Manufacturer of Controlled Substances; Notice of Registration, 4054 [E9-1196]

Download as PDF 4054 Federal Register / Vol. 74, No. 13 / Thursday, January 22, 2009 / Notices $16.00 (25 cents per page reproduction cost) payable to the U.S. Treasury or, if by e-mail or fax, forward a check in that amount to the Consent Decree Library at the stated address. Ronald Gluck, Assistant Chief, Environmental Enforcement Section, Environment and Natural Resources Division. [FR Doc. E9–1155 Filed 1–21–09; 8:45 am] BILLING CODE 4410–15–P DEPARTMENT OF JUSTICE Drug Enforcement Administration rmajette on PRODPC74 with NOTICES 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) 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 Title 21 Code of Federal Regulations (CFR), 1301.34(a), this is notice that on September 18, 2008, ISP Freetown Fine Chemicals, 238 South Main Street, Assonet, Massachusetts 02702, made application by renewal to the Drug Enforcement Administration (DEA) to be registered as an importer of Phenylacetone (8501), a basic class of controlled substance listed in schedule II. The company plans to import the Phenylacetone to manufacture Amphetamine. 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 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 February 23, 2009. 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 VerDate Nov<24>2008 14:47 Jan 21, 2009 Jkt 217001 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. Dated: January 14, 2009. Joseph T. Rannazzisi, Deputy Assistant Administrator, Office of Diversion Control, Drug Enforcement Administration. [FR Doc. E9–1198 Filed 1–21–09; 8:45 am] BILLING CODE 4410–09–P DEPARTMENT OF JUSTICE Drug Enforcement Administration Manufacturer of Controlled Substances; Notice of Registration By Notice dated October 9, 2008 and published in the Federal Register on October 17, 2008 (73 FR 61909), Noramco Inc., Division of Ortho McNeil, Inc., 500 Swedes Landing Road, Wilmington, Delaware 19801–4417, 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 schedules I and II: Drug Schedule Codeine-N-oxide (9053) ............... Dihydromorphine (9145) ............... Morphine-N-oxide (9307) ............. Methylphenidate (1724) ................ Codeine (9050) ............................. Dihydrocodeine (9120) ................. Oxycodone (9143) ........................ Hydromorphone (9150) ................ Hydrocodone (9193) ..................... Morphine (9300) ........................... Thebaine (9333) ........................... Opium extracts (9610) .................. Opium fluid extract (9620) ............ Opium tincture (9630) .................. Opium, powdered (9639) ............. Opium, granulated (9640) ............ Oxymorphone (9652) ................... I I I II II II II II II II II II II II II II II The company plans to bulk manufacture the above listed controlled substances for sale and distribution to manufacturers for product development and formulation. Drug code 1726 (methylphenidate) has been withdrawn from the application for registration as all PO 00000 Frm 00074 Fmt 4703 Sfmt 4703 manufacturing activity for methylphenidate can be conducted under drug code 1724 for the same substance. 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 Noramco Inc. to manufacture the listed basic classes of controlled substances is consistent with the public interest at this time. DEA has investigated Noramco 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: January 14, 2009. Joseph T. Rannazzisi, Deputy Assistant Administrator, Office of Diversion Control, Drug Enforcement Administration. [FR Doc. E9–1196 Filed 1–21–09; 8:45 am] BILLING CODE 4410–09–P DEPARTMENT OF JUSTICE Drug Enforcement Administration Manufacturer of Controlled Substances; Notice of Registration By Notice dated September 8, 2008, and published in the Federal Register on September 15, 2008 (73 FR 53280), Chattem Chemicals Inc., 3801 St. Elmo Avenue, Building 18, Chattanooga, Tennessee 37409, 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 schedules I and II: Drug 4-Methoxyamphetamine (7411) ... Dihydromorphine (9145) ............... Difenoxin (9168) ........................... Amphetamine (1100) .................... Methamphetamine (1105) ............ Lisdexamfetamine (1205) ............. Methylphenidate (1724) ................ Pentobarbital (2270) ..................... Codeine (9050) ............................. Dihydrocodeine (9120) ................. Oxycodone (9143) ........................ Hydromorphone (9150) ................ Hydrocodone (9193) ..................... Meperidine (9230) ........................ E:\FR\FM\22JAN1.SGM 22JAN1 Schedule I I I II II II II II II II II II II II

Agencies

[Federal Register Volume 74, Number 13 (Thursday, January 22, 2009)]
[Notices]
[Page 4054]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E9-1196]


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

DEPARTMENT OF JUSTICE

Drug Enforcement Administration


Manufacturer of Controlled Substances; Notice of Registration

    By Notice dated October 9, 2008 and published in the Federal 
Register on October 17, 2008 (73 FR 61909), Noramco Inc., Division of 
Ortho McNeil, Inc., 500 Swedes Landing Road, Wilmington, Delaware 
19801-4417, 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 schedules I and II:

------------------------------------------------------------------------
                    Drug                               Schedule
------------------------------------------------------------------------
Codeine-N-oxide (9053).....................  I
Dihydromorphine (9145).....................  I
Morphine-N-oxide (9307)....................  I
Methylphenidate (1724).....................  II
Codeine (9050).............................  II
Dihydrocodeine (9120)......................  II
Oxycodone (9143)...........................  II
Hydromorphone (9150).......................  II
Hydrocodone (9193).........................  II
Morphine (9300)............................  II
Thebaine (9333)............................  II
Opium extracts (9610)......................  II
Opium fluid extract (9620).................  II
Opium tincture (9630)......................  II
Opium, powdered (9639).....................  II
Opium, granulated (9640)...................  II
Oxymorphone (9652).........................  II
------------------------------------------------------------------------

    The company plans to bulk manufacture the above listed controlled 
substances for sale and distribution to manufacturers for product 
development and formulation.
    Drug code 1726 (methylphenidate) has been withdrawn from the 
application for registration as all manufacturing activity for 
methylphenidate can be conducted under drug code 1724 for the same 
substance.
    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 
Noramco Inc. to manufacture the listed basic classes of controlled 
substances is consistent with the public interest at this time. DEA has 
investigated Noramco 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: January 14, 2009.
Joseph T. Rannazzisi,
Deputy Assistant Administrator, Office of Diversion Control, Drug 
Enforcement Administration.
[FR Doc. E9-1196 Filed 1-21-09; 8:45 am]
BILLING CODE 4410-09-P
This site is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply.