Rituximab Monoclonal Antibody Injection from Japan
Rituximab is a genetically engineered chimeric monoclonal antibody targeting CD20 on B-cells, used for treating non-Hodgkin lymphoma and rheumatoid arthritis. It falls under HTS 3002.15.00.11 as an immunological product containing monoclonal antibodies, put up in measured doses for retail sale in pre-filled syringes or vials.
Duty Rate — Japan → United States
15%
Rate breakdown
9903.04.6215%Pharmaceuticals: patented pharma from JP/EU/KR/CH/LI — 15% floor rate
9903.05.860%Universal product exemption (U.S. note 52(b))
9903.05.900%Articles already subject to Section 232 (steel/aluminum/copper + derivatives, autos + parts, wood, medium/heavy vehicles + parts, semiconductors, patented pharma) — U.S. note 52(f)
Import Tips
• Obtain FDA biologics license and ensure proper cold chain documentation (2-8°C) to avoid spoilage during import
• Include certificates of analysis verifying monoclonal antibody purity and biotech origin; declare as immunological product
• Avoid misclassification as general pharmaceuticals; common pitfall is insufficient proof of measured doses for retail