Manufacturer of Controlled Substances; Notice of Application, 6579-6580 [E7-2320]

Download as PDF 6579 Federal Register / Vol. 72, No. 28 / Monday, February 12, 2007 / Notices Administration (DEA) to be registered as an importer of Noroxymorphone (9668), a basic class of controlled substance listed in schedule II. The company plans to import the listed substance for analytical research and clinical trials. Any bulk manufacturer who is presently, or is applying to be, registered with DEA to manufacture such basic class of controlled substance may file comments or objections to the issuance of the proposed registration and may, at the same time, file a written request for a hearing on such application pursuant to 21 CFR 1301.43 and in such form as prescribed by 21 CFR 1316.47. Any such written comments or objections being sent via regular mail should be addressed, in quintuplicate, to the Deputy Assistant Administrator, Office of Diversion Control, Drug Enforcement Administration, Washington, DC 20537, Attention: DEA Federal Register Representative/ODL; or any being sent via express mail should be sent to DEA Headquarters, Attention: DEA Federal Register Representative/ ODL, 2401 Jefferson-Davis Highway, Alexandria, Virginia 22301; and must be filed no later than March 14, 2007. This procedure is to be conducted simultaneously with and independent of the procedures described in 21 CFR 1301.34(b), (c), (d), (e) and (f). As noted in a previous notice published in the Federal Register on September 23, 1975, (40 FR 43745–46), all applicants for registration to import a basic class of any controlled substance listed in schedule I or II are, and will continue to be required to demonstrate to the Deputy Assistant Administrator, Office of Diversion Control, Drug Enforcement Administration, that the requirements for such registration pursuant to 21 U.S.C. 958(a), 21 U.S.C. 823(a), and 21 CFR 1301.34(b), (c), (d), (e) and (f) are satisfied. Dated: February 5, 2007. Joseph T. Rannazzisi, Deputy Assistant Administrator, Office of Diversion Control, Drug Enforcement Administration. [FR Doc. E7–2328 Filed 2–9–07; 8:45 am] BILLING CODE 4410–09–P DEPARTMENT OF JUSTICE sroberts on PROD1PC70 with NOTICES Drug Enforcement Administration Importer of Controlled Substances; Notice of Application Pursuant to 21 U.S.C. 958(i), the Attorney General shall, prior to issuing a registration under this Section to a VerDate Aug<31>2005 19:52 Feb 09, 2007 Jkt 211001 bulk manufacturer of a controlled substance in schedule I or II and prior to issuing a regulation under 21 U.S.C. 952(a)(2)(B) authorizing the importation of such a substance, provide manufacturers holding registrations for the bulk manufacture of the substance an opportunity for a hearing. Therefore, in accordance with 21 CFR 1301.34(a), this is notice that on December 14, 2006, Mallinckrodt Inc., 3600 North Second Street, St. Louis, Missouri 63147, made application by renewal to the Drug Enforcement Administration (DEA) to be registered as an importer of the basic classes of controlled substances listed in schedule II: Drug Schedule Phenylacetone (8501) .................. Coca Leaves (9040) ..................... Opium, raw (9600) ....................... Poppy Straw (9650) ..................... Poppy Straw Concentrate (9670) II II II II II The company plans to import the listed controlled substances for the manufacture of controlled substances in bulk for distribution to its customers. Any bulk manufacturer who is presently, or is applying to be, registered with DEA to manufacture such basic classes of controlled substances may file comments or objections to the issuance of the proposed registration and may, at the same time, file a written request for a hearing on such application pursuant to 21 CFR 1301.43 and in such form as prescribed by 21 CFR 1316.47. Any such written comments or objections being sent via regular mail should be addressed, in quintuplicate, to the Deputy Assistant Administrator, Office of Diversion Control, Drug Enforcement Administration, Washington, D.C. 20537, Attention: DEA Federal Register Representative/ODL; or any being sent via express mail should be sent to DEA Headquarters, Attention: DEA Federal Register Representative/ ODL, 2401 Jefferson-Davis Highway, Alexandria, Virginia 22301; and must be filed no later than March 14, 2007. This procedure is to be conducted simultaneously with and independent of the procedures described in 21 CFR 1301.34(b), (c), (d), (e) and (f). As noted in a previous notice published in the Federal Register on September 23, 1975, (40 FR 43745–46), all applicants for registration to import a basic class of any controlled substance listed in