CLA-2-29:OT:RR:NC:N3:138
Ms. Lea M. Ford
DF Young Inc.
176-20 147th Avenue
Jamaica, NY 11434
RE: The tariff classification of Lumateperone Tosylate (CAS No. 1187020-80-9) in bulk form and Lumateperone Capsules in dosage form, from Switzerland
Dear Ms. Ford:
In your letter dated October 2, 2019, on behalf of Intra-Cellular Therapies, Inc., you requested a tariff classification ruling.
The first product, Lumaterperone Tosylate, is an investigational antipsychotic drug. In a follow-up correspondence to our office, you stated Lumaterperone Tosylate is currently between phase III and phase IV clinical trials for the treatment of schizophrenia.
The second product, Lumateperone Capsules, imported in 14 mg, 28 mg and 42 mg capsule form, is an antipsychotic drug that is indicated for the treatment of schizophrenia, bipolar disorder, depression, sleep and behavioral disturbance in dementia, autism and other neuropsychiatric disorders. In your letter, you stated clinical trials are ongoing for this product.
The applicable subheading for the Lumaterperone Tosylate in bulk form will be 2933.99.6100, 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: Drugs primarily affecting the central nervous system: Antidepressants, tranquilizers and other psychotherapeutic agents: Other.” The rate of duty will be 6.5 percent ad valorem. Currently, Lumaterperone Tosylate is not listed in the Pharmaceutical Appendix to the Tariff Schedule.
The applicable subheading for the Lumateperone Capsules in dosage form will be 3004.90.9235, HTSUS, which provides for “Medicaments … consisting of mixed or unmixed products for therapeutic or prophylactic uses, put up in measured doses … or in forms or packings for retail sale: Other: Other: Other: Medicaments primarily affecting the central nervous system: Antidepressants, tranquilizers, and other psychotherapeutic agents.” 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 the 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