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Code · REGISTER · 2006-05-25 · DEPARTMENT OF JUSTICE · Notices

Notices. DEPARTMENT OF JUSTICE

3,314 words·~15 min read·/register/2006/05/25/06-4837·

A research copy — for the controlling text, always check the official state or federal source. Not legal advice.

BILLING CODE 4410-15-M 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 January 2, 2006, Applied Science Labs., Division of Alltech Associates Inc., 2701 Carolean Industrial Drive, State College, Pennsylvania 16801, made application by letter to the Drug Enforcement Administration
(DEA)to be registered as a bulk manufacturer of Tetrahydrocannabinols (7370), a basic class of controlled substance listed in Schedules I. The company plans to manufacture metabolites of Delta-9-THC to be used as chromatographic standards. These compounds fall under drug code 7370 (Tetrahydrocannabinols) 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 may be addressed, in quintuplicate, to the Deputy Assistant Administrator, Office of Diversion Control, Drug Enforcement Administration, Washington, DC 20537, Attention: DEA Federal Register Representative, Liaison and Policy Section (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 July 24, 2006. Dated: May 17, 2006. Joseph T. Rannazzisi, Deputy Assistant Administrator, Office of Diversion Control, Drug Enforcement Administration. [FR Doc. E6-7986 Filed 5-24-06; 8:45 am] BILLING CODE 4410-09-P DEPARTMENT OF JUSTICE Drug Enforcement Administration Manufacturer of Controlled Substances; Notice of Registration By Notice dated January 11, 2006, and published in the **Federal Register** on January 23, 2006, (71 FR 3545), Clariant LSM (Missouri), Inc., 2460 W. Bennett Street (or P.O. Box 1246, Zip: 65801), Springfield, Missouri 65807-1229, made application by letter to the Drug Enforcement Administration
(DEA)to be registered as a bulk manufacturer of Phenylacetone (8501), and Methadone Intermediate (9254), basic classes of controlled substances listed in Schedules II: The company plans to manufacture in bulk, for sale to its customers. No comments or objections have been received. DEA has considered the factors in 21 U.S.C. 823(a) and determined that the registration of Clariant LSM (Missouri) to manufacture the listed basic classes of controlled substances is consistent with the public interest at this time. DEA has investigated Clariant LSM (Missouri) 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. 823, and in accordance with 21 CFR 1301.33, the above named company is granted registration as a bulk manufacturer of the basic classes of controlled substances listed. Dated: May 17, 2006. Joseph T. Rannazzisi, Deputy Assistant Administrator, Office of Diversion Control, Drug Enforcement Administration. [FR Doc. E6-7980 Filed 5-24-06; 8:45 am] BILLING CODE 4410-09-P DEPARTMENT OF JUSTICE Drug Enforcement Administration Importer of Controlled Substances; Notice of Registration By Notice dated January 11, 2006 and published in the **Federal Register** on January 23, 2006, (71 FR 3545), Clinical Trial Services (US), 2661 Audubon Road, Audubon, Pennsylvania 19403, made application by renewal to the Drug Enforcement Administration
(DEA)to be registered as an importer of Fentanyl
(9801)and Oxycodone (9143), basic classes of controlled substances listed in Schedule II. The company plans to import small quantities of the listed controlled substances in dosage form to conduct clinical trials. No comments or objections have been received. DEA has considered the factors in 21 U.S.C. Sections 823(a) and 952(a) and determined that the registration of Clinical Trial Services
(US)to import the basic class of controlled substances 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 Clinical Trial Services
(US)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. Sections 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 substances listed. Dated: May 18, 2006. Joseph T. Rannazzisi, Deputy Assistant Administrator, Office of Diversion Control, Drug Enforcement Administration. [FR Doc. E6-7981 Filed 5-24-06; 8:45 am] BILLING CODE 4410-09-P DEPARTMENT OF JUSTICE Drug Enforcement Administration Importer of Controlled Substances; Notice of Registration By Notice dated February 16, 2006 and published in the **Federal Register** on February 24, 2006, (71 FR 9606), JFC Technologies, LLC., 100 West Main Street, P.O. Box 669, Bound Brook, New Jersey 08805, made application by renewal to the Drug Enforcement Administration