schedule I or II are, and will continue to be required to demonstrate to the Deputy Assistant Administrator, Office of Diversion Control, Drug Enforcement PO 00000 Frm 00063 Fmt 4703 Sfmt 4703 Administration, that the requirements for such registration pursuant to 21 U.S.C. 958(a), 21 U.S.C. 823(a), and 21 CFR 1301.34(b), (c), (d), (e) and (f) are satisfied. Dated: February 5, 2007. Joseph T. Rannazzisi, Deputy Assistant Administrator, Office of Diversion Control, Drug Enforcement Administration. [FR Doc. E7–2326 Filed 2–9–07; 8:45 am] BILLING CODE 4410–09–P DEPARTMENT OF JUSTICE Drug Enforcement Administration Manufacturer of Controlled Substances; Notice of Application Pursuant to § 1301.33(a) of Title 21 of the Code of Federal Regulations (CFR), this is notice that on December 12, 2006, Orasure Technologies, Inc., Lehigh University, Seeley G Mudd-Building 6, 220 East First Street, Bethlehem, Pennsylvania 18015, made application by renewal to the Drug Enforcement Administration (DEA) as a bulk manufacturer of the basic classes of controlled substances listed in schedule I and II: Drug Lysergic acid diethylamide (LSD) (7315). 4–Methoxyamphetamine (7411) ... Normorphine (9313) ..................... Tetrahydrocannabinols (THC) (7370). Alphamethadol (9605) .................. Amphetamine (1100) .................... Methamphetamine (1105) ............ Cocaine (9041) ............................. Hydromorphone (9150) ................ Benzoylecgonine (9180) ............... Hydrocodone (9193) ..................... Morphine (9300) ........................... Oxycodone (9143) ........................ Meperidine (9230) ........................ Methadone (9250) ........................ Oxymorphone (9652) ................... Schedule I I I I I II II II II II II II II II II II The company plans to manufacture the listed controlled substances in bulk to manufacture controlled substance derivatives. These derivatives will be used in diagnostic products created specifically for internal use only. Any other such applicant and any person who is presently registered with DEA to manufacture such a substance may file comments or objections to the issuance of the proposed registration pursuant to 21 CFR 1301.33(a). Any such written comments or objections being sent via regular mail should be addressed, in quintuplicate, to the Deputy Assistant Administrator, E:\FR\FM\12FEN1.SGM 12FEN1 6580 Federal Register / Vol. 72, No. 28 / Monday, February 12, 2007 / Notices Office of Diversion Control, Drug Enforcement Administration, Washington, DC 20537, Attention: DEA Federal Register Representative/ODL; or any being sent via express mail should be sent to DEA Headquarters, Attention: DEA Federal Register Representative/ ODL, 2401 Jefferson-Davis Highway, Alexandria, Virginia 22301; and must be filed no later than April 13, 2007. Dated: February 5, 2007. Joseph T. Rannazzisi, Deputy Assistant Administrator, Office of Diversion Control, Drug Enforcement Administration. [FR Doc. E7–2330 Filed 2–9–07; 8:45 am] Dated: February 5, 2007. Joseph T. Rannazzisi, Deputy Assistant Administrator, Office of Diversion Control, Drug Enforcement Administration. [FR Doc. E7–2320 Filed 2–9–07; 8:45 am] Drug Enforcement Administration BILLING CODE 4410–09–P Introduction and Procedural History This is a consolidated proceeding. On November 7, 2001, the then Administrator of the Drug Enforcement Administration, issued an Order to Show Cause and Notice of Immediate Suspension of the practitioner’s Certificate of Registration, AC1643661, issued to Edmund Chein, M.D. (Respondent) of Palm Springs, California. The Notice of Immediate Suspension was based on the Administrator’s preliminary conclusion that Respondent’s continued registration constituted ‘‘an imminent danger to the public health and safety because of the substantial likelihood that [Respondent would] continue exporting and diverting controlled substances.’’ Order to Show Cause and Notice of Immediate Suspension at 6 (2001 OSC). The Order further proposed to revoke Respondent’s practitioner’s registration and deny any pending applications for renewal of the registration on the ground that Respondent’s continued registration would be inconsistent with the public interest. See id. at 1; see also 21 U.S.C. 823(f) & 824(a)(4). Subsequently, on May 24, 2002, the Deputy Assistant Administrator, Office of Diversion Control, issued an additional Order to Show Cause (hereinafter 2002 OSC) to Respondent. This Show Cause Order proposed to deny Respondent’s pending application for a registration as an exporter on the ground that issuance of a registration would be inconsistent with the public interest. 