EpiPen Auto-Injector 0.3mg from China
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 — China → United States
100%
Rate breakdown
9903.04.60100%Except as provided in heading 9903.04.61, patented pharmaceutical articles as provided for in subdivisions (c) and (d) 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
• 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