83_FR_64398 83 FR 64159 - Bulk Manufacturer of Controlled Substances Application: Cambrex High Point, Inc.

83 FR 64159 - Bulk Manufacturer of Controlled Substances Application: Cambrex High Point, Inc.

DEPARTMENT OF JUSTICE
Drug Enforcement Administration

Federal Register Volume 83, Issue 239 (December 13, 2018)

Page Range64159-64159
FR Document2018-27039

Federal Register, Volume 83 Issue 239 (Thursday, December 13, 2018)
[Federal Register Volume 83, Number 239 (Thursday, December 13, 2018)]
[Notices]
[Page 64159]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2018-27039]


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DEPARTMENT OF JUSTICE

Drug Enforcement Administration

[Docket No. DEA-392]


Bulk Manufacturer of Controlled Substances Application: Cambrex 
High Point, 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 February 11, 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 
16, 2018, Cambrex High Point Inc., 4180 Mendenhall Oaks Parkway, High 
Point, North Carolina 27265 applied to be registered as a bulk 
manufacturer of the following basic classes of controlled substances:

------------------------------------------------------------------------
                                           Drug
         Controlled substances             code          Schedule
------------------------------------------------------------------------
Oxymorphone............................     9652  II
Noroxymorphone.........................     9668  II
------------------------------------------------------------------------

    The company plans to manufacture the above listed controlled 
substances in bulk for distribution to its customers.

    Dated: December 3, 2018.
John J. Martin,
Assistant Administrator.
[FR Doc. 2018-27039 Filed 12-12-18; 8:45 am]
 BILLING CODE 4410-09-P



                                                                            Federal Register / Vol. 83, No. 239 / Thursday, December 13, 2018 / Notices                                                      64159

