Bulk Manufacturer of Controlled Substances Application: IRIX Manufacturing, Inc., 50035 [2015-20285]

Download as PDF 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: asabaliauskas on DSK5VPTVN1PROD with NOTICES Drug Enforcement Administration VerDate Sep<11>2014 17:02 Aug 17, 2015 Jkt 235001 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 18AUN1

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]


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DEPARTMENT OF JUSTICE

Drug Enforcement Administration

[Docket No. DEA-392]


Bulk Manufacturer of Controlled Substances Application: IRIX 
Manufacturing, Inc.

ACTION: Notice of application.

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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