HDA and the healthcare distribution industry have led on federal traceability issues for over two decades. This work culminated in the passage of the Drug Supply Chain Security Act (DSCSA) in 2013. The DSCSA will fundamentally change 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:
After the DSCSA’s final deadline of November 27, 2023, supply chain trading partners will be required to provide serialized data in their transaction information along with product upon a change of ownership (for example, a manufacturer to distributor, or a distributor to a pharmacy). Transaction data does not need to be shared once a product is administered or dispensed to a patient.
As we move closer to the 2023 deadline, it is critical for all stakeholders to align on expectations for DSCSA compliance. Watch the video below to learn more about HDA’s role in achieving 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, to engage trading partners with compliance information and support.
Below are highlights of HDA’s participation in DSCSA implementation:
2021 |
HDA voices industry concerns regarding FDA’s Enhanced Drug Distribution Security Draft Guidance in written comments and at a public meeting on November 16 |
2021 |
The HDA Research Foundation launches an inaugural survey, the EPCIS Implementation Benchmarking Survey |
2020 |
HDA releases a position statement in September 2020 sharing information on successfully implementing EPCIS by November 27, 2023 |
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 |
2018 |
In March, HDA submits a letter of comments in response to FDA’s February 28, 2018 Public Meeting in connection with Enhanced Drug Distribution Security under the Drug Supply Chain Security Act |
2017 |
HDA convenes industry stakeholders to write business requirements for the Verification Router Service (VRS) and publishes substantial updates to industry bar coding guidelines |
2016 |
HDA partners with EY (Ernst & Young) to initiate a pilot study for distributors and manufacturers to examine different methods of verifying product identifiers on saleable returns |
2015 |
The HDA Research Foundation launches annual Serialization Readiness Survey to help gauge industry progress towards meeting the DSCSA deadline |
2014 |
HDA issues several resources for industry, including “Supply Chain Product Transaction Scenarios,” which represent the organization’s interpretation of 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 the exchange of Transaction Information (TI), Transaction History (TH) and the Transaction Statement (TS) under the DSCSA |
2013 |
After nearly a decade of advocacy, HDA and its members help secure passage and subsequent enactment of DSCSA; association transitions internal working group to a work group addressing key implementation issues and milestones |
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HDA Guidelines and Documents
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Presentations
Brian Waldman, Esq., MBA, Arent Fox LLP; HDMA 2015 Distribution Management Conference
Dr. Connie Jung, FDA; HDMA 2014 Business and Leadership Conference
Scott A. Mooney (McKesson Corporation); Brad Pine (Smith Drug Company); and Heather Zenk (AmerisourceBergen Corporation); HDMA 2014 Business and Leadership Conference
Slide from FDA Webinar, "FDA Perspectives on Implementation of the Drug Supply Chain Security Act"
Julie Kuhn (H. D. Smith); Scott A. Mooney (McKesson Corporation); and Heather Zenk (AmerisourceBergen Corporation); HDMA 2014 Distribution Management Conference
Brian Waldman, Esq., Arent Fox LLP; HDMA 2014 Distribution Management Conference
Regulatory Federal
Regulatory State
Verification Router Service Documents
Drugs sold or designated for sale in other countries likely will not conform with the DSCSA, exposing the U.S. supply chain and patients to unnecessary health risks without the promise of reduced costs for prescription drugs. That is why HDA strongly opposes prescription drug importation policies. Get the facts.