Waste Pharmaceuticals

Waste pharmaceuticals are typically imported when a US-based company needs to destroy or process expired, recalled, or contaminated drug products that were distributed or stored abroad, or when specialized destruction facilities in the US are used for international pharmaceutical waste. Clinical trial material that was shipped overseas and must be returned for destruction is another common scenario. The importer must have a lawful disposal plan in place before entry.

FDA retains authority over the drug product itself and may require documentation confirming the material's status as waste rather than a product intended for distribution. EPA may assert jurisdiction under the Resource Conservation and Recovery Act (RCRA) if the waste is classified as hazardous. Importers should engage both agencies — and a licensed customs broker with pharmaceutical experience — to confirm the correct entry procedure and disposal documentation requirements.