80_FR_38593 80 FR 38465 - Manufacturer of Controlled Substances Registration: Johnson Matthey, Inc.

80 FR 38465 - Manufacturer of Controlled Substances Registration: Johnson Matthey, Inc.

DEPARTMENT OF JUSTICE
Drug Enforcement Administration

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

Page Range38465-38465
FR Document2015-16452

Johnson Matthey, Inc. applied to be registered as a manufacturer of certain basic classes of controlled substances. The Drug Enforcement Administration (DEA) grants Johnson Matthey, Inc. 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]
[Page 38465]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2015-16452]


=======================================================================
-----------------------------------------------------------------------

DEPARTMENT OF JUSTICE

Drug Enforcement Administration

[Docket No. DEA-392]


Manufacturer of Controlled Substances Registration: Johnson 
Matthey, Inc.

ACTION: Notice of registration.

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

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

SUPPLEMENTARY INFORMATION: By notice dated February 11, 2015, and 
published in the Federal Register on February 19, 2015, 80 FR 8901, 
Johnson Matthey, Inc., Custom Pharmaceuticals Department, 2003 Nolte 
Drive, West Deptford, New Jersey 08066-1742 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 Johnson Matthey, Inc. 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 basic classes of controlled substances listed:

------------------------------------------------------------------------
            Controlled substance                       Schedule
------------------------------------------------------------------------
Gamma Hydroxybutyric Acid (2010)...........  I
Marihuana (7360)...........................  I
Tetrahydrocannabinols (7370)...............  I
Dihydromorphine (9145).....................  I
Difenoxin (9168)...........................  I
Propiram (9649)............................  I
Amphetamine (1100).........................  II
Methamphetamine (1105).....................  II
Lisdexamfetamine (1205)....................  II
Methylphenidate (1724).....................  II
Nabilone (7379)............................  II
Cocaine (9041).............................  II
Codeine (9050).............................  II
Dihydrocodeine (9120)......................  II
Oxycodone (9143)...........................  II
Hydromorphone (9150).......................  II
Diphenoxylate (9170).......................  II
Ecgonine (9180)............................  II
Hydrocodone (9193).........................  II
Meperidine (9230)..........................  II
Methadone (9250)...........................  II
Methadone intermediate (9254)..............  II
Morphine (9300)............................  II
Thebaine (9333)............................  II
Oxymorphone (9652).........................  II
Noroxymorphone (9668)......................  II
Alfentanil (9737)..........................  II
Remifentanil (9739)........................  II
Sufentanil (9740)..........................  II
Tapentadol (9780)..........................  II
Fentanyl (9801)............................  II
------------------------------------------------------------------------

    The company plans to manufacture the listed controlled substances 
in bulk for sale to its customers.

    Dated: June 25, 2015.
Joseph T. Rannazzisi,
Deputy Assistant Administrator.
[FR Doc. 2015-16452 Filed 7-2-15; 8:45 am]
 BILLING CODE 4410-09-P



                                                                              Federal Register / Vol. 80, No. 128 / Monday, July 6, 2015 / Notices                                                               38465

