The tariff classification of Investigational New Drug VX-770 (N-(2,4-Di-tert-butyl-5-hydroxyphenyl)-1,4-dihydro-4-oxoquinoline-3-carboxamide) in bulk and in dosage forms, from Portugal and the United Kingdom

N013396 June 28, 2007 CLA-2-29:RR:NC:2:238 CATEGORY: Classification TARIFF NO.: 2933.49.2600; 3004.90.9185 Mr. Herbert J. Lynch Sullivan & Lynch, P.C. Inner Tech Park 56 Roland Street, Suite 303 Boston, MA 02129-1223 RE: The tariff classification of Investigational New Drug VX-770 (N-(2,4-Di-tert-butyl-5-hydroxyphenyl)-1,4-dihydro-4-oxoquinoline-3-carboxamide) in bulk and in dosage forms, from Portugal and the United Kingdom Dear Mr. Lynch: In your letter dated June 21, 2007, on behalf of your client, Vertex Pharmaceuticals Incorporated, you requested a tariff classification ruling. VX-770 is the subject of an Investigational New Drug Application (IND) filed with the U.S. Food and Drug Administration (FDA). The FDA has granted Fast Track designation to VX-770. Phase II clinical FDA testing was started in May, 2007. VX-770 is a small molecule drug candidate for the treatment of cystic fibrosis (CF). It may act as a potentiator to restore the function of the cystic fibrosis transmembrane conductance regulator (CFTR) protein, the defective cell membrane protein responsible for the progression of CF. You state that VX-770 has not yet received an approved INN or USAN name and has not yet been assigned a Chemical Abstracts Service (CAS) registry number. You correctly state that this product is not listed in the Chemical Appendix or in the Pharmaceutical Appendix of the Harmonized Tariff Schedule of the United States (HTSUS). You have provided the chemical name and molecular structure to assist in classification. Pursuant to the General Notice entitled “Guidance Concerning the Tariff Classification of Pharmaceutical Products Imported for Clinical Research,” published in the Customs Bulletin, Volume 34, No. 21, dated May 24, 2000, the applicable subheading for the VX-770 imported in bulk form will be 2933.49.2600, Harmonized Tariff Schedule of the United States (HTSUS), which provides for “Heterocyclic compounds with nitrogen hetero-atom(s) only: Compounds containing in the structure a quinoline or isoquinoline ring (whether or not hydrogenated), not further fused: Other: Other Drugs: Other." The rate of duty will be 6.5 percent ad valorem. Pursuant to the General Notice entitled “Guidance Concerning the Tariff Classification of Pharmaceutical Products Imported for Clinical Research,” published in the Customs Bulletin, Volume 34, No. 21, dated May 24, 2000, the applicable subheading for the VX-770 when imported in measured doses (in tablet form with appropriate excipients) will be 3004.90.9185, Harmonized Tariff Schedule of the United States (HTSUS), which provides for "Medicaments ... consisting of mixed or unmixed products for therapeutic or prophylactic uses, put up in measured doses ... or in forms or packings for retail sale: Other: Other: Other: Medicaments primarily affecting the eyes, ears or respiratory system: Other: Other.” The rate of duty will be free. 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