DSCSA Product Tracing Implementation Plan
Implementation plan for the US tracing regime, opening with a side-by-side comparison against the EU scheme because neither satisfies the other. Covers authorised trading partner status, the product identifier and where its syntax comes from, electronic exchange that is also interoperable, verification response as a system design requirement, suspect and illegitimate product handling, and exemption status re-checked against a current source. Maps to the DSCSA and the GS1 General Specifications.
What a template is not
A template is a document baseline to adapt inside your own quality system. SPEQ does not approve, validate, or take responsibility for what you issue from it, and using one is not evidence of compliance.
The US supply-chain security law and the EU falsified-medicines scheme address the same threat and are structurally different. The US regime rests on trading partners exchanging tracing information and responding to verification requests; the EU scheme on verifying an identifier at the point of supply. Neither satisfies the other, and assuming otherwise is the most costly error here. Which regimes apply to your trading model is your determination.
What's Inside
How to Use It
The full section structure of this template — every section and sub-section, so you can use it as a baseline for your own site document.
The DSCSA (FD&C Act §§581–585) establishes the US product tracing, verification and authorised trading partner requirements, together with the suspect and illegitimate product obligations; the GS1 General Specifications supply the identifier syntax the law leaves open while specifying the outcome. Neither decides which of your trading relationships fall in scope, what response time your systems must achieve, or when an exemption applies to you. Those determinations are yours. The comparison and implementation structure are SPEQ practitioner synthesis.