Matt Campasano, Criterion Consulting

LogiPharma USA 2025: Determining DSCSA Readiness

HDA 2025 Traceability Seminar: Pharma Industry Shows Strong Readiness for DSCSA Enforcement

DSCSA Distributor Exemption Ends, Marking Major Milestone in Pharma Supply Chain Security

The pharmaceutical supply chain has just crossed a major regulatory threshold. The Aug. 27, 2025, wholesale distributor Drug Supply Chain Security Act (DSCSA) deadline has passed, marking the end of the FDA’s stabilization period and the beginning of full enforcement for electronic, package-level traceability. Distributors are now expected to verify product, transmit transaction data electronically, and manage exceptions in real time.

This milestone strengthens the foundation for a more secure and transparent supply chain, but it also introduces new risks if exceptions are not managed effectively. With large dispensers facing their own compliance deadline in November 2025, and smaller dispensers following in 2026, the pressure to prepare has never been greater.

The distributor deadline improves security and traceability across the supply chain. Counterfeit detection, diversion prevention, and verification of returns are now integrated into daily operations. According to the Healthcare Distribution Alliance (HDA),

 distributors reported transaction data accuracy exceeding 98% leading up to enforcement, a strong signal that the industry has made progress.

Still, the risks are real. Exceptions, mismatches in transaction data, missing serial numbers, or system downtime can stall product flow. A shipment on hold because it cannot be verified is not just a compliance issue—it can delay life-saving medicines, cause product to be rejected or destroyed, and generate costly returns and dispute fees. In short, the supply chain is more secure, but it is also less forgiving.

Looking ahead: The November dispenser deadline

The focus now shifts to dispensers. Large dispensers (with 26 or more staff) must comply with the DSCSA’s enhanced security requirements by Nov. 27, 2025. Smaller dispensers (25 or fewer staff) have until Nov. 27, 2026.

These deadlines are not abstract dates on a calendar. Dispensers are already feeling the impact of distributor enforcement, particularly with saleable returns. If a return cannot be matched to the original transaction data, it may be refused. This is happening now, even before the dispenser deadline takes effect.

Verification at the point of receipt: A critical weakness

Perhaps the greatest risk for dispensers is the failure to verify product upon receipt. Verification is no longer optional. Every package that enters the pharmacy must be checked against serialization data to confirm authenticity.

If product dispensers lack the tools or processes to do this, they risk:

Accepting illegitimate product into inventory.

Falling out of compliance in an FDA audit.

Delays and backlogs caused by unverified exceptions.

This is the blind spot that many dispensers underestimate. It is not enough to receive the pharmaceutical product. It must be verified quickly, consistently, and with a documented process.

Tools available to dispensers and trading partners

Dispensers and other supply chain actors are not without resources. Several categories of tools are available to support compliance:

Technology platforms and tools such as NABP Pulse and Movilitas.Cloud allow dispensers to query manufacturers’ repositories to confirm serialized identifiers in near real-time.

Authenticated trade partner tokens (ATP):

 Software Providers such as German-based Spherity issue digital credentials that enable trading partners to securely prove their identity when exchanging DSCSA data.

 Technology only works if paired with well-defined workflows. Receiving processes, escalation pathways, and exception response protocols must be documented and enforced.

 External teams, such as Criterion SECURE Support, can provide rapid response to exceptions, handle error resolution within one hour, and deliver root-cause analysis to prevent recurring issues.

A critical self-assessment: Do you have the right provider?

One of the most urgent tasks right now is to evaluate your current serialization service provider. The August deadline has exposed weaknesses across the industry. Some providers have struggled with downtime, delayed verification responses, or limited exception-reporting capabilities.

Is my provider consistently meeting response time expectations?

Do they support both VRS queries and ATP token integration?

Are exceptions logged transparently, with clear escalation?

Have they demonstrated stability since the distributor deadline passed?

If the answer to any of these is uncertain, organizations should strongly consider whether a change in provider is needed before November. Waiting until after the dispenser deadline to switch risks compounding compliance failures with operational disruption.

Exceptions handling: The real cost of delay

The ability to respond to exceptions in real time is now central to DSCSA compliance. Failure carries steep costs, including:

Unverified product may need to be quarantined and destroyed.

Wholesalers may refuse to accept product that cannot be matched.

 Returns and disputes tie up working capital.

The FDA has emphasized that inadequate exception handling may constitute non-compliance. In prior warning letters, the agency has highlighted failure to maintain effective verification processes as a violation with potential enforcement consequences.

Having the right processes and resources in place is not optional. This is where external support tools provide value, offering dedicated experts to manage exceptions, correct data, and protect product flow.

The passing of the August 2025 distributor deadline is a reminder that DSCSA is no longer on the horizon. It is here. The supply chain is more secure but also more fragile when exceptions arise. With the November 2025 dispenser deadline approaching, organizations must act now. It’s imperative to:

Audit your providers and make changes if necessary

Establish clear exception-management resources

The cost of delay is high: lost product, increased fees, and regulatory exposure. The benefit of readiness is clear: uninterrupted product flow, patient safety, and regulatory compliance.

Matt Campasano is a principal consultant with Criterion Consulting.

1. HDA Statement on DSCSA Implementation Milestone for Distributors. August 27, 2025. 

https://www.hda.org/newsroom/2025/august/hda-statement-on-dscsa-implementation-milestone-for-distributors/?utm_source=chatgpt.com

Articles

The pharmaceutical supply chain has reached a significant regulatory milestone with the enforcement of the Drug Supply Chain Security Act (DSCSA) for wholesale distributors, emphasizing electronic, package-level traceability. This advancement enhances security and transparency but also introduces risks if exceptions are not managed effectively. Dispensers face upcoming compliance deadlines, with large dispensers by November 2025 and smaller ones by 2026. Verification at receipt is crucial to avoid compliance issues. Tools like Verification Router Services and Authenticated Trade Partner tokens support compliance, but evaluating serialization service providers is essential to ensure readiness.

Advice for pharma distributors and dispensers on what they should do now in order to solidify a secure supply chain.