Importer of Controlled Substances Registration: Almac Clinical Services Incorp (ACSI), 27473 [2016-10730]
Download as PDF
<![CDATA[
Federal Register / Vol. 81, No. 88 / Friday, May 6, 2016 / Notices
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 21 U.S.C. 952(a)(2). Authorization
will not extend to the import of FDA
approved or non-approved finished
dosage forms for commercial sale.
Dated: April 29, 2016.
Louis J. Milione,
Deputy Assistant Administrator.
[FR Doc. 2016–10728 Filed 5–5–16; 8:45 am]
BILLING CODE 4410–09–P
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. DEA–392]
Manufacturer of Controlled
Substances Registration: Noramco,
Inc.
ACTION:
Noramco, Inc. applied to be
registered as a manufacturer of certain
basic classes of controlled substances.
The Drug Enforcement Administration
(DEA) grants Noramco, Inc. registration
as a manufacturer of those controlled
substances.
SUMMARY:
By notice
dated November 23, 2015, and
published in the Federal Register on
December 3, 2015, 80 FR 75692,
Noramco, Inc., 500 Swedes Landing
Road, Wilmington, Delaware 19801–
4417 applied to be registered as a
manufacturer of certain basic classes of
controlled substances. No comments or
objections were submitted for this
notice.
The DEA has considered the factors in
21 U.S.C. 823(a) and determined that
the registration of Noramco, Inc. to
asabaliauskas on DSK3SPTVN1PROD with NOTICES
VerDate Sep<11>2014
17:20 May 05, 2016
Jkt 238001
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.
Notice of registration.
SUPPLEMENTARY INFORMATION:
manufacture 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. 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.
823(a), and in accordance with 21 CFR
1301.33, the above-named company is
granted registration as a bulk
manufacturer of the following basic
classes of controlled substances:
Dated: April 29, 2016.
Louis J. Milione,
Deputy Assistant Administrator.
[FR Doc. 2016–10731 Filed 5–5–16; 8:45 am]
BILLING CODE 4410–09–P
27473
grants Almac Clinical Services Incorp
(ACSI) registration as an importer of this
controlled substance.
SUPPLEMENTARY INFORMATION: By notice
dated December 15, 2015, and
published in the Federal Register on
December 24, 2015, 80 FR 80387, Almac
Clinical Services Incorp (ACSI), 25 Fretz
Road, Souderton, Pennsylvania 18964
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
Almac Clinical Services Incorp (ACSI)
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 Morphine (9300), a basic
class of controlled substance listed in
schedule II.
The company plans to import the
listed controlled substance in dosage
form for clinical trial only. Approval of
permit applications will occur only
when the registrant’s business activity is
consistent with what is authorized
under 21 U.S.C. 952(a)(2). Authorization
will not extend to the import of FDA
approved or non-approved finished
dosage forms for commercial sale.
Dated: April 29, 2016.
Louis J. Milione,
Deputy Assistant Administrator.
[FR Doc. 2016–10730 Filed 5–5–16; 8:45 am]
BILLING CODE 4410–09–P
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
DEPARTMENT OF JUSTICE
[Docket No. DEA–392]
Drug Enforcement Administration
Importer of Controlled Substances
Registration: Almac Clinical Services
Incorp (ACSI)
[Docket No. DEA–392]
ACTION:
Notice of registration.
Almac Clinical Services
Incorp (ACSI) applied to be registered as
an importer of a certain basic class of
controlled substance. The Drug
Enforcement Administration (DEA)
SUMMARY:
PO 00000
Frm 00087
Fmt 4703
Sfmt 4703
Importer of Controlled Substances
Registration: Noramco, Inc.
ACTION:
Notice of registration.
Noramco, Inc. applied to be
registered as an importer of certain basic
classes of controlled substances. The
Drug Enforcement Administration
SUMMARY:
E:\FR\FM\06MYN1.SGM
06MYN1
]]>Agencies
[Federal Register Volume 81, Number 88 (Friday, May 6, 2016)]
[Notices]
[Page 27473]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-10730]
-----------------------------------------------------------------------
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. DEA-392]
Importer of Controlled Substances Registration: Almac Clinical
Services Incorp (ACSI)
ACTION: Notice of registration.
-----------------------------------------------------------------------
SUMMARY: Almac Clinical Services Incorp (ACSI) applied to be registered
as an importer of a certain basic class of controlled substance. The
Drug Enforcement Administration (DEA) grants Almac Clinical Services
Incorp (ACSI) registration as an importer of this controlled substance.
SUPPLEMENTARY INFORMATION: By notice dated December 15, 2015, and
published in the Federal Register on December 24, 2015, 80 FR 80387,
Almac Clinical Services Incorp (ACSI), 25 Fretz Road, Souderton,
Pennsylvania 18964 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 Almac Clinical Services
Incorp (ACSI) 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 Morphine (9300), a basic class of
controlled substance listed in schedule II.
The company plans to import the listed controlled substance in
dosage form for clinical trial only. Approval of permit applications
will occur only when the registrant's business activity is consistent
with what is authorized under 21 U.S.C. 952(a)(2). Authorization will
not extend to the import of FDA approved or non-approved finished
dosage forms for commercial sale.
Dated: April 29, 2016.
Louis J. Milione,
Deputy Assistant Administrator.
[FR Doc. 2016-10730 Filed 5-5-16; 8:45 am]
BILLING CODE 4410-09-P