                                                Dated: December 3, 2018.                                                                       Drug                  connection with suspension, denial, or
                                                                                                          Controlled substance                            Schedule
                                              John J. Martin,                                                                                  code                  revocation of registration) has been
                                              Assistant Administrator.                                                                                               redelegated to the Assistant
                                                                                                        Cocaine .........................        9041    II          Administrator of the DEA Diversion
                                              [FR Doc. 2018–27036 Filed 12–12–18; 8:45 am]
                                                                                                        Codeine .........................        9050    II          Control Division (‘‘Assistant
                                              BILLING CODE 4410–09–P                                    Dihydrocodeine ..............            9120    II
                                                                                                        Oxycodone ....................           9143    II          Administrator’’) pursuant to section 7 of
                                                                                                        Hydromorphone .............              9150    II          28 CFR part 0, appendix to subpart R.
                                              DEPARTMENT OF JUSTICE                                     Ecgonine ........................        9180    II            In accordance with 21 CFR
                                                                                                        Hydrocodone .................            9193    II          1301.33(a), this is notice that on July 16,
                                              Drug Enforcement Administration                           Morphine ........................        9300    II          2018, Cambrex High Point Inc., 4180
                                                                                                        Thebaine ........................        9333    II          Mendenhall Oaks Parkway, High Point,
                                              [Docket No. DEA–392]
                                                                                                                                                                     North Carolina 27265 applied to be
                                                                                                          The company plans to manufacture                           registered as a bulk manufacturer of the
                                              Bulk Manufacturer of Controlled
                                                                                                        the listed controlled substances for                         following basic classes of controlled
                                              Substances Application: Eli-Elsohly
                                                                                                        product development and reference                            substances:
                                              Laboratories
                                                                                                        standards. In reference to drug codes
                                              ACTION:    Notice of application.                         7360 (marihuana) and 7370 (THC), the                                   Controlled           Drug    Schedule
                                                                                                        company plans to isolate these                                        substances            code
                                              DATES:  Registered bulk manufacturers of                  controlled substances from procured
                                                                                                        7350 (marihuana extract). In reference to                    Oxymorphone ................    9652   II
                                              the affected basic classes, and                                                                                        Noroxymorphone ...........      9668   II
                                              applicants therefore, may file written                    drug code 7360 (marihuana), no
                                              comments on or objections to the                          cultivation activities are authorized for                      The company plans to manufacture
                                              issuance of the proposed registration on                  this registration. No other activities for                   the above listed controlled substances in
                                              or before February 11, 2019.                              these drug codes are authorized for this                     bulk for distribution to its customers.
                                              ADDRESSES: Written comments should                        registration.
                                                                                                                                                                       Dated: December 3, 2018.
                                              be sent to: Drug Enforcement                                Dated: December 3, 2018.
                                                                                                                                                                     John J. Martin,
                                              Administration, Attention: DEA Federal                    John J. Martin,
                                                                                                                                                                     Assistant Administrator.
                                              Register Representative/DPW, 8701                         Assistant Administrator.
                                              Morrissette Drive, Springfield, Virginia                                                                               [FR Doc. 2018–27039 Filed 12–12–18; 8:45 am]
                                                                                                        [FR Doc. 2018–27029 Filed 12–12–18; 8:45 am]
                                              22152.                                                                                                                 BILLING CODE 4410–09–P
                                                                                                        BILLING CODE 4410–09–P
                                              SUPPLEMENTARY INFORMATION:      The
                                              Attorney General has delegated his                                                                                     DEPARTMENT OF JUSTICE
                                              authority under the Controlled                            DEPARTMENT OF JUSTICE
                                              Substances Act to the Administrator of                                                                                 Drug Enforcement Administration
                                              the Drug Enforcement Administration                       Drug Enforcement Administration
                                                                                                                                                                     [Docket No. DEA–392]
                                              (DEA), 28 CFR 0.100(b). Authority to                      [Docket No. DEA–392]
                                              exercise all necessary functions with                                                                                  Importer of Controlled Substances
                                              respect to the promulgation and                           Bulk Manufacturer of Controlled                              Application: Noramco Inc.
                                              implementation of 21 CFR part 1301,                       Substances Application: Cambrex
                                              incident to the registration of                           High Point, Inc.                                             ACTION:    Notice of application.
                                              manufacturers, distributors, dispensers,
                                              importers, and exporters of controlled                    ACTION:     Notice of application.                           DATES:  Registered bulk manufacturers of
                                              substances (other than final orders in                                                                                 the affected basic classes, and
                                                                                                        DATES:  Registered bulk manufacturers of                     applicants therefore, may file written
                                              connection with suspension, denial, or                    the affected basic classes, and
                                              revocation of registration) has been                                                                                   comments on or objections to the
                                                                                                        applicants therefore, may file written                       issuance of the proposed registration on
                                              redelegated to the Assistant                              comments on or objections to the
                                              Administrator of the DEA Diversion                                                                                     or before January 14, 2019. Such
                                                                                                        issuance of the proposed registration on                     persons may also file a written request
                                              Control Division (‘‘Assistant                             or before February 11, 2019.
                                              Administrator’’) pursuant to section 7 of                                                                              for a hearing on the application on or
                                                                                                        ADDRESSES: Written comments should                           before January 14, 2019.
                                              28 CFR part 0, appendix to subpart R.
                                                In accordance with 21 CFR                               be sent to: Drug Enforcement                                 ADDRESSES: Written comments should
                                              1301.33(a), this is notice that on                        Administration, Attention: DEA Federal                       be sent to: Drug Enforcement
                                              November 22, 2017, Eli-Elsohly                            Register Representative/DPW, 8701                            Administration, Attention: DEA Federal
                                              Laboratories, Mahmoud A. Elsohly                          Morrissette Drive, Springfield, Virginia                     Register Representative/DPW, 8701
                                              Ph.D., 5 Industrial Park Drive, Oxford,                   22152.                                                       Morrissette Drive, Springfield, Virginia
                                              Mississippi 38655 applied to be                           SUPPLEMENTARY INFORMATION: The                               22152. All requests for hearing must be
                                              registered as a bulk manufacturer of the                  Attorney General has delegated his                           sent to: Drug Enforcement
                                              following basic classes of controlled                     authority under the Controlled                               Administration, Attn: Administrator,
                                              substances:                                               Substances Act to the Administrator of                       8701 Morrissette Drive, Springfield,
                                                                                                        the Drug Enforcement Administration                          Virginia 22152. All requests for hearing
                                                                                 Drug                   (DEA), 28 CFR 0.100(b). Authority to                         should also be sent to: (1) Drug
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                                                Controlled substance                      Schedule
                                                                                 code                   exercise all necessary functions with                        Enforcement Administration, Attn:
                                                                                                        respect to the promulgation and                              Hearing Clerk/OALJ, 8701 Morrissette
                                              Marihuana Extract .........         7350    I
                                              Marihuana ......................    7360    I
                                                                                                        implementation of 21 CFR part 1301,                          Drive, Springfield, Virginia 22152; and
                                              Tetrahydrocannabinols ..            7370    I             incident to the registration of                              (2) Drug Enforcement Administration,
                                              Dihydromorphine ...........         9145    I             manufacturers, distributors, dispensers,                     Attn: DEA Federal Register
                                              Amphetamine ................        1100    II            importers, and exporters of controlled                       Representative/DPW, 8701 Morrissette
                                              Methamphetamine .........           1105    II            substances (other than final orders in                       Drive, Springfield, Virginia 22152.


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Document Created: 2018-12-13 01:16:07
Document Modified: 2018-12-13 01:16:07
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 February 11, 2019.
FR Citation83 FR 64159 

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