FDA may issue a Notice of Action detaining a pharmaceutical shipment if the product appears to be adulterated, misbranded, or from an unregistered facility. The importer of record typically has an opportunity to submit testimony or reconditioning proposals to bring the goods into compliance. If the detention is not resolved, FDA can refuse admission and require the goods to be re-exported or destroyed. Working with a licensed customs broker and an FDA regulatory consultant before shipment is the most effective way to avoid detention.

Bulk APIs are generally classified under HTS Chapter 29 (organic chemicals) or Chapter 28 (inorganic chemicals) based on their chemical structure, while finished dosage forms — tablets, capsules, solutions, and similar preparations — are classified under Chapter 30 as medicaments. This distinction affects not only the duty rate but also the FDA import alert and admissibility framework that applies, since finished dosage forms trigger different review procedures than bulk chemical imports.