FDA details plans for DSCSA drug tracing pilots

FDA unveiled on July 19 plans for a pilot program aimed at exploring issues related to the interoperable electronic system for drug tracing required under the Drug Supply Chain Security Act (DSCSA) by 2023.

FDA unveiled on July 19 plans for a pilot program aimed at exploring issues related to the interoperable electronic system for drug tracing required under the Drug Supply Chain Security Act (DSCSA) by 2023. The DSCSA, passed by Congress in November 2013, introduced new requirements for identifying and tracing drugs throughout the supply chain to safeguard against counterfeiting and diversion of drugs sold in this country. FDA said it would delay enforcement of the protect identifier requirement until November 2018, but its overall timeline for setting up an interoperable drug-tracing system by 2023 has not changed. According to FDA, the pilot program aims to "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." The agency said it plans to approve one or more pilots, proposed and conducted by stakeholders, that evaluate such issues as product identifier management and investigating suspected illegitimate product and error handling. FDA also said it will hold a series of three public meetings on DSCSA-related issues through February 2018.