FDA lays out plans for DSCSA pilots and public meetings

The US FDA has unveiled plans to launch a pilot programme that will put the medicines tracing system planned for the US through its paces.

The regulator has also said it will hold three public meetings that will "provide members of the pharmaceutical distribution supply chain and other interested stakeholders an opportunity to discuss with FDA, and provide input on, strategies and issues related to the enhanced drug distribution security provisions."

The meetings will be held on August 23, December 5 and 6 and February 28, 2017, around a year before the next – and recently delayed – deadline in the DSCSA implementation timeframe.

The DSCSA stipulates that all medicine packs sold in the US must be marked with a product identifier, serial number, lot number and expiration date using a 2D datamatrix barcode that will help create an electronic, interoperable system that will identify and trace certain prescription drugs as they are distributed within the US supply chain by 2023.

The system "will enhance FDA's ability to protect US consumers from exposure to drugs that may be counterfeit, diverted, stolen, intentionally-adulterated, or otherwise harmful by improving the detection and removal of potentially dangerous drugs from the drug supply chain," said the agency.

The agency says its planned pilot programme will "explore issues related to utilize the product identifier for product tracing, improving the technical capabilities of the supply chain, [and] identifying the system attributes that are necessary to implement the requirements established under the DSCSA."

It is looking for volunteer companies – both large and small – that span the range of pharma supply chain actors, including manufacturers, repackagers, wholesale distributors and dispensers, and says proposed pilots should focus on the requirements for package-level tracing and verification that go into effect in 2023.

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