The tariff classification of Pirenoxine Sodium (CAS 51410-30-1) from Japan

N012299 June 15, 2007 CLA-2-29:RR:E:NC:2:239 CATEGORY: Classification TARIFF NO.: 2934.99.3900 Ms. Iliana G. Fuller Allergan Sales, LLC 2525 Dupont Drive Irvine, CA 92612 RE: The tariff classification of Pirenoxine Sodium (CAS 51410-30-1) from Japan Dear Ms. Fuller: In your letter dated June 5, 2007, you requested a tariff classification ruling for Sodium Pirenoxine (Chemical Name - sodium 1-hydroxy-5-oxo-5H-pyrido[3,2-a]phenoxazine-3-carboxylate). As stated in your letter, Pirenoxine sodium will be imported for research and development testing and laboratory analysis. Although the product is available in other countries as an ingredient in eye drop formulations for cataracts, there is no indication of any clinical trials being conducted on Pirenoxine sodium in the United States at this time. The drug provisions in Chapter 29 are based on product use (Additional U.S. Rule of Interpretation 1(a)).  In Customs Bulletin, Vol. 34, No. 21, dated May 24, 2000, Customs published a document entitled "Guidance Concerning the Tariff Classification of Pharmaceutical Products Imported for Clinical Research" announcing its intention to classify organic compounds, imported in bulk for use in Phase II or Phase III clinical trials, as “Drugs” of Chapter 29, Harmonized Tariff Schedule of the United States (HTSUS). Products which are not in any stage of clinical trials or products which are in Phase I may not be classified as “Drugs” of Chapter 29. The applicable subheading will be 2934.99.3900, HTSUS, which provides for other aromatic heterocyclic compounds: other: products described in additional U.S. note 3 to section VI. Pursuant to General Note 13, HTSUS, this product is free of duty. 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 Richard Dunkel at 646-733-3032. Sincerely, Robert B. Swierupski Director, National Commodity Specialist Division