Manufacturer of Controlled Substances Registration: Johnson Matthey, Inc., 46334-46335 [2015-19100]
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Federal Register / Vol. 80, No. 149 / Tuesday, August 4, 2015 / Notices
and analytical purposes. 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 to 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.
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 28,
2014, Cedarburg Pharmaceuticals, Inc.,
870 Badger Circle, Grafton, Wisconsin
53024 applied to be registered as a bulk
manufacturer of the following basic
classes of controlled substances:
Dated: July 29, 2015.
Joseph T. Rannazzisi,
Deputy Assistant Administrator.
[Docket No. DEA–392]
The company plans to manufacture
the above-listed controlled substances
in bulk for distribution to its customers.
In reference to drug code 7360
marihuana, the company plans to bulk
manufacture cannabidiol as a synthetic
intermediate. This controlled substance
will be further synthesized to bulk
manufacture a synthetic
tetrahydrocannabinol 7370. No other
activity for this drug code is authorized
for this registration.
Bulk Manufacturer of Controlled
Substances Application: Cedarburg
Pharmaceuticals, Inc.
Dated: July 29, 2015.
Joseph T. Rannazzisi,
Deputy Assistant Administrator.
[FR Doc. 2015–19158 Filed 8–3–15; 8:45 am]
BILLING CODE 4410–09–P
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
Controlled substance
Marihuana (7360) .........................
Tetrahydrocannabinols (7370) .....
Schedule
I
I
[FR Doc. 2015–19165 Filed 8–3–15; 8:45 am]
ACTION:
Notice of application.
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 in
accordance with 21 CFR 1301.33(a) on
or before October 5, 2015.
ADDRESSES: Written comments should
be sent to: Drug Enforcement
Administration, Attention: DEA Federal
Register Representative/ODXL, 8701
Morrissette Drive, Springfield, Virginia
22152. Request for hearings should be
sent to: Drug Enforcement
Administration, Attention: Hearing
Clerk/LJ, 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 Deputy Assistant
Administrator of the DEA Office of
Diversion Control (‘‘Deputy Assistant
tkelley on DSK3SPTVN1PROD with NOTICES
DATES:
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18:45 Aug 03, 2015
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DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. DEA–392]
Manufacturer of Controlled
Substances Registration: Cody
Laboratories, Inc.
ACTION:
Notice of registration.
Cody Laboratories, Inc.
applied to be registered as a
manufacturer of certain basic classes of
controlled substances. The Drug
Enforcement Administration (DEA)
grants Cody Laboratories, Inc.
registration as a manufacturer of those
controlled substances.
SUPPLEMENTARY INFORMATION: By notice
dated April 14, 2015, and published in
the Federal Register on April 22, 2015,
80 FR 22560, Cody Laboratories, Inc.,
Steve Hartman-Vice President of
Compliance, 601 Yellowstone Avenue,
Cody, Wyoming 82414 applied to be
registered as a manufacturer of certain
basic classes of controlled substances.
No comments or objections were
submitted for this notice.
The DEA has considered the factors in
21 U.S.C. 823(a) and determined that
the registration of Cody Laboratories,
Inc. to manufacture the basic classes of
controlled substances is consistent with
SUMMARY:
PO 00000
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Fmt 4703
Sfmt 4703
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 above-named company is
granted registration as a bulk
manufacturer of the basic classes of
controlled substances listed:
Controlled substance
Dihydromorphine (9145) ...............
Amphetamine (1100) ....................
Methamphetamine (1105) ............
Amobarbital (2125) .......................
Pentobarbital (2270) .....................
Secobarbital (2315) ......................
4-Anilino-N-phenethyl-4-piperidine
(ANPP) (8333).
Phenylacetone (8501) ..................
Cocaine (9041) .............................
Codeine (9050) .............................
Dihydrocodeine (9120) .................
Oxycodone (9143) ........................
Hydromorphone (9150) ................
Diphenoxylate (9170) ...................
Ecgonine (9180) ...........................
Hydrocodone (9193) .....................
Meperidine (9230) ........................
Methadone (9250) ........................
Morphine (9300) ...........................
