[Federal Register Volume 75, Number 24 (Friday, February 5, 2010)]
[Notices]
[Pages 6061-6062]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2010-2570]


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DEPARTMENT OF JUSTICE

Drug Enforcement Administration


Importer of Controlled Substances; Notice of Registration

    By Notice dated January 9, 2009, and published in the Federal 
Register on January 21, 2009, (74 FR 3641), Kenco VPI, Division of 
Kenco Group, Inc., 350 Corporate Place, Chattanooga, Tennessee 37419, 
made application by renewal to the Drug Enforcement Administration 
(DEA) to be registered as an importer of Nabilone (7379), a basic class 
of controlled substance listed in schedule II.
    The company plans to import the listed controlled substance for 
distribution to its customers.
    One comment was received concerning this application. The comment 
states that DEA added Schedule II and the drug code for Nabilone (7379) 
to Kenco VPI's importer registration without the benefit of the 
required legal process for modifying the DEA registration. The comment 
further states that, after Kenco VPI was properly registered as an 
importer of Nabilone on November 1, 2006, there was no further mention 
of Nabilone in any subsequent notices of Kenco VPI's applications or 
approval of its applications published in the Federal Register by DEA 
until the application published on January 21, 2009. (74 FR 3641) The 
comment also requested clarification whether Kenco VPI imports Nabilone 
in finished drug product in dosage form or in bulk active 
pharmaceutical ingredient (API) form. Finally, the comment inquires if 
the aggregate national quota for Nabilone established by DEA will be 
affected by Kenco VPI's application.
    DEA's response to the issues raised in the comment are as follows: 
DEA has already admitted that Kenco VPI's importer registration 
received Schedule II and the drug code for Nabilone without the benefit 
of the required legal process. On August 1, 2006, a Notice of 
Application (71 FR 43526) was published for Kenco VPI in the Federal 
Register. Subsequently, on November 1, 2006, a Notice of Registration 
(71 FR 64298) was published. These notices addressed DEA's issuance to 
Kenco VPI's importer registration of Schedule II and the drug code for 
Nabilone without the benefit of the required legal process. As a result 
of the publication of these notices, Kenco VPI's importer registration 
has been legally authorized to import Nabilone, effective: November 1, 
2006.
    DEA rejects the comment's assertion that, between November 1, 2006 
and January 21, 2009, there was no further mention of Nabilone in any 
subsequent notices of Kenco VPI's applications or approval of its 
applications published in the Federal Register by DEA. This assertion 
is incorrect. Four notices were published between November 1, 2006 and 
January 21, 2009 as follows: (71 FR 66974, November 17, 2006), (72 FR 
8792, February 27, 2007), (73 FR 14840, March 19, 2008), (73 FR 31510, 
June 2, 2008). Each of these notices mentions Nabilone.
    With regard to the comment's request for clarification of whether 
Kenco VPI imports Nabilone in finished drug product in dosage form or 
in bulk active pharmaceutical ingredient (API) form, the company 
imports finished drug products in dosage form only. Kenco VPI does not 
import Nabilone in bulk active pharmaceutical ingredient (API) form. 
Since there are no domestic sources of Nabilone in finished drug 
product form available within the United States and since the product 
which Kenco VPI imports has been approved for medical use within the 
United States by the U.S. Food and Drug Administration, DEA finds no 
reason to reject Kenco VPI's application. The

[[Page 6062]]

aggregate national quota for Nabilone established by DEA will not be 
affected by this application of Kenco VPI since the company imports 
Nabilone in finished drug product form only.
    DEA has considered the factors in 21 U.S.C. 823(a) and 952(a) and 
determined that the registration of Kenco VPI to import the basic class 
of controlled substance is consistent with the public interest, and 
with United States obligations under international treaties, 
conventions, or protocols in effect on May 1, 1971, at this time. DEA 
has investigated Kenco VPI to ensure that the company's registration is 
consistent with the public interest. The investigation has included 
inspection and testing of the company's physical security systems, 
verification of the company's compliance with state and local laws, and 
a review of the company's background and history. Therefore, pursuant 
to 21 U.S.C. 952(a) and Sec.  958(a), and in accordance with 21 CFR 
1301.34, the above named company is granted registration as an importer 
of the basic class of controlled substance listed.

    Dated: January 29, 2010.
Joseph T. Rannazzisi,
Deputy Assistant Administrator, Office of Diversion Control, Drug 
Enforcement Administration.
[FR Doc. 2010-2570 Filed 2-4-10; 8:45 am]
BILLING CODE 4410-09-P