The tariff classification of Copanlisib (CAS No. 1032568-63-0) in bulk form and in dosage form, from Germany

N284250 April 5, 2017 CLA-2-29:OT:RR:NC:N2:238 CATEGORY: Classification TARIFF NO.: 2934.99.3000; 3004.90.9215 Mr. Mark D. Pinchok Bayer International Trade Services Corporation 651 Colliers Way, Suite 414 Weirton, WV 26062 RE: The tariff classification of Copanlisib (CAS No. 1032568-63-0) in bulk form and in dosage form, from Germany Dear Mr. Pinchok: In your letter dated March 7, 2017, on behalf of Bayer HealthCare LLC., you requested a tariff classification ruling. Copanlisib is a phosphoinositide 3-kinase (PI3K) inhibitor that functions by inhibiting one or more of the phosphoinositide 3-kinase enzymes, which are a part of the PI3K/AKT/mTOR pathway, thereby suppressing tumor growth. In your letter, you stated that Copanlisib is an investigational compound undergoing Phase III clinical trials for the treatment of patients with relapsed/refractory B-cell non-Hodgkin’s lymphoma (NHL). In a follow-up email to this office dated April 3, 2017, you stated that Copanlisib will be also be imported in dosages of 60 mg and 0.8mg/kg put up in single vials. It is administered as an intravenous infusion (over 60 minutes) on days 1, 8 and 15 of a 28-day cycle. The applicable subheading for Copanlisib in bulk form will be 2934.99.3000, Harmonized Tariff Schedule of the United States (HTSUS), which provides for “Nucleic acids and their salts, whether or not chemically defined; other heterocyclic compounds: Other: Other: Aromatic or modified aromatic: Other: Drugs.” The rate of duty will be 6.5 percent ad valorem. Currently, Copanlisib is not listed in the Pharmaceutical Appendix to the Tarriff Schedule. The applicable subheading for Copanlisib 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 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