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 scheduled to be enforceable on 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 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.
CSRC and DEA Licensure Tools
CSR_18VAC110-20-710. Requirements for storage and security for controlled.pdf
CSR_Storage and Security of Medications for EMS Controlled Substance] Registered and Designated Locations v1May 2024.pdf
DEA POA template.pdf
DEA Record Keeping Requirements tip sheet.pdf
DEA_Biennial Controlled Substance II-V inventory form.pdf
DEA_CSOS_Guide_Cardinal Distribution.pdf
DEA_Initial-Opening Controlled Substance II-V inventory form.pdf
DEA_Ordering CII Medications with DEA 222 Form.pdf
EMS Agency Controlled Substances policy and procedure example.pdf
Pharmacy Controlled Substances Registration Inspection Report Revised 8-20-2024.pdf
Financial Assistance
Drug Transition Finance Tool.xlsx
Funder Email Sample.pdf
Funding Sources Final.xlsx
Hospital System, VHSP, and VA BOP Updates
Pharmacy Emergency Regulations Allowances for Emergency Drugs by EMS Agencies - 8-20-24 to 2-19-26.pdf
Virginia BOP FAQ Emergency Regulations 7-24-2024.pdf
Policies and Procedures
Medication Policy and Procedure Guidance for Virginia EMS Agencies 6-6-2024.pdf
Sample Policy_303-als-controlled-substances-revised-12624.pdf
Purchasing
Virginia EMS Medication Purchasing Tool Kit 05 10 2024.pdf
Resources
DEA Guidance 7_3_24.pdf
DEA notice of proposed rules for EMS drug kits.pdf
DSCSA 582g1_Exemptions_for_Connected_tps_Oct_2024_final_signed.pdf
FDA Guidance Document Draft - Identifying Trading Partners Under the Drug Supply Chain Security Act.pdf
Memorandum - Changes to Virginia EMS Drug Box Exchange Program.pdf
Requirements-for-Transactions-with-First-Responders-under-Section-582-of-the-Federal-Food--Drug--and-Cosmetic-Act—-Compliance-Policy-Guidance-for-Industry.pdf
Waivers and Exemptions Beyond the Stabilization Period FDA.pdf