82_FR_23163 82 FR 23067 - Bulk Manufacturer of Controlled Substances Application: Eli-Elsohly Laboratories

82 FR 23067 - Bulk Manufacturer of Controlled Substances Application: Eli-Elsohly Laboratories

DEPARTMENT OF JUSTICE
Drug Enforcement Administration

Federal Register Volume 82, Issue 96 (May 19, 2017)

Page Range23067-23068
FR Document2017-10241

Federal Register, Volume 82 Issue 96 (Friday, May 19, 2017)
[Federal Register Volume 82, Number 96 (Friday, May 19, 2017)]
[Notices]
[Pages 23067-23068]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2017-10241]


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

DEPARTMENT OF JUSTICE

Drug Enforcement Administration

[Docket No. DEA-392]


Bulk Manufacturer of Controlled Substances Application: Eli-
Elsohly Laboratories

ACTION: Notice of application.

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

DATES: Registered bulk manufacturers of the affected basic class, 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 July 18, 2017.

ADDRESSES: 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 March 
3, 2017, Eli-Elsohly Laboratories, Mahmoud A. Elsohly Ph. D., 5 
Industrial Park Drive, Oxford, Mississippi 38655 applied to be 
registered as a bulk manufacturer of the following basic classes of 
controlled substances:

------------------------------------------------------------------------
        Controlled substance            Drug code          Schedule
------------------------------------------------------------------------
Marihuana Extract..................            7350  I
Marihuana..........................            7360  I
Tetrahydrocannabinols..............            7370  I
Dihydromorphine....................            9145  I
Amphetamine........................            1100  II
Methamphetamine....................            1105  II
Cocaine............................            9041  II
Codeine............................            9050  II
Dihydrocodeine.....................            9120  II
Oxycodone..........................            9143  II
Hydromorphone......................            9150  II
Ecgonine...........................            9180  II
Hydrocodone........................            9193  II
Morphine...........................            9300  II
Thebaine...........................            9333  II
------------------------------------------------------------------------


[[Page 23068]]

    The company plans to manufacture the listed controlled substances 
for product development and reference standards. In reference to drug 
codes 7360 (marihuana) and 7370 (THC) the company plans to isolate 
these controlled substances from procured 7350 (marihuana extract). In 
reference to drug code 7360 no cultivation activities are authorized 
for this registration. No other activities for these drug codes are 
authorized for this registration.

    Dated: May 15, 2017.
Louis J. Milione,
Assistant Administrator.
[FR Doc. 2017-10241 Filed 5-18-17; 8:45 am]
 BILLING CODE P



                                                                                                  Federal Register / Vol. 82, No. 96 / Friday, May 19, 2017 / Notices                                                                                        23067

