CLA-2-28:OT:RR:NC:2:236

Mr. Mark D. Pinchok
Bayer International Trade Services Corporation
651 Colliers Way, Suite 414
Weirton, WV, 26062

RE: The tariff classification of Radium-223 Chloride Solution from Norway

Dear Mr. Pinchok:

In your ruling request dated May 20, 2013, on behalf of your client, Bayer Healthcare LLC, you requested a tariff classification ruling.

Your submission describes the product at issue as Xofigo single-use vials of radium-223 chloride solution consisting of 1000 kBq/ml. This product will be used for injection into patients with ration-resistant prostate cancer. You have suggested classification in 3004.90.9115, however, pursuant to Section 6, Note 1(a) of the Harmonized Tariff Schedule of the United States (HTSUS), this product will be classified in heading 2844.

The applicable subheading for the radium-223 chloride solution will be 2844.40.0028, HTSUS, which provides for Radioactive elements and isotopes and compounds other than those of subheadings 2844.10, 2844.20, and 2844.30; alloys, dispersions (including cermets), ceramic products and mixtures containing these elements, isotopes or compounds; radioactive residues: Other. The general rate of duty will be free.

This merchandise may be subject to the requirements of the Toxic Substances Control Act (TSCA), which are administered by the U.S. Environmental Protection Agency. Information on the TSCA can be obtained by contacting the EPA at 1200 Pennsylvania Avenue, N.W., Mail Code 70480, Washington, D.C., by telephone at (202) 554-1404, or by visiting their website at www.epa.gov.

This merchandise may be subject to The Public Health Security and Bioterrorism Preparedness and Response Act of 2002 (The Bioterrorism Act), which is regulated by the Food and Drug Administration (FDA). Information on the Bioterrorism Act can be obtained by calling FDA at telephone number (301) 575-0156, or at the Web site www.fda.gov/oc/bioterrorism/bioact.html.

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 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 Nuccio Fera at (646) 733-3034.

Sincerely,

Thomas J. Russo
Director
National Commodity Specialist Division