Importer of Controlled Substances; Notice of Application; Meridian Medical Technologies, 23374 [2014-09571]

Download as PDF 23374 Federal Register / Vol. 79, No. 81 / Monday, April 28, 2014 / Notices tkelley on DSK3SPTVN1PROD with NOTICES The company plans to import small quantities of the listed controlled substances in dosage form to conduct clinical trials. The import of the above listed basic classes of controlled substances will be granted only for analytical testing and clinical trials. This authorization does not extend to the import of finished FDA approved or non-approved dosage forms for commercial distribution in the United States. Any bulk manufacturer who is presently, or is applying to be, registered with the DEA to manufacture such basic classes of controlled substances listed in schedule II, which falls 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 (ODW), 8701 Morrissette Drive, Springfield, Virginia 22152; and must be filed no later than May 28, 2014. 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 schedules 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: April 21, 2014. Joseph T. Rannazzisi, Deputy Assistant Administrator, Office of Diversion Control, Drug Enforcement Administration. [FR Doc. 2014–09567 Filed 4–25–14; 8:45 am] BILLING CODE 4410–09–P VerDate Mar<15>2010 17:06 Apr 25, 2014 Jkt 232001 DEPARTMENT OF JUSTICE Drug Enforcement Administration Importer of Controlled Substances; Notice of Application; Meridian Medical Technologies Pursuant to 21 CFR 1301.34(a), this is notice that on January 3, 2014, Meridian Medical Technologies, 2555 Hermelin Drive, St. Louis, Missouri 63144, made application by renewal to the Drug Enforcement Administration (DEA) for registration as an importer of Morphine (9300), a basic class of controlled substance listed in schedule II. The company manufactures a product containing morphine in the United States. The company exports this product to customers around the world. The company has been asked to ensure that its product, which is sold to European customers, meets the standards established by the European Pharmacopeia, administered by the Directorate for the Quality of Medicines (EDQM). In order to ensure that its product will meet European specifications, the company seeks to import morphine supplied by EDQM for use as reference standards. This is the sole purpose for which the company will be authorized by the DEA to import morphine. Any bulk manufacturer who is presently, or is applying to be, registered with the DEA to manufacture such basic class of controlled substance listed in schedules 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 (ODW), 8701 Morrissette Drive, Springfield, Virginia 22152; and must be filed no later than May 28, 2014. 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 schedules I or II are, and will continue to be, required to demonstrate to the Deputy PO 00000 Frm 00058 Fmt 4703 Sfmt 4703 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: April 21, 2014. Joseph T. Rannazzisi, Deputy Assistant Administrator, Office of Diversion Control, Drug Enforcement Administration. [FR Doc. 2014–09571 Filed 4–25–14; 8:45 am] BILLING CODE 4410–09–P DEPARTMENT OF JUSTICE Drug Enforcement Administration Importer of Controlled Substances; Notice of Registration; S & B Pharma, Inc. By Notice dated January 15, 2014, and published in the Federal Register on February 4, 2014, 79 FR 6630, S & B Pharma, Inc., DBA Norac Pharma, 405 S. Motor Avenue, Azusa, California 91702–3232, made application 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). Tapentadol (9780) ........................ Schedule II II The company plans to import the listed controlled substances for internal use, and to manufacture bulk intermediates for sale to its customers. On February 10, 2014, S & B Pharma, Inc., withdrew its request for the addition of Fentanyl (9801) to this registration. No comments or objections have been received. The DEA has considered the factors in 21 U.S.C. 823(a) and 952(a), and determined that the registration of S & B Pharma, Inc. to import the basic classes of controlled substances is consistent with the public interest and in accordance with United States obligations under international treaties, conventions, or protocols in effect on May 1, 1971. The DEA has investigated S & B 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. E:\FR\FM\28APN1.SGM 28APN1

Agencies

[Federal Register Volume 79, Number 81 (Monday, April 28, 2014)]
[Notices]
[Page 23374]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-09571]


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

DEPARTMENT OF JUSTICE

Drug Enforcement Administration


Importer of Controlled Substances; Notice of Application; 
Meridian Medical Technologies

    Pursuant to 21 CFR 1301.34(a), this is notice that on January 3, 
2014, Meridian Medical Technologies, 2555 Hermelin Drive, St. Louis, 
Missouri 63144, made application by renewal to the Drug Enforcement 
Administration (DEA) for registration as an importer of Morphine 
(9300), a basic class of controlled substance listed in schedule II.
    The company manufactures a product containing morphine in the 
United States. The company exports this product to customers around the 
world. The company has been asked to ensure that its product, which is 
sold to European customers, meets the standards established by the 
European Pharmacopeia, administered by the Directorate for the Quality 
of Medicines (EDQM). In order to ensure that its product will meet 
European specifications, the company seeks to import morphine supplied 
by EDQM for use as reference standards.
    This is the sole purpose for which the company will be authorized 
by the DEA to import morphine.
    Any bulk manufacturer who is presently, or is applying to be, 
registered with the DEA to manufacture such basic class of controlled 
substance listed in schedules 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 (ODW), 8701 
Morrissette Drive, Springfield, Virginia 22152; and must be filed no 
later than May 28, 2014.
    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 
schedules 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: April 21, 2014.
Joseph T. Rannazzisi,
Deputy Assistant Administrator, Office of Diversion Control, Drug 
Enforcement Administration.
[FR Doc. 2014-09571 Filed 4-25-14; 8:45 am]
BILLING CODE 4410-09-P

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