81_FR_9256 81 FR 9220 - Manufacturer of Controlled Substances Registration: Chemtos, LLC

81 FR 9220 - Manufacturer of Controlled Substances Registration: Chemtos, LLC

DEPARTMENT OF JUSTICE
Drug Enforcement Administration

Federal Register Volume 81, Issue 36 (February 24, 2016)

Page Range9220-9220
FR Document2016-03856

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

Federal Register, Volume 81 Issue 36 (Wednesday, February 24, 2016)
[Federal Register Volume 81, Number 36 (Wednesday, February 24, 2016)]
[Notices]
[Page 9220]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2016-03856]


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DEPARTMENT OF JUSTICE

Drug Enforcement Administration

[Docket No. DEA-392]


Manufacturer of Controlled Substances Registration: Chemtos, LLC

ACTION: Notice of registration.

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

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

SUPPLEMENTARY INFORMATION: By notice dated September 16, 2015, and 
published in the Federal Register on September 23, 2015, 80 FR 57389, 
Chemtos, LLC, 14101 W. Highway 290, Building 2000B, Austin, Texas 
78737-9331 applied to be registered as a manufacturer of certain basic 
classes of controlled substances. No comments or objections were 
submitted for this notice.
    The DEA has considered the factors in 21 U.S.C. 823(a) and 
determined that the registration of Chemtos, LLC 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 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 following basic classes of controlled substances:

------------------------------------------------------------------------
            Controlled substance                       Schedule
------------------------------------------------------------------------
Marihuana (7360)...........................  I
Amphetamine (1100).........................  II
Methamphetamine (1105).....................  II
Lisdexamfetamine (1205)....................  II
Methylphenidate (1724).....................  II
Nabilone (7379)............................  II
Phenylacetone (8501).......................  II
Cocaine (9041).............................  II
Codeine (9050).............................  II
Etorphine HCI (9059).......................  II
Dihydrocodeine (9120)......................  II
Oxycodone (9143)...........................  II
Hydromorphone (9150).......................  II
Ecgonine (9180)............................  II
Ethylmorphine (9190).......................  II
Hydrocodone (9193).........................  II
Levomethorphan (9210)......................  II
Levorphanol (9220).........................  II
Isomethadone (9226)........................  II
Meperidine (9230)..........................  II
Meperidine intermediate-A (9232)...........  II
Meperidine intermediate-B (9233)...........  II
Meperidine intermediate-C (9234)...........  II
Methadone (9250)...........................  II
Methadone intermediate (9254)..............  II
Morphine (9300)............................  II
Thebaine (9333)............................  II
Dihydroetorphine (9334)....................  II
Levo-alphacetylmethadol (9648).............  II
Oxymorphone (9652).........................  II
Racemethorphan (9732)......................  II
Racemorphan (9733).........................  II
------------------------------------------------------------------------

    The company plans to manufacture small quantities of the listed 
controlled substances in bulk for distribution to its customers for use 
as reference standards.

    Dated: February 16, 2016.
Louis J. Milione,
Deputy Assistant Administrator.
[FR Doc. 2016-03856 Filed 2-23-16; 8:45 am]
 BILLING CODE 4410-09-P



