Manufacturer of Controlled Substances; Notice of Registration; Morton Grove Pharmaceuticals, 52802 [2013-20761]

Download as PDF 52802 Federal Register / Vol. 78, No. 165 / Monday, August 26, 2013 / Notices Dated: August 20, 2013. Joseph T. Rannazzisi, Deputy Assistant Administrator, Office of Diversion Control, Drug Enforcement Administration. [FR Doc. 2013–20724 Filed 8–23–13; 8:45 am] BILLING CODE 4410–09–P DEPARTMENT OF JUSTICE Drug Enforcement Administration Manufacturer of Controlled Substances; Notice of Application; Cambridge Isotope Lab Pursuant to § 1301.33(a), Title 21 of the Code of Federal Regulations (CFR), this is notice that on July 01, 2013, Cambridge Isotope Lab, 50 Frontage Road, Andover, Massachusetts 01810, made application by renewal to the Drug Enforcement Administration (DEA) to be registered as a bulk manufacturer of Morphine (9300), a basic class of controlled substance listed in schedule II. The company plans to utilize small quantities of the listed controlled substance in the preparation of analytical standards. Any other such applicant, and any person who is presently registered with DEA to manufacture such a substance, 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 October 25, 2013. Dated: August 15, 2013. Joseph T. Rannazzisi, Deputy Assistant Administrator, Office of Diversion Control, Drug Enforcement Administration. [FR Doc. 2013–20723 Filed 8–23–13; 8:45 am] BILLING CODE 4410–09–P DEPARTMENT OF JUSTICE Drug Enforcement Administration ehiers on DSK2VPTVN1PROD with NOTICES Manufacturer of Controlled Substances; Notice of Registration; Morton Grove Pharmaceuticals By Notice dated March 12, 2013, and published in the Federal Register on March 20, 2013, 78 FR 17231, Morton Grove Pharmaceuticals, 6451 Main Street, Morton Grove, Illinois 60053– 2633, made application by renewal to the Drug Enforcement Administration VerDate Mar<15>2010 13:45 Aug 23, 2013 Jkt 229001 (DEA) to be registered as a bulk manufacturer of Gamma Hydroxybutyric Acid (2010), a basic class of controlled substance listed in schedule I. The company plans to manufacture the listed controlled substance 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 Morton Grove Pharmaceuticals to manufacture the listed basic class of controlled substance is consistent with the public interest at this time. DEA has investigated Morton Grove Pharmaceuticals 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 class of controlled substance listed. Dated: August 15, 2013. Joseph T. Rannazzisi, Deputy Assistant Administrator, Office of Diversion Control, Drug Enforcement Administration. [FR Doc. 2013–20761 Filed 8–23–13; 8:45 am] 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 Navinta, LLC., to manufacture the listed basic classes of controlled substances is consistent with the public interest at this time. DEA has investigated Navinta, 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 the basic classes of controlled substances listed. Dated: August 15, 2013. Joseph T. Rannazzisi, Deputy Assistant Administrator, Office of Diversion Control, Drug Enforcement Administration. [FR Doc. 2013–20757 Filed 8–23–13; 8:45 am] BILLING CODE 4410–09–P DEPARTMENT OF JUSTICE Drug Enforcement Administration Tin T. Win, M.D., Dismissal of Proceeding BILLING CODE 4410–09–P On February 27, 2013, I, the Administrator of the Drug Enforcement Administration, issued an Order to DEPARTMENT OF JUSTICE Show Cause and Immediate Suspension of Registration to Tin T. Win, M.D. Drug Enforcement Administration (hereinafter, Registrant), of Lake Havasu, Arizona. GX 10, at 1. Among various Manufacturer of Controlled charges, the Order alleged that Substances; Notice of Registration: Registrant issued numerous controlled Navinta, LLC substance prescriptions after the By Notice dated April 10, 2013, and Arizona Medical Board had prohibited published in the Federal Register on her ‘‘from prescribing controlled April 19, 2013, 78 FR 23596, Navinta, substances’’ and thus violated both the LLC., 1499 Lower Ferry Road, Ewing, Board’s order and federal law. Id. at 1– New Jersey 08618–1414, made 3 (citing Ariz. Rev. Stat. § 32– application to the Drug Enforcement 1401(27)(r); 21 U.S.C. 841). The Order Administration (DEA) to be registered as also notified Registrant of her right to a bulk manufacturer of the following either request a hearing on the basic classes of controlled substances: allegations or submit a written statement of position in lieu of a hearing Drug Schedule within thirty (30) days of her receipt of Pentobarbital (2270) ..................... II the Order, the procedure for electing Remifentanil (9739) ...................... II either option, and the consequence of failing to elect either option. The company plans initially to On March 6, 2013, the Order was manufacture API quantities of the listed personally served on Registrant by a controlled substances for validation DEA Special Agent and a Diversion purposes and FDA approval, then to Investigator. See GX 11. On May 20, produce commercial size batches for 2013, the Government filed a Request distribution to dosage form for Final Agency Action, which sought manufacturers upon FDA approval. the revocation of Registrant’s PO 00000 Frm 00045 Fmt 4703 Sfmt 4703 E:\FR\FM\26AUN1.SGM 26AUN1

Agencies

[Federal Register Volume 78, Number 165 (Monday, August 26, 2013)]
[Notices]
[Page 52802]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-20761]


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DEPARTMENT OF JUSTICE

Drug Enforcement Administration


Manufacturer of Controlled Substances; Notice of Registration; 
Morton Grove Pharmaceuticals

    By Notice dated March 12, 2013, and published in the Federal 
Register on March 20, 2013, 78 FR 17231, Morton Grove Pharmaceuticals, 
6451 Main Street, Morton Grove, Illinois 60053-2633, made application 
by renewal to the Drug Enforcement Administration (DEA) to be 
registered as a bulk manufacturer of Gamma Hydroxybutyric Acid (2010), 
a basic class of controlled substance listed in schedule I.
    The company plans to manufacture the listed controlled substance 
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 Morton Grove Pharmaceuticals to manufacture the listed basic class 
of controlled substance is consistent with the public interest at this 
time. DEA has investigated Morton Grove Pharmaceuticals 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 class of controlled substance listed.

    Dated: August 15, 2013.
 Joseph T. Rannazzisi,
Deputy Assistant Administrator, Office of Diversion Control, Drug 
Enforcement Administration.
[FR Doc. 2013-20761 Filed 8-23-13; 8:45 am]
BILLING CODE 4410-09-P