OVERVIEW
On February 5, 2026, the Drug Enforcement Administration (DEA) published a final rule to implement the Protecting Patient Access to Emergency Medications Act of 2017 (PPAEMA). This long-awaited regulation amends multiple parts of Title 21 of the Code of Federal Regulations (CFR) by revising registration, security, recordkeeping, storage, delivery, and administration requirements for EMS agencies that handle controlled substances. The rule codifies statutory changes already enacted by Congress and adds additional DEA-authorized regulatory detail to effectuate those changes. The rule will go into effect on March 9, 2026.
Although DEA largely adopts the 2020 Notice of Proposed Rulemaking (NPRM), it incorporates some important targeted revisions driven by EMS stakeholder comments, most notably refining the definition and use of “stationhouses,” clarifying recordkeeping flexibility, and tailoring security requirements to reflect the realities of field-based EMS operations without compromising diversion controls.
BACKGROUND
PPAEMA amended the Controlled Substances Act (CSA), 21 U.S.C. §§ 801–971, by adding a new subsection at 21 U.S.C. § 823(k) to restructure how controlled substances may be handled in the pre-hospital emergency care setting. PPAEMA specifically authorized the creation of a distinct DEA registration category for EMS agencies that are permitted under state law to handle controlled substances, and allowed EMS professionals to administer Schedule II–V controlled substances outside the physical presence of a medical director or other authorizing practitioner, provided such administration is authorized by state law and conducted pursuant to standing or verbal orders. In addition, the statute permits hospital-based EMS agencies to operate under their hospital’s DEA registration, rather than requiring those agencies to obtain separate DEA registrations of their own.
Although these statutory amendments took effect upon enactment in 2017 and carried the force of law, they were not immediately incorporated into DEA regulations. Thus, to address this omission, DEA issued an NPRM on October 5, 2020, proposing revisions to its regulations to align them with PPAEMA’s requirements.
The NPRM public comment period drew substantial input from EMS agencies, national EMS organizations, clinicians, and EMS medical directors. While commenters generally supported the rule’s overall direction, many asked DEA to add clearer guidance and more flexibility. That feedback led DEA to make several targeted changes in the final rule issued on February 5, 2026.
REGULATORY CHANGES – DEA’S FINAL RULE
DEA’s final rule revises five major parts of the CFR (1300, 1301, 1304, 1306, and 1307) to implement PPAEMA and DEA’s authority. Below are the most notable changes that your agency should know about:
1. New Definitions (21 CFR § 1300.06):
The final rule broadens the DEA’s definitions section to incorporate terms essential to EMS operations, including:
“Designated Location” - a location designated by an emergency medical services agency under 21 U.S.C. 823(k)(5).
“Emergency medical services” - emergency medical response and emergency mobile medical services provided outside of a fixed medical facility
“Emergency medical services agency” - a public or private entity that provides emergency medical services consistent with state law.
“Emergency medical services professional” - a credentialed individual authorized under state law to provide emergency care.
“Emergency medical services vehicle” - includes ambulances, fire apparatus, and other vehicles used for emergency patient care and transport or transport of controlled substances to/from registered and designated locations.
“Hospital-based” - an EMS agency owned/operated by a hospital.
“Standing order” and “Verbal order” - authorization from an approved medical practitioner that allows EMS personnel to administer controlled substances either in advance under defined protocols or in real time by oral direction, with required documentation to follow.
“Stationhouse” - an enclosed structure within a State where the EMS agency is registered that may house EMS vehicles at its premises and is actively and primarily used by that EMS agency.
“Actively in use” and “On call” - clarify when a vehicle is treated as engaged in service and thus subject to storage/security rules.
“Registered location/specific state authority” - used for delivery and recordkeeping rules.
One of the most frequent areas of concern among commenters was the NPRM’s proposed narrow definition of “stationhouse.” Many EMS stakeholders urged the DEA to expand this definition. They noted that real-world EMS operations vary extensively, and not all operational locations “house vehicles” in a traditional sense (i.e., larger vehicles, aircraft, or sites used for storage, training, or logistics).
Accordingly, in the 2026 final rule, DEA revised the stationhouse definition in response to comments by removing the requirement that a stationhouse must house an EMS vehicle, removing the phrase “for emergency response,” and adding “at its premises,” while retaining that the EMS agency must actively and primarily use the stationhouse.
2. Establishment of EMS Agency Registration (21 CFR §§ 1301.12, 1301.13, 1301.20):
New Registrant Category
The final rule formally establishes “Emergency Medical Services Agency” as its own DEA registrant category. An EMS agency may obtain a registration if it can show that it is authorized to operate under the state law where it provides services. Rather than requiring separate registrations for every stationhouse or base, the rule allows an agency to request a single registration per state. The agency is still subject to the standard DEA registration process and three-year renewal cycle, using Forms 224 and 224A and paying the $888 fee. Furthermore, if the EMS agency is hospital-based, it may continue to operate under the hospital’s DEA registration, so long as that registration covers controlled substance administration for the agency’s activities.
Delivery to Unregistered Stationhouses
The final rule also clarifies how controlled substances may be delivered to EMS facilities that are not themselves registered. Under amended § 1301.20, a registered EMS agency may deliver controlled substances from its registered location to an unregistered stationhouse, provided that the location is designated as a “stationhouse” and the DEA is notified at least 30 days before the first delivery. Importantly, these transfers are not treated as “distribution” under the Controlled Substances Act, resolving a longstanding ambiguity that complicated EMS procedures.
However, controlled substances must first be delivered to the EMS agency’s registered location (or to the hospital if the EMS agency operates under the hospital’s registration). Direct deliveries from distributors to designated unregistered locations are not permitted.
