US FDA track and trace: Industry welcomes data standardisation

By Flora Southey

- Last updated on GMT

The US FDA’s latest guidance is a positive step towards data integrity in the supply chain, says serialisation firm SEA Vision.

The US Food and Drug Administration (FDA) released the Standardisation of Data and Documentation Practices for Product Tracing​ – guidance last week, which elaborates on industry standards relating to the Drug Supply Chain Security Act​ (DSCSA).

The DSCSA aims to build an electronic system to trace prescription medicines in the US.

Serialisation provider SEA Vision said moving to a fully electronic track and trace system is a big step for many countries.

“But that said, the FDA has taken a phased approach to track and trace and extended its timeline well beyond those in countries such as Russia and Brazil,” ​said commercial director Marco Baietti.

“The move to fully electronic traceability information is a positive step in terms of data integrity, availability and exchange in the supply chain,”​ Baietti added.

It is important firms within the pharmaceutical supply chain move in the same direction and “embrace the advantages of technology and digitisation,” ​he said.


Contract development and manufacturing organisation (CDMO) Recipharm similarly welcomed the latest update.

“Moving to a completely electronic system should only bring advantages to CMOs and the wider industry, improving data integrity and security and reducing the time and resource needed to produce and exchange traceability,” ​director of corporate projects Staffan Widengren told us.

Data transactions

TraceLink’s VP for industry marketing Brian Daleiden questioned whether the guidance could have an impact on 3T documentation​.

T3 refers to transaction information (T1), transaction history (TH), and a transaction statement (TS), which firms much capture and maintain for six years in compliance with FDA regulations.

“There are a few scenarios where the FDA has suggested alternative data management approaches for Transaction Information data and handling of Transaction History content, some of which may be at variance to how companies today have implemented their traceability systems,” ​he told us.

“It will be interesting to see if this guidance drives some change in current TH/TI/TS data exchange practices,” ​he added.

Last week, the FDA also released a Definitions of Suspect Product and Illegitimate Product for Verification Obligations​ draft guidance to help firms identify if a product is ‘suspect’, ‘illegitimate’, ‘counterfeit’, ‘diverted’, or ‘unfit for distribution.’

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