20 Feb DSCSA Compliance – Is Your Business Ready?

After years of phased implementation, the final requirements of the Drug Supply Chain Security Act (DSCSA) officially took effect, and the pressure is on. Compliance with the DSCSA is no longer a future concern. It’s here!

The clock has run out, and the supply chain involved must operate with complete compliance to the new mandated systems. If your organization is still scrambling, here’s what you need to know… and fast.

The DSCSA’s full implementation means: no tolerance for manual processes, paper-based tracking, or incomplete transaction data. Pharmaceutical companies must meet the strict electronic tracing requirements now, or risk supply chain disruptions, regulatory penalties, and exclusion from business networks.

At core focus of this legislation is patient safety and supply chain security. With pharmaceutical falsification continuing to be a global issue, the DSCSA ensures that drugs can be tracked, verified, and traced from manufacturing all the way to the dispensary. For businesses, failure to comply will cost your reputation, business relationships, and even legal action.

The focus is on interoperable electronic systems for product tracking. These systems are now mandatory. Here’s the most important elements you should already have in place:

Interoperable Electronic Systems for Product Tracing

All pharmaceutical supply chain members (manufacturers, wholesalers, distributors, and dispensers) are required to use fully electronic, interoperable systems to exchange product tracing information.

The data will be shared electronically, ensuring that transaction information (TI), transaction history (TH), and transaction statements (TS) are captured and transmitted through the entire supply chain.

Gone are the days of manual records, real-time data exchange is the new norm.

Enhanced Product Verification

All members must be able to verify the legitimacy of prescription drugs. This includes verifying the product identifier, which consists of standardized data elements, including the National Drug Code (NDC), serial number, lot number, and expiration date.  Verifying serialized products becomes mandatory.

Aggregation and Serialization

Products are required to be serialized with a unique identifier at the unit level, meaning, each product should have a distinct serial number. In addition, package-to-case aggregation may become essential, allowing for quicker verification of products that have been bundled together.

Product Returns 

Companies must have the ability to verify returned products and ensure their validity through electronic tracing data. Any product re-entering the supply chain must be authenticated and documented.

Verification Requests 

Trading partners and the FDA can demand proof of legitimacy, and you must be ready to respond quickly. Full traceability is essential, and any gaps will raise red flags during audits.

For organizations that haven’t implemented fully compliant systems, today is your final warning. The FDA’s capacity to enforce penalties for non-compliance is now fully operational. Non-compliant stakeholders can expect penalties and business interruptions.

If your organization hasn’t met all requirements, you need to take action now.

Here are some steps to prioritize:

1. Implement an Interoperable Electronic System: DOit ERP is designed to ensure seamless DSCSA compliance, providing real-time product tracking, verification, and data exchange capabilities.
2. Ensure Full Serialization: Review your inventory and supply chain processes to guarantee every unit is properly serialized and trackable. Serialization is not optional.
3. Establish Clear Verification Protocols: Make sure your team is equipped to handle verification requests promptly, whether from the FDA or supply chain partners. This includes having access to real-time transaction data and historical product information.

Don’t forget to get it right, and if you haven’t yet, it’s time to act.

Partner with DOit ERP now and learn how we can help you meet the new FDA requirements and achieve your business goals.