The tariff classification of ACULAR® PF (ketorolac tromethamine ophthalmic solution) 0.5%

NY H83715 July 18, 2001 CLA-2-30:RR:NC:2:238 H83715 CATEGORY: Classification TARIFF NO.: 3004.90.9085 Ms. Iliana G. Fuller Allergan, Inc. 2525 Dupont Drive P.O. Box 19534 Irvine, CA 92623-9534 RE: The tariff classification of ACULAR® PF (ketorolac tromethamine ophthalmic solution) 0.5% Dear Ms. Fuller: In your letter dated July 10, 2001, you requested a tariff classification ruling. The subject product (a sample of which was submitted), ACULAR® PF (ketorolac tromethamine ophthalmic solution) 0.5%, is an ophthalmic medicament containing ketorolac tromethamine, a nonsteroidal anti-inflammatory drug, as the active ingredient. The product is supplied as a sterile solution put up in single-use vials, each of which contains 0.4 ml. Sealed, aluminum foil packets, containing 4 vials per packet, are then put up packed for retail sale in paperboard boxes, each of which contains 3 foil packets. According to the package insert, “ACULAR® PF ophthalmic solution is indicated for the reduction of ocular pain and photophobia following incisional refractive surgery.” The applicable subheading for the subject product will be 3004.90.9085, Harmonized Tariff Schedule of the United States (HTS), 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. 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