PLANREFERENCE OUTLINE

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.

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HOW TO FILL THIS IN
How to Implement DSCSA Product Tracing, step by step →
REGULATIONS MAPPED
DSCSA (FD&C Act §§581–585)GS1 General Specifications
DOCUMENT TYPE
Plan
LAST UPDATED
August 2026
PURPOSE

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

✓Side-by-side comparison of the two regimes, ending in a statement of which apply to your operations
✓Authorised trading partner verification for every partner you buy from or sell to, with a re-verification cycle
✓Product identifier elements, and the standard supplying the syntax the law itself leaves open
✓Electronic exchange that is interoperable rather than merely electronic, tested with a real partner
✓Verification response capability with measured response times rather than a written commitment
✓Suspect and illegitimate product process, including quarantine, investigation, notification and the decision to clear or destroy
✓Exemption status recorded with the date it was last checked against a current primary source

How to Use It

1State which regimes apply before designing anything; compliance with one does not satisfy the other, and the mechanisms are not interchangeable.
2Verify authorised trading partner status for each partner and re-verify on a defined cycle, because status lapses without anyone telling you.
3Test that exchange is interoperable, not merely electronic — a bilateral file format meets one requirement and fails the other entirely.
4Treat verification response as a system design requirement rather than a written process; the response window runs in hours, not working days.
5Rehearse the suspect product process end to end, because the first real case is the worst time to discover who notifies whom.
6Re-check exemption dates against a current primary source and record the date you checked; these dates have moved more than once.
DOCUMENT CONTENTS

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.

—Document Control
› Document Information› Approval Signatures› Revision History› Distribution List
1Regime — And Why the EU Scheme Does Not Substitute
2Authorised Trading Partner Status
3Product Identifier
4Interoperable Electronic Exchange
5Verification Response Capability
6Suspect and Illegitimate Product, and Exemption Status
REGULATORY CONTEXT

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.

MAPPED STANDARDS
DSCSA (FD&C Act §§581–585)GS1 General Specifications
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