on May 31, 2019, Catalent Pharma Solutions, LLC, 3031
Red Lion Road, Philadelphia, Pennsylvania 19114 applied to be
registered as an importer of the following basic class of controlled
substance:
------------------------------------------------------------------------
Controlled substance Drug code Schedule
------------------------------------------------------------------------
Gamma Hydroxybutyric Acid............. 2010 I
------------------------------------------------------------------------
The company plans to import finished dosage unit products
containing gamma-hydroxybutyric acid for clinical trials, research, and
analytical activities.
Dated: July 16, 2019.
John J. Martin,
Assistant Administrator.
[FR Doc. 2019-16166 Filed 7-29-19; 8:45 am]
BILLING CODE 4410-09-P
