The tariff classification of Obeticholic Acid (CAS No. 459789-99-2) in bulk form, from Spain

N288850 August 31, 2017 CLA-2-29:OT:RR:NC:N2:238 CATEGORY: Classification TARIFF NO.: 2937.29.9095 Ms. Sheila Heerdt Ren Pharm International Ltd. 350 Jericho Turnpike, Suite 204 Jericho, NY 11753 RE: The tariff classification of Obeticholic Acid (CAS No. 459789-99-2) in bulk form, from Spain Dear Ms. Heerdt: In your letter dated August 1, 2017, you requested a tariff classification ruling. Obeticholic Acid is a semi synthetic analogue of the primary bile acid chenodexycholic acid (CDCA) which selectively activates the nuclear hormone receptor farneosid X receptor (FXR). It is indicated for the treatment of primary biliary cholangitis. The applicable subheading for the Obeticholic Acid in bulk form will be 2937.29.9095, Harmonized Tariff Schedule of the United States (HTSUS), which provides for "Steroidal hormones, their derivatives and structural analogues: Other: Other: 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 on World Wide Web 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 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 Judy Lee at judy.h.lee@cbp.dhs.gov. Sincerely, Steven A. Mack Director National Commodity Specialist Division