The Drug Supply Chain Security Act (DSCSA) is more than a regulatory requirement—it’s a safeguard for patients and a critical responsibility for every organization in the pharmaceutical supply chain. With final DSCSA exemptions expiring and enforcement moving into full effect, companies of all sizes are asking the same question:

Is our workforce truly ready for DSCSA compliance?

At Ten Count Consulting, we’ve seen firsthand how DSCSA requirements affect manufacturers, wholesale distributors, 3PLs, and pharmacies differently. But one challenge remains constant: the strain that DSCSA training places on leaders and their teams.

The Challenges Leaders Face in DSCSA Training

1. Overburdened Departments

For many companies, a single department or group has carried the weight of DSCSA implementation. As focus shifts from implementation to compliance and enforcement, this creates stress, slows progress, and leaves knowledge gaps. Organizations are now moving toward cross-functional governance, which requires developing, delivering, and tracking DSCSA training across the organization.

2. Ensuring Organization-Wide Awareness

DSCSA touches everyone, from warehouse staff scanning serialized barcodes to commercial teams discussing compliance with customers and beyond. Leaders must ensure organization-wide DSCSA awareness training so that every employee understands not only what’s required but why it matters.

3. Role-Based Training Planning

Leaders face the complex task of mapping responsibilities to DSCSA requirements. Creating a training matrix by role is time-intensive but essential to ensure the right people receive the right training at the right time.

4. Hidden Costs of Training Development

Developing DSCSA training in-house requires time, expertise, and resources—often at the expense of other business priorities. Without a long-term strategy, content quickly becomes outdated as FDA guidance and industry best practices evolve.

5. Maintaining Engagement

DSCSA regulations are complex and technical. Leaders must make training engaging, relevant, and actionable for employees whose daily work may not directly involve compliance oversight.

Turning Challenges Into Confidence

Effective DSCSA employee training doesn’t just check a compliance box—it empowers teams and relieves the burden on leaders. When employees understand what DSCSA requires, how it affects their role, and why it matters to patients, compliance becomes part of everyday operations rather than an added task.

At Ten Count Consulting, we’ve spent over 12 years helping organizations build effective DSCSA compliance programs, including training. We help deliver training solutions that are:

• Targeted – From awareness-level content to role-based DSCSA training for subject matter experts.
• Practical – Focused on real-world application, not just regulations.
• Current – Built by DSCSA specialists who stay ahead of FDA updates and industry developments.

Building Trust Across the Supply Chain

DSCSA training is about more than compliance—it’s about trust.

• Patients trust that medicines they receive are safe and authentic.
• Trading partners trust that your company can verify products and manage exceptions with confidence.
• Leaders trust that their teams are prepared, knowledgeable, and engaged.

When DSCSA training is built into your organization’s culture, that trust strengthens every link in the supply chain.

Next Steps for Leaders: Upgrading Your DSCSA Training

To build a strong DSCSA training program, organizations should:

1. Assess Knowledge Gaps – Identify where employees need more awareness or role-specific DSCSA training. Review training records and determine whether evidence exists to demonstrate compliance in an audit.
2. Define Role-Based Needs – Create a DSCSA training matrix to map knowledge requirements by role.
3. Assess Annual Training Budget – Integrate DSCSA training into existing compliance training programs, such as:
   • GMP / GDP (Good Manufacturing & Distribution Practices)
   • 21 CFR Part 11 / Data Integrity
   • Pharmacovigilance / Drug Safety Training
   • GCP (Good Clinical Practice)
   • Corporate compliance (HIPAA, Anti-bribery/FCPA, Code of Conduct)

Most organizations already invest heavily in compliance training. The key is ensuring DSCSA training is included in annual planning and budget allocations, so it becomes a sustainable, repeatable process.

The Bottom Line

DSCSA training is no longer optional—it’s a strategic necessity. Companies that invest in role-based, current, and practical training position themselves for smoother audits, stronger trading partner relationships, and most importantly, safer outcomes for patients.

At Ten Count Consulting, we partner with organizations to transform DSCSA training from a compliance burden into a business advantage.

👉 Ready to strengthen your DSCSA training program? Contact Ten Count Consulting today to learn how we can help your team prepare with confidence.

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