FDA Issues Guidance Delaying Select Drug Supply Chain Security Act (DSCSA) Requirements


Milwaukee, WI – The FDA recently issued updated guidance for industry surrounding DSCSA and the upcoming requirement deadline. Passed in 2013, DSCSA aims to reduce counterfeit and illegitimate products from reaching dispensers, improving patient outcomes and securing the pharmacy supply chain. The 10-year rollout was set to go into effect on November 27, 2023. The recent guidance provides a year-long extension for specific requirements, with others remaining on track for 2023 enforcement.

Remember, this is a delay of enforcements, not an admission of impossibility. Make no mistakes, adherence to DSCSA compliance requirements is possible, and the FDA “strongly urges trading partners to continue their efforts to implement necessary measure to satisfy these enhanced drug distribution security requirements.”

The following requirements have been delayed until November 27, 2024:

EPCIS – the requirement that transaction information include package-level product identifiers (i.e, the standardized numerical identifier consisting of the NDC and serial number, lot number and expiration date); this applies to all applicable product introduced to the supply chain prior to November 27, 2024, through the expiration date of such product.

Interoperable Exchange of Information – the requirement that the transaction information and statements be exchanged in a secure, interoperable and electronic manner.

Package Level Verification – the requirement that systems and processes for verification at the package-level include the standardized numerical identifier.

Audit Response – the requirement for systems and processes to promptly facilitate the gathering and delivery of the transaction information and statement, for a product upon request, by the Secretary or other appropriate official, in the event of a product investigation or recall.

Salable Returns – the requirement that each person accepting a saleable return have systems and processes in place to allow acceptance of such product and may accept saleable returns only if such person can associate the saleable return product with the transaction information and transaction statement for the product.

ConsoritEX encourages all dispensers to continue on the path towards compliance by the 2023 deadline. The benefits of product verification can be felt today. If you have any concerns about your facilities ability to meet 2023 requirements, please contact us today!


Disclaimer: The content above is meant to serve as a high-level summary of updates and should not be relied upon to make policy changes. The full guidance can be accessed below; ConsortiEX urges all parties to defer to the guidance document to inform any policy or procedural changes.  

Access the full guidance, here: https://www.fda.gov/media/171592/download


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