The US Food and Drug Administration (FDA) on Wednesday announced it plans to launch 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 agency also announced that it will hold a series of public meetings on DSCSA-related issues in August 2017, December 2017 and February 2018.
At the meetings, FDA says it plans to discuss issues ranging from supply chain security needs, electronic interoperability and data exchange standards, as well as capacity building for a unit-level drug tracing system.
Background
In November 2013, Congress passed the DSCSA, which introduced new requirements for identifying and tracing drugs throughout the supply chain to protect against counterfeiting and diversion of drugs sold in the US.
The act does so by requiring companies to add a product identifier at the package level of their products that can be traced via an interoperable electronic system.
While FDA announced it would delay enforcement of the product identifier requirement until November 2018, its overall timeline for establishing an interoperable system for tracing drugs by 2023 remains unchanged.
Pilot Program
FDA says the pilot program is meant 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."
As such, FDA says it is looking for participants from industry—large and small—that represent various aspects of the pharmaceutical supply chain, including authorized manufacturers, repackagers, wholesale distributors and dispensers.
Under the program, FDA says it plans to sign off on one or more pilots—proposed and run by stakeholders—that evaluate issues such as product identifier management, barcode quality, system interoperability, database and data exchange, investigating suspected illegitimate product and error handling.
If a pilot proposal is selected by FDA, the agency says it expects the participant to start the pilot within four months and run for less than six months, though some projects with later start dates or longer timelines may be considered. FDA also says it expects to receive monthly progress reports from the participant, and a final report on the results of the pilot within 30 days of its completion.
FDA