Importer of Controlled Substances; Notice of Application, 16717-16718 [E8-6375]
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Federal Register / Vol. 73, No. 61 / Friday, March 28, 2008 / Notices
Discussion
Section 303(h) of the Controlled
Substances Act (CSA) provides that
‘‘[t]he Attorney General shall register an
applicant to distribute a list I chemical
unless the Attorney General determines
that registration of the applicant is
inconsistent with the public interest.’’
21 U.S.C. 823(h). In making this
determination, Congress directed that I
consider the following factors:
(1) Maintenance by the applicant of
effective controls against diversion of listed
chemicals into other than legitimate
channels;
(2) Compliance by the applicant with
applicable Federal, State, and local law;
(3) Any prior conviction record of the
applicant under Federal or State laws relating
to controlled substances or to chemicals
controlled under Federal or State law;
(4) Any past experience of the applicant in
the manufacture and distribution of
chemicals; and
(5) Such other factors as are relevant to and
consistent with the public health and safety.
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Id.
‘‘These factors are considered in the
disjunctive.’’ Joy’s Ideas, 70 FR 33195,
33197 (2005). I may rely on any one or
a combination of factors, and may give
each factor the weight I deem
appropriate in determining whether an
application for a registration should be
denied. See, e.g., David M. Starr, 71 FR
39367, 39368 (2006); Energy Outlet, 64
FR 14269 (1999). Moreover, I am ‘‘not
required to make findings as to all of the
factors.’’ Hoxie v. DEA, 419 F.3d 477,
482 (6th Cir. 2005); Morall v. DEA, 412
F.3d 165, 173–74 (D.C. Cir. 2005).
Having considered all of the factors, I
conclude that factors two and four
establish that Respondent’s registration
would be ‘‘inconsistent with the public
interest.’’ 21 U.S.C. 823(h).
Respondent’s application will therefore
be denied.
Here, the record establishes that
between September 2005 and February
2006, Respondent illegally imported
into the United States, 1,000 kilograms
of Ma Huang extract, which contained
ephedrine alkaloids in a concentration
of approximately eight percent. While at
the time of the importation, ‘‘harvested
plant material * * * contain[ing]
ephedrine * * * that preserve[d] the
natural constituents in the ratios that are
found in the plant’s natural state’’ was
exempt from the CSA’s requirements,
DEA’s regulation further provided that
‘‘[p]lant material subjected to chemical
or physical extraction, concentration,
chemical reaction, or other treatment
that alters the plant’s natural
constituents [was] not exempt.’’ 21 CFR
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17:57 Mar 27, 2008
Jkt 214001
1310.12(d)(1).4 Respondent did not have
a registration to import the product,
which contains a list I chemical and was
produced through an extraction process,
and thus was not exempt from the
application of the Act. See 21 U.S.C.
957(a); 21 CFR 1310.12(d)(1).
Respondent’s importation of Ma Huang
extract therefore violated federal law.
Moreover, substantial evidence
establishes that Respondent, its owner
(Mr. Wheat), and vice-president (Mr.
Smith), violated the CSA by importing
schedule III and IV controlled
substances (including anabolic steroids,
multiple benzodiazepines, as well as
phentermine and zolpidem) into the
United States from Belize in violation of
21 U.S.C. 952 and 957(a)(b). While the
indictment sets forth only allegations,
the plea agreements of several coconspirators implicated Respondent,
Mr. Wheat, and Mr. Smith, in the
conspiracy to knowingly import
controlled substances into the United
States in violation of federal law. The
agreements thus provide substantial
evidence to support a finding that
Respondent, Mr. Wheat, and Mr. Smith
violated federal law.5 See Richardson v.
Perales, 402 U.S. 389 (1971) (upholding
use of hearsay evidence in
administrative proceedings).
Accordingly, I conclude that granting
Respondent’s application would be
‘‘inconsistent with the public interest.’’
