Drug Supply Chain Security Act (DSCSA)

The Drug Quality and Security Act (DSCSA) was signed into law in November 2013 and establishes a national system for tracing pharmaceutical products through the supply chain and sets national licensing standards for wholesale distributors and third-party logistics providers.

By partnering with TraceLink, Value Drug and our member pharmacies can retrieve, exchange and archive compliance documents on-demand. TraceLink’s cloud platform allows for the tracking of prescription drug products to prevent counterfeit prescription drugs from entering the U.S. supply chain. As an authorized trading partner, we will continue to ensure our member pharmacies have a secure infrastructure for prescription drug orders.

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May 22, 2025:

Update on Value Drug Vendor Policy Concerning May 27, 2025 Supplier DSCSA Compliance Date

Dear Value Drug Company Suppliers,

On May 27, 2025, Value Drug Company suppliers must pass compliant, timely and accurate EPCIS transaction data for DSCSA prescription drug products. This includes aggregated products with product identifiers at the saleable unit level. All manufacturer and repackage requirements will need to be met under Section 582(g)(1)(A)-(F) as stated in the FDA Exemption letter issued on Oct. 9, 2024. If you are unable to meet this FDA requirement, then you will need an FDA approved WEE and provide written notice on company letterhead to Value Drug. All DSCSA products without EPCIS data will be quarantined with follow-up by VDC Category Management.

New suppliers and new DSCSA prescription drug product currently in the onboarding process will not be covered after this May 27, 2025 deadline and will need to send accurate EPCIS data. Effective May 27, 2025, Value Drug may quarantine impacted product as required under the FDA exemption deadline with follow-up by Category Management for communication on how to proceed with the product.

Additionally, if you have a DSCSA prescription drug product that is suspect or is illegitimate please communicate this information immediately to VDC. We also require immediate notification if you have a change to GLN number, NDC, GTIN, label, 2D Barcode or human readable for your DSCSA prescription drug product to be transacted.

Please note that Value Drug is still requiring the ASN as we continue to move forward to full compliance by August 27, 2024.

We request that you respond to this letter at [email protected]. Thank you for your partnership as we move forward with the goal of protecting the patients we serve.

November 26, 2024:

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.