DSCSA in the Warehouse:

Along with establishing compliance and avoiding penalties, proactive companies recognize the importance of implementing best practices. These practices, beyond serialization, traceability and verification capabilities, set the industry standards for quality and reliability.

By doing so, they also avoid costly supply chain disruptions, strengthen their reputations and establish increased trust with partners in the pharmaceutical supply chain.

Responding to evolving DSCSA timelines

Although the DSCSA goalposts have shifted a few times since it was introduced 10 years ago, now is the time to address a strategy that meets compliance and drives success. This is crucial, especially given the complex changes it introduces across the supply chain.

Indeed, the FDA is signaling that companies that are not proactive may find themselves scrambling to catch up in 2025.

This phase of the DSCSA rollout represents an opportunity for organizations to audit and find operational efficiencies and gaps. It is also a window for developing a robust compliance process, enhancing communication with vendors and driving effective data management.

Organizations can meet standards and ensure greater patient safety by building contingency plans for disruptions and identifying potential pitfalls ahead of DSCSA changes.

Best practices for DSCSA success

Key best practices can help set authorized trading partners (ATPs) up for success with DSCSA beyond the bare minimum requirements.

To further maximize the positive outcomes of these efforts, a software partner with deep expertise in the nuances of integrating DSCSA into real-world workflows is also essential.

Audit current systems for future compliance

Many companies find upgrading legacy systems challenging. Financial constraints, the complexity of integrating new systems and processes into existing operations, data interoperability issues and regulatory uncertainty can lead to hesitation and incomplete solutions.

Additionally, without looking ahead at the impacts of DSCSA regulations and preparing now, companies may find themselves short on time to establish robust standard operating procedures (SOPs) and guide employees through regulatory changes.

A structured approach to auditing current systems and processes ensures an organization is ready for full DSCSA compliance.

Key considerations include:

• •Identify current data issues and where reconciliation problems exist. The data must match the product. A software solution provider should be able to support finding specific technical solutions to these individual challenges.
• •Consider what problems are happening in the warehouse now and what could happen in the future. New changes may compound smaller issues now.
• •Train warehouse staff on new regulations and new SOPs now, well before final deadlines.

Proactively manage exceptions

Given the complexity of serialization and data management, reducing the likelihood of exceptions and knowing the next steps when encountering an exception is vital to preventing disruptions in moving products.

Clear SOPs are essential to prevent disruptions. They also help demonstrate compliance efforts.

SOPs should be established to identify suspect products quickly, ensuring compliance with DSCSA’s 24-hour time requirement. Once identified, employees should be fully trained on what happens next: Who the product goes to and what the SOP is from there.

Additionally, SOPs should be developed for receivers to address other potential situations, such as missing EPCIS data. For example, what happens if an EPCIS file doesn’t arrive with a shipment?

Ensure supply chain visibility with the correct data

Real-time visibility is essential for tracking inventory levels, monitoring shipments and managing orders. With access to this information at their fingertips, supply chain leaders can make informed decisions quickly and clearly understand the current state of their operations.

Consider a solution that enables a quick response to recalls, expired medications or other supply chain events.

At first glance, DSCSA may not seem to change how recalls are managed in the warehouse. Initially, you’ll still follow the same processes, such as isolating and quarantining products and might even continue receiving multiple advisories for the same product — even those you’ve never purchased.

But what if DSCSA could actually enhance recall management? Consider two scenarios:

• •As DSCSA tracks all inbound products at the item and lot levels, you could filter out recalls for products you’ve never received, saving valuable time.
• •As DSCSA advances to tracking at the serial number level, recalls may one day target smaller subsets of affected products instead of entire lots.

This precision could minimize recall impact, reduce disruptions and streamline operations. As you evaluate DSCSA vendors, think about how these capabilities could transform your recall processes and shape your future operations.

Ensure any solution you choose has integration capabilities with multiple repositories so there is a clear line of sight into all information required for managing and verifying unique serial numbers for individual drug packages.

Safeguard the receiving process with contingency plans

Identifying gaps and building SOPs is crucial, but what happens if an SOP is not followed precisely? Is there a secondary safeguard to prevent standstills in the receiving process?

Even a simple 10-second error, such as scanning against the wrong order, can cause a complicated and costly discrepancy.

For example, when data is incorrect or missing, the time spent fixing the data gap may cost more than the inventory is worth. Typically, with manual workflows this data may take days or weeks, not hours, to resolve. This results in a loss of inventory and potential shortages when the best option is to write it off.

Access to real-time data with the right solution can shorten these data gaps. Additionally, developing secondary SOPs for these scenarios helps avoid confusion and further delays. Who is assigned to resolve these discrepancies and who are the stakeholders that should be contacted? Once the correct data has been identified, it’s essential to ensure there are systems in place to resend or reconcile data.

It’s also critical to prioritize interoperable solutions that offer the flexibility to customize existing workflows or even create entirely new workflows. This flexibility gives you control to drive additional efficiencies and safeguards, saving valuable time and supporting warehouse employees in resolving discrepancies.

Tecsys’ Itopia® is a powerful low-code platform designed for easy configuration and customization. Unlike traditional software, Itopia® drives scalability, continuous improvement and operational efficiency. It empowers organizations to optimize processes, quickly adapt to market changes and leverage data for actionable insights.

Maximizing opportunities beyond DSCSA compliance

On the path to DSCSA compliance, implementation of best practices must include a robust technology platform to meet all requirements ahead of deadlines and ensure end-to-end visibility across the supply chain.

Alongside software solutions, companies must proactively develop comprehensive processes, including handling expected exceptions, providing thorough training to staff on DSCSA complexities and establishing robust contingency plans.

The right software offers the framework and support needed to adjust these processes and effectively create conditions for success. Looking for tools like Tecsys’ solution for pharmacies, wholesalers and 3PLs provides a unified platform that addresses the diverse requirements across the supply chain.