Ensuring DSCSA compliance: Critical focus areas & common blind spots for dispensers

The Drug Supply Chain Security Act (DSCSA) strengthens the safety and integrity of the pharmaceutical supply chain. Now that the Nov. 27, 2025 deadline for large dispensers is in effect, pharmacies, hospitals and other healthcare providers must ensure their systems and processes are ready to meet requirements and avoid disruption. 
 
The following guide outlines key focus areas, common blind spots and practical steps to support compliance.

Key focus areas, blind spots and action steps

1. Verification and authentication of incoming products  

Ensuring the authenticity of prescription medications is essential. Dispensers must authenticate serialized product identifiers and verify each unit received and dispensed.

Blind spot: Relying on paper or manual checks increases the risk of overlooking counterfeit products.
What to do: Implement automated verification at receipt and dispensing, matching serial numbers to manufacturer databases.
Example: A retail pharmacy chain uses barcode scanners integrated with NDC and serialization databases to authenticate incoming products and prevent counterfeit dispensing. 

2. Serialization and tracking system integration

Systems must capture, store and transmit transaction data, including lot numbers, serial numbers, product identifiers and shipment details. 

Blind spot: Many organizations underestimate the complexity of integrating serialization data with existing inventory tools, leading to traceability gaps. 
What to do: Integrate serialization data into your inventory management system to enable seamless tracking and documentation. 
Example: A hospital pharmacy links manufacturer serialization data to its inventory platform to ensure every dispense is validated and traceable.

3. Efficient recall and verification workflows 

Fast, accurate recall processes reduce patient risk when affected products enter circulation. 

Blind spot: Delayed access to real-time data can slow recall actions and increase compliance risk.
What to do: Establish real-time traceability tools that support rapid product verification during recalls.
Example: A compounding pharmacy uses its IT system to identify dispensed units from a recalled batch, flag affected patient records and accelerate removal.

4. Staff training and ongoing education 

Personnel must understand DSCSA compliance procedures. Consistent training reduces operational risk. 

Blind spot: Assuming one-time training is sufficient. Staff turnover makes continuous education essential. 
What to do: Deliver recurring DSCSA and serialization training supported by scenario-based exercises. 
Example: A community pharmacy chain holds quarterly workshops to reinforce verification and serialization protocols. 

5. Supply chain collaboration

Strong communication with distributors, manufacturers and partners is key to receiving and validating product data.

Blind spot: Inconsistent data sharing, especially with small or new suppliers, can create traceability gaps. 
What to do: Standardize secure data-sharing practices across all trading partners.
Example: A distributor collaborates with pharmacies via a shared platform that provides real-time transaction histories and alerts. 

6. Technology infrastructure upgrades

Meeting DSCSA standards often requires updated IT capabilities that support serialization, transaction history and verification workflows. 

Blind spot: Delaying technology upgrades risks non-compliance. 
What to do: Invest in software that supports serialization, data storage and DSCSA reporting. 
Example: A hospital upgrades its inventory system and serialization validation tools to streamline compliance.

7. Monitoring regulatory updates 

Ongoing regulatory changes require continuous monitoring of FDA guidance and industry advisories. 

Blind spot: Assuming previous compliance efforts remain sufficient. 
What to do: Review official updates regularly and adjust internal policies promptly. 
Example: A pharmacy network subscribes to FDA alerts and industry briefings to stay ahead of regulatory changes. 

Common blind spots and how to avoid them 

A strategic action plan for compliance 

Step 1: Assess current capabilities

• Conduct a gap analysis.
• Identify missing components for serialization, tracking and verification. 

Step 2: Develop a timetable

• Define short-term and long-term tasks aligned to the DSCSA deadline.

Step 3: Upgrade and integrate technology 

• Select tools that support serialization and integrate with existing systems. 

Step 4: Train your staff 

• Deliver ongoing training. 
• Use real-world scenarios to reinforce key procedures. 

Step 5: Collaborate with partners 

• Share data securely.
• Confirm serialization compatibility across partners. 

Step 6: Test and validate processes 

• Run mock recalls and verification drills. 
• Address weaknesses quickly. 

Step 7: Stay informed 

• Review regulatory updates and industry practices regularly. 
• Adjust workflows proactively. 

Final thoughts

The DSCSA deadline is an important milestone for dispensers. By prioritizing automation, integration, training and collaboration — and by addressing common blind spots — organizations can strengthen operational integrity and protect patient safety. Start early, stay informed and ensure your systems are ready.