The tariff classification of Omacor® (omega-3-acid ethyl esters), imported in bulk form, from Norway

NY R04608 August 21, 2006 CLA-2-30:RR:E:NC:2:238 R04608 CATEGORY: Classification TARIFF NO.: 3003.90.0000 Michael K.Tomenga, Esq. Neville Peterson LLP 1900 M Street, N.W., Suite 850 Washungton, DC 20036 RE: The tariff classification of Omacor® (omega-3-acid ethyl esters), imported in bulk form, from Norway Dear Mr. Tomenga: In your letter dated August 11, 2006, on behalf of your client, Reliant Pharmaceuticals, Inc., you requested a tariff classification ruling. The subject product, Omacor® (omega-3-acid ethyl esters), is a mixture composed of >90% omega-3-acid ethyl esters (synthesized from purified fish oil) and alpha tocopherol (<1%), in a carrier of partially hydrogenated vegetable oils. Omacor® is indicated for the treatment of hypertriglyceridemia. You indicate that the subject product will be imported in bulk form for encapsulation, without any further processing, in one-gram capsules. You further indicate that the capsules can only be dispensed by prescription (“RX only”). The applicable subheading for Omacor® (omega-3 acid ethyl esters), imported in bulk form, will be 3003.90.0000, Harmonized Tariff Schedule of the United States (HTSUS), 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. 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 http://www.usitc.gov/tata/hts/. 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 Harvey Kuperstein at 646-733-3033. Sincerely, Robert B. Swierupski Director, National Commodity Specialist Division