Virginia’s transition away from hospital-stocked emergency medication kits toward EMS-agency-stocked drug kits—required by federal changes under the Drug Supply Chain Security Act (DSCSA) and the Protecting Patient Access to Emergency Medications Act—has largely been completed despite the challenges posed to local governments to implement the shift in services. A 2025 report issued by the Virginia Board of Pharmacy, in collaboration with the Virginia Department of Health and the Office of Emergency Medical Services, provides a comprehensive overview of the Commonwealth’s progress and lessons learned during this complex, statewide transition. The report finds that most EMS agencies across Virginia have successfully transitioned from the long-standing hospital kit-exchange model to compliant, agency-stocked medication systems, meeting federal and state regulatory requirements while maintaining service levels for patients.
As previously reported, Federal legislation passed in 2017 known as the Protecting Patient Access to Emergency Medications Act, subsequent proposed regulations published by DEA, and FDA’s announcement of its intention to enforce certain requirements of the Drug Supply Chain Security Act, 21 U.S.C. § 351 et seq. (“DSCSA”), resulted in a determination by hospital pharmacies in late 2023 that the hospitals could no longer legally participate in an emergency drug kit exchange process with EMS agencies as of November 27, 2024.
Beginning in January 2024, stakeholder meetings were convened, by the Virginia Department of Health EMS Medical Direction Committee and the Virginia Regional EMS Medication Kit Transition Workgroup, to discuss a transition plan. After significant input from stakeholders, the Board of Pharmacy adopted emergency regulations in a specially convened meeting to create a new model consistent with the federal law and DEA’s proposed regulations. The emergency regulations became effective on August 20, 2024.
Concurrently, regional EMS councils worked diligently with EMS agencies in their regions to determine the optimal model to obtain and transfer drugs for use in emergency drug kits. The Board developed a virtual inspection process for expeditiously performing initial inspections prior to issuing 300 controlled substance registrations to EMS agencies and approving over 700 designated locations.
In October 2024, FDA announced a DSCSA exemption from the enhanced drug distribution security requirements of section 582 of the Federal Food, Drug, and Cosmetic Act for eligible trading partners which extended until November 27, 2025. Based on this announcement, hospital pharmacies agreed to continue providing emergency drug kits, if needed, until April 15, 2025, with the understanding that both EMS and hospital pharmacy stakeholders would actively continue to complete the transition.
According to report findings, “While current and future challenges exist, most stakeholders agree that the transition for how EMS agencies receive and handle emergency drug kits in Virginia has gone well. One hospital pharmacist reported that she could not recall a hospital project, short of building a new hospital, in which so much time was invested with involvement from multiple disciplines, health system leadership, and the convening of dozens and dozens of meetings. Strong collaboration from stakeholders and state and federal partners was invaluable during this transition.”
Among the report’s notable findings:
- Approximately 300 controlled substance registrations have been issued to EMS agencies and regional EMS councils, covering more than 700 designated locations statewide.
- Most EMS agencies reported no reduction in service levels, although a small number—primarily rural or low-call-volume agencies—adjusted service levels or limited the scope of medications carried due to cost and operational concerns.
- Regional EMS councils played a critical role in helping agencies select compliant models, navigate DEA and Board of Pharmacy requirements, and coordinate purchasing, storage, and disposal practices.
The report emphasizes that the success of the transition hinged on unprecedented collaboration among EMS agencies, regional EMS councils, hospital pharmacists, state regulators, and federal partners. Emergency regulations adopted by the Board of Pharmacy in August 2024 provided a flexible, EMS-informed framework that allowed regions to tailor compliance models to local needs while meeting federal requirements.
VACo previously highlighted this collaborative effort in County Connections with an article recognizing the work of the Virginia Regional EMS Medication Kit Transition Workgroup the presentation of a 2025 PEMS Special Recognition Award. That article underscored the scale and urgency of the transition and the extraordinary efforts undertaken by EMS leaders, pharmacists, and partner organizations to meet the April 15, 2025, deadline.
While the report acknowledges ongoing challenges related to costs, long-term sustainability, and medication disposal, it concludes that Virginia’s EMS system is now on a more secure and compliant footing with respect to emergency medications. Continued monitoring, technical assistance, and potential future policy discussions will be critical to ensuring that smaller and rural agencies can sustain compliance without compromising patient care.
More information on the report can be accessed here. VACo will continue to track implementation issues, funding concerns, and any future federal or state regulatory developments affecting EMS medication management.
VACo Contact: Jeremy R. Bennett