The tariff classification of Protonix® (pantoprazole sodium) Delayed-Release Tablets

N003244 November 16, 2006 CLA-2-30:RR:NC:2:238 CATEGORY: Classification TARIFF NO.: 3004.90.9160 Mr. Lawrence H. Price Wyeth Pharmaceuticals 200 Campus Drive Collegeville, PA 19426 RE: The tariff classification of Protonix® (pantoprazole sodium) Delayed-Release Tablets Dear Mr. Price: In your letter dated November 7, 2006, you requested a tariff classification ruling. The subject product, Protonix® (pantoprazole sodium) Delayed-Release Tablets, is a gastrointestinal medication containing pantoprazole sodium, a proton pump inhibitor, as the active ingredient. You indicate in your letter that you believe the subject product is correctly classified as an antacid. We disagree. Pantoprazole sodium (the active ingredient) suppresses the secretion of gastric acid by inhibition of the gastric H+, K+ - ATPase. In contrast, antacids are drugs that react with hydrochloric acid in the stomach, neutralizing it, to form salt and water. The applicable subheading for Protonix® (pantoprazole sodium) Delayed-Release Tablets will be 3004.90.9160, 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 digestive system: 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