Pharmaceutical Traceability (DSCSA)

Leading the Industry on Federal Traceability Issues

HDA and the healthcare distribution industry have led on federal traceability issues for nearly two decades. This work culminated in the passage of the Drug Supply Chain Security Act (DSCSA) in 2013. The DSCSA has fundamentally changed the way pharmaceutical products and their associated data move in tandem through the supply chain, while increasing safety and security for patients.

This groundbreaking law:

Replaced a 50-state patchwork of pedigree requirements with one federal solution. (A pedigree refers to the “product ownership” information associated with a drug as it travels through the supply chain.)
Clarified and consolidated supply chain regulations, increasing overall supply chain security — and ultimately patient safety.

Strengthened distributor licensure standards across the United States. 
Established new processes for identifying suspect and illegitimate products in the supply chain.

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HDA Guide for Submitting a DSCSA Waiver, Exception or Exemption Request 

Companies seeking additional time to finalize DSCSA-compliant systems can file a Waiver, Exemption and Exception (WEE) request, which FDA will evaluate on an individual basis. 

Download HDA’s newly published guide for submitting a WEE request here.  

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HDA VRS Provider Network

The Verification Router Service Provider Network (VRS PN) is an HDA service offering that provides a forum for pharmaceutical supply chain thought leaders on technology-based solutions and innovation to network with peers and regulatory officials, participate in meetings and exchange information that advances ongoing interoperability for DSCSA compliance.

The VRS is an industry-developed solution that allows companies to verify products in compliance with the 2019 DSCSA requirement for serialized saleable returns. It enables verification of product identifiers for suspect or illegitimate product investigations, exception processing, status checks and saleable returns.

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Exceptions Handling Guidelines

Prepare for DSCSA Exceptions and Data Errors with HDA Guides

HDA’s Exceptions Handling Guidelines for the DSCSA address the exceptions that may arise when passing or failing to pass DSCSA-required information to authorized trading partners. Published addendums to the guidelines share best practices for distributors and manufacturers to manage communications and correct data errors.

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Highlights of HDA Activities to Support Implementation

  • 2013
    After nearly a decade of advocacy, HDA and members help secure passage and subsequent enactment of DSCSA; association transitions internal working group to address key implementation issues and milestones
  • 2014
    HDA issues several resources for industry, including “Supply Chain Product Transaction Scenarios,” representing how physical product, product ownership and data move between trading partners under numerous product transaction scenarios, and an EDI implementation guideline providing a streamlined format for exchanging the Transaction Information, History and Statement elements
  • 2015
    The HDA Research Foundation launches annual Serialization Readiness Survey to gauge industry progress towards meeting the DSCSA deadline
  • 2016
    HDA testifies and provides comments to FDA regarding the “Progress Toward Implementing the Product Identification Requirements of the Drug Supply Chain Security Act (DSCSA)” and other DSCSA requirements; the association partners with EY (Ernst & Young) to complete a pilot study for distributors and manufacturers to examine different methods of verifying product identifiers to process serialization saleable returns
  • 2017
    HDA convenes industry stakeholders to write business requirements for the Verification Router Service (VRS) and publishes substantial updates to industry bar coding guidelines 
  • 2021
    The HDA Research Foundation launches an inaugural survey, the EPCIS Implementation Benchmarking Survey (now conducted by HDA); HDA voices industry concerns regarding FDA’s Enhanced Drug Distribution Security Draft Guidance in written comments and at a public meeting on November 16 and releases a video illustrating its perspective
  • 2023
    Given the complexities of the DSCSA’s requirements, FDA issued a “stabilization period” until November 27, 2024, for trading partners to build capacity and stabilize processes. HDA supports the stabilization period as a useful tool that moves the supply chain to full DSCSA compliance.
    a frame in distribution
  • 2024
    HDA, other industry groups and 21 members of Congress advocated for additional time to stabilize the complex processes necessary for compliance of the DSCSA. On October 9, 2024, the FDA issued an exemption for HDA distributor members and other eligible trading partners to comply with the final requirements.
    Private public partnership
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Resources

The resources below address the industry’s approach on federal traceability issues and DSCSA implementation.

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Our Advocacy Work on Behalf of Members 

HDA advocates for pharmaceutical distributors by working with policymakers and industry stakeholders to advance policies, standards and practices that strengthen the healthcare supply chain. HDA members have a powerful, unique voice that helps to shape public policy, educate lawmakers and provide critical insights.

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