Fresh Frozen Human Plasma from Japan
Fresh frozen human plasma is obtained from whole human blood and frozen within 8 hours of collection to preserve clotting factors. It is used therapeutically for patients with coagulopathies or massive transfusion needs. Classified under HTS 3002.12.00.10 as human blood plasma prepared for therapeutic uses.
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 donor screening documentation complies with 21 CFR 640
• Maintain cold chain with validated -18°C or colder shipping; include temperature logs in import filings
• Avoid common pitfalls like incomplete viral inactivation records, which trigger CBP holds