Bulk Manufacturer of Controlled Substances Application: Cambrex High Point, Inc., 44639-44640 [2019-18324]
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44639
Federal Register / Vol. 84, No. 165 / Monday, August 26, 2019 / Notices
Drug
code
Controlled substance
khammond on DSKBBV9HB2PROD with NOTICES
4-Fluoroisobutyryl fentanyl (N-(4-fluorophenyl)-N-(1phenethylpiperidin-4-yl)isobutyramide) .......................................................
2-methoxy-N-(1-phenethylpiperidin-4-yl)-N-phenylacetamide ......................................................................................................
Para-chloroisobutyryl fentanyl ......................................................................................................................................................
Isobutyryl fentanyl ........................................................................................................................................................................
Beta-hydroxyfentanyl ....................................................................................................................................................................
Beta-hydroxy-3-methylfentanyl .....................................................................................................................................................
Alpha-methylthiofentanyl ..............................................................................................................................................................
3-Methylthiofentanyl .....................................................................................................................................................................
Furanyl fentanyl (N-(1-phenethylpiperidin-4-yl)-N-phenylfuran-2-carboxamide) ..........................................................................
Thiofentanyl ..................................................................................................................................................................................
Beta-hydroxythiofentanyl ..............................................................................................................................................................
Para-methoxybutyryl fentanyl .......................................................................................................................................................
Ocfentanil .....................................................................................................................................................................................
Valeryl fentanyl .............................................................................................................................................................................
N-(1-phenethylpiperidin-4-yl)-N-phenyltetrahydrofuran-2-carboxamide .......................................................................................
Cyclopropyl Fentanyl ....................................................................................................................................................................
Cyclopentyl fentanyl .....................................................................................................................................................................
Fentanyl related-compounds as defined in 21 CFR 1308.11(h) ..................................................................................................
Amphetamine ...............................................................................................................................................................................
Methamphetamine ........................................................................................................................................................................
Lisdexamfetamine ........................................................................................................................................................................
Phenmetrazine .............................................................................................................................................................................
Methylphenidate ...........................................................................................................................................................................
Amobarbital ..................................................................................................................................................................................
Pentobarbital ................................................................................................................................................................................
Secobarbital ..................................................................................................................................................................................
Phencyclidine ...............................................................................................................................................................................
4-Anilino-N-phenethyl-4-piperidine (ANPP) ..................................................................................................................................
Phenylacetone ..............................................................................................................................................................................
1-Piperidinocyclohexanecarbonitrile .............................................................................................................................................
Cocaine ........................................................................................................................................................................................
Codeine ........................................................................................................................................................................................
Etorphine HCl ...............................................................................................................................................................................
Dihydrocodeine .............................................................................................................................................................................
Oxycodone ...................................................................................................................................................................................
Hydromorphone ............................................................................................................................................................................
Ecgonine .......................................................................................................................................................................................
Ethylmorphine ...............................................................................................................................................................................
Hydrocodone ................................................................................................................................................................................
Levomethorphan ...........................................................................................................................................................................
Levorphanol ..................................................................................................................................................................................
Isomethadone ...............................................................................................................................................................................
Meperidine ....................................................................................................................................................................................
Meperidine intermediate–B ..........................................................................................................................................................
Methadone ....................................................................................................................................................................................
Dextropropoxyphene, bulk (non-dosage forms) ...........................................................................................................................
Morphine .......................................................................................................................................................................................
Thebaine .......................................................................................................................................................................................
Oxymorphone ...............................................................................................................................................................................
Thiafentanil ...................................................................................................................................................................................
Alfentanil .......................................................................................................................................................................................
Remifentanil ..................................................................................................................................................................................
Sufentanil ......................................................................................................................................................................................
Carfentanil ....................................................................................................................................................................................
Tapentadol ....................................................................................................................................................................................
Fentanyl ........................................................................................................................................................................................
The company plans to bulk
manufacture the listed controlled
substances to produce forensic and
research of analytical reference
standards for distribution to its
customers. In reference to marihuana
(7360) and tetrahydrocannabinols (7370)
the company will manufacture as
synthetics only. No other activities for
these drug codes are authorized for this
registration.
VerDate Sep<11>2014
16:09 Aug 23, 2019
Jkt 247001
9824
9825
9826
9827
9830
9831
9832
9833
9834
9835
9836
9837
9838
9840
9843
9845
9847
9850
1100
1105
1205
1631
1724
2125
2270
2315
7471
8333
8501
8603
9041
9050
9059
9120
9143
9150
9180
9190
9193
9210
9220
9226
9230
9233
9250
9273
9300
9333
9652
9729
9737
9739
9740
9743
9780
9801
Dated: August 9, 2019.
Neil D. Doherty,
Acting Assistant Administrator.
DEPARTMENT OF JUSTICE
[FR Doc. 2019–18322 Filed 8–23–19; 8:45 am]
[Docket No. DEA–392]
BILLING CODE 4410–09–P
PO 00000
Schedule
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Drug Enforcement Administration
Bulk Manufacturer of Controlled
Substances Application: Cambrex
High Point, Inc.
ACTION:
Notice of application.
Registered bulk manufacturers of
the affected basic classes, and
DATES:
Frm 00042
Fmt 4703
Sfmt 4703
E:\FR\FM\26AUN1.SGM
26AUN1
44640
Federal Register / Vol. 84, No. 165 / Monday, August 26, 2019 / Notices
applicants therefore, may file written
comments on or objections to the
issuance of the proposed registration on
or before October 25, 2019.
ADDRESS: Written comments should be
sent to: Drug Enforcement
Administration, Attention: DEA Federal
Register Representative/DPW, 8701
Morrissette Drive, Springfield, Virginia
22152.
