Countdown to Regional Drug Box Transition
This page contains important information updates, resource documents, and helpful tools developed by the Virginia Regional EMS Medication Kit Transition Workgroup to assist ODEMSA’s EMS Agencies in successfully navigating the transition from hospital-stocked Regional EMS Medication Kits to agency-stocked kits.
Health Systems are moving towards EMS agency ownership of Medication Drug Kits due to regulatory changes from the FDA Drug Supply Chain and Security Act of 2013, which was scheduled to be enforceable on November 27, 2024. This scheduled date has now been extended until November 27, 2025. The Protecting Patient Access to Emergency Medications Act of 2017 may ultimately require additional paperwork for the transfer of Schedule II medications.
The ODEMSA Regional Medication Kit (Drug Box) Exchange Program, which has been operational for nearly four decades, WAS slated to be discontinued on November 12, 2024, at noon. With the change to the enforcement date by the FDA, the Regional Drug Box Program has been extended until April 15, 2025. EMS agencies in the ODEMSA Region must understand that they will require a Controlled Substance Registry (CSR) for Class II through VI drugs and an EMS Agency DEA license for the purchase and storage of DEA-scheduled drugs for EMS agency drug boxes.
Transition Plan and Forms
Regional Transition Plan
The ODEMSA Regional EMS Medication Kit Transition Plan outlines the necessary steps and procedures for ALS agencies in the ODEMSA region to transition from the Regional Drug Box Program to managing their own medication kits. Included in this document are program milestones, guidance for agencies unable to meet milestones, steps for full transition, final program termination procedures, and the collection process from hospital pharmacies.
Transition Forms
The following documents are essential for ALS agencies that participate in the ODEMSA Regional Drug Box Program as they transition to managing their medication kits:
- EMS Agency Partial Withdrawal from Restocking Agreement: Use this form to formally withdraw from the drug kit restocking portion of the Regional Ambulance Restocking Agreement. It should be submitted to ODEMSA at least five (5) days prior to your agency’s anticipated transition date.
- Council to EMS Drug Kit Transfer Agreement: This form documents the transfer of drug kits from ODEMSA to your agency. It must be completed and submitted to ODEMSA within three (3) business days after your agency’s transition date.
- Drug Box Inventory Form: An optional form designed to assist your agency in logging the contents and expiration dates of your drug kits following the transition.
These documents support the transition process detailed in the ODEMSA Regional EMS Medication Kit Transition Plan, which is available above for guidance.
Communiqués to EMS
- 01/24/2024 – ODEMSA Memo to Agencies
- 03/27/2024 – ODEMSA Memo to Agencies
- 04/16/2024 – EMS Drug Kit Joint Message VHHA VSHP
- 05/09/2024 – ODEMSA Memo to Agencies
- 06/17/2024 – Joint Letter to ODEMSA EMS Agencies from VCU Health, HCA, and Bon Secours
- 06/18/2024 – ODEMSA Memo to Agencies
- 09/24/2024 – DEA Registration for OMDs from Dr. Linbeck
- 10/24/2024 – ODEMSA Memo to Agencies
- 10/30/2024 – ODEMSA Memo to Agencies
- 10/31/2024 – EMS Drug Kit Joint Message from VHHA-VSHP
- 10/31/2024 – OEMS EMS Drug Kit Transition Plan Update – Press Release
- 03/12/2025 – ODEMSA Memo to Agencies
Resources
- ***BOP Report Project 7873 final emergency language***
- DEA Notice of Proposed Rules for EMS Drug Kits
- FDA Guidance Document Draft Identifying Trading Partners Under the Drug Supply Chain Security Act
- EMS Replenishment DEA, DSCSA, and Anti-Kickback Requirements November 2023
- DEA Alphabetical Listing of Controlled Substances
Regional Drugbox Suppliers
- Orange Drug Box – Flambeau First Aid Box PM1872 (9 Compartments) Qty 4 per Case
- Yellow Narcotics Box – S3 Cases T3000
- Vendor – satmodo.com
- Vendor – Amazon
VA Regional EMS Medication Kit Transition Workgroup Tools
CSR and DEA Application Guidance:
We have developed the ODEMSA Guide for Controlled Substance Registration Certificate Application for an EMS Agency to aid agencies in filling out the CSR Initial Application and crafting the necessary Description of Process/Business Practices Letter as referenced in the CSR application’s “Footnotes.” This guide offers relevant questions and sample responses to help you draft a clear and concise letter. Our aim with this guidance is to expedite the completion of your letter, ensuring your CSR application is processed swiftly with minimal if any, delays due to additional inquiries.