21 U.S.C. § 823(h).
Order
Pursuant to the authority vested in me
by 21 U.S.C. 823(h), as well as 28 CFR
0.100(b) & 0.104, I order that the
application of Hi-Tech Pharmaceuticals,
Inc., for a DEA Certificate of Registration
to import ephedrine, a list I chemical,
be, and it hereby is, denied. I further
order that the application of HiPharmaceuticals, Inc., for a DEA
Certificate of Registration to
4 On July 25, 2007, DEA published an interim rule
which removed the exemption ‘‘for unaltered
ephedra plant material.’’ 72 FR 40738, 40741
(2007). This rule became effective on August 24,
2007. Id. at 40742.
5 In light of the evidence establishing that Mr.
Wheat and Mr. Smith have committed offenses in
violation of the CSA, I need not decide whether
their prior convictions are too dated to be
considered.
I further note that Respondent imported listed
chemicals which it then used to manufacture and
distribute products which a federal court has held
were adulterated within the meaning of the Food,
Drug, and Cosmetic Act. See Hi-Tech
Pharmaceuticals, Inc., v. Crawford, 505 F.Supp.2d
at 1357. See also 21 U.S.C. 823(h)(5) (directing
consideration of ‘‘such other factors as are relevant
to and consistent with the public health and
safety’’). This conduct also supports the conclusion
that granting Respondent a registration would be
‘‘inconsistent with the public interest.’’ 21 U.S.C.
823(h).
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manufacture ephedrine, a list I
chemical, be, and it hereby is, denied.
This order is effective April 28, 2008.
Dated: March 17, 2008.
Michele M. Leonhart,
Deputy Administrator.
[FR Doc. E8–6377 Filed 3–27–08; 8:45 am]
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DEPARTMENT OF JUSTICE
Drug Enforcement Administration
Importer of Controlled Substances;
Notice of Application
Pursuant to Title 21 Code of Federal
Regulations 1301.34(a), this is notice
that on November 29, 2007,
Mallinckrodt Inc., 3600 North Second
Street, St. Louis, Missouri 63147, made
application by renewal to the Drug
Enforcement Administration (DEA) for
registration as an importer of the basic
classes of controlled substances listed in
schedule II:
Drug
Phenylacetone (8501) ..................
Coca Leaves (9040) .....................
Opium, raw (9600) .......................
Poppy Straw (9650) .....................
Poppy Straw Concentrate (9670)
Schedule
II
II
II
II
II
The company plans to import the
listed controlled substances for the
manufacture of controlled substances in
bulk for distribution to its customers.
No comments, objections, or requests
for any hearings will be accepted on any
application for registration or reregistration to import crude opium,
poppy straw, concentrate of poppy
straw or coca leaves. As explained in
the Correction to Notice of Application
pertaining to Rhodes Technologies, 72
FR 3417 (2007), comments and requests
for hearings on applications to import
narcotic raw material are not
appropriate.
Any bulk manufacturer who is
presently, or is applying to be,
registered with DEA to manufacture
such basic classes of controlled
substances listed in schedule I or II,
which fall under the authority of section
1002(a)(2)(B) of the Act (21 U.S.C.
952(a)(2)(B)) may, in the circumstances
set forth in 21 U.S.C. 958(i), file
comments or objections to the issuance
of the proposed registration and may, at
the same time, file a written request for
a hearing on such application pursuant
to 21 CFR 1301.43 and in such form as
prescribed by 21 CFR 1316.47.
Any such comments or objections
being sent via regular mail should be
addressed, in quintuplicate, to the Drug
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16718
Federal Register / Vol. 73, No. 61 / Friday, March 28, 2008 / Notices
Enforcement Administration, Office of
Diversion Control, Federal Register
Representative (ODL), Washington, DC
20537, or any being sent via express
mail should be sent to Drug
Enforcement Administration, Office of
Diversion Control, Federal Register
Representative (ODL), 8701 Morrissette
Drive, Springfield, VA 22152; and must
be filed no later than April 28, 2008.
