FDA Releases Supply Chain Guidance

On August 18, 2017, FDA published draft guidance on how to identify trading partners in the supply chain in accordance with Drug Supply Chain Security Act (DSCSA) product tracing requirements. The intent of the guidance is to help industry and state and local governments identify the type of trading partner they may be working with and clarify if that trading partner requires licensure or annual reporting.

DSCSA requires manufacturers, repackagers, wholesale distributors, and dispensers to meet certain requirements in order to be considered authorized trading partners. The guidance defines drug supply entities under DSCSA, what qualifies these entities as authorized partners, and outlines the licensure and reporting requirements for such entities, going into specifics on how to identify each type of partner in the supply chain.