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FDA Guidance for Industry: DSCSA Standards for the Interoperable Exchange of Information for Tracing of Certain Human, Finished, Prescription Drugs: How to Exchange Product Tracing Information



This guidance addresses the pharmaceutical security provisions in section 582 of the Federal Food, Drug, and Cosmetic Act (FD&C Act). Section 582 was added by the Drug Supply Chain Security Act (DSCSA) (Title II of Public Law 113-54) and facilitates the tracing of products through the pharmaceutical distribution supply chain by requiring certain trading partners(manufacturers, repackagers, wholesale distributors, and dispensers) to exchange transaction information, transaction history, and a transaction statement (product tracing information) when engaging in transactions involving certain prescription drugs.

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