DSCSA Compliance Made SimpleDSCSA Compliance Made Simple

The Drug Supply Chain Security Act (DSCSA) represents a significant shift in how pharmaceutical products are tracked and verified within the United States. This comprehensive set of data-driven regulations applies to manufacturers, wholesale distributors, dispensers, and repackagers subject to these requirements for enhanced drug distribution security. Originally intended to be fully operational in 2023, DSCSA enforcement has been in a discretionary phase, meaning that although regulations are technically live, full enforcement has been delayed.

Exemptions aim to alleviate supply chain pressures.

As of October 9, 2024, the US Food and Drug Administration (FDA) has issued exemptions to the DSCSA for connected trading partners and proposed a stepwise approach with new timelines for manufacturers, repackagers, distributors, and dispensers. The FDA’s updated guidance underscores the importance of achieving secure, end-to-end traceability in the pharmaceutical supply chain to help ensure patient access to life-saving medications.

The duration of the exemption varies depending on the eligible trading partners:

Related:Unpacking the DSCSA Compliance Extension

Prior to this notification, the FDA had granted exemptions to small dispensers — with 25 or fewer full-time employees licensed as pharmacists or qualified as pharmacy technicians — until November 27, 2026, and other trading partners were already filing individual waivers, exceptions, and exemptions (WEEs).

By November 27, 2026, this phased approach will transition to full enforcement of all DSCSA requirements. This final phase will be the push for interoperability and full data exchange across the industry, to help ensure that product authenticity is maintained and that counterfeit drugs are kept out of the legitimate supply chain.

Navigating exception management.

One of the major challenges under DSCSA is exception management. Exceptions refer to supply chain disruptions such as incorrect shipments, wrong addresses, and damaged products. If exceptions are not managed within a specific Service Level Agreement (SLA), the products are quarantined and cannot continue moving through the supply chain.

Exceptions have caused wholesalers to prepare for an anticipated influx of quarantined products. Such preparations may include ordering additional storage spaces to house the expected volume. This highlights the immense scale and potential backlog the industry may face, as exceptions cause significant delays in product flow, directly affecting patient access to essential medicines.

As trading partners continue to implement and fine-tune their processes to adhere to the DSCSA guidelines and systems, the errors related to discrepancies between the data and the product received in shipments are expected to increase significantly. Considering the increasing challenges related to counterfeits, drug shortages and patient safety, efficient handling of exceptions becomes imperative. 

Exception management: A four-step approach.

This four-step process that allows businesses to manage exceptions quickly, whether they occur on the line, in the warehouse, or across the supply chain.

1. Automate: The first step is to implement a built-in data inspector to streamline operations by reducing hours spent checking and reconciling data.

2. Analyze: Next, identify potential exceptions by scrutinizing files for data accuracy. This involves using tools that can check the formatting and completeness of data, helping to prevent errors before they escalate into larger issues.

3. Collaborate: Exceptions often involve multiple stakeholders across the supply chain. Effective collaboration requires all involved parties — such as manufacturers, distributors, and contract packagers — to work together to resolve issues.

4. Rework: Rework refers to fixing issues after they have occurred. Advanced rework tools enable companies to handle physical product corrections, a crucial component of managing exceptions that go beyond data adjustments. These capabilities should be built into the supply chain management systems, making rework a seamless part of the exception management process.

The path forward.

The path forward for DSCSA implementation will require continued collaboration across the supply chain. The exemptions the FDA issued on October 9, 2024, indicate that industry players are not yet fully prepared, and additional delays may occur. However, robust tools and feature-rich systems are providing critical support in managing exceptions and improving compliance in the meantime.

Key industry players should remain proactive by identifying potential issues before they become exceptions and collaborating effectively with all stakeholders involved. As the industry continues to adjust to DSCSA requirements, the ability to manage exceptions and quarantine products efficiently will be essential for a smooth and secure pharmaceutical supply chain.

Next steps for drug traceability.

The DSCSA represents a significant regulatory challenge for the pharmaceutical industry, especially in managing exceptions. As companies work to comply with these requirements and ever-changing deadlines, rework solutions will play a pivotal role in ensuring the supply chain remains functional and that patients continue to have access to essential medicines. Collaboration and proactive exception management are key to overcoming these obstacles and achieving compliance in the long run.