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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%Patented pharmaceutical articles that are the product of Japan, of a European Union member country, of South Korea, of Switzerland, or of Liechtenstein as provided for in subdivisions (c) and (f) of U.S. note 40 to this subchapter
9903.05.860%Articles provided for in subdivision (b) of U.S. note 52 to this subchapter

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