81_FR_22712 81 FR 22638 - Importer of Controlled Substances Registration: Johnson Matthey, Inc.

81 FR 22638 - Importer of Controlled Substances Registration: Johnson Matthey, Inc.

DEPARTMENT OF JUSTICE
Drug Enforcement Administration

Federal Register Volume 81, Issue 74 (April 18, 2016)

Page Range22638-22638
FR Document2016-08847

Johnson Matthey, Inc. applied to be registered as an importer of certain basic classes of controlled substances. The Drug Enforcement Administration (DEA) grants Johnson Matthey, Inc. registration as an importer of those controlled substances.

Federal Register, Volume 81 Issue 74 (Monday, April 18, 2016)
[Federal Register Volume 81, Number 74 (Monday, April 18, 2016)]
[Notices]
[Page 22638]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2016-08847]


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DEPARTMENT OF JUSTICE

Drug Enforcement Administration

[Docket No. DEA-392]


Importer of Controlled Substances Registration: Johnson Matthey, 
Inc.

ACTION: Notice of registration.

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

SUMMARY: Johnson Matthey, Inc. applied to be registered as an importer 
of certain basic classes of controlled substances. The Drug Enforcement 
Administration (DEA) grants Johnson Matthey, Inc. registration as an 
importer of those controlled substances.

SUPPLEMENTARY INFORMATION: By notice dated December 21, 2015, and 
published in the Federal Register on December 29, 2015, 80 FR 81367, 
Johnson Matthey, Inc., Pharmaceutical Materials, 2003 Nolte Drive, West 
Deptford, New Jersey 08066-1742 applied to be registered as an importer 
of certain basic classes of controlled substances. Comments and request 
for hearings on applications to import narcotic raw material are not 
appropriate. 72 FR 3417, (January 25, 2007). Also no comments or 
objections were submitted for this notice.
    The DEA has considered the factors in 21 U.S.C. 823, 952(a) and 
958(a) and determined that the registration of Johnson Matthey, Inc. to 
import 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 onMay 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. 952(a) and 958(a), and in 
accordance with 21 CFR 1301.34, the above-named company is granted 
registration as an importer of the following basic classes of 
controlled substances:

------------------------------------------------------------------------
            Controlled substance                       Schedule
------------------------------------------------------------------------
Coca Leaves (9040).........................  II
Thebaine (9333)............................  II
Opium, raw (9600)..........................  II
Noroxymorphone (9668)......................  II
Poppy Straw Concentrate (9670).............  II
Fentanyl (9801)............................  II
------------------------------------------------------------------------

    The company plans to import thebaine derivatives and fentanyl as 
reference standards.
    The company plans to import the remaining listed controlled 
substances as raw materials, to be used in the manufacture of bulk 
controlled substances, for distribution to its customers. 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 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: April 11, 2016.
Louis J. Milione,
Deputy Assistant Administrator.
[FR Doc. 2016-08847 Filed 4-15-16; 8:45 am]
 BILLING CODE 4410-09-P



