The tariff classification of Fluzone® High-Dose Influenza Virus Vaccine of United States origin put up in dosage form in France

N132157 November 24, 2010 CLA-2-30:OT:RR:NC:2:238 CATEGORY: Classification TARIFF NO.: 3002.20.0000; 9801.00.1028 Ms. Paula Swanson Sanofi Pasteur Inc. Discovery Drive Swiftwater, PA 18370 RE: The tariff classification of Fluzone® High-Dose Influenza Virus Vaccine of United States origin put up in dosage form in France Dear Ms. Swanson: In your letter dated November 9, 2011 you requested a tariff classification ruling. Fluzone® High-Dose is an inactivated influenza virus vaccine indicated for active immunization of persons 65 years of age and older against influenza disease caused by influenza subtypes A and B contained in the vaccine. You state that the vaccine is manufactured in the United States and then shipped in bulk to France where it is filled into 0.5 mL syringes and packed for retail sale. It is then shipped back to the United States. The applicable subheading for the Fluzone® High-Dose in bulk or in dosage form will be 3002.20.0000, Harmonized Tariff Schedule of the United States (HTSUS), which provides for “Human blood; animal blood prepared for therapeutic, prophylactic or diagnostic uses; antisera and other blood fractions and modified immunological products, whether or not obtained by means of biotechnological processes; vaccines, toxins, cultures of micro-organisms (excluding yeasts) and similar products: Vaccines for human medicine”. The rate of duty will be free. Additionally, you request confirmation that this merchandise would be eligible for classification in Subheading 9801.00.10, HTSUS, which provides for the free entry of products of the U.S. that are exported and returned without having been advanced in value or improved in condition by any process of manufacture or other means while abroad. In United States v. John V. Carr & Sons. Inc., 69 Cust. Ct. 78, C.D. 4377, 347 F.Supp. 1390 (1972, 61 CCPA 52, C.A.D. 1118, 496 F.2d 1225 (1974), the court stated that, absent some alteration or change in the item itself, the mere repackaging of the item, even for the purpose of resale to the ultimate consumer, is not sufficient to preclude the merchandise from being classified in subheading 9801.00.10 HTSUS. Thus, the U.S. origin bulk vaccine, filled into 0.5 mL syringes and packaged for retail sale in France, and returned to the United States, is not considered to have been advanced in value or improved in condition for the purposes of subheading 9801.00.10, HTS. As a result, the vaccine, a product of the United States, may be eligible for entry as American Goods Returned. If the documentary requirements of 19 C.F.R. §10.1 are satisfied, the applicable subheading for the vaccine will be 9801.00.1028, HTSUS, which provides for “Products of the United States when returned after having been exported, without having been advanced in value or improved in condition by any process of manufacture or other means while abroad. Other: Articles provided for in chapter 30.” Products classified in subheading 9801.00.1028 are free of duty. 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