FDA Announces Launch Of DSCSA Supply Chain Security Pilot Program
Executive Summary
FDA is accepting applications from the pharmaceutical industry to pilot electronic tracking systems for prescription drugs in preparation for a Nov. 27, 2023, implementation deadline.
FDA has announced it is accepting applications from the pharmaceutical industry and its supply chain partners to participate in a supply chain security pilot program to test the use of product identifiers, barcodes and the interoperable systems used to track and trace prescription drugs through the distribution chain.
The announcement was published in the Feb. 8 Federal Register. The Drug Supply Chain Security Act, signed into law on Nov. 27, 2013, outlines the steps for building an electronic, interoperable system that will identify and trace certain prescription drugs as they are distributed within the US. These systems must be in place by Nov. 27, 2023.
FDA said “the pilot program will be designed to explore issues related to utilizing the product identifier for product tracing, improving the technical capabilities of the supply chain, identifying the system attributes that are necessary to implement the requirements established under the DSCSA, and any other issues identified by FDA.”
The law required FDA to establish a pilot program, in coordination with manufacturers, repackagers, wholesale distributors and dispensers, to explore and evaluate methods to enhance the safety and security of the pharmaceutical distribution supply chain.
FDA Commissioner Scott Gottlieb announced that through the pilots “we’re giving industry an opportunity to test new technologies that can help spur greater accountability for participants in the supply chain and improve our ability to trace prescription drugs at every point in the distribution chain. Using new innovations, we believe we can improve the overall security of our closed system and improve our ability to trace prescription drugs and improve our ability to trace prescription drugs at every point in the distribution chain.”
FDA announced plans to develop the pilot in July 2017 and sought an estimate from industry on the time involved in participating. (Also see "FDA Announces Plans To Develop Supply Chain Security Pilot Program" - Pink Sheet, 19 Jul, 2017.)
At an April 2016 public workshop on DSCSA pilot projects, members of the pharmaceutical distribution supply chain offered some ideas on the design objectives for these pilot projects. Based on the information gathered at that workshop, FDA identified several potential issues to examine, and evaluation methods to use.
The pilots will have five focus areas: product identifiers, barcodes, interoperability, database system issues and aggregation/disaggregation.
FDA intends to make the following information about each pilot project available to the public in a final report: the names and industry sectors of the pilot project participants, the pilot project’s objectives and evaluation methods, the duration of the pilot project and the key findings and lessons learned from the pilot project. FDA intends to post the information on its website.
Participants will be responsible for funding their pilot projects.
Stakeholders interested in participating in the DSCSA pilot program may submit a request by email to [email protected]. The selected participants should be ready to start their pilot project within four months of receiving a letter of acceptance from FDA. The duration of a pilot project should not exceed six months.
From the editors of The Gold Sheet.