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FDA Pilot Program Will Assess Product Tracking Systems

July 21, 2017

The FDA is launching a voluntary pilot program for manufacturers, distributors, and dispensers to help develop package-level tracing systems required by 2023 under the Drug Supply Chain Security Act.

The agency plans to use the pilot to assess industry’s ability to meet the DSCSA’s requirements, including identifying illegitimate products and preventing diversion. The FDA said it would like to see participation by large and small companies across the supply chain, to represent a mix of products and levels of packaging.

Potential issues include technical challenges for affixing individual product identifiers to each package — such as barcodes, QR codes and serial numbers — and the interoperability of systems used for exchanging tracking information among trading partners.

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