This guidance is intended to assist trading partners in standardizing the data contained in the product tracing information that trading partners must provide, capture, and maintain under section 582. This guidance is also intended to help trading partners understand the data elements that should be included in the product tracing information, particularly in situations where trading partners are permitted by law to provide other trading partners with product tracing information that omits certain elements that would otherwise be required. In addition, this guidance recommends documentation practices that trading partners can use to satisfy the product tracing requirements of section 582. This guidance does not address all provisions of the DSCSA. As FDA works to implement other provisions of the DSCSA, the Agency expects to issue additional guidance and/or regulations and conduct public meetings to further delineate the requirements of the DSCSA.

 

DOWNLOAD HERE