This procedure is to be conducted
simultaneously with and independent
of the procedures described in 21 CFR
1301.34(b), (c), (d), (e) and (f). As noted
in a previous notice published in the
Federal Register on September 23, 1975,
(40 FR 43745), all applicants for
registration to import a basic class of
any controlled substances in schedule I
or II are and will continue to be required
to demonstrate to the Deputy Assistant
Administrator, Office of Diversion
Control, Drug Enforcement
Administration, that the requirements
for such registration pursuant to 21
U.S.C. 958(a); 21 U.S.C. 823(a); and 21
CFR 1301.34(b), (c), (d), (e) and (f) are
satisfied.
Dated: March 19, 2008.
Joseph T. Rannazzisi,
Deputy Assistant Administrator, Office of
Diversion Control, Drug Enforcement
Administration.
[FR Doc. E8–6375 Filed 3–27–08; 8:45 am]
BILLING CODE 4410–09–P
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
Importer of Controlled Substances;
Notice of Application
This is notice that on March 6, 2008,
Penick Corporation, 33 Industrial Park
Road, Pennsville, New Jersey 08070,
made application by renewal to the
Drug Enforcement Administration
(DEA) for registration as an importer of
the basic classes of controlled
substances listed in schedule II.
Drug
Schedule
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Coca Leaves (9040) .....................
Raw Opium (9600) .......................
Poppy Straw (9650) .....................
Concentrate of Poppy Straw
(9670).
II
II
II
II
The company plans to import the
listed controlled substances to
manufacture bulk controlled substance
intermediates for sale to its customers.
As noted in a previous notice
published in the Federal Register on
September 23, 1975, (40 FR 43745), all
applicants for registration to import a
basic class of any controlled substances
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17:57 Mar 27, 2008
Jkt 214001
in schedule I or II are, and will continue
to be, required to demonstrate to the
Deputy Assistant Administrator, Office
of Diversion Control, Drug Enforcement
Administration, that the requirements
for such registration pursuant to 21
U.S.C. 958(a); 21 U.S.C. 823(a); and 21
CFR 1301.34(b), (c), (d), (e) and (f) are
satisfied.
Dated: March 19, 2008.
Joseph T. Rannazzisi,
Deputy Assistant Administrator, Office of
Diversion Control, Drug Enforcement
Administration.
[FR Doc. E8–6368 Filed 3–27–08; 8:45 am]
Dated: March 19, 2008.
Joseph T. Rannazzisi,
Deputy Assistant Administrator, Office of
Diversion Control, Drug Enforcement
Administration.
[FR Doc. E8–6376 Filed 3–27–08; 8:45 am]
DEPARTMENT OF JUSTICE
BILLING CODE 4410–09–P
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
Importer of Controlled Substances;
Notice of Registration
By Notice dated December 17, 2007
and published in the Federal Register
on December 27, 2007, (72 FR 73357),
Cambrex Charles City, Inc., 1205 11th
Street, Charles City, Iowa 50616, made
application by renewal to the Drug
Enforcement Administration (DEA) to
be registered as an importer of
Phenylacetone (8501), a basic class of
controlled substance listed in schedule
II:
The company plans to import
Phenylacetone for use as a precursor in
the manufacturer of amphetamine only.
No comments or objections have been
received. DEA has considered the
factors in 21 U.S.C. 823(a) and 952(a)
and determined that the registration of
Cambrex Charles City, Inc. to import the
basic class of controlled substance is
consistent with the public interest and
with United States obligations under
international treaties, conventions, or
protocols in effect on May 1, 1971, at
this time. DEA has investigated
Cambrex Charles City, Inc. to ensure
that the company’s registration is
consistent with the public interest. The
investigation has 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.
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 class of controlled substance
listed.
