81_FR_63398 81 FR 63220 - Importer of Controlled Substances Application: United States Pharmacopeial Convention

81 FR 63220 - Importer of Controlled Substances Application: United States Pharmacopeial Convention

DEPARTMENT OF JUSTICE
Drug Enforcement Administration

Federal Register Volume 81, Issue 178 (September 14, 2016)

Page Range63220-63221
FR Document2016-22079

Federal Register, Volume 81 Issue 178 (Wednesday, September 14, 2016)
[Federal Register Volume 81, Number 178 (Wednesday, September 14, 2016)]
[Notices]
[Pages 63220-63221]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2016-22079]


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

DEPARTMENT OF JUSTICE

Drug Enforcement Administration

[Docket No. DEA-392]


Importer of Controlled Substances Application: United States 
Pharmacopeial Convention

ACTION: Notice of application.

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

DATES: Registered bulk manufacturers of the affected basic classes, and 
applicants therefore, may file written comments on or objections to the 
issuance of the proposed registration in accordance with 21 CFR 
1301.34(a) on or before October 14, 2016. Such persons may also file a 
written request for a hearing on the application pursuant to 21 CFR 
1301.43 on or before October 14, 2016.

ADDRESSES: Written comments should be sent to: Drug Enforcement 
Administration, Attention: DEA Federal Register Representative/ODW, 
8701 Morrissette Drive, Springfield, Virginia 22152. All requests for 
hearing must be sent to: Drug Enforcement Administration, Attn: 
Administrator, 8701 Morrissette Drive, Springfield, Virginia 22152. All 
requests for hearing should also be sent to: (1) Drug Enforcement 
Administration, Attn: Hearing Clerk/LJ, 8701 Morrissette Drive, 
Springfield, Virginia 22152; and (2) Drug Enforcement Administration, 
Attn: DEA Federal Register Representative/ODW, 8701 Morrissette Drive, 
Springfield, Virginia 22152.

SUPPLEMENTARY INFORMATION: The Attorney General has delegated her 
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 Deputy Assistant Administrator of the DEA Office of Diversion 
Control (``Deputy Assistant Administrator'') pursuant to section 7 of 
28 CFR part 0, appendix to subpart R.
    In accordance with 21 CFR 1301.34(a), this is notice that on 
February 26, 2016, United States Pharmacopeial Convention, 12601 
Twinbrook Parkway, Rockville, Maryland 20852 applied to be registered 
as an importer of the following basic classes of controlled substances:

------------------------------------------------------------------------
            Controlled substance                       Schedule
------------------------------------------------------------------------
Cathinone (1235)............................  I
Methaqualone (2565).........................  I
Lysergic acid diethylamide (7315)...........  I
Marihuana (7360)............................  I

[[Page 63221]]

 
Tetrahydrocannabinols (7370)................  I
4-Methyl-2,5-dimethoxyamphetamine (7395)....  I
3,4-Methylenedioxyamphetamine (7400)........  I
Codeine-N-oxide (9053)......................  I
Difenoxin (9168)............................  I
Heroin (9200)...............................  I
Morphine-N-oxide (9307).....................  I
Norlevorphanol (9634).......................  I
Methamphetamine (1105)......................  II
Phenmetrazine (1631)........................  II
Methylphenidate (1724)......................  II
Amobarbital (2125)..........................  II
Pentobarbital (2270)........................  II
Secobarbital (2315).........................  II
Glutethimide (2550).........................  II
Phencyclidine (7471)........................  II
4-Anilino-N-phenethyl-4-piperidine (ANPP)     II
 (8333).
Phenylacetone (8501)........................  II
Alphaprodine (9010).........................  II
Anileridine (9020)..........................  II
Cocaine (9041)..............................  II
Dihydrocodeine (9120).......................  II
Diphenoxylate (9170)........................  II
Levomethorphan (9210).......................  II
Levorphanol (9220)..........................  II
Meperidine (9230)...........................  II
Dextropropoxyphene, bulk (non-dosage forms)   II
 (9273).
Thebaine (9333).............................  II
Noroxymorphone (9668).......................  II
Alfentanil (9737)...........................  II
Sufentanil (9740)...........................  II
------------------------------------------------------------------------

    The company plans to import the listed controlled substances in 
bulk powder form from foreign sources for the manufacture of analytical 
reference standards for sale to their customers.
    The company plans to import analytical reference standards for 
distribution to its customers for research and analytical purposes. 
Placement of these drug codes onto the company's registration does not 
translate into automatic approval of subsequent permit applications to 
import controlled substances. Approval of permit applications will 
occur only when the registrant's business activity is consistent with 
what is authorized under to 21 U.S.C. 952(a)(2). Authorization will not 
extend to the import of FDA approved or non-approved finished dosage 
forms for commercial sale.

    Dated: September 7, 2016.
Louis J. Milione,
Deputy Assistant Administrator.
[FR Doc. 2016-22079 Filed 9-13-16; 8:45 am]
BILLING CODE 4410-09-P



                                                    63220                            Federal Register / Vol. 81, No. 178 / Wednesday, September 14, 2016 / Notices

                                                                                                                 Company                                                                                        FR Docket                                 Published

                                                    Sigma Aldrich Research Biochemicals, Inc .............................................................................                       81 FR 38217 ..........................            June 13, 2016.



                                                       The DEA has considered the factors in                                  authority under the Controlled                                             applicants therefore, may file written
                                                    21 U.S.C. 823(a) and determined that                                      Substances Act to the Administrator of                                     comments on or objections to the
                                                    the registration of these registrants to                                  the Drug Enforcement Administration                                        issuance of the proposed registration in
                                                    manufacture the applicable basic classes                                  (DEA), 28 CFR 0.100(b). Authority to                                       accordance with 21 CFR 1301.34(a) on
                                                    of controlled substances is consistent                                    exercise all necessary functions with                                      or before October 14, 2016. Such
                                                    with the public interest and with United                                  respect to the promulgation and                                            persons may also file a written request
                                                    States obligations under international                                    implementation of 21 CFR part 1301,                                        for a hearing on the application
                                                    treaties, conventions, or protocols in                                    incident to the registration of                                            pursuant to 21 CFR 1301.43 on or before
                                                    effect on May 1, 1971. The DEA                                            manufacturers, distributors, dispensers,                                   October 14, 2016.
                                                    investigated each of the company’s                                        importers, and exporters of controlled
                                                                                                                                                                                                         ADDRESSES:   Written comments should
                                                    maintenance of effective controls                                         substances (other than final orders in
                                                                                                                                                                                                         be sent to: Drug Enforcement
                                                    against diversion by inspecting and                                       connection with suspension, denial, or
                                                                                                                                                                                                         Administration, Attention: DEA Federal
                                                    testing each company’s physical                                           revocation of registration) has been
                                                                                                                              redelegated to the Deputy Assistant                                        Register Representative/ODW, 8701
                                                    security systems, verifying each                                                                                                                     Morrissette Drive, Springfield, Virginia
                                                    company’s compliance with state and                                       Administrator of the DEA Office of
                                                                                                                              Diversion Control (‘‘Deputy Assistant                                      22152. All requests for hearing must be
                                                    local laws, and reviewing each                                                                                                                       sent to: Drug Enforcement
                                                    company’s background and history.                                         Administrator’’) pursuant to section 7 of
                                                                                                                              28 CFR part 0, appendix to subpart R.                                      Administration, Attn: Administrator,
                                                       Therefore, pursuant to 21 U.S.C.                                                                                                                  8701 Morrissette Drive, Springfield,
                                                    823(a), and in accordance with 21 CFR                                       In accordance with 21 CFR
                                                                                                                              1301.33(a), this is notice that on July 27,                                Virginia 22152. All requests for hearing
                                                    1301.33, the DEA has granted                                                                                                                         should also be sent to: (1) Drug
                                                    registration as a bulk manufacturer to                                    2016, Halo Pharmaceutical, Inc., 30
                                                                                                                              North Jefferson Road, Whippany, New                                        Enforcement Administration, Attn:
                                                    the above listed persons.                                                                                                                            Hearing Clerk/LJ, 8701 Morrissette
                                                                                                                              Jersey 07981 applied to be registered as
                                                      Dated: September 7, 2016.                                               a bulk manufacturer of the following                                       Drive, Springfield, Virginia 22152; and
