Importer of Controlled Substances Application: Meridian Medical Technologies, 13135-13136 [2017-04647]
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13135
Federal Register / Vol. 82, No. 45 / Thursday, March 9, 2017 / Notices
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 April 10, 2017. Such persons
may also file a written request for a
hearing on the application pursuant to
21 CFR 1301.43 on or before April 10,
2017.
ADDRESSES: Written comments should
be sent to: Drug Enforcement
Administration, Attention: DEA Federal
Register Representative/DRW, 8701
Morrissette Drive, Springfield, Virginia
22152. All requests for hearing must be
sent to: Drug Enforcement
Administration, Attn: Administrator,
DATES:
8701 Morrissette Drive, Springfield,
Virginia 22152. All requests for hearing
should also be sent to: (1) Drug
Enforcement Administration, Attn:
Hearing Clerk/LJ, 8701 Morrissette
Drive, Springfield, Virginia 22152; and
(2) Drug Enforcement Administration,
Attn: DEA Federal Register
Representative/DRW, 8701 Morrissette
Drive, Springfield, Virginia 22152.
SUPPLEMENTARY INFORMATION: The
Attorney General has delegated his
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 Assistant
Administrator of the DEA Diversion
Control Division (‘‘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
November 11, 2016, Myoderm, 48 East
Main Street, Norristown, Pennsylvania
19401 applied to be registered as an
importer of the following basic classes
of controlled substances:
Controlled substance
Drug code
Amphetamine .............................................................................................................................................................
Lisdexamfetamine ......................................................................................................................................................
Methylphenidate .........................................................................................................................................................
Nabilone .....................................................................................................................................................................
Oxycodone .................................................................................................................................................................
Hydromorphone ..........................................................................................................................................................
Hydrocodone ..............................................................................................................................................................
Morphine ....................................................................................................................................................................
Oxymorphone .............................................................................................................................................................
Fentanyl ......................................................................................................................................................................
The company plans to import the
listed controlled substances in finished
dosage form for clinical trials, research,
and analytical purposes.
The import of the above listed basic
classes of controlled substances will be
granted only for analytical testing,
research, and clinical trials. This
authorization does not extend to the
import of a finished FDA approved or
non-approved dosage form for
commercial sale.
Louis J. Milione,
Assistant Administrator.
[FR Doc. 2017–04646 Filed 3–8–17; 8:45 am]
BILLING CODE 4410–09–P
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
asabaliauskas on DSK3SPTVN1PROD with NOTICES
[Docket No. DEA–392]
Importer of Controlled Substances
Application: Meridian Medical
Technologies
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
DATES:
VerDate Sep<11>2014
18:42 Mar 08, 2017
Jkt 241001
or before April 10, 2017. Such persons
may also file a written request for a
hearing on the application pursuant to
21 CFR 1301.43 on or before April 10,
2017.
ADDRESSES: Written comments should
be sent to: Drug Enforcement
Administration, Attention: DEA Federal
Register Representative/DRW, 8701
Morrissette Drive, Springfield, Virginia
22152. All requests for hearing must be
sent to: Drug Enforcement
Administration, Attn: Administrator,
8701 Morrissette Drive, Springfield,
Virginia 22152. All requests for hearing
should also be sent to: (1) Drug
Enforcement Administration, Attn:
Hearing Clerk/LJ, 8701 Morrissette
Drive, Springfield, Virginia 22152; and
(2) Drug Enforcement Administration,
Attn: DEA Federal Register
Representative/DRW, 8701 Morrissette
Drive, Springfield, Virginia 22152.
SUPPLEMENTARY INFORMATION: The
Attorney General has delegated his
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
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substances (other than final orders in
connection with suspension, denial, or
revocation of registration) has been
redelegated to the Assistant
Administrator of the DEA Diversion
Control Division (‘‘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
December 29, 2016, 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
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.
E:\FR\FM\09MRN1.SGM
09MRN1
13136
Federal Register / Vol. 82, No. 45 / Thursday, March 9, 2017 / Notices
This is the sole purpose for which the
company will be authorized by the DEA
to import morphine.
Louis J. Milione,
Assistant Administrator.
[FR Doc. 2017–04647 Filed 3–8–17; 8:45 am]
BILLING CODE 4410–09–P
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. DEA–392]
Bulk Manufacturer of Controlled
Substances Application: Mallinckrodt,
LLC
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 May 8, 2017.