                                                  22638                          Federal Register / Vol. 81, No. 74 / Monday, April 18, 2016 / Notices

                                                    The company plans to import small                     protocols in effect onMay 1, 1971. The                      Enforcement Administration (DEA)
                                                  quantities of the listed controlled                     DEA investigated the company’s                              grants Meridian Medical Technologies
                                                  substances for the National Institute on                maintenance of effective controls                           registration as an importer of this
                                                  Drug Abuse (NIDA) for research                          against diversion by inspecting and                         controlled substance.
                                                  activities.                                             testing the company’s physical security
                                                    The company plans to import                           systems, verifying the company’s                            SUPPLEMENTARY INFORMATION:     By notice
                                                  analytical reference standards for                      compliance with state and local laws,                       dated November 27, 2015, and
                                                  distribution to its customers for research              and reviewing the company’s                                 published in the Federal Register on
                                                  and analytical purposes. Placement of                   background and history.                                     December 3, 2015, 80 FR 75691,
                                                  these drug codes onto the company’s                       Therefore, pursuant to 21 U.S.C.                          Meridian Medical Technologies, 2555
                                                  registration does not translate into                    952(a) and 958(a), and in accordance                        Hermelin Drive, Saint Louis, Missouri
                                                  automatic approval of subsequent                        with 21 CFR 1301.34, the above-named                        63144 applied to be registered as an
                                                  permit applications to import controlled                company is granted registration as an                       importer of a certain basic class of
                                                  substances. Approval of permit                          importer of the following basic classes                     controlled substance. No comments or
                                                  applications will occur only when the                   of controlled substances:                                   objections were submitted for this
                                                  registrant’s business activity is                                                                                   notice.
                                                  consistent with what is authorized                              Controlled substance                     Schedule
                                                                                                                                                                        The DEA has considered the factors in
                                                  under 21 U.S.C. 952(a)(2). Authorization                                                                            21 U.S.C. 823, 952(a) and 958(a) and
                                                  will not extend to the import of FDA                    Coca Leaves (9040) .....................        II
                                                                                                          Thebaine (9333) ...........................     II          determined that the registration of
                                                  approved or non-approved finished                       Opium, raw (9600) .......................       II          Meridian Medical Technologies to
                                                  dosage forms for commercial sale.                       Noroxymorphone (9668) ..............            II          import the basic class of controlled
                                                    Dated: April 11, 2016.                                Poppy Straw Concentrate (9670)                  II          substance is consistent with the public
                                                  Louis J. Milione,                                       Fentanyl (9801) ............................    II
                                                                                                                                                                      interest and with United States
                                                  Deputy Assistant Administrator.                                                                                     obligations under international treaties,
                                                                                                             The company plans to import
                                                  [FR Doc. 2016–08842 Filed 4–15–16; 8:45 am]
                                                                                                          thebaine derivatives and fentanyl as                        conventions, or protocols in effect on
                                                  BILLING CODE 4410–09–P
                                                                                                          reference standards.                                        May 1, 1971. The DEA investigated the
                                                                                                             The company plans to import the                          company’s maintenance of effective
                                                                                                          remaining listed controlled substances                      controls against diversion by inspecting
                                                  DEPARTMENT OF JUSTICE                                                                                               and testing the company’s physical
                                                                                                          as raw materials, to be used in the
                                                  Drug Enforcement Administration                         manufacture of bulk controlled                              security systems, verifying the
                                                                                                          substances, for distribution to its                         company’s compliance with state and
                                                  [Docket No. DEA–392]                                    customers. Placement of these drug                          local laws, and reviewing the company’s
                                                                                                          codes onto the company’s registration                       background and history.
                                                  Importer of Controlled Substances
                                                                                                          does not translate into automatic                             Therefore, pursuant to 21 U.S.C.
                                                  Registration: Johnson Matthey, Inc.
                                                                                                          approval of subsequent permit                               952(a) and 958(a), and in accordance
                                                  ACTION:   Notice of registration.                       applications to import controlled                           with 21 CFR 1301.34, the above-named
                                                                                                          substances.                                                 company is granted registration as an
                                                  SUMMARY:   Johnson Matthey, Inc. applied                   Approval of permit applications will                     importer of morphine (9300), a basic
                                                  to be registered as an importer of certain              occur only when the registrant’s
                                                                                                                                                                      class of controlled substance listed in
                                                  basic classes of controlled substances.                 business activity is consistent with what
                                                                                                                                                                      schedule II.
                                                  The Drug Enforcement Administration                     is authorized under 21 U.S.C. 952(a)(2).
                                                  (DEA) grants Johnson Matthey, Inc.                      Authorization will not extend to the                          The company manufactures a product
                                                  registration as an importer of those                    import of FDA approved or non-                              containing morphine in the United
                                                  controlled substances.                                  approved finished dosage forms for                          States. The company exports this
                                                  SUPPLEMENTARY INFORMATION: By notice                    commercial sale.                                            product to customers around the world.
                                                  dated December 21, 2015, and                              Dated: April 11, 2016.                                    The company has been asked to ensure
                                                  published in the Federal Register on                    Louis J. Milione,                                           that its product, which is sold to
                                                  December 29, 2015, 80 FR 81367,                         Deputy Assistant Administrator.
                                                                                                                                                                      European customers, meets the
                                                  Johnson Matthey, Inc., Pharmaceutical                                                                               standards established by the European
                                                                                                          [FR Doc. 2016–08847 Filed 4–15–16; 8:45 am]
                                                  Materials, 2003 Nolte Drive, West                                                                                   Pharmacopeia, administered by the
                                                                                                          BILLING CODE 4410–09–P
                                                  Deptford, New Jersey 08066–1742                                                                                     Directorate for the Quality of Medicines
                                                  applied to be registered as an importer                                                                             (EDQM). In order to ensure that its
                                                  of certain basic classes of controlled                  DEPARTMENT OF JUSTICE                                       product will meet European
                                                  substances. Comments and request for                                                                                specifications, the company seeks to
                                                  hearings on applications to import                      Drug Enforcement Administration                             import morphine supplied by EDQM for
                                                  narcotic raw material are not                                                                                       use as reference standards.
                                                  appropriate. 72 FR 3417, (January 25,                   [Docket No. DEA–392]
                                                  2007). Also no comments or objections                                                                                 This is the sole purpose for which the
                                                                                                          Importer of Controlled Substances                           company will be authorized by the DEA
                                                  were submitted for this notice.                         Registration: Meridian Medical                              to import morphine.
mstockstill on DSK4VPTVN1PROD with NOTICES




                                                    The DEA has considered the factors in                 Technologies
                                                  21 U.S.C. 823, 952(a) and 958(a) and                                                                                  Dated: April 11, 2016.
                                                  determined that the registration of                     ACTION:    Notice of registration.                          Louis J. Milione,
                                                  Johnson Matthey, Inc. to import the                                                                                 Deputy Assistant Administrator.
                                                  basic classes of controlled substances is               SUMMARY:  Meridian Medical
                                                                                                                                                                      [FR Doc. 2016–08844 Filed 4–15–16; 8:45 am]
                                                  consistent with the public interest and                 Technologies applied to be registered as
                                                                                                          an importer of a certain basic class of                     BILLING CODE 4410–09–P
                                                  with United States obligations under
                                                  international treaties, conventions, or                 controlled substance. The Drug


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Document Created: 2016-04-16 01:46:07
Document Modified: 2016-04-16 01:46:07
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 22638 

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