The tariff classification of Ceftolozane Sulfate (CAS-936111-69-2) in bulk form

N248693 December 23, 2013 CLA-2-29:OT:RR:NC:2:238 CATEGORY: Classification TARIFF NO.: 2941.90.5000 Mr. Mathew Mermigousis Pricewaterhouse Coopers, LLP 300 Madison Avenue New York, NY 10017 RE: The tariff classification of Ceftolozane Sulfate (CAS-936111-69-2) in bulk form Dear Mr. Mermigousis: In your letter dated December 10, 2013, you requested a tariff classification ruling on behalf of Cubist Pharmaceuticals, Inc. The subject product, Ceftolozane Sulfate, is a novel cephalosporin type antibiotic with potent activity against Pseudomonas aeruginosa and Enterobacteriaceae. In your letter, you stated that it will be used as the active pharmaceutical ingredient (API) for the drug, Ceftolozane/Tazobactam (CXA-201), which is currently undergoing phase 3 clinical trials. Ceftolozane/Tazobactam will be used to fight certain infections caused by multi-drug resistant (MDR) gram-negative pathogens. The applicable subheading for the Ceftolozane Sulfate in bulk form will be 2941.90.5000, Harmonized Tariff Schedule of the United States (HTSUS), which provides for “Antibiotics: 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, Gwenn Klein Kirschner Acting Director National Commodity Specialist Division