                                                    Louis J. Milione,                                                         basic classes of controlled substances:                                    (2) Drug Enforcement Administration,
                                                    Deputy Assistant Administrator.                                                                                                                      Attn: DEA Federal Register
                                                    [FR Doc. 2016–22082 Filed 9–13–16; 8:45 am]                                         Controlled substance                           Schedule          Representative/ODW, 8701 Morrissette
                                                    BILLING CODE 4410–09–P                                                                                                                               Drive, Springfield, Virginia 22152.
                                                                                                                              Dihydromorphine (9145) ...............                  I
                                                                                                                              Hydromorphone (9150) ................                   II                 SUPPLEMENTARY INFORMATION:      The
                                                                                                                                                                                                         Attorney General has delegated her
                                                    DEPARTMENT OF JUSTICE                                                                                                                                authority under the Controlled
                                                                                                                                The company plans to manufacture
                                                                                                                              Hydromorphone (9150) for distribution                                      Substances Act to the Administrator of
                                                    Drug Enforcement Administration
                                                                                                                              to its customers. Dihydromorphine                                          the Drug Enforcement Administration
                                                    [Docket No. DEA–392]                                                      (9145) is an intermediate in the                                           (DEA), 28 CFR 0.100(b). Authority to
                                                                                                                              manufacture of Hydromorphone and is                                        exercise all necessary functions with
                                                    Bulk Manufacturer of Controlled                                           not for commercial distribution.                                           respect to the promulgation and
                                                    Substances Application: Halo                                                                                                                         implementation of 21 CFR part 1301,
                                                                                                                                Dated: September 7, 2016.
                                                    Pharmaceutical, Inc.                                                                                                                                 incident to the registration of
                                                                                                                              Louis J. Milione,
                                                                                                                                                                                                         manufacturers, distributors, dispensers,
                                                    ACTION:      Notice of application.                                       Deputy Assistant Administrator.                                            importers, and exporters of controlled
                                                                                                                              [FR Doc. 2016–22074 Filed 9–13–16; 8:45 am]                                substances (other than final orders in
                                                    DATES:  Registered bulk manufacturers of                                  BILLING CODE 4410–09–P                                                     connection with suspension, denial, or
                                                    the affected basic classes, and                                                                                                                      revocation of registration) has been
                                                    applicants therefore, may file written                                                                                                               redelegated to the Deputy Assistant
                                                    comments on or objections to the                                          DEPARTMENT OF JUSTICE                                                      Administrator of the DEA Office of
                                                    issuance of the proposed registration in                                                                                                             Diversion Control (‘‘Deputy Assistant
                                                    accordance with 21 CFR 1301.33(a) on                                      Drug Enforcement Administration
                                                                                                                                                                                                         Administrator’’) pursuant to section 7 of
                                                    or before November 14, 2016.                                              [Docket No. DEA–392]                                                       28 CFR part 0, appendix to subpart R.
                                                    ADDRESSES: Written comments should
                                                                                                                              Importer of Controlled Substances                                            In accordance with 21 CFR
                                                    be sent to: Drug Enforcement                                                                                                                         1301.34(a), this is notice that on
                                                    Administration, Attention: DEA Federal                                    Application: United States
                                                                                                                              Pharmacopeial Convention                                                   February 26, 2016, United States
                                                    Register Representative/ODW, 8701                                                                                                                    Pharmacopeial Convention, 12601
                                                    Morrissette Drive, Springfield, Virginia                                                                                                             Twinbrook Parkway, Rockville,
                                                                                                                              ACTION:       Notice of application.
                                                    22152.                                                                                                                                               Maryland 20852 applied to be registered
                                                                                 The                                          DATES:  Registered bulk manufacturers of                                   as an importer of the following basic
asabaliauskas on DSK3SPTVN1PROD with NOTICES




