EpiPen Auto-Injector 0.3mg from Japan
The EpiPen Auto-Injector 0.3mg is a single-use device containing epinephrine injection for emergency treatment of anaphylaxis. It consists of epinephrine (a hormone derivative of heading 2937) in a measured dose of 0.3mg, put up in a form for retail sale. Classified under HTS 3004.39.0020 due to containing epinephrine for therapeutic use.
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
• Verify FDA approval and NDC number on labeling for epinephrine products to ensure compliance with US drug import regulations
• Include Certificate of Pharmaceutical Product (CPP) and batch certificates; common pitfall is missing stability data for auto-injectors
• Declare exact epinephrine concentration and delivery mechanism to avoid reclassification as a medical device