RhoGAM Human Immune Serum from Japan
RhoGAM is a human immune globulin derived from plasma containing antibodies against the Rho(D) antigen, used to prevent Rh hemolytic disease in newborns. It qualifies under HTS 3002.12.0030 as human immune blood sera prepared for prophylactic use in preventing alloimmunization in Rh-negative mothers. This sterile, injectable product is biotechnologically processed from human plasma.
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
• Obtain FDA biologics license application (BLA) approval and ensure cold chain documentation for plasma products to maintain potency
• Provide certificates of analysis verifying human plasma origin and absence of adventitious agents per 21 CFR 630
• Avoid misclassification as non-immune sera; confirm immunological activity via donor screening records