Importer of Controlled Substances Application: KVK-Tech, Inc., 42119-42120 [2017-18787]
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Federal Register / Vol. 82, No. 171 / Wednesday, September 6, 2017 / Notices
asabaliauskas on DSKBBXCHB2PROD with NOTICES
person licensed, registered or otherwise
permitted, by . . . the jurisdiction in
which he practices . . . to distribute,
dispense, [or] administer . . . a
controlled substance in the course of
professional practice.’’ 21 U.S.C.
802(21). Second, in setting the
requirements for obtaining a
practitioner’s registration, Congress
directed that ‘‘[t]he Attorney General
shall register practitioners . . . if the
applicant is authorized to dispense . . .
controlled substances under the laws of
the State in which [s]he practices.’’ 21
U.S.C. 823(f). Because Congress has
clearly mandated that a practitioner
possess state authority in order to be
deemed a practitioner under the Act,
DEA has held repeatedly that revocation
of a practitioner’s registration is the
appropriate sanction whenever he is no
longer authorized to dispense controlled
substances under the laws of the State
in which he engages in professional
practice. See, e.g., Calvin Ramsey, 76 FR
20034, 20036 (2011); Sheran Arden
Yeates, M.D., 71 FR 39130, 39131
(2006); Dominick A. Ricci, 58 FR 51104,
51105 (1993); Bobby Watts, 53 FR
11919, 11920 (1988); Blanton, 43 FR
27616 (1978).
Moreover, because ‘‘the controlling
question’’ in a proceeding brought
under 21 U.S.C. 824(a)(3) is whether the
holder of a practitioner’s registration ‘‘is
currently authorized to handle
controlled substances in the [S]tate,’’
Hooper, 76 FR at 71371 (quoting Anne
Lazar Thorn, 62 FR 12847, 12848
(1997)), the Agency has also long held
that revocation is warranted even where
a practitioner has lost his state authority
by virtue of the State’s use of summary
process and the State has yet to provide
a hearing to challenge the suspension.
Bourne Pharmacy, 72 FR 18273, 18274
(2007); Wingfield Drugs, 52 FR 27070,
27071 (1987). Thus, it is of no
consequence that the Florida State
Board of Medical Examiners has
employed summary process in
suspending Registrant’s state medical
license. What is consequential is that
Registrant is no longer currently
authorized to dispense controlled
substances in Florida, the State in
which he is registered. I will therefore
order that his registration be revoked.
Order
Pursuant to the authority vested in me
by 21 U.S.C. 823(f) and 824(a), as well
as 28 CFR 0.100(b), I order that DEA
Certificate of Registration No.
FA3645213, issued to Marcus W.
Anderson, M.D., be, and it hereby is,
revoked. I further order that any
pending application of Marcus W.
Anderson to renew or modify the above
VerDate Sep<11>2014
17:37 Sep 05, 2017
Jkt 241001
registration, or any pending application
of Marcus W. Anderson for any other
registration, be, and it hereby is, denied.
This Order is effective immediately.5
Dated: August 28, 2017.
Chuck Rosenberg,
Acting Administrator.
[FR Doc. 2017–18784 Filed 9–5–17; 8:45 am]
BILLING CODE 4410–09–P
DEPARTMENT OF JUSTICE
[Docket No. DEA–392]
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 November 6, 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
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 January
20, 2017, Stepan Company, Natural
Products Dept., 100 W. Hunter Avenue,
Maywood, New Jersey 07607 applied to
be registered as a bulk manufacturer of
the following basic classes of controlled
substances:
DATES:
5 For the same reasons that led the Florida Board
of Medicine to summarily suspend Registrant’s
medical license, I find that the public interest
necessitates that this Order be effective
immediately. 21 CFR 1316.67.
Frm 00064
Fmt 4703
9041
9180
Schedule
II
II
The company plans to manufacture
the listed controlled substances in bulk
for distribution to its customers.
Dated: August 28, 2017.
Demetra Ashley,
Acting Assistant Administrator.
BILLING CODE 4410–09–P
DEPARTMENT OF JUSTICE
Bulk Manufacturer of Controlled
Substances Application: Stepan
Company
PO 00000
Cocaine ...................................
Ecgonine .................................
