Manufacturer of Controlled Substances Registration: Cody Laboratories, Inc., 31987 [2014-12799]

Download as PDF 31987 Federal Register / Vol. 79, No. 106 / Tuesday, June 3, 2014 / Notices Controlled substance Schedule Tetrahydrocannabinols (7370) ..... Codeine-N-oxide (9053) ............... Dihydromorphine (9145) ............... Difenoxin (9168) ........................... Morphine-N-oxide (9307) ............. Normorphine (9313) ..................... Norlevorphanol (9634) .................. Amphetamine (1100) .................... Methamphetamine (1105) ............ Phenylacetone (8501) .................. Methylphenidate (1724) ................ Nabilone (7379) ............................ 4-Anilino-N-phenethyl-4-piperidine (8333). Codeine (9050) ............................. Dihydrocodeine (9120) ................. Oxycodone (9143) ........................ Hydromorphone (9150) ................ Diphenoxylate (9170) ................... Ecgonine (9180) ........................... Hydrocodone (9193) ..................... Levorphanol (9220) ...................... Meperidine (9230) ........................ Methadone (9250) ........................ Methadone intermediate (9254) ... Dextropropoxyphene, bulk (nondosage forms) (9273). Morphine (9300) ........................... Thebaine (9333) ........................... Opium tincture (9630) .................. Opium, powdered (9639) ............. Oxymorphone (9652) ................... Noroxymorphone (9668) .............. Alfentanil (9737) ........................... Remifentanil (9739) ...................... Sufentanil (9740) .......................... Fentanyl (9801) ............................ I I I I I I 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 II II II II The company plans to manufacture the listed controlled substances for internal use and for distribution to other companies. Dated: May 28, 2014. Joseph T. Rannazzisi, Deputy Assistant Administrator. Drug Enforcement Administration [Docket No. DEA–392] DEPARTMENT OF JUSTICE Manufacturer of Controlled Substances Registration: Cody Laboratories, Inc. Drug Enforcement Administration [Docket No. DEA–392] Bulk Manufacturer of Controlled Substances Application: Pharmacore, Inc. Notice of application. 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 August 4, 2014. ADDRESSES: Written comments should be sent to: Drug Enforcement Administration, Attention: DEA Federal sroberts on DSK4SPTVN1PROD with NOTICES DATES: 17:35 Jun 02, 2014 [FR Doc. 2014–12797 Filed 6–2–14; 8:45 am] DEPARTMENT OF JUSTICE BILLING CODE 4410–09–P VerDate Mar<15>2010 Dated: May 28, 2014. Joseph T. Rannazzisi, Deputy Assistant Administrator. BILLING CODE 4410–09–P [FR Doc. 2014–12794 Filed 6–2–14; 8:45 am] ACTION: Register Representative/ODW, 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, and dispensers 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 Administrator’’) pursuant to sec. 7(g) of 28 CFR part 0, subpart R, App. In accordance with 21 CFR 1301.33(a), this is notice that on March 20, 2014, Pharmacore, Inc., 4180 Mendenhall Oaks Parkway, High Point, North Carolina 27265, applied to be registered as a bulk manufacturer of Noroxymorphone (9668), a basic class of narcotic controlled substance listed in schedule II. The company plans to manufacture the listed controlled substance as an active pharmaceutical ingredient (API) for clinical trials. Jkt 232001 ACTION: Notice of registration. Cody Laboratories, Inc. applied to be registered as a manufacturer of certain basic classes of narcotic or non-narcotic controlled substances. The DEA grants Cody Laboratories, Inc. registration as a manufacturer of those controlled substances. SUPPLEMENTARY INFORMATION: By notice dated December 31, 2013, and published in the Federal Register on January 10, 2014, 79 FR 1890, Cody Laboratories, Inc., 601 Yellowstone Avenue, Cody, Wyoming 82414–9321, SUMMARY: PO 00000 Frm 00072 Fmt 4703 Sfmt 9990 applied to be registered as a manufacturer of certain basic classes of narcotic or non-narcotic controlled substances. The Drug Enforcement Administration (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 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, verified the company’s compliance with state and local laws, and reviewed 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 narcotic or non-narcotic controlled substances listed: Controlled Substance Dihydromorphine (9145) ............... Amphetamine (1100) .................... Methamphetamine (1105) ............ Methylphenidate (1724) ................ 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) .......................... Tapentadol (9780) ........................ 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 II II The company plans to manufacture the listed controlled substances in bulk for sale to its customers. No comments or objections have been received. Dated: May 27, 2014. Joseph T. Rannazzisi, Deputy Assistant Administrator. [FR Doc. 2014–12799 Filed 6–2–14; 8:45 am] BILLING CODE 4410–09–P E:\FR\FM\03JNN1.SGM 03JNN1

Agencies

[Federal Register Volume 79, Number 106 (Tuesday, June 3, 2014)]
[Notices]
[Page 31987]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-12799]


-----------------------------------------------------------------------

DEPARTMENT OF JUSTICE

Drug Enforcement Administration

[Docket No. DEA-392]


Manufacturer of Controlled Substances Registration: Cody 
Laboratories, Inc.

ACTION: Notice of registration.

-----------------------------------------------------------------------

SUMMARY: Cody Laboratories, Inc. applied to be registered as a 
manufacturer of certain basic classes of narcotic or non-narcotic 
controlled substances. The DEA grants Cody Laboratories, Inc. 
registration as a manufacturer of those controlled substances.

SUPPLEMENTARY INFORMATION: By notice dated December 31, 2013, and 
published in the Federal Register on January 10, 2014, 79 FR 1890, Cody 
Laboratories, Inc., 601 Yellowstone Avenue, Cody, Wyoming 82414-9321, 
applied to be registered as a manufacturer of certain basic classes of 
narcotic or non-narcotic controlled substances.
    The Drug Enforcement Administration (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 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, verified the company's 
compliance with state and local laws, and reviewed 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 narcotic or non-narcotic 
controlled substances listed:

------------------------------------------------------------------------
            Controlled Substance                       Schedule
------------------------------------------------------------------------
Dihydromorphine (9145).....................  I
Amphetamine (1100).........................  II
Methamphetamine (1105).....................  II
Methylphenidate (1724).....................  II
Amobarbital (2125).........................  II
Pentobarbital (2270).......................  II
Secobarbital (2315)........................  II
4-Anilino-N-phenethyl-4-piperidine (ANPP)    II
 (8333).
Phenylacetone (8501).......................  II
Cocaine (9041).............................  II
Codeine (9050).............................  II
Dihydrocodeine (9120)......................  II
Oxycodone (9143)...........................  II
Hydromorphone (9150).......................  II
Diphenoxylate (9170).......................  II
Ecgonine (9180)............................  II
Hydrocodone (9193).........................  II
Meperidine (9230)..........................  II
Methadone (9250)...........................  II
Morphine (9300)............................  II
Thebaine (9333)............................  II
Oxymorphone (9652).........................  II
Alfentanil (9737)..........................  II
Remifentanil (9739)........................  II
Sufentanil (9740)..........................  II
Tapentadol (9780)..........................  II
Fentanyl (9801)............................  II
------------------------------------------------------------------------

    The company plans to manufacture the listed controlled substances 
in bulk for sale to its customers.
    No comments or objections have been received.

    Dated: May 27, 2014.
Joseph T. Rannazzisi,
Deputy Assistant Administrator.
[FR Doc. 2014-12799 Filed 6-2-14; 8:45 am]
BILLING CODE 4410-09-P