Manufacturer of Controlled Substances Registration: Johnson Matthey, Inc., 46334-46335 [2015-19100]

Download as PDF 46334 Federal Register / Vol. 80, No. 149 / Tuesday, August 4, 2015 / Notices and analytical purposes. Placement of these drug codes onto the company’s registration does not translate into automatic approval of subsequent permit applications to import controlled substances. Approval of permit applications will occur only when the registrant’s business activity is consistent with what is authorized under to 21 U.S.C. 952(a)(2). Authorization will not extend to the import of FDA approved or nonapproved finished dosage forms for commercial sale. Administrator’’) pursuant to section 7 of 28 CFR part 0, appendix to subpart R. In accordance with 21 CFR 1301.33(a), this is notice that on July 28, 2014, Cedarburg Pharmaceuticals, Inc., 870 Badger Circle, Grafton, Wisconsin 53024 applied to be registered as a bulk manufacturer of the following basic classes of controlled substances: Dated: July 29, 2015. Joseph T. Rannazzisi, Deputy Assistant Administrator. [Docket No. DEA–392] The company plans to manufacture the above-listed controlled substances in bulk for distribution to its customers. In reference to drug code 7360 marihuana, the company plans to bulk manufacture cannabidiol as a synthetic intermediate. This controlled substance will be further synthesized to bulk manufacture a synthetic tetrahydrocannabinol 7370. No other activity for this drug code is authorized for this registration. Bulk Manufacturer of Controlled Substances Application: Cedarburg Pharmaceuticals, Inc. Dated: July 29, 2015. Joseph T. Rannazzisi, Deputy Assistant Administrator. [FR Doc. 2015–19158 Filed 8–3–15; 8:45 am] BILLING CODE 4410–09–P DEPARTMENT OF JUSTICE Drug Enforcement Administration Controlled substance Marihuana (7360) ......................... Tetrahydrocannabinols (7370) ..... Schedule I I [FR Doc. 2015–19165 Filed 8–3–15; 8:45 am] ACTION: Notice of application. BILLING CODE 4410–09–P Registered bulk manufacturers of the affected basic classes, and applicants therefore, may file written comments on or objections to the issuance of the proposed registration in accordance with 21 CFR 1301.33(a) on or before October 5, 2015. ADDRESSES: Written comments should be sent to: Drug Enforcement Administration, Attention: DEA Federal Register Representative/ODXL, 8701 Morrissette Drive, Springfield, Virginia 22152. Request for hearings should be sent to: Drug Enforcement Administration, Attention: Hearing Clerk/LJ, 8701 Morrissette Drive, Springfield, Virginia 22152. SUPPLEMENTARY INFORMATION: The Attorney General has delegated his authority under the Controlled Substances Act to the Administrator of the Drug Enforcement Administration (DEA), 28 CFR 0.100(b). Authority to exercise all necessary functions with respect to the promulgation and implementation of 21 CFR part 1301, incident to the registration of manufacturers, distributors, dispensers, importers, and exporters of controlled substances (other than final orders in connection with suspension, denial, or revocation of registration) has been redelegated to the Deputy Assistant Administrator of the DEA Office of Diversion Control (‘‘Deputy Assistant tkelley on DSK3SPTVN1PROD with NOTICES DATES: VerDate Sep<11>2014 18:45 Aug 03, 2015 Jkt 235001 DEPARTMENT OF JUSTICE Drug Enforcement Administration [Docket No. DEA–392] Manufacturer of Controlled Substances Registration: Cody Laboratories, Inc. ACTION: Notice of registration. Cody Laboratories, Inc. applied to be registered as a manufacturer of certain basic classes of controlled substances. The Drug Enforcement Administration (DEA) grants Cody Laboratories, Inc. registration as a manufacturer of those controlled substances. SUPPLEMENTARY INFORMATION: By notice dated April 14, 2015, and published in the Federal Register on April 22, 2015, 80 FR 22560, Cody Laboratories, Inc., Steve Hartman-Vice President of Compliance, 601 Yellowstone Avenue, Cody, Wyoming 82414 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 Cody Laboratories, Inc. to manufacture the basic classes of controlled substances is consistent with SUMMARY: PO 00000 Frm 00101 Fmt 4703 Sfmt 4703 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: Controlled substance Dihydromorphine (9145) ............... Amphetamine (1100) .................... Methamphetamine (1105) ............ Amobarbital (2125) ....................... Pentobarbital (2270) ..................... Secobarbital (2315) ...................... 4-Anilino-N-phenethyl-4-piperidine (ANPP) (8333). Phenylacetone (8501) .................. Cocaine (9041) ............................. Codeine (9050) ............................. Dihydrocodeine (9120) ................. Oxycodone (9143) ........................ Hydromorphone (9150) ................ Diphenoxylate (9170) ................... Ecgonine (9180) ........................... Hydrocodone (9193) ..................... Meperidine (9230) ........................ Methadone (9250) ........................ Morphine (9300) ........................... Thebaine (9333) ........................... Oxymorphone (9652) ................... Alfentanil (9737) ........................... Remifentanil (9739) ...................... Sufentanil (9740) .......................... Fentanyl (9801) ............................ Schedule I II II II II II II II II II II II II II II II II II II II II II II II II The company plans to manufacture the listed controlled substances in bulk for sale to its customers. Dated: July 29, 2015. Joseph T. Rannazzisi, Deputy Assistant Administrator. [FR Doc. 2015–19168 Filed 8–3–15; 8:45 am] BILLING CODE P DEPARTMENT OF JUSTICE Drug Enforcement Administration [Docket No. DEA–392] Manufacturer of Controlled Substances Registration: Johnson Matthey, Inc. ACTION: Notice of registration. Johnson Matthey, Inc. applied to be registered as a manufacturer of certain basic classes of controlled SUMMARY: E:\FR\FM\04AUN1.SGM 04AUN1 46335 Federal Register / Vol. 80, No. 149 / Tuesday, August 4, 2015 / Notices substances. The Drug Enforcement Administration (DEA) grants Johnson Matthey, Inc. registration as a manufacturer of those controlled substances. DEPARTMENT OF JUSTICE Drug Enforcement Administration [Docket No. DEA–392] By notice dated February 11, 2015, and published in the Federal Register on February 19, 2015, 80 FR 8902, Johnson Matthey, Inc., Pharmaceuticals Materials, 900 River Road, Conshohocken, Pennsylvania 19428 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 Johnson Matthey, Inc. 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: Controlled substance Schedule tkelley on DSK3SPTVN1PROD with NOTICES Gamma Hydroxybutyric Acid (2010). Amphetamine (1100) .................... Methylphenidate (1724) ................ Codeine (9050) ............................. Oxycodone (9143) ........................ Diphenoxylate (9170) ................... Hydrocodone (9193) ..................... Meperidine (9230) ........................ Methadone (9250) ........................ Methadone intermediate (9254) ... Morphine (9300) ........................... Thebaine (9333) ........................... I II II II II II II II II II II II [FR Doc. 2015–19100 Filed 8–3–15; 8:45 am] BILLING CODE 4410–09–P VerDate Sep<11>2014 18:45 Aug 03, 2015 Jkt 235001 ACTION: Notice of registration. Dated: July 29, 2015. Joseph T. Rannazzisi, Deputy Assistant Administrator. [FR Doc. 2015–19162 Filed 8–3–15; 8:45 am] BILLING CODE P Actavis Laboratories FL, Inc. applied to be registered as an importer of certain basic classes of controlled substances. The Drug Enforcement Administration (DEA) grants Actavis Laboratories FL, Inc., 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 22554, Actavis Laboratories FL, Inc., 4955 Orange Drive, Davie, Florida 33314 applied to be registered as an importer of a 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, 952(a) and 958(a) and determined that the registration of Actavis Laboratories FL, Inc. 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 importer of the following basic classes of controlled substances: SUMMARY: Controlled substance The company plans to manufacture the listed controlled substances in bulk for distribution and sale to its customers. The thebaine (9333) will be used to manufacture other controlled substances for sale in bulk to its customers. Dated: July 29, 2015. Joseph T. Rannazzisi, Deputy Assistant Administrator. Importer of Controlled Substances Registration: Actavis Laboratories FL, Inc. finished Food and Drug Administration approved or non-approved dosage form for commercial distribution in the United States. Amphetamine (1100) .................... Methylphenidate (1724) ................ Oxycodone (9143) ........................ Hydromorphone (9150) ................ Hydrocodone (9193) ..................... Fentanyl (9801) ............................ Schedule II II II II II II The company plans to import the above-listed controlled substances for clinical trials, research and analytical purposes. The import of the above-listed basic classes of controlled substances would be granted only for analytical testing and clinical trials. This authorization does not extend to the import of a PO 00000 Frm 00102 Fmt 4703 Sfmt 4703 DEPARTMENT OF JUSTICE Drug Enforcement Administration [Docket No. DEA–392] Importer of Controlled Substances Registration: Almac Clinical Services Inc. (ACSI) ACTION: Notice of registration. Almac Clinical Services Inc. (ACSI) applied to be registered as an importer of certain basic classes of controlled substances. The Drug Enforcement Administration (DEA) grants Almac Clinical Services Inc. (ACSI) 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 22556, Almac Clinical Services Inc. (ACSI), 25 Fretz Road, Souderton, Pennsylvania 18964 applied to be registered as an importer 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, 952(a) and 958(a) and determined that the registration of Almac Clinical Services Inc. (ACSI) 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 importer of the following basic classes of controlled substances: SUMMARY: Controlled substance Oxycodone (9143) ........................ Hydromorphone (9150) ................ Tapentadol (9780) ........................ E:\FR\FM\04AUN1.SGM 04AUN1 Schedule II II II

