In Response to the FDA Announcement

Following a recent statement issued by the FDA, ConsortiEX would like to inform all partners of an extension of the DSCSA Stabilization Period. Despite this announcement, the FDA advises, “eligible dispensers and their trading partners [to] continue to rely on current methods for verification of product at the package level for products transacted by eligible dispensers from November 27, 2024, until November 27, 2025.”

For dispensers, the deferment includes:

• verifying the product identifier against electronic data
  
• exchanging transaction information and transaction statements in a secure, interoperable, electronic manner
  
• that required exchanged transaction information include the product identifier at the package-level for each package included in the transaction
  
• systems and processes for verification of product at the package-level, including the standardized numerical identifier
  
• systems and processes to promptly respond with the transaction information and transaction statement upon request
  
• systems and processes to promptly facilitate gathering the information necessary to produce the transaction information for each transaction going back to the manufacturer
  
• systems and processes to allow acceptance of saleable returns; accepting saleable returns only if the accepting entity can associate the product with its received transaction information and transaction statement

 Updated enforcement deadlines differ for the various trading partners, and can be found below:

Manufacturers/Re-packagers:  05/27/2025
Wholesaler Distributors:              08/27/2025
Dispensers:                                            11/27/2025

The updated DSCSA enforcement deadline for dispensers is November 27, 2025.

Despite the deferment, ConsortiEX will continue working with your supply chain partners to satisfy all DSCSA requirements, as soon as made possible by industry trading partners.

We continue on this path in alignment with the FDA, who added that “trading partners [whom] do not need to rely on the exemptions in this document … or any other previously established DSCSA exemption, we advise them to exchange electronic DSCSA transaction information and transaction statements and meet all other requirements of section 582(g)(1) of the FD&C Act beginning November 27, 2024.”

The centerpiece of ConsortiEX DSCSA compliance suite for dispensers is ConsortiEX Verify on Receipt^®, used with ScanCast™. This Universal Receiving System and workflow efficiency add-on, provide product-level verification as an industry best-practice, ensuring your organization benefits from the identification of adulterated, counterfeit, recalled, expired, and short-dated medications, protecting patients and supply chain. ConsortiEX provides this market-leading DSCSA verification solution to over 1,000 hospitals nationwide.

Please stay tuned for additional information in the coming days.