The tariff classification of IDD-D™ Propofol Injectable Emulsion 2%, imported put up in vials for use in Phase III clinical trials, from Sweden

NY J83036 April 14, 2003 CLA-2-30:RR:NC:2:238 J83036 CATEGORY: Classification TARIFF NO.: 3004.90.9130 Ms. Veronica Colmenar SkyePharma Inc. 10450 Science Center Drive San Diego, CA 92121 RE: The tariff classification of IDD-D™ Propofol Injectable Emulsion 2%, imported put up in vials for use in Phase III clinical trials, from Sweden Dear Ms. Colmenar: In your letter dated April 3, 2003, you requested a tariff classification ruling. The subject product, IDD-D™ Propofol Injectable Emulsion 2%, is an investigational sedative-hypnotic medicament intended for use (presumably, by intravenous administration) in Phase III clinical trials, in an ongoing effort at evaluating its efficacy in inducing and maintaining anesthesia or sedation. The product contains propofol, a parenteral anesthetic agent, as the active ingredient. Pursuant to the General Notice entitled Guidance Concerning the Tariff Classification of Pharmaceutical Products Imported for Clinical Research (see Customs Bulletin and Decisions, dated May 24, 2000) the applicable subheading for the subject product will be 3004.90.9130, Harmonized Tariff Schedule of the United States (HTS), which provides for “Medicaments … consisting of mixed or unmixed goods for therapeutic or prophylactic uses, put up in measured doses (including those in the form of transdermal administration systems) or in forms or packings for retail sale: Other: Other: Other: Medicaments primarily affecting the central nervous system: Anticonvulsants, hypnotics and sedatives.” The rate of duty will be free. 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