Bulk Manufacturer of Controlled Substances Application: Euticals, Inc., 57391 [2015-24124]
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Federal Register / Vol. 80, No. 184 / Wednesday, September 23, 2015 / Notices
Dated: September 16, 2015.
Joseph T. Rannazzisi,
Deputy Assistant Administrator.
Controlled Substance
Phenylacetone (8501) ................
Methadone (9250) ......................
Methadone intermediate (9254)
Oripavine (9330) .........................
Tapentadol (9780) ......................
[FR Doc. 2015–24120 Filed 9–22–15; 8:45 am]
BILLING CODE 4410–09–P
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. DEA–392]
Bulk Manufacturer of Controlled
Substances Application: 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 in
accordance with 21 CFR 1301.33(a) on
or before November 23, 2015.
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
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 July 23,
2015, 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:
mstockstill on DSK4VPTVN1PROD with NOTICES
DATES:
Controlled Substance
Schedule
Gamma Hydroxybutyric Acid
(2010).
Amphetamine (1100) ..................
Lisdexamfetamine (1205) ...........
Methylphenidate (1724) ..............
VerDate Sep<11>2014
18:00 Sep 22, 2015
I
II
II
II
Jkt 235001
Schedule
II
II
II
II
II
The company plans to manufacture
the listed controlled substances in bulk
for distribution and sale to its
customers.
In reference to oripavine (9330), the
company plans to acquire the listed
controlled substance in bulk from a
domestic source in order to manufacture
other controlled substances in bulk for
distribution to its customers.
Dated: September 16, 2015.
Joseph T. Rannazzisi,
Deputy Assistant Administrator.
[FR Doc. 2015–24124 Filed 9–22–15; 8:45 am]
BILLING CODE 4410–09–P
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. 15–25]
James Alvin Chaney, M.D.: Decision
and Order
On July 23, 2015, Chief
Administrative Law Judge (CALJ) John J.
Mulrooney, II, issued the attached
Recommended Decision (cited as R.D.).
Respondent filed Exceptions to the
Recommended Decision.
In his Recommended Decision, the
CALJ found that on October 21, 2014,
the Commonwealth of Kentucky, Board
of Medical Licensure, had issued
Respondent an Emergency Order of
Suspension against his medical license.
R.D. at 2. The CALJ further found that
on November 17, 2014, the Board issued
a final order that affirmed the
emergency order of suspension ‘‘and
that the suspension order remains in
effect.’’ Id. Noting that the Controlled
Substances Act defines ‘‘term
‘practitioner’ [to] mean[ ] a physician
. . . licensed, registered, or otherwise
permitted, by . . . the jurisdiction in
which he practices . . . to . . . dispense
[or] administer . . . a controlled
substance in the course of professional
practice,’’ id. at 3 (quoting 21 U.S.C.
802(21), as well as that the registration
provision applicable to practitioners
directs the Attorney General to ‘‘register
[a] practitioner[] . . . if the applicant is
authorized to dispense . . . controlled
substances under the laws of the State
in which he practices,’’ id. (quoting 21
U.S.C. 823(f)), the CALJ then noted that
the Agency ‘‘has long held that
possession of authority under state law
PO 00000
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Fmt 4703
Sfmt 4703
57391
to dispense controlled substances is an
essential condition for obtaining and
maintaining a DEA registration.’’ Id.
(collecting cases). Because there is no
dispute that ‘‘Respondent lacks state
authority to handle controlled
substances in’’ Kentucky, the CALJ
granted the Government’s motion for
summary disposition and recommended
that Respondent’s registration be
revoked.1 Id. at 5.
In his Exceptions, Respondent argues
that Board’s Emergency Order
suspending his license ‘‘is not a final
order as it has been appealed and is
currently being reviewed by the
Kentucky Court of Appeals.’’ Exceptions
at 1. He argues that the CALJ’s
Recommended Decision is therefore
‘‘based upon an order that is not final
and consequently will constitute
arbitrary and capricious action.’’ Id. at 2.
Finally, Respondent contends that
‘‘[s]ummary judgment is improper
because issues of fact exist concerning
the enforceability of the temporary
suspension of [his] medical license
given its unconstitutionality.’’ Id.
I reject Respondent’s contentions.
Putting aside whether—in light of the
state Hearing Officer’s issuance of the
‘‘Final Order Affirming The Emergency
Order of Suspension’’—Respondent has
accurately described the procedural
posture of the state licensing matter,
based on the plain language of sections
802(21) and 823(f), this Agency has held
repeatedly that ‘‘the controlling
question’’ in a proceeding brought
under 21 U.S.C. 824(a)(3) is whether the
holder of a DEA registration ‘‘‘is
currently authorized to handle
controlled substances in the [S]tate.’’’
James L. Hooper, 76 FR 71371, 71371
(2011) (quoting Anne Lazar Thorn, 62
FR 12847, 12848 (1997)), pet. for rev.
1 While the Government alleged in the Order to
Show Cause that Respondent’s registration does not
expire until August 31, 2016, Show Cause Order,
at 1; and in his hearing request, Respondent states
that he ‘‘holds a medical license . . . and a DEA
registration,’’ Hearing Request, at 1; the Agency is
still required to establish that it has jurisdiction to
act. See Sharad C. Patel, 80 FR 28693, 28694 n.3
(2015) (‘‘Even in summary disposition proceedings
which are based on a lack of state authority, the ALJ
is obligated to make a finding establishing that the
Agency has jurisdiction.’’); see also 5 U.S.C.
706(2)(C) (directing reviewing courts ‘‘to hold
unlawful and set aside agency action, findings and
conclusions found to be . . . in excess of statutory
jurisdiction’’). This generally requires the ALJ to
make a finding either that a respondent retains an
active registration or has submitted an application
for registration.
In the interest of conducting an expeditious
review of this matter, I have taken official notice of
Respondent’s registration record with the Agency
and find that his registration does not expire until
August 31, 2016. See 5 U.S.C. 556(e); 21 CFR
1316.59(e). However, in the future, where a
recommended decision lacks the requisite finding,
I will remand the matter for this purpose.
E:\FR\FM\23SEN1.SGM
23SEN1
]]>Agencies
[Federal Register Volume 80, Number 184 (Wednesday, September 23, 2015)]
[Notices]
[Page 57391]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-24124]
-----------------------------------------------------------------------
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. DEA-392]
Bulk Manufacturer of Controlled Substances Application: Euticals,
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 November 23, 2015.
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 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 July
23, 2015, 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:
------------------------------------------------------------------------
Controlled Substance Schedule
------------------------------------------------------------------------
Gamma Hydroxybutyric Acid (2010).......... I
Amphetamine (1100)........................ II
Lisdexamfetamine (1205)................... II
Methylphenidate (1724).................... II
Phenylacetone (8501)...................... II
Methadone (9250).......................... II
Methadone intermediate (9254)............. II
Oripavine (9330).......................... II
Tapentadol (9780)......................... II
------------------------------------------------------------------------
The company plans to manufacture the listed controlled substances
in bulk for distribution and sale to its customers.
In reference to oripavine (9330), the company plans to acquire the
listed controlled substance in bulk from a domestic source in order to
manufacture other controlled substances in bulk for distribution to its
customers.
Dated: September 16, 2015.
Joseph T. Rannazzisi,
Deputy Assistant Administrator.
[FR Doc. 2015-24124 Filed 9-22-15; 8:45 am]
BILLING CODE 4410-09-P
