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FDA Seeks to Establish DSCSA Pilot Projects

Posted 07 February 2019 | By Zachary Brennan 

FDA Seeks to Establish DSCSA Pilot Projects

As part of efforts to reduce the diversion of drugs in the US and to help deter counterfeit drugs from entering the supply chain, the US Food and Drug Administration (FDA) is seeking participants for pilot projects related to the requirements of the Drug Supply Chain Security Act (DSCSA).

The pilot projects are intended to assist FDA and members of the pharmaceutical distribution supply chain in the development of an interoperable electronic system to be established by 2023. Specifically, FDA says the pilot projects should focus on the enhanced requirements for package-level tracing and verification.

“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 other issues identified by FDA.

Other potential issues to examine and evaluate include processes related to the requirement for manufacturers to affix or imprint a product identifier on each package and homogenous case of product, the readability of barcodes, data governance and ways to maintain the integrity of information contained in the barcode of a serialized product throughout the supply chain.

As for participants, FDA is seeking to hear from those in the pharmaceutical distribution supply chain (e.g., authorized manufacturers, repackagers, wholesale distributors, and dispensers) and other stakeholders, though the agency intends to meet with selected pilot project participants to ensure that the learnings from the pilot project(s) will be complementary in informing all stakeholders in the development of the electronic, interoperable system that will go into effect in 2023.

The duration of a pilot project should not exceed six months, FDA says, noting that participants will be responsible for the funding and resources necessary to conduct the pilot.

In terms of final reports on the projects, FDA said it intends to make the following information about each pilot project of the program available to the public online in a final program report: “(1) the names and industry sector(s) of the pilot project participant(s); (2) the pilot project’s objectives and evaluation methods; (3) the duration of the pilot project; and (4) the key findings and lessons learned from the pilot project.”

Federal Register

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