The tariff classification of Darolutamide (CAS No. 1297538-32-9) in bulk form and Nubeqa® Tablets in dosage form, from Finland

N306530 October 30, 2019 CLA-2-29:OT:RR:NC:N3:138 CATEGORY: Classification TARIFF NO.: 2933.19.3500; 3004.90.9215 Mr. Mark Pinchok Bayer International Trade Services Corporation 651 Colliers Way, Suite 414 Weirton, WV 26062 RE: The tariff classification of Darolutamide (CAS No. 1297538-32-9) in bulk form and Nubeqa® Tablets in dosage form, from Finland Dear Mr. Pinchok: In your letter dated October 2, 2019, on behalf of Bayer HealthCare LLC, you requested a tariff classification ruling. The first product, Darolutamide, is an androgen receptor (AR) inhibitor. It is indicated for the treatment of patients with non-metastic castration resistant prostate cancer. The second product, Nubeqa Tablets, imported in 300 mg tablet form, is a medicinal preparation containing, Darolutamide, as the active ingredient. It is indicated for the treatment of patients with non-metastic castration resistant prostate cancer (nmCRPC). Nubeqa is also used to treat men with prostate cancer that has not spread to other parts of the body and who no longer respond to a medical or surgical treatment that lowers testosterone. The applicable subheading for the Darolutamide in bulk form will be 2933.19.3500, Harmonized Tariff Schedule of the United States (HTSUS), which provides for “Heterocyclic compounds with nitrogen hetero-atom(s) only: Compounds containing an unfused pyrazole ring (whether or not hydrogenated) in the structure: Other: Aromatic or modified aromatic: Other: Drugs.” The rate of duty will be 6.5% ad valorem. Currently, Darolutamide is not listed in the Pharmaceutical Appendix to the Tariff Schedule. The applicable subheading for the Nubeqa Tablets in dosage form will be 3004.90.9215, (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.” 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 [email protected]. Sincerely, Steven A. Mack Director National Commodity Specialist Division