Manufacturer of Controlled Substances; Notice of Application; Organix, Inc., 52801-52802 [2013-20724]
Download as PDF
<![CDATA[
52801
Federal Register / Vol. 78, No. 165 / Monday, August 26, 2013 / Notices
Schedule
Drug
Marihuana (7360) .........................
Poppy Straw Concentrate (9670)
DEPARTMENT OF JUSTICE
I
II
Drug Enforcement Administration
ehiers on DSK2VPTVN1PROD with NOTICES
The company plans to import a
finished pharmaceutical product
containing cannabis extracts in dosage
form for a clinical trial study. In
addition, the company plans to import
an ointment for the treatment of wounds
which contain trace amounts of the
controlled substances normally found in
poppy straw concentrate for packaging
and labeling to be used in clinical trials.
Comments and requests for any
hearings on applications to import
narcotic raw material are not
appropriate. 72 FR 3417(2007).
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 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, VA 22152; and must be
filed no later than September 25, 2013.
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.
Dated: August 15, 2013.
Joseph T. Rannazzisi,
Deputy Assistant Administrator, Office of
Diversion Control, Drug Enforcement
Administration.
[FR Doc. 2013–20717 Filed 8–23–13; 8:45 am]
BILLING CODE 4410–09–P
VerDate Mar<15>2010
17:12 Aug 23, 2013
Jkt 229001
Importer of Controlled Substances;
Notice of Application; Chattem
Chemicals, Inc.
Pursuant to Title 21 Code of Federal
Regulations 1301.34(a), this is notice
that on June 21, 2013, Chattem
Chemicals, Inc., 3801 St. Elmo Avenue,
Chattanooga, Tennessee 37409, made
application by renewal to the Drug
Enforcement Administration (DEA) for
registration as an importer of the
following basic classes of controlled
substances:
Drug
Schedule
Methamphetamine (1105) ............
4-Anilino-N-phenethyl-4-piperidine
(8333).
Phenylacetone (8501) ..................
Opium, raw (9600) .......................
Poppy Straw Concentrate (9670)
Tapentadol (9780) ........................
II
II
II
II
II
II
The company plans to import the
listed controlled substances to
manufacture bulk controlled substances
for sale to its customers. The company
plans to import an intermediate form of
Tapentadol (9780); and then to bulk
manufacture Tapentadol for distribution
to its customers.
Comments and requests for hearings
on applications to import narcotic raw
material are not appropriate. 72 FR
3417(2007).
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 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 September 25, 2013.
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,
PO 00000
Frm 00044
Fmt 4703
Sfmt 4703
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.
Dated: August 15, 2013.
Joseph T. Rannazzisi,
Deputy Assistant Administrator, Office of
Diversion Control, Drug Enforcement
Administration.
[FR Doc. 2013–20720 Filed 8–23–13; 8:45 am]
BILLING CODE 4410–09–P
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
Manufacturer of Controlled
Substances; Notice of Application;
Organix, Inc.
Pursuant to § 1301.33(a), Title 21 of
the Code of Federal Regulations (CFR),
this is notice that on July 2, 2013,
Organix, Inc., 240 Salem Street,
Woburn, Massachusetts 01801, made
application to the Drug Enforcement
Administration (DEA) to be registered as
a bulk manufacturer of the following
basic classes of controlled substances:
Drug
Marihuana (7360) .........................
Tetrahydrocannabinols (7370) .....
Psilocybin (7437) ..........................
Psilocyn (7438) .............................
Schedule
I
I
I
I
The company plans to synthesize
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 October 25, 2013.
E:\FR\FM\26AUN1.SGM
26AUN1
52802
Federal Register / Vol. 78, No. 165 / Monday, August 26, 2013 / Notices
Dated: August 20, 2013.
Joseph T. Rannazzisi,
Deputy Assistant Administrator, Office of
Diversion Control, Drug Enforcement
Administration.
[FR Doc. 2013–20724 Filed 8–23–13; 8:45 am]
BILLING CODE 4410–09–P
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
Manufacturer of Controlled
Substances; Notice of Application;
Cambridge Isotope Lab
Pursuant to § 1301.33(a), Title 21 of
the Code of Federal Regulations (CFR),
this is notice that on July 01, 2013,
Cambridge Isotope Lab, 50 Frontage
Road, Andover, Massachusetts 01810,
made application by renewal to the
Drug Enforcement Administration
(DEA) to be registered as a bulk
manufacturer of Morphine (9300), a
basic class of controlled substance listed
in schedule II.
The company plans to utilize small
quantities of the listed controlled
substance in the preparation of
analytical standards.
Any other such applicant, and any
person who is presently registered with
DEA to manufacture such a substance,
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 October 25, 2013.
Dated: August 15, 2013.
Joseph T. Rannazzisi,
Deputy Assistant Administrator, Office of
Diversion Control, Drug Enforcement
Administration.
