The FDA’s enforcement of the Drug Supply Chain Security Act (DSCSA) is set to begin in August 2025 for distributors and 3PLs. Although earlier DSCSA milestones already require compliance, the upcoming final enforcement ushers in a crucial phase for manufacturers, distributors, 3PLs and dispensers. All pharmaceutical supply chain stakeholders must act quickly to meet the final compliance requirements.
The approaching DSCSA enforcement deadline calls for immediate action from teams involved in the handling of prescription drugs. Organizations must assess their readiness and implement compliant, end-to-end supply chain solutions to meet final requirements. The following focus areas highlight where attention is most needed as the industry moves into the final stretch before the August deadline.
It is important that each key stakeholder in the supply chain is aware of their respective responsibilities. Each stakeholder group should already have an identified team of experts to own these responsibilities, training and execution of policies and procedures. To prepare for the DSCSA 2025 deadline and achieve full compliance, you need to focus on several key areas, some of which should already be completed but particularly those related to the following.
1. Interoperable data exchange:
- Establish secure connections: Ensure all authorized trading partners (ATPs) can share transaction information (TI) and transaction statements (TS) electronically in a secure manner.
- Adopt standardized formats: Implement the Electronic Product Code Information Services (EPCIS) standard for efficient and standardized data exchange with trading partners.
2. Product serialization and verification:
- Implement unit-level serialization: Assign unique product identifiers to each individual prescription drug package and homogeneous case.
- Utilize GS1-compliant serial numbers: Use standardized 2D DataMatrix barcodes with GS1-compliant serial numbers.
- Verify product identifiers: Develop robust systems and processes to verify product identifiers at the unit level.
- Handle suspect/illegitimate products: Establish procedures for identifying, quarantining, investigating and reporting suspect or illegitimate products.
- Efficient saleable returns: Implement processes for verifying and accepting saleable returns, ensuring the product can be associated with its transaction information and statement.
3. Data management and accessibility:
- Store transaction data: Maintain secure and readily accessible storage of transaction information for at least six years.
- Respond to verification requests: Develop systems and processes to promptly provide transaction information to regulatory agencies or trading partners upon request during investigations or recalls.
4. Trading partner collaboration and communication:
- Know your GLN: Ensure each pharmacy location has a Global Location Number (GLN) to support product tracking and data exchange.
- Coordinate data exchange: Collaborate with trading partners to ensure smooth data flow and address any discrepancies.
- Communicate exemptions (if applicable): If you rely on an FDA exemption, communicate your status to trading partners.
5. Internal procedures and training:
- Develop standard operating procedures (SOPs): Create clear SOPs for managing serialized products, handling exceptions and responding to data requests.
- Provide staff training: Regularly train staff on DSCSA regulations, serialization protocols and data exchange processes.
- Conduct internal audits: Regularly conduct internal audits and mock inspections to identify compliance gaps.
6. Staying informed and proactive:
- Stay up to date on regulations: Keep informed about evolving DSCSA regulations and enforcement strategies.
- Monitor progress and address challenges: Address challenges like data accuracy, data integration and exception handling proactively.
By focusing on these areas and the future adjustments, your organization can effectively prepare for the DSCSA 2025 deadlines and contribute to a safer, more secure pharmaceutical supply chain. Remember, the FDA has provided exemptions for certain trading partners, but it's crucial to understand these exemptions and continue working towards full compliance.
What risks are enhanced when ATPs are not ready?
Failing to be ready for the DSCSA 2025 deadline poses significant risks for authorized trading partners, including:
1. Regulatory non-compliance and enforcement actions:
- Fines and penalties: Trading partners can face substantial financial penalties, potentially reaching up to $500,000 per violation.
- Product seizures and distribution restrictions: Non-compliant products may be seized or subject to distribution restrictions, leading to losses and disruptions.
- Legal action and civil/criminal penalties: Persistent non-compliance can result in legal actions, including lawsuits, injunctions and even criminal charges, potentially leading to imprisonment in severe cases.
- Warning letters and public scrutiny: Regulatory agencies, such as the FDA, may issue warning letters, publicly posting them and damaging the trading partner's reputation.
2. Supply chain disruptions:
- Refusal of transactions: Trading partners may refuse to conduct business with non-compliant entities, jeopardizing the flow of medicines and causing delays.
- Delayed shipments and product recalls: Missing or inaccurate serialization data can lead to delayed shipments and costly product recalls.
- Quarantined products: Regulatory authorities may quarantine non-compliant products, disrupting the supply chain and potentially causing drug shortages.
3. Business impacts:
- Loss of business opportunities: Non-compliance can result in lost revenue and a competitive disadvantage, as compliant companies gain market share.
- Reputational damage: Negative publicity and loss of trust from customers, partners and patients can harm the trading partner's brand image and impact business long-term.
- Liability: Companies may be held liable for damages or losses resulting from non-compliance, particularly if patient harm occurs.
4. Data management issues:
- Data accuracy and integration challenges: Inaccurate or incomplete data can lead to disruptions and non-compliance.
- Inefficient exception handling: Failure to quickly and correctly resolve data discrepancies and exceptions can cause delays and disruptions.
ATPs risk facing serious consequences, including legal action, financial losses and disruptions to their supply chains, if they are not prepared for the DSCSA 2025 deadline. Ensuring compliance is not just about meeting regulatory requirements but also about protecting patient safety, maintaining a secure and efficient supply chain, preparing for future changes and preserving business viability and reputation.