Pharmaceutical, biotech, and medical device imports tend to have very high per-unit values, often into the hundreds or thousands of dollars per unit for specialty pharmaceuticals, APIs, and advanced medical devices. Even with lower volume than commodity sectors, the dollar value per drawback claim can be substantial. The sector also has highly complex sourcing, with imports drawn from specialized global suppliers.

Manufacturing Drawback applies to imported APIs, intermediates, and components used in the production of exported finished pharmaceuticals or medical devices. Unused Merchandise Drawback applies to imports re-exported without use, common in clinical trial supply chains.  Rejected Merchandise Drawback covers non-conforming product. Substitution Drawback can apply to commodity-grade chemical inputs.

Drawback is a CBP function and doesn't require FDA involvement, but FDA regulations affect how pharmaceutical and medical device imports are documented. The customs entries and FDA filings need to be consistent. Caspian's Trade Audit operates on the CBP side, while FDA-specific compliance work is handled separately.

Pharmaceutical and medical device imports for clinical trials, R&D, and research use often qualify for drawback when the materials are later exported or destroyed. This is particularly relevant for biotech companies with international research operations or contract research organizations (CROs) operating across borders.

Pharmaceutical HTS codes are in Chapter 30 and have specific structures for active ingredients, formulated products, and medical devices. Classification affects both duty rate and trade program eligibility. Some pharmaceutical products qualify for duty-free treatment under the Pharmaceutical Appendix. Caspian's Classification work locks in correct codes and identifies trade program eligibility importers may be missing.

The drawback mechanics are the same, but documentation and HTS classification differ. Medical devices span multiple chapters: Chapter 90 for instruments, Chapter 30 for medical supplies, and Chapter 39 for plastic device components. Caspian's platform handles both pharma and device data structures within the same drawback framework.