FDA Creates New Import Alert for Drugs Found Adulterated After Testing
FDA on July 2 created new Import Alert 66-78 for drugs that appear to be adulterated based on analytic test results. The import alert, which does not yet list any products for detention without physical examination (DWPE), covers “drugs, including…
Sign up for a free preview to unlock the rest of this article
If your job depends on informed compliance, you need International Trade Today. Delivered every business day and available any time online, only International Trade Today helps you stay current on the increasingly complex international trade regulatory environment.
finished dosage drug products and active pharmaceutical ingredients, considered at risk for adulteration that pose a health risk due to contamination, substandard quality, or ingredient substitution.” Reasons for listing include instances in which testing has revealed harmful impurities; violations of current good manufacturing practices; substandard strength, quality or purity; drugs not recognized in an official compendium; mixing or packing to reduce quality or strength; and drugs that have been entirely substituted. “To secure release of an individual shipment subject to DWPE under this Import Alert, the importer and/or another responsible party to the shipment should provide evidence that the shipment does not contain drugs that appear to be adulterated,” FDA said.