The tariff classification of ZD4522(calcium salt) (CAS-147098-20-2), imported in bulk form, from the United Kingdom

NY F84689 March 30, 2000 CLA-2-29:RR:NC:2:238 F84689 CATEGORY: Classification TARIFF NO.: 2935.00.6000 Mr. J.M. Altieri Fast Transportation Services, Inc. P.O. Box 4430 Carolina PR 00984-4430 RE: The tariff classification of ZD4522(calcium salt) (CAS-147098-20-2), imported in bulk form, from the United Kingdom Dear Mr. Altieri: In your letter dated January 18, 2000, resubmitted on March 16, 2000, on behalf of your client, IPR Pharmaceuticals, Inc., you requested a tariff classification ruling. The subject product , ZD4522(calcium salt), is an inhibitor of HMG-CoA reductase (a rate-limiting enzyme in cholesterol synthesis). According to your client, the subject product is an investigational new drug (IND 56,385) currently in Phase 3 of human clinical trials, wherein it will continue to be evaluated for its efficacy for use as an antihyperlipidemic drug (cholesterol-lowering agent). Your client also notes that the filing of a New Drug Application (NDA) with the FDA is planned for March 2001. The applicable subheading for the subject product, imported in bulk form, will be 2935.00.6000, Harmonized Tariff Schedule of the United States (HTS), which provides for "Sulfonamides: Other: Drugs: Other." The rate of duty will be 6.5 percent ad valorem. We note that, at the present time, the subject compound is not listed in Tables 1 or 3 of the Pharmaceutical Appendix to the Tariff Shedule. This merchandise may be subject to the requirements of the Federal Food, Drug, and Cosmetic Act, which is administered by the U.S. Food and Drug Administration. You may contact them at 5600 Fishers Lane, Rockville, Maryland 20857, telephone number 301-443-1544. 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 212-637-7068. Sincerely, Robert B. Swierupski Director, National Commodity Specialist Division