The tariff classification of Mircera (methoxy polyethylene glycol-epoetin beta) in dosage form, from Switzerland

N269182 October 15, 2015 CLA-2-30:OT:RR:NC:2:238 CATEGORY: Classification TARIFF NO.: 3002.10.0290 Mr. Stephen S. Spraitzar Tuttle Law Offices 100 Larkspur Landing Circle, Suite 385 Larkspur, CA 94939 RE: The tariff classification of Mircera (methoxy polyethylene glycol-epoetin beta) in dosage form, from Switzerland Dear Mr. Spraitzar: In your letter dated September, 22, 2015 on behalf of Fresenius Medical Services Group, LLC dba Fresenius Medical Care North America, you requested a tariff classification ruling. The subject product Mircera, is a medicinal preparation containing methoxy polyethylene glycol-epoetin beta, a chemically modified erythropoiesis stimulating agent (ESA), as the active ingredient. It is indicated for the treatment of anemia associated with chronic kidney disease. Mircera will be imported in pre-filled syringes in various doses ranging from 50 to 250 mcg/0.30mL. The applicable subheading for Mircera (methoxy polyethylene glycol-epoetin beta), imported in dosage form, will be 3002.10.0290, Harmonized Tariff Schedule of the United States (HTSUS), which provides for “Antisera, other blood fractions and immunological products, whether or not obtained by means of biotechnological processes: 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 [email protected]. Sincerely, Gwenn Klein Kirschner Director National Commodity Specialist Division