[Federal Register Volume 78, Number 54 (Wednesday, March 20, 2013)]
[Notices]
[Page 17230]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2013-06318]


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

DEPARTMENT OF JUSTICE

Drug Enforcement Administration


Importer of Controlled Substances, Notice of Application, United 
States Pharmacopeial Convention

    Pursuant to Title 21 Code of Federal Regulations 1301.34(a), this 
is notice that on January 21, 2013, United States Pharmacopeial 
Convention, 12601 Twinbrook Parkway, Rockville, Maryland 20852, made 
application to the Drug Enforcement Administration (DEA) to be 
registered as an importer of the following basic classes of controlled 
substances:

------------------------------------------------------------------------
                    Drug                               Schedule
------------------------------------------------------------------------
Norlevorphanol (9634)......................  I
Levomethorphan (9210)......................  II
Difenoxin (9168)...........................  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.
    Any bulk manufacturer who is presently, or is applying to be, 
registered with DEA to manufacture such basic classes of controlled 
substances listed in schedules I and II, which falls under the 
authority of section 1002(a)(2)(B) of the Act (21 U.S.C. 952(a)(2)(B)) 
may, in the circumstances set forth in 21 U.S.C. 958(i), file comments 
or objections to the issuance of the proposed registration and may, at 
the same time, file a written request for a hearing on such application 
pursuant to 21 CFR Sec.  1301.43 and in such form as prescribed by 21 
CFR 1316.47.
    Any such written comments or objections should be addressed, in 
quintuplicate, to the Drug Enforcement Administration, Office of 
Diversion Control, Federal Register Representative (ODL), 8701 
Morrissette Drive, Springfield, Virginia 22152; and must be filed no 
later than April 19, 2013.
    This procedure is to be conducted simultaneously with, and 
independent of, the procedures described in 21 CFR Sec.  1301.34(b), 
(c), (d), (e), and (f). As noted in a previous notice published in the 
Federal Register on September 23, 1975, 40 FR 43745-46, all applicants 
for registration to import a basic classes of any controlled substances 
in schedules I or II are, and will continue to be, required to 
demonstrate to the Deputy Assistant Administrator, Office of Diversion 
Control, Drug Enforcement Administration, that the requirements for 
such registration pursuant to 21 U.S.C. 958(a); 21 U.S.C. 823(a); and 
21 CFR 1301.34(b), (c), (d), (e), and (f) are satisfied.

    Dated: March 12, 2013.
Joseph T. Rannazzisi,
Deputy Assistant Administrator, Office of Diversion Control, Drug 
Enforcement Administration.
[FR Doc. 2013-06318 Filed 3-19-13; 8:45 am]
BILLING CODE 4410-09-P