80_FR_46483 80 FR 46334 - Manufacturer of Controlled Substances Registration: Cody Laboratories, Inc.

80 FR 46334 - Manufacturer of Controlled Substances Registration: Cody Laboratories, Inc.

DEPARTMENT OF JUSTICE
Drug Enforcement Administration

Federal Register Volume 80, Issue 149 (August 4, 2015)

Page Range46334-46334
FR Document2015-19168

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.

Federal Register, Volume 80 Issue 149 (Tuesday, August 4, 2015)
[Federal Register Volume 80, Number 149 (Tuesday, August 4, 2015)]
[Notices]
[Page 46334]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2015-19168]


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DEPARTMENT OF JUSTICE

Drug Enforcement Administration

[Docket No. DEA-392]


Manufacturer of Controlled Substances Registration: Cody 
Laboratories, Inc.

ACTION: Notice of registration.

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SUMMARY: 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 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
------------------------------------------------------------------------
Dihydromorphine (9145).....................  I
Amphetamine (1100).........................  II
Methamphetamine (1105).....................  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
Fentanyl (9801)............................  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



                                              46334                         Federal Register / Vol. 80, No. 149 / Tuesday, August 4, 2015 / Notices

                                              and analytical purposes. Placement of                   Administrator’’) pursuant to section 7 of                 the public interest and with United
                                              these drug codes onto the company’s                     28 CFR part 0, appendix to subpart R.                     States obligations under international
                                              registration does not translate into                      In accordance with 21 CFR                               treaties, conventions, or protocols in
                                              automatic approval of subsequent                        1301.33(a), this is notice that on July 28,               effect on May 1, 1971. The DEA
                                              permit applications to import controlled                2014, Cedarburg Pharmaceuticals, Inc.,                    investigated the company’s maintenance
                                              substances. Approval of permit                          870 Badger Circle, Grafton, Wisconsin                     of effective controls against diversion by
                                              applications will occur only when the                   53024 applied to be registered as a bulk                  inspecting and testing the company’s
                                              registrant’s business activity is                       manufacturer of the following basic                       physical security systems, verifying the
                                              consistent with what is authorized                      classes of controlled substances:                         company’s compliance with state and
                                              under to 21 U.S.C. 952(a)(2).                                                                                     local laws, and reviewing the company’s
                                              Authorization will not extend to the                            Controlled substance                  Schedule    background and history.
                                              import of FDA approved or non-                                                                                       Therefore, pursuant to 21 U.S.C.
                                                                                                      Marihuana (7360) .........................    I
                                              approved finished dosage forms for                      Tetrahydrocannabinols (7370) .....            I           823(a), and in accordance with 21 CFR
                                              commercial sale.                                                                                                  1301.33, the above-named company is
                                                Dated: July 29, 2015.                                    The company plans to manufacture                       granted registration as a bulk
                                              Joseph T. Rannazzisi,                                   the above-listed controlled substances                    manufacturer of the basic classes of
                                                                                                      in bulk for distribution to its customers.                controlled substances listed:
                                              Deputy Assistant Administrator.
                                              [FR Doc. 2015–19158 Filed 8–3–15; 8:45 am]              In reference to drug code 7360
                                                                                                      marihuana, the company plans to bulk                               Controlled substance                   Schedule
                                              BILLING CODE 4410–09–P
                                                                                                      manufacture cannabidiol as a synthetic                    Dihydromorphine (9145) ...............          I
                                                                                                      intermediate. This controlled substance                   Amphetamine (1100) ....................         II
                                              DEPARTMENT OF JUSTICE                                   will be further synthesized to bulk                       Methamphetamine (1105) ............             II
                                                                                                      manufacture a synthetic                                   Amobarbital (2125) .......................      II
                                              Drug Enforcement Administration                         tetrahydrocannabinol 7370. No other                       Pentobarbital (2270) .....................      II
                                                                                                      activity for this drug code is authorized                 Secobarbital (2315) ......................      II
                                              [Docket No. DEA–392]                                    for this registration.                                    4-Anilino-N-phenethyl-4-piperidine              II
                                                                                                                                                                  (ANPP) (8333).
                                                                                                        Dated: July 29, 2015.                                   Phenylacetone (8501) ..................         II
                                              Bulk Manufacturer of Controlled
                                                                                                      Joseph T. Rannazzisi,                                     Cocaine (9041) .............................    II
                                              Substances Application: Cedarburg
                                                                                                      Deputy Assistant Administrator.                           Codeine (9050) .............................    II
                                              Pharmaceuticals, Inc.                                                                                             Dihydrocodeine (9120) .................         II
                                                                                                      [FR Doc. 2015–19165 Filed 8–3–15; 8:45 am]
