The tariff classification of MRx0518 Capsules in dosage form, from the United Kingdom

N300583 October 12, 2018 CLA-2-30:OT:RR:NC:N1:138 CATEGORY: Classification TARIFF NO.: 3004.90.9215 Mr. Robert Shapiro Thompson Coburn LLP 1909 K Street, NW Washington, D.C. 20006 RE: The tariff classification of MRx0518 Capsules in dosage form, from the United Kingdom Dear Mr. Shapiro: In your letter dated September 13, 2018, on behalf of 4D Pharma PLC, you requested a tariff classification ruling. The subject product, MRx0518, is a medicinal preparation in capsule form containing Enterococcus gallinarium, a live bacteria, as the active ingredient. It will be imported for use in clinical trials for the treatment of multiple solid tumor types. In your letter, you stated MRx0518 has the potential to be administered as a monotherapy, combination therapy or in the neoadjuvant setting to treat a range of cancers. The applicable subheading for MRx0518 Capsules in dosage form will be 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.” 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 merchandise may also be subject to the rules and regulations of the U.S. Department of Health and Human Services, Centers for Disease Control and Prevention. You may contact them at 1600 Clifton Road, Atlanta, GA 30333, telephone number (404) 633-5313 or (800) CDC-INFO, or at the Web address cdcinfo@cdc.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