The tariff classification of Ingenol Mebutate (CAS-75567-37-2) in bulk form, from Australia

N204675 April 13, 2012 CLA-2-29:OT:RR:NC:2:238 CATEGORY: Classification TARIFF NO.: 2916.19.5000 Ms. Michele McGuire Deloitte Tax LLP 111 S. Wacker Dr Chicago, IL 60606 RE: The tariff classification of Ingenol Mebutate (CAS-75567-37-2) in bulk form, from Australia Dear Ms. McGuire: In your letter dated February 13, 2011, you requested a tariff classification ruling on behalf of your client LEO Laboratories Ltd. We apologize for the delay as the information was submitted to our Laboratory for analysis. The subject product, Ingenol Mebutate, is an inducer of apoptosis (cell death). According to your letter, the Petty Spurge plant which is a weed that is grown in Australia is refined into Ingenol Mebutate, an active pharmaceutical ingredient. It is indicated for the treatment of actinic keratosis and superficial basal cell carcinoma. The applicable subheading for the Ingenol Mebutate in bulk form will be 2916.19.5000, Harmonized Tariff Schedule of the United States (HTSUS), which provides for “Unsaturated acyclic monocarboxylic acids, their anhydrides, halides, peroxides, peroxyacids and their derivatives: Other: Other: Other.” The rate of duty will be 3.7 percent ad valorem. 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 ruling is being issued under the provisions of Part 177 of the Customs Regulations (19 C.F.R. 177). 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. 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 (646) 733-3033. Sincerely, Thomas J. Russo Director National Commodity Specialist Division