                                                  9220                          Federal Register / Vol. 81, No. 36 / Wednesday, February 24, 2016 / Notices

                                                          Controlled substance                   Schedule     physical security systems, verifying the                    SUMMARY:  The Attorney General has
                                                                                                              company’s compliance with state and                         delegated her authority under the
                                                  Marihuana (7360) .........................     I            local laws, and reviewing the company’s                     Controlled Substances Act to the
                                                  Tetrahydrocannabinols (7370) .....             I            background and history.                                     Administrator of the Drug Enforcement
                                                  4-Anilino-N-phenethyl-4-piperidine             II             Therefore, pursuant to 21 U.S.C.                          Administration (DEA).
                                                    (ANPP) (8333).
                                                  Remifentanil (9739) ......................     II
                                                                                                              823(a), and in accordance with 21 CFR
                                                                                                                                                                          DATES:  Registered bulk manufacturers of
                                                  Fentanyl (9801) ............................   II           1301.33, the above-named company is
                                                                                                                                                                          the affected basic classes, and
                                                                                                              granted registration as a bulk
                                                                                                                                                                          applicants therefore, may file written
                                                     The company plans to manufacture                         manufacturer of the following basic
                                                                                                                                                                          comments on or objections to the
                                                  the above-listed controlled substances                      classes of controlled substances:
                                                                                                                                                                          issuance of the proposed registration in
                                                  in bulk for distribution to its customers.                                                                              accordance with 21 CFR 1301.33(a) on
                                                  In reference to drug code 7360,                                     Controlled substance                    Schedule
                                                                                                                                                                          or before April 25, 2016.
                                                  marihuana, the company plans to bulk
                                                                                                              Marihuana (7360) .........................      I
                                                  manufacture cannabidiol as a synthetic                                                                                  ADDRESSES:   Written comments should
                                                                                                              Amphetamine (1100) ....................         II
                                                  intermediate. This controlled substance                     Methamphetamine (1105) ............             II          be sent to: Drug Enforcement
                                                  will be further synthesized to bulk                         Lisdexamfetamine (1205) .............           II          Administration, Attention: DEA Federal
                                                  manufacture a synthetic                                     Methylphenidate (1724) ................         II          Register Representative/ODW, 8701
                                                  tetrahydrocannabinols (7370). No other                      Nabilone (7379) ............................    II          Morrissette Drive, Springfield, Virginia
                                                  activity for this drug code is authorized                   Phenylacetone (8501) ..................         II          22152.
                                                  for this registration.                                      Cocaine (9041) .............................    II
                                                                                                              Codeine (9050) .............................    II          SUPPLEMENTARY INFORMATION:      The
                                                    Dated: February 16, 2016.                                 Etorphine HCI (9059) ...................        II          Attorney General has delegated her
                                                  Louis J. Milione,                                           Dihydrocodeine (9120) .................         II          authority under the Controlled
                                                  Deputy Assistant Administrator.                             Oxycodone (9143) ........................       II          Substances Act to the DEA, 28 CFR
                                                  [FR Doc. 2016–03853 Filed 2–23–16; 8:45 am]                 Hydromorphone (9150) ................           II          0.100(b). Authority to exercise all
                                                                                                              Ecgonine (9180) ...........................     II
                                                  BILLING CODE 4410–09–P
                                                                                                              Ethylmorphine (9190) ...................        II
                                                                                                                                                                          necessary functions with respect to the
                                                                                                              Hydrocodone (9193) .....................        II          promulgation and implementation of 21
                                                                                                              Levomethorphan (9210) ...............           II          CFR part 1301, incident to the
                                                  DEPARTMENT OF JUSTICE                                       Levorphanol (9220) ......................       II          registration of manufacturers,
                                                                                                              Isomethadone (9226) ...................         II          distributors, dispensers, importers, and
                                                  Drug Enforcement Administration                             Meperidine (9230) ........................      II          exporters of controlled substances (other
                                                  [Docket No. DEA–392]                                        Meperidine intermediate–A (9232)                II          than final orders in connection with
                                                                                                              Meperidine intermediate–B (9233)                II          suspension, denial, or revocation of
                                                  Manufacturer of Controlled                                  Meperidine intermediate–C (9234)                II          registration) has been redelegated to the