                                             the Commission determined that it                        Commission’s Web site at http://                      the public interest and with United
                                             would conduct expedited reviews                          edis.usitc.gov.                                       States obligations under international
                                             pursuant to section 751(c)(3) of the                        In accordance with sections 201.16(c)              treaties, conventions, or protocols in
                                             Tariff Act of 1930 (19 U.S.C. 1675(c)(3)).               and 207.3 of the rules, each document                 effect on May 1, 1971. The DEA
                                                For further information concerning                    filed by a party to the reviews must be               investigated the company’s maintenance
                                             the conduct of these reviews and rules                   served on all other parties to the reviews            of effective controls against diversion by
                                                                                                      (as identified by either the public or BPI            inspecting and testing the company’s
                                             of general application, consult the
                                                                                                      service list), and a certificate of service           physical security systems, verifying the
                                             Commission’s Rules of Practice and
                                                                                                      must be timely filed. The Secretary will              company’s compliance with state and
                                             Procedure, part 201, subparts A and B
                                                                                                      not accept a document for filing without              local laws, and reviewing the company’s
                                             (19 CFR part 201), and part 207,
                                                                                                      a certificate of service.
                                             subparts A, D, E, and F (19 CFR part                        Determination. The Commission has                  background and history.
                                             207).                                                    determined these reviews are                             Therefore, pursuant to 21 U.S.C.
                                                Staff report. A staff report containing               extraordinarily complicated and                       823(a), and in accordance with 21 CFR
                                             information concerning the subject                       therefore has determined to exercise its              1301.33, the above-named company is
                                             matter of these reviews was placed in                    authority to extend the review period by              granted registration as a bulk
                                             the nonpublic record on June 19, 2015,                   up to 90 days pursuant to 19 U.S.C.                   manufacturer of the basic classes of
                                             and made available to persons on the                     1675(c)(5)(B).                                        controlled substances listed:
                                             Administrative Protective Order service                    Authority: These reviews are being
                                             list for these reviews. A public version                 conducted under authority of title VII of the                 Controlled substance                    Schedule
                                             will be issued thereafter, pursuant to                   Tariff Act of 1930; this notice is published
                                             section 207.62(d)(4) of the                              pursuant to section 207.62 of the                     Gamma        Hydroxybutyric           Acid      I
                                             Commission’s rules.                                      Commission’s rules.                                     (2010).
                                                                                                                                                            Marihuana (7360) .........................      I
                                                Written submissions. As provided in                     By order of the Commission.
                                                                                                                                                            Tetrahydrocannabinols (7370) .....              I
                                             section 207.62(d) of the Commission’s                      Issued: June 29, 2015.                              Dihydromorphine (9145) ...............          I
                                             rules, interested parties that are parties               William R. Bishop,                                    Difenoxin (9168) ...........................    I
                                             to these reviews and that have provided                  Supervisory Hearings and Information                  Propiram (9649) ...........................     I
                                             individually adequate responses to the                   Officer.                                              Amphetamine (1100) ....................         II
                                             notice of institution,2 and any party                    [FR Doc. 2015–16434 Filed 7–2–15; 8:45 am]            Methamphetamine (1105) ............             II
                                             other than an interested party to these                  BILLING CODE 7020–02–P                                Lisdexamfetamine (1205) .............           II
                                             reviews may file written comments with                                                                         Methylphenidate (1724) ................         II
                                             the Secretary on what determination the                                                                        Nabilone (7379) ............................    II
                                             Commission should reach in these                         DEPARTMENT OF JUSTICE                                 Cocaine (9041) .............................    II
                                             reviews. Comments are due on or before                                                                         Codeine (9050) .............................    II
                                             July 6, 2015 and may not contain new                     Drug Enforcement Administration                       Dihydrocodeine (9120) .................         II
                                             factual information. Any person that is                                                                        Oxycodone (9143) ........................       II
                                                                                                      [Docket No. DEA–392]
                                             neither a party to these five-year reviews                                                                     Hydromorphone (9150) ................           II
                                             nor an interested party may submit a                     Manufacturer of Controlled                            Diphenoxylate (9170) ...................        II
                                             brief written statement (which shall not                 Substances Registration: Johnson                      Ecgonine (9180) ...........................     II
                                             contain any new factual information)                     Matthey, Inc.                                         Hydrocodone (9193) .....................        II
                                             pertinent to the reviews by July 6, 2015.                                                                      Meperidine (9230) ........................      II
                                             However, should the Department of                        ACTION:   Notice of registration.                     Methadone (9250) ........................       II
                                             Commerce extend the time limit for its                                                                         Methadone intermediate (9254) ...               II
                                             completion of the final results of its                   SUMMARY:   Johnson Matthey, Inc. applied              Morphine (9300) ...........................     II
                                             reviews, the deadline for comments                       to be registered as a manufacturer of                 Thebaine (9333) ...........................     II
                                             (which may not contain new factual                       certain basic classes of controlled                   Oxymorphone (9652) ...................          II
                                             information) on Commerce’s final                         substances. The Drug Enforcement                      Noroxymorphone (9668) ..............            II
                                             results is three business days after the                 Administration (DEA) grants Johnson                   Alfentanil (9737) ...........................   II
                                                                                                      Matthey, Inc. registration as a                       Remifentanil (9739) ......................      II
                                             issuance of Commerce’s results. If
                                                                                                      manufacturer of those controlled                      Sufentanil (9740) ..........................    II
                                             comments contain business proprietary
                                                                                                      substances.                                           Tapentadol (9780) ........................      II
                                             information (BPI), they must conform
                                             with the requirements of sections 201.6,                 SUPPLEMENTARY INFORMATION: By notice                  Fentanyl (9801) ............................    II
                                             207.3, and 207.7 of the Commission’s                     dated February 11, 2015, and published
                                             rules. Please be aware that the                          in the Federal Register on February 19,                 The company plans to manufacture
                                             Commission’s rules with respect to                       2015, 80 FR 8901, Johnson Matthey,                    the listed controlled substances in bulk
                                             filing have changed. The most recent                     Inc., Custom Pharmaceuticals                          for sale to its customers.
                                             amendments took effect on July 25,                       Department, 2003 Nolte Drive, West
                                                                                                                                                              Dated: June 25, 2015.
                                             2014. See 79 FR 35920 (June 25, 2014),                   Deptford, New Jersey 08066–1742
                                                                                                      applied to be registered as a                         Joseph T. Rannazzisi,
                                             and the revised Commission Handbook
                                             on E-filing, available from the                          manufacturer of certain basic classes of              Deputy Assistant Administrator.
                                                                                                      controlled substances. No comments or                 [FR Doc. 2015–16452 Filed 7–2–15; 8:45 am]
Lhorne on DSK7TPTVN1PROD with NOTICES




                                             available from the Office of the Secretary and at the    objections were submitted for this                    BILLING CODE 4410–09–P
                                             Commission’s Web site.                                   notice.
                                               2 The Commission has found the responses                 The DEA has considered the factors in
                                             submitted by L.K. Bowman Co., Monterey                   21 U.S.C. 823(a) and determined that
                                             Mushrooms, Inc., and The Mushroom Co. to be
                                             individually adequate. Comments from other
                                                                                                      the registration of Johnson Matthey, Inc.
                                             interested parties will not be accepted (see 19 CFR      to manufacture the basic classes of
                                             207.62(d)(2)).                                           controlled substances is consistent with


                                        VerDate Sep<11>2014   14:37 Jul 02, 2015   Jkt 235001   PO 00000   Frm 00039   Fmt 4703   Sfmt 9990   E:\FR\FM\06JYN1.SGM   06JYN1



Document Created: 2015-12-15 13:17:11
Document Modified: 2015-12-15 13:17:11
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 38465 

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