CLA-2-2:OT:RR:NC:N2:238

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

RE: The tariff classification of Cysteamine Bitartrate (CAS 27761-19-9) in bulk powder form, from Italy

Dear Ms. Cox:

In your letter dated June 30, 2016, you requested a tariff classification ruling.

Cysteamine bitartrate is a cysteine depleting agent. It is indicated for the management of nephropathic cystinosis in children and adults. Cysteamine is also known as mercaptamine (INN).

The applicable subheading for the Cysteamine Bitartrate in bulk form will be 2930.90.9135, Harmonized Tariff Schedule of the United States (HTSUS), which provides for "Organo-sulfur compounds: Other: Other: Other: Other: Other: Other: Drugs." Pursuant to General Note 13, HTSUS, 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 judy.h.lee@cbp.dhs.gov.

Sincerely,

Steven A. Mack
Director
National Commodity Specialist Division