On November 27, 2024, the regulations set forth by the U.S. Food and Drug Administration (FDA) will come into effect. 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.
In the interim, it is strongly advised that EMS agencies in the Commonwealth take the necessary steps to acquire a Controlled Substances Registration (CSR) through the Department of Health Professions (DHP). It’s important to note that with over 600 EMS agencies statewide, delaying the acquisition of a CSR may delay the ability of an agency to purchase and/or store medications, which could impact the agency’s ability to participate in the regional drug box program.
Communiqués to EMS in the ODEMSA Region
CSR 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.
Additional CSR Resources:
Below is a list of resources to assist your agency with obtaining a CSR.
Frequently Asked Questions
When completing the application for a CSR, do we need to include a Processes/Business Practices Letter?
What if my OMD does not want to be the Supervising Practitioner for the CSR?
If your OMD is unwilling to serve as the Supervising Practitioner for the CSR, your alternatives are restricted. The Supervising Practitioner needs to be an endorsed EMS physician, so you should first try to resolve this issue with your current OMD to secure a CSR. If resolving the issue is not possible and your agency’s operations are at risk of shutting down due to non-compliance, you may need to find a different OMD.
Can my agency store drugs in our building without a Controlled Substance Registration (CSR)?
No, storing drugs in your agency’s building without securing them on an ambulance may result in your agency possibly being cited for deficiencies by the Board of Pharmacy.
Should my agency purchase or store drugs prior to having a CSR?
No. Prior to an EMS agency ordering drugs from a permitted pharmaceutical manufacturer, wholesale distributor, or third-party logistics provider, the EMS agency should obtain 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 prior to the issuance of the CSR. Any deficiencies identified during the inspection must be corrected prior to issuance.
Does my agency need a CSR to store IV fluids?
Yes. At this time IV fluids must be securely stored; however, an alarm system is not required for agencies stocking only intravenous fluids with no added drug.
Can I store Regional Drug Kits in my station when not secured in an ambulance?
No. The drug kit must remain secured in the ambulance at appropriate temperatures at all times. These kits are not intended to be stored within the EMS facility.
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.
Does my agency need a CSR for each station?
No. Your agency does not require a Controlled Substances Registration (CSR) for each station. If your agency operates multiple stations and designates specific stations for restocking drugs or storing regional drug kits, a CSR is only needed for those locations. However, if drugs or drug kits will be stored at each station, then a CSR is required for each station.
If I have out of box drugs, do I need a CSR?
Yes. If you will be storing and restocking drugs that are not in a regional med kit, then you will need a CSR.
Is it necessary for the responsible party to be a doctor or paramedic?
Does my storage area need a security system?
A security system is required if your building is not staffed 24/7. Even if your building is usually staffed around the clock, any period it is left unattended necessitates a security system. Per the Virginia Board of Pharmacy Emergency Medical Services Drug Kits Guidance Document: 110-41, “If it’s possible that all EMS personnel will leave the building simultaneously to address patient needs, then the facility is not staffed 24 hours a day and an alarm system compliant with 18VAC110-20-710 is required”. Securing the entire building is not mandatory; however, any drug storage area(s) must be equipped with an alarm that is monitored.
Does my station need video surveillance?
While NOT required, installing video surveillance is recommended, when possible, to enhance security.
Does my agency need to get a DEA registration?
Maybe. If you plan to purchase drugs, then you will need to obtain a DEA registration depending on the drug.
Does my agency need to have a CSR prior to applying for a DEA registration?
The DEA generally prefers for the state CSR to be issued prior to the issuance of a DEA registration.
How long will it take for an inspector to come out to complete the CSR inspection?
The sooner you submit a complete application along with the fee and letter, the sooner your chances of getting an inspection. Due to a high volume of requests from EMS agencies across the state, the Department of Health Professions may not schedule the actual inspection within 14 days of the application date. Your inspection may be scheduled several weeks after applying. Although inspectors have 14 days to schedule an inspection, this does not guarantee an on-site visit within that period. Prompt responses to requests for additional information are crucial, as delays in providing this information can significantly postpone your inspection date. Be aware that applications are valid for one year only.
How can my agency prepare for their CSR inspection?
What documents will the Responsible Party receive at the conclusion of an inspection?
The inspector will provide the Responsible Party with a link via email to download the inspection document. This link is only available for a limited time therefore it is best to download the inspection documents shortly after the inspector sends it. If there are any questions regarding the results of the inspection or if the link expires and a copy of the inspection is needed, you will need to contact DHP to have the link reissued.
My agency has a CSR and wants to change an approved location of the drug stock, make structural changes to an existing approved drug storage location, or make changes to a previously approved security system. Do we need to do anything prior to making a change?
Any EMS agency wishing to change an approved location of the drug stock, make structural changes to an existing approved drug storage location, or make changes to a previously approved security system shall submit a CSR application to the Board for the change of location or remodel and be inspected. No drugs may be stored in the remodeled space or new location until approved by the Board and DEA.
Can my agency throw away or dispose of expired drugs?
Any drug that has exceeded the expiration date shall not be administered; it shall be separated from the stock used for administration and maintained in a separate, locked area until properly disposed. If a controlled substances registrant wishes to dispose of unwanted or expired Schedules II through VI drugs, he shall transfer the drugs to another person or entity authorized to possess and to provide for proper disposal of such drugs. For more information, visit https://law.lis.virginia.gov/admincode/title18/agency110/chapter20/section710/
If you need assistance, please don't hesitate to reach out to us at (804) 560-3300, extension 104.
RSS - Posts
