The tariff classification of Bivalirudin (CAS-128270-60-0) and Octreotide Acetate (CAS-79517-01-4) in bulk form, from Italy

N096364 March 16, 2010 CLA-2-29:OT:RR:NC:N2:238 CATEGORY: Classification TARIFF NO.: 2937.19.0000; 2933.99.5300 Ms. Inge Forstenzer Ren-Pharm International, Ltd. 350 Jericho Turnpike, Suite 204 Jericho, NY 11753 RE: The tariff classification of Bivalirudin (CAS-128270-60-0) and Octreotide Acetate (CAS-79517-01-4) in bulk form, from Italy Dear Ms. Forstenzer: In your letter dated February 19, 2010, you requested a tariff classification ruling. The first product, Bivalirudin, is an anticoagulant. It is indicated for use in patients with unstable angina undergoing percutaneous transluminal coronary angioplasty (PTCA). The second product, Octreotide Acetate, is the acetate salt of a synthetic long-acting cyclic octapeptide with pharmacologic properties mimicking those of the natural hormone somatostatin. It is indicated for the treatment of acromegaly, carcinoid tumors, and vasoactive intestinal peptide tumors (VIPomas). The applicable subheading for the Bivalirudin in bulk form will be 2933.99.5300 Harmonized Tariff Schedule of the United States (HTSUS), which provides for “Heterocyclic compounds with nitrogen hetero-atom(s) only: Other: Other: Aromatic or modified aromatic: Other: Drugs: Cardiovascular drugs: Other.” Pursuant to General Note 13, HTSUS, the rate of duty will be free. The applicable subheading for the Octreotide Acetate in bulk form will be 2937.19.0000, Harmonized Tariff Schedule of the United States (HTSUS), which provides for “Hormones, prostaglandins, thromboxanes and leukotrienes, natural or reproduced by synthesis; derivatives and structural analogues thereof, including chain modified polypeptides, used primarily as hormones: Polypeptide hormones, protein hormones and glycoprotein hormones, their derivatives and structural analogues: 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