2002 OSC at 1; see also 21 U.S.C. 958(c) &(d); id. 823(d). The 2001 OSC alleged that Respondent had purchased ‘‘large amounts of anabolic steroids’’ from a Mexican pharmacy and ‘‘other illegitimate sources’’ and had distributed these substances to individuals who did not have a legitimate medical need for them. 2001 OSC at 2. The OSC further alleged that on May 28, 1996, Federal agents Edmund Chein, M.D.; Revocation of Practitioner’s Registration, Denial of Application for Exporter’s Registration Drug Enforcement Administration sroberts on PROD1PC70 with NOTICES Importer of Controlled Substances; Notice of Registration By Notice dated October 12, 2006 and published in the Federal Register on October 19, 2006, (71 FR 61800–61801), Tocris Cookson, Inc., 16144 Westwoods Business Park, Ellisville, Missouri 63021–7683, made application by letter to the Drug Enforcement Administration (DEA) to be registered as an importer of Marihuana (7360), a basic class of controlled substance listed in schedule I. The company plans to import this product for non-clinical laboratory based research only. No comments or objections have been received. DEA has considered the factors in 21 U.S.C. § 823(a) and 952(a) and determined that the registration of Tocris Cookson, Inc. to import the basic class of controlled substance is consistent with the public interest and with United States obligations under international treaties, conventions, or protocols in effect on May 1, 1971, at this time. DEA has investigated Tocris Cookson, Inc. to ensure that the company’s registration is consistent with the public interest. The investigation has included inspection and testing of the company’s physical security systems, verification of the company’s compliance with state and local laws, and a review of the company’s background and history. Therefore, pursuant to 21 U.S.C. 952(a) and 958(a), and in accordance with 21 CFR 1301.34, the above named company is granted registration as an importer of the basic class of controlled substance listed. 19:52 Feb 09, 2007 Jkt 211001 DEPARTMENT OF JUSTICE [Docket Nos. 02–09, 02–43] DEPARTMENT OF JUSTICE VerDate Aug<31>2005 BILLING CODE 4410–09–P PO 00000 Frm 00064 Fmt 4703 Sfmt 4703 executed a search warrant at Respondent’s medical office and seized several vials of steroids for which there were no records. Id. The OSC further alleged that in June 1996, DEA obtained from Henry Schein, Inc., copies of invoices which documented that Respondent had purchased controlled substances on nine different occasions between January 1995 and May 1996. Id. at 3. The OSC alleged that Respondent had failed to keep accurate records of the purchase, inventory, and dispensation of controlled substances. Id. The 2001 OSC next alleged that on January 31, 2001, DEA Diversion Investigators (DIs) went to Respondent’s Palm Springs medical office, the Palm Springs Life Extension Institute (hereinafter PSLEI), to conduct an administrative inspection. Id. The OSC alleged that the invoices documenting the purchases of controlled substances were at an accounting firm and not at the office. Id. The 2001 OSC further alleged that ‘‘none of [the] required controlled substance records were accessible,’’ because the records were stored in a computer and none of the office personnel then present were capable of retrieving them. Id. The OSC thus alleged that Respondent had violated the Controlled Substance Act by failing ‘‘to maintain in a readily available condition’’ initial and biennial inventory records, purchase invoices, and dispensing records. Id. The 2001 OSC further alleged that on February 5, 2001, DEA personnel returned to Respondent’s office and obtained an inventory of controlled substances that was dated February 5, 2001, dispensing records for the period July 1, 2000, through February 1, 2001, and invoices for purchases of controlled substances from Barnes Wholesale, Inc., for the period January 1, 1999, through February 4, 2001. Id. The OSC also alleged that the dispensing records showed that between July 1, 2000, and February 5, 2001, Respondent dispensed anabolic steroids, a Schedule III controlled substance, and phentermine, a Schedule IV controlled substance, to persons in Korea, Belgium, Indonesia, Canada, Japan, Spain, Germany, Switzerland, Mexico, England, and Hong Kong. Id. at 3–4. More specifically, the OSC alleged that Respondent had made 328 illegal exports comprised of 20 exports of phentermine 30 mg., 58 exports of phentermine 15 mg., 73 exports of testosterone gel 8 mg., 12 exports of testosterone gel 100 mg., 50 exports of testosterone estradiol gel 4 mg, 113 exports of Depo testosterone 200 mg., and two exports of testosterone 50 mg. E:\FR\FM\12FEN1.SGM 12FEN1

