Importer of Controlled Substances; Notice of Registration; Cambrex Charles City, Inc., 4973-4974 [2014-01707]

Download as PDF 4973 mstockstill on DSK4VPTVN1PROD with NOTICES Federal Register / Vol. 79, No. 20 / Thursday, January 30, 2014 / Notices Tapia, M.D., 52 FR 30458, 30459 (1987) (considering evidence that a physician did not perform physical exams and issued medically unnecessary prescriptions under factor two); Thomas Parker Elliott, D.O., 52 FR 36312, 36313 (1987) (adopting ALJ’s conclusion that physician’s ‘‘experience in the handling [of] controlled substances clearly warrants finding that his continued registration is inconsistent with the public interest,’’ based on the physician’s having ‘‘prescribed enormous quantities of highly addictive drugs to [ten] individuals’’ without adequate medical justification). Under agency precedent, ‘‘where a registrant [or applicant] has committed acts inconsistent with the public interest, [he] must accept responsibility for his . . . actions and demonstrate that he . . . will not engage in future misconduct.’’ Jayam Krishna-Iyer, 74 FR 459, 463 (2009); see also Medicine Shoppe-Jonesborough, 73 FR 364, 387 (2008). Here, because Applicant waived his right to a hearing (as well as his right to submit a written statement in lieu of a hearing), GX 4, at 2, the only evidence in the record to refute the conclusion that his continued registration is ‘‘inconsistent with the public interest’’ is that he apparently completed the courses required by the Florida Board of Medicine as evidenced by the fact that his medical license remains current and active. There is, however, no evidence that Applicant acknowledges his misconduct, which is egregious, and accepts responsibility for it. Indeed, the Expert’s report identifies dozens of patients (beyond the seven specifically discussed above) to whom Applicant diverted controlled substances. Accordingly, Applicant’s application will be denied.22 See Krishna-Iyer, 74 FR 464 (‘‘[E]ven where the Agency’s proof establishes that a practitioner has committed only a few acts of diversion, this Agency will not grant [an application for] registration unless he accepts responsibility for his misconduct.’’); see also MacKay v. DEA, 664 F.3d 808, 822 (10th Cir. 2011) (sustaining agency order revoking practitioner’s registration based on proof physician knowingly diverted drugs to two patients). 22 As found above, because Applicant did not submit his renewal application at least 45 days before the expiration of his registration, and had been served previously with the Order to Show Cause, pursuant to 21 CFR 1301.36(i), his registration expired on August 25, 2013. Had his registration not expired per the Agency’s rule, I would have revoked it. VerDate Mar<15>2010 18:24 Jan 29, 2014 Jkt 232001 Order Pursuant to the authority vested in me by 21 U.S.C. 823(f), as well as 28 CFR 0.100(b) and 0.104, I order that the pending application of Ralph J. Chambers, M.D., for a DEA Certificate of Registration be, and it hereby is, denied. This Order is effective immediately. BILLING CODE 4410–09–P DEPARTMENT OF JUSTICE Drug Enforcement Administration Importer of Controlled Substances; Notice of Registration; United States Pharmacopeial Convention By Notice dated September 27, 2013, and published in the Federal Register on October 25, 2013, 78 FR 64014, United States Pharmacopeial Convention, 12601 Twinbrook Parkway, Rockville, Maryland 20852, made application to the Drug Enforcement 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 reference standards for sale to researchers and analytical labs. 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 United States Pharmacopeial Convention 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. DEA has investigated United States Pharmacopeial Convention 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. Fmt 4703 Sfmt 4703 BILLING CODE 4410–09–P Drug Enforcement Administration [FR Doc. 2014–01797 Filed 1–29–14; 8:45 am] Frm 00110 [FR Doc. 2014–01784 Filed 1–29–14; 8:45 am] DEPARTMENT OF JUSTICE Dated: January 17, 2014. Thomas M. Harrigan, Deputy Administrator. PO 00000 Dated: January 15, 2014. Joseph T. Rannazzisi, Deputy Assistant Administrator, Office of Diversion Control, Drug Enforcement Administration. Importer of Controlled Substances; Notice of Registration; Cambrex Charles City, Inc. By Notice dated September 27, 2013, and published in the Federal Register on October 25, 2013, 78 FR 64013, Cambrex Charles City, Inc., 1205 11th Street, Charles City, Iowa 50616–3466, made application by renewal to the Drug Enforcement Administration (DEA) to be registered as an importer of the following basic classes of controlled substances: Drug 4-Anilino-N-phenethyl-4-piperidine (8333). Phenylacetone (8501) .................. Cocaine (9041) ............................. Opium, raw (9600) ....................... Poppy Straw Concentrate (9670) Schedule II II II II II The company plans to import the listed controlled substances for internal use, and to manufacture bulk intermediates for sale to its customers. Comments and requests for hearings on application to import narcotic raw material are not appropriate. 72 FR 3417 (2007). 