H.R. 4365, Protecting Patient Access to Emergency Medications Act, as amended

H.R. 4365

Protecting Patient Access to Emergency Medications Act, as amended

November 14, 2016 (114th Congress, 2nd Session)

Staff Contact
John Huston

Floor Situation

On­­­­ Monday, November 14, 2016, the House will begin consideration of H.R. 4365, the Protecting Patient Access to Emergency Medications Act, as amended, under suspension of the rules. H.R. 4365 was introduced on January 12, 2016, by Rep. Richard Hudson (R-NC) and was referred to the Committee on Energy and Commerce, and in addition to the Committee on the Judiciary. The Energy and Commerce Committee ordered the bill reported by voice vote on September 21, 2016.

Bill Summary

H.R. 4365 amends the Controlled Substances Act to ensure that paramedics and other emergency medical services (EMS) professionals are able to continue to administer controlled substances, such as pain narcotics and anti-seizure medications, pursuant to standing or verbal orders when authorized by State law. Further, the bill specifies that EMS agencies are permitted to have one DEA registration, rather than having separate registrations for each EMS location, so long as certain requirements are met relating to the transportation and storage of controlled substances are met.


The Controlled Substances Act (CSA) regulates the use of controlled substances for legitimate medical, scientific, research, and industrial purposes, and prevents these substances from being diverted for illegal purposes and gives the Drug Enforcement Agency (DEA) the authority to regulate and enforce certain provisions in the Act. The CSA regulates the use and administration of controlled substances at health care facilities, but does not explicitly address allowable uses by emergency medical services (EMS).

In 2014, the DEA announced that they would be creating DEA regulations to simplify EMS administration of controlled substances. However, the DEA later announced that the CSA only allowed for patient-specific orders for controlled substances. According to reports, “in further discussion, it was their position (the DEA) that the language of the statute did not give them any leeway for interpretation and that the regulations would very specifically state that protocol-driven usage of controlled substances is not allowed.”[1] H.R. 4365 would amend the CSA to clarify that EMS are able to administer certain controlled substances, under standing orders issued by a EMS medical director physician.

According to the bill sponsor, “Without this solution, we risk sacrificing quality emergency care and endangering patients simply because law and regulation have not kept up with the evolution of modern medicine. This legislation is an important clarification of law that allows our first responders to continue administering life-saving medications to patients when they need them most.”[2]

[1] See Emergency Physicians Monthly article, “Will DEA Regulations Hinder EMS Use of Controlled Substances?” October 31, 2016.
[2] See Rep. Richard Hudson Press Release, “Hudson Introduces Bill To Improve Emergency Medical Services,” January 14,  2016.


A Congressional Budget Office (CBO) cost estimate is not currently available.

Additional Information

For questions or further information please contact John Huston with the House Republican Policy Committee by email or at 6-5539.