Below are additional CSR and DEA tools.
- Virginia Board of Pharmacy Emergency Medical Services Drug Kits Guidance Document: 110-41
- Guide for Controlled Substance Registration Certificate Application EMS agency
- Requirements for storage and security for controlled substances registrants
- Virginia Board of Pharmacy Controlled Substances Registration Inspection Report
- Virginia Office of EMS Transport EMS Vehicle Supplies Quick Reference Guide
- Virginia Office of EMS Scope of Practice – Formulary for EMS Personnel
- Westmoreland EMS Pharmacy Tutorial (Note: Cameras are not required)
- EMS Agency Controlled Substances Policy and Procedure Example
- Storage and Security of Medications for EMS Controlled Substance] Registered and Designated Locations
- DEA Licensing Steps
- DEA Licensing Steps Williamsburg EMS
- DEA Record-Keeping Requirements Tip Sheet
- DEA POA Template
- DEA Biennial Controlled Substance II V Inventory Form
- DEA CSOS Guide Cardinal Distribution
- DEA Initial Opening Controlled Substance II V Inventory Form
- DEA Ordering CII Medications with DEA 222 Form
Policies and Procedures Tools
- Medication Policy and Procedure Guidance for Virginia EMS Agencies 6 6 2024
- Sample Policy 303 ALS Controlled Substances Revised 01-26-24
- Tool Preventing Diversion of Controlled Substances
- Tool Sample Controlled Substance Tracking Log
- Tool Ordering CII Medications with DEA 222 Form
- Tool CSOS Guide Cardinal Distribution
- Tool Drug Inventory Management for EMS Agencies Boundtree
- Tool Controlled Substances Daily Log Example
- Tool Creating Order LIsts Templates Cardinal Order Express
- Sample Policy Resupply of EMS Agencies
- Sample Policy LA County Medication Procurement Policy and Procedure
- Sample Policy MCFRS Controlled Substance Use and Security
- Sample Policy EMS Pharmacy Manual
- Sample Policy Controlled Substance Policy
- Sample Policy EMS Equipment and Supply Ordering
- Sample Policy C6 EMS Controlled Substance Program
- Sample Policy Controlled Substance 2018
- Sample Policy 439 00 Controlled Substances
- Sample Policy 303 ALS Controlled Substances revised 12624
Purchasing Tools
Financial Assistance Tools
Frequently Asked Questions
Click on each question to reveal the answer.
General Requirements and Basics
If storing regional drug kits or additional medications within your station, then yes.
An EMS agency should apply for a CSR if:
- The EMS agency will need to stock drugs in Schedules II-VI, including irrigation or IV fluids, naloxone, or epinephrine, in the building beyond the temporary storage of drugs in a kit because the EMS vehicle or other EMS vehicle cannot maintain appropriate storage temperature, or it is out of service; or
- The EMS agency will receive drug from another registered EMS agency, regional EMS council, wholesale distributor, warehouser, third-party logistics provider, or pharmacy that is not part of a kit for kit exchange and the EMS agency is not a designated location of another EMS agency or regional EMS council.
An EMS agency does not need to apply for its own CSR under the following circumstances:
- It does not receive drugs in Schedules II-VI outside of a kit for kit exchange with a hospital and does not store any drugs in Schedules II-VI, including irrigation or IV fluids, in the building except for the temporary storage of drugs in a kit because the EMS vehicle or other EMS vehicle cannot maintain appropriate storage temperature, or it is out of service; or
- It only stores medical devices, medical gases, needles and syringes with no added drug in the building; or
- It is a designated location of another EMS agency or regional EMS council that maintains a CSR from the Board.
Not necessarily. A CSR is only required for stations where drugs or kits are stored or stocked.
Obtaining a CSR and DEA Registration
Yes. You must include a Processes/Business Practices Letter with your CSR application and fee. Guidance can be found here.
Per the emergency regulations adopted by the Board on May 2, 2024, and currently under administrative review, an EMS agency or regional EMS council may obtain a CSR from the Board and submit application to the DEA for a DEA registration to obtain drugs in Schedule II-VI.
