Bulk Manufacturer of Controlled Substances Application: IRIX Manufacturing, Inc., 50035 [2015-20285]
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Federal Register / Vol. 80, No. 159 / Tuesday, August 18, 2015 / Notices
therefore not entitled to maintain her
DEA registration. See 21 U.S.C. 802(21),
823(f), and 824(a)(3). Accordingly, I will
order that her registration be revoked.
Order
Pursuant to the authority vested in me
by 21 U.S.C. 824(a), as well as 28 CFR
0.100(b), I order that DEA Certificate of
Registration MH2194176 issued to
Devra A. Hamilton, A.P.N., be, and it
hereby is, revoked. I further order that
any pending application of Devra A.
Hamilton, A.P.N., to renew or modify
her registration, be, and it hereby is,
denied. This Order is effective
September 17, 2015.
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 March
30, 2015, IRIX Manufacturing, Inc., 309
Delaware Street, Building 1106,
Greenville, South Carolina 29605
applied to be registered as a bulk
manufacturer of the following basic
classes of controlled substances:
Controlled Substance
Marihuana (7360) .........................
Tetrahydrocannabinols (7370) .....
Schedule
I
I
The company plans to manufacture
the above-listed controlled substances
as Active Pharmaceutical Ingredient
(API) for clinical trials.
Dated: August 10, 2015.
Chuck Rosenberg,
Acting Administrator.
[FR Doc. 2015–20348 Filed 8–17–15; 8:45 am]
Dated: August 10, 2015.
Joseph T. Rannazzisi,
Deputy Assistant Administrator.
BILLING CODE 4410–09–P
DEPARTMENT OF JUSTICE
[FR Doc. 2015–20285 Filed 8–17–15; 8:45 am]
BILLING CODE 4410–09–P
Drug Enforcement Administration
[Docket No. DEA–392]
DEPARTMENT OF JUSTICE
Bulk Manufacturer of Controlled
Substances Application: IRIX
Manufacturing, Inc.
ACTION:
Arthur H. Bell, D.O.; Decision and
Order
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 October 19, 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 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 Deputy Assistant
DATES:
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Drug Enforcement Administration
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On July 15, 2014, the Deputy
Assistant Administrator, Office of
Diversion Control, Drug Enforcement
Administration, issued an Order to
Show Cause to Arthur H. Bell, D.O.
(Respondent), of Covington, Kentucky.
GX 1, at 1. The Show Cause Order
proposed the denial of Respondent’s
application for a DEA Certificate of
Registration as a practitioner on
multiple grounds, including that he had
materially falsified his application for a
registration, as well as that he had
committed acts which render his
registration inconsistent with the public
interest. Id. at 1–2 (citing 21 U.S.C.
823(f) and 824(a)(1)).
As for the material falsification
allegation, the Show Cause Order
alleged that on November 9, 2011,
Respondent had voluntarily surrendered
his previous DEA Registration. Id. The
Order then alleged that on March 14,
2013, Respondent applied for a new
DEA registration, but materially falsified
the application when he ‘‘answered ‘no’
to question which asked, ‘[h]as the
Respondent ever surrendered (for cause)
or had a federal controlled substance
registration revoked, suspended,
restricted or denied, or is any such
action pending?’’’ Id.
As for the allegations that Respondent
had committed acts which render his
PO 00000
Frm 00051
Fmt 4703
Sfmt 4703
50035
registration inconsistent with the public
interest, the Show Cause Order alleged
that Respondent violated federal law by
issuing controlled substance
prescriptions when he ‘‘no longer
possessed a DEA registration.’’ Id. at 2
(citing 21 CFR 1306.03(a)). More
specifically, the Order alleged that on
May 5, 2012, Respondent had issued a
prescription for 60 tablets of Lyrica 75
mg, a schedule V controlled substance,
and on September 12, 2012, Respondent
had issued a prescription for Zutripro
120 ml, a schedule III controlled
substance. Id.
The Show Cause Order also alleged
that from July 11, 2011 through
November 4, 2011, Respondent
‘‘dispensed controlled substances on
behalf of Care Plus Medical Group
(CPMG), a purported pain management
clinic formerly located in Creve Coeur,
Missouri, [which] was owned by Scott
Whitney.’’ Id. The Order alleged that
prior to beginning his employment with
CPMG, Respondent arranged with
Whitney to order schedule II controlled
substances under his previous
registration and that ‘‘[t]o that end, . . .
Whitney sent 20 DEA 222 forms to
[Respondent’s] residence, and asked
that [he] pre-sign them so that
controlled substances could be ordered
on behalf of CPMG.’’ Id. The Order then
alleged that Respondent ‘‘pre-signed the
forms, dated them . . . and mailed them
to . . . Whitney . . . [who] then used one
. . . to place orders for oxycodone 30 mg
and oxycodone 10/325 mg.’’ Id. The
Order alleged that this violated federal
law because it ‘‘authoriz[ed] . . .
Whitney to place an order for controlled
substances under [Respondent’s]
previous . . . registration without
executing a power of attorney for . . .
Whitney.’’ Id. (citing 21 CFR
1303.05(a)).
Next, the Show Cause Order alleged
that on October 28, 2013, Respondent
falsified his application for his Ohio
medical license, when he failed to
disclose that he had previously
surrendered his DEA registration. Id. at
1–2. The Order further alleged that this
‘‘conduct evidences a lack of candor to
Ohio licensing authorities.’’ Id. (citing
21 U.S.C. 823(f)(5)).
Finally, the Show Cause Order
notified Respondent of his right to
request a hearing on the allegations or
to submit a written statement in lieu of
a hearing, the procedure for electing
either option, and the consequence of
failing to elect either option. Id. at 2–3
(citing 21 CFR 1301.43). The
Government also included with the
Order a sample Request for Hearing
form. Id. at 4.
E:\FR\FM\18AUN1.SGM
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]]>Agencies
[Federal Register Volume 80, Number 159 (Tuesday, August 18, 2015)]
[Notices]
[Page 50035]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-20285]
-----------------------------------------------------------------------
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. DEA-392]
Bulk Manufacturer of Controlled Substances Application: IRIX
Manufacturing, 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 October 19, 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 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 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 March
30, 2015, IRIX Manufacturing, Inc., 309 Delaware Street, Building 1106,
Greenville, South Carolina 29605 applied to be registered as a bulk
manufacturer of the following basic classes of controlled substances:
------------------------------------------------------------------------
Controlled Substance Schedule
------------------------------------------------------------------------
Marihuana (7360)........................... I
Tetrahydrocannabinols (7370)............... I
------------------------------------------------------------------------
The company plans to manufacture the above-listed controlled
substances as Active Pharmaceutical Ingredient (API) for clinical
trials.
Dated: August 10, 2015.
Joseph T. Rannazzisi,
Deputy Assistant Administrator.
[FR Doc. 2015-20285 Filed 8-17-15; 8:45 am]
BILLING CODE 4410-09-P
