Will FDA Finally Enforce DSCSA Interoperability In 2025?

A conversation with Ana-Zeralda Canals Hamann and Matt Campasano

Few pharma supply chain stories from 2024 stand out like the drama surrounding the Drug Supply Chain Security Act’s second enforcement extension.

After the FDA’s yearlong stabilization period, companies up and down the supply chain expressed concern that they or their trading partners wouldn’t be ready. Facing increasing pressure from industry and lawmakers alike, the agency pulled the plug on its Nov. 27 deadline as it appeared the plan was careening toward trouble, including potential drug shortages. Now regulators have laid out a phased approach, and manufacturers and repackagers are due to reach compliance first — on May 27.

Experts have indicated there’s no reason to think the agency will kick the can down the road again, so it’s important for manufacturers to complete their data interoperability projects or face steep penalties.

To talk about some of these issues, we asked industry consultant Matt Campasano of Criterion Consulting and Ana-Zeralda Canals Hamann, associate director of clinical trial supplies at Debiopharm, for their thoughts.

Here’s what they told us. Answers have been edited for clarity.

From the manufacturers' perspective, what are the biggest bottlenecks to compliance?

Integration issues will happen and ensuring end-to-end traceability will remain complex. A lot of manufacturers, especially small ones that rely on third-party logistics providers, will add additional layers of compliance complexity. Expertise will be an issue, too, as there is a shortage of specialized personnel in compliance technology that will therefore cause delays

— Ana-Zeralda Canals Hamann, Debiopharm

The biggest bottlenecks remain the same: outdated technology and the high costs of upgrading systems, particularly for smaller manufacturers. These companies often lack the internal resources and technical expertise needed to implement compliance solutions, let alone maintain them. While larger companies have made significant strides, smaller organizations are constrained by tight budgets and the complexity of DSCSA requirements. Unfortunately, this dynamic has not changed much. Many smaller manufacturers are opting for minimal investments, which leaves them vulnerable to compliance gaps and increased exceptions handling post-deadline.

We’ve also seen that misaligned master data and inconsistent EPCIS record formats continue to be pervasive issues across manufacturers of all sizes. These issues stem from either rushed implementations or a lack of proper data governance frameworks, and they often lead to costly exceptions downstream.

— Matt Campasano, Criterion Consulting

Previously, we've talked about outdated technology and the high cost of upgrading as a significant barrier, especially for smaller companies. Has that dynamic changed at all?

Upgrading will be costly and time-consuming, especially for the smaller manufacturers, due to not being able to use advanced tools like blockchain-based platforms or serialized aggregation.

— Ana-Zeralda Canals Hamann, Debiopharm

Recent estimates from Cencora show that less than 10% of manufacturers have done nothing to prepare. Will those companies immediately lose business and face penalties?

Noncompliant manufacturers may lose access to some of their trading partners, as distributors and pharmacies are required to only engage with compliant entities. This could lead to a sharp decline in market share and revenue. The FDA has the authority to impose civil monetary penalties, issue warning letters, and potentially initiate product recalls for noncompliance.

— Ana-Zeralda Canals Hamann, Debiopharm

It’s very likely. Trading partners, especially wholesale distributors, are increasingly unwilling to transact with noncompliant manufacturers. This is evident from the DSCSA scorecards and letters many distributors began issuing earlier this year. These scorecards act as warnings that suppliers must meet specific data-sharing and traceability benchmarks — or face deactivation.

For those in the 10% that have done nothing, the immediate risks include:

• Loss of trading partner relationships, cutting them off from distribution networks.
• Revenue disruption, as products cannot legally flow without serialized, traceable data.
• Increased scrutiny from the FDA, leading to audits and potential enforcement actions.

While distributors might offer grace periods or temporary waivers for critical products, the pressure to comply will only intensify.

— Matt Campasano, Criterion Consulting

Speaking of penalties, a quick refresher on what's at stake is in order. What penalties could companies face?

Civil penalties can reach up to hundreds of thousands per violation, especially if it is for willful negligence or repeat offenses. Noncompliance may result in manufacturers being barred from distributing their products. The failure to comply could also have an effect on reputation, affecting trading partners, patients, and healthcare providers.

— Ana-Zeralda Canals Hamann, Debiopharm

The penalties for DSCSA noncompliance include:

• Fines and civil penalties: The FDA can issue fines of up to $100,000 per violation, depending on the severity and whether it jeopardizes public health.
• Product holds or recalls: Noncompliance with serialization requirements can lead to products being held at distribution centers or recalled from the market.
• Loss of business partnerships: Noncompliance could result in delisting by trading partners, particularly distributors.
• Reputational damage: This can have lasting effects on relationships with trading partners and customers, particularly in a highly competitive market.

— Matt Campasano, Criterion Consulting

Is FDA likely to make exceptions for critical-need/sole-source drugs?

The FDA has shown flexibility in the past when patient care could become compromised. Critical need or sole-source drugs could receive temporary allowances to maintain supply continuity, although they are not guaranteed. Those that have those drugs should proactively communicate with the FDA and establish contingency plan to minimize supply disruptions.

— Ana-Zeralda Canals Hamann, Debiopharm

Yes, the FDA has already signaled its willingness to issue waivers, exceptions, and exemptions (WEE) under certain circumstances. Critical-need or sole-source drugs, where disruption to supply could have significant public health impacts, are strong candidates for such exemptions. However, the WEE process is stringent, requiring manufacturers to provide clear evidence of undue burden and assurance that they are working toward compliance.

That said, exemptions are not a free pass. Manufacturers granted exceptions are still expected to take steps to align with compliance as soon as possible and must closely collaborate with trading partners to minimize disruptions.

_­— Matt Campasano, Criterion Consulting

Is there a scenario in which FDA extends the enforcement deadline again? What does that look like, and what are the implications?

They have done it before, therefore if there is industrywide noncompliance it might pressure the FDA to delay enforcement. Advocacy groups could also influence the decision.

— Ana-Zeralda Canals Hamann, Debiopharm

While an additional extension seems unlikely, it cannot be ruled out entirely. For the FDA to consider extending enforcement again, we’d likely need a scenario where:

• There is evidence of widespread noncompliance across multiple supply chain segments.
• Noncompliance poses an immediate risk of drug shortages.
• Industry stakeholders demonstrate an inability to resolve systemic issues in time.

If another extension were granted, it would reflect poorly on the industry’s ability to adapt to regulatory requirements and could potentially damage public confidence in the safety and integrity of the pharmaceutical supply chain. Moreover, it would put additional strain on compliant companies that have already invested significant resources into meeting DSCSA standards.

The best approach for manufacturers, especially smaller ones, is to focus on process development and training, ensure their master data is clean, and adopt manageable solutions to address exceptions proactively. Waiting for another extension is not a viable strategy.

— Matt Campasano, Criterion Consulting

About The Experts:

Ana-Zeralda Canals Hamann is an associate director of clinical trial supplies at Debiopharm. She has more than a decade in sponsor-side pharmaceutical clinical operations, CMC, supply chain management, regulatory, IP, project management, and preclinical services. She earned her M.Sc. in clinical research administration and a Ph.D. in molecular medicine from the University of Oxford.

Matt Campasano is the principal consultant at Criterion Consulting LLC, where he specializes in DSCSA compliance, serialization, and traceability for the pharmaceutical industry. He has more than a decade of experience helping companies manage data quality and resolve exceptions to meet regulatory standards. Connect with him via email at mcampasano@criterionconsultingllc.com or find him on LinkedIn.