(DEA)to be registered as an importer of Meperidine intermediate-B (9233), a basic class of controlled substance listed in Schedule II. The company plans to import the basic class of controlled substance for the production of controlled substances for distribution to its customers. 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 JFC Technologies, LLC to import the basic class of controlled substances 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 JFC Technologies, LLC 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 substances listed. Dated: May 17, 2006. Joseph T. Ranazzissi, Deputy Assistant Administrator, Office of Diversion Control, Drug Enforcement Administration. [FR Doc. E6-7976 Filed 5-24-06; 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 February 22, 2006, Lilly Del Caribe, Inc., Chemical Plant, Kilometer 146.7, State Road 2, Mayaguez, Puerto Rico 00680, made application by renewal to the Drug Enforcement Administration
(DEA)to be registered as a bulk manufacturer of Dextropropoxyphen (9273), a basic class of controlled substance listed in Schedule II. The company plans to manufacture the listed controlled substances in bulk for distribution to its customers. 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 may be addressed, in quintuplicate, to the Deputy Assistant Administrator, Office of Diversion Control, Drug Enforcement Administration, Washington, DC 20537, Attention: DEA Federal Register Representative, Liaison and Policy Section (ODL); or any being sent via express mail should be sent to DEA Headquarters, Attention: DEA Federal RegisterRepresentative/ODL, 2401 Jefferson-Davis Highway, Alexandria, Virginia 22301; and must be filed no later than July 24, 2006. Dated: May 17, 2006. Joseph T. Rannazzisi, Deputy Assistant Administrator, Office of Diversion Control, Drug Enforcement Administration. [FR Doc. E6-7977 Filed 5-24-06; 8:45 am] BILLING CODE 4410-09-P DEPARTMENT OF JUSTICE 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 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 9, 2005, 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)II Coca Leaves
(9040)II Opium, raw
(9600)II Poppy Straw
(9650)II Poppy Straw Concentrate
(9670)II The company plans to import the listed controlled substances for the manufacture of controlled substances in bulk for distribution to its customers. Any 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 may be addressed, in quintuplicate, to the Deputy Assistant Administrator, Office of Diversion Control, Drug Enforcement Administration, Washington, DC 20537, Attention: DEA Federal Register Representative, Liaison and Policy Section (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 June 26, 2006. 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 301.34(b), (c), (d),
(e)and
(f)are satisfied. Dated: May 17, 2006. Joseph T. Rannazzisi, Deputy Assistant Administrator, Office of Diversion Control, Drug Enforcement Administration. [FR Doc. E6-7978 Filed 5-24-06; 8:45 am] BILLING CODE 4410-09-P DEPARTMENT OF JUSTICE Drug Enforcement Administration Manufacturer of Controlled Substances; Notice of Registration By Notice dated December 8, 2005, and published in the **Federal Register** on December 19, 2005, (70 FR 242), Norac, Inc., 405 S. Motor Avenue, P.O. Box 577, Azusa, California 91702, made application by renewal to the Drug Enforcement Administration
(DEA)to be registered as a bulk manufacturer of THC Tetrahydrocannabinols (7370), a basic class of controlled substance listed in Schedules I. The company plans to manufacture the listed controlled substance in bulk for formulation into the pharmaceutical controlled substance Marinol®. No comments or objections have been received. DEA has considered the factors in 21 U.S.C. 823(a) and determined that the registration of Norac, Inc. to manufacture the listed basic classes of controlled substances is consistent with the public interest at this time. DEA has investigated Norac, 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. 823, and in accordance with 21 CFR 1301.33, the above named company is granted registration as a bulk manufacturer of the basic classes of controlled substances listed. Dated: May 17, 2006. Joseph T. Rannazzisi, Deputy Assistant Administrator, Office of Diversion Control, Drug Enforcement Administration. [FR Doc. E6-7982 Filed 5-24-06; 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 January 24, 2006, Stepan Company, Natural Products Dept., 100 W. Hunter Avenue, Maywood, New Jersey 07607, made application by renewal to the Drug Enforcement Administration
