[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]
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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:
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Drug Schedule
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Norlevorphanol (9634)...................... I
Levomethorphan (9210)...................... II
Difenoxin (9168)........................... II
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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