DCSCA Compliance Update: Why EMS Agencies Must Now Source Medications from Distributors, Not Hospitals
The healthcare landscape is once again shifting under the influence of the DSCSA (Drug Supply Chain Security Act) - legislation aimed at increasing the traceability and security of the pharmaceutical supply chain. One significant outcome? Emergency Medical Services (EMS) agencies are being redirected away from sourcing drugs from hospitals and toward licensed distributors instead.
Let’s break down what this means, why it’s happening, and how EMS organizations can stay compliant.
Understanding the DSCSA and Its Goals
The DSCSA, passed in 2013, is designed to create a national electronic, interoperable system for identifying and tracing certain prescription drugs throughout the U.S. supply chain. The legislation has been implemented in phases, with the final interoperability and tracking requirements originally scheduled to take effect in November 2024.
However, the FDA announced a stabilization period to allow wholesale distributors additional time to implement the necessary systems and processes. Enforcement of these requirements has been deferred until August 27, 2025.
To learn more about DSCSA requirements and what they mean for your organization, download our DSCSA Compliance Guide for Distributors.
Why Hospitals Can No Longer Supply Drugs to EMS Agencies
Historically, many EMS (Emergency Medical Services) agencies such as paramedics, received medications from local hospital pharmacies. This was convenient and cost-effective. However, the DSCSA’s tracking requirements have revealed a critical compliance gap in this practice.
The Core Issue:
Hospitals do not have a way to track and report the final destination of medications once they are transferred to EMS providers. This violates the DSCSA’s requirement for full transparency and traceability in the pharmaceutical supply chain.
Because hospitals typically act as dispensers—the final stop before a drug reaches a patient—they are not equipped to pass along the required Transaction Information (TI), Transaction History (TH), and Transaction Statement (TS) when transferring medications to EMS agencies. As a result, they are no longer considered compliant sources for EMS medication supply under the DSCSA.
What This Means for EMS Providers
EMS agencies may be considered dispensers under the DSCSA if they handle or administer prescription drugs to patients and meet applicable licensing requirements. However, to be compliant with DSCSA regulations, EMS organizations must make significant changes in how they procure and manage their drug supply.
Key Actions EMS Agencies Must Take:
- Establish relationships with licensed wholesale distributors:
These entities are fully integrated into the DSCSA-compliant supply chain and can provide the necessary transaction documentation. - Implement systems to manage DSCSA compliance:
EMS providers must be able to electronically receive, store, and retrieve DSCSA transaction data for audit purposes. - Train staff on new compliance protocols:
Personnel must understand chain-of-custody responsibilities and be prepared to manage documentation and tracking requirements.
Staying Ahead of Compliance Challenges
The transition will undoubtedly require adjustments—especially for smaller EMS agencies accustomed to hospital support. However, this shift also brings opportunities for operational improvements:
- Standardized procurement processes
- Enhanced inventory management
- Improved drug safety and traceability
Many wholesale distributors are already working with EMS providers to streamline onboarding and ensure that DSCSA compliance is built into their service models. Additionally, some EMS-specific software vendors are updating their platforms to include DSCSA recordkeeping features and automation.
Final Thoughts
While the DSCSA’s impact on EMS procurement might initially seem like a regulatory burden, it ultimately supports patient safety and supply chain integrity. With enforcement on the horizon, EMS agencies must take proactive steps to align with the new standards.
By partnering with licensed distributors, implementing appropriate recordkeeping systems like Blue Link ERP, and investing in staff training, EMS providers can not only achieve compliance but also build a stronger, more resilient operational model.
