83_FR_61126 83 FR 60898 - Bulk Manufacturer of Controlled Substances Application: Noramco Inc.

83 FR 60898 - Bulk Manufacturer of Controlled Substances Application: Noramco Inc.

DEPARTMENT OF JUSTICE
Drug Enforcement Administration

Federal Register Volume 83, Issue 228 (November 27, 2018)

Page Range60898-60898
FR Document2018-25874

Federal Register, Volume 83 Issue 228 (Tuesday, November 27, 2018)
[Federal Register Volume 83, Number 228 (Tuesday, November 27, 2018)]
[Notices]
[Page 60898]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2018-25874]


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DEPARTMENT OF JUSTICE

Drug Enforcement Administration

[Docket No. DEA-392]


Bulk Manufacturer of Controlled Substances Application: Noramco 
Inc.

ACTION: Notice of application.

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

DATES: 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 on or before January 28, 2019.

ADDRESSES: Written comments should be sent to: Drug Enforcement 
Administration, Attention: DEA Federal Register Representative/DPW, 
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 Assistant Administrator of the DEA Diversion Control Division 
(``Assistant 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 
4, 2018, Noramco Inc., 1550 Olympic Dr. Athens, Georgia 30601 applied 
to be registered as a bulk manufacturer for the basic classes of 
controlled substances:

------------------------------------------------------------------------
      Controlled substance           Drug code           Schedule
------------------------------------------------------------------------
Cathinone.......................            1235  I
Gamma Hydroxybutyric Acid.......            2010  I
Marihuana.......................            7360  I
Tetrahydrocannabinols...........            7370  I
Codeine-N-oxide.................            9053  I
Dihydromorphine.................            9145  I
Hydromorphinol..................            9301  I
Morphine-N-oxide................            9307  I
Amphetamine.....................            1100  II
Lisdexamfetamine................            1205  II
Methylphenidate.................            1724  II
Nabilone........................            7379  II
Codeine.........................            9050  II
Dihydrocodeine..................            9120  II
Oxycodone.......................            9143  II
Hydromorphone...................            9150  II
Hydrocodone.....................            9193  II
Morphine........................            9300  II
Oripavine.......................            9330  II
Thebaine........................            9333  II
Opium tincture..................            9630  II
Oxymorphone.....................            9652  II
Noroxymorphone..................            9668  II
Alfentanil......................            9737  II
Sufentanil......................            9740  II
Carfentanil.....................            9743  II
Tapentadol......................            9780  II
Fentanyl........................            9801  II
------------------------------------------------------------------------

    The company plans to manufacture bulk active pharmaceutical 
ingredients (APIs) and reference standards for distribution to their 
customers.
    In reference to drug codes 7360 (marihuana) and 7370 
(tetrahydrocannabinols), the company plans to bulk manufacture these 
drugs as synthetic. No other activities for these drug codes are 
authorized for this registration.

    Dated: November 16, 2018.
John J. Martin,
Assistant Administrator.
[FR Doc. 2018-25874 Filed 11-26-18; 8:45 am]
 BILLING CODE 4410-09-P



                                              60898                                Federal Register / Vol. 83, No. 228 / Tuesday, November 27, 2018 / Notices

                                              The company plans to import the listed                                       DATES:  Registered bulk manufacturers of                                     respect to the promulgation and
                                              controlled substances for analytical                                         the affected basic classes, and                                              implementation of 21 CFR part 1301,
                                              research, testing and clinical trials.                                       applicants therefore, may file written                                       incident to the registration of
                                                Dated: November 16, 2018.                                                  comments on or objections to the                                             manufacturers, distributors, dispensers,
                                              John J. Martin,                                                              issuance of the proposed registration on                                     importers, and exporters of controlled
                                                                                                                           or before January 28, 2019.                                                  substances (other than final orders in
                                              Assistant Administrator.
                                              [FR Doc. 2018–25869 Filed 11–26–18; 8:45 am]                                 ADDRESSES: Written comments should                                           connection with suspension, denial, or
                                                                                                                           be sent to: Drug Enforcement                                                 revocation of registration) has been
                                              BILLING CODE 4410–09–P
                                                                                                                           Administration, Attention: DEA Federal                                       redelegated to the Assistant
                                                                                                                           Register Representative/DPW, 8701                                            Administrator of the DEA Diversion
                                              DEPARTMENT OF JUSTICE                                                        Morrissette Drive, Springfield, Virginia                                     Control Division (‘‘Assistant
                                                                                                                           22152.                                                                       Administrator’’) pursuant to section 7 of
                                              Drug Enforcement Administration                                                                                                                           28 CFR part 0, appendix to subpart R.
                                                                                                                           SUPPLEMENTARY INFORMATION:    The
                                              [Docket No. DEA–392]                                                         Attorney General has delegated his                                             In accordance with 21 CFR
                                                                                                                           authority under the Controlled                                               1301.33(a), this is notice that on July 4,
                                              Bulk Manufacturer of Controlled                                              Substances Act to the Administrator of                                       2018, Noramco Inc., 1550 Olympic Dr.
                                              Substances Application: Noramco Inc.                                         the Drug Enforcement Administration                                          Athens, Georgia 30601 applied to be
                                                                                                                           (DEA), 28 CFR 0.100(b). Authority to                                         registered as a bulk manufacturer for the
                                              ACTION:       Notice of application.
                                                                                                                           exercise all necessary functions with                                        basic classes of controlled substances:

