The tariff classification of TC5214 (CAS-107596-30-5) in bulk form, from Italy

N116248 August 12, 2010 CLA-2-29:OT:RR:NC:N2:238 CATEGORY: Classification TARIFF NO.: 2921.30.5000 Ms. Zenaida Rodriguez IPR Pharmaceuticals, Inc. P.O. Box 1624 Canóvanas, PR 00729-1624 RE: The tariff classification of TC5214 (CAS-107596-30-5) in bulk form, from Italy Dear Ms. Rodriguez: In your letter dated July 21, 2010, you requested a tariff classification ruling. You state that the subject product, TC5214, is a nicotine channel blocker believed to help normalize cholinergic tone, resulting in antidepressant effects. Currently it is undergoing Phase III clinical studies for the adjunct treatment of major depressive disorder (MDD). The Investigational New Drug (IND) number is 101,333. We note that the CAS chemical name for this product is Bicyclo[2.2.1]heptan-2-amine, N,2,3,3-tetramethyl. It also has the International Nonproprietary Name (INN) Mecamylamine and the alternative CAS Number 60-40-2. The United States Patent for the manufacturing process of Mecamylamine shows the starting material as Camphene, a non-aromatic compound. The applicable subheading for the TC5214 in bulk form will be 2921.30.5000, Harmonized Tariff Schedule of the United States (HTSUS), which provides for “Amine-function compounds: Cyclanic, cyclenic or cycloterpenic mono- or polyamines, and their derivatives; salts thereof: Other.” Pursuant to General Note 13, HTSUS, the rate of duty will be free. Mecamylamine, also known as TC5214, is listed in the Pharmaceutical Appendix to the Harmonized Tariff Schedule. Duty rates are provided for your convenience and are subject to change. The text of the most recent HTSUS and the accompanying duty rates are provided on World Wide Web at http://www.usitc.gov/tata/hts/. This merchandise may be subject to the Federal Food, Drug, and Cosmetic Act and/or The Public Health Security and Bioterrorism Preparedness and Response Act of 2002 (The Bioterrorism Act), which are administered by the U.S. Food and Drug Administration (FDA). Information on the Federal Food, Drug, and Cosmetic Act, as well as The Bioterrorism Act, can be obtained by calling the FDA at 1-888-463-6332, or by visiting their website at www.fda.gov. This ruling is being issued under the provisions of Part 177 of the Customs Regulations (19 C.F.R. 177). A copy of the ruling or the control number indicated above should be provided with the entry documents filed at the time this merchandise is imported. If you have any questions regarding the ruling, contact National Import Specialist Harvey Kuperstein at (646) 733-3033. Sincerely, Robert B. Swierupski Director National Commodity Specialist Division