The tariff classification of Thyroid (CAS No.50809-32-0) mixed with Lactose Monohydrate (CAS No. 64044-51-5) in bulk powder form, from Italy

N302626 February 19, 2019 CLA-2-30:OT:RR:NC:N3:138 CATEGORY: Classification TARIFF NO.: 3003.90.0100 Ms. Sheila Heerdt Ren Pharm International Ltd. 350 Jericho Turnpike, Suite 204 Jericho, NY 11753 RE: The tariff classification of Thyroid (CAS No.50809-32-0) mixed with Lactose Monohydrate (CAS No. 64044-51-5) in bulk powder form, from Italy Dear Ms. Heerdt: In your letter dated January 22, 2019, you requested a tariff classification ruling. Thyroid mixed with lactose monohydrate is a medicinal preparation containing porcine thyroid, USP as the active ingredient mixed with lactose monohydrate as the excipient. In your letter, you stated this product will be imported for use in a prescription only medication for the treatment of hypothyroidism. The applicable subheading for the Thyroid mixed with lactose monohydrate in bulk powder form will be 3003.90.0100, Harmonized Tariff Schedule of the United States (HTSUS), which provides for "Medicaments … consisting of two or more constituents which have been mixed together for therapeutic or prophylactic uses, not put up in measured doses or in forms or packings for retail sale: 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 [email protected]. Sincerely, Steven A. Mack Director National Commodity Specialist Division