The tariff classification of Magnevist® (Gadopentetate Dimeglumine) injection from Germany

N291562 November 21, 2017 CLA-2-30:OT:RR:NC:N1:138 CATEGORY: Classification TARIFF NO.: 3006.30.5000 Mr. Mark D. Pinchok Bayer International Trade Services Corporation 651 Colliers Way, Suite 414 Weirton, WV 26062 RE: The tariff classification of Magnevist® (Gadopentetate Dimeglumine) injection from Germany Dear Mr. Pinchok: In your letter dated October 27, 2017, you requested a tariff classification ruling. Magnevist is a clear, colorless to slightly yellow solution containing 0.5 mmol gadopentetate dimeglumine/mL (equivalent to 469.01 mg/mL of gadopentetate dimeglumine), as the active ingredient. Gadopentetate Dimeglumine is the N-methylglucamine salt of the gadolinium complex of diethylenetriamine pentaacetic acid, and is an injectable contrast medium for magnetic resonance imaging (MRI). Magnevist is a gadolinium-based contrast agent indicated for intravenous use in diagnostic MRI in adults and children (2 years of age and older) to facilitate the visualization of lesions and abnormal vascularity in the central nervous system of the brain, spine and associated tissues, as well as in the extracranial/extraspinal tissues of the head and neck. It is also indicated for use in adults and children 2 years of age and older to facilitate the visualization of lesions with abnormal vascularity in the body. The recommended dosage of Magnevist injection is 0.2 mL/kg (0.1 mmol/kg) administered intravenously, at a rate not to exceed 10 mL per 15 seconds and is available in vials and prefilled syringes. The applicable subheading for the Magnevist injection in dosage form will 3006.30.5000, Harmonized Tariff Schedule of the United States (HTSUS), which provides for “Pharmaceutical goods specified in note 4 to this chapter: Opacifying preparations for X-ray examinations; diagnostic reagents designed to be administered to the patient: 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 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