The tariff classification of Calcium Acetate Gelcaps, in dosage form, from Germany

N253822 June 6, 2014 CLA-2-30:OT:RR:NC:2:238 CATEGORY: Classification TARIFF NO.: 3004.90.9170 Mr. Stephen S. Spraitzar Law Offices of George R. Tuttle 1 Embarcadero Center, Suite 730 San Francisco, CA 94111 RE: The tariff classification of Calcium Acetate Gelcaps, in dosage form, from Germany Dear Mr. Spraitzar: In your letter dated May 19, 2014, you requested a tariff classification ruling. The subject product, Calcium Acetate Gelcaps, is a medicinal preparation in capsule form containing calcium acetate, a phosphate binder, as the active ingredient. It is indicated for the management of phosphorus levels in patients with chronic kidney disease on dialysis. In your letter, you indicated that the purpose of the Gelcaps is to help patients control elevated levels of phosphorus in the blood, a condition known as hyperphosphatemia. The Gelcaps will be imported in bottles of 200 capsules and will be available by prescription only. The applicable subheading for the Calcium Acetate Gelcaps, imported in dosage form, will be 3004.90.9170, 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: Preparations primarily affecting the electrolytic, caloric or water balance: 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 World Wide Web at http://www.usitc.gov/tata/hts/. 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, Gwenn Klein Kirschner Acting Director National Commodity Specialist Division