US: Grandfathering policy for packages and products without PI

21 December 2017

This draft guidance addresses product distribution security provisions in section 582 of the Federal Food, Drug, and Cosmetic Act (FD&C Act).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).
Click here to download the full draft guidance for industry (393 kB).
Click here for more information about the NVC project Pharmaceutical Packaging Innovation.
Click here for more information about the Live Online NVC E-Course Pharmaceutical Packaging.

This news item is also included in our monthly overview, the NVC Members-only Update. If you have any questions, please contact us:, +31-(0)182-512411.