                                                  Substances Registration: Chemtos,                           Methadone (9250) ........................       II
                                                                                                              Methadone intermediate (9254) ...               II
                                                                                                                                                                          Deputy Assistant Administrator of the
                                                  LLC                                                                                                                     DEA Office of Diversion Control
                                                                                                              Morphine (9300) ...........................     II
                                                                                                              Thebaine (9333) ...........................     II          (‘‘Deputy Assistant Administrator’’)
                                                  ACTION:    Notice of registration.
                                                                                                              Dihydroetorphine (9334) ...............         II          pursuant to section 7 of 28 CFR part 0,
                                                  SUMMARY:    Chemtos, LLC applied to be                      Levo-alphacetylmethadol (9648) ..               II          appendix to subpart R.
                                                  registered as a manufacturer of certain                     Oxymorphone (9652) ...................          II             In accordance with 21 CFR
                                                  basic classes of controlled substances.                     Racemethorphan (9732) ..............            II
                                                                                                              Racemorphan (9733) ...................          II
                                                                                                                                                                          1301.33(a), this is notice that on
                                                  The Drug Enforcement Administration                                                                                     November 12, 2015, Insys Therapeutics,
                                                  (DEA) grants Chemtos, LLC registration                                                                                  Inc., 2700 Oakmont, Round Rock, Texas
                                                  as a manufacturer of those controlled                         The company plans to manufacture
                                                                                                              small quantities of the listed controlled                   78665 applied to be registered as a bulk
                                                  substances.                                                                                                             manufacturer of the following basic
                                                                                                              substances in bulk for distribution to its
                                                  SUPPLEMENTARY INFORMATION: By notice                        customers for use as reference                              classes of controlled substances:
                                                  dated September 16, 2015, and                               standards.
                                                  published in the Federal Register on                                                                                             Controlled substance                Schedule
                                                                                                                Dated: February 16, 2016.
                                                  September 23, 2015, 80 FR 57389,
                                                  Chemtos, LLC, 14101 W. Highway 290,                         Louis J. Milione,                                           Marihuana (7360) .........................   I
                                                  Building 2000B, Austin, Texas 78737–                        Deputy Assistant Administrator.                             Tetrahydrocannabinols (7370) .....           I
                                                  9331 applied to be registered as a                          [FR Doc. 2016–03856 Filed 2–23–16; 8:45 am]
                                                  manufacturer of certain basic classes of                    BILLING CODE 4410–09–P                                         The company plans to manufacture
                                                  controlled substances. No comments or                                                                                   the above-listed controlled substances
                                                  objections were submitted for this                                                                                      in bulk for distribution to its customers.
                                                  notice.                                                     DEPARTMENT OF JUSTICE                                       In reference to drug codes 7360,
                                                     The DEA has considered the factors in                                                                                marihuana, and 7370,
                                                  21 U.S.C. 823(a) and determined that                        Drug Enforcement Administration                             tetrahydrocannabinols, the company
                                                  the registration of Chemtos, LLC to                                                                                     plans to bulk manufacture both as
                                                  manufacture the basic classes of                            [Docket No. DEA–392]                                        synthetic substances. No other activity
                                                                                                                                                                          for these drug codes is authorized for
mstockstill on DSK4VPTVN1PROD with NOTICES




                                                  controlled substances is consistent with
                                                  the public interest and with United                         Bulk Manufacturer of Controlled                             this registration.
                                                  States obligations under international                      Substances Application: Insys
                                                                                                              Therapeutics, Inc.                                            Dated: February 16, 2016.
                                                  treaties, conventions, or protocols in
                                                                                                                                                                          Louis J. Milione,
                                                  effect on May 1, 1971. The DEA                              AGENCY: Drug Enforcement
                                                  investigated the company’s maintenance                                                                                  Deputy Assistant Administrator.
                                                                                                              Administration, Justice.
                                                  of effective controls against diversion by                                                                              [FR Doc. 2016–03855 Filed 2–23–16; 8:45 am]
                                                                                                              ACTION: Notice of application.
                                                  inspecting and testing the company’s                                                                                    BILLING CODE 4410–09–P




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Document Created: 2016-02-23 23:55:24
Document Modified: 2016-02-23 23:55:24
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 Citation81 FR 9220 

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