Ms. Inge Forstenzer
Ren-Pharm International, Ltd.
350 Jericho Turnpike, Suite 204
Jericho, NY 11753
RE: The tariff classification of Lurasidone Hydrochloride (CAS No. 367514-88-3), imported in bulk form, from Italy
Dear Ms. Forstenzer:
In your letter dated February 4, 2011, you requested a tariff classification ruling.
The subject product, Lurasidone Hydrochloride, is an atypical antipsychotic agent and is indicated for the treatment of schizophrenia. It is currently pending approval for the treatment of bipolar disorder.
The applicable subheading for Lurasidone Hydrochloride, imported in bulk form, will be 2934.20.4000, Harmonized Tariff Schedule of the United States (HTSUS), which provides for “Nucleic acids and their salts, whether or not chemically defined; other heterocyclic compounds: Compounds containing in the structure a benzothiazole ring-system (whether or not hydrogenated), not further fused: Other: Other: Products described in additional U.S. note 3 to section VI.” 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