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Cytomegalovirus Immune Globulin Intravenous (CMV IGIV) from Japan

CMV IGIV is a human immune serum containing high-titer antibodies against cytomegalovirus, used prophylactically in transplant patients. It falls under HTS 3002.12.0030 as human immune blood sera fractionated from pooled plasma of immunized donors. The product is formulated for intravenous administration to prevent CMV disease.

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

Submit lot-specific Certificates of Analysis (CoA) confirming CMV antibody titers > specific IU/g

Ensure CBP review of plasma donor seroprevalence data; non-compliance leads to quarantine

Label as 'human origin' explicitly to avoid reclassification as synthetic biologics