Potential Impact of FDA changes on Drug Box Programs

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This site contains important information updates and resource documents, as well as helpful tools developed by the Virginia Regional EMS Medication Kit Transition Workgroup to assist northern Virginia EMS agencies in successfully navigating the transition from hospital-stocked Regional EMS Medication Kits to EMS Agency stocked kits.

 

Health Systems are moving towards EMS agency ownership of EMS medications and controlled substance kits due to regulatory changes from the FDA Drug Supply Chain and Security Act of 2013, which is enforceable as of November 27, 2024, and the Protecting Patient Access to Emergency Medications Act of 2017, which may ultimately require additional paperwork for the transfer of Schedule II medications.  The northern Virginia area hospitals have agreed to postpone the transition until April 15, 2025, but all agencies should continue to have their EMS pharmacies ready as soon as they are able, and ahead of the April 2025 deadline.

The northern Virginia regional medication and CSK exchange program currently in practice will end with the FDA DSCSA enforcement changes. Discussions regarding the role of the hospital systems during the transition are underway. Regardless, EMS agencies must understand that they will require a Controlled Substance Registry (CSR) for Class II through VI Medications and an EMS Agency DEA license for the purchase and storage of medications for EMS agency drug boxes.

 

The Virginia Regional EMS Medication Kit Transition Workgroup created tools in specific categories to assist EMS agencies with the changes.  Documents will be added as they are received, so check back frequently for updates!

 

CSRC and DEA Licensure

Financial Assistance

Hospital System & VSHSP Updates

Policies and Procedures

Purchasing

Resources

 

 

 

Specific questions regarding the medication and CSK exchange changes can be directed to Council staff at This email address is being protected from spambots. You need JavaScript enabled to view it..