FDA seeks info on medicine traceability pilot trials

The US FDA is seeking information from groups that have already run drug traceability pilot studies to help it develop its own programmes.

A Federal Register notice published late last week said the agency is looking for feedback on "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 DSCSA [Drug Supply Chain Security Act]."

This information "will assist FDA with the design and development aspects of the proposed pilot projects," it added.

In particular, the FDA is interested in information concerning current or past pilot programmes on supply chain safety and security, with an emphasis on the use of unique product identifiers, for verification as well as aggregation/inference.

Manufacturers, repackagers, wholesale distributors, dispensers, state and federal authorities, solution providers, and standards organizations may be interested in responding to the request, suggests the agency, which will accept comments until May 16.

The DSCSA was signed into law by President Obama in November 2013 and sets out a timeline for the implementation of a system for identifying and tracing prescription drugs as they are distributed throughout the US.

The act calls for the FDA to establish pilot programmes "to explore and evaluate methods to enhance the safety and security of the pharmaceutical distribution supply chain."

Earlier this month, the agency held a workshop to get feedback from stakeholders on the design of pilot medicine traceability studies, and opened a comment period that closes tomorrow.

It is seeking insight into improving the technical capabilities of the pharmaceutical distribution supply chain, and identifying the system attributes that are necessary to implement the requirements.