On Friday, October 23, 2020 FDA announced a further delay of enforcement of the requirement for wholesale distributors to verify saleable returned product. The extension means that the industry will have an additional 3 years, until November 27, 2023, until enforcement of the requirement to verify a prescription drug return prior to resale begins. FDA also announced that it is delaying until November 27, 2023, its requirement that pharmacies and other dispensers begin verifying product identifiers in suspect and illegitimate product investigations.
FDA cited the readiness of wholesale distrbutors to comply with the requirement in its explanation for the delayed enforcement. The deadline for readiness according to the law was November 2019, and was met with the successful launch of the Verification Router System (VRS), however activity on the VRS has been light.
Prior to its launch, Cardinal Health was among the distributors partnering with the Healthcare Distribution Alliance (HDA) to test and validate the VRS system. As a leader in DSCSA preparedness, Cardinal Health has implemented the MediLedger Product Verification Solution (PVS) to ensure compliance with the saleable returns requirement. MediLedger is the first commercially launched, decentralized blockchain network in the pharmaceutical industry. In fact, Cardinal Health was the first to launch a MediLedger blockchain node within its infrastructure and the first to launch the PVS solution within its commercial operations. Cardinal Health 3PL Services was among the first third party logistics providers to go live on the VRS. We are pleased to report that the system has been running smoothly.
Industry watchers will recall that enforcement of returns verification had initially been delayed until November 2020. The previous recommendation was to have 100% of manufacturers live on the VRS by June 2020, however uncertainty about enforcement and disruption from COVID-19 impacted adoption. Informal estimates from our colleagues within Cardinal Health Pharmaceutical Distribution are that over 60% of biopharma companies are ready for DSCSA enforcement, an assessment based on observing the number of GTINs (global trade item numbers, an identifier for trade items developed by global standards organization, GS1) registered on the market.
The delay of enforcement, along with low activity on the VRS, makes now an ideal time to plan your serialization solution for enforcement in the coming years. A proactive start will allow distributors to ramp up their verification volume and ensure your customers have access to the information they need.
Cardinal Health 3PL Services stands ready to support your company’s next steps in track and trace planning. To help your business comply with the Drug Supply Chain and Security Act (DSCSA) requirements, we offer configurable DSCSA solutions, from serial number generation to creation and transfer of event data and VRS support. Our solutions come backed by the knowledge, scale and resources of Cardinal Health Pharmaceutical distribution, IT and Regulatory teams.
Adding DSCSA support services to your existing 3PL services agreement helps reduce the risk of disconnects in the supply chain that come with introducing new partners and allows you to maintain a single point of contact for support.
Contact your Client Relationship Manager today to learn more and evaluate your options for DSCSA preparedness.