The Drug Supply Chain Security Act (DSCSA) is reshaping the pharmaceutical industry, emphasizing the need for stringent compliance, advanced data management, and enhanced collaboration among stakeholders.

Understanding DSCSA: Deadlines and implications

The DSCSA is a landmark regulation that mandates the comprehensive tracking and tracing of prescription pharmaceuticals through the U.S. supply chain. As one deadline passes and new ones approach, stakeholders must understand the profound changes required for compliance.

• Key deadlines: With the end of the FDA stabilization period on November 27, 2024, the pharmaceutical industry is now in a phased rollout with the next major manufacturer deadline on May 27, 2025. The full enhanced drug distribution security requirements demand serial number tracking and validation, a process that previously involved only direct trading partners.
• Implications: The anticipated increase in product queries, from 1-2% to potentially 5-15%, highlights the growing demand for accurate data tracking, and the need for robust systems to manage the influx of data and ensure product authenticity.

Electronic interoperable data for supply chain security is a specific phrase that is broadly worded, offering a unique opportunity for interpretation and application.

Enhancements in DSCSA compliance and enforcement

Recent developments indicate a heightened focus on DSCSA compliance, with both federal and state regulators ramping up their enforcement activities.

Federal oversight

The FDA has intensified its inspection activities, issuing several 483 warning letters to manufacturers. This surge in regulatory oversight emphasizes the need for stakeholders to align their standard operating procedures (SOPs) with DSCSA requirements.

• Enforcement trends: Recent inspections have revealed gaps in SOPs, particularly in areas like product verification and suspect product investigations.
• Waiver, Exception, or Exemption (WEE): The FDA has introduced a phased approach, allowing trading partners temporary relief based on their position in the supply chain.

State-level activities

State regulators are also increasing their inspections, particularly focusing on out-of-state licensees. This trend requires manufacturers and wholesalers to ensure compliance with state-specific regulations.

DSCSA compliance: Policies, procedures, and data management

Compliance with DSCSA involves a comprehensive set of policies and procedures, coupled with effective data management strategies.

• First order policies: Include prerequisites like Authorized Trading Partner (ATP) status, data retention, and suspect product verification.
• Second order policies: These involve managing exceptions and ensuring accurate data exchange, crucial for maintaining compliance across trading partners.

Managing exceptions is critical when your data and real-life discrepancies arise, ensuring data matches real-life in a compliant manner.

Leveraging data solutions for DSCSA compliance

Accurate reference data is paramount for DSCSA compliance. Solutions like IQVIA's OneKey and LedgerDomain's credential-powered systems play a crucial role in facilitating seamless data management and identity-driven compliance.

OneKey data solutions

OneKey offers comprehensive data solutions, providing essential data elements like state license numbers and GLN numbers. This data is vital for tracking, tracing, and communicating effectively with trading partners.

• Global reach: With coverage in over 115 countries, OneKey provides a harmonized data model, essential for global companies navigating DSCSA requirements.
• Data accuracy: Continuous monitoring ensures high accuracy and reliability, supporting stakeholders in maintaining compliance.

Credential-powered solutions

LedgerDomain focuses on open standards and trusted partnerships, enabling efficient DSCSA workflows through credential-powered solutions. These solutions enhance interoperability and facilitate seamless communication across the supply chain.

Credentialing serves as the passport to gaining access to this network of networks, ensuring compliance and enhancing supply chain transparency.

The Role of technology in DSCSA compliance and beyond

Technology plays a pivotal role in enhancing DSCSA compliance, offering insights beyond mere regulatory adherence.

• Data integration: Leveraging DSCSA data with commercial and internal data sources provides valuable insights into product distribution, market access, and compliance trends.
• Strategic benefits: Accurate data management aids in identifying chargeback anomalies, verifying saleable returns, and ensuring 340B compliance.

Achieving DSCSA compliance and unlocking value

The DSCSA presents both challenges and opportunities for the pharmaceutical industry. By understanding the regulatory landscape, enhancing data management capabilities, and leveraging advanced technology solutions, stakeholders can not only achieve compliance but also unlock strategic value.

Actionable steps:

• Review and update SOPs: Ensure alignment with DSCSA requirements and address any gaps in current procedures.
• Enhance data management: Invest in robust data solutions like OneKey to ensure accurate tracking and compliance.
• Leverage technology: Utilize credential-powered solutions and explore data integration opportunities to enhance compliance and strategic decision-making.

By adopting these strategies, stakeholders can navigate the complex DSCSA landscape, not only ensuring compliance but also driving value across the supply chain.