The tariff classification of Risedronic Acid Sodium Hemipentahydrate (CAS-329003-65-8) in bulk form, from Switzerland

N030917 June 25, 2008 CLA-2-29:OT:RR:NC:2:238 CATEGORY: Classification TARIFF NO.: 2933.39.4100 Mr. Gregory S. McCue Steptoe & Johnson LLP 1330 Connecticut Avenue, NW Washington, DC 20036-1795 RE: The tariff classification of Risedronic Acid Sodium Hemipentahydrate (CAS-329003-65-8) in bulk form, from Switzerland Dear Mr. McCue: In your letter dated June 12, 2008, on behalf of your client, Lonza Inc, you requested a tariff classification ruling. You also inquired about the applicability of General Note 13 of the Harmonized Tariff Schedule of the United States (HTSUS). The subject product, Risedronic Acid Sodium Hemipentahydrate, is a drug that inhibits osteoclast-mediated bone resorption and modulates bone metabolism. It is used in the treatment of Postmenopausal Osteoporosis, Osteoporosis in men, Glucocorticoid-Induced Osteoporosis, and Paget’s Disease. The applicable subheading for the Risedronic Acid Sodium Hemipentahydrate will be 2933.39.4100, Harmonized Tariff Schedule of the United States (HTSUS), which provides for "Heterocyclic compounds with nitrogen hetero-atom(s) only: Compounds containing an unfused pyridine ring (whether or not hydrogenated) in the structure: Other: Other: Drugs: Other." Based on the analysis to follow, this office finds that Risedronic Acid Sodium Hemipentahydrate classified in subheading 2933.39.4100 is free of duty pursuant to General Note 13, HTS. 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/. To determine the eligibility of Risedronic Acid Sodium Hemipentahydrate for duty free treatment under General Note 13, HTSUS, we have to establish that all conditions are satisfied. First, the symbol "K" in parentheses appears in the "Special Rates of Duty” subcolumn for subheading 2933.39.4100. Second, Risedronic acid (CAS-105462-24-6) is included in Table 1 of Pharmaceutical Appendix to the Tariff Schedule. Third, based on the Chemical Abstract Service SciFinder Databse printout (provided in your Attachment 3) for Risedronic Acid Sodium Hemipentahydrate (CAS-329003-65-8), the product is clearly both a sodium salt and a hydrate of Risedronic Acid. Products in the Pharmaceutical Appendix include the salts, esters and hydrates of the International Non-proprietary Name (INN) products enumerated in Table 1 of the appendix that contain in their names any of the prefixes or suffixes listed in Table 2 of the Appendix, provided that any such salt, ester or hydrate is classifiable in the same 6-digit tariff provision as the relevant product enumerated in Table 1. The final requirement is satisfied in that Risedronic Acid Sodium Hemipentahydrate is classified in the same six-digit subheading as Risedronic Acid. The Chemical Abstracts Service SciFinder database provides the Chemical Abstract Index Name as Phosphonic acid, P, P’-[1-hydroxy-2-(3-pyridinyl)ethylidene]bis-, sodium salt, hydrate (2:2.5). Other names provided are Phosphonic acid, [1-hydroxy-2-(3-pyridinyl)ethylidene]bis-, monosodium salt, hydrate (2:5) and Risedronic acid monosodium salt hemipentahydrate. The Material Safety Data Sheet (MSDS) (also Attachment 3) uses the name [1-hydroxy-2-(3-pyridinyl)ethylidene]bis[phosphonic acid] monosodium salt (Risedronate Sodium) while including the empirical formula for risedronate sodium hemipentahydrate, C7H10NO7P2Na•2.5 H2O. There are additional synonyms and systematic names for this product. Chemical Abstracts Service (CAS) registry numbers set forth in the Pharmaceutical Appendix are included to assist in the identification of the products concerned. If a CAS Number does not clearly represent a different product, or represents a number of alternative names for the same product, it would not necessarily indicate that a product is excluded from Tables 1 or 2. The introductory text to Tables 1 and 2 of the Appendix states, that “[f]or purposes of the tariff schedule, any references to a product enumerated in this table includes such product by whatever name known” [emphasis ours]. This office is of the opinion that, given the identification of the subject merchandise alternately as a sodium salt alone, or as a hydrate of a sodium salt of Risedronic Acid, the “by whatever name known” rule is satisfied. That is, the names are alternately applied to the same active pharmaceutical ingredient. We are also in agreement with your observations regarding the non-inclusion of the specific term “hemipentahydrate” in Table 2. We note that the terms “Sodium,” “Hydrate,” “Hemihydrate“and “Pentahydrate” are all included in Table 2. As mentioned, products enumerated in Table 1 of the appendix that contain in their names any of prefixes or suffixes listed in Table 2 of the Appendix are eligible for duty free treatment. There is no authority to limit the number of prefixes or suffixes that may be contained in the products of Table 1, nor is there authority to preclude any combination of prefixes and suffixes listed in Table 2 (HQ 966382). 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