Manufacturer of Controlled Substances; Notice of Application, 23627 [2011-10139]

Download as PDF 23627 Federal Register / Vol. 76, No. 81 / Wednesday, April 27, 2011 / Notices Drug Schedule Ecgonine (9180) .......................................................................................................................................................................................... Ethylmorphine (9190) .................................................................................................................................................................................. Hydrocodone (9193) .................................................................................................................................................................................... Levorphanol (9220) ..................................................................................................................................................................................... Meperidine (9230) ....................................................................................................................................................................................... Methadone (9250) ....................................................................................................................................................................................... Morphine (9300) .......................................................................................................................................................................................... Thebaine (9333) .......................................................................................................................................................................................... Opium, powdered (9639) ............................................................................................................................................................................. Levo-alphacetylmethadol (9648) ................................................................................................................................................................. Oxymorphone (9652) ................................................................................................................................................................................... Fentanyl (9801) ........................................................................................................................................................................................... The company plans to import the listed controlled substances for sale to research facilities for drug testing and analysis. 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 Sigma Aldrich Manufacturing LLC. 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, at this time. DEA has investigated Sigma Aldrich Manufacturing 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 classes of controlled substances listed. By Notice dated October 6, 2010, and published in the Federal Register on October 14, 2010, 75 FR 63203, PCASNanosyn, LLC, 3331–B Industrial Drive, Santa Rosa, California 95403, made application to the Drug Enforcement Administration (DEA) to be registered as a bulk manufacturer of the following basic classes of controlled substances: DEPARTMENT OF JUSTICE Drug Enforcement Administration WReier-Aviles on DSKGBLS3C1PROD with NOTICES BILLING CODE 4410–09–P Manufacturer of Controlled Substances; Notice of Registration BILLING CODE 4410–09–P Manufacturer of Controlled Substances; Notice of Application Pursuant to § 1301.33(a) Title 21 of the Code of Federal Regulations (CFR), this is notice that on March 31, 2011, Cedarburg Pharmaceuticals, Inc., 870 Badger Circle, Grafton, Wisconsin 53024, made application by letter to the Drug Enforcement Administration Jkt 223001 [FR Doc. 2011–10139 Filed 4–26–11; 8:45 am] Drug Enforcement Administration [FR Doc. 2011–10145 Filed 4–26–11; 8:45 am] 15:36 Apr 26, 2011 Dated: April 15, 2011. Joseph T. Rannazzisi, Deputy Assistant Administrator, Office of Diversion Control, Drug Enforcement Administration. DEPARTMENT OF JUSTICE Dated: April 15, 2011. Joseph T. Rannazzisi, Deputy Assistant Administrator, Office of Diversion Control, Drug Enforcement Administration. VerDate Mar<15>2010 (DEA) to be registered as a bulk manufacturer of 4-Anilino-N-phenethyl4-Piperidine (8333), a basic class of controlled substance listed in schedule II. The company plans to use this controlled substance in the manufacture of another controlled substance. Any other such applicant, and any person who is presently registered with DEA to manufacture such substances, 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 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 27, 2011. Drug Schedule Amphetamine (1100) .................... Methamphetamine (1105) ............ Methylphenidate (1724) ................ Phencyclidine (7471) .................... Codeine (9050) ............................. PO 00000 Frm 00092 Fmt 4703 Sfmt 4703 II II II II II Drug Diprenorphine (9058) ................... Oxycodone (9143) ........................ Hydromorphone (9150) ................ Hydrocodone (9193) ..................... Methadone (9250) ........................ Morphine (9300) ........................... Oxymorphone (9652) ................... Fentanyl (9801) ............................ II II II II II II II II II II II II Schedule II II II II II II II II The company is a contract manufacturer. At the request of the company’s customers, it manufactures derivatives of controlled substances in bulk form only. The primary service provided by the company to its customers is the development of the process of manufacturing the derivative. As part of its service to its customers, the company distributes the derivatives of the controlled substances it manufactures to those customers. The company’s customers use the newlycreated processes and the manufactured derivatives in furtherance of formulation processes and dosage form manufacturing; pre-clinical studies, including toxicological studies; clinical studies supporting investigational Drug Applications; and use in stability studies. 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 PCAS-Nanosyn, LLC to manufacture the listed basic classes of controlled substances is consistent with the public interest at this time. DEA has investigated PCAS-Nanosyn, 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. 823(a), and in accordance with 21 CFR 1301.33, the above named company is granted registration as a bulk manufacturer of E:\FR\FM\27APN1.SGM 27APN1

Agencies

[Federal Register Volume 76, Number 81 (Wednesday, April 27, 2011)]
[Notices]
[Page 23627]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-10139]


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DEPARTMENT OF JUSTICE

Drug Enforcement Administration


Manufacturer of Controlled Substances; Notice of Application

    Pursuant to Sec.  1301.33(a) Title 21 of the Code of Federal 
Regulations (CFR), this is notice that on March 31, 2011, Cedarburg 
Pharmaceuticals, Inc., 870 Badger Circle, Grafton, Wisconsin 53024, 
made application by letter to the Drug Enforcement Administration (DEA) 
to be registered as a bulk manufacturer of 4-Anilino-N-phenethyl-4-
Piperidine (8333), a basic class of controlled substance listed in 
schedule II.
    The company plans to use this controlled substance in the 
manufacture of another controlled substance.
    Any other such applicant, and any person who is presently 
registered with DEA to manufacture such substances, 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 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 27, 2011.

    Dated: April 15, 2011.
Joseph T. Rannazzisi,
Deputy Assistant Administrator, Office of Diversion Control, Drug 
Enforcement Administration.
[FR Doc. 2011-10139 Filed 4-26-11; 8:45 am]
BILLING CODE 4410-09-P

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