FDA Begins DSCSA Pharmaceutical Supply Chain Electronic Tracing Pilot Program
The Food and Drug Administration is announcing the beginning of a new pilot program to test product tracing required under the Drug Supply Chain Security Act. Participants, including drug manufacturers, wholesale distributors and “other supply chain stakeholders,” will develop pilots to test out electronic product tracing at the package level required under DSCSA by 2023. FDA may begin more than one pilot associated with the effort, and each will require periodic progress reports and a final report by participants.
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Lessons learned in the pilot program will go toward development of the “interoperable electronic system to be established by 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 agency said.
Specific goals identified by FDA include “identifying system attributes” to implement the product tracing requirements, and “assessing the ability of supply chain members” to meet the requirements and identify, manage and prevent the distribution of suspect and illegitimate products, as well as “exchange product tracing information across the pharmaceutical distribution supply chain in an electronic and interoperable manner.”
Participation is voluntary and “will be open to pharmaceutical distribution supply chain members,” FDA said. FDA “plans to coordinate with stakeholders to ensure that pilot projects reflect the diversity of the pharmaceutical distribution supply chain, including large and small entities from all industry sectors,” it said.
Interested participants should submit a request to participate by email. A group of entities that want to partner in a pilot project can submit a single request. Participants should be ready to start their pilot within four months of receiving a letter of acceptance, with the length of the pilot not to exceed six months, FDA said.