US: FDA releases guidance on DSCSA implementation

26 November 2015

The Drug Supply Chain Security Act (DSCSA) required dispensers, which primarily include pharmacies, to comply with new requirements related to product tracing beginning July 1, 2015.
The FDA issued a guidance, "DSCSA Implementation: Product Tracing Requirements for Dispensers–Compliance Policy (Revised)," announcing that it is extending a previously issued Compliance Policy from November 1, 2015 to March 1, 2016 because some dispensers—primarily smaller, independent pharmacies and health systems—have expressed that they need additional time. This is an extension of the FDA Compliance Policy that was published on July 6, 2015 (Pharmaceutical Processing, 10 October. 2015).
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Click here to download the revised DSCSA Implementation: Product Tracing Requirements for Dispensers–Compliance Policy (56 kB).
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