Exposure to potentially harmful levels of toxic fumes or radiation is considered to be an improper storage condition. It is essential that firms exercise due diligence to ensure that their drugs were manufactured, processed, packaged, and held under conditions consistent with current good manufacturing practice. This includes assuring acceptability of both raw materials and drug products.
FDA routinely monitors the quality of marketed drug products, including those imported into the U.S. In response to natural disasters, FDA may increase its monitoring and detection capabilities and apply appropriate regulatory action to help ensure the quality and safety of the drug supply.