3. Security Controls for EMS Agencies (21 CFR § 1301.80)
Security requirements apply only to those EMS agencies registered under PPAEMA and include the following:
Permitted Secured Storage Locations
Controlled substances may be stored at their registered location; at a designated location (including a stationhouse) beginning 30 days after notification to DEA (absent objection); in EMS vehicles that are situated at a registered or designated location, and in EMS vehicles that are “actively in use,” such as when responding to emergencies or while on call.
Locking & Unattended Requirements
EMS vehicles that carry controlled substances must be secured whenever they are parked outside an enclosed registered or designated location or left unattended during non-emergency stops. Locking the vehicle in these situations helps reduce the risk of theft or diversion when no direct supervision is available.
Exceptions apply when parked within an enclosed registered or designated location and during active operations. Moreover, vehicles do not need to be locked when at the scene of an emergency or when EMS personnel are present and able to monitor the vehicle, such as during patient transport.
Storage Components
Controlled substances must be stored in a manner that maintains security and prevents unauthorized access. Acceptable storage includes a securely locked cabinet or safe that cannot be easily removed from its location, or an automated dispensing system (ADS) that incorporates required safeguards and is used exclusively by the EMS agency.
Carrying During Emergencies
EMS personnel may carry controlled substances on their person or in a jump bag while responding to an emergency, rather than storing them in a safe. However, when they are no longer actively responding to an emergency, the controlled substances must be returned to an approved storage component.
4. Recordkeeping & Reporting Requirements (21 CFR § § 1304.03, 1304.04, 1304.27)
DEA’s final rule adds several EMS-specific recordkeeping requirements. Recordkeeping requirements were among the most detailed areas of public comment, with concerns about the burdensome recordkeeping mandates under the NPRM. DEA ultimately did not eliminate or substantially scale back these documentation requirements. However, the final rule emphasizes flexibility in how records may be maintained, including the use of electronic recordkeeping systems that meet CSA standards. DEA also acknowledges in the preamble that existing EMS quality assurance and clinical documentation systems may be used as part of an agency’s overall compliance approach.
Employee Authorization Records (§ 1304.03(i))
Each EMS agency must maintain readily retrievable documentation showing an EMS professional’s state-based authority to administer controlled substances, including standing or verbal orders as required by § 823(k). These must be available for inspection/copying by the DEA.
General EMS Controlled Substance Records (§ 1304.03(j))
This subsection requires a registered EMS agency to maintain accurate and complete records for all controlled substances handled under its DEA registration. In accordance with § 1304.27, the agency must document every controlled substance received, administered to patients, or otherwise disposed of, ensuring that all activities involving these medications are properly tracked and accounted for.
Maintenance of Records and Inventories (§ 1304.04)
Under the revised general record retention rule, all required inventories and records must be maintained by the registrant, made available for inspection and copying by the DEA, and retained for a minimum of two years from the date the record is created.
§ 1304.04(a)(4) requires EMS agencies to maintain records of deliveries of controlled substances between all locations operated by the agency. This includes transfers between registered locations and designated locations such as stationhouses. Although these internal movements are not considered distributions under the Controlled Substances Act, the DEA requires such documentation.
§ 1304.04(a)(5) requires records to be maintained at each registered and designated location where controlled substances are received, administered, or disposed of. Records may be kept electronically or in another approved format, which is particularly important for EMS systems.
Additional Recordkeeping Requirements for EMS Agencies
This provision requires all DEA-registered EMS agencies, including hospital-based services, to maintain detailed, standardized records for every stage of controlled substance handling. Agencies must document each dose administered or disposed of at the individual dose level, documenting what controlled substance was used, in what form and amount, when it was given or wasted, who administered and authorized it, and how any disposal occurred.
Beyond patient care, EMS agencies must fully record all acquisitions, distributions, internal transfers between registered and designated locations, and destruction events, using the same transaction-level detail expected of other DEA registrants. The rule also adds a 72-hour notification requirement, requiring registered locations to be promptly informed when designated locations receive controlled substances through hospital restocking or internal transfers.
5. Administering/Dispensing Rules (21 CFR § 1306.07(g))
DEA’s final rule updates CSA administration rules to permit EMS professionals to administer controlled substances in schedules II-V outside a medical director’s physical presence, but only if the EMS professional is authorized to do so under state law and the controlled substance is administered pursuant to a standing order or a verbal order, as defined by statute.
Across the public comments, there was broad agreement that the final rule must clearly allow standing orders and verbal orders consistent with PPAEMA’s statutory text, especially since EMS professionals often provide care outside direct medical presence. DEA’s revisions reflect this sentiment.
6. Special Exceptions (21 CFR §§ 1307.14–1307.15)
These sections of the DEA’s final rule create limited special exceptions to help reconcile real-world EMS operations with the CSA’s closed-system requirements. Specifically, they allow controlled substances to be delivered to designated stationhouses without creating distribution liability, provided the required procedures are followed.
The provisions also permit EMS agencies to receive controlled substances from hospitals for restocking after emergency responses, which is especially important when vehicles cannot return to base between calls. Notably, for those EMS agencies operating under the DEA registration of a hospital, the DEA clarified that ambulances are not limited to restocking only from their affiliated hospital. Restocking can be done at any hospital with proper recordkeeping in place, and this specifically includes hospital-based ambulances restocking at a hospital other than their own. “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 the purpose of restocking an EMS vehicle following an emergency response.
CONCLUSION
DEA’s final rule makes several significant updates to its controlled substances regulations that reflect almost ten years of changes under PPAEMA. The rule creates a new registration category specifically for EMS, updates how medications can be stored and delivered, and clearly allows the use of standing and verbal orders. These comprehensive changes should certainly provide EMS agencies nationwide with a clearer roadmap for complying with Federal requirements.
