CLA-2-29:OT:RR:NC:N2:238

Ms. Inge Forstenzer
Ren-Pharm International Ltd.
350 Jericho Turnpike, Suite 204
Jericho, NY 11753

RE: The tariff classification of Alprostadil (CAS-745-65-3) in bulk powder form, from Taiwan

Dear Ms. Forstenzer:

In your letter dated December 9, 2008, you requested a tariff classification ruling.

The subject product, Alprostadil, is in a class of medication called vasodilators and is a prostaglandin E1 (PGE1). It is indicated for palliative, not definitive, therapy to temporarily maintain the patency of the ductus arteriosus until corrective or palliative surgery can be performed in neonates who have congenital heart defects and who depend upon the patent ductus for survival. It is also indicated for the treatment of erectile dysfunction due to neurogenic, vasculogenic, psychogenic, or mixed etiology.

The applicable subheading for the Alprostadil in bulk powder form will be 2937.50.0000, Harmonized Tariff Schedule of the United States (HTSUS), which provides “Prostaglandins, thromboxanes and leukotrienes, their derivatives and structural analogues.” 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 Harvey Kuperstein at (646) 733-3033.

Sincerely,

Robert B. Swierupski
Director
National Commodity Specialist Division