                                                                                                                   Controlled substance                                                                                       Drug code         Schedule

                                              Cathinone ................................................................................................................................................................            1235   I
                                              Gamma Hydroxybutyric Acid ...................................................................................................................................                         2010   I
                                              Marihuana ................................................................................................................................................................            7360   I
                                              Tetrahydrocannabinols ............................................................................................................................................                    7370   I
                                              Codeine-N-oxide ......................................................................................................................................................                9053   I
                                              Dihydromorphine .....................................................................................................................................................                 9145   I
                                              Hydromorphinol .......................................................................................................................................................                9301   I
                                              Morphine-N-oxide ....................................................................................................................................................                 9307   I
                                              Amphetamine ..........................................................................................................................................................                1100   II
                                              Lisdexamfetamine ...................................................................................................................................................                  1205   II
                                              Methylphenidate ......................................................................................................................................................                1724   II
                                              Nabilone ..................................................................................................................................................................           7379   II
                                              Codeine ...................................................................................................................................................................           9050   II
                                              Dihydrocodeine ........................................................................................................................................................               9120   II
                                              Oxycodone ..............................................................................................................................................................              9143   II
                                              Hydromorphone .......................................................................................................................................................                 9150   II
                                              Hydrocodone ...........................................................................................................................................................               9193   II
                                              Morphine ..................................................................................................................................................................           9300   II
                                              Oripavine .................................................................................................................................................................           9330   II
                                              Thebaine ..................................................................................................................................................................           9333   II
                                              Opium tincture .........................................................................................................................................................              9630   II
                                              Oxymorphone ..........................................................................................................................................................                9652   II
                                              Noroxymorphone .....................................................................................................................................................                  9668   II
                                              Alfentanil ..................................................................................................................................................................         9737   II
                                              Sufentanil .................................................................................................................................................................          9740   II
                                              Carfentanil ...............................................................................................................................................................           9743   II
                                              Tapentadol ...............................................................................................................................................................            9780   II
                                              Fentanyl ...................................................................................................................................................................          9801   II



                                                 The company plans to manufacture                                            Dated: November 16, 2018.                                                  SUMMARY:   The registrant listed below
                                              bulk active pharmaceutical ingredients                                       John J. Martin,                                                              has applied for and has been granted
                                              (APIs) and reference standards for                                           Assistant Administrator.                                                     registration by the Drug Enforcement
                                              distribution to their customers.                                             [FR Doc. 2018–25874 Filed 11–26–18; 8:45 am]                                 Administration (DEA) as an importer of
                                                 In reference to drug codes 7360                                           BILLING CODE 4410–09–P                                                       schedule I or II controlled substances.
                                              (marihuana) and 7370                                                                                                                                      SUPPLEMENTARY INFORMATION:       The
                                              (tetrahydrocannabinols), the company                                                                                                                      company listed below applied to be
                                                                                                                           DEPARTMENT OF JUSTICE
                                              plans to bulk manufacture these drugs                                                                                                                     registered as an importer of various
                                              as synthetic. No other activities for these                                  Drug Enforcement Administration                                              basic classes of controlled substances.
                                              drug codes are authorized for this                                                                                                                        Information on the previously published
                                                                                                                           [Docket No. DEA–392]
amozie on DSK3GDR082PROD with NOTICES1




                                              registration.                                                                                                                                             notice is listed in the table below. No
                                                                                                                           Importer of Controlled Substances                                            comments or objections were submitted
                                                                                                                           Registration                                                                 and no requests for a hearing were
                                                                                                                                                                                                        submitted for this notice.
                                                                                                                           ACTION:       Notice of registration.




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Document Created: 2018-11-27 01:24:11
Document Modified: 2018-11-27 01:24:11
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 application.
DatesRegistered bulk manufacturers of the affected basic classes, and applicants therefore, may file written comments on or objections to the issuance of the proposed registration on or before January 28, 2019.
FR Citation83 FR 60898 

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