Agencies

[Federal Register Volume 80, Number 149 (Tuesday, August 4, 2015)]
[Notices]
[Pages 46334-46335]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-19100]


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DEPARTMENT OF JUSTICE

Drug Enforcement Administration

[Docket No. DEA-392]


Manufacturer of Controlled Substances Registration: Johnson 
Matthey, Inc.

ACTION: Notice of registration.

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SUMMARY: Johnson Matthey, Inc. applied to be registered as a 
manufacturer of certain basic classes of controlled

[[Page 46335]]

substances. The Drug Enforcement Administration (DEA) grants Johnson 
Matthey, Inc. registration as a manufacturer of those controlled 
substances.

SUPPLEMENTARY INFORMATION: By notice dated February 11, 2015, and 
published in the Federal Register on February 19, 2015, 80 FR 8902, 
Johnson Matthey, Inc., Pharmaceuticals Materials, 900 River Road, 
Conshohocken, Pennsylvania 19428 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 Johnson Matthey, Inc. 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:

------------------------------------------------------------------------
            Controlled substance                       Schedule
------------------------------------------------------------------------
Gamma Hydroxybutyric Acid (2010)...........  I
Amphetamine (1100).........................  II
Methylphenidate (1724).....................  II
Codeine (9050).............................  II
Oxycodone (9143)...........................  II
Diphenoxylate (9170).......................  II
Hydrocodone (9193).........................  II
Meperidine (9230)..........................  II
Methadone (9250)...........................  II
Methadone intermediate (9254)..............  II
Morphine (9300)............................  II
Thebaine (9333)............................  II
------------------------------------------------------------------------

    The company plans to manufacture the listed controlled substances 
in bulk for distribution and sale to its customers.
    The thebaine (9333) will be used to manufacture other controlled 
substances for sale in bulk to its customers.

    Dated: July 29, 2015.
Joseph T. Rannazzisi,
Deputy Assistant Administrator.
[FR Doc. 2015-19100 Filed 8-3-15; 8:45 am]
BILLING CODE 4410-09-P