CLA-2-30:OT:RR:NC:N3:138
Justine H. Bacani
Kite Pharma
2400 Broadway
Santa Monica, CA 90404
RE: The tariff classification of YESCARTA® (Axicabtagene Ciloleucel) from the Netherlands
Dear Ms. Bacani:
In your letter dated April 28, 2022, you requested a tariff classification ruling.
YESCARTA® (Axicabtagene Ciloleucel) is a CD19-directed genetically modified autologous T cell immunotherapy. It is indicated for the treatment of adult patients with relapsed or refractory large B-cell lymphoma after two or more lines of systemic therapy, including diffuse large B-cell lymphoma (DLBCL) not otherwise specified, primary mediastinal large B-cell lymphoma, high-grade B-cell lymphoma, and DLBCL arising from follicular lymphoma.
In your letter, you stated that YESCARTA® is different than other cancer medicine because it is a personalized, single-infusion, autologous CAR T immunotherapy engineered individually for each and every patient. Each single infusion bag of YESCARTA® contains a suspension of
chimeric antigen receptor (CAR)-positive T cells depending on the patient’s body weight. The target dose is 2 x 106 CAR-positive viable T cells per kg body weight, with a maximum of 2 x 108 CAR-positive viable T cells in approximately 68 mL. You suggest classification of YESCARTA® (Axicabtagene Ciloleucel) as a cell therapy product based on the 2022 Harmonized Tariff Schedule of the United States (HTSUS) changes. We agree with your classification since NY ruling N315919, dated December 10, 2020, did not have a specific subheading breakout for cell therapy products.
The applicable subheading for the YESCARTA® (Axicabtagene Ciloleucel) will be 3002.51.0000, Harmonized Tariff Schedule of the United States (HTSUS), which provides for “Cell cultures, whether or not modified: Cell therapy products.” 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 merchandise may also be subject to the rules and regulations of the U.S. Department of Health and Human Services, Centers for Disease Control and Prevention. You may contact them at 1600 Clifton Road, Atlanta, GA 30333, telephone number (404) 633-5313 or (800) CDC-INFO, or at the Web address [email protected].
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