The Drug Supply Chain Security Act (DSCSA) is a critical regulation aimed at ensuring that drug products are tracked and traced electronically across the supply chain. On October 9, 2024, the FDA issued new guidance providing temporary exemptions from certain DSCSA requirements, allowing businesses more time to implement solutions. However, while these exemptions offer relief, it is essential to act now to avoid penalties and ensure your business remains compliant. Understanding the DSCSA Exemptions: What They Mean for Your Business, this article outlines how these exemptions affect your operations and provides actionable steps to help your business prepare for full DSCSA compliance.

What Are the DSCSA Exemptions and Why Are They Important?

The DSCSA mandates the electronic exchange of transaction data using EPCIS (Electronic Product Code Information Services) standards to ensure the traceability of pharmaceutical products. However, many businesses face challenges implementing these requirements due to technical issues and data accuracy problems.

Recognizing these difficulties, the FDA granted temporary exemptions to give businesses additional time to refine their systems. However, it’s important to understand that the FDA is closely monitoring compliance efforts. Businesses without a functioning solution still risk facing penalties, even if they qualify for the exemption. It’s crucial to have a solution in place—even if you’re still resolving some technical challenges—as not having one at all can lead to significant regulatory and business consequences.

Key Exemption Dates and Eligibility

The FDA’s exemptions apply to businesses that have made progress toward DSCSA compliance, particularly those with established electronic data connections by November 27, 2024. Key exemption deadlines include:

• Manufacturers and Repackagers: Exemption until May 27, 2025
• Wholesale Distributors: Exemption until August 27, 2025
• Dispensers with 26+ employees: Exemption until November 27, 2025
• Small Dispensers (fewer than 26 employees): Exemption until November 27, 2026

While notification to the FDA is not required, companies are expected to continue working toward full compliance during this exemption period.

Why You Must Act Now – The Importance of Getting a Solution in Place

Even though the FDA has extended deadlines, it is critical that your business implements a DSCSA solution immediately. The FDA has clearly indicated that they will be monitoring compliance, and businesses without a functioning solution risk penalties.

Beyond regulatory concerns, failing to implement a solution could also harm your business relationships. Major trading partners like AmerisourceBergen, McKesson, and Cardinal require that DSCSA compliance data be transmitted electronically through EPCIS. If your company cannot meet this requirement, these partners may refuse to do business with you, resulting in serious disruptions to your supply chain and revenue streams.

Having a solution in place is not just a regulatory obligation—it’s essential for maintaining smooth operations and securing key trading partnerships. Without a system in place, you could face both regulatory fines and significant business disruptions.

The Importance of a Solid SOP for DSCSA ComplianceIn addition to having the right technology in place, it’s vital to have a solid SOP (Standard Operating Procedure) for managing DSCSA compliance. One of the first things an auditor will request is to review your SOP, and failing to provide one could expose your business to compliance risks.

Your SOP should clearly outline your company’s processes for handling serialized data, transaction verification, and real-time data exchange. If you don’t have an SOP in place, TrackTraceRX can help you create one. We have extensive experience with DSCSA compliance and can guide you in developing a robust, audit-ready SOP that aligns with FDA expectations.

How Does This Impact Your Business?

Whether you’re a pharmacy, wholesaler, or manufacturer, the FDA’s exemptions give you additional time to get your DSCSA systems in order. However, delaying action could lead to serious consequences, both regulatory and operational. Here’s how this affects different sectors:

• Pharmacies and Dispensers: The extension gives you time to stabilize your systems, but you must ensure that serialized transaction data is exchanged properly to maintain smooth business relationships with suppliers and customers.
• Manufacturers and Wholesalers: If your electronic systems for serialization data exchange are still under development, this exemption allows you to refine them. However, without a solution in place, major trading partners like AmerisourceBergen, McKesson, and Cardinal may refuse to do business with you.

Actionable Steps to Prepare for DSCSA Compliance

Given the limited time before full enforcement, here are some steps your business should take to ensure DSCSA compliance:

1. Assess Your Current Systems: Audit your DSCSA systems to ensure they are equipped to handle serialized data exchanges with trading partners.
2. Implement or Upgrade Technology: If your system is outdated or struggling with real-time EPCIS data exchange, it’s essential to upgrade now. Having a solution in place will help you avoid penalties and prevent disruptions with trading partners.
3. Ensure Seamless Data Exchange: It’s not enough to have the infrastructure set up—the real exchange of serialized data must be accurate and reliable. The FDA and your trading partners will both expect this.
4. Train Your Team: Make sure your employees are familiar with your DSCSA solution and understand how to manage serialized data exchanges effectively.
5. Create or Update Your SOP: Ensure you have a clear and comprehensive SOP that outlines your DSCSA compliance procedures. If you need help creating an SOP, contact TrackTraceRX for expert assistance.
6. Monitor Trading Partner Compliance: Be proactive in assessing your trading partners’ compliance and help any ineligible partners upgrade their systems to avoid potential disruptions.

How TrackTraceRX Can Help

At TrackTraceRX, we offer the only DSCSA compliance solution that doesn’t increase your workload. In fact, our platform boosts your performance by utilizing multi-scanning technology and augmented reality (AR) to streamline compliance processes. Here’s how our solution stands out:

• Augmented Reality (AR) for Real-Time Compliance: Our unique AR feature provides real-time visuals to confirm that each shipment meets DSCSA requirements. For example, the system displays a green checkmark for compliant shipments, eliminating the need for you to manually check and re-check your internal systems. This reduces delays in receiving or shipping operations and increases efficiency.
• Full Lifecycle Tracking: TrackTraceRX enables you to track products throughout their entire lifecycle, from manufacturing to dispensing, ensuring that all stages are fully compliant.
• EPCIS Data Management: We manage the real-time exchange of serialized data, ensuring your compliance with DSCSA standards while helping you maintain seamless business operations with trading partners.
• Compliance Without the Burden: We are the only solution provider that solves DSCSA requirements without impacting your business workload. Our platform improves your operational performance by streamlining processes and providing real-time data while keeping you compliant.
• SOP Development: Need help with your SOP? TrackTraceRX can assist in creating a comprehensive SOP that satisfies FDA expectations and ensures you’re ready for any audit.

DSCSA Compliance Checklist

To ensure your business is fully prepared for DSCSA compliance, follow this checklist:

• Verify Serialized Data Exchange: Ensure that serialized data is accurately exchanged with your trading partners.
• Upgrade IT Systems: Implement or upgrade systems that support real-time EPCIS data exchange.
• Document Compliance Efforts: Keep thorough records of your compliance activities, as they will be critical during audits.
• Develop or Review Your SOP: Ensure your SOP is clear and comprehensive. Contact TrackTraceRX if you need help creating one.
• Collaborate with Trading Partners: Ensure that your trading partners are compliant and help any ineligible partners upgrade their systems.

Final Thoughts

The FDA’s DSCSA exemptions offer businesses a reprieve, but having a DSCSA solution in place is non-negotiable. Without a functioning system, you risk penalties and losing key trading partners like AmerisourceBergen, McKesson, and Cardinal. Additionally, ensure you have a solid SOP in place, as this will be one of the first things an auditor requests during an inspection.

At TrackTraceRX, we provide industry-leading solutions that ensure compliance without adding to your workload. With our multi-scanning technology and augmented reality features, we not only keep you compliant but also improve your operational efficiency. Visit our website to learn more about how TrackTraceRX can help your business meet DSCSA requirements and streamline your supply chain.