In
accordance with 21 CFR 1301.33(a), this
is notice that on June 19, 2019, Cambrex
High Point, Inc., 4180 Mendenhall Oaks
Parkway, High Point, North Carolina
27265–8017 applied to be registered as
a bulk manufacturer of the following
basic classes of controlled substances:
SUPPLEMENTARY INFORMATION:
Controlled
substance
Oxymorphone ................
Noroxymorphone ...........
Drug
code
9652
9668
Schedule
II
II
The company plans to manufacture
the above listed controlled substances in
bulk for distribution to its customers.
No other activities for these drug codes
are authorized for this registration.
Dated: August 9, 2019.
Neil D. Doherty,
Acting Assistant Administrator.
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 June 5, 2019, Clinical
Supplies Management Holdings, Inc.,
342 42nd Street South, Fargo, North
Dakota 58103 applied to be registered as
an importer of the following basic
classes of controlled substances:
Drug
code
Controlled substance
Marihuana .....................
Tetrahydrocannabinols
7360
7370
Schedule
I
I
The company plans to import listed
controlled substances in their finished
dosage form for use in clinical trials
only. Drug codes 7350 (marihuana
extract) and 7360 (marihuana) will be
used for the manufacture of cannabidiol
only.
Dated: August 9, 2019.
Neil D. Doherty,
Acting Assistant Administrator.
Dated: August 9, 2019.
Neil D. Doherty,
Acting Assistant Administrator.
[FR Doc. 2019–18325 Filed 8–23–19; 8:45 am]
BILLING CODE 4410–09–P
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. DEA–392]
[FR Doc. 2019–18320 Filed 8–23–19; 8:45 am]
BILLING CODE 4410–09–P
[FR Doc. 2019–18324 Filed 8–23–19; 8:45 am]
manufacture the applicable various
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 the company’s
maintenance of effective controls
against diversion by inspecting and
testing 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.
823(a), and in accordance with 21 CFR
1301.33, the DEA has granted a
registration as a bulk manufacturer to
the above listed company.
BILLING CODE 4410–09–P
Bulk Manufacturer of Controlled
Substances Application: AMRI
Renesselaer, Inc.
ACTION:
DEPARTMENT OF JUSTICE
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
Drug Enforcement Administration
[Docket No. DEA–392]
[Docket No. DEA–392]
Bulk Manufacturer of Controlled
Substances Registration AMPAC Fine
Chemicals Virginia, LLC
Importer of Controlled Substances
Application: Clinical Supplies
Management Holdings, Inc.
ACTION:
VerDate Sep<11>2014
16:09 Aug 23, 2019
Jkt 247001
Notice of registration.
The registrant listed below
have applied for and been granted a
registration by the Drug Enforcement
Administration (DEA) as a bulk
manufacturer of various basic classes of
schedule II controlled substances.
SUPPLEMENTARY INFORMATION: The
company listed below applied to be
registered as a bulk manufacturer of
various basic classes of scheduled II
controlled substances. Information on a
previously published notice is listed
below. No comments or objections were
submitted for this notice.
SUMMARY:
Registered bulk importers 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
September 25, 2019. Such persons may
also file a written request for a hearing
on the application on or before
September 25, 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,
Virginia 22152. All requests for a
hearing should also be sent to: (1) Drug
DATES:
khammond on DSKBBV9HB2PROD with NOTICES
ACTION:
Notice of application.
Company
FR docket
Published
AMPAC Fine Chemicals Virginia, LLC.
84 FR 21810
May 15, 2019.
The DEA has considered the factors in
21 U.S.C. 823(a) and determined that
the registration of this registrant to
PO 00000
Frm 00043
Fmt 4703
Sfmt 4703
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 October 25, 2019.
ADDRESS: 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
is notice that on March 15, 2019, AMRI
Rensselaer, Inc., 33 Riverside Avenue,
Rennselaer, New York 12144–2951
applied to be registered as a bulk
manufacturer of the following basic
classes of controlled substances:
DATES:
Controlled substance
Marihuana ......................
Tetrahydrocannabinols ..
Amphetamine ................
Lisdexamfetamine .........
Pentobarbital .................
4-Anilino-N-phenethyl-4piperidine (ANPP).
Codeine .........................
E:\FR\FM\26AUN1.SGM
26AUN1
Drug
code
Schedule
7360
7370
1100
1205
2270
8333
I
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II
II
II
II
9050
II
]]>Agencies
[Federal Register Volume 84, Number 165 (Monday, August 26, 2019)]
[Notices]
[Pages 44639-44640]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-18324]
-----------------------------------------------------------------------
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. DEA-392]
Bulk Manufacturer of Controlled Substances Application: Cambrex
High Point, Inc.
ACTION: Notice of application.
-----------------------------------------------------------------------
DATES: Registered bulk manufacturers of the affected basic classes, and
[[Page 44640]]
applicants therefore, may file written comments on or objections to the
issuance of the proposed registration on or before October 25, 2019.
ADDRESS: 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
is notice that on June 19, 2019, Cambrex High Point, Inc., 4180
Mendenhall Oaks Parkway, High Point, North Carolina 27265-8017 applied
to be registered as a bulk manufacturer of the following basic classes
of controlled substances:
------------------------------------------------------------------------
Drug
Controlled substance code Schedule
------------------------------------------------------------------------
Oxymorphone............................ 9652 II
Noroxymorphone......................... 9668 II
------------------------------------------------------------------------
The company plans to manufacture the above listed controlled
substances in bulk for distribution to its customers. No other
activities for these drug codes are authorized for this registration.
Dated: August 9, 2019.
Neil D. Doherty,
Acting Assistant Administrator.
[FR Doc. 2019-18324 Filed 8-23-19; 8:45 am]
BILLING CODE 4410-09-P
