Importer of Controlled Substances; Notice of Registration, 43259 [E8-16906]
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Federal Register / Vol. 73, No. 143 / Thursday, July 24, 2008 / Notices
The proposed Consent Decree may be
examined at the Clerk’s Office, United
States District Court for the Eastern
District of California, 4–200 Robert T.
Matsui United States Courthouse, 501 I
Street, Sacramento, California 95814. In
addition, the proposed Consent Decree
may be viewed at https://www.usdoj.gov/
enrd/Consent_Decrees.html.
Stephen Samuels,
Assistant Chief, Environmental Defense
Section, Environment & Natural Resources
Division.
[FR Doc. E8–16976 Filed 7–23–08; 8:45 am]
BILLING CODE 4410–15–P
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
Importer of Controlled Substances;
Notice of Registration
By Notice dated January 11, 2006 and
published in the Federal Register on
January 23, 2006, (71 FR 3545), Cody
Laboratories, Inc., 601 Yellowstone
Avenue, Cody, Wyoming 82414–9321,
made application to the Drug
Enforcement Administration (DEA) to
be registered as an importer of the basic
classes of controlled substances listed in
schedule II:
Drug
Schedule
ebenthall on PRODPC60 with NOTICES
Raw Opium (9600) .......................
Poppy Straw (9650) .....................
Concentrate of Poppy Straw
(9670).
II.
II.
II.
The company plans to import narcotic
raw materials for manufacturing and
further distribution to its customers.
The company is registered with DEA as
a manufacturer of several controlled
substances that are manufactured from
raw opium, poppy straw, and
concentrate of poppy straw.
Comments, objections, and requests
for a hearing were received. However,
after a thorough review of this matter
DEA has concluded that, per 21 CFR
1301.34(a), the objectors are not entitled
to a hearing. As explained in the
Correction to Notice of Application
dated January 25, 2007, pertaining to
Cody Laboratories et al. (72 FR 3417),
comments and requests for hearings on
applications to import narcotic raw
material are not appropriate.
DEA has considered the factors in 21
U.S.C. 823(a) and 952(a) and determined
that the registration of Cody
Laboratories, 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
VerDate Aug<31>2005
15:14 Jul 23, 2008
Jkt 214001
protocols in effect on May 1, 1971. DEA
investigated Cody Laboratories, Inc. to
ensure that the company’s registration
would be consistent with the public
interest. The investigation included
inspection and testing of the company’s
physical security systems, verification
of the company’s compliance with state
and local laws, and a review of the
company’s background and history.
After investigating these and other
matters, I have concluded that
registering Cody Laboratories, Inc. to
import raw opium, poppy straw, and
concentrate of poppy straw is consistent
with the factors set forth in 21 U.S.C.
823(a)(2)–(6), as incorporated in 21
U.S.C. 958(a).
The DEA also considered whether the
registration of Cody Laboratories, Inc.
would be consistent with 21 U.S.C.
823(a)(1) that requires the DEA to limit
the importation of certain controlled
substances (including raw opium,
poppy straw, and concentrate of poppy
straw) ‘‘to a number of establishments
which can produce an adequate and
uninterrupted supply of these
substances under adequately
competitive conditions* * *.’’ I find
that the establishments currently
registered with DEA to import raw
opium, poppy straw, and concentrate of
poppy straw provide an adequate and
uninterrupted supply of those
substances. The DEA found no evidence
that the supply of such substances was
inadequate or interrupted in supplying
the needs of the United States for
legitimate medical, scientific, research,
and industrial purposes.
However, I find that the adequate and
uninterrupted supply of these
substances did not occur under
adequately competitive conditions.
Specifically, I find that Cody
Laboratories, Inc. has demonstrated that
the current importers of raw opium,
poppy straw, and concentrate of poppy
straw have, in some cases, refused to
sell these substances to Cody
Laboratories, Inc. Some of the current
importers also use their position to
demand restrictive contractual terms
when selling narcotic raw material to
Cody Laboratories, Inc. Many of the
current importers also manufacture
active pharmaceutical ingredients or
have corporate ties to firms that
manufacture active pharmaceutical
ingredients from raw opium, poppy
straw, and concentrate of poppy straw.
These importers have a direct financial
interest in refusing to sell narcotic raw
material to Cody Laboratories, Inc. or in
demanding significant contractual
restrictions when selling narcotic raw
material to Cody Laboratories, Inc.
PO 00000
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Fmt 4703
Sfmt 4703
43259
Based on the information in the
investigative file that is summarized
herein, I find that the current
importation of raw opium, poppy straw,
and concentrate of poppy straw is not
being conducted under adequately
competitive conditions. Therefore,
under 21 U.S.C. 823(a)(1), DEA may
grant the application of Cody
Laboratories, Inc. to import raw opium,
poppy straw, and concentrate of poppy
straw. Having already found that
registering Cody Laboratories, Inc. to
import raw opium, poppy straw, and
concentrate of poppy straw is consistent
with the factors set forth in 21 U.S.C.
823(a)(2)–(6), I find that the statutory
factor set forth in 21 U.S.C. 823(a)(1)
also weighs in favor of granting the
application.
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 basic classes of
controlled substances listed.
Dated: July 18, 2008.
Joseph T. Rannazzisi,
Deputy Assistant Administrator, Office of
Diversion Control, Drug Enforcement
Administration.
