Fresh Frozen Human Plasma
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.
Import Duty Rates by Country of Origin
| Origin Country | MFN Rate | Ch.99 Surcharges | Total Effective Rate |
|---|---|---|---|
| 🇨🇳China | Free | — | Free |
| 🇲🇽Mexico | Free | — | Free |
| 🇨🇦Canada | Free | — | Free |
| 🇩🇪Germany | Free | — | Free |
| 🇯🇵Japan | Free | — | Free |
Alternative Classifications
This product could be classified differently depending on its characteristics or intended use.
If derived from animal blood
Animal blood plasma for therapeutic uses falls under a separate subheading for non-human sources.
If modified into specific immunological products like concentrates
Highly processed blood fractions beyond basic plasma may classify as other immunological products.
If packaged as sterile medical appliances for ostomy or wound care
Blood plasma in appliance form for specific surgical uses moves to heading 3006.
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Import Tips & Compliance
• 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
Related Products under HTS 3002.12.00.10
Cryoprecipitated Antihemophilic Factor from Human Plasma
Cryoprecipitate is a human plasma fraction rich in factor VIII, fibrinogen, and von Willebrand factor, prepared by thawing frozen plasma at 1-6°C. It treats hemophilia A and fibrinogen deficiencies. Falls under HTS 3002.12.00.10 as a human blood fraction derived from plasma.
Human Plasma-Derived Immunoglobulin Fraction
IVIG (intravenous immunoglobulin) is a pooled human plasma fraction containing antibodies for immune deficiency treatment. Prepared via cold ethanol fractionation. While purified, retains blood fraction classification under HTS 3002.12.00.10.
Human Plasma for Further Manufacture
Bulk human plasma supplied to fractionators for producing albumin, IVIG, and clotting factors. Prepared with therapeutic end-use in mind. Classified HTS 3002.12.00.10 as blood plasma for therapeutic applications.
Lyophilized Human Plasma for Surgical Use
Lyophilized (freeze-dried) human plasma is dehydrated plasma reconstituted with sterile water for volume replacement in surgery. It provides essential proteins and clotting factors. Classified in HTS 3002.12.00.10 as processed human blood plasma for therapeutic applications.
Pathogen-Reduced Human Plasma
Human plasma treated with amotosalen/UVA light to inactivate viruses, bacteria, and parasites while preserving therapeutic proteins. Used for transfusion in immunocompromised patients. HTS 3002.12.00.10 covers this modified human blood plasma.
Solvent/Detergent Treated Human Plasma
Human plasma treated with TNBP/Tween 80 to disrupt lipid envelopes of viruses, then purified. Used for transfusion medicine. Classifies as human blood fraction under HTS 3002.12.00.10 despite viral inactivation processing.