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Issues

Pharmaceutical Traceability

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:

  • 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 the 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.

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.

HDA — and Distributors — 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, 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HDA voices industry concerns regarding FDA’s Enhanced Drug Distribution Security Draft Guidance in written comments and at a public meeting on November 16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



Resources

CONTACT

  • Elizabeth A. Gallenagh
  • General Counsel and Senior Vice President, Supply Chain Integrity
  • (703) 885-0234
  • egallenagh@hda.org
  • Anita T. Ducca
  • Senior Vice President, Regulatory Affairs
  • (703) 885-0240
  • aducca@hda.org
  • Matthew J. DiLoreto
  • Vice President, State Government Affairs
  • (703) 885-0236
  • mdiloreto@hda.org
  • Elyse Petroni
  • Vice President, Communications and Marketing
  • (703) 885-0221
  • epetroni@hda.org

DSCSA Resources for Dispensers

Did You Know?

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

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