The tariff classification of GRASTEK® and RAGWITEK® sublingual tablets in dosage form, from Denmark

N276775 July 18, 2016 CLA-2-30:OT:RR:NC:N2:238 CATEGORY: Classification TARIFF NO.: 3004.90.9190 Mr. Joseph Issa Merck & Co. 2 Merck Access Road Whitehouse Station, NJ 08889 RE: The tariff classification of GRASTEK® and RAGWITEK® sublingual tablets in dosage form, from Denmark Dear Mr. Issa: In your letter dated June 20, 2016, you requested a tariff classification ruling. GRASTEK® is an allergen immunotherapy medicament containing pollen allergen extract from Timothy grass, gelatin NF (fish source), mannitol USP and sodium hydroxide NF. It is indicated for the treatment of grass pollen-induced allergic rhinitis with or without conjunctivitis. GRASTEK® is available as 2800 Bioequivalent Allergy Unit (BAU) sublingual tablets by prescription only. RAGWITEK®is an allergen immunotherapy medicament containing pollen allergen extract from Short Ragweed, gelatin NF (fish source), mannitol USP and sodium hydroxide NF. It is indicated for the treatment of short ragweed pollen-induced allergic rhinitis with or without conjunctivitis. RAGWITEK® is available as 2 Amb a 1-Unit sublingual tablets by prescription only. The applicable subheading for the GRASTEK® and RAGWITEK® sublingual tablets in dosage form will be 3004.90.9190, Harmonized Tariff Schedule of the United States (HTSUS), 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: Other.” The rate of duty will be free. Duty rates are provided for your convenience and are subject to change. The text of the most recent HTSUS and the accompanying duty rates are provided on World Wide Web at https://hts.usitc.gov/current. This merchandise may be subject to the Federal Food, Drug, and Cosmetic Act and/or The Public Health Security and Bioterrorism Preparedness and Response Act of 2002 (The Bioterrorism Act), which are administered by the U.S. Food and Drug Administration (FDA). Information on the Federal Food, Drug, and Cosmetic Act, as well as The Bioterrorism Act, can be obtained by calling the FDA at 1-888-463-6332, or by visiting their website at www.fda.gov. 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 Judy Lee at [email protected]. Sincerely, Steven A. Mack Director National Commodity Specialist Division