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NY N003244

November 16, 2006



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

“The proton pump inhibitors are used for the short-term treatment of acid peptic disease, gastroesophageal reflux, gastric ulcer, duodenal ulcer, and Zollinger-Ellison syndrome and for maintenance treatment of GERD.” Remington, The Science and Practice of Pharmacy (21st edition, at p.1300)., 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 Goodman & Gilman’s The Pharmacological Basis of Therapeutics (eleventh edition, at p. 968).. In contrast, antacids are drugs that react with hydrochloric acid in the stomach, neutralizing it, to form salt and water Remington, The Science and Practice of Pharmacy (21st edition, at p.1295)..

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.


Robert B. Swierupski

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