The tariff classification of Istradefylline (CAS No. 155270-99-8) in bulk form, from Italy

N331868 April 13, 2023 CLA-2-29:OT:RR:NC:N3:138 CATEGORY: Classification TARIFF NO.: 2939.59.0000 Patricia Luhrs Procos USA, Inc. 2000 Regency ParkwayCary, NC 27518 RE: The tariff classification of Istradefylline (CAS No. 155270-99-8) in bulk form, from Italy Dear Ms. Luhrs: In your letter dated March 30, 2023, you requested a tariff classification ruling. Istradefylline is an adenosine receptor antagonist and a derivative of Theophylline.  It is indicated as adjunctive treatment to levodopa/carbidopa in adult patients with Parkinson's disease (PD) experiencing “off" episodes. The applicable subheading for the Istradefylline in bulk form will be 2939.59.0000, Harmonized Tariff Schedule of the United States (HTSUS), which provides for “Alkaloids, natural or reproduced by synthesis, and their salts, ethers, esters and other derivatives: Theophylline and aminophylline (theophylline-ethylenediamine) and their derivatives; salts thereof: 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 at https://hts.usitc.gov/current 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 and Border Protection 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, please contact National Import Specialist Judy Lee at judy.h.lee@cbp.dhs.gov. Sincerely, Steven A. Mack Director National Commodity Specialist Division