The tariff classification of Sapropterin Dihydrochloride (CAS-69056-38-8) in bulk form, from Italy

N106016 May 27, 2010 CLA-2-29:OT:RR:NC:N2:238 CATEGORY: Classification TARIFF NO.: 2933.59.5900 Ms. Inge Forstenzer Ren-Pharm International, Ltd. 350 Jericho Turnpike, Suite 204 Jericho, NY 11753 RE: The tariff classification of Sapropterin Dihydrochloride (CAS-69056-38-8) in bulk form, from Italy Dear Ms. Forstenzer: In your letter dated May 13, 2010, you requested a tariff classification ruling. The subject product, Sapropterin Dihydrochloride, is a synthetic preparation of the dihydrochloride salt of naturally occurring tetrahydrobiopterin (BH4). It is indicated for the treatment in conjunction with a phenylalanine-restricted diet to reduce blood phenylalanine levels in patients with hyperphenylalaninemia due to BH4-responsive PKU. The applicable subheading for the Sapropterin Dihydrochloride in bulk form will be 2933.59.5900 Harmonized Tariff Schedule of the United States (HTSUS), which provides for “Heterocyclic compounds with nitrogen hetero-atom(s) only: Compounds containing a pyrimidine ring (whether or not hydrogenated) or piperazine ring in the structure: Other: Drugs: Other.” Pursuant to General Note 13, HTSUS, 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