(DEA)to be registered as a bulk manufacturer of the basic classes of controlled substances listed in Schedule I and II: Drug Schedule Cocaine
(9041)II Benzoylecgonine
(9180)II The company plans to manufacture the listed controlled substances in bulk for distribution to its customer. 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 may be addressed, in quintuplicate, to the Deputy Assistant Administrator, Office of Diversion Control, Drug Enforcement Administration, Washington, DC 20537, Attention: DEA Federal Register Representative, Liaison and Policy Section (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 July 24, 2006. Dated: May 17, 2006. Joseph T. Rannazzisi, Deputy Assistant Administrator, Office of Diversion Control, Drug Enforcement Administration. [FR Doc. E6-7989 Filed 5-24-06; 8:45 am] BILLING CODE 4410-09-P DEPARTMENT OF JUSTICE Drug Enforcement Administration Kevin Dean Brockbank, M.D.; Revocation of Registration On October 14, 2004, the Deputy Administrator of the Drug Enforcement Administration
(DEA)issued an Order to Show Cause and Immediate Suspension of Registration to Kevin Dean Brockbank, M.D. (Dr. Brockbank) of Lakeside, Arizona. Dr. Brockbank was notified of an opportunity to show cause as to why DEA should not revoke his DEA Certificate of Registration, AB2053027, as a practitioner, and deny any pending applications for renewal or modification of that registration pursuant to 21 U.S.C. 823(f) and 824(a)(4) on the basis that his continued registration would be inconsistent with the public interest. Dr. Brockbank was further notified that pursuant to 21 U.S.C. 824(d), his DEA registration was being immediately suspended as an imminent danger to the public health and safety. The Order to Show Cause and Immediate Suspension of Registration alleged, in sum, that Dr. Brockbank was issuing prescriptions for large amounts of controlled substances to individuals without physical examinations, testing or evaluations consistent with a legitimate doctor-patient relationship. These prescriptions, which included OxyContin and hydrocodone, were not issued for legitimate medical purposes or in the usual course of professional treatment, thus violating 21 CFR 1306.04 and 21 U.S.C. 841(a). It was also alleged that over a six month period in 2004, on six occasions Dr. Brockbank issued prescriptions under such circumstances to local law enforcement officers posing undercover as patients. The Order to Show Cause and Immediate Suspension of Registration alleged that over a 13 month period, Dr. Brockbank prescribed an estimated 690,000 dosage units of controlled substances to patients and that local pharmacies were refusing to fill or drastically reducing the ordered amounts of medication he was prescribing. As a result, individuals were traveling long distances to fill their prescriptions at out-of-area pharmacies. It was also alleged that one individual died of an accidental overdose of Schedule II controlled substances, which had been excessively prescribed by Dr. Brockbank to a friend of the victim and obtained by the decedent while visiting. Finally, it was alleged Dr. Brockbank had sexually assaulted a female patient during a home visit after administering her a Schedule II controlled substance. According to the investigative file, the Order to Show Cause and Immediate Suspension of Registration was personally served on Dr. Brockbank by a DEA Diversion Investigator on October 26, 2004. More than thirty days have passed since service of the Order to Show Cause and Immediate Suspension of Registration and DEA has not received a request for hearing or any other reply from Dr. Brockbank or anyone purporting to represent him in this matter. Therefore, the Deputy Administrator of DEA, finding that
(1)thirty days having passed since the delivery of the Order to Show Cause and Immediate Suspension of Registration to Dr. Brockbank, and
