FDA Workshop to Focus on Traceability in the Supply Chain

The FDA will hold a public workshop in early May to discuss the development of standards for the interoperable exchange of information pertaining to prescription drug tracing.

The May 8-9 workshop, prompted by supply chain security measures laid out in the 2013 Drug Supply Chain Security Act, is intended to gather input from stakeholders on current practices, research, and ideas on “the feasibility of establishing standardized documentation” to enable information about a drug, including lot level data, to be easily exchanged among all parties in the supply chain, a notice in today’s Federal Register says.

The agency also wants to know about practices, processes and systems that stakeholders currently use to exchange information and how trading partners respond to requests for verification of suspect products and requests from the FDA or other regulators.

Registration for the workshop, to be held at the FDA’s White Oak campus, closes April 24. Comments on the topic may be submitted through June 9 and will be posted on regulations.gov.

View the Federal Register notice at www.fdanews.com/ext/resources/files/04/04-02-14-TransferWorkshop.pdf. — Lena Freund

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