The tariff classification of Rapamune® (Sirolimus) NanoSystems Dispersion imported in bulk form, from Ireland

N016271 September 7, 2007 CLA-2-30:RR:NC:N2:238 CATEGORY: Classification TARIFF NO.: 3003.20.0000 Ms. Deborah C. Mower Wyeth Pharmaceuticals 200 Campus Drive Collegeville, PA 19426 RE: The tariff classification of Rapamune® (Sirolimus) NanoSystems Dispersion imported in bulk form, from Ireland Dear Ms. Mower: In your letter dated August 17, 2007, you requested a tariff classification ruling. The subject product, Rapamune® (Sirolimus) NanoSystems Dispersion is an immunosuppressant drug. It is used for the treatment of preventing rejection in organ transplantation and is typically used in combination with other medications to prevent rejection of kidney transplants. The Rapamune® (Sirolimus) NanoSystems Dispersion is a medicinal preparation mixture consisting of the following composition by weight described below: 15% Sirolimus (CAS- 53123-88-9) - an active pharmaceutical ingredient 7.5% Poloxamer 188 (CAS-9003-11-6) - acts as a stabilizer 77.5% Water (CAS-7732-18-5) - acts as a solvent According to your letter, it will be used as an active filler coat in the manufacturing process for Rapamune® tablets. The applicable subheading for the Rapamune® (Sirolimus) NanoSystems Dispersion, imported in bulk form, will be 3003.20.0000, Harmonized Tariff Schedule of the United States (HTSUS), which provides for "Medicaments…consisting of two or more constituents which have been mixed together for therapeutic or prophylactic uses, not put up in measured doses or in forms or packings for retail sale: Containing other antibiotics." The rate of duty will be free. 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. 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 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