                                                                                                                                                                Oxycodone (9143) ........................       II
                                              ACTION:   Notice of application.                        BILLING CODE 4410–09–P
                                                                                                                                                                Hydromorphone (9150) ................           II
                                                                                                                                                                Diphenoxylate (9170) ...................        II
                                              DATES:  Registered bulk manufacturers of                                                                          Ecgonine (9180) ...........................     II
                                              the affected basic classes, and                         DEPARTMENT OF JUSTICE                                     Hydrocodone (9193) .....................        II
                                              applicants therefore, may file written                                                                            Meperidine (9230) ........................      II
                                              comments on or objections to the                        Drug Enforcement Administration                           Methadone (9250) ........................       II
                                              issuance of the proposed registration in                [Docket No. DEA–392]                                      Morphine (9300) ...........................     II
                                              accordance with 21 CFR 1301.33(a) on                                                                              Thebaine (9333) ...........................     II
                                              or before October 5, 2015.                              Manufacturer of Controlled                                Oxymorphone (9652) ...................          II
                                                                                                      Substances Registration: Cody                             Alfentanil (9737) ...........................   II
                                              ADDRESSES: Written comments should                                                                                Remifentanil (9739) ......................      II
                                              be sent to: Drug Enforcement                            Laboratories, Inc.
                                                                                                                                                                Sufentanil (9740) ..........................    II
                                              Administration, Attention: DEA Federal                                                                            Fentanyl (9801) ............................    II
                                                                                                      ACTION:    Notice of registration.
                                              Register Representative/ODXL, 8701
                                              Morrissette Drive, Springfield, Virginia                SUMMARY:   Cody Laboratories, Inc.                          The company plans to manufacture
                                              22152. Request for hearings should be                   applied to be registered as a                             the listed controlled substances in bulk
                                              sent to: Drug Enforcement                               manufacturer of certain basic classes of                  for sale to its customers.
                                              Administration, Attention: Hearing                      controlled substances. The Drug                             Dated: July 29, 2015.
                                              Clerk/LJ, 8701 Morrissette Drive,                       Enforcement Administration (DEA)                          Joseph T. Rannazzisi,
                                              Springfield, Virginia 22152.                            grants Cody Laboratories, Inc.                            Deputy Assistant Administrator.
                                              SUPPLEMENTARY INFORMATION: The                          registration as a manufacturer of those
                                                                                                                                                                [FR Doc. 2015–19168 Filed 8–3–15; 8:45 am]
                                              Attorney General has delegated his                      controlled substances.
                                                                                                                                                                BILLING CODE P
                                              authority under the Controlled                          SUPPLEMENTARY INFORMATION: By notice
                                              Substances Act to the Administrator of                  dated April 14, 2015, and published in
                                              the Drug Enforcement Administration                     the Federal Register on April 22, 2015,                   DEPARTMENT OF JUSTICE
                                              (DEA), 28 CFR 0.100(b). Authority to                    80 FR 22560, Cody Laboratories, Inc.,
                                              exercise all necessary functions with                   Steve Hartman-Vice President of                           Drug Enforcement Administration
                                              respect to the promulgation and                         Compliance, 601 Yellowstone Avenue,
                                              implementation of 21 CFR part 1301,                                                                               [Docket No. DEA–392]
                                                                                                      Cody, Wyoming 82414 applied to be
                                              incident to the registration of                         registered as a manufacturer of certain                   Manufacturer of Controlled
                                              manufacturers, distributors, dispensers,                basic classes of controlled substances.                   Substances Registration: Johnson
tkelley on DSK3SPTVN1PROD with NOTICES




                                              importers, and exporters of controlled                  No comments or objections were                            Matthey, Inc.
                                              substances (other than final orders in                  submitted for this notice.
                                              connection with suspension, denial, or                    The DEA has considered the factors in                   ACTION:    Notice of registration.
                                              revocation of registration) has been                    21 U.S.C. 823(a) and determined that
                                              redelegated to the Deputy Assistant                     the registration of Cody Laboratories,                    SUMMARY:   Johnson Matthey, Inc. applied
                                              Administrator of the DEA Office of                      Inc. to manufacture the basic classes of                  to be registered as a manufacturer of
                                              Diversion Control (‘‘Deputy Assistant                   controlled substances is consistent with                  certain basic classes of controlled


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Document Created: 2015-12-18 14:51:41
Document Modified: 2015-12-18 14:51:41
CategoryRegulatory Information
CollectionFederal Register
sudoc ClassAE 2.7:
GS 4.107:
AE 2.106:
PublisherOffice of the Federal Register, National Archives and Records Administration
SectionNotices
ActionNotice of registration.
FR Citation80 FR 46334 

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