Bulk Manufacturer of Controlled Substances Application: Organix, Inc., 75691-75692 [2015-30554]
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75691
Federal Register / Vol. 80, No. 232 / Thursday, December 3, 2015 / Notices
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 for
use as reference standards.
This is the sole purpose for which the
company will be authorized by the DEA
to import morphine.
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. DEA–392]
Importer of Controlled Substances
Application: Meridian Medical
Technologies
ACTION:
Notice of application.
Registered bulk manufacturers of
the affected basic class, and applicants
therefore, may file written comments on
or objections to the issuance of the
proposed registration in accordance
with 21 CFR 1301.34(a) on or before
January 4, 2016. Such persons may also
file a written request for a hearing on
the application pursuant to 21 CFR
1301.43 on or before January 4, 2016.
ADDRESSES: Written comments should
be sent to: Drug Enforcement
Administration, Attention: DEA Federal
Register Representative/OD/D, 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 her
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
Administrator’’) pursuant to section 7 of
28 CFR part 0, appendix to subpart R.
In accordance with 21 CFR
1301.34(a), this is notice that on October
20, 2015, Meridian Medical
Technologies, 2555 Hermelin Drive,
Saint Louis, Missouri 63144 applied 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.
The company has been asked to ensure
that its product, which is sold to
European customers, meets the
standards established by the European
Pharmacopeia, administered by the
Lhorne on DSK5TPTVN1PROD with NOTICES
DATES:
VerDate Sep<11>2014
15:11 Dec 02, 2015
Jkt 238001
Controlled substance
Dated: November 27, 2015.
Louis J. Milione,
Deputy Assistant Administrator.
[FR Doc. 2015–30553 Filed 12–2–15; 8:45 am]
BILLING CODE 4410–09–P
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. DEA–392]
Importer of Controlled Substances
Application: Mylan Pharmaceuticals,
Inc.
ACTION:
Notice of application.
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 1301.34(a) on
or before January 4, 2016. Such persons
may also file a written request for a
hearing on the application pursuant to
21 CFR 1301.43 on or before January 4,
2016.
ADDRESSES: Written comments should
be sent to: Drug Enforcement
Administration, Attention: DEA Federal
Register Representative/OD/D, 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 her
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
Administrator’’) pursuant to section 7 of
28 CFR part 0, appendix to subpart R.
DATES:
PO 00000
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In accordance with 21 CFR
1301.34(a), this is notice that on October
12, 2015, Mylan Pharmaceuticals, Inc.,
781 Chestnut Ridge Road, Morgantown,
West Virginia 26505 applied to be
registered as an importer of the
following basic classes of controlled
substances:
Amphetamine (1100) ....................
Methylphenidate (1724) ................
Oxycodone (9143) ........................
Hydromorphone (9150) ................
Methadone (9250) ........................
Morphine (9300) ...........................
Fentanyl (9801) ............................
Schedule
II
II
II
II
II
II
II
The company plans to import the
listed controlled substances in finished
dosage form (FDF) from foreign sources
for analytical testing and clinical trials
in which the foreign FDF will be
compared to the company’s own
domestically-manufactured FDF. This
analysis is required to allow the
company to export domesticallymanufactured FDF to foreign markets.
Dated: November 23, 2015.
Louis J. Milione,
Deputy Assistant Administrator.
[FR Doc. 2015–30549 Filed 12–2–15; 8:45 am]
BILLING CODE 4410–09–P
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. DEA–392]
Bulk Manufacturer of Controlled
Substances Application: Organix, Inc.
ACTION:
Notice of application.
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 February 1, 2016.
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 her
authority under the Controlled
Substances Act to the Administrator of
the Drug Enforcement Administration
(DEA), 28 CFR 0.100(b). Authority to
DATES:
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03DEN1
75692
Federal Register / Vol. 80, No. 232 / Thursday, December 3, 2015 / Notices
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
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
September 7, 2015, Organix, Inc., 240
Salem Street, Woburn, Massachusetts
01801 applied to be registered as a bulk
manufacturer of the following basic
classes of controlled substances:
Controlled substance
Schedule
Gamma
Hydroxybutyric
Acid
(2010).
Lysergic acid diethylamide (7315)
Marihuana (7360) .........................
Tetrahydrocannabinols (7370) .....
Psilocybin (7437) ..........................
Psilocyn (7438) .............................
Heroin (9200) ...............................
Morphine (9300) ...........................
I
I
I
I
I
I
I
II
The company plans to manufacture
reference standards for distribution to
its research and forensics customers. In
reference to drug codes 7360
(marihuana) and 7370 (THC) the
company plans to manufacture these
drugs as synthetic. No other activities
for these drug codes are authorized for
this registration.
Dated: November 27, 2015.
Louis J. Milione,
Deputy Assistant Administrator.