                                                    SUPPLEMENTARY INFORMATION:
                                                    Attorney General has delegated her                                        the affected basic classes, and                                            classes of controlled substances:

                                                                                                                                        Controlled substance                                                                                                     Schedule

                                                    Cathinone (1235) .........................................................................................................................................................................................   I
                                                    Methaqualone (2565) ..................................................................................................................................................................................       I
                                                    Lysergic acid diethylamide (7315) ...............................................................................................................................................................            I
                                                    Marihuana (7360) ........................................................................................................................................................................................    I



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                                                                                     Federal Register / Vol. 81, No. 178 / Wednesday, September 14, 2016 / Notices                                                                                                       63221

                                                                                                                                          Controlled substance                                                                                                      Schedule

                                                    Tetrahydrocannabinols (7370) .....................................................................................................................................................................              I
                                                    4-Methyl-2,5-dimethoxyamphetamine (7395) ..............................................................................................................................................                         I
                                                    3,4-Methylenedioxyamphetamine (7400) ....................................................................................................................................................                       I
                                                    Codeine-N-oxide (9053) ..............................................................................................................................................................................           I
                                                    Difenoxin (9168) ..........................................................................................................................................................................................     I
                                                    Heroin (9200) ...............................................................................................................................................................................................   I
                                                    Morphine-N-oxide (9307) .............................................................................................................................................................................           I
                                                    Norlevorphanol (9634) .................................................................................................................................................................................         I
                                                    Methamphetamine (1105) ...........................................................................................................................................................................              II
                                                    Phenmetrazine (1631) .................................................................................................................................................................................          II
                                                    Methylphenidate (1724) ...............................................................................................................................................................................          II
                                                    Amobarbital (2125) ......................................................................................................................................................................................       II
                                                    Pentobarbital (2270) ....................................................................................................................................................................................       II
                                                    Secobarbital (2315) .....................................................................................................................................................................................       II
                                                    Glutethimide (2550) .....................................................................................................................................................................................       II
                                                    Phencyclidine (7471) ...................................................................................................................................................................................        II
                                                    4-Anilino-N-phenethyl-4-piperidine (ANPP) (8333) .....................................................................................................................................                          II
                                                    Phenylacetone (8501) .................................................................................................................................................................................          II
                                                    Alphaprodine (9010) ....................................................................................................................................................................................        II
                                                    Anileridine (9020) ........................................................................................................................................................................................     II
                                                    Cocaine (9041) ............................................................................................................................................................................................     II
                                                    Dihydrocodeine (9120) ................................................................................................................................................................................          II
                                                    Diphenoxylate (9170) ..................................................................................................................................................................................         II
                                                    Levomethorphan (9210) ..............................................................................................................................................................................            II
                                                    Levorphanol (9220) .....................................................................................................................................................................................        II
                                                    Meperidine (9230) .......................................................................................................................................................................................       II
                                                    Dextropropoxyphene, bulk (non-dosage forms) (9273) ..............................................................................................................................                               II
                                                    Thebaine (9333) ..........................................................................................................................................................................................      II
                                                    Noroxymorphone (9668) ..............................................................................................................................................................................            II
                                                    Alfentanil (9737) ..........................................................................................................................................................................................    II
                                                    Sufentanil (9740) .........................................................................................................................................................................................     II



