Grandfathering Policy for Packages and Homogenous Cases of Product Without a Product Identifier

12/01/2017

The FDA released a guidance document for comment purposes.

The DSCSA (Title II of Public Law 113 - 54) was signed into law on November 27, 2013. Section 202 of the DSCSA added section 582 to the FD&C Act, which established product tracing requirements for manufacturers, repackagers, wholesale distributors, and dispensers of most prescription drugs in a finished dosage form for administration to a patient without substantial further manufacturing (products). The DSCSA phases in its new requirements over a period of 10 years.

Full guidance document:
https://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM586509.pdf

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