The tariff classification of Xeomin® intramuscular injection from Germany

N111260 July 6, 2010 CLA-2-30:OT:RR:NC:N2:238 CATEGORY: Classification TARIFF NO.: 3002.90.5150 Mr. Wiley Knight Agility 2105 Water Ridge Parkway, Ste 590 Charlotte, NC 28217 RE: The tariff classification of Xeomin® intramuscular injection from Germany Dear Mr. Knight: In your letter dated June 17, 2010, you requested a tariff classification ruling on behalf of Merz Pharmaceuticals, LLC. The subject product, Xeomin®, also known as NT201 is a highly purified botulinum neurotoxin type A (free from complexing proteins). Xeomin® combines high biologic activity with low bacterial protein load. It is intended for intramuscular injection and is indicated for the treatment of cervical dystonia and blepharospasms in adults. Currently, Xeomin® has not been approved for use by the U.S. Food and Drug Administration (FDA). The applicable subheading for the Xeomin® intramuscular injection will be 3002.90.5150, 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 immunoglogical products, … ; vaccines, toxins, cultures of micro-organisms (excluding yeasts) and similar products: 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 Harvey Kuperstein at (646) 733-3033. Sincerely, Robert B. Swierupski Director National Commodity Specialist Division