Registered EMS Agencies: The New Kid on the DEA Block

The Drug Enforcement Administration (“DEA”) has welcomed a new category of registrant: emergency medical services (“EMS”) agencies.  DEA has finalized its regulations to conform with the Protecting Patient Access to Emergency Medications Act of 2017 (“the Act”), establishing a new registrant category, registration standards and controlled substance delivery, storage, and recordkeeping requirements for EMS agencies.  Registering Emergency Medical Services Agencies Under the Protecting Patient Access to Emergency Medications Act of 2017, 91 Fed. Reg. 5216 (Feb. 5, 2026).  The agency’s October 2020 notice of proposed rulemaking elicited 81 public comments.  The new registration and controlled substance requirements for EMS agencies are dense and nuanced; we can only scratch the surface in this post.

The Act

The Act amended the Controlled Substances Act (“CSA”), establishing EMS agency requirements for controlled substances “while ensuring adequate safeguards against theft and diversion” by:

• Creating a new registration category for EMS agencies directing the Attorney General (delegated to the DEA Administrator) to register EMS agencies that submit an application demonstrating their authorization to conduct emergency medical services under state law where the agency practices but denying an application if registration is inconsistent with registration requirements or with the public interest factors.
• Directing the Attorney General (again delegated to the DEA Administrator) to allow an EMS agency to obtain a single registration for each state in which the agency administers controlled substances rather than requiring it obtain a separate registration for each location where it operates within that state. A DEA-registered, hospital-based EMS may use the registration of the hospital to administer controlled substances without a separate registration.
• Authorizing EMS professionals of a registered EMS agency to administer controlled substances outside the physical presence of a medical director or authorizing medical professional while providing emergency medical services if authorized by state law and standing or verbal orders.
• Establishing requirements for how registered EMS agencies deliver controlled substances to unregistered locations, store controlled substances, restock EMS vehicles, maintain records, and otherwise handle controlled substances.
• Authorizing the Attorney General (delegated to the DEA Administrator) to issue regulations governing the delivery and storage of controlled substances by EMS agencies.

Emergency Medical Services (“EMS”) Agencies

EMS agencies are defined as organizations providing emergency medical services, including organizations that:

1. Are governmental (including fire-based and hospital-based agencies); non-governmental (including hospital-based agencies), private, or volunteer-based;
2. Provide emergency medical services by ground, air, or otherwise; and
3. Are authorized by the state where the organizations provide emergency medical care, including administering controlled substances to general public members on an emergency basis.

EMS Registrations

Historically, EMS agency vehicles obtained needed controlled substances by operating under a hospital’s registration via one of two scenarios.  First, the EMS vehicle owned and operated by a hospital handled controlled substances under the hospital’s registration as an extension of the hospital pharmacy.  Secondly, an EMS agency was registered under a hospital registration by formal agreement with the hospital to act as the hospital’s agent.

EMS registrants may now obtain a single registration for multiple locations in each state where they operate.  (An EMS agency that operates facilities in multiple states must continue to have a separate registration in each state where the agency operates.)  Hospital-based EMS agencies may continue to operate under the registration of a hospital to administer controlled substances without obtaining a separate registration.  Controlled substances must be delivered to the registered location of the EMS agency or the hospital, if the EMS agency operates under the hospital’s registration.  EMS agencies may then distribute the controlled substances to designated unregistered locations.

DEA recommends three alternatives for EMS agencies to transition their own registrations:

1. Transition immediately on March 9, 2025, the final rule’s effective date;
2. Transition when the current registration expires; or
3. Transition 3 to 6 months prior to the renewal date.

Registrants should contact their local DEA field office to complete the registration transition.

Designated Locations

A registered EMS agency may deliver controlled substances from an agency’s registered location to a designated unregistered location of the agency.  The agency must designate the unregistered location as a “stationhouse” and notify DEA through its website at least 30 days prior to the first delivery.  Direct deliveries from distributors to designated unregistered locations are prohibited.  (DEA defines “stationhouse” as an enclosed structure, in a state where the EMS agency is registered, that may house EMS vehicles and that is actively and primarily being used by that EMS agency.)  An unregistered location becomes a designated location 30 days after notifying DEA, unless the agency objects.

