Clinical Trial Pharmaceutical Sample from Japan
Small batch of experimental drug formulation for Phase II clinical trials evaluating bioavailability. Imported by research hospital for human subject testing under FDA IND protocol. Qualifies under 9813.00.30 for review and testing purposes only.
Duty Rate — Japan → United States
12.5%
Rate breakdown
9903.05.4912.5%Except for products described in headings 9903.05.85–9903.05.92, articles the product of Japan, with an ad valorem (or ad valorem equivalent) rate of duty under column 1 less than 12.5 percent, as provided for in U.S. note 52 to this subchapter
Import Tips
• Include FDA IND number and protocol summary with entry documents
• Quantities must match approved trial protocol to avoid commercial classification
• Maintain chain of custody records showing delivery to approved research site