The tariff classification of Teflaro™ (Ceftaroline Fosamil is INN) for injection imported in powdered dosage form, from Italy

N163151 May 9, 2011 CLA-2-30:OT:RR:NC:N2:238 CATEGORY: Classification TARIFF NO.: 3004.20.0060 Mr. Mark Huntebrinker Forest Pharmaceuticals 13600 Shoreline Earth City, MO 63045 RE: The tariff classification of Teflaro™ (Ceftaroline Fosamil is INN) for injection imported in powdered dosage form, from Italy Dear Mr. Huntebrinker: In your letter dated April 28, 2011, you requested a tariff classification ruling. The subject product, Teflaro™ for injection is a medicinal preparation containing Ceftaroline (CAS-400827-46-5), as the active ingredient. It is a cephalosporin antibacterial indicated for the treatment of acute bacterial skin infections and community-acquired bacterial pneumonia. Per your letter, the product will be imported in cartons of 10 single-use clear glass vials of powder containing 400 mg and 600 mg dosages from a manufacturing plant in Italy for wholesale distribution in the United States. The applicable subheading for the Teflaro™ for injection in powdered dosage form will be 3004.20.0060, 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 (including those in the form of transdermal administration systems) or in forms or packings for retail sale: Containing other antibiotics: 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 Harvey Kuperstein at (646) 733-3033. Sincerely, Robert B. Swierupski Director National Commodity Specialist Division