                                                       The company plans to import the                                         DEPARTMENT OF JUSTICE                                                        substances (other than final orders in
                                                    listed controlled substances in bulk                                                                                                                    connection with suspension, denial, or
                                                    powder form from foreign sources for                                       Drug Enforcement Administration                                              revocation of registration) has been
                                                    the manufacture of analytical reference                                    [Docket No. DEA–392]                                                         redelegated to the Deputy Assistant
                                                    standards for sale to their customers.                                                                                                                  Administrator of the DEA Office of
                                                       The company plans to import                                             Bulk Manufacturer of Controlled                                              Diversion Control (‘‘Deputy Assistant
                                                    analytical reference standards for                                         Substances Application: Insys                                                Administrator’’) pursuant to section 7 of
                                                                                                                               Manufacturing LLC                                                            28 CFR part 0, appendix to subpart R.
                                                    distribution to its customers for research
                                                    and analytical purposes. Placement of                                      ACTION:        Notice of application.                                          In accordance with 21 CFR
                                                    these drug codes onto the company’s                                                                                                                     1301.33(a), this is notice that on June
                                                    registration does not translate into                                       DATES:  Registered bulk manufacturers of                                     29, 2016, Insys Manufacturing LLC, 811
                                                    automatic approval of subsequent                                           the affected basic classes, and                                              Paloma Drive, Suite C, Round Rock,
                                                    permit applications to import controlled                                   applicants therefore, may file written                                       Texas 78665–2402 applied to be
                                                    substances. Approval of permit                                             comments on or objections to the                                             registered as a bulk manufacturer the
                                                    applications will occur only when the                                      issuance of the proposed registration in                                     following basic classes of controlled
                                                    registrant’s business activity is                                          accordance with 21 CFR 1301.33(a) on                                         substances:
                                                    consistent with what is authorized                                         or before November 14, 2016.
                                                    under to 21 U.S.C. 952(a)(2).                                              ADDRESSES: Written comments should                                                     Controlled substance                          Schedule
                                                    Authorization will not extend to the                                       be sent to: Drug Enforcement
                                                                                                                               Administration, Attention: DEA Federal                                       Marihuana (7360) .........................              I
                                                    import of FDA approved or non-
                                                                                                                               Register Representative/ODW, 8701                                            Tetrahydrocannabinols (7370) .....                      I
                                                    approved finished dosage forms for
                                                                                                                               Morrissette Drive, Springfield, Virginia
                                                    commercial sale.
                                                                                                                               22152.                                                                         The company plans to manufacture
                                                      Dated: September 7, 2016.                                                                                                                             bulk synthetic active pharmaceutical
                                                                                                                               SUPPLEMENTARY INFORMATION: The
                                                    Louis J. Milione,                                                          Attorney General has delegated her                                           ingredients (APIs) for product
                                                    Deputy Assistant Administrator.                                            authority under the Controlled                                               development and distribution to its
                                                                                                                               Substances Act to the Administrator of                                       customers. No other activity for these
asabaliauskas on DSK3SPTVN1PROD with NOTICES




                                                    [FR Doc. 2016–22079 Filed 9–13–16; 8:45 am]
                                                    BILLING CODE 4410–09–P                                                     the Drug Enforcement Administration                                          drug codes are authorized for this
                                                                                                                               (DEA), 28 CFR 0.100(b). Authority to                                         registration.
                                                                                                                               exercise all necessary functions with                                          Dated: September 7, 2016.
                                                                                                                               respect to the promulgation and
                                                                                                                                                                                                            Louis J. Milione,
                                                                                                                               implementation of 21 CFR part 1301,
                                                                                                                               incident to the registration of                                              Deputy Assistant Administrator.
                                                                                                                               manufacturers, distributors, dispensers,                                     [FR Doc. 2016–22075 Filed 9–13–16; 8:45 am]
                                                                                                                               importers, and exporters of controlled                                       BILLING CODE 4410–09–P




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Document Created: 2016-09-14 02:27:20
Document Modified: 2016-09-14 02:27:20
CategoryRegulatory Information
CollectionFederal Register
sudoc ClassAE 2.7:
GS 4.107:
AE 2.106:
PublisherOffice of the Federal Register, National Archives and Records Administration
SectionNotices
ActionNotice of application.
DatesRegistered bulk manufacturers of the affected basic classes, and applicants therefore, may file written comments on or objections to the issuance of the proposed registration in accordance with 21 CFR 1301.34(a) on or before October 14, 2016. Such persons may also file a written request for a hearing on the application pursuant to 21 CFR 1301.43 on or before October 14, 2016.
FR Citation81 FR 63220 

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