Drug
code
[FR Doc. 2017–18789 Filed 9–5–17; 8:45 am]
Drug Enforcement Administration
ACTION:
Controlled substance
Sfmt 4703
Drug Enforcement Administration
[Docket No. DEA–392]
Importer of Controlled Substances
Application: KVK–Tech, 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 October 6, 2017. Such persons
may also file a written request for a
hearing on the application pursuant to
21 CFR 1301.43 on or before October 6,
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 request 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
DATES:
E:\FR\FM\06SEN1.SGM
06SEN1
42120
Federal Register / Vol. 82, No. 171 / Wednesday, September 6, 2017 / Notices
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 July 18,
2016, KVK–Tech, Inc., 110 Terry Drive,
Newtown, Pennsylvania 18940 applied
to be registered as an importer of
Lisdexamfetamine (1205), a basic class
of controlled substance listed in
schedule II.
The company plans to import the
listed controlled substance in finished
dosage form for clinical trials, research,
and analytical purposes. 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: August 28, 2017.
Demetra Ashley,
Acting Assistant Administrator.
[FR Doc. 2017–18787 Filed 9–5–17; 8:45 am]
BILLING CODE 4410–09–P
(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 of subpart R.
In accordance with 21 CFR
1301.34(a), this is notice that on October
31, 2016, Spex Certiprep Group, LLC,
203 Norcross Avenue, Metuchen, New
Jersey 08840 applied to be registered as
an importer of the following basic
classes of controlled substances:
Drug
code
Controlled substance
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
Marihuana ...............................
Tetrahydrocannabinols ...........
7360
7370
Schedule
I
I
[Docket No. DEA–392]
Importer of Controlled Substances
Application: Spex Certiprep Group,
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 1301.34(a) on
or before October 6, 2017. Such persons
may also file a written request for a
hearing on the application pursuant to
21 CFR 1301.43 on or before October 6,
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 request for hearing
should also be sent to: (1) Drug
Enforcement Administration, Attn:
Hearing Clerk/LJ, 8701 Morrissette
Drive, Springfield, Virginia 22152; and
asabaliauskas on DSKBBXCHB2PROD with NOTICES
DATES:
VerDate Sep<11>2014
17:37 Sep 05, 2017
Jkt 241001
The company plans to import the
listed controlled substances for sale to
research facilities for drug testing and
analysis.
In reference to drug codes 7360
(marihuana) and 7370 (THC), the
company plans to import a synthetic
cannabidiol and a synthetic
tetrahydrocannabinol. No other activity
for these drug codes is authorized for
this registration.
Dated: August 28, 2017.
Demetra Ashley,
Acting Assistant Administrator.
[FR Doc. 2017–18788 Filed 9–5–17; 8:45 am]
BILLING CODE 4410–09–P
DEPARTMENT OF JUSTICE
Controlled substance
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
DATES:
PO 00000
Frm 00065
Fmt 4703
Sfmt 4703
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 October 6, 2017. Such persons
may also file a written request for a
hearing on the application pursuant to
21 CFR 1301.43 on or before October 6,
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 9, 2016, 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 ..........................
Methylphenidate ......................
Oxycodone ..............................
Hydromorphone ......................
Methadone ..............................
Morphine .................................
Fentanyl ..................................
Drug
code
1100
1724
9143
9150
9250
9300
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
E:\FR\FM\06SEN1.SGM
06SEN1
]]>Agencies
[Federal Register Volume 82, Number 171 (Wednesday, September 6, 2017)]
[Notices]
[Pages 42119-42120]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-18787]
-----------------------------------------------------------------------
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. DEA-392]
Importer of Controlled Substances Application: KVK-Tech, 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
1301.34(a) on or before October 6, 2017. Such persons may also file a
written request for a hearing on the application pursuant to 21 CFR
1301.43 on or before October 6, 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
request 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
[[Page 42120]]
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 July
18, 2016, KVK-Tech, Inc., 110 Terry Drive, Newtown, Pennsylvania 18940
applied to be registered as an importer of Lisdexamfetamine (1205), a
basic class of controlled substance listed in schedule II.
The company plans to import the listed controlled substance in
finished dosage form for clinical trials, research, and analytical
purposes. 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: August 28, 2017.
Demetra Ashley,
Acting Assistant Administrator.
[FR Doc. 2017-18787 Filed 9-5-17; 8:45 am]
BILLING CODE 4410-09-P