Emergency Medical Service Vehicles

An emergency vehicle is an ambulance, fire apparatus, supervisor truck, or other vehicle used by an EMS agency to provide or facilitate emergency medical care and transport or the transporting of controlled substances to and from registered and designated locations.  EMS agencies may store controlled substances in an EMS vehicle located at a registered location, a designated location, or in an EMS vehicle used by the agency that is traveling from, or returning to, a registered or designated location of the agency in the course of responding to an emergency or otherwise is in use by the agency.

Restocking Meds

Non-hospital-based EMS agencies may receive controlled substances from a hospital for restocking an EMS vehicle following an emergency response.  Hospital-based EMS agency vehicles operating away from the hospital where they are registered can be restocked by non-affiliated hospitals.

EMS Agency Personnel Records

EMS agencies are required to maintain records of EMS personnel whose state licenses or certifications enable them to administer controlled substances in compliance with state law.

Maintenance of Records

Records must be maintained electronically or otherwise at each registered and designated location of the agency where the controlled substances are received, administered, or disposed of in the course of providing emergency medical services.  EMS personnel who dispose of or administer controlled substances in providing emergency medical care must document the name of the controlled substance(s), date, and identification of the patient.

EMS agencies must maintain records of controlled substances delivered between registered and designated locations.  EMS agencies that restock at the hospital under which they are operating are not required to maintain records because the hospital maintains restocking records.  Such records must include:

• Name of the controlled substance;
• Finished dosage form;
• Number of units in each commercial container;
• Date delivered; and
• Address of the EMS agency location where the controlled substances were delivered.

Designated locations of an EMS agency must notify the registered location of their EMS agency within 72 hours of receiving controlled substances from a hospital for restocking an EMS vehicle, following an emergency response.

Security

Controlled substances may be stored at EMS registered locations, designated locations, inside EMS vehicles stationed at registered or designated locations, and inside of EMS vehicles actively in use by the agency.  Controlled substances must be stored in a securely locked, substantially constructed cabinet or safe that cannot be removed if not being carried in a jump bag or on the person of EMS personnel responding to an emergency, whether within a vehicle or at a registered or designated location.

Controlled substances may also be stored in an automated dispensing machine at a registered or designated location.

An EMS agency may also store controlled substances in an automated dispensing system (“ADS”) machine.  An ADS is “a mechanical system that performs operations or activities, other than compounding or administration, relative to the storage, packing, counting, labeling, and dispensing of medications, and which collects, controls, and maintains all transaction information.”  For an EMS agency to use an ADS machine to store controlled substances:

1. The ADS machine must be located at an EMS registered location or designated location;
2. The EMS agency cannot permit any entity other than itself to install and operate the ADS machine;
3. The ADS machine cannot be used to directly dispense controlled substances to an ultimate user; and
4. The EMS agency must operate the ADS machine in compliance with state law.

An ADS machine cannot be used to provide secure storage on an EMS vehicle.

EMS vehicles storing controlled substances must be locked when parked outside of an enclosed registered or designated location or when actively in use, but unattended.  Thus, EMS vehicles storing controlled substances do not have to be locked if they are:

1. Parked within an enclosed registered or designated location;
2. At the scene of an emergency; or
3. EMS personnel are in attendance, though controlled substances must be stored in a securely locked, substantially constructed cabinet or safe that cannot be readily removed.

Carrying Controlled Substances

EMS personnel may carry controlled substances on their person or in a jump bag when responding to an emergency, instead of storing controlled substances in a safe during an emergency response.  They must return the controlled substances to a storage compartment that is either inside the EMS vehicle or designated location when EMS personnel are not engaged in responding to an emergency.

Delivery/Receipt

Only medical directors of the agency or a person designated in writing by the medical director may accept delivery of controlled substances at a registered or designated location.  The medical director or designated person accepting the controlled substances must maintain a record that provides the medical director or designated person’s signature, title, date received, quantity, and any additional information required.

Hospitals and EMS agencies may deliver controlled substances to one another during shortages, public health emergencies, or mass casualty events rather than relying on distributors or hospital restocking, but such transfers require written approval from the DEA Special Agent in Charge for the area or DEA headquarters.

Administration

Registered EMS agency professionals can administer controlled substances outside the physical presence of a medical director or authorizing medical professional when providing emergency medical services, if they have authority from their EMS agency and a proper standing or verbal order issued and adopted by one or more medical directors of the agency.  EMS professionals must also be authorized by their state to administer controlled substances.

Effective Date

The final rule becomes effective March 9th.