Importer of Controlled Substances; Notice of Registration; Capricorn Pharma, Inc., 31388 [2012-12824]

Download as PDF 31388 Federal Register / Vol. 77, No. 102 / Friday, May 25, 2012 / Notices Control, Federal Register Representative (ODL), 8701 Morrissette Drive, Springfield, Virginia 22152; and must be filed no later than June 25, 2012. 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 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: May 15, 2012. Joseph T. Rannazzisi, Deputy Assistant Administrator, Office of Diversion Control, Drug Enforcement Administration. [FR Doc. 2012–12828 Filed 5–24–12; 8:45 am] BILLING CODE 4410–09–P DEPARTMENT OF JUSTICE Drug Enforcement Administration Importer of Controlled Substances; Notice of Application; Noramco, Inc. Pursuant to Title 21 Code of Federal Regulations § 1301.34(a), this is notice that on August 18, 2011, Noramco, Inc., 500 Swedes Landing Road, Wilmington, Delaware 19801–4417, made application by renewal to the Drug Enforcement Administration (DEA) for registration as an importer of the following basic classes of controlled substances: Drug mstockstill on DSK4VPTVN1PROD with NOTICES [FR Doc. 2012–12825 Filed 5–24–12; 8:45 am] II II II II BILLING CODE P Jkt 226001 The company plans to import the listed controlled substance in finished dosage form (FDF) from foreign sources for analytical testing and clinical trials in which the foreign FDF will be compared to the company’s own domestically manufactured FDF. This analysis is required to allow the company to export domestically manufactured FDF to foreign markets. In reference to the import of Fentanyl (9801), the authorization for the import of this basic class of controlled substance is granted only for analytical testing and clinical trials. This authorization does not extend to the import of a finished FDA approved or non-approved dosage form for commercial distribution in the United States. 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 Capricorn Pharma, 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 Capricorn Pharma, 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: May 15, 2012. Joseph T. Rannazzisi, Deputy Assistant Administrator, Office of Diversion Control, Drug Enforcement Administration. [FR Doc. 2012–12824 Filed 5–24–12; 8:45 am] DEPARTMENT OF JUSTICE The company plans to import the raw Opium (9600) and Poppy Straw Concentrate (9670) to manufacture other controlled substances. The company plans to import Tapentadol (9780) in intermediate form for the bulk manufacture of Tapentadol (9780) which it will distribute to its customers. The company plans to import the Phenylacetone (8501) in bulk for the manufacture of a controlled substance. Comments and requests for hearings on applications to import narcotic raw material are not appropriate. 72 FR 3417 (2007). 17:55 May 24, 2012 Dated: May 15, 2012. Joseph T. Rannazzisi, Deputy Assistant Administrator, Office of Diversion Control, Drug Enforcement Administration. Schedule Phenylacetone (8501) .................. Opium, raw (9600) ....................... Poppy Straw Concentrate (9670) Tapentadol (9780) ........................ VerDate Mar<15>2010 In regard to the non-narcotic raw material, any bulk manufacturer who is presently, or is applying to be, registered with DEA to manufacture such basic classes of controlled substances listed in schedule I or II, which fall under the authority of section 1002(a)(2)(B) of the Act (21 U.S.C. 952(a)(2)(B)) may, in the circumstances set forth in 21 U.S.C. 958(i), 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 should be addressed, in quintuplicate, to the Drug Enforcement Administration, Office of Diversion Control, Federal Register Representative (ODL), 8701 Morrissette Drive, Springfield, Virginia 22152; and must be filed no later than June 25, 2012. 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 substances 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. BILLING CODE 4410–09–P Drug Enforcement Administration Importer of Controlled Substances; Notice of Registration; Capricorn Pharma, Inc. By Notice dated March 8, 2012, and published in the Federal Register on March 20, 2012, 77 FR 16262, Capricorn Pharma, Inc., 6900 English Muffin Way, Unit A, Frederick, Maryland 21703, made application to the Drug Enforcement Administration (DEA) to be registered as an importer of Fentanyl (9801), a basic class of controlled substance listed in schedule II. PO 00000 Frm 00099 Fmt 4703 Sfmt 4703 DEPARTMENT OF JUSTICE Drug Enforcement Administration Importer of Controlled Substances; Notice of Registration; Meridian Medical Technologies By Notice dated March 23, 2012, and published in the Federal Register on April 2, 2012, 77 FR 19716, Meridian Medical Technologies, 2555 Hermelin Drive, St. Louis, Missouri 63144, made application by renewal to the Drug Enforcement Administration (DEA) to E:\FR\FM\25MYN1.SGM 25MYN1

Agencies

[Federal Register Volume 77, Number 102 (Friday, May 25, 2012)]
[Notices]
[Page 31388]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-12824]


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

DEPARTMENT OF JUSTICE

Drug Enforcement Administration


Importer of Controlled Substances; Notice of Registration; 
Capricorn Pharma, Inc.

    By Notice dated March 8, 2012, and published in the Federal 
Register on March 20, 2012, 77 FR 16262, Capricorn Pharma, Inc., 6900 
English Muffin Way, Unit A, Frederick, Maryland 21703, made application 
to the Drug Enforcement Administration (DEA) to be registered as an 
importer of Fentanyl (9801), a basic class of controlled substance 
listed in schedule II.
    The company plans to import the listed controlled substance in 
finished dosage form (FDF) from foreign sources for analytical testing 
and clinical trials in which the foreign FDF will be compared to the 
company's own domestically manufactured FDF. This analysis is required 
to allow the company to export domestically manufactured FDF to foreign 
markets.
    In reference to the import of Fentanyl (9801), the authorization 
for the import of this basic class of controlled substance is granted 
only for analytical testing and clinical trials. This authorization 
does not extend to the import of a finished FDA approved or non-
approved dosage form for commercial distribution in the United States.
    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 Capricorn Pharma, 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 Capricorn 
Pharma, 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: May 15, 2012.
Joseph T. Rannazzisi,
Deputy Assistant Administrator, Office of Diversion Control, Drug 
Enforcement Administration.
[FR Doc. 2012-12824 Filed 5-24-12; 8:45 am]
BILLING CODE 4410-09-P

This site is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply.