80_FR_38595 80 FR 38467 - Manufacturer of Controlled Substances Registration: Rhodes Technologies

80 FR 38467 - Manufacturer of Controlled Substances Registration: Rhodes Technologies

DEPARTMENT OF JUSTICE
Drug Enforcement Administration

Federal Register Volume 80, Issue 128 (July 6, 2015)

Page Range38467-38468
FR Document2015-16458

Rhodes Technologies applied to be registered as a manufacturer of certain basic classes of controlled substances. The Drug Enforcement Administration (DEA) grants Rhodes Technologies registration as a manufacturer of those controlled substances.

Federal Register, Volume 80 Issue 128 (Monday, July 6, 2015)
[Federal Register Volume 80, Number 128 (Monday, July 6, 2015)]
[Notices]
[Pages 38467-38468]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2015-16458]


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

DEPARTMENT OF JUSTICE

Drug Enforcement Administration

[Docket No. DEA-392]


Manufacturer of Controlled Substances Registration: Rhodes 
Technologies

ACTION: Notice of registration.

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

SUMMARY: Rhodes Technologies applied to be registered as a manufacturer 
of certain basic classes of controlled substances. The Drug Enforcement 
Administration (DEA) grants Rhodes Technologies registration as a 
manufacturer of those controlled substances.

SUPPLEMENTARY INFORMATION: By notice dated January 21, 2015, and 
published in the Federal Register on January 28, 2015, 80 FR 4593, 
Rhodes Technologies, 498 Washington Street, Coventry, Rhode Island 
02816 applied to be registered as a manufacturer of certain basic 
classes of controlled substances. One objection was received on March 
27, 2015. However, after a thorough review of this matter, the Drug 
Enforcement Administration has concluded that the issues raised in the 
objection do not warrant the denial of this application.
    The DEA has considered the factors in 21 U.S.C. 823(a) and 
determined that the registration of Rhodes Technologies to manufacture 
the basic classes of controlled substances is consistent with the 
public interest and with United States obligations under international 
treaties, conventions, or protocols in effect on May 1, 1971. The DEA 
investigated the company's maintenance

[[Page 38468]]

of effective controls against diversion by inspecting and testing the 
company's physical security systems, verifying the company's compliance 
with state and local laws, and reviewing the company's background and 
history.
    Therefore, pursuant to 21 U.S.C. 823(a), and in accordance with 21 
CFR 1301.33, the above-named company is granted registration as a bulk 
manufacturer of the basic classes of controlled substances:

------------------------------------------------------------------------
            Controlled substance                       Schedule
------------------------------------------------------------------------
Tetrahydrocannabinols (7370)...............  I
Methylphenidate (1724).....................  II
Codeine (9050).............................  II
Dihydrocodeine (9120)......................  II
Oxycodone (9143)...........................  II
Hydromorphone (9150).......................  II
Hydrocodone (9193).........................  II
Levorphanol (9220).........................  II
Morphine (9300)............................  II
Oripavine (9330)...........................  II
Thebaine (9333)............................  II
Oxymorphone (9652).........................  II
Noroxymorphone (9668)......................  II
Tapentadol (9780)..........................  II
Fentanyl (9801)............................  II
------------------------------------------------------------------------

    The company plans to manufacture the above-listed controlled 
substances in bulk for conversion and sale to dosage form 
manufacturers.
    In reference to drug code 7370, the company plans to bulk 
manufacture a synthetic tetrahydrocannabinol. No other activity for 
this drug code is authorized for this registration.

    Dated: June 25, 2015.
Joseph T. Rannazzisi,
Deputy Assistant Administrator.
[FR Doc. 2015-16458 Filed 7-2-15; 8:45 am]
BILLING CODE 4410-09-P



                                                                              Federal Register / Vol. 80, No. 128 / Monday, July 6, 2015 / Notices                                                             38467

                                               Dated: June 25, 2015.                                  form (FDF) from foreign sources for                   California 95670 applied to be registered
                                             Joseph T. Rannazzisi,                                    analytical testing and clinical trials in             as a bulk manufacturer of the following
                                             Deputy Assistant Administrator.                          which the foreign FDF will be compared                basic classes of controlled substances:
                                             [FR Doc. 2015–16456 Filed 7–2–15; 8:45 am]               to the company’s own domestically-
                                             BILLING CODE 4410–09–P                                   manufactured FDF. This analysis is                            Controlled substance                  Schedule
                                                                                                      required to allow the company to export
                                                                                                                                                            Methylphenidate (1724) ................       II
                                                                                                      domestically-manufactured FDF to
                                                                                                                                                            Thebaine (9333) ...........................   II
                                             DEPARTMENT OF JUSTICE                                    foreign markets.                                      Poppy Straw Concentrate (9670)                II
                                                                                                        Dated: June 25, 2015.                               Tapentadol (9780) ........................    II
                                             Drug Enforcement Administration
                                                                                                      Joseph T. Rannazzisi,
                                             [Docket No. DEA–392]                                     Deputy Assistant Administrator.                         The company is a contract
                                                                                                                                                            manufacturer. In reference to Poppy
                                                                                                      [FR Doc. 2015–16444 Filed 7–2–15; 8:45 am]
                                             Importer of Controlled Substances                                                                              Straw Concentrate the company will
                                                                                                      BILLING CODE 4410–09–P
                                             Application: Kremers Urban                                                                                     manufacture thebaine intermediates for
                                             Pharmaceuticals, Inc.                                                                                          sale to its customers for further
                                                                                                      DEPARTMENT OF JUSTICE                                 manufacture. No other activity for this
                                             ACTION:   Notice of application.                                                                               drug code is authorized for this
                                                                                                      Drug Enforcement Administration                       registration.
                                             DATES:   Registered bulk manufacturers of
                                             the affected basic class, and applicants                 [Docket No. DEA–392]                                    Dated: June 25, 2015.
                                             therefore, may file written comments on                                                                        Joseph T. Rannazzisi,
                                             or objections to the issuance of the                     Bulk Manufacturer of Controlled                       Deputy Assistant Administrator.
                                             proposed registration in accordance                      Substances Application: AMPAC Fine                    [FR Doc. 2015–16443 Filed 7–2–15; 8:45 am]
                                             with 21 CFR 1301.34(a) on or before                      Chemicals LLC                                         BILLING CODE 4410–09–P
                                             August 5, 2015. Such persons may also
                                             file a written request for a hearing on                  ACTION:   Notice of application.
                                             the application pursuant to 21 CFR                                                                             DEPARTMENT OF JUSTICE
                                                                                                      DATES:  Registered bulk manufacturers of
                                             1301.43 on or before August 5, 2015.
                                                                                                      the affected basic classes, and                       Drug Enforcement Administration
                                             ADDRESSES: Written comments should
                                                                                                      applicants therefore, may file written
                                             be sent to: Drug Enforcement                             comments on or objections to the                      [Docket No. DEA–392]
                                             Administration, Attention: DEA Federal                   issuance of the proposed registration in
                                             Register Representative/ODXL/8701                                                                              Manufacturer of Controlled
                                                                                                      accordance with 21 CFR 1301.33(a) on
                                             Morrissette Drive, Springfield, Virginia                                                                       Substances Registration: Rhodes
                                                                                                      or before September 4, 2015.
                                             22152. Request for hearings should be                                                                          Technologies
                                                                                                      ADDRESSES: Written comments should
                                             sent to: Drug Enforcement
                                             Administration, Attention: Hearing                       be sent to: Drug Enforcement                          ACTION:    Notice of registration.
                                             Clerk/LJ, 8701 Morrissette Drive,                        Administration, Attention: DEA Federal
                                                                                                      Register Representative/ODXL, 8701                    SUMMARY:    Rhodes Technologies applied
                                             Springfield, Virginia 22152.                                                                                   to be registered as a manufacturer of
                                                                                                      Morrissette Drive, Springfield, Virginia
                                             SUPPLEMENTARY INFORMATION: The                                                                                 certain basic classes of controlled
                                                                                                      22152. Request for hearings should be
                                             Attorney General has delegated his                                                                             substances. The Drug Enforcement
                                                                                                      sent to: Drug Enforcement
                                             authority under the Controlled                                                                                 Administration (DEA) grants Rhodes
                                                                                                      Administration, Attention: Hearing
                                             Substances Act to the Administrator of                                                                         Technologies registration as a
                                             the Drug Enforcement Administration                      Clerk/LJ, 8701 Morrissette Drive,
                                                                                                      Springfield, Virginia 22152.                          manufacturer of those controlled
                                             (DEA), 28 CFR 0.100(b). Authority to                                                                           substances.
                                             exercise all necessary functions with                    SUPPLEMENTARY INFORMATION: The
                                             respect to the promulgation and                          Attorney General has delegated his                    SUPPLEMENTARY INFORMATION: By notice
                                             implementation of 21 CFR part 1301,                      authority under the Controlled                        dated January 21, 2015, and published
                                             incident to the registration of                          Substances Act to the Administrator of                in the Federal Register on January 28,
                                             manufacturers, distributors, dispensers,                 the Drug Enforcement Administration                   2015, 80 FR 4593, Rhodes Technologies,
                                             importers, and exporters of controlled                   (DEA), 28 CFR 0.100(b). Authority to                  498 Washington Street, Coventry, Rhode
                                             substances (other than final orders in                   exercise all necessary functions with                 Island 02816 applied to be registered as
                                             connection with suspension, denial, or                   respect to the promulgation and                       a manufacturer of certain basic classes
                                             revocation of registration) has been                     implementation of 21 CFR part 1301,                   of controlled substances. One objection
                                             redelegated to the Deputy Assistant                      incident to the registration of                       was received on March 27, 2015.
                                             Administrator of the DEA Office of                       manufacturers, distributors, dispensers,              However, after a thorough review of this
                                             Diversion Control (‘‘Deputy Assistant                    importers, and exporters of controlled                matter, the Drug Enforcement
                                             Administrator’’) pursuant to section 7 of                substances (other than final orders in                Administration has concluded that the
                                             28 CFR part 0, appendix to subpart R.                    connection with suspension, denial, or                issues raised in the objection do not
                                                 In accordance with 21 CFR                            revocation of registration) has been                  warrant the denial of this application.
                                             1301.34(a), this is notice that on January               redelegated to the Deputy Assistant                      The DEA has considered the factors in
                                             12, 2015, Kremers Urban                                  Administrator of the DEA Office of                    21 U.S.C. 823(a) and determined that
                                             Pharmaceuticals, Inc., 1101 C Avenue                     Diversion Control (‘‘Deputy Assistant                 the registration of Rhodes Technologies
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                                             West, Seymour, Indiana 47274 applied                     Administrator’’) pursuant to section 7 of             to manufacture the basic classes of
                                             to be registered as an importer of                       28 CFR part 0, appendix to subpart R.                 controlled substances is consistent with
                                             methylphenidate (1724), a basic class of                    In accordance with 21 CFR                          the public interest and with United
                                             controlled substance listed in schedule                  1301.33(a), this is notice that on March              States obligations under international
                                             II.                                                      20, 2015, AMPAC Fine Chemicals LLC,                   treaties, conventions, or protocols in
                                                 The company plans to import the                      Highway 50 and Hazel Avenue,                          effect on May 1, 1971. The DEA
                                             listed substances in finished dosage                     Building 05001, Rancho Cordova,                       investigated the company’s maintenance


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                                             38468                                       Federal Register / Vol. 80, No. 128 / Monday, July 6, 2015 / Notices

                                             of effective controls against diversion by                                 synthetic tetrahydrocannabinol. No                                         Register Representative/ODXL, 8701
                                             inspecting and testing the company’s                                       other activity for this drug code is                                       Morrissette Drive, Springfield, Virginia
                                             physical security systems, verifying the                                   authorized for this registration.                                          22152. Request for hearings should be
                                             company’s compliance with state and                                          Dated: June 25, 2015.                                                    sent to: Drug Enforcement
                                             local laws, and reviewing the company’s                                    Joseph T. Rannazzisi,
                                                                                                                                                                                                   Administration, Attention: Hearing
                                             background and history.                                                                                                                               Clerk/LJ, 8701 Morrissette Drive,
                                               Therefore, pursuant to 21 U.S.C.                                         Deputy Assistant Administrator.
                                                                                                                                                                                                   Springfield, Virginia 22152.
                                             823(a), and in accordance with 21 CFR                                      [FR Doc. 2015–16458 Filed 7–2–15; 8:45 am]
                                                                                                                                                                                                   SUPPLEMENTARY INFORMATION:      The
                                             1301.33, the above-named company is                                        BILLING CODE 4410–09–P
                                                                                                                                                                                                   Attorney General has delegated his
                                             granted registration as a bulk
                                                                                                                                                                                                   authority under the Controlled
                                             manufacturer of the basic classes of
                                                                                                                        DEPARTMENT OF JUSTICE                                                      Substances Act to the Administrator of
                                             controlled substances:
                                                                                                                                                                                                   the Drug Enforcement Administration
                                                       Controlled substance                          Schedule           Drug Enforcement Administration                                            (DEA), 28 CFR 0.100(b). Authority to
                                                                                                                        [Docket No. DEA–392]
                                                                                                                                                                                                   exercise all necessary functions with
                                             Tetrahydrocannabinols (7370) .....                     I                                                                                              respect to the promulgation and
                                             Methylphenidate (1724) ................                II                  Importer of Controlled Substances                                          implementation of 21 CFR part 1301,
                                             Codeine (9050) .............................           II                                                                                             incident to the registration of
                                             Dihydrocodeine (9120) .................                II
                                                                                                                        Application: Lipomed, Inc.
                                                                                                                                                                                                   manufacturers, distributors, dispensers,
                                             Oxycodone (9143) ........................              II
                                             Hydromorphone (9150) ................                  II                  ACTION:       Notice of application.                                       importers, and exporters of controlled
                                             Hydrocodone (9193) .....................               II                                                                                             substances (other than final orders in
                                             Levorphanol (9220) ......................              II                  DATES:  Registered bulk manufacturers of                                   connection with suspension, denial, or
                                             Morphine (9300) ...........................            II                  the affected basic classes, and                                            revocation of registration) has been
                                             Oripavine (9330) ...........................           II                  applicants therefore, may file written                                     redelegated to the Deputy Assistant
                                             Thebaine (9333) ...........................            II                  comments on or objections to the                                           Administrator of the DEA Office of
                                             Oxymorphone (9652) ...................                 II                  issuance of the proposed registration in                                   Diversion Control (‘‘Deputy Assistant
                                             Noroxymorphone (9668) ..............                   II                  accordance with 21 CFR 1301.34(a) on                                       Administrator’’) pursuant to section 7 of
                                             Tapentadol (9780) ........................             II
                                             Fentanyl (9801) ............................           II                  or before August 5, 2015. Such persons                                     28 CFR part 0, appendix to subpart R.
                                                                                                                        may also file a written request for a                                        In accordance with 21 CFR
                                               The company plans to manufacture                                         hearing on the application pursuant to                                     1301.34(a), this is notice that on March
                                             the above-listed controlled substances                                     21 CFR 1301.43 on or before August 5,                                      31, 2014, Lipomed, Inc., One Broadway,
                                             in bulk for conversion and sale to                                         2015.                                                                      Cambridge, Massachusetts 02142
                                             dosage form manufacturers.                                                 ADDRESSES: Written comments should                                         applied to be registered as an importer
                                               In reference to drug code 7370, the                                      be sent to: Drug Enforcement                                               of the following basic classes of
                                             company plans to bulk manufacture a                                        Administration, Attention: DEA Federal                                     controlled substances:

                                                                                                                               Controlled substance                                                                                                      Schedule

                                             Cathinone (1235) ..................................................................................................................................................................................     I
                                             Methcathinone (1237) ...........................................................................................................................................................................        I
                                             Mephedrone (4-Methyl-N-methylcathinone) (1248) ..............................................................................................................................                           I
                                             N-Ethylamphetamine (1475) .................................................................................................................................................................             I
                                             N,N-Dimethylamphetamine (1480) ........................................................................................................................................................                 I
                                             Fenethylline (1503) ...............................................................................................................................................................................     I
                                             Aminorex (1585) ....................................................................................................................................................................................    I
                                             4-Methylaminorex (cis isomer) (1590) ..................................................................................................................................................                 I
                                             Gamma Hydroxybutyric Acid (2010) .....................................................................................................................................................                  I
                                             Methaqualone (2565) ............................................................................................................................................................................        I
                                             Mecloqualone (2572) ............................................................................................................................................................................        I
                                             JWH–250 (1-Pentyl-3-(2-methoxyphenylacetyl) indole) (6250) ............................................................................................................                                 I
                                             SR–18 (Also known as RCS–8) (1-Cyclohexylethyl-3-(2-methoxyphenylacetyl) indole) (7008) ..........................................................                                                      I
                                             JWH–019 (1-Hexyl-3-(1-naphthoyl)indole) (7019) ................................................................................................................................                         I
                                             JWH–081 (1-Pentyl-3-(1-(4-methoxynaphthoyl) indole) (7081) ............................................................................................................                                 I
                                             SR–19 (Also known as RCS–4) (1-Pentyl-3-[(4-methoxy)-benzoyl] indole (7104) ..............................................................................                                              I
                                             JWH–018 (also known as AM678) (1-Pentyl-3-(1-naphthoyl) indole) (7118) ......................................................................................                                           I
                                             JWH–122 (1-Pentyl-3-(4-methyl-1-naphthoyl) indole) (7122) ...............................................................................................................                               I
                                             JWH–073 (1-Butyl-3-(1-naphthoyl)indole) (7173) .................................................................................................................................                        I
                                             JWH–200 (1-[2-(4-Morpholinyl)ethyl]-3-(1-naphthoyl) indole) (7200) ...................................................................................................                                  I
                                             AM–2201 (1-(5-Fluoropentyl)-3-(1-naphthoyl) indole) (7201) ...............................................................................................................                              I
                                             JWH–203 (1-Pentyl-3-(2-chlorophenylacetyl) indole) (7203) ................................................................................................................                              I
                                             Alpha-ethyltryptamine (7249) ................................................................................................................................................................           I
                                             Ibogaine (7260) .....................................................................................................................................................................................   I
                                             CP–47,497 (5-(1,1-Dimethylheptyl)-2-[(1R,3S)-3-hydroxycyclohexyl-phenol) (7297) ..........................................................................                                              I
                                             CP–47,497 C8 Homologue (5-(1,1-Dimethyloctyl)-2-[(1R,3S)3-hydroxycyclohexyl-phenol) (7298) ....................................................                                                         I
                                             Lysergic acid diethylamide (7315) ........................................................................................................................................................              I
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                                             2,5-Dimethoxy-4-(n)-propylthiophenethylamine (2C–T–7) (7348) ........................................................................................................                                   I
                                             Marihuana (7360) ..................................................................................................................................................................................     I
                                             Tetrahydrocannabinols (7370) ..............................................................................................................................................................             I
                                             Parahexyl (7374) ...................................................................................................................................................................................    I
                                             Mescaline (7381) ...................................................................................................................................................................................    I
                                             2-(4-Ethylthio-2,5-dimethoxyphenyl) ethanamine (2C–T–2) (7385) .....................................................................................................                                    I
                                             3,4,5-Trimethoxyamphetamine (7390) ..................................................................................................................................................                   I
                                             4-Bromo-2,5-dimethoxyamphetamine (7391) .......................................................................................................................................                         I



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Document Created: 2015-12-15 13:17:18
Document Modified: 2015-12-15 13:17:18
CategoryRegulatory Information
CollectionFederal Register
sudoc ClassAE 2.7:
GS 4.107:
AE 2.106:
PublisherOffice of the Federal Register, National Archives and Records Administration
SectionNotices
ActionNotice of registration.
FR Citation80 FR 38467 

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