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

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

RE: The tariff classification of Aripiprazole Lauroxil (CAS No. 1259305-29-7) in bulk form, from Spain

Dear Ms. Heerdt:

In your letter dated August 15, 2017, you requested a tariff classification ruling.

Aripiprazole Lauroxil is an atypical antipsychotic indicated for the treatment of schizophrenia.

The applicable subheading for the Aripiprazole Lauroxil in bulk form will be 2933.79.0080, Harmonized Tariff Schedule of the United States (HTSUS), which provides for "Heterocyclic compounds with nitrogen hetero-atom(s) only: Lactams: Other lactams: Aromatic or modified aromatic: Other: Products described in additional U.S. note 3 to section VI." The general rate of duty will be 6.5 percent ad valorem. Currently, Aripiprazole Lauroxil is not listed in the Pharmaceutical Appendix to the Tariff Schedule.

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 [email protected].

Sincerely,

Steven A. Mack
Director
National Commodity Specialist Division