FDA holds another meeting on DSCSA implementation

The US FDA is convening a meeting next month to discuss requirements laid out in the US's medicines track-and-trace legislation.

The meeting is intended to allow stakeholders to "share information with FDA about the efforts underway to implement the Drug Supply Chain Security Act (DSCSA) product identification requirements, including the use of product identifiers to enhance tracing at the product level."

The FDA is required to conduct at least five such meetings during the DSCSA implementation period between 2015 and 2021 in order to get feedback on various elements of the new requirements. Earlier this year, the agency held a workshop to discuss the design of pilot medicine traceability studies.

"The main topic FDA is interested in discussing at the public meeting is the supply chain's progress toward implementing the DSCSA's product identification requirements," said the agency in a Federal Register post.

It is interested to hear about best practices in each sector of the pharmaceutical distribution supply chain to conduct product tracing, verification, and product identification.

"This may include the processes needed to utilize the product identifiers to enhance tracing of product at the package level, including allowing for verification, aggregation, and inference, as necessary," said the agency.

The DSCSA was signed into law by President Obama in November 2013, setting a 10-year deadline to implement an individual package level system to track medicines through the supply chain and allow them to be verified using the unique product identifier.

The aim of the DSCSA is protect US consumers from exposure to drugs that may be counterfeit, stolen, contaminated, or otherwise harmful.