Rx-360 summary of FDA guidance

The Drug Supply Chain Security Act Implementation: Product Tracing Requirements for Dispensers — Compliance Policy.

FDA has recognized that some dispensers may need more time beyond the original 1 July 2015 deadline to work with trading partners to ensure they can properly receive, capture and maintain the product tracing information required by the Act. As such, FDA is issuing this revised guidance and extending this Compliance Policy to transactions that occur before 1 March 2016. FDA does not intend to take action against dispensers who, prior to March 1, 2016, accept ownership of product without receiving transaction information, transaction history, and transaction statements (product tracing information), prior to or at the time of a transaction, or do not capture and maintain the product tracing information, as required by the FD&C Act. This delay in enforcement until 1 March 2016, an additional 4 months, extends the full delay in enforcement to a total of 8 months from the date mandated by Congress.