Agencies

[Federal Register Volume 72, Number 28 (Monday, February 12, 2007)]
[Notices]
[Pages 6579-6580]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E7-2320]


-----------------------------------------------------------------------

DEPARTMENT OF JUSTICE

Drug Enforcement Administration


Manufacturer of Controlled Substances; Notice of Application

    Pursuant to Sec.  1301.33(a) of Title 21 of the Code of Federal 
Regulations (CFR), this is notice that on December 12, 2006, Orasure 
Technologies, Inc., Lehigh University, Seeley G Mudd-Building 6, 220 
East First Street, Bethlehem, Pennsylvania 18015, made application by 
renewal to the Drug Enforcement Administration (DEA) as a bulk 
manufacturer of the basic classes of controlled substances listed in 
schedule I and II:

------------------------------------------------------------------------
                    Drug                               Schedule
------------------------------------------------------------------------
Lysergic acid diethylamide (LSD) (7315)....  I
4-Methoxyamphetamine (7411)................  I
Normorphine (9313).........................  I
Tetrahydrocannabinols (THC) (7370).........  I
Alphamethadol (9605).......................  I
Amphetamine (1100).........................  II
Methamphetamine (1105).....................  II
Cocaine (9041).............................  II
Hydromorphone (9150).......................  II
Benzoylecgonine (9180).....................  II
Hydrocodone (9193).........................  II
Morphine (9300)............................  II
Oxycodone (9143)...........................  II
Meperidine (9230)..........................  II
Methadone (9250)...........................  II
Oxymorphone (9652).........................  II
------------------------------------------------------------------------

    The company plans to manufacture the listed controlled substances 
in bulk to manufacture controlled substance derivatives. These 
derivatives will be used in diagnostic products created specifically 
for internal use only.
    Any other such applicant and any person who is presently registered 
with DEA to manufacture such a substance may file comments or 
objections to the issuance of the proposed registration pursuant to 21 
CFR 1301.33(a).
    Any such written comments or objections being sent via regular mail 
should be addressed, in quintuplicate, to the Deputy Assistant 
Administrator,

[[Page 6580]]

Office of Diversion Control, Drug Enforcement Administration, 
Washington, DC 20537, Attention: DEA Federal Register Representative/
ODL; or any being sent via express mail should be sent to DEA 
Headquarters, Attention: DEA Federal Register Representative/ODL, 2401 
Jefferson-Davis Highway, Alexandria, Virginia 22301; and must be filed 
no later than April 13, 2007.

     Dated: February 5, 2007.
 Joseph T. Rannazzisi,
Deputy Assistant Administrator, Office of Diversion Control, Drug 
Enforcement Administration.
 [FR Doc. E7-2320 Filed 2-9-07; 8:45 am]
BILLING CODE 4410-09-P