The tariff classification of Linaclotide (CAS-851199-59-2) in bulk form, from Spain

N243162 August 6, 2013 CLA-2-30:OT:RR:NC:2:238 CATEGORY: Classification TARIFF NO.: 3002.90.5150 Ms. Inge Forstenzer Ren-Pharm International, Ltd. 350 Jericho Turnpike, Suite 204 Jericho, NY 11753 RE: The tariff classification of Linaclotide (CAS-851199-59-2) in bulk form, from Spain Dear Ms. Forstenzer: In your letter dated June 12, 2013, you requested a tariff classification ruling. We apologize for the delay as the information you submitted was sent to our laboratory for analysis. The subject product, Linaclotide, is a peptide agonist of guanylate cyclase 2C. It is a peptide consisting of 14 amino acids and three disulfide bonds. It is indicated for the treatment of irritable bowel syndrome with constipation (IBS-C) and chronic idiopathic constipation (CIC). Linaclotide exerts its biological effect in a similar manner as the E. coli heat-stable enterotoxin and it is also an analog of the naturally occurring E. coli heat-stable enterotoxin ST 1b, differing only in a single amino acid. The applicable subheading for the Linaclotide in bulk form will be 3002.90.5150, Harmonized Tariff Schedule of the United States (HTSUS), which provides for “Human blood; … ; vaccines, toxins, cultures of micro-organisms (excluding yeasts) and similar products: 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 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