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.

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:

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2021	HDA voices industry concerns regarding FDA’s Enhanced Drug Distribution Security Draft Guidance in written comments and at a public meeting on November 16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

- A Call to Action on EPCIS Adoption for DSCSA
  September 20, 2021
- New HDA Resources Available: Recall Guidelines and Standard Product Form
  August 4, 2021
- DSCSA, the 2023 Requirements and EPCIS
  November 11, 2020
- Verification Network Update: Less than 60 Days Remain
  October 9, 2020
- DSCSA Saleable Returns: Industry Plan for Best Using the Enforcement Discretion Period
  November 21, 2019
- VRS Update: Past, Present, Future
  December 12, 2018
- HDA Traceability Seminar to Feature FDA Update, Discussions on DSCSA Milestones
  August 10, 2018
- Verification Router Service Progress Update
  June 27, 2018
- Three Takeaways from the FDA Public Meetings on DSCSA
  March 26, 2018
- Transitioning to Traceability — and a Verification Router Service Update
  February 16, 2018
- Traceability Seminar
  October 17, 2018
- Serialization Readiness Survey
  November 1, 2021
- Enhanced Drug Distribution Security Traceability in 2023 and Beyond (Position Statement)
  September 29, 2020
- Getting Ready for EPCIS
  September 29, 2020
- HDMA Standard Product Information Form - Pharmaceutical Products
  February 21, 2017
- HDA Saleable Returns Pilots Report
  February 7, 2017
- HDA Saleable Returns Pilot Study: 2019 Compliance Scenarios
  November 10, 2016
- HDA Questions and Answers on the Drug Supply Chain Security Act (Version 4)
  June 24, 2016
- HDMA ASN Exceptions Guidelines for the Drug Supply Chain Security Act
  January 5, 2015
- Supply Chain Product Transaction Scenarios: Drug Supply Chain Security Act Implementation (Updated December 2014)
  December 16, 2014
- EDI Guidelines for the 856 Advance Ship Notice to Support Implementation of DSCSA (July 2014, with Business Examples Updated in December 2014)
  December 9, 2014
- HDA Saleable Returns Pilot Study Preview
- Imported Medicines, at What Cost? (Infographic)
- HDA Guidelines for Bar Coding in the Pharmaceutical Supply Chain
- Traceability: Transforming the Supply Chain (Fact Sheet)
- American Society of Health-System Pharmacists DSCSA Resource Center
- DSCSA Resources for Dispensers
- HDA Foundation Survey Reveals Uneven Progress on Rx Product Serialization, with 2023 DSCSA Requirements Around the Corner
  November 1, 2021
- HDA-Supported Pilot Results in Successful Automation of Authorized Trading Partner Credentialing for DSCSA
  March 30, 2021
- HDA and NACDS Call on Congress to Protect Patient Safety by Rejecting Drug Importation Proposals
  May 8, 2017
- HDA Saleable Returns Pilot Study Identifies Two Recommendations to Meet 2019 DSCSA Requirements
  November 10, 2016
- New Release of GS1 US Guideline Helps Pharmaceutical Industry Prepare for DSCSA Item-Level Traceability Requirements
  November 9, 2016
- DSCSA Track-and-Trace: Next Steps for Pharmacists
  August 28, 2015
- FDA Grants Pharmacies More Time for Track & Trace Requirement
  July 2, 2015
- Nashville Drug Case Highlights National Problem
  May 20, 2014
- HDMA Sets Out a Preliminary EDI Guideline to Meet Drug Supply Chain Security Act Requirements
  April 30, 2014
- Just Released – The HDMA ASN Guidance for DSCSA
  April 30, 2014
- EPCglobal US
- GS1 Healthcare US
- DSCSA Today
  March 9, 2015
  
  Brian Waldman, Esq., MBA, Arent Fox LLP; HDMA 2015 Distribution Management Conference
- DSCSA Update
  November 11, 2014
  
  Dr. Connie Jung, FDA; HDA 2014 Traceability Seminar
- Drug Supply Chain Security Act
  June 3, 2014
  
  Dr. Connie Jung, FDA; HDMA 2014 Business and Leadership Conference
- Preparing for Traceability
  June 3, 2014
  
  Scott A. Mooney (McKesson Corporation); Brad Pine (Smith Drug Company); and Heather Zenk (AmerisourceBergen Corporation); HDMA 2014 Business and Leadership Conference
- FDA Description of TI, TH and TS
  April 7, 2014
  
  Slide from FDA Webinar, "FDA Perspectives on Implementation of the Drug Supply Chain Security Act"
- Distributor Traceability Updates
  March 11, 2014
  
  Julie Kuhn (H. D. Smith); Scott A. Mooney (McKesson Corporation); and Heather Zenk (AmerisourceBergen Corporation); HDMA 2014 Distribution Management Conference
- State of the States
  March 10, 2014
  
  Devin Boerm, HDA; HDMA 2014 Distribution Management Conference
- Title II of the Drug Quality and Security Act (H.R. 3204): A Traceability and Licensing Overview
  March 10, 2014
  
  Brian Waldman, Esq., Arent Fox LLP; HDMA 2014 Distribution Management Conference
- HDMA Letter to State Wholesale Licensing Authorities
  June 22, 2015
- HDMA Memo to State Wholesale Drug Distributor Licensing Authorities on DQSA
  January 17, 2014
- VRS Current Security Approach
  May 15, 2019
- VRS Operational Guidance FAQs
  May 7, 2019
- VRS Business Requirements Document
  April 12, 2019
- VRS Solution Architecture Reference Document
  April 12, 2019
- VRS Authorized Trading Partner Requirements
  April 10, 2019
- VRS Task Force Report to Industry
  April 1, 2019
- VRS Specifications for Responder Connectivity Information (CI) Upload to Look-Up Directory (LD) and LD Synchronization
  August 1, 2018
- VRS Governance Body Charter
  July 17, 2018
- VRS Request and Response Messaging Standard (Version 1.0)
  April 27, 2018
- Meeting the 2019 DSCSA 2019 Verification Deadline (Presentation)
  March 5, 2018

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
Senior Vice President, State Government Affairs and Alliance Development
(703) 885-0236
mdiloreto@hda.org

Jaidalyn Rand
Director, Industry Relations
jrand@hda.org

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.