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 Cambrex Charles City, Inc., to import the basic classes 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. DEA has investigated Cambrex Charles City, 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 E:\FR\FM\30JAN1.SGM 30JAN1 4974 Federal Register / Vol. 79, No. 20 / Thursday, January 30, 2014 / Notices the basic classes of controlled substances listed. DEPARTMENT OF JUSTICE DEPARTMENT OF JUSTICE Dated: January 16, 2014. Joseph T. Rannazzisi, Deputy Assistant Administrator, Office of Diversion Control, Drug Enforcement Administration. Drug Enforcement Administration Drug Enforcement Administration Manufacturer of Controlled Substances; Notice of Registration; Halo Pharmaceutical, Inc. Manufacturer of Controlled Substances; Notice of Registration; Chattem Chemicals, Inc. By Notice dated August 14, 2013, and published in the Federal Register on August 20, 2013, 78 FR 51210, Halo Pharmaceutical, Inc., 30 North Jefferson Road, Whippany, New Jersey 07981, made application by renewal to the Drug Enforcement Administration (DEA) to be registered as a bulk manufacturer of the following basic classes of controlled substances: By Notice dated August 14, 2013, and published in the Federal Register on August 20, 2013, 78 FR 51210, Chattem Chemicals, Inc., 3801 St. Elmo Avenue, Chattanooga, Tennessee 37409, made application by renewal to the Drug Enforcement Administration (DEA) to be registered as a bulk manufacturer of the following basic classes of controlled substances: [FR Doc. 2014–01707 Filed 1–29–14; 8:45 am] BILLING CODE 4410–09–P DEPARTMENT OF JUSTICE Drug Enforcement Administration mstockstill on DSK4VPTVN1PROD with NOTICES Importer of Controlled Substances; Notice of Registration; Clinical Supplies Management, Inc. By Notice dated August 29, 2013, and published in the Federal Register on September 6, 2013, 78 FR 54913, Clinical Supplies Management, Inc., 342 42nd Street South, Fargo, North Dakota 58103, made application by renewal to the Drug Enforcement Administration (DEA) to be registered as an importer of Sufentanil (9740), a basic class of controlled substance listed in schedule II. The company plans to import the listed controlled substance with the sole purpose of packaging, labeling, and distributing to customers which are qualified clinical sites, conducting FDAapproved clinical trials. 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 Clinical Supplies Management, 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. DEA has investigated Clinical Supplies Management, 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. Dated: January 14, 2014. Joseph T. Rannazzisi, Deputy Assistant Administrator, Office of Diversion Control, Drug Enforcement Administration. Drug Drug Dihydromorphine (9145) ............... Hydromorphone (9150) ................ Dated: January 15, 2014. Joseph T. Rannazzisi, Deputy Assistant Administrator, Office of Diversion Control, Drug Enforcement Administration. [FR Doc. 2014–01785 Filed 1–29–14; 8:45 am] BILLING CODE 4410–09–P BILLING CODE 4410–09–P 18:24 Jan 29, 2014 Jkt 232001 I II Dihydromorphine is an intermediate in the manufacture of Hydromorphone and is not for commercial distribution. The company plans to manufacture Hydromorphone for sale to other manufacturers and to manufacture other 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 determined that the registration of Halo Pharmaceutical, Inc., to manufacture the listed basic classes of controlled substances is consistent with the public interest at this time. DEA has investigated Halo Pharmaceutical, 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(a), 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. [FR Doc. 2014–01788 Filed 1–29–14; 8:45 am] VerDate Mar<15>2010 PO 00000 Frm 00111 Fmt 4703 Schedule Schedule Sfmt 4703 Gamma Hydroxybutyric Acid (2010). 4-Methoxyamphetamine (7411) ... Dihydromorphine (9145) ............... Amphetamine (1100) .................... Methamphetamine (1105) ............ Lisdexamfetamine (1205) ............. Methylphenidate (1724) ................ Pentobarbital (2270) ..................... Codeine (9050) ............................. Dihydrocodeine (9120) ................. Oxycodone (9143) ........................ Hydromorphone (9150) ................ Hydrocodone (9193) ..................... Meperidine (9230) ........................ Methadone (9250) ........................ Methadone intermediate (9254) ... Morphine (9300) ........................... Oripavine (9330) ........................... Thebaine (9333) ........................... Opium tincture (9630) .................. Opium, powdered (9639) ............. Opium, granulated (9640) ............ Oxymorphone (9652) ................... Noroxymorphone (9668) .............. Alfentanil (9737) ........................... Remifentanil (9739) ...................... Sufentanil (9740) .......................... Tapentadol (9780) ........................ Fentanyl (9801) ............................ I I I II II II II II II II II II II II II II II II II II II II II II II II II II II The company plans to manufacture the listed controlled substances in bulk for distribution and sale to its customers. Regarding (9640), the company plans to manufacture another controlled substance 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 Chattem Chemicals, Inc., to manufacture the listed basic classes of controlled substances is consistent with the public interest at this time. DEA has investigated Chattem Chemicals, 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 E:\FR\FM\30JAN1.SGM 30JAN1

