9813.00.30/Clinical Trial Pharmaceutical Sample/Japan

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

10%

Rate breakdown

9903.03.0110%Except for products described in headings 9903.03.02–9903.03.11, articles the product of any country, as provided for in subdivision (aa) of U.S. note 2 to this subchapter

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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