DSCSA Enforcement Phase – Post-Nov 2024.

Description

The Drug Supply Chain Security Act (DSCSA), enacted in 2013, was designed to strengthen the integrity and security of the U.S. pharmaceutical supply chain. Its goal is to protect patients from counterfeit, stolen, or contaminated drugs by requiring that prescription medicines be traceable at every stage—from manufacturer to dispenser. Over the past decade, the DSCSA has been implemented in phases, gradually introducing serialization, verification, and data-sharing requirements. These incremental steps have allowed the industry time to adapt systems and processes in preparation for full enforcement. Now, with the final compliance deadline passed in November 2024, the law’s complete framework is active, requiring all supply chain partners to participate in an interoperable, electronic system of product tracking.

This final enforcement phase represents a major change in how the pharmaceutical industry manages compliance. Companies must now use standardized methods, such as the Electronic Product Code Information Services (EPCIS), to exchange data about every transaction involving prescription drugs. Beyond serialization and recordkeeping, the DSCSA requires stakeholders to verify product identifiers, investigate suspect products, and maintain the ability to provide complete transaction histories. With FDA inspections underway, regulators are scrutinizing onboarding of dispensers, system testing, and verification processes. This shift underscores the industry’s responsibility not only to comply with regulatory mandates but also to strengthen supply chain security against evolving risks such as counterfeiting and diversion.

Why should you attend:

Participants should take this training to gain a clear understanding of the FDA’s full enforcement of the Drug Supply Chain Security Act (DSCSA) and how it directly impacts daily operations across the pharmaceutical supply chain. With the shift to serialized product tracing, EPCIS-based data exchange, and strict verification requirements, companies that are unprepared risk FDA 483 observations, costly disruptions, and reputational harm. This training will break down the complex requirements into practical steps, highlight common compliance pitfalls, and provide actionable strategies to ensure seamless interoperability with trading partners. By attending, participants will be better equipped to protect patients, safeguard their organization’s compliance posture, and maintain uninterrupted participation in the U.S. drug supply chain.

The Drug Supply Chain Security Act (DSCSA) entered its full enforcement phase in November 2024, marking a pivotal shift in how pharmaceutical products are tracked and verified throughout the U.S. supply chain. Beginning in 2025, all stakeholders—including manufacturers, wholesalers, repackagers, and dispensers—must comply with strict requirements for serialization, product tracing, and electronic interoperability. Central to compliance is the use of EPCIS (Electronic Product Code Information Services) standards to exchange transaction data seamlessly with trading partners. These measures are designed to protect patients by ensuring that every drug package can be traced back through the supply chain, helping to prevent counterfeit or diverted products from entering the market.

With enforcement now underway, the FDA is intensifying oversight, including issuing Form 483 observations for gaps in dispenser onboarding, verification processes, and system testing. Companies that fail to meet DSCSA standards risk not only regulatory penalties but also supply disruptions and reputational damage. This new regulatory environment requires organizations to move beyond paper-based or ad hoc processes and embrace fully interoperable systems that support real-time data sharing and verification. Understanding the post-2024 expectations is critical for all supply chain stakeholders to remain compliant, protect patients, and ensure a secure and transparent pharmaceutical marketplace.

Areas Covered in the Session:

1. Welcome and Introduction (5 min)
• Introduction of presenter and session goals.
• Quick poll: “Where is your organization today in DSCSA readiness?”
• Why DSCSA matters: protecting patients and securing the drug supply chain.

2. DSCSA Basics Refresher (10 min)
• Purpose of the Drug Supply Chain Security Act.
• Key milestones leading up to Nov 2024 enforcement.
• Scope: manufacturers, wholesalers, repackagers, and dispensers.
• What “full enforcement” means in 2025.

3. Post-2024 Requirements Explained (10 min)
• Serialization: every package must carry a unique product identifier.
• Product Tracing: electronic, interoperable exchange of transaction information.
• Verification: ability to confirm legitimacy and respond to suspect product alerts.
• EPCIS Data Exchange: why it is the FDA-preferred standard for interoperability.

4. Compliance in Practice (15 min)
• How manufacturers must share serialized data with trading partners.
• Wholesaler and dispenser responsibilities for receiving and verifying data.
• System testing and onboarding trading partners.
• Practical example: tracing a product through manufacturer → wholesaler → dispenser.
• Using EPCIS files to exchange data across the supply chain.

5. FDA Enforcement and Common Gaps (10 min)
• FDA inspection focus areas: data exchange, verification, and dispenser compliance.
• Form 483 examples: dispenser onboarding failures, missing system testing, incomplete verification processes.
• The risks of non-compliance: enforcement actions, supply disruptions, reputational damage.

6. Next Steps for Industry Stakeholders (5 min)
• Building internal compliance roadmaps.
• Training teams on DSCSA responsibilities.
• Collaborating with trading partners on EPCIS and interoperability.
• Leveraging technology providers for compliance support.

7. Wrap-Up and Q&A (5 min)
• Key takeaways: serialization, interoperability, EPCIS, and proactive compliance.
• Resources: FDA guidance, industry consortiums, and technology tools.
• Live Q&A with participants.

Target Companies:
• Quality Assurance (QA) and Compliance Teams
• Regulatory Affairs Professionals
• Supply Chain and Logistics Managers
• Pharmaceutical Manufacturers and Operations Leaders
• Wholesaler and Distributor Compliance Teams
• Pharmacy and Dispenser Management
• IT and Data Management Teams
• Validation and System Implementation Specialists
• Clinical and Commercial Project Managers
• Executive Leadership

Target Audience to market:
This training is designed for professionals across the pharmaceutical supply chain—including manufacturers, wholesalers, distributors, and dispensers—who are responsible for ensuring compliance with the FDA’s fully enforced Drug Supply Chain Security Act (DSCSA). It is particularly relevant for quality assurance and compliance teams, regulatory affairs professionals, supply chain managers, IT and data management specialists, and pharmacy operations leaders. Whether participants are directly involved in managing serialized product data, overseeing EPCIS system integration, or preparing for FDA inspections, this session provides practical, accessible guidance. The content is tailored to those with minimal prior exposure to DSCSA details, making it an ideal learning opportunity for both operational staff and decision-makers who must align their organizations with the 2025 compliance expectations.

Instructor Profile:
Charles H. Paul is the President of C. H. Paul Consulting, Inc. – a regulatory, training, and technical documentation consulting firm. Charles has been a regulatory consultant for over 20 years and has published numerous white papers on various regulatory subjects. The firm works with both domestic and international clients designing solutions for complex training and documentation issues.