Agencies

[Federal Register Volume 79, Number 20 (Thursday, January 30, 2014)]
[Notices]
[Pages 4973-4974]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-01707]


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DEPARTMENT OF JUSTICE

Drug Enforcement Administration


Importer of Controlled Substances; Notice of Registration; 
Cambrex Charles City, Inc.

    By Notice dated September 27, 2013, and published in the Federal 
Register on October 25, 2013, 78 FR 64013, Cambrex Charles City, Inc., 
1205 11th Street, Charles City, Iowa 50616-3466, made application by 
renewal to the Drug Enforcement Administration (DEA) to be registered 
as an importer of the following basic classes of controlled substances:

------------------------------------------------------------------------
                    Drug                               Schedule
------------------------------------------------------------------------
4-Anilino-N-phenethyl-4-piperidine (8333)..  II
Phenylacetone (8501).......................  II
Cocaine (9041).............................  II
Opium, raw (9600)..........................  II
Poppy Straw Concentrate (9670).............  II
------------------------------------------------------------------------

    The company plans to import the listed controlled substances for 
internal use, and to manufacture bulk intermediates for sale to its 
customers.
    Comments and requests for hearings on application to import 
narcotic raw material are not appropriate. 72 FR 3417 (2007).
    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 Cambrex Charles City, Inc., to import the basic classes 
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. DEA has 
investigated Cambrex Charles City, 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

[[Page 4974]]

the basic classes of controlled substances listed.

    Dated: January 16, 2014.
Joseph T. Rannazzisi,
Deputy Assistant Administrator, Office of Diversion Control, Drug 
Enforcement Administration.
[FR Doc. 2014-01707 Filed 1-29-14; 8:45 am]
BILLING CODE 4410-09-P