Yes. The DEA requires the state CSR before issuing registration. Failure to obtain a CSR first may result in the loss of fees paid to the DEA.
Possibly. A DEA registration is required if storing and purchasing drugs that are Schedule II-V.
Storage and Compliance
No. Storing drugs outside of an ambulance without a CSR may result in a citation by the Board of Pharmacy and possibly delay receiving your CSR.
No. Obtain a CSR and DEA registration before purchasing or storing drugs. Inspections will be required before CSR issuance.
Yes. IV fluids must be securely stored, but no alarm system is required if only fluids are stocked without added drugs.
No. The kits must stay in ambulances at proper temperatures and cannot be stored at EMS facilities without a CSR.
Yes. A CSR is required for storing scheduled II-VI drugs.
Yes, if the building is not staffed 24/7. An alarm system must be installed for drug storage areas.
While not mandatory, video surveillance is recommended to enhance security.
Roles, Responsibilities, and Processes
Expired drugs must be separated from stock and disposed of through a reverse distributor. More details can be found here.
No, but the person must be authorized to administer medications as per the Virginia EMS Scope of Practice.
The Supervising Practitioner must be an endorsed EMS physician. Try resolving the issue with your OMD or you may need to find a new OMD to avoid non-compliance.
A self-inspection using the CSR Inspection Report is recommended.
Inspections may not be scheduled within 14 days. Applications remain valid for one year, and timely responses to inspectors are essential to prevent delays.
The Responsible Party will receive a downloadable link to the inspection document via email. This link is time-sensitive and documents should be downloaded promptly.
Times can vary depending on circumstances but there is a 30 day waiting period before your application is processed.
Changes and Transfers
Yes. Submit a CSR application for changes, and the new or remodeled area must pass inspection before storing drugs.
Yes, per the emergency regulations adopted by the Board on May 2, 2024, and currently under administrative review. Such notification should be made in writing via email highlighting the changes since last notification to the Board, to include both name and physical address of the designated locations. If the change involves adding new designated locations, the responsible party should print his/her name, signature, and date, along with the following statement at the bottom of the list: “I attest that each designated location complies with the physical and security requirements as adopted by the Board in regulation and currently under administrative review.” Such requirements include:
- The designated area for storing drugs is in a fixed and secured room, cabinet or area that can maintain appropriate temperature pursuant to the drug manufacturer’s directions at all times; or
- Drugs in Schedules II-VI will be stored in an automated dispensing device which is located at a secured site in the building which is: (i) installed and operated by the EMS agency or regional EMS council, (ii) not used to directly dispense controlled substances to an ultimate user, and (iii) is in compliance with the requirements of state law; or
- Drugs will only be stored on an EMS vehicle except for temporary storage in the building when the EMS vehicle or other EMS vehicle cannot maintain appropriate drug storage temperature or is out of service; and
- The designated area for storing drugs has a compliant alarm system monitoring the drug storage area if the building is not staffed 24/7 and the designated location intends to stock drugs in Schedules II-V. Note, an alarm is not required if such drugs are only temporarily stored in the building when the EMS vehicle or other EMS vehicle cannot maintain appropriate drug storage temperature or is out of service.
First, verify that the CSR is current active using the online License Lookup featureand that it has not expired. To search, enter the registration number listed on the CSR, or choose “Business CSR” for “Occupation” and enter the “Business Name” of the EMS agency.
Secondly, confirm internally that the CSR was issued for the purpose of stocking drugs and that the corresponding drug Schedules listed on the CSR match the agency’s current drug needs. CSRs are issued for multiple reasons including 1:1 exchange of Schedule VI drugs which does not authorize the stocking of drugs.
Thirdly, confirm that there have been no changes to the responsible party and supervising practitioner since the issuance of the CSR or last application submission to the Board. If there have been changes, a CSR application must be immediately submitted to the Board for a “Change of Responsible Party” or “Change of Supervising Practitioner”.