[FR Doc. E8–16906 Filed 7–23–08; 8:45 am]
BILLING CODE 4410–09–P
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
Manufacturer of Controlled
Substances; Notice of Registration
By Notice dated February 13, 2008
and published in the Federal Register
on February 21, 2008, (73 FR 9592),
Johnson Matthey, Inc., Custom
Pharmaceuticals Department, 2003
Nolte Drive, West Deptford, New Jersey
08066–1742, made application by letter
to the Drug Enforcement Administration
(DEA) to be registered as a bulk
manufacturer of Lisdexamfetamine
(1205), a basic class of controlled
substance listed in schedule II.
The company plans to manufacture
the listed controlled substance in bulk
for sale to its customers.
No comments or objections have been
received. DEA has considered the
factors in 21 U.S.C. 823(a) and
determined that the registration of
Johnson Matthey, Inc. to manufacture
the listed basic class of controlled
substance is consistent with the public
interest at this time. DEA has
investigated Johnson Matthey, Inc. to
ensure that the company’s registration is
consistent with the public interest. The
investigation has included inspection
E:\FR\FM\24JYN1.SGM
24JYN1
]]>Agencies
[Federal Register Volume 73, Number 143 (Thursday, July 24, 2008)]
[Notices]
[Page 43259]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E8-16906]
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DEPARTMENT OF JUSTICE
Drug Enforcement Administration
Importer of Controlled Substances; Notice of Registration
By Notice dated January 11, 2006 and published in the Federal
Register on January 23, 2006, (71 FR 3545), Cody Laboratories, Inc.,
601 Yellowstone Avenue, Cody, Wyoming 82414-9321, made application to
the Drug Enforcement Administration (DEA) to be registered as an
importer of the basic classes of controlled substances listed in
schedule II:
------------------------------------------------------------------------
Drug Schedule
------------------------------------------------------------------------
Raw Opium (9600)........................... II.
Poppy Straw (9650)......................... II.
Concentrate of Poppy Straw (9670).......... II.
------------------------------------------------------------------------
The company plans to import narcotic raw materials for
manufacturing and further distribution to its customers. The company is
registered with DEA as a manufacturer of several controlled substances
that are manufactured from raw opium, poppy straw, and concentrate of
poppy straw.
Comments, objections, and requests for a hearing were received.
However, after a thorough review of this matter DEA has concluded that,
per 21 CFR 1301.34(a), the objectors are not entitled to a hearing. As
explained in the Correction to Notice of Application dated January 25,
2007, pertaining to Cody Laboratories et al. (72 FR 3417), comments and
requests for hearings on applications to import narcotic raw material
are not appropriate.
DEA has considered the factors in 21 U.S.C. 823(a) and 952(a) and
determined that the registration of Cody Laboratories, 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. DEA
investigated Cody Laboratories, Inc. to ensure that the company's
registration would be consistent with the public interest. The
investigation included inspection and testing of the company's physical
security systems, verification of the company's compliance with state
and local laws, and a review of the company's background and history.
After investigating these and other matters, I have concluded that
registering Cody Laboratories, Inc. to import raw opium, poppy straw,
and concentrate of poppy straw is consistent with the factors set forth
in 21 U.S.C. 823(a)(2)-(6), as incorporated in 21 U.S.C. 958(a).
The DEA also considered whether the registration of Cody
Laboratories, Inc. would be consistent with 21 U.S.C. 823(a)(1) that
requires the DEA to limit the importation of certain controlled
substances (including raw opium, poppy straw, and concentrate of poppy
straw) ``to a number of establishments which can produce an adequate
and uninterrupted supply of these substances under adequately
competitive conditions* * *.'' I find that the establishments currently
registered with DEA to import raw opium, poppy straw, and concentrate
of poppy straw provide an adequate and uninterrupted supply of those
substances. The DEA found no evidence that the supply of such
substances was inadequate or interrupted in supplying the needs of the
United States for legitimate medical, scientific, research, and
industrial purposes.
However, I find that the adequate and uninterrupted supply of these
substances did not occur under adequately competitive conditions.
Specifically, I find that Cody Laboratories, Inc. has demonstrated that
the current importers of raw opium, poppy straw, and concentrate of
poppy straw have, in some cases, refused to sell these substances to
Cody Laboratories, Inc. Some of the current importers also use their
position to demand restrictive contractual terms when selling narcotic
raw material to Cody Laboratories, Inc. Many of the current importers
also manufacture active pharmaceutical ingredients or have corporate
ties to firms that manufacture active pharmaceutical ingredients from
raw opium, poppy straw, and concentrate of poppy straw. These importers
have a direct financial interest in refusing to sell narcotic raw
material to Cody Laboratories, Inc. or in demanding significant
contractual restrictions when selling narcotic raw material to Cody
Laboratories, Inc.
Based on the information in the investigative file that is
summarized herein, I find that the current importation of raw opium,
poppy straw, and concentrate of poppy straw is not being conducted
under adequately competitive conditions. Therefore, under 21 U.S.C.
823(a)(1), DEA may grant the application of Cody Laboratories, Inc. to
import raw opium, poppy straw, and concentrate of poppy straw. Having
already found that registering Cody Laboratories, Inc. to import raw
opium, poppy straw, and concentrate of poppy straw is consistent with
the factors set forth in 21 U.S.C. 823(a)(2)-(6), I find that the
statutory factor set forth in 21 U.S.C. 823(a)(1) also weighs in favor
of granting the application.
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 basic classes of controlled
substances listed.
Dated: July 18, 2008.
Joseph T. Rannazzisi,
Deputy Assistant Administrator, Office of Diversion Control, Drug
Enforcement Administration.
[FR Doc. E8-16906 Filed 7-23-08; 8:45 am]
BILLING CODE 4410-09-P
