Importer of Controlled Substances; Notice of Registration Mallinckrodt LLC, 19717 [2012-7758]
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Federal Register / Vol. 77, No. 63 / Monday, April 2, 2012 / Notices
the bulk manufacture of the substance
an opportunity for a hearing.
Therefore, in accordance with 21 CFR
1301.34(a), this is notice that on January
4, 2012, Meridian Medical
Technologies, 2555 Hermelin Drive, St.
Louis, Missouri 63144, made
application by renewal to the Drug
Enforcement Administration (DEA) to
be registered as an importer of
Morphine (9300), a basic class of
controlled substance listed in schedule
II.
The company manufactures a product
containing morphine in the United
States. The company exports this
product to customers around the world,
including in Europe. The company has
been asked to ensure that its product
sold to European customers meets
standards established by the European
Pharmacopeia, which is administered
by the Directorate for the Quality of
Medicines (EDQM). In order to ensure
that its product will meet European
specifications, the company seeks to
import morphine supplied by EDQM to
use as reference standards. This is the
sole purpose for which the company
will be authorized by DEA to import
morphine.
Any bulk manufacturer who is
presently, or is applying to be,
registered with DEA to manufacture
such basic class of controlled substance
may 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 written comments or
objections should be addressed, in
quintuplicate, to the Drug Enforcement
Administration, Office of Diversion
Control, Federal Register Representative
(ODL), 8701 Morrissette Drive,
Springfield, Virginia 22152; and must be
filed no later than May 2, 2012.
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 43745–46, all applicants for
registration to import a basic class of
any controlled substance 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.
VerDate Mar<15>2010
17:42 Mar 30, 2012
Jkt 226001
Dated: March 23, 2012.
Joseph T. Rannazzisi,
Deputy Assistant Administrator, Office of
Diversion Control, Drug Enforcement
Administration.
[FR Doc. 2012–7755 Filed 3–30–12; 8:45 am]
BILLING CODE 4410–09–P
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
Importer of Controlled Substances;
Notice of Registration Mallinckrodt
LLC
By Notice dated January 23, 2012, and
published in the Federal Register on
January 31, 2012, 77 FR 4831,
Mallinckrodt LLC, 3600 North Second
Street, St. Louis, Missouri 63147, made
application by renewal to the Drug
Enforcement Administration (DEA) to
be registered as an importer of the
following basic classes of controlled
substances:
Drug
Schedule
Phenylacetone (8501) ..................
Coca Leaves (9040) .....................
Opium, raw (9600) .......................
Poppy Straw Concentrate (9670)
II
II
II
II
The company plans to import the
listed controlled substances to
manufacture bulk controlled substances
for distribution to its customers, and for
research and analytical standards.
The company has withdrawn its
application for registration to import the
following drug codes: Methylphenidate
(1724), Oxycodone (9143),
Hydromorphone (9150), Hydrocodone
(9193), Morphine (9300), and Fentanyl
(9801).
Comments and requests for hearings
on applications to import narcotic raw
material are not appropriate, 72 FR 3417
(2007). Regarding all other basic classes
of controlled substances, 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 Mallinckrodt LLC, 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 has investigated
Mallinckrodt LLC 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
PO 00000
Frm 00108
Fmt 4703
Sfmt 4703
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.
Dated: March 23, 2012.
Joseph T. Rannazzisi,
Deputy Assistant Administrator, Office of
Diversion Control, Drug Enforcement
Administration.
[FR Doc. 2012–7758 Filed 3–30–12; 8:45 am]
BILLING CODE 4410–09–P
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
Manufacturer of Controlled
Substances; Notice of Application;
Cerilliant Corporation
Pursuant to § 1301.33(a), Title 21 of
the Code of Federal Regulations (CFR),
this is notice that on February 17, 2012,
Cerilliant Corporation, 811 Paloma
Drive, Suite A, Round Rock, Texas
78665–2402, made application by letter
to the Drug Enforcement Administration
(DEA) to be registered as a bulk
manufacturer of the following basic
classes of controlled substances:
Drug
4-methyl-N-methylcathinone
(1248).
3,4-methylenedioxypyrovalerone
(7535).
3,4-methylenedioxy-Nmethylcathinone (7540).
Desomorphine (9055) ...................
Schedule
I
I
I
I
The company plans to manufacture
small quantities of the listed controlled
substances to make reference standards
which will be distributed to their
customers.
Any other such applicant, and any
person who is presently registered with
DEA to manufacture such substances,
may file comments or objections to the
issuance of the proposed registration
pursuant to 21 CFR 1301.33(a).
Any such written comments or
objections should be addressed, in
quintuplicate, to the Drug Enforcement
Administration, Office of Diversion
Control, Federal Register Representative
(ODL), 8701 Morrissette Drive,
Springfield, Virginia 22152; and must be
filed no later than June 1, 2012.
E:\FR\FM\02APN1.SGM
02APN1
]]>Agencies
[Federal Register Volume 77, Number 63 (Monday, April 2, 2012)]
[Notices]
[Page 19717]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-7758]
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DEPARTMENT OF JUSTICE
Drug Enforcement Administration
Importer of Controlled Substances; Notice of Registration
Mallinckrodt LLC
By Notice dated January 23, 2012, and published in the Federal
Register on January 31, 2012, 77 FR 4831, Mallinckrodt LLC, 3600 North
Second Street, St. Louis, Missouri 63147, made application by renewal
to the Drug Enforcement Administration (DEA) to be registered as an
importer of the following basic classes of controlled substances:
------------------------------------------------------------------------
Drug Schedule
------------------------------------------------------------------------
Phenylacetone (8501)....................... II
Coca Leaves (9040)......................... II
Opium, raw (9600).......................... II
Poppy Straw Concentrate (9670)............. II
------------------------------------------------------------------------
The company plans to import the listed controlled substances to
manufacture bulk controlled substances for distribution to its
customers, and for research and analytical standards.
The company has withdrawn its application for registration to
import the following drug codes: Methylphenidate (1724), Oxycodone
(9143), Hydromorphone (9150), Hydrocodone (9193), Morphine (9300), and
Fentanyl (9801).
Comments and requests for hearings on applications to import
narcotic raw material are not appropriate, 72 FR 3417 (2007). Regarding
all other basic classes of controlled substances, 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
Mallinckrodt LLC, 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 has investigated Mallinckrodt LLC 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.
Dated: March 23, 2012.
Joseph T. Rannazzisi,
Deputy Assistant Administrator, Office of Diversion Control, Drug
Enforcement Administration.
[FR Doc. 2012-7758 Filed 3-30-12; 8:45 am]
BILLING CODE 4410-09-P
