Importer of Controlled Substances Application: Catalent CTS, LLC, 57748 [2019-23502]
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57748
Federal Register / Vol. 84, No. 208 / Monday, October 28, 2019 / Notices
Company
FR docket
Eli-Elsohly Laboratories .............................................................................
84 FR 27661 .......................................................
The DEA has considered the factors in
21 U.S.C. 823(a) and determined that
the registration of these registrants to
manufacture the applicable 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 each company’s
physical security systems, verifying
each 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 DEA has granted a
registration as a bulk manufacturer to
the above listed companies.
Dated: October 18, 2019.
William T. McDermott,
Assistant Administrator.
[FR Doc. 2019–23501 Filed 10–25–19; 8:45 am]
BILLING CODE 4410–09–P
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. DEA–392]
Importer of Controlled Substances
Application: Catalent CTS, 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 on
or before November 27, 2019. Such
persons may also file a written request
for a hearing on the application on or
before November 27, 2019.
ADDRESSES: Written comments should
be sent to: Drug Enforcement
Administration, Attention: DEA Federal
Register Representative/DPW, 8701
Morrissette Drive, Springfield, Virginia
22152. All requests for a hearing must
be sent to: Drug Enforcement
Administration, Attn: Administrator,
8701 Morrissette Drive, Springfield,
Virginia 22152. All requests for a
hearing should also be sent to: (1) Drug
Enforcement Administration, Attn:
Hearing Clerk/OALJ, 8701 Morrissette
Drive, Springfield, Virginia 22152; and
(2) Drug Enforcement Administration,
Attn: DEA Federal Register
khammond on DSKJM1Z7X2PROD with NOTICES
DATES:
VerDate Sep<11>2014
16:58 Oct 25, 2019
Jkt 250001
Representative/DPW, 8701 Morrissette
Drive, Springfield, Virginia 22152.
SUPPLEMENTARY INFORMATION: In
accordance with 21 CFR 1301.34(a), this
is notice that on July 16, 2019, Catalent
CTS, LLC, 10245 Hickman Mills Drive,
Kansas City, Missouri 64137–1418
applied to be registered as an importer
of the following basic classes of
controlled substances:
Controlled substance
Gamma Hydroxybutyric
Acid.
Marihuana Extract ..........
Marihuana .......................
Tetrahydrocannabinols ...
Drug
code
Schedule
2010
I
7350
7360
7370
I
I
I
Published
June 13, 2019.
Morrissette Drive, Springfield, Virginia
22152.
In
accordance with 21 CFR 1301.33(a), this
is notice that on June 27, 2019, Euticals
Inc., 2460 W Bennett Street, Springfield,
Missouri 65807–1229 applied to be
registered as a bulk manufacturer of the
following basic classes of controlled
substances:
SUPPLEMENTARY INFORMATION:
Controlled substance
Gamma Hydroxybutyric
Acid.
Amphetamine ...............
Lisdexamfetamine ........
Methylphenidate ...........
Phenylacetone ..............
Methadone ....................
Methadone intermediate
Oripavine ......................
Tapentadol ....................
Drug
code
Schedule
2010
I
1100
1205
1724
8501
9250
9254
9330
9780
II
II
II
II
II
II
II
II
The company plans to import finished
dosage unit products containing gammahydroxybutryic acid and marihuana
extracts for clinical trial studies. These
marihuana extracts compounds are
listed under drug code 7350. No other
activity for these drug codes is
authorized for this registration.
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 nonapproved finished dosage forms for
commercial sale.
The company plans to manufacture
the above-listed controlled substances
in bulk for distribution to its customers.
Dated: October 18, 2019.
William T. McDermott,
Assistant Administrator.
DEPARTMENT OF JUSTICE
[FR Doc. 2019–23502 Filed 10–25–19; 8:45 am]
Drug Enforcement Administration
Dated: October 18, 2019.
William T. McDermott,
Assistant Administrator.
[FR Doc. 2019–23499 Filed 10–25–19; 8:45 am]
BILLING CODE 4410–09–P
BILLING CODE 4410–09–P
[Docket No. DEA–392]
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
ACTION:
[Docket No. DEA–392]
Bulk Manufacturer of Controlled
Substances Application: Euticals 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 on
or before December 27, 2019.
ADDRESSES: Written comments should
be sent to: Drug Enforcement
Administration, Attention: DEA Federal
Register Representative/DPW, 8701
DATES:
PO 00000
Frm 00061
Fmt 4703
[Bulk Manufacturer of Controlled
Substances Registration
Sfmt 4703
Notice of registration.
The registrants listed below
have applied for and been granted
registration by the Drug Enforcement
Administration (DEA) as bulk
manufacturers of various classes of
schedule I and II controlled substances.
SUMMARY:
The
companies listed below applied to be
registered as a bulk manufacturers of
various classes of scheduled I and II
controlled substances. Information on
previously published notices is listed
below. No comments or objections were
submitted for these notices.
SUPPLEMENTARY INFORMATION:
E:\FR\FM\28OCN1.SGM
28OCN1
]]>Agencies
[Federal Register Volume 84, Number 208 (Monday, October 28, 2019)]
[Notices]
[Page 57748]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-23502]
-----------------------------------------------------------------------
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. DEA-392]
Importer of Controlled Substances Application: Catalent CTS, LLC
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 on or before November 27, 2019.
Such persons may also file a written request for a hearing on the
application on or before November 27, 2019.
ADDRESSES: Written comments should be sent to: Drug Enforcement
Administration, Attention: DEA Federal Register Representative/DPW,
8701 Morrissette Drive, Springfield, Virginia 22152. All requests for a
hearing must be sent to: Drug Enforcement Administration, Attn:
Administrator, 8701 Morrissette Drive, Springfield, Virginia 22152. All
requests for a hearing should also be sent to: (1) Drug Enforcement
Administration, Attn: Hearing Clerk/OALJ, 8701 Morrissette Drive,
Springfield, Virginia 22152; and (2) Drug Enforcement Administration,
Attn: DEA Federal Register Representative/DPW, 8701 Morrissette Drive,
Springfield, Virginia 22152.
SUPPLEMENTARY INFORMATION: In accordance with 21 CFR 1301.34(a), this
is notice that on July 16, 2019, Catalent CTS, LLC, 10245 Hickman Mills
Drive, Kansas City, Missouri 64137-1418 applied to be registered as an
importer of the following basic classes of controlled substances:
------------------------------------------------------------------------
Drug
Controlled substance code Schedule
------------------------------------------------------------------------
Gamma Hydroxybutyric Acid.............. 2010 I
Marihuana Extract...................... 7350 I
Marihuana.............................. 7360 I
Tetrahydrocannabinols.................. 7370 I
------------------------------------------------------------------------
The company plans to import finished dosage unit products
containing gamma-hydroxybutryic acid and marihuana extracts for
clinical trial studies. These marihuana extracts compounds are listed
under drug code 7350. No other activity for these drug codes is
authorized for this registration.
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: October 18, 2019.
William T. McDermott,
Assistant Administrator.
[FR Doc. 2019-23502 Filed 10-25-19; 8:45 am]
BILLING CODE 4410-09-P
