Transition 
On November 27, 2024, the U.S. Food and Drug Administration (FDA) will begin enforcing new regulations that will make current regional medication kit exchange programs noncompliant. As such, participation by healthcare facilities in traditional drug box exchange programs will cease. We are actively collaborating with stakeholders, other Regional EMS Councils, the Virginia Office of EMS, and various entities to assess the potential impact of these FDA changes on the Drug Box Program for each council.
This page has been created to provide essential information regarding this transition and to ensure that EMS agencies meet Virginia Board of Pharmacy (VBOP) and Drug Enforcement Agency (DEA) requirements. Please review the information provided here and through the sources linked below:
- pdf Council Guidance Memo (142 KB)
- pdf Virginia Regional EMS Medication Kit Transition Workgroup Final Report (107 KB)
- Emergency Medical Services Drug Kits Guidance Document (Virginia Board of Pharmacy)
- pdf CSR Registration Guidance Toolkit (2.83 MB)
- Requirements for storage and security for controlled substances registrants (Virginia Board of Pharmacy)
- Controlled Substances Registration Inspection Report (Virginia Board of Pharmacy)
Tools 
Frequently Asked Questions (FAQ)
Why is this change being made?
The Drug Supply Chain Security Act (DSCSA), promulgated by the Food and Drug Administration, outlines steps to achieve interoperable, electronic tracing of products at the package level to identify and trace certain prescription drugs as they are distributed in the United States. This act was passed in 2013, with a current delayed enforcement date of November 27, 2024. The delayed enforcement date expires this year, meaning healthcare facilities must comply with these requirements. The current kit-for-kit exchange system does not meet these requirements. Further, Congress passed the Patient Access to Medication Act in 2017, establishing a mechanism for EMS agencies to obtain and carry Schedule II-V medications. Although the DEA has drafted regulations, they have not been published. We anticipate their release in the near future, which may introduce additional constraints.
Is this change being made because healthcare facilities no longer want to assist EMS agencies?
No. Healthcare facilities must implement electronic tracking processes at the package level for drug distribution. Current medication kit exchange systems do not meet these requirements. Healthcare facilities could face enforcement actions if they continue supporting the current medication kit system.
Does my agency need a CSR?
Yes. If you plan on storing regional drug kits or stocking additional medications and IV fluids within your station.
Can I store drugs in our building without a controlled substance registration certificate (CSRC)?
No, storing drugs in your agency’s building without securing them in an ambulance may result in your agency possibly being cited for deficiencies by the Board of Pharmacy.
Can my agency purchase or store drugs before having a CSRC?
No. Before an EMS agency orders drugs from a permitted pharmaceutical manufacturer, wholesale distributor, or third-party logistics provider, the EMS agency must apply for a CSR from the Board of Pharmacy and a registration from the DEA. An inspection of the drug storage location within the building will be performed before the issuance of the CSR. Any deficiencies identified during the inspection must be corrected before issuance.
Does my agency need a DEA registration?
If you plan to purchase drugs, then you will need to obtain a DEA registration. Agencies must apply for a state CRS before issuance of a DEA registration.
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