The tariff classification of Verteporfin Presome, imported in bulk form, from Japan

NY F83000 March 23, 2000 CLA-2-30:RR:NC:2:238 F83000 CATEGORY: Classification TARIFF NO.: 3003.90.0000 Mr. Patrick Kiyama Yamato Customs Brokers 5500 W. Rosencrans Ave., Suite D Hawthorne, CA 90250 RE: The tariff classification of Verteporfin Presome, imported in bulk form, from Japan Dear Mr. Kiyama: In your letter dated February 8, 2000, on behalf of your client, Nissho Iwai America Corporation, you requested a tariff classification ruling. The subject product, Verteporfin Presome, is a medicament containing Verteporfin (CAS-129497-78-5), as the active ingredient. Verteporfin is described in your letter as a light-activated drug indicated for the treatment of age-related macular degeneration (AMD). You indicate that Verteporfin is initially manufactured in Canada and then sent to Japan, where it is coated with a pharmaceutical-grade phosphoaminolipid that allows the drug to be administered intravenously. The coated Verteporfin (i.e., the subject product, Verteporfin Presome) is then shipped to the U.S., for final processing. In addition to descriptive literature and MSDS sheets, you have submitted a press release, dated October 4, 1999, from CIBA Vision Corporation and QLT PhotoTherapeutics, Inc., indicating the FDA’s intent to review their (i.e., CIBA and QLT’s) New Drug Application (NDA), filed on August 16, 1999, for clearance to market Visudyne™ (the trade name for the medicament containing Verteporfin as the active ingredient) to treat age-related macular degeneration (AMD). The press release further indicates the FDA’s intent to act on the application within six months of the August filing date, and that, “[P]ending regulatory approval, CIBA Vision and QLT expect Visudyne™ therapy will be available in the U.S. in early 2000.”  The applicable subheading for Verteporfin Presome, imported in bulk form, will be 3003.90.0000, Harmonized Tariff Schedule of the United States (HTS), which provides for "Medicaments … consisting of two or more constituents which have been mixed together for therapeutic or prophylactic uses, not put up in measured doses or in forms or packings for retail sale: Other." 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 212-637-7068. Sincerely, Robert B. Swierupski Director, National Commodity Specialist Division