(2)no request for hearing having been received, concludes that Dr. Brockbank is deemed to have waived his hearing right. See *David W. Linder,* 67 FR 12,579 (2002). After considering material from the investigation file in this matter, the Deputy Administrator now enters her final order without a hearing pursuant to 21 CFR 1301.43(d) and
(e)and 1301.46. The Deputy Administrator finds that Dr. Brockbank is currently registered with DEA as a practitioner under DEA Certificate of Registration AB2053027. According to information in the investigative file, on October 18, 2004, Dr. Brockbank entered into a Consent Agreement for Surrender of Active License (Consent Agreement) with the Arizona Medical Board. In that Consent Agreement Dr. Brockbank admitted prescribing narcotic medications to two female patients without obtaining and recording detailed patient and family histories, performing minimum physical examinations or informing the individuals of the risks and benefits of taking the controlled medications. These actions were found to be outside the standard of care for a physician licensed to practice in Arizona. Dr. Brockbank also admitted making “house calls” to two female patients, where he injected them with controlled substances and then made sexual comments and advances toward them. The Arizona Board concluded Dr. Brockbank had engaged in unprofessional conduct under state law and directed him to immediately surrender his license to practice medicine. There is no evidence before the Deputy Administrator that the Consent Agreement has been modified, lifted or stayed or that Dr. Brockbank's Arizona medical license has been renewed or reinstated. Pursuant to 21 U.S.C. 824(a)(3), the Deputy Administrator may revoke a DEA Certificate of Registration if she finds the registrant has had his state license revoked and is no longer authorized to dispense controlled substances in the jurisdiction of registration. Alternatively, revocation is authorized if the registrant has committed such acts as would render his registration contrary to the public interest, as determined by factors listed in 21 U.S.C. 823(f). See *Thomas B. Pelkowski,* D.D.S., 57 FR 28,538 (1992). Nevertheless, despite Dr. Brockbank's egregious prescribing activities, his grossly inappropriate conduct with female patients and the public interest factors that are implemented by such unprofessional and unlawful conduct, his lack of state authorization to handle controlled substances is dispositive of this matter. DEA does not have statutory authority under the Controlled Substances Act to issue or maintain a registration if the applicant or registrant is without state authority to handle controlled substances in the state in which he conducts business. *See* 21 U.S.C. 802(21), 823(f) and 824(a)(3). This prerequisite has been consistently upheld. See *Rory Patrick Doyle, M.D.,* 69 FR 11,655 (2004); *Dominick A. Ricci, M.D.,* 58 FR 51,104 (1993); *Bobby Watts, M.D.,* 53 FR 11,919 (1988). Here, it is clear Dr. Brockbank surrendered his medical license and it is reasonable to infer that he is currently not authorized to handle controlled substances in Arizona and is therefore not entitled to a DEA registration in that state. As a result of the finding that Dr. Brockbank lacks any state authorization to handle controlled substances, the Deputy Administrator concludes it is unnecessary to address further whether his DEA registration should be revoked based upon the public interest grounds asserted in the Order to Show Cause and Immediate Suspension of Registration. *See* Gilbert C. Aragon, Jr., D.O., 69 FR 58,536 (2004); Samuel Silas Jackson, D.D.S., 67 FR 65,145 (2002); Nathaniel-Aikens-Afful, M.D., 62 FR 16,871 (1997); Sam F. Moore, D.V.M., 58 FR 14,428 (1993). Accordingly, the Deputy Administrator of the Drug Enforcement Administration, pursuant to the authority vested in her by 21 U.S.C. 823 and 824 and 28 CFR 0.100(b) and 0.104, hereby orders that DEA Certificate of Registration, AB2053027, issued to Kevin Dean Brockbank, M.D., be, and it hereby is, revoked. The Deputy Administrator further orders that any pending applications for renewal or modification of such registration be, and they hereby are, denied. This order is effective June 26, 2006. Dated: May 5, 2006. Michele M. Leonhart, Deputy Administrator. [FR Doc. 06-4837 Filed 5-24-06; 8:45am]
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