The tariff classification of Tudorza™ Pressair™ (Aclidinium Bromide Inhalation Powder CAS-320345-99-1), imported in dosage form, from Spain.

N233744 October 3, 2012 CLA-2-30:OT:RR:NC:N2:238 CATEGORY: Classification TARIFF NO.: 3004.90.9185 Mr. Mark Huntebrinker Forest Pharmaceuticals, Inc. 13600 Shoreline Drive Earth City, MO 63045 RE: The tariff classification of Tudorza™ Pressair™ (Aclidinium Bromide Inhalation Powder CAS-320345-99-1), imported in dosage form, from Spain. Dear Mr. Huntebrinker: This replaces Ruling Number N232905, dated September 24, 2012, which contained a typographical error. The correct spelling of the product should be Tudorza™ Pressair™, instead of Turdorza™ Pressair™. A complete corrected ruling follows. The subject product, Tudorza™ Pressair™, is a dry powder formulation containing aclidinium bromide, an anticholinergic, as the active ingredient. It is indicated for the long term maintenance treatment of bronchospasm associated with chronic obstructive pulmonary disease (COPD), chronic bronchitis and emphysema. The product will be imported in 400 mcg packed in a sealed labeled aluminum pouch. The applicable subheading for the Tudorza™ Pressair™ (Aclidinium Bromide Inhalation Powder) in dosage form will be 3004.90.9185, 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 ... or in forms or packings for retail sale: Other: Other: Other: Medicaments primarily affecting the eyes, ears or respiratory system: 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, Thomas J. Russo Director National Commodity Specialist Division