What is DSCSA and what does it mean for VHA members?

The Drug Supply Chain Security Act (DSCSA) continues to move toward full implementation of electronic, end-to-end traceability for human prescription medications. Recent enforcement milestones have direct implications for how products move through the supply chain, including how VHA can sell and distribute select human injectable products to our members.

As these requirements evolve, VHA is forced to adjust how some products are packaged and sold to remain compliant while maintaining supply chain integrity.

A Brief Overview of DSCSA

The DSCSA was enacted to strengthen the security of the US pharmaceutical supply chain by requiring trading partners [manufacturers, repackagers, distributors, and dispensers] to track and trace human prescription drugs at the package level.

A key element of DSCSA compliance is serialization, meaning that each package of select human injectables carries a unique product identifier that can be electronically traced as it moves through the supply chain.

For example, VHA may receive a package of 25 bottles of a medication. We in turn, sell each individual bottle. If this medication now qualifies as a DSCSA product, we cannot break up that package and we must sell it in the same manner received, which would be the 25ct.

What this Means for VHA Members

At the VHA level, these changes are about how products are distributed, not how they are used clinically. DSCSA requirements do not apply to non-prescription (OTC) or veterinary-specific medications.

Members may notice:

• Pack-size changes on select human injectable medications: Some medications may now only be available in a 10ct or 25ct versus an individual bottle.
• Packaging changes from suppliers who are repackaging into smaller, traceable packs: Some medications may be received repackaged in a labeled and sealed plastic bag.

These updates are not unique to VHA; they reflect broader changes across the pharmaceutical supply chain as distributors align with DSCSA requirements.

Affected Products:

VHA has compiled and will maintain a working list of products impacted by these requirements; while this list is ever-evolving and may not be comprehensive, it provides a helpful starting point for identifying affected items.

Why this Matters

Maintaining DSCSA compliance is critical to ensuring:

• Continued access to essential human injectable products
• A secure and transparent pharmaceutical supply chain
• Alignment with national standards enforced across manufacturers and distributors

Looking Ahead

DSCSA implementation continues to evolve, and VHA will monitor guidance from manufacturers, wholesalers, and regulatory agencies closely. As requirements change, we will communicate any additional updates that affect product availability, packaging, or purchasing options.

If you have questions about a specific product or packaging change, the VHA team is always available to help.