Thebaine (9333) ...........................
Oxymorphone (9652) ...................
Alfentanil (9737) ...........................
Remifentanil (9739) ......................
Sufentanil (9740) ..........................
Fentanyl (9801) ............................
Schedule
I
II
II
II
II
II
II
II
II
II
II
II
II
II
II
II
II
II
II
II
II
II
II
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The company plans to manufacture
the listed controlled substances in bulk
for sale to its customers.
Dated: July 29, 2015.
Joseph T. Rannazzisi,
Deputy Assistant Administrator.
[FR Doc. 2015–19168 Filed 8–3–15; 8:45 am]
BILLING CODE P
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. DEA–392]
Manufacturer of Controlled
Substances Registration: Johnson
Matthey, Inc.
ACTION:
Notice of registration.
Johnson Matthey, Inc. applied
to be registered as a manufacturer of
certain basic classes of controlled
SUMMARY:
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46335
Federal Register / Vol. 80, No. 149 / Tuesday, August 4, 2015 / Notices
substances. The Drug Enforcement
Administration (DEA) grants Johnson
Matthey, Inc. registration as a
manufacturer of those controlled
substances.
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. DEA–392]
By notice
dated February 11, 2015, and published
in the Federal Register on February 19,
2015, 80 FR 8902, Johnson Matthey,
Inc., Pharmaceuticals Materials, 900
River Road, Conshohocken,
Pennsylvania 19428 applied to be
registered as a manufacturer of certain
basic classes of controlled substances.
No comments or objections were
submitted to this notice.
The DEA has considered the factors in
21 U.S.C. 823(a) and determined that
the registration of Johnson Matthey, Inc.
to manufacture the 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 above-named company is
granted registration as a bulk
manufacturer of the basic classes of
controlled substances listed:
SUPPLEMENTARY INFORMATION:
Controlled substance
Schedule
tkelley on DSK3SPTVN1PROD with NOTICES
Gamma
Hydroxybutyric
Acid
(2010).
Amphetamine (1100) ....................
Methylphenidate (1724) ................
Codeine (9050) .............................
Oxycodone (9143) ........................
Diphenoxylate (9170) ...................
Hydrocodone (9193) .....................
Meperidine (9230) ........................
Methadone (9250) ........................
Methadone intermediate (9254) ...
Morphine (9300) ...........................
Thebaine (9333) ...........................
I
II
II
II
II
II
II
II
II
II
II
II
[FR Doc. 2015–19100 Filed 8–3–15; 8:45 am]
BILLING CODE 4410–09–P
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Jkt 235001
ACTION:
Notice of registration.
Dated: July 29, 2015.
Joseph T. Rannazzisi,
Deputy Assistant Administrator.
[FR Doc. 2015–19162 Filed 8–3–15; 8:45 am]
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Actavis Laboratories FL, Inc.
applied to be registered as an importer
of certain basic classes of controlled
substances. The Drug Enforcement
Administration (DEA) grants Actavis
Laboratories FL, Inc., registration as an
importer of those controlled substances.
SUPPLEMENTARY INFORMATION: By notice
dated April 14, 2015, and published in
the Federal Register on April 22, 2015,
80 FR 22554, Actavis Laboratories FL,
Inc., 4955 Orange Drive, Davie, Florida
33314 applied to be registered as an
importer of a certain basic classes of
controlled substances. No comments or
objections were submitted for this
notice.
The DEA has considered the factors in
21 U.S.C. 823, 952(a) and 958(a) and
determined that the registration of
Actavis Laboratories FL, Inc. to import
the 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.
952(a) and 958(a), and in accordance
with 21 CFR 1301.34, the above-named
company is granted registration as an
importer of the following basic classes
of controlled substances:
SUMMARY:
Controlled substance
The company plans to manufacture
the listed controlled substances in bulk
for distribution and sale to its
customers.
The thebaine (9333) will be used to
manufacture other controlled substances
for sale in bulk to its customers.
Dated: July 29, 2015.
Joseph T. Rannazzisi,
Deputy Assistant Administrator.
