The FDA Wants You – For a DSCSA Pilot Program

By February 19, 2019 March 14th, 2019 DSCSA, News, Uncategorized

Even if the FDA has left the pharma industry hanging on the question of verification, the agency is moving ahead with the pilot project to explore solutions to meet the November 2023 requirement for Interoperable Electronic Product Tracing.

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Submit applications to the pilot DSCSA program by March 11

Earlier this month the FDA announced that it’s seeking partners for an effort to explore “innovative and emerging approaches” in technology to develop an enhanced electronic, interoperable track-and-trace system.

“We’re giving industry an opportunity to test new technologies that can help spur greater accountability for participants in the supply chain,” FDA Commissioner Scott Gottlieb said in a statement. “We recognize that tracking and tracing products is critical to industry’s ability to detect and remove potentially dangerous drugs from the drug supply chain.”

The scope of the project includes examining processes to manage Product Identifiers, barcode readability, technical aspects of the Interoperability requirement, database systems, verification requests and more. The FDA has issued a detailed outline in the project announcement, based on results of the agency’s April 2016 workshop and public comments.

Under the DSCSA, the FDA will require manufacturers to aggregate unit packages to case packages, case packages to pallet, and provide the aggregated shipment data to downstream trading partners.  Wholesale distributors won’t be allowed to accept DSCSA products that aren’t serialized or aggregated starting Nov. 27, 2023.

The FDA says the project is open to all pharma supply chain stakeholders, including large and small companies in all sectors of the industry. To apply, submit an application by March 11. Instructions and details about what to include in an application are here.

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