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12 May 2016

Pharmaceutical distribution supply chain pilot projects — FDA request for information

The information gathered from public comments will assist with the design and development of the pilot project(s) that FDA establishes under the DSCSA.

FDA is soliciting information regarding issues related to utilizing the product identifier for product tracing, improving the technical capabilities of the supply chain, and identifying system attributes that are necessary to implement the requirements established under the Drug Supply Chain Security Act (DSCSA). The information gathered from public comments will assist with the design and development of the pilot project(s) that FDA establishes under the DSCSA.

FDA is particularly interested in comments regarding past or present pilot projects related to enhancing the safety and security of the pharmaceutical distribution supply chain. FDA is particularly interested in learning about the practices, processes, and systems that supply chain stakeholders have used or considered using in such pilot projects.

This includes, but is not limited to, information about the following:

  • Utilizing the product identifier for tracing of a product, which may include verification of the product identifier of a product, including the use of aggregation and inference
  • Technical capabilities of each section of the supply chain to comply with systems and processes needed to utilize the product identifier to enhance the tracing of a product
  • System attributes that are necessary to implement the requirements established under the DSCSA.
  • Interested persons are requested to provide any other relevant information that may assist with FDA's development of a pilot project under the DSCSA.

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