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Cytomegalovirus (CMV) Hyperimmune Globulin from Japan

Hyperimmune plasma fraction enriched with CMV-specific antibodies for preventing CMV infection in transplant patients. Falls under HTS 3002.12.0090 as an other blood fraction/antisera prepared for prophylactic use through plasma fractionation. It meets the definition of immunological products from human blood.

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

Provide viral safety dossiers (e.g

PCR negative for CMV, HIV) as required for blood product imports

Label as 'human origin' with donor screening records to pass FDA review

Avoid bulk import without fractionation proof; could misclassify as raw plasma