ADDRESSES: Written comments should
be sent to: Drug Enforcement
Administration, Attention: DEA Federal
Register Representative/DRW, 8701
Morrissette Drive, Springfield, Virginia
22152.
SUPPLEMENTARY INFORMATION: The
Attorney General has delegated his
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
DATES:
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 Assistant
Administrator of the DEA Diversion
Control Division (‘‘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
November 14, 2016, Mallinckrodt, LLC,
3600 North Second Street, Saint Louis,
Missouri 63147 applied to be registered
as a bulk manufacturer of the following
basic classes of controlled substances:
Controlled substance
Drug code
asabaliauskas on DSK3SPTVN1PROD with NOTICES
Gamma Hydroxybutyric Acid .....................................................................................................................................
Tetrahydrocannabinols ...............................................................................................................................................
Codeine-N-oxide ........................................................................................................................................................
Dihydromorphine ........................................................................................................................................................
Difenoxin ....................................................................................................................................................................
Morphine-N-oxide .......................................................................................................................................................
Normorphine ...............................................................................................................................................................
Norlevorphanol ...........................................................................................................................................................
Acetyl Fentanyl (N-(1-phenethylpiperidin-4-yl)-N-phenylacetamide) .........................................................................
Butyryl Fentanyl .........................................................................................................................................................
Amphetamine .............................................................................................................................................................
Methamphetamine ......................................................................................................................................................
Lisdexamfetamine ......................................................................................................................................................
Methylphenidate .........................................................................................................................................................
Nabilone .....................................................................................................................................................................
4-Anilino-N-phenethyl-4-piperidine (ANPP) ...............................................................................................................
Codeine ......................................................................................................................................................................
Dihydrocodeine ..........................................................................................................................................................
Oxycodone .................................................................................................................................................................
Hydromorphone ..........................................................................................................................................................
Diphenoxylate .............................................................................................................................................................
Ecgonine ....................................................................................................................................................................
Hydrocodone ..............................................................................................................................................................
Levorphanol ................................................................................................................................................................
Meperidine ..................................................................................................................................................................
Methadone .................................................................................................................................................................
Methadone intermediate ............................................................................................................................................
Dextropropoxyphene, bulk (non-dosage forms) ........................................................................................................
Morphine ....................................................................................................................................................................
Oripavine ....................................................................................................................................................................
Thebaine ....................................................................................................................................................................
Opium tincture ............................................................................................................................................................
Opium, powdered .......................................................................................................................................................
Oxymorphone .............................................................................................................................................................
Noroxymorphone ........................................................................................................................................................
Alfentanil .....................................................................................................................................................................
Remifentanil ...............................................................................................................................................................
Sufentanil ...................................................................................................................................................................
Tapentadol .................................................................................................................................................................
Fentanyl ......................................................................................................................................................................
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17:43 Mar 08, 2017
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]]>Agencies
[Federal Register Volume 82, Number 45 (Thursday, March 9, 2017)]
[Notices]
[Pages 13135-13136]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-04647]
-----------------------------------------------------------------------
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. DEA-392]
Importer of Controlled Substances Application: Meridian Medical
Technologies
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
1301.34(a) on or before April 10, 2017. Such persons may also file a
written request for a hearing on the application pursuant to 21 CFR
1301.43 on or before April 10, 2017.
ADDRESSES: Written comments should be sent to: Drug Enforcement
Administration, Attention: DEA Federal Register Representative/DRW,
8701 Morrissette Drive, Springfield, Virginia 22152. All requests for
hearing must be sent to: Drug Enforcement Administration, Attn:
Administrator, 8701 Morrissette Drive, Springfield, Virginia 22152. All
requests for hearing should also be sent to: (1) Drug Enforcement
Administration, Attn: Hearing Clerk/LJ, 8701 Morrissette Drive,
Springfield, Virginia 22152; and (2) Drug Enforcement Administration,
Attn: DEA Federal Register Representative/DRW, 8701 Morrissette Drive,
Springfield, Virginia 22152.
SUPPLEMENTARY INFORMATION: The Attorney General has delegated his
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 Assistant Administrator of the DEA Diversion Control Division
(``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
December 29, 2016, 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 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.
[[Page 13136]]
This is the sole purpose for which the company will be authorized
by the DEA to import morphine.
Louis J. Milione,
Assistant Administrator.
[FR Doc. 2017-04647 Filed 3-8-17; 8:45 am]
BILLING CODE 4410-09-P