[FR Doc. 2015–30554 Filed 12–2–15; 8:45 am]
BILLING CODE 4410–09–P
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. DEA–392]
Bulk Manufacturer of Controlled
Substances Application: Noramco, Inc.
ACTION:
Notice of application.
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 February 1, 2016.
ADDRESSES: Written comments should
be sent to: Drug Enforcement
Lhorne on DSK5TPTVN1PROD with NOTICES
DATES:
VerDate Sep<11>2014
15:11 Dec 02, 2015
Jkt 238001
Administration, Attention: DEA Federal
Register Representative/OD/D, 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.
DEPARTMENT OF JUSTICE
The
Attorney General has delegated her
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
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 October
6, 2015, Noramco, Inc., 500 Swedes
Landing Road, Wilmington, Delaware
19801–4417 applied to be registered as
a bulk manufacturer of the following
basic classes of controlled substances:
ACTION:
SUPPLEMENTARY INFORMATION:
Controlled substance
Codeine-N-oxide (9053) ...............
Dihydromorphine (9145) ...............
Morphine-N-oxide (9307) .............
Amphetamine (1100) ....................
Methylphenidate (1724) ................
Phenylacetone (8501) ..................
Codeine (9050) .............................
Dihydrocodeine (9120) .................
Oxycodone (9143) ........................
Hydromorphone (9150) ................
Hydrocodone (9193) .....................
Morphine (9300) ...........................
Oripavine (9330) ...........................
Thebaine (9333) ...........................
Opium extracts (9610) ..................
Opium fluid extract (9620) ............
Opium tincture (9630) ..................
Opium, powdered (9639) .............
Opium, granulated (9640) ............
Oxymorphone (9652) ...................
Noroxymorphone (9668) ..............
Tapentadol (9780) ........................
Schedule
I
I
I
II
II
II
II
II
II
II
II
II
II
II
II
II
II
II
II
II
II
II
The company plans to manufacture
the above-listed controlled substances
in bulk for distribution to its customers.
Dated: November 23, 2015.
Louis J. Milione,
Deputy Assistant Administrator.
[FR Doc. 2015–30550 Filed 12–2–15; 8:45 am]
BILLING CODE 4410–09–P
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Drug Enforcement Administration
[Docket No. DEA–392]
Importer of Controlled Substances
Registration: Catalent CTS, LLC
Notice of registration.
Catalent CTS, LLC applied to
be registered as an importer of a certain
basic class of controlled substance. The
Drug Enforcement Administration
(DEA) grants Catalent CTS, LLC
registration as an importer of this
controlled substance.
SUPPLEMENTARY INFORMATION: By notice
dated August 21, 2015, and published in
the Federal Register on August 31,
2015, 80 FR 52509, Catalent CTS, LLC,
10245 Hickman Mills Drive, Kansas
City, Missouri 64137 applied to be
registered as an importer of a certain
basic class of controlled substance. 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
Catalent CTS, LLC 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. 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 marihuana (7360), a basic
class of controlled substance listed in
schedule I.
The company plans to import finished
pharmaceutical products containing
cannabis extracts in dosage form for
clinical trial studies.
This compound is listed under drug
code 7360. No other activity for this
drug code is authorized for this
registration. Approval of permits
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.
SUMMARY:
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]]>Agencies
[Federal Register Volume 80, Number 232 (Thursday, December 3, 2015)]
[Notices]
[Pages 75691-75692]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-30554]
-----------------------------------------------------------------------
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. DEA-392]
Bulk Manufacturer of Controlled Substances Application: Organix,
Inc.
ACTION: Notice of application.
-----------------------------------------------------------------------
DATES: 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 February 1, 2016.
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 her
authority under the Controlled Substances Act to the Administrator of
the Drug Enforcement Administration (DEA), 28 CFR 0.100(b). Authority
to
[[Page 75692]]
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 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
September 7, 2015, Organix, Inc., 240 Salem Street, Woburn,
Massachusetts 01801 applied to be registered as a bulk manufacturer of
the following basic classes of controlled substances:
------------------------------------------------------------------------
Controlled substance Schedule
------------------------------------------------------------------------
Gamma Hydroxybutyric Acid (2010)........... I
Lysergic acid diethylamide (7315).......... I
Marihuana (7360)........................... I
Tetrahydrocannabinols (7370)............... I
Psilocybin (7437).......................... I
Psilocyn (7438)............................ I
Heroin (9200).............................. I
Morphine (9300)............................ II
------------------------------------------------------------------------
The company plans to manufacture reference standards for
distribution to its research and forensics customers. In reference to
drug codes 7360 (marihuana) and 7370 (THC) the company plans to
manufacture these drugs as synthetic. No other activities for these
drug codes are authorized for this registration.
Dated: November 27, 2015.
Louis J. Milione,
Deputy Assistant Administrator.
[FR Doc. 2015-30554 Filed 12-2-15; 8:45 am]
BILLING CODE 4410-09-P
