CLA-2-30:OT:RR:NC:2:238

Ms. Kelly Jo Cox
Mylan Pharmaceuticals Inc.
781 Chestnut Ridge Road
Morgantown, WV 26505

RE: The tariff classification of Isosulfan Blue Injection 1% in dosage form, from Ireland

Dear Ms. Cox:

In your letter dated September 30, 2015, you requested a tariff classification ruling.

The subject product, Isosulfan Blue Injection 1%, is a contrast agent that is indicated for lymphatic vessel delineation and for lymphography. It is supplied in 5 mL single use vials and administered subcutaneously one half (1/2) mL into three (3) interdigital spaces of each extremity per study.

The applicable subheading for the Isosulfan Blue Injection 1% in dosage form, will be 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 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 [email protected].

Sincerely,

Gwenn Klein Kirschner
Director
National Commodity Specialist Division