The tariff classification of Abiraterone Tablets in dosage form, from India

N304482 June 19, 2019 CLA-2-30:OT:RR:NC:N3:138 CATEGORY: Classification TARIFF NO.: 3004.39.0050 Mr. Rennie Mathew Alston Rising Pharmaceutical Park West Plaza 1 250 Pehle Avenue, Suite 601 Saddle Brook, NJ 07663 RE: The tariff classification of Abiraterone Tablets in dosage form, from India Dear Mr. Alston: In your letter dated May 23, 2019, you requested a tariff classification ruling. Abiraterone, imported in tablet form, is a medicinal preparation containing Abiraterone Acetate, a prodrug of Abiraterone and a structural analogue of a steroid hormone with anti-androgen activity, as the active ingredient. It is indicated for use in combination with prednisone for the treatment of patients with metastatic castration-resistant prostate cancer. You suggest classification in subheading 3004.90.9215, Harmonized Tariff Schedule of the United States (HTSUS), which provides for “Medicaments … consisting of mixed or unmixed products for therapeutic or prophylactic uses, put up in measured doses … or in forms or packings for retail sale: Other: Other: Other: Antineoplastic and immunosuppressive medicaments.” However, Abiraterone is an analogue of a steroid hormone and will be classified elsewhere. The applicable subheading for the Abiraterone Tablets in dosage form will be 3004.39.0050, HTSUS, which provides for "Medicaments … consisting of mixed or unmixed products for therapeutic or prophylactic uses, put up in measured doses … or in forms or packings for retail sale: Other, containing hormones or other products of heading 2937: 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 the 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