83_FR_39282 83 FR 39129 - Bulk Manufacturer of Controlled Substances Application: Euticals Inc.

83 FR 39129 - Bulk Manufacturer of Controlled Substances Application: Euticals Inc.

DEPARTMENT OF JUSTICE
Drug Enforcement Administration

Federal Register Volume 83, Issue 153 (August 8, 2018)

Page Range39129-39129
FR Document2018-16942

Federal Register, Volume 83 Issue 153 (Wednesday, August 8, 2018)
[Federal Register Volume 83, Number 153 (Wednesday, August 8, 2018)]
[Notices]
[Page 39129]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2018-16942]


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DEPARTMENT OF JUSTICE

Drug Enforcement Administration

[Docket No. DEA-392]


Bulk Manufacturer of Controlled Substances Application: Euticals 
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 October 9, 2018.

ADDRESS:  Written comments should be sent to: Drug Enforcement 
Administration, Attention: DEA Federal Register Representative/DRW, 
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 June 
25, 2018, Euticals, Inc., 2460 W Bennett Street, Springfield, Missouri 
65807-1229 applied to be registered as a bulk manufacturer of the 
following basic classes of controlled substances:

------------------------------------------------------------------------
                                           Drug
          Controlled substance             code          Schedule
------------------------------------------------------------------------
Gamma Hydroxybutyric Acid..............     2010  I
Amphetamine............................     1100  II
Lisdexamfetamine.......................     1205  II
Methylphenidate........................     1724  II
Phenylacetone..........................     8501  II
Methadone..............................     9250  II
Methadone intermediate.................     9254  II
Oripavine..............................     9330  II
Tapentadol.............................     9780  II
------------------------------------------------------------------------

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

    Dated: July 31, 2018.
John J. Martin,
Assistant Administrator.
[FR Doc. 2018-16942 Filed 8-7-18; 8:45 am]
 BILLING CODE 4410-09-P



                                                                                    Federal Register / Vol. 83, No. 153 / Wednesday, August 8, 2018 / Notices                                                                                39129

                                                                                                           Company                                                                         FR docket                        Published

                                                Restek Corporation ...................................................................................................................   83 FR 27634       June 13, 2018.
                                                Bellwyck Clinical Services ........................................................................................................      83 FR 27633       June 13, 2018.
                                                Cambrex Charles City ..............................................................................................................      83 FR 27633       June 13, 2018.




