The tariff classification of Diquafosol Tetrasodium (CAS-211427-08-6), imported in bulk form, from Japan

NY J82826 April 2, 2003 CLA-2-29:RR:NC:2:238 J82826 CATEGORY: Classification TARIFF NO.: 2934.99.4700 Ms. Iliana G. Fuller Allergan, Inc. 2525 Dupont Drive P.O. Box 19534 Irvine, CA 92623-9534 RE: The tariff classification of Diquafosol Tetrasodium (CAS-211427-08-6), imported in bulk form, from Japan Dear Ms. Fuller In your letter dated March 18, 2003, you requested a tariff classification ruling. The subject product, Diquafosol Tetrasodium, is an investigational drug indicated for the treatment of dry eye. A press release by Inspire Pharmaceuticals, Inc. (the drug’s developer), dated January 7, 2003, indicated their (Inspire’s) intention to submit a New Drug Application (NDA) for Diquafosol to the FDA “mid-year” (2003). You state in your letter that Allergan will import Diquafosol Tetrasodium for use in the manufacture of an investigational medicament containing Diquafosol Tetrasodium as the active ingredient, as well as for research analysis. The applicable subheading for Diquafosol Tetrasodium, imported in bulk form, will be 2934.99.4700, Harmonized Tariff Schedule of the United States (HTS), which provides for “Nucleic acids and their salts, whether or not chemically defined; other heterocyclic compounds: Other: Other: Other: Drugs.” The rate of duty will be 3.7 percent ad valorem. We note that, at the present time, the subject product is not listed in the Pharmaceutical Appendix to the Tariff Schedule. 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 646-733-3033. Sincerely, Robert B. Swierupski Director, National Commodity Specialist Division