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Drug Enforcement Administration
Importer of Controlled Substances;
Notice of Registration
By Notice dated December 18, 2007
and published in the Federal Register
on December 27, 2007, (72 FR 73359),
Johnson Matthey, Inc., Pharmaceutical
Materials, 2003 Nolte Drive, West
Deptford, New Jersey 08066–1742, made
application by renewal to the Drug
Enforcement Administration (DEA) to
be registered as an importer of the basic
classes of controlled substances listed in
schedule II:
Drug
Phenylacetone (8501) ..................
Raw Opium (9600) .......................
Concentrate of Poppy Straw
(9670).
Schedule
II
II
II
The company plans to import the
listed controlled substances as raw
materials for use in the manufacture of
bulk controlled substances for
distribution to its customers.
No comments or objections have been
received. DEA has considered the
factors in 21 U.S.C. 823(a) and 952(a)
and determined that the registration of
Johnson Matthey, 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, 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
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.
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.
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[Federal Register Volume 73, Number 61 (Friday, March 28, 2008)]
[Notices]
[Pages 16717-16718]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E8-6375]
-----------------------------------------------------------------------
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
Importer of Controlled Substances; Notice of Application
Pursuant to Title 21 Code of Federal Regulations 1301.34(a), this
is notice that on November 29, 2007, Mallinckrodt Inc., 3600 North
Second Street, St. Louis, Missouri 63147, made application by renewal
to the Drug Enforcement Administration (DEA) for registration as an
importer of the basic classes of controlled substances listed in
schedule II:
------------------------------------------------------------------------
Drug Schedule
------------------------------------------------------------------------
Phenylacetone (8501)....................... II
Coca Leaves (9040)......................... II
Opium, raw (9600).......................... II
Poppy Straw (9650)......................... II
Poppy Straw Concentrate (9670)............. II
------------------------------------------------------------------------
The company plans to import the listed controlled substances for
the manufacture of controlled substances in bulk for distribution to
its customers.
No comments, objections, or requests for any hearings will be
accepted on any application for registration or re-registration to
import crude opium, poppy straw, concentrate of poppy straw or coca
leaves. As explained in the Correction to Notice of Application
pertaining to Rhodes Technologies, 72 FR 3417 (2007), comments and
requests for hearings on applications to import narcotic raw material
are not appropriate.
Any bulk manufacturer who is presently, or is applying to be,
registered with DEA to manufacture such basic classes of controlled
substances listed in schedule I or II, which fall under the authority
of section 1002(a)(2)(B) of the Act (21 U.S.C. 952(a)(2)(B)) may, in
the circumstances set forth in 21 U.S.C. 958(i), file comments or
objections to the issuance of the proposed registration and may, at the
same time, file a written request for a hearing on such application
pursuant to 21 CFR 1301.43 and in such form as prescribed by 21 CFR
1316.47.
Any such comments or objections being sent via regular mail should
be addressed, in quintuplicate, to the Drug
[[Page 16718]]
Enforcement Administration, Office of Diversion Control, Federal
Register Representative (ODL), Washington, DC 20537, or any being sent
via express mail should be sent to Drug Enforcement Administration,
Office of Diversion Control, Federal Register Representative (ODL),
8701 Morrissette Drive, Springfield, VA 22152; and must be filed no
later than April 28, 2008.
This procedure is to be conducted simultaneously with and
independent of the procedures described in 21 CFR 1301.34(b), (c), (d),
(e) and (f). As noted in a previous notice published in the Federal
Register on September 23, 1975, (40 FR 43745), all applicants for
registration to import a basic class of any controlled substances in
schedule I or II are and will continue to be required to demonstrate to
the Deputy Assistant Administrator, Office of Diversion Control, Drug
Enforcement Administration, that the requirements for such registration
pursuant to 21 U.S.C. 958(a); 21 U.S.C. 823(a); and 21 CFR 1301.34(b),
(c), (d), (e) and (f) are satisfied.
Dated: March 19, 2008.
Joseph T. Rannazzisi,
Deputy Assistant Administrator, Office of Diversion Control, Drug
Enforcement Administration.
[FR Doc. E8-6375 Filed 3-27-08; 8:45 am]
BILLING CODE 4410-09-P