                                                  The Drug Enforcement                                                  exercise all necessary functions with                               persons may also file a written request
                                                Administration (DEA) has considered                                     respect to the promulgation and                                     for a hearing on the application on or
                                                the factors in 21 U.S.C. 823, 952(a) and                                implementation of 21 CFR part 1301,                                 before September 7, 2018.
                                                958(a) and determined that the                                          incident to the registration of                                     ADDRESSES: Written comments should
                                                registration of the listed registrants to                               manufacturers, distributors, dispensers,                            be sent to: Drug Enforcement
                                                import the applicable basic classes of                                  importers, and exporters of controlled                              Administration, Attention: DEA Federal
                                                schedule I or II controlled substances is                               substances (other than final orders in                              Register Representative/DRW, 8701
                                                consistent with the public interest and                                 connection with suspension, denial, or                              Morrissette Drive, Springfield, Virginia
                                                with United States obligations under                                    revocation of registration) has been                                22152. All requests for hearing must be
                                                international treaties, conventions, or                                 redelegated to the Assistant                                        sent to: Drug Enforcement
                                                protocols in effect on May 1, 1971. The                                 Administrator of the DEA Diversion                                  Administration, Attn: Administrator,
                                                DEA investigated each company’s                                         Control Division (‘‘Assistant                                       8701 Morrissette Drive, Springfield,
                                                maintenance of effective controls                                       Administrator’’) pursuant to section 7 of                           Virginia 22152. All request for hearing
                                                against diversion by inspecting and                                     28 CFR part 0, appendix to subpart R.                               should also be sent to: (1) Drug
                                                testing each company’s physical                                           In accordance with 21 CFR                                         Enforcement Administration, Attn:
                                                security systems, verifying each                                        1301.33(a), this is notice that on June                             Hearing Clerk/LJ, 8701 Morrissette
                                                company’s compliance with state and                                     25, 2018, Euticals, Inc., 2460 W Bennett                            Drive, Springfield, Virginia 22152; and
                                                local laws, and reviewing each                                          Street, Springfield, Missouri 65807–                                (2) Drug Enforcement Administration,
                                                company’s background and history.                                       1229 applied to be registered as a bulk                             Attn: DEA Federal Register
                                                  Therefore, pursuant to 21 U.S.C.                                      manufacturer of the following basic                                 Representative/DRW, 8701 Morrissette
                                                952(a) and 958(a), and in accordance                                    classes of controlled substances:                                   Drive, Springfield, Virginia 22152.
                                                with 21 CFR 1301.34, the DEA has                                                                                                            Comments and requests for hearings on
                                                granted a registration as an importer for                                 Controlled substance                   Drug         Schedule      applications to import narcotic raw
                                                schedule I or II controlled substances to                                                                        code
                                                                                                                                                                                            material are not appropriate. 72 FR
                                                the above listed companies.                                                                                                                 3417, (January 25, 2007)
                                                                                                                        Gamma Hydroxybutyric                       2010      I
                                                  Dated: July 31, 2018.                                                   Acid.                                                             SUPPLEMENTARY INFORMATION: The
                                                John J. Martin,                                                         Amphetamine ...............                1100      II             Attorney General has delegated his
                                                Assistant Administrator.                                                Lisdexamfetamine ........                  1205      II             authority under the Controlled
                                                                                                                        Methylphenidate ...........                1724      II             Substances Act to the Administrator of
                                                [FR Doc. 2018–16941 Filed 8–7–18; 8:45 am]                              Phenylacetone ..............               8501      II
                                                BILLING CODE 4410–09–P                                                  Methadone ....................             9250      II             the Drug Enforcement Administration
                                                                                                                        Methadone intermediate                     9254      II             (DEA), 28 CFR 0.100(b). Authority to
                                                                                                                        Oripavine ......................           9330      II             exercise all necessary functions with
                                                DEPARTMENT OF JUSTICE                                                   Tapentadol ....................            9780      II             respect to the promulgation and
                                                                                                                                                                                            implementation of 21 CFR part 1301,
                                                Drug Enforcement Administration                                           The company plans to manufacture                                  incident to the registration of
                                                [Docket No. DEA–392]                                                    the above-listed controlled substances                              manufacturers, distributors, dispensers,
                                                                                                                        in bulk for distribution to its customers.                          importers, and exporters of controlled
                                                Bulk Manufacturer of Controlled                                           Dated: July 31, 2018.                                             substances (other than final orders in
                                                Substances Application: Euticals Inc.                                   John J. Martin,                                                     connection with suspension, denial, or
                                                                                                                        Assistant Administrator.                                            revocation of registration) has been
                                                ACTION:      Notice of application.                                                                                                         redelegated to the Assistant
                                                                                                                        [FR Doc. 2018–16942 Filed 8–7–18; 8:45 am]
                                                                                                                                                                                            Administrator of the DEA Diversion
                                                DATES:  Registered bulk manufacturers of                                BILLING CODE 4410–09–P
                                                                                                                                                                                            Control Division (‘‘Assistant
                                                the affected basic classes, and                                                                                                             Administrator’’) pursuant to section 7 of
                                                applicants therefore, may file written                                                                                                      28 CFR part 0, appendix to subpart R.
                                                comments on or objections to the                                        DEPARTMENT OF JUSTICE
                                                                                                                                                                                              In accordance with 21 CFR
                                                issuance of the proposed registration on                                                                                                    1301.34(a), this is notice that on August
                                                or before October 9, 2018.                                              Drug Enforcement Administration
                                                                                                                                                                                            16, 2017, Chattem Chemicals, Inc., 3801
                                                ADDRESS: Written comments should be                                     [Docket No. DEA–392]                                                St. Elmo Avenue, Chattanooga,
                                                sent to: Drug Enforcement                                                                                                                   Tennessee 37409 applied to be
                                                Administration, Attention: DEA Federal                                  Importer of Controlled Substances
                                                                                                                                                                                            registered as an importer of the
                                                Register Representative/DRW, 8701                                       Application: Chattem Chemicals, Inc.
                                                                                                                                                                                            following basic classes of controlled
                                                Morrissette Drive, Springfield, Virginia                                                                                                    substances:
sradovich on DSK3GMQ082PROD with NOTICES




                                                                                                                        ACTION:      Notice of application.
                                                22152.
                                                SUPPLEMENTARY INFORMATION: The                                          DATES:  Registered bulk manufacturers of                                     Controlled               Drug      Schedule
                                                                                                                        the affected basic classes, and                                              substance                code
                                                Attorney General has delegated his
                                                authority under the Controlled                                          applicants therefore, may file written                               Methamphetamine ........           1105    II
                                                Substances Act to the Administrator of                                  comments on or objections to the                                     4-Anilino-N-phenethyl-4-           8333    II
                                                the Drug Enforcement Administration                                     issuance of the proposed registration on                               piperidine (ANPP).
                                                (DEA), 28 CFR 0.100(b). Authority to                                    or before September 7, 2018. Such                                    Phenylacetone ..............       8501    II



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Document Created: 2018-08-08 02:05:42
Document Modified: 2018-08-08 02:05:42
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 October 9, 2018.
FR Citation83 FR 39129 

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