2010-2570. 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 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 § 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.