The tariff classification of Cervidil® vaginal insert in dosage form, from Scotland

N197696 January 19, 2012 CLA-2-30:OT:RR:NC:2:238 CATEGORY: Classification TARIFF NO.: 3004.90.9190 Mr. Mark Huntebrinker Forest Pharmaceuticals, Inc. 13600 Shoreline Drive Earth City, MO 63045 RE: The tariff classification of Cervidil® vaginal insert in dosage form, from Scotland Dear Mr. Huntebrinker: In your letter dated December 19, 2011 you requested a tariff classification ruling. The subject product, Cervidil® is a vaginal insert containing 10 mg of Dinoprostone (commonly known as prostaglandin E2 or PGE2), as the active ingredient. Per your letter, the vaginal insert is a thin, flat, polymeric slab which is rectangular in shape with rounded corners contained within the pouch of an off-white knitted polyester retrieval system. Each slab is buff colored, semitransparent and contains 10mg of Dinoprostone in a hydrogel insert. It is supplied in an individually wrapped aluminum/polyethylene pack. Cervidil® is indicated for the initiation and or continuation of cervical ripening in patients at or near term. The applicable subheading for the Cervidil® vaginal insert in dosage form will be 3004.90.9190, 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: 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