DSCSA update: Where we are and what’s next

June 2019

When it comes to the Drug Supply Chain Security Act (DSCSA), you’ll be hard pressed to find a more knowledgeable expert than Cardinal Health’s Maryann Nelson, Regulatory Manager.

She’s been closely following the law’s evolution for the past 7 years and shared the latest updates with attendees at our Channel Management Forum.

Here’s a rundown of the highlights – or watch the recording of her presentation now:

• Serialized product: Manufacturers and repackagers must now place a unique product identifier on each package and homogenous case (unless those products are grandfathered). As of November 2019, wholesale distributors will only be able to trade in serialized product, unless grandfathered.
• Verification: Manufacturers must now be able to determine whether the product identifier affixed to a package corresponds to the NDC, serial number, lot number and expiration date they have assigned to the product. Verification requests must be responded to within 24 hours.
• Saleable returns: Beginning in November, before re-distributing a saleable returned product, a wholesale distributor must verify the product identifier on each package or homogenous case. The preferred options to verify saleable returns are for manufacturers to send serialized data with each shipment or to use a verification routing service (VRS).
• Suspicious product: Manufacturers and wholesale distributors are required to have systems in place to quarantine and investigate suspicious products, as well as processes to quarantine, disposition and notify partners of illegitimate products.

• Grandfathering: Any product packaged by the manufacturer before November 27, 2018 is considered grandfathered or exempt from being serialized and may be sold until expiration date.
• Serialized product: Transaction statements may be used as an indication that non-serialized products are grandfathered. 2D barcodes should be near the human-readable if space permits. The linear barcode rule, 21 CFR 201.25, still applies.
• Waivers, exceptions and exemptions: FDA has shared specific guidance regarding how trading partners should request waivers, exceptions and exemptions, and several have already been granted. Exemptions from serializing product are generally for a limited timeframe.

• Complexities in developing a VRS solution: Nelson explained that the Healthcare Distribution Alliance (HDA) has been facilitating a VRS Task Force which has designed the solution architecture and messaging standard for the VRS – but interoperability among multiple service providers is not yet proven. Lack of governance and conflicting interpretations of requirements makes industry-wide readiness for November 2019 uncertain at best.
• FDA’s Product Identifier Draft Guidance: This guidance does not recognize that industry has widely adopted GS1 standards, where a product’s GTIN (with embedded NDC), serial number, lot number and expiration date are encoded in the GS1 2D DataMatrix.  Issued just two months before the serialization deadline, it made alignment difficult because most manufacturers were already serializing product using GS1 standards.

• Nelson advises manufacturers to let downstream partners know if a product is covered by a waiver, exception or exemption, to ensure product is not held up due to perceived lack of compliance.
• She also cautions manufacturers to be prepared for enforcement of Verification Systems related to the identification and handling of suspect and illegitimate products.  Have detailed, written processes and procedures so FDA can inspect and evaluate them. Make sure those processes are carefully followed by employees, and that appropriate documentation is maintained.
• FDA invited stakeholders to submit pilot projects to explore and evaluate methods to enhance supply chain security, with a focus on advancing the 2023 interoperable track and trace system. Be sure to watch for the final reports, which the FDA will make available to the public upon completion of the program.
• Phase II: The next step in DSCSA—enhanced drug distribution security—will be implemented in November 2023. At that point, data must be exchanged in a secure, interoperable, electronic manner.  Industry has begun discussion around the formation of a governance body—an independent, balanced, sector-neutral entity that can develop and advance a shared vision for DSCSA interoperability.

2023, the final deadline for full DSCSA implementation, may seem a long way off, but the deadlines for each phase will arrive quickly.

Cardinal Health has already processed 14.8 million inbound, serialized units and nearly 2,000 serialized lots of product. In April 2019, Cardinal Health 3PL Services operationalized outbound scanning and we are nearing our final selection for a VRS partner. We are on track to capture serialized returns by July 2019. 

Pharma manufacturers can learn more about their responsibilities and working with Cardinal Health on DSCSA readiness by joining the Cardinal Health DSCSA Forum the first Monday of every month at 1 p.m. Eastern. Dial-in: 855.241.2663; Conference ID, 3863795.

Regardless of whether you’re on track with preliminary DSCSA requirements, or need assistance putting a program in place, Cardinal Health 3PL Services can help ensure you’re ready for 2023. To learn more about how we can help you comply with DSCSA, contact your CRM today.