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The DEA is modifying the regulations related to the registration requirements of DEA registrants to allow emergency medical services (EMS) registrants to transport controlled substances for the purpose of dispensing under certain circumstances, and provide the EMS community with specific requirements for EMS programs handling controlled substances. As a result of these modifications, the DEA would also modify the security, ordering, and recordkeeping requirements for those registrants who wish to transport controlled substances for the purpose of dispensing.

Statement of Need:

DEA’s existing regulations do not adequately address the mobile, decentralized, and time-critical nature of EMS operations.  This rule would establish a clear, consistent, and uniform regulatory framework that both supports timely patient care and maintains the necessary controls to prevent diversion.

Summary of the Legal Basis:

The Protecting Patient Access to Emergency Medications Act of 2017, (hereafter the Act) amended the Controlled Substances Act (CSA) to allow for a new registration category for emergency medical services agencies that handle controlled substances.  Consistent with the Act, DEA is modifying its regulations to explicitly include EMS agencies handling controlled substances as registrants under the CSA, and to delineate the security, and recordkeeping requirements for EMS registrants who store, transport, and administer controlled substances.  DEA is also establishing regulations that would codify the Act’s provisions that allow EMS personnel to administer controlled substances in schedules II-V outside of the physical presence of a medical director or authorizing medical professional in the course of providing emergency medical services if authorized in the State in which the medical service occurs and pursuant to a standing order or verbal order.

Alternatives:

This rulemaking is the only effective method for ensuring consistent oversight, patient access, operational efficiencies, and diversion control for all EMS agencies nationwide.

Anticipated Costs and Benefits:

Benefits of the rule are expected to be generated by reducing regulatory uncertainty among EMS agencies and personnel regarding the administration, transfer, and disposal of controlled substances.  By allowing EMS registrants to consolidate multiple registrations into a single registration for each State in which they currently operate, there will be a resulting reduction in transfer payments for current registrants.  DEA also expects there to be benefits resulting from allowing EMS vehicles to restock their supply of controlled substances at hospitals following an emergency, and by allowing EMS vehicles and hospitals to transfer controlled substances between each other in the event of a shortage, public health emergency, or mass casualty event.  

Risks:

Potential risks associated with this regulation include temporary administrative burdens on EMS agencies during implementation, resource constraints for smaller or rural EMS providers, and transitional compliance challenges.  However, these risks will be mitigated through phased implementation where appropriate, outreach and technical assistance, and alignment with existing State and Federal frameworks.