Guide on Drug Supply Verification Systems

Federal Register notice: FDA is making available a final guidance entitled “Verification Systems Under the Drug Supply Chain Security Act for Certain Prescription Drugs.” The document addresses the verification systems that manufacturers, repackagers, wholesale distributors, and dispensers must have in place to comply with provisions in the Drug Supply Chain Security Act. It covers the statutory verification systems requirements that include the quarantine and investigation of a product determined to be suspect and the quarantine and disposition of a product determined to be illegitimate. The guidance also addresses the statutory requirement for notifying the agency about a product that has been cleared by a manufacturer, repackager, wholesale distributor, or dispenser (‘trading partners’) after a suspect product investigation because it is determined that the product is not an illegitimate product. To view the notice, click here.