                                                    Administrator’’) pursuant to section 7 of                                   Morrissette Drive, Springfield, Virginia                                     DATES:  Registered bulk manufacturers of
                                                    28 CFR part 0, appendix to subpart R.                                       22152.                                                                       the affected basic class, and applicants
                                                      In accordance with 21 CFR                                                 SUPPLEMENTARY INFORMATION: The                                               therefore, may file written comments on
                                                    1301.33(a), this is notice that on March                                    Attorney General has delegated his                                           or objections to the issuance of the
                                                    21, 2017, Insys Manufacturing, LLC,                                         authority under the Controlled                                               proposed registration in accordance
                                                    2700 Oakmont Drive, Round Rock,                                             Substances Act to the Administrator of                                       with 21 CFR 1301.33(a) on or before July
                                                    Texas 78665 applied to be registered as                                     the Drug Enforcement Administration                                          18, 2017.
                                                    a bulk manufacturer of the following                                        (DEA), 28 CFR 0.100(b). Authority to
                                                    basic classes of controlled substances:                                                                                                                  ADDRESSES:   Written comments should
                                                                                                                                exercise all necessary functions with
                                                                                                                                respect to the promulgation and                                              be sent to: Drug Enforcement
                                                              Controlled substance                           Schedule           implementation of 21 CFR part 1301,                                          Administration, Attention: DEA Federal
                                                                                                                                incident to the registration of                                              Register Representative/DRW, 8701
                                                    Marihuana (7360) .........................              I                                                                                                Morrissette Drive, Springfield, Virginia
                                                    Tetrahydrocannabinols (7370) .....                      I                   manufacturers, distributors, dispensers,
                                                                                                                                importers, and exporters of controlled                                       22152.
                                                      The company plans to manufacture                                          substances (other than final orders in
                                                                                                                                                                                                             SUPPLEMENTARY INFORMATION:      The
                                                    bulk synthetic active pharmaceutical                                        connection with suspension, denial, or
                                                                                                                                                                                                             Attorney General has delegated his
                                                    ingredients (APIs) for product                                              revocation of registration) has been
                                                                                                                                redelegated to the Assistant                                                 authority under the Controlled
                                                    development and distribution to its                                                                                                                      Substances Act to the Administrator of
                                                    customers. No other activity for these                                      Administrator of the DEA Diversion
                                                                                                                                Control Division (‘‘Assistant                                                the Drug Enforcement Administration
                                                    drug codes is authorized for this                                                                                                                        (DEA), 28 CFR 0.100(b). Authority to
                                                    registration.                                                               Administrator’’) pursuant to section 7 of
                                                                                                                                28 CFR part 0, appendix to subpart R.                                        exercise all necessary functions with
                                                      Dated: May 15, 2017.                                                        In accordance with 21 CFR                                                  respect to the promulgation and
                                                    Louis J. Milione,                                                           1301.33(a), this is notice that on                                           implementation of 21 CFR part 1301,
                                                    Assistant Administrator.                                                    December 2, 2016, Patheon                                                    incident to the registration of
                                                    [FR Doc. 2017–10230 Filed 5–18–17; 8:45 am]                                 Pharmaceuticals, Inc., 2110 E. Galbraith                                     manufacturers, distributors, dispensers,
                                                    BILLING CODE 4410–09–P                                                      Road, Cincinnati, Ohio 45237 applied to                                      importers, and exporters of controlled
                                                                                                                                be registered as a bulk manufacturer of                                      substances (other than final orders in
                                                                                                                                gamma hydroxybutyric acid (2010) a                                           connection with suspension, denial, or
                                                    DEPARTMENT OF JUSTICE                                                       basic class of controlled substance listed                                   revocation of registration) has been
                                                                                                                                in schedule I.                                                               redelegated to the Assistant
                                                    Drug Enforcement Administration                                               The company plans to manufacture                                           Administrator of the DEA Diversion
                                                                                                                                the listed controlled substance for                                          Control Division (‘‘Assistant
                                                    [Docket No. DEA–392]                                                        product development.
                                                                                                                                                                                                             Administrator’’) pursuant to section 7 of
                                                                                                                                  Dated: May 15, 2017.                                                       28 CFR part 0, appendix to subpart R.
                                                    Bulk Manufacturer of Controlled
                                                    Substances Application: Patheon                                             Louis J. Milione,
                                                                                                                                                                                                                In accordance with 21 CFR
                                                    Pharmaceuticals, Inc.                                                       Assistant Administrator.
                                                                                                                                                                                                             1301.33(a), this is notice that on March
                                                                                                                                [FR Doc. 2017–10238 Filed 5–18–17; 8:45 am]
                                                                                                                                                                                                             3, 2017, Eli-Elsohly Laboratories,
                                                    ACTION:       Notice of application.                                        BILLING CODE 4410–09–P
                                                                                                                                                                                                             Mahmoud A. Elsohly Ph. D., 5
                                                    DATES:  Registered bulk manufacturers of                                                                                                                 Industrial Park Drive, Oxford,
                                                    the affected basic class, and applicants                                    DEPARTMENT OF JUSTICE                                                        Mississippi 38655 applied to be
                                                    therefore, may file written comments on                                                                                                                  registered as a bulk manufacturer of the
                                                    or objections to the issuance of the                                        Drug Enforcement Administration                                              following basic classes of controlled
                                                    proposed registration in accordance                                                                                                                      substances:
                                                                                                                                [Docket No. DEA–392]
                                                    with 21 CFR 1301.33(a) on or before July
                                                    18, 2017.                                                                   Bulk Manufacturer of Controlled
                                                    ADDRESSES: Written comments should                                          Substances Application: Eli-Elsohly
                                                    be sent to: Drug Enforcement                                                Laboratories
                                                    Administration, Attention: DEA Federal
                                                                                                                                ACTION:        Notice of application.
                                                    Register Representative/DRW 8701

                                                                                                                             Controlled substance                                                                                          Drug code    Schedule

                                                    Marihuana Extract ...........................................................................................................................................................                7350   I
                                                    Marihuana ........................................................................................................................................................................           7360   I
                                                    Tetrahydrocannabinols ....................................................................................................................................................                   7370   I
                                                    Dihydromorphine .............................................................................................................................................................                9145   I
                                                    Amphetamine ...................................................................................................................................................................              1100   II
                                                    Methamphetamine ...........................................................................................................................................................                  1105   II
asabaliauskas on DSK3SPTVN1PROD with NOTICES




                                                    Cocaine ............................................................................................................................................................................         9041   II
                                                    Codeine ...........................................................................................................................................................................          9050   II
                                                    Dihydrocodeine ................................................................................................................................................................              9120   II
                                                    Oxycodone .......................................................................................................................................................................            9143   II
                                                    Hydromorphone ...............................................................................................................................................................                9150   II
                                                    Ecgonine ..........................................................................................................................................................................          9180   II
                                                    Hydrocodone ...................................................................................................................................................................              9193   II
                                                    Morphine ..........................................................................................................................................................................          9300   II
                                                    Thebaine ..........................................................................................................................................................................          9333   II



                                               VerDate Sep<11>2014         19:15 May 18, 2017          Jkt 241001       PO 00000        Frm 00115        Fmt 4703       Sfmt 4703      E:\FR\FM\19MYN1.SGM                19MYN1


                                                    23068                                        Federal Register / Vol. 82, No. 96 / Friday, May 19, 2017 / Notices

                                                      The company plans to manufacture                                         DEPARTMENT OF JUSTICE                                                       Substances Act to the Administrator of
                                                    the listed controlled substances for                                                                                                                   the Drug Enforcement Administration
                                                    product development and reference                                          Drug Enforcement Administration                                             (DEA), 28 CFR 0.100(b). Authority to
                                                    standards. In reference to drug codes                                      [Docket No. DEA–392]                                                        exercise all necessary functions with
                                                    7360 (marihuana) and 7370 (THC) the                                                                                                                    respect to the promulgation and
                                                    company plans to isolate these                                             Bulk Manufacturer of Controlled                                             implementation of 21 CFR part 1301,
                                                    controlled substances from procured                                        Substances Application: National                                            incident to the registration of
                                                    7350 (marihuana extract). In reference to                                  Center for Natural Products Research                                        manufacturers, distributors, dispensers,
                                                    drug code 7360 no cultivation activities                                   NIDA MPROJECT                                                               importers, and exporters of controlled
                                                    are authorized for this registration. No                                                                                                               substances (other than final orders in
                                                                                                                               ACTION:        Notice of application.
                                                    other activities for these drug codes are                                                                                                              connection with suspension, denial, or
                                                    authorized for this registration.                                          DATES:  Registered bulk manufacturers of                                    revocation of registration) has been
                                                                                                                               the affected basic class, and applicants                                    redelegated to the Assistant
                                                      Dated: May 15, 2017.
                                                                                                                               therefore, may file written comments on                                     Administrator of the DEA Diversion
                                                    Louis J. Milione,
                                                                                                                               or objections to the issuance of the                                        Control Division (‘‘Assistant
                                                    Assistant Administrator.                                                                                                                               Administrator’’) pursuant to section 7 of
                                                                                                                               proposed registration in accordance
                                                    [FR Doc. 2017–10241 Filed 5–18–17; 8:45 am]                                with 21 CFR 1301.33(a) on or before July                                    28 CFR part 0, appendix to subpart R.
                                                    BILLING CODE P                                                             18, 2017.                                                                     In accordance with 21 CFR
                                                                                                                               ADDRESSES: Written comments should                                          1301.33(a), this is notice that on January
                                                                                                                               be sent to: Drug Enforcement                                                20, 2017, National Center for Natural
                                                                                                                               Administration, Attention: DEA Federal                                      Products Research NIDA MPROJECT,
                                                                                                                               Register Representative/DRW, 8701                                           University of Mississippi, 135 Coy
                                                                                                                               Morrissette Drive, Springfield, Virginia                                    Waller Complex, P.O. Box 1848,
                                                                                                                               22152.                                                                      University, Mississippi 38677–1848
                                                                                                                               SUPPLEMENTARY INFORMATION: The                                              applied to be registered as a bulk
                                                                                                                               Attorney General has delegated his                                          manufacturer of the following basic
                                                                                                                               authority under the Controlled                                              classes of controlled substances:

