US: Grandfathering policy for packages and products without PI
This draft guidance addresses product distribution security provisions in section 582 of the Federal Food, Drug, and Cosmetic Act (FD&C Act).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) and facilitates the tracing of products through the pharmaceutical distribution supply chain by requiring trading partners to exchange information when engaging in transactions involving certain prescription drug products.
Section 582 also requires manufacturers and repackagers to start affixing or imprinting a product identifier to each package and homogenous case of product no later than November 27, 2017 (for manufacturers) and November 27, 2018 (for repackagers) (FDA, November 2017).
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