CLA-2-29:OT:RR:NC:N1:138

Ms. Sheila Heerdt
Rem Pharm International Ltd.
350 Jericho Turnpike, Suite 204
Jericho, NY 11753

RE: The tariff classification of Lurasidone (CAS No. 367514-87-2) in bulk powder form, from Italy

Dear Ms. Heerdt:

In your letter dated November 11, 2017, you requested a tariff classification ruling.

Lurasidone is an atypical antipsychotic agent indicated for the treatment of schizophrenia. It is also indicated for treating depressive episodes in adults with bipolar I disorder. The applicable subheading for the Lurasidone in bulk powder 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 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