DSCSA

At the beginning of October FDA issued an exemption from the enhanced drug distribution security requirements of section 582 of the FD&C Act for eligible trading partners. This exemption applies to any product transacted by eligible trading partners who have successfully completed, or made documented efforts to complete, data connections with their immediate trading partners and still face challenges in exchanging data.

Below are the new timelines for the exemption:
Manufacturers and Repackagers: May 27, 2025
Wholesale Distributors: August 27, 2025
Dispensers with 26 or more full-time employees: November 27, 2025
Dispensers with 25 or fewer employees licensed as pharmacists or qualified as pharmacy technician: November 27, 2026

A full copy of the notice is available at https://www.fda.gov/media/182584/download and provides additional details on how this notice impacts each stakeholder in the supply chain. We encourage you to take a moment to review the full announcement.

Value Drug Company has been actively working towards the DSCSA serialization compliance deadline law since it was first signed into law in November of 2013.

• Over the past 10 years, Value Drug has made investments in our capital resources to enhance our systems and processes to support the law.

• We partnered with TraceLink to orchestrate our B2B connectivity and data translation to exchange and store EPCIS transactions, master data, and verification requests.

• We have been actively involved in industry planning workgroups to recommend best practices and standards to transact data in a secure and interoperable manner.

• We have conducted extensive outreach initiatives to onboard our trading partners to establish the required system connection to exchange data.

While good progress has been made to connect our trading partners and exchange information, a significant percentage of the non-exempt products we receive in our warehouse month over month simply do not contain the required EPCIS data to meet the requirements. As a result, Value Drug Company will recognize August 27, 2025, as a new target date for full compliance by wholesalers. This additional time will allow our trading partners and industry the additional time they need to further stabilize their systems and processes so we can continue to supply uninterrupted lifesaving medications to our customers and their patients.