The two-year countdown to the Drug Supply Chain Security Act (DSCSA) deadline has begun. This final milestone, in combination with those already completed, will fundamentally change how product and data move together across the healthcare supply chain.
The HDA Research Foundation’s most recent Serialization Readiness Survey found that HDA-member manufacturers and distributors report being in various states of preparedness to meet the 2023 deadline. As industry partners enter a critical work phase in DSCSA implementation, we must ensure supply chain sectors are aligned on the path forward. For those companies that have not finalized their plans — or may be waiting on FDA to move forward with one — it is time to begin taking the crucial steps toward DSCSA compliance, in coordination with standards groups and other supply chain stakeholder organizations.
Despite Industry Progress, There’s Significant Work To Be Done
HDA and its members have been at the forefront of DSCSA implementation. Distributors are making headway with compliance requirements, collaborating with industry stakeholders to gain consensus on milestones, identifying gaps or implementation challenges and sharing the industry’s perspective and expertise with FDA. While these early actions have been critical to progress, there is a need for increased participation from all sectors at this junction.
Below are goals HDA developed by and with our distributor members that we encourage supply chain partners to strive for. All will require industry participation and collaboration so that the supply chain is equipped to meet the 2023 deadline:
The supply chain is moving forward with sharing data via EPCIS; manufacturers should work with distributors now to get connected.
In these final two years, it is critical for companies to ensure they are ready to correctly employ GS1 standards and implement EPCIS. As noted in a previous blog post, it is an extensive process to connect with and onboard trading partners through EPCIS. HDA continues to work with GS1 and other supply chain stakeholder organizations, helping connect supply chain partners embarking on the complex undertaking of adopting EPCIS standards.
Manufacturers should review their data quality; trading partners should be ready to exchange data by the end of 2022 to allow adequate time to address any quality or accuracy problems, correct transaction data and to manage any other issues.
Manufacturers should begin sending quality data as soon as possible. According to the Foundation’s 2021 Serialization Readiness Survey, only 40 percent of manufacturers are currently sending or plan to send, by the end of 2021, at least some serialized data to their wholesale distributor customers upon shipment. HDA plans to continue to work with manufacturer members to provide information and resources on manufacturer data quality in future publications and at the 2022 Distribution Management Conference.
To reach this objective, distributors also will need to make strides in preparing for data exchange. Only 60 percent of HDA member distributors surveyed in the Serialization Readiness Survey can accept data today.
Dispensers should be preparing for their requirements and discussing plans with their distributor partners to give adequate time for DSCSA compliance.
Two-thirds of HDA-member distributors that responded to the Foundation’s Serialization Readiness Survey reported that dispensers’ understanding of their 2020 and 2023 obligations varies considerably. HDA and supply chain partners created a helpful page of resources for dispenser DSCSA compliance to help boost their knowledge of requirements.
Don’t Wait for FDA To Move Forward
As reported in the Foundation’s Serialization Readiness Survey, some trading partners may be waiting for FDA to extend the 2023 implementation deadline; however, the industry should not make this assumption. In fact, in FDA’s recent public meeting, they once again stated that they expect industry to meet the end goal on time.
At that public meeting, HDA executives and representatives from distributor-member companies reiterated a call for the agency to withdraw draft guidance for DSCSA, encouraged the agency to endorse EPCIS for data exchange, voiced opposition to the agency’s vision for a “communications hub” if it differs from what is currently being built and underscored the importance of aligning FDA’s guidance on DSCSA compliance and what industry has collectively been constructing since 2013.
While FDA has not yet responded to these and other comments and recommendations, we urge industry to continue moving forward on DSCSA implementation. HDA will continue to advocate on behalf of the supply chain to achieve alignment between the industry and FDA’s respective vision for 2023 compliance.
The Finish Line Is in Sight
Industry progress toward the DSCSA 2023 deadline will provide momentum as supply chain partners march toward the finish line. However, many companies will need to pick up the pace to get the necessary measures in place. After November 27, 2023, pharmaceutical products cannot be sold unless serialized and accompanied by data. If industry does not become fully compliant with DSCSA, this will risk both the commercial ability to transact products in the supply chain and threaten patient access to vital medicines across the country.
To sum up, the final DSCSA deadline is sooner than you think. Make sure that your organization has developed its path forward both internally, with cross-functional teams, and externally, with trading partners. HDA will continue to serve as a convener for industry stakeholders until the supply chain successfully meets our collective goal. With the end in sight, it is critical now more than ever that each sector of the healthcare supply chain redouble their efforts to ensure full compliance.
Visit the HDA website to access DSCSA implementation resources.
ABOUT THE HEALTHCARE DISTRIBUTION ALLIANCE
The Healthcare Distribution Alliance (HDA) represents primary pharmaceutical distributors — the vital link between the nation’s pharmaceutical manufacturers and pharmacies, hospitals, long-term care facilities, clinics and others nationwide. Since 1876, HDA has helped members navigate regulations and innovations to get the right medicines to the right patients at the right time, safely and efficiently. The HDA Research Foundation, HDA’s nonprofit charitable foundation, serves the healthcare industry by providing research and education focused on priority healthcare supply chain issues.