[FR Doc. 2013–20723 Filed 8–23–13; 8:45 am]
BILLING CODE 4410–09–P
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
ehiers on DSK2VPTVN1PROD with NOTICES
Manufacturer of Controlled
Substances; Notice of Registration;
Morton Grove Pharmaceuticals
By Notice dated March 12, 2013, and
published in the Federal Register on
March 20, 2013, 78 FR 17231, Morton
Grove Pharmaceuticals, 6451 Main
Street, Morton Grove, Illinois 60053–
2633, made application by renewal to
the Drug Enforcement Administration
VerDate Mar<15>2010
13:45 Aug 23, 2013
Jkt 229001
(DEA) to be registered as a bulk
manufacturer of Gamma Hydroxybutyric
Acid (2010), a basic class of controlled
substance listed in schedule I.
The company plans to manufacture
the listed controlled substance 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
determined that the registration of
Morton Grove Pharmaceuticals to
manufacture the listed basic class of
controlled substance is consistent with
the public interest at this time. DEA has
investigated Morton Grove
Pharmaceuticals 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.
823(a), and in accordance with 21 CFR
1301.33, the above named company is
granted registration as a bulk
manufacturer of the basic class of
controlled substance listed.
Dated: August 15, 2013.
Joseph T. Rannazzisi,
Deputy Assistant Administrator, Office of
Diversion Control, Drug Enforcement
Administration.
[FR Doc. 2013–20761 Filed 8–23–13; 8:45 am]
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
Navinta, LLC., to manufacture the listed
basic classes of controlled substances is
consistent with the public interest at
this time. DEA has investigated Navinta,
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. 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.
Dated: August 15, 2013.
Joseph T. Rannazzisi,
Deputy Assistant Administrator, Office of
Diversion Control, Drug Enforcement
Administration.
[FR Doc. 2013–20757 Filed 8–23–13; 8:45 am]
BILLING CODE 4410–09–P
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
Tin T. Win, M.D., Dismissal of
Proceeding
BILLING CODE 4410–09–P
On February 27, 2013, I, the
Administrator of the Drug Enforcement
Administration, issued an Order to
DEPARTMENT OF JUSTICE
Show Cause and Immediate Suspension
of Registration to Tin T. Win, M.D.
Drug Enforcement Administration
(hereinafter, Registrant), of Lake Havasu,
Arizona. GX 10, at 1. Among various
Manufacturer of Controlled
charges, the Order alleged that
Substances; Notice of Registration:
Registrant issued numerous controlled
Navinta, LLC
substance prescriptions after the
By Notice dated April 10, 2013, and
Arizona Medical Board had prohibited
published in the Federal Register on
her ‘‘from prescribing controlled
April 19, 2013, 78 FR 23596, Navinta,
substances’’ and thus violated both the
LLC., 1499 Lower Ferry Road, Ewing,
Board’s order and federal law. Id. at 1–
New Jersey 08618–1414, made
3 (citing Ariz. Rev. Stat. § 32–
application to the Drug Enforcement
1401(27)(r); 21 U.S.C. 841). The Order
Administration (DEA) to be registered as
also notified Registrant of her right to
a bulk manufacturer of the following
either request a hearing on the
basic classes of controlled substances:
allegations or submit a written
statement of position in lieu of a hearing
Drug
Schedule
within thirty (30) days of her receipt of
Pentobarbital (2270) .....................
II the Order, the procedure for electing
Remifentanil (9739) ......................
II either option, and the consequence of
failing to elect either option.
The company plans initially to
On March 6, 2013, the Order was
manufacture API quantities of the listed personally served on Registrant by a
controlled substances for validation
DEA Special Agent and a Diversion
purposes and FDA approval, then to
Investigator. See GX 11. On May 20,
produce commercial size batches for
2013, the Government filed a Request
distribution to dosage form
for Final Agency Action, which sought
manufacturers upon FDA approval.
the revocation of Registrant’s
PO 00000
Frm 00045
Fmt 4703
Sfmt 4703
E:\FR\FM\26AUN1.SGM
26AUN1
]]>Agencies
[Federal Register Volume 78, Number 165 (Monday, August 26, 2013)]
[Notices]
[Pages 52801-52802]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-20724]
-----------------------------------------------------------------------
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
Manufacturer of Controlled Substances; Notice of Application;
Organix, Inc.
Pursuant to Sec. 1301.33(a), Title 21 of the Code of Federal
Regulations (CFR), this is notice that on July 2, 2013, Organix, Inc.,
240 Salem Street, Woburn, Massachusetts 01801, made application to the
Drug Enforcement Administration (DEA) to be registered as a bulk
manufacturer of the following basic classes of controlled substances:
------------------------------------------------------------------------
Drug Schedule
------------------------------------------------------------------------
Marihuana (7360)........................... I
Tetrahydrocannabinols (7370)............... I
Psilocybin (7437).......................... I
Psilocyn (7438)............................ I
------------------------------------------------------------------------
The company plans to synthesize 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 October 25, 2013.
[[Page 52802]]
Dated: August 20, 2013.
Joseph T. Rannazzisi,
Deputy Assistant Administrator, Office of Diversion Control, Drug
Enforcement Administration.
[FR Doc. 2013-20724 Filed 8-23-13; 8:45 am]
BILLING CODE 4410-09-P
