CLA-2-29:OT:RR:NC:N3:138
Mr. Mark D. Pinchok
Bayer International Trade Services Corporation
651 Colliers Way, Suite 414
Weirton, WV 26062
RE: The tariff classification of VITRAKVI™ capsules in dosage form and Larotrectinib (CAS No. 1223403-58-4) in bulk form, from the United States and imported from the United Kingdom
Dear Mr. Pinchok:
In your letter dated December 5, 2018, on behalf of Bayer HealthCare LLC, you requested a tariff classification ruling
Larotrectinib is a tropomyosin receptor kinase (TRK) inhibitor designed to treat TRK fusion cancer, regardless of a patient's age or tumor type. In your letter, you stated Larotrectinib will be synthesized in the United States and then formulated into Vitrakvi capsules of 25 mg in the United Kingdom.
VITRAKVI™ capsules imported in 25 mg is a medicinal preparation containing Larotrectinib, as the active ingredient. It is indicated for the treatment of adult and pediatric patients with solid tumors with a neurotrophic receptor tyrosine kinase (NTRK) gene fusion without a known acquired resistance mutation that are either metastatic or where surgical resection will likely result in severe morbidity, and have no satisfactory alternative treatments or have progressed following treatment.
The applicable subheading for Larotrectinib in bulk form will be 2933.59.5300, Harmonized Tariff Schedule of the United States (HTSUS), which provides for “Heterocyclic compounds with nitrogen hetero-atom(s) only: Compounds containing a pyrimidine ring (…) or piperazine ring in the structure: Other: Drugs: Aromatic or modified aromatic: Other.” The rate of duty will be 6.5 percent ad valorem. Currently, Larotrectinib is not listed in the Pharmaceutical Appendix to the Tariff Schedule.
The applicable subheading for the VITRAKVI™ capsules in 25 mg will be 3004.90.9215, 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: Antineoplastic and immunosuppressive medicaments." 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