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.

Recognizing Milestones During DSCSA Stabilization

The FDA has made clear that its “stabilization policy” is a time to finalize implementation of the DSCSA before November 2024. HDA has recommended that the agency support a phased approach over the additional year to help the supply chain achieve interoperability.

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After the DSCSA’s final deadline of November 27, 2023, supply chain trading partners will be required to provide transaction data along with serialized product upon a change of ownership (for example, a manufacturer to distributor or a distributor to a pharmacy). Transaction data do not need to be shared once a product is administered or dispensed to a patient.

At the Nexus of DSCSA Implementation

DSCSA implementation is a perfect example of how the distribution industry’s collaborative spirit and logistics expertise benefit the entire supply chain. By extension, through every milestone of DSCSA implementation, HDA has served as a convener and intermediary between regulatory and industry stakeholders; voiced the interests of its members that are leading implementation efforts for the industry; assembled supply chain stakeholders to develop collaborative, industry-driven solutions to complex challenges; and spearheaded educational offerings, including an annual Traceability Seminar and a cross-sector dispenser working group, to engage trading partners by providing compliance information and support. 


Highlights of HDA's Participation

  • 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 
  • 2018
    In March, HDA submits comments to take out “of” and instead say “providing” in response to FDA’s February 28, 2018 Public Meeting in connection with Enhanced Drug Distribution Security under the Drug Supply Chain Security Act
  • 2020
    HDA supports the Open Credentialing Initiative (OCI), an industry-wide pilot of an interoperable “Authorized Trading Partner” credentialing ecosystem, in coordination with the Center for Supply Chain Studies; further, the association releases a position statement sharing information on successfully implementing EPCIS by November 27, 2023
  • 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
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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 reviews key priority issues and advocates on behalf of its pharmaceutical distributor members in areas like standards, public policies and business processes. HDA members have a powerful, unique voice and perspective and an opportunity to help educate lawmakers and inform public policy.

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