The Drug Supply Chain Security Act (DSCSA) has been a focal point for the pharmaceutical industry for years. While much of the early effort centered on systems, data exchange, and stabilization, compliance expectations have clearly shifted. Regulators are no longer focused solely on implementation readiness. They are now assessing how DSCSA requirements are being executed and maintained in day-to-day operations.
That shift became even more tangible with the FDA’s issuance of the first DSCSA-focused 483 to a dispenser. This enforcement action signals that DSCSA oversight is no longer theoretical. Inspections are happening now, and regulators are documenting gaps where compliance expectations are not being met.
At the center of this operational maturity is trading partner verification. For manufacturers, wholesale distributors, and dispensers, understanding what verification really requires is critical to maintaining DSCSA compliance in practice.
Trading Partner Verification Is a Foundational DSCSA Requirement
DSCSA requires that manufacturers, distributors, and dispensers only engage in transactions with authorized trading partners. Authorization is not assumed, it must be verified and documented.
An authorized trading partner is one that holds a valid license or registration, where required, and complies with applicable federal and state laws. While this definition seems straightforward, its application varies based on the role a company plays in the supply chain.
Manufacturer Responsibilities Under DSCSA
Manufacturers are responsible for ensuring that their downstream trading partners, including distributors and dispensers, are properly licensed and authorized. This obligation extends beyond initial onboarding.
Manufacturers should be able to demonstrate that they:
- Verified the licensure status of trading partners prior to engaging in transactions
- Monitor license status on an ongoing basis
- Maintain documentation supporting verification efforts
As supply chains become more complex, relying on one-time checks or informal confirmation increases compliance risk.
Wholesale Distributor Obligations
Wholesale distributors occupy a central role in the supply chain and face heightened scrutiny under DSCSA. In addition to verifying trading partners, distributors must also ensure their own licensing remains current and aligned with the states in which they operate.
For distributors, trading partner verification includes:
- Confirming licensure and authorization of manufacturers and dispensers
- Monitoring changes in license status across multiple states
- Ensuring that verification processes are consistently applied
Inconsistent or undocumented verification practices can create vulnerabilities during audits or inspections.
Dispenser Responsibilities Are Often Overlooked
Dispensers are not exempt from DSCSA verification requirements, as made clear by the recently published 483. Pharmacies, health systems, and other dispensers must also ensure that their upstream trading partners are authorized.
This responsibility is sometimes underestimated, particularly in organizations that assume distributors have already performed sufficient checks. DSCSA requires each trading partner to take responsibility for its own verification processes.
Clear procedures and documented verification help dispensers demonstrate compliance and avoid reliance on assumptions.
Why License Verification Supports DSCSA Readiness
State licensing plays a critical role in determining whether a trading partner is authorized. License verification helps confirm that partners are legally permitted to engage in specific activities within specific states.
However, DSCSA readiness requires more than simply confirming that a license exists. Companies should understand:
- Whether the license type aligns with the partner’s activities
- Whether the license is active and in good standing
- Whether the license applies to the correct location and state
Ongoing verification helps ensure that authorization is maintained as licenses change, expire, or are modified.
Common Gaps in Trading Partner Verification
Even well-intentioned compliance programs can fall short when verification processes are not clearly defined or consistently applied. Common gaps include:
- Relying on outdated license information
- Failing to monitor non-resident licenses
- Inconsistent verification across different partner types
- Limited documentation of verification activities
These gaps often surface during inspections, audits, or investigations, when companies are asked to demonstrate how compliance is maintained over time.
Preparing for Audits and Inspections
As DSCSA enforcement continues to mature, companies should expect increased regulatory attention on trading partner verification practices. Inspectors may ask not only whether verification occurred but how it is performed and how often it is reviewed.
Companies with structured processes, centralized records, and regular monitoring are better positioned to respond confidently. Verification should be treated as an ongoing compliance function, not a box-checking exercise.
Moving From Theory to Practice
DSCSA compliance is no longer theoretical, it is operational. The issuance of DSCSA-focused enforcement actions makes it clear that regulators are evaluating real-world practices across the supply chain.
Trading partner verification sits at the intersection of state licensing, supply chain oversight, and regulatory accountability. Organizations that invest in clear verification processes and reliable license data are better equipped to support compliance today and adapt as enforcement expectations continue to evolve.
If your team is evaluating how trading partner verification fits into your broader DSCSA strategy, now is a good time to assess whether your current processes provide the visibility and documentation regulators expect. Our team can support license verification and monitoring efforts that help strengthen DSCSA readiness across the supply chain. Contact us if you’d like to learn how we can ensure you remain proactive and compliant.