Ms. Inge Forstenzer
Ren-Pharm International Ltd.
350 Jericho Turnpike, Suite 304
Jericho, NY 11753
RE: The tariff classification of Bendamustine Hydrochloride (CAS-3543-75-7) in bulk from Italy
Dear Ms. Forstenzer:
In your letter dated May 21, 2009, you requested a tariff classification ruling.
The subject product, Bendamustine Hydrochloride, is a chemotherapy agent. It is indicated for the treatment of chronic lymphocytic leukemia and in patients with indolent B-cell non-Hodgkin's lymphoma that has progressed during or within six months of treatment with rituximab or a rituximab-containing regimen.
The applicable subheading for the Bendamustin Hydrochloride in bulk form will be 2933.99.7500, Harmonized Tariff Schedule of the United States (HTSUS), which provides for “Heterocyclic compounds with nitrogen hetero-atom(s) only: Other: Other: Aromatic or modified aromatic: Other: Drugs: Other.” 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 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.
Robert B. Swierupski
National Commodity Specialist Division