Manufacturer of Controlled Substances Registration: Mallinckrodt, LLC, 42545 [2015-17523]

Download as PDF 42545 Federal Register / Vol. 80, No. 137 / Friday, July 17, 2015 / Notices The company plans to import the FDA approved drug product in finished dosage form for distribution to its customers. Tapentadol (9780) ........................ Dated: July 10, 2015. Joseph T. Rannazzisi, Deputy Assistant Administrator. The company plans to manufacturer bulk active pharmaceutical ingredients (API) for distribution and product development to its customers. [FR Doc. 2015–17514 Filed 7–16–15; 8:45 am] Controlled substance Schedule II Dated: July 10, 2015. Joseph T. Rannazzisi, Deputy Assistant Administrator. BILLING CODE 4410–09–P DEPARTMENT OF JUSTICE [FR Doc. 2015–17523 Filed 7–16–15; 8:45 am] Drug Enforcement Administration BILLING CODE 4410–09–P DEPARTMENT OF JUSTICE Manufacturer of Controlled Substances Registration: Mallinckrodt, LLC Notice of registration. Mallinckrodt, LLC applied to be registered as a manufacturer of certain basic classes of controlled substances. The Drug Enforcement Administration (DEA) grants Mallinckrodt, LLC registration as a manufacturer of those controlled substances. SUPPLEMENTARY INFORMATION: By notice dated January 21, 2015, and published in the Federal Register on January 28, 2015, 80 FR 4592, Mallinckrodt LLC, 3600 North Second Street, St. Louis, Missouri 63147 applied to be registered as a manufacturer of certain basic classes of controlled substances. No comments or objections were submitted to this notice. The DEA has considered the factors in 21 U.S.C. 823(a) and determined that the registration of Mallinckrodt, LLC to manufacture 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. The DEA investigated the company’s maintenance of effective controls against diversion by inspecting and testing the company’s physical security systems, verifying the company’s compliance with state and local laws, and reviewing 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 following basic classes of controlled substances: srobinson on DSK5SPTVN1PROD with NOTICES SUMMARY: Controlled substance Schedule Gamma Hydroxybutyric Acid (2010). Lisdexamfetamine (1205) ............. Oripavine (9330) ........................... VerDate Sep<11>2014 20:59 Jul 16, 2015 Remifentanil (9739) ...................... Schedule II The company plans to initially manufacture API quantities of the listed controlled substances for validation purposes and FDA approval, and then produce commercial size batches for distribution to dosage form manufacturers upon FDA approval. Dated: July 10, 2015. Joseph T. Rannazzisi, Deputy Assistant Administrator. [FR Doc. 2015–17525 Filed 7–16–15; 8:45 am] [Docket No. DEA–392] ACTION: Controlled substance BILLING CODE 4410–09–P Drug Enforcement Administration [Docket No. DEA–392] DEPARTMENT OF JUSTICE Manufacturer of Controlled Substances Registration: Navinta LLC Drug Enforcement Administration ACTION: Notice of registration. Navinta LLC applied to be registered as a manufacturer of certain basic classes of controlled substances. The Drug Enforcement Administration (DEA) grants Navinta LLC registration as a manufacturer of those controlled substances. SUMMARY: By notice dated February 11, 2015, and published in the Federal Register on February 19, 2015, 80 FR 8901, Navinta LLC, 1499 Lower Ferry Road, Ewing, New Jersey 08618–1414 applied to be registered as a manufacturer of certain basic classes of controlled substances. No comments or objections were submitted for this notice. The DEA has considered the factors in 21 U.S.C. 823(a) and determined that the registration of Navinta LLC to manufacture 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. The DEA investigated the company’s maintenance of effective controls against diversion by inspecting and testing the company’s physical security systems, verifying the company’s compliance with state and local laws, and reviewing 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: SUPPLEMENTARY INFORMATION: I Controlled substance II II Jkt 235001 Pentobarbital (2270) ..................... PO 00000 Frm 00079 Fmt 4703 Sfmt 4703 Schedule II [Docket No. DEA–392] Importer of Controlled Substances Registration: Siegfried USA, LLC ACTION: Notice of registration. Siegfried USA, LLC applied to be registered as an importer of certain basic classes of controlled substances. The Drug Enforcement Administration (DEA) grants Siegfried USA, LLC registration as an importer of those controlled substances. SUPPLEMENTARY INFORMATION: By notice dated April 14, 2015, and published in the Federal Register on April 22, 2015, 80 FR 22561, Siegfried USA, LLC, 33 Industrial Park Road, Pennsville, New Jersey 08070 applied to be registered as an importer of certain basic classes of controlled substances. Comments and requests for hearings on applications to import narcotic raw material are not appropriate. 72 FR 3417 (January 25, 2007). The DEA has considered the factors in 21 U.S.C. 823, 952(a) and 958(a) and determined that the registration of Siegfried USA, 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. The DEA investigated the company’s maintenance of effective controls against diversion by inspecting and testing the company’s physical security systems, verifying the company’s compliance with state and local laws, and reviewing 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 SUMMARY: E:\FR\FM\17JYN1.SGM 17JYN1

Agencies

[Federal Register Volume 80, Number 137 (Friday, July 17, 2015)]
[Notices]
[Page 42545]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-17523]


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DEPARTMENT OF JUSTICE

Drug Enforcement Administration

[Docket No. DEA-392]


Manufacturer of Controlled Substances Registration: Mallinckrodt, 
LLC

ACTION: Notice of registration.

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SUMMARY: Mallinckrodt, LLC applied to be registered as a manufacturer 
of certain basic classes of controlled substances. The Drug Enforcement 
Administration (DEA) grants Mallinckrodt, LLC registration as a 
manufacturer of those controlled substances.

SUPPLEMENTARY INFORMATION: By notice dated January 21, 2015, and 
published in the Federal Register on January 28, 2015, 80 FR 4592, 
Mallinckrodt LLC, 3600 North Second Street, St. Louis, Missouri 63147 
applied to be registered as a manufacturer of certain basic classes of 
controlled substances. No comments or objections were submitted to this 
notice.
    The DEA has considered the factors in 21 U.S.C. 823(a) and 
determined that the registration of Mallinckrodt, LLC to manufacture 
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. The DEA 
investigated the company's maintenance of effective controls against 
diversion by inspecting and testing the company's physical security 
systems, verifying the company's compliance with state and local laws, 
and reviewing 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 following basic classes of controlled substances:

------------------------------------------------------------------------
            Controlled substance                       Schedule
------------------------------------------------------------------------
Gamma Hydroxybutyric Acid (2010)...........  I
Lisdexamfetamine (1205)....................  II
Oripavine (9330)...........................  II
Tapentadol (9780)..........................  II
------------------------------------------------------------------------

    The company plans to manufacturer bulk active pharmaceutical 
ingredients (API) for distribution and product development to its 
customers.

    Dated: July 10, 2015.
Joseph T. Rannazzisi,
Deputy Assistant Administrator.
[FR Doc. 2015-17523 Filed 7-16-15; 8:45 am]
 BILLING CODE 4410-09-P

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