The tariff classification of Linaclotide (CAS-851199-59-2), imported in dosage form, from Sweden

N233631 October 23, 2012 CLA-2-30:OT:RR:NC:N2:238 CATEGORY: Classification TARIFF NO.: 3004.90.9160 Mr. Mark Huntebrinker Forest Pharmaceuticals, Inc. 13600 Shoreline Drive Earth City, MO 63045 RE: The tariff classification of Linaclotide (CAS-851199-59-2), imported in dosage form, from Sweden Dear Mr. Huntebrinker: In your letter dated September 24, 2012, you requested a tariff classification ruling. The subject product, Linaclotide, imported in 145 mcg and 290 mcg capsules, is a guanylate cyclase-c agonist. Currently, it is undergoing phase III clinical trials for the treatment of irritable bowel syndrome with constipation (IBS-C). The applicable subheading for the Linaclotide imported in dosage form will be 3004.90.9160, 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: Medicaments primarily affecting the digestive system: 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 Judy Lee at (646) 733-3033. Sincerely, Thomas J. Russo Director National Commodity Specialist Division