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.
HDA’s Recommended Phased Approach to DSCSA
In 2023, HDA sent a letter to FDA recommending a phased approach to implementing DSCSA serialization requirements. These recommendations were made amid uneven stakeholder readiness ahead of the deadline, with the goal of minimizing the potential for supply disruptions and interruptions to patient care. Through the phased approach, HDA recommends FDA allow for the DSCSA’s final requirements to be met in phases to build capacity and stabilize these complex processes over two years.
Please view HDA’s materials on the phased approach to learn more.View HDA's Materials
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
2013After 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
2014HDA 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
2015The HDA Research Foundation launches annual Serialization Readiness Survey to gauge industry progress towards meeting the DSCSA deadline
2016HDA 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
2017HDA convenes industry stakeholders to write business requirements for the Verification Router Service (VRS) and publishes substantial updates to industry bar coding guidelines
2018In 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
2020HDA 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
2021The 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
The resources below address the industry’s approach on federal traceability issues and DSCSA implementation.
- Fact Sheet: Achieving Full Traceability in the Pharmaceutical Supply Chain
- Letter to FDA on Recommended Phased Approach to DSCSA Implementation
- Fact Sheet: The Drug Supply Chain Security Act
- Fact Sheet: The Distribution Industry at the Nexus of DSCSA Implementation
- 2022 Serialization Readiness Survey
- Exceptions Handling Guidelines for DSCSA
- HDA Guidelines for Bar Coding in the Pharmaceutical Supply Chain
- HDA Saleable Returns Pilot Study: 2019 Compliance Scenarios
- HDA Standard Pharmaceutical Product and Medical Device Information (New Product Form)
- Imported Medicines, at What Cost? (Infographic)
- Manufacturer Data Quality: Best Practice Considerations for DSCSA
- Supply Chain Product Transaction Scenarios: Drug Supply Chain Security Act Implementation (Updated December 2014)
- The Risks and Realities of Commercial Drug Importation
- Congressional Letter to FDA on DSCSA
- HDA Comments to FDA on the State of DSCSA Readiness
- HDA Statement for the FDA DSCSA Public Meeting Implementation and Readiness Efforts for 2023
- HDA Comments on FDA's Proposed National Standards for Licensure of Distributors and 3PLs
- HDA Comments on the FDA Revised Guidance: DSCSA Standards for the Interoperable Exchange of Information for Tracing of Certain Human, Finished, Prescription Drugs Guidance for Industry
- HDA Comments on the FDA Revised Guidance: Identifying Trading Partners Under the DSCSA
- HDA Comments on FDA’s Verification Draft Guidance
- HDA Comments to Follow-up on FDA’s November 16, 2021, DSCSA Public Meeting
- HDA Statement to FDA on November 16, 2021, DSCSA Public Meeting
- Authorized Trading Partner Requirements
- Business Requirements Document
- Current Security Approach
- Governance Body Charter
- Operational Guidance FAQs
- Request and Response Messaging Standard (Version 1.0)
- Solution Architecture Reference Document
- Specifications for Responder Connectivity Information (CI) Upload to Look-Up Directory (LD) and LD Synchronization
- Task Force Report to Industry
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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