Fourthly, if the agency wants to transfer drug to a designated location, then the agency must submit a CSR application and attach a listing of the “EMS designated locations”. The list of designated locations must include the name and physical address of each designated location. The responsible party should print his/her name, signature, and date, along with the following statement at the bottom of the list: “I attest that each designated location complies with the physical and security requirements as adopted by the Board in regulation and currently under administrative review.” Such requirements include:
- The designated area for storing drugs is in a fixed and secured room, cabinet or area that can maintain appropriate temperature pursuant to the drug manufacturer’s directions at all times; or
- Drugs in Schedules II-VI will be stored in an automated dispensing device which is located at a secured site in the building which is: (i) installed and operated by the EMS agency or regional EMS council, (ii) not used to directly dispense controlled substances to an ultimate user, and (iii) is in compliance with the requirements of state law; or
- Drugs will only be stored on an EMS vehicle except for temporary storage in the building when the EMS vehicle or other EMS vehicle cannot maintain appropriate drug storage temperature or is out of service; and
- The designated area for storing drugs has a compliant alarm system monitoring the drug storage area if the building is not staffed 24/7 and the designated location intends to stock drugs in Schedules II-V. Note, an alarm is not required if such drugs are only temporarily stored in the building when the EMS vehicle or other EMS vehicle cannot maintain appropriate drug storage temperature or is out of service.
The CSR issued for 1:1 exchange of Schedule VI drugs may be returned to the Board with a memo informing the Board that it is no longer needed because the EMS agency intends to become a designated location of a registered EMS agency or regional EMS council. Once the CSR application from the other EMS agency or regional EMS council is received designating this EMS agency as a designated location and the emergency regulations become effective, a CSR card will be mailed to this EMS agency.
Emergency regulations adopted by the Board on May 2, 2024, and currently under administrative review do not appear to prohibit this.
Per the emergency regulations adopted by the Board on May 2, 2024, and currently under administrative review, an EMS agency or regional EMS council may transfer drug to a designated location of the EMS agency or regional EMS council as listed on the CSR application submitted to the Board or subsequently revised.
Per a summary of the emergency regulations adopted by the Board on May 2, 2024, and currently under administrative review, a record that must be maintained by the EMS agency or EMS council transferring the drug and the designated location receiving the drug must include the following information:
- Name of the drug;
- Finished form of the drug (e.g., 10-milligram tablet or 10-milligram concentration per fluid ounce or milliliter);
- Number of units or volume of finished form in each commercial container (e.g., 100-tablet bottle or 3-milliliter vial);
- Number of commercial containers transferred/acquired;
- Date of the transfer/acquisition;
- Name, address, and registration number of the person from whom the substance was acquired and to whom the drug was transferred; and
- Name and title of the person receiving the drug.
Regulatory Updates and Final Notes
The emergency regulations are currently under administrative review. While it is unknown when the regulations will become effective, it is possible they will become effective by the end of July 2024. An application for a controlled substances registration (CSR) may currently be submitted per this document to facilitate the processing of a large number of applications. While a CSR for the registered location can currently be issued, a designated location cannot be officially recognized until the emergency regulations are effective.
Scenario 1:
- EMS agency will receive drugs in Schedules VI from a regional EMS council and drugs in Schedules II-V from a registered EMS agency.
- EMS agency will need to store drugs in Schedules II-VI in the building such as intravenous and irrigation fluids.
- EMS agency will not transfer drugs in Schedules II-V to another location except under an approved emergency.
- This EMS agency will either need to be a designated location of another registered EMS agency or regional EMS council, or combination of the two, whose CSR or DEA registration authorizes the transfer of drugs in Schedules II-VI.
- Alternatively, it can obtain its own CSR and DEA registration, paying all initial and renewal fees.
- If the EMS agency only stores drugs in Schedules VI in the building such as intravenous and irrigation fluids, epinephrine, or naloxone, then no alarm is needed. If drugs in Schedules II-V are stored in the building outside of the allowance for temporary storage of an emergency kit when the EMS vehicle cannot maintain appropriate storage temperature or is out of service, then the drug storage area must be alarmed in compliance with board regulation.
- EMS agency or regional EMS council will receive drugs in Schedules II-VI from a wholesale distributor with the intent to prepare kits and/or transfer drugs to designated locations for their use.
- The EMS agency or regional EMS council will need to apply for its own CSR and DEA registration, indicating the name and physical addresses of the designated locations, and the responsible party must attest to each designated location’s compliance with the physical and security requirements as indicated in the board’s adopted regulations.
- The storage of drugs in Schedules II-V in the building will necessitate an alarm in compliance with the adopted regulations.
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