Importer of Controlled Substances Registration: Meda Pharmaceuticals, Inc., 42544-42545 [2015-17514]

Download as PDF 42544 Federal Register / Vol. 80, No. 137 / Friday, July 17, 2015 / Notices Proposed 2016 quotas (g) Basic class Methadone (for sale) ..................................................................................................................................................................... Methadone Intermediate ................................................................................................................................................................ Methamphetamine ......................................................................................................................................................................... 31,875,000 34,375,000 2,061,375 [1,250,000 grams of levo-desoxyephedrine for use in a non-controlled, non-prescription product; 750,000 grams for methamphetamine mostly for conversion to a schedule III product; and 61,375 grams for methamphetamine (for sale)] Methylphenidate ............................................................................................................................................................................. Morphine (for conversion) .............................................................................................................................................................. Morphine (for sale) ........................................................................................................................................................................ Nabilone ......................................................................................................................................................................................... Noroxymorphone (for conversion) ................................................................................................................................................. Noroxymorphone (for sale) ............................................................................................................................................................ Opium (powder) ............................................................................................................................................................................. Opium (tincture) ............................................................................................................................................................................. Oripavine ........................................................................................................................................................................................ Oxycodone (for conversion) .......................................................................................................................................................... Oxycodone (for sale) ..................................................................................................................................................................... Oxymorphone (for conversion) ...................................................................................................................................................... Oxymorphone (for sale) ................................................................................................................................................................. Pentobarbital .................................................................................................................................................................................. Phenazocine .................................................................................................................................................................................. Phencyclidine ................................................................................................................................................................................. Phenmetrazine ............................................................................................................................................................................... Phenylacetone ............................................................................................................................................................................... Racemethorphan ........................................................................................................................................................................... Remifentanil ................................................................................................................................................................................... Secobarbital ................................................................................................................................................................................... Sufentanil ....................................................................................................................................................................................... Tapentadol ..................................................................................................................................................................................... Thebaine ........................................................................................................................................................................................ 87,500,000 91,250,000 62,500,000 18,750 17,500,000 1,475,000 112,500 687,500 30,000,000 6,250,000 139,150,000 29,000,000 7,750,000 38,125,000 6 50 3 50 3 3,750 215,003 6,255 25,500,000 125,000,000 List I Chemicals Ephedrine (for conversion) ............................................................................................................................................................ Ephedrine (for sale) ....................................................................................................................................................................... Phenylpropanolamine (for conversion) .......................................................................................................................................... Phenylpropanolamine (for sale) ..................................................................................................................................................... Pseudoephedrine (for conversion) ................................................................................................................................................ Pseudoephedrine (for sale) ........................................................................................................................................................... The Administrator further proposes that the aggregate production quotas for all other basic classes of schedule I and II controlled substances included in 21 CFR 1308.11 and 1308.12 remain at zero. In accordance with 21 CFR 1303.13 and 21 CFR 1315.13, upon consideration of the relevant factors, the Administrator may adjust the 2016 aggregate production quotas and assessment of annual needs as necessary. Dated: July 13, 2015. Chuck Rosenberg, Acting Administrator. [FR Doc. 2015–17561 Filed 7–16–15; 8:45 am] srobinson on DSK5SPTVN1PROD with NOTICES BILLING CODE P VerDate Sep<11>2014 20:59 Jul 16, 2015 Jkt 235001 DEPARTMENT OF JUSTICE Drug Enforcement Administration [Docket No. DEA–392] Importer of Controlled Substances Registration: Meda Pharmaceuticals, Inc. ACTION: Notice of registration. Meda Pharmaceuticals, Inc. applied to be registered as an importer of a certain basic class of controlled substance. The Drug Enforcement Administration (DEA) grants Meda Pharmaceuticals, Inc. registration as an importer of this controlled substance. SUPPLEMENTARY INFORMATION: By notice dated March 20, 2015, and published in the Federal Register on March 27, 2015, 80 FR 16426, Meda Pharmaceuticals, Inc., 705 Eldorado Street, Decatur, Illinois 62523 applied to be registered as an importer of a certain basic class of controlled substance. No comments or SUMMARY: PO 00000 Frm 00078 Fmt 4703 Sfmt 4703 100,000 4,000,000 22,400,000 8,500,000 7,000 224,500,000 objections were submitted for this notice. The DEA has considered the factors in 21 U.S.C. 823, 952(a) and 958(a) and determined that the registration of Meda Pharmaceuticals, Inc. to import the basic class of controlled substance 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 importer of nabilone (7379) a basic class of controlled substance listed in schedule II. E:\FR\FM\17JYN1.SGM 17JYN1 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]
[Pages 42544-42545]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-17514]


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DEPARTMENT OF JUSTICE

Drug Enforcement Administration

[Docket No. DEA-392]


Importer of Controlled Substances Registration: Meda 
Pharmaceuticals, Inc.

ACTION: Notice of registration.

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SUMMARY: Meda Pharmaceuticals, Inc. applied to be registered as an 
importer of a certain basic class of controlled substance. The Drug 
Enforcement Administration (DEA) grants Meda Pharmaceuticals, Inc. 
registration as an importer of this controlled substance.

SUPPLEMENTARY INFORMATION: By notice dated March 20, 2015, and 
published in the Federal Register on March 27, 2015, 80 FR 16426, Meda 
Pharmaceuticals, Inc., 705 Eldorado Street, Decatur, Illinois 62523 
applied to be registered as an importer of a certain basic class of 
controlled substance. No comments or objections were submitted for this 
notice.
    The DEA has considered the factors in 21 U.S.C. 823, 952(a) and 
958(a) and determined that the registration of Meda Pharmaceuticals, 
Inc. to import the basic class of controlled substance 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 importer of nabilone (7379) a basic class of 
controlled substance listed in schedule II.

[[Page 42545]]

    The company plans to import the FDA approved drug product in 
finished dosage form for distribution to its customers.

    Dated: July 10, 2015.
Joseph T. Rannazzisi,
Deputy Assistant Administrator.
[FR Doc. 2015-17514 Filed 7-16-15; 8:45 am]
 BILLING CODE 4410-09-P