                                                                                                                            Controlled substance                                                                                         Drug code    Schedule

                                                    Marihuana Extract ...........................................................................................................................................................              7350   I
                                                    Marihuana ........................................................................................................................................................................         7360   I
                                                    Tetrahydrocannabinols ....................................................................................................................................................                 7370   I



                                                      The company plans to bulk                                                DEPARTMENT OF JUSTICE                                                       authority under the Controlled
                                                    manufacture the listed controlled                                                                                                                      Substances Act to the Administrator of
                                                    substances to make available to the                                        Drug Enforcement Administration                                             the Drug Enforcement Administration
                                                    National Institute on Drug Abuse                                           [Docket No. DEA–392]                                                        (DEA), 28 CFR 0.100(b). Authority to
                                                    (NIDA) a supply of bulk marihuana for                                                                                                                  exercise all necessary functions with
                                                    distribution to research investigators in                                  Bulk Manufacturer of Controlled                                             respect to the promulgation and
                                                    support of the national research                                           Substances Application: Chemtos,                                            implementation of 21 CFR part 1301,
                                                    program needs. No other activities for                                     LLC                                                                         incident to the registration of
                                                    these drug codes are authorized for this                                                                                                               manufacturers, distributors, dispensers,
                                                                                                                               ACTION:        Notice of application.
                                                    registration.                                                                                                                                          importers, and exporters of controlled
                                                      Dated: May 15, 2017.                                                     DATES:  Registered bulk manufacturers of                                    substances (other than final orders in
                                                                                                                               the affected basic class, and applicants                                    connection with suspension, denial, or
                                                    Louis J. Milione,
                                                                                                                               therefore, may file written comments on                                     revocation of registration) has been
                                                    Assistant Administrator.                                                                                                                               redelegated to the Assistant
                                                                                                                               or objections to the issuance of the
                                                    [FR Doc. 2017–10239 Filed 5–18–17; 8:45 am]                                                                                                            Administrator of the DEA Diversion
                                                                                                                               proposed registration in accordance
                                                    BILLING CODE P                                                             with 21 CFR 1301.33(a) on or before July                                    Control Division (‘‘Assistant
                                                                                                                               18, 2017.                                                                   Administrator’’) pursuant to section 7 of
                                                                                                                               ADDRESSES: Written comments should                                          28 CFR part 0, appendix to subpart R.
                                                                                                                               be sent to: Drug Enforcement                                                  In accordance with 21 CFR
                                                                                                                               Administration, Attention: DEA Federal                                      1301.33(a), this is notice that on July 5,
                                                                                                                               Register Representative/DRW, 8701                                           2016, Chemtos, LLC, 14101 W. Highway
                                                                                                                               Morrissette Drive, Springfield, Virginia                                    290, Building 2000B, Austin, Texas
                                                                                                                               22152.                                                                      78737–9331 applied to be registered as
asabaliauskas on DSK3SPTVN1PROD with NOTICES




                                                                                                                               SUPPLEMENTARY INFORMATION: The                                              a bulk manufacturer for the following
                                                                                                                               Attorney General has delegated his                                          basic classes of controlled substances:

                                                                                                                            Controlled substance                                                                                         Drug code    Schedule

                                                    Mephedrone (4-Methyl-N-methylcathinone) ....................................................................................................................                               1248   I
                                                    Methaqualone ..................................................................................................................................................................            2565   I
                                                    JWH-250 (1-Pentyl-3-(2-methoxyphenylacetyl) indole) ...................................................................................................                                    6250   I
                                                    5-Flouro-UR-144 and XLR11 [1-(5-Fluoro-pentyl)1H-indol-3-yl](2,2,3,3-tetramethylcyclopropyl)methanone .................                                                                    7011   I



                                               VerDate Sep<11>2014         19:15 May 18, 2017          Jkt 241001      PO 00000        Frm 00116       Fmt 4703       Sfmt 4703       E:\FR\FM\19MYN1.SGM               19MYN1



Document Created: 2018-11-08 08:48:14
Document Modified: 2018-11-08 08:48:14
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 class, 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 July 18, 2017.
FR Citation82 FR 23067 

2025 Federal Register | Disclaimer | Privacy Policy
USC | CFR | eCFR