Importer of Controlled Substances
Registration: Actavis Laboratories FL,
Inc.
finished Food and Drug Administration
approved or non-approved dosage form
for commercial distribution in the
United States.
Amphetamine (1100) ....................
Methylphenidate (1724) ................
Oxycodone (9143) ........................
Hydromorphone (9150) ................
Hydrocodone (9193) .....................
Fentanyl (9801) ............................
Schedule
II
II
II
II
II
II
The company plans to import the
above-listed controlled substances for
clinical trials, research and analytical
purposes.
The import of the above-listed basic
classes of controlled substances would
be granted only for analytical testing
and clinical trials. This authorization
does not extend to the import of a
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DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. DEA–392]
Importer of Controlled Substances
Registration: Almac Clinical Services
Inc. (ACSI)
ACTION:
Notice of registration.
Almac Clinical Services Inc.
(ACSI) applied to be registered as an
importer of certain basic classes of
controlled substances. The Drug
Enforcement Administration (DEA)
grants Almac Clinical Services Inc.
(ACSI) registration as an importer of
those controlled substances.
SUPPLEMENTARY INFORMATION: By notice
dated April 14, 2015, and published in
the Federal Register on April 22, 2015,
80 FR 22556, Almac Clinical Services
Inc. (ACSI), 25 Fretz Road, Souderton,
Pennsylvania 18964 applied to be
registered as an importer of certain basic
classes of controlled substances. No
comments or objections were submitted
for this notice.
The DEA has considered the factors in
21 U.S.C. 823, 952(a) and 958(a) and
determined that the registration of
Almac Clinical Services Inc. (ACSI) to
import the 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.
952(a) and 958(a), and in accordance
with 21 CFR 1301.34, the above-named
company is granted registration as an
importer of the following basic classes
of controlled substances:
SUMMARY:
Controlled substance
Oxycodone (9143) ........................
Hydromorphone (9150) ................
Tapentadol (9780) ........................
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]]>Agencies
[Federal Register Volume 80, Number 149 (Tuesday, August 4, 2015)]
[Notices]
[Pages 46334-46335]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-19100]
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DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. DEA-392]
Manufacturer of Controlled Substances Registration: Johnson
Matthey, Inc.
ACTION: Notice of registration.
-----------------------------------------------------------------------
SUMMARY: Johnson Matthey, Inc. applied to be registered as a
manufacturer of certain basic classes of controlled
[[Page 46335]]
substances. The Drug Enforcement Administration (DEA) grants Johnson
Matthey, Inc. registration as a manufacturer of those controlled
substances.
SUPPLEMENTARY INFORMATION: By notice dated February 11, 2015, and
published in the Federal Register on February 19, 2015, 80 FR 8902,
Johnson Matthey, Inc., Pharmaceuticals Materials, 900 River Road,
Conshohocken, Pennsylvania 19428 applied to be registered as a
manufacturer of certain basic classes of controlled substances. No
comments or objections were submitted to this notice.
The DEA has considered the factors in 21 U.S.C. 823(a) and
determined that the registration of Johnson Matthey, Inc. to
manufacture the 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 above-named company is granted registration as a bulk
manufacturer of the basic classes of controlled substances listed:
------------------------------------------------------------------------
Controlled substance Schedule
------------------------------------------------------------------------
Gamma Hydroxybutyric Acid (2010)........... I
Amphetamine (1100)......................... II
Methylphenidate (1724)..................... II
Codeine (9050)............................. II
Oxycodone (9143)........................... II
Diphenoxylate (9170)....................... II
Hydrocodone (9193)......................... II
Meperidine (9230).......................... II
Methadone (9250)........................... II
Methadone intermediate (9254).............. II
Morphine (9300)............................ II
Thebaine (9333)............................ II
------------------------------------------------------------------------
The company plans to manufacture the listed controlled substances
in bulk for distribution and sale to its customers.
The thebaine (9333) will be used to manufacture other controlled
substances for sale in bulk to its customers.
Dated: July 29, 2015.
Joseph T. Rannazzisi,
Deputy Assistant Administrator.
[FR Doc. 2015-19100 Filed 8-3-15; 8:45 am]
BILLING CODE 4410-09-P
