The tariff classification of Daliresp™ ( Roflumilast is INN) in measured dosage tablet form, imported in bulk from Germany

N163149 May 9, 2011 CLA-2-30:OT:RR:NC:N2:238 CATEGORY: Classification TARIFF NO.: 3004.90.9185 Mr. Mark Huntebrinker Forest Pharmaceuticals 13600 Shoreline Earth City, MO 63045 RE: The tariff classification of Daliresp™ ( Roflumilast is INN) in measured dosage tablet form, imported in bulk from Germany Dear Mr. Huntebrinker: In your letter dated April 28, 2011, you requested a tariff classification ruling. The subject product, Daliresp™ is a medicinal preparation containing Roflumilast (CAS-162401-32-3), a selective phosphodiesterase 4 (PDE4) inhibitor, as the active ingredient. It is indicated as a treatment to reduce the risk of chronic obstructive pulmonary disease (COPD) exacerbations in patients with severe COPD associated with chronic bronchitis and a history of exacerbations. Per your letter, the product will be imported in bulk put up in measured dosage form in tablets of 500 mcg from Germany . Afterwards, it will be repackaged in the United States as samples and trade packaging. The applicable subheading for the Daliresp™ in bulk put up in measured dosage tablet 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 Harvey Kuperstein at (646) 733-3033. Sincerely, Robert B. Swierupski Director National Commodity Specialist Division