Registering Emergency Medical Services Agencies Under the Protecting Patient Access to Emergency Medications Act of 2017

<RULE> DEPARTMENT OF JUSTICE <SUBAGY>Drug Enforcement Administration</SUBAGY> <CFR>21 CFR Parts 1300, 1301, 1304, 1306, and 1307</CFR> <DEPDOC>[Docket No. DEA-377]</DEPDOC> <RIN>RIN 1117-AB37</RIN> <SUBJECT>Registering Emergency Medical Services Agencies Under the Protecting Patient Access to Emergency Medications Act of 2017</SUBJECT> <HD SOURCE="HED">AGENCY:</HD> Drug Enforcement Administration, Department of Justice. <HD SOURCE="HED">ACTION:</HD> Final rule. <SUM> <HD SOURCE="HED">SUMMARY:</HD> The “Protecting Patient Access to Emergency Medications Act of 2017,” (the Act) which became law on November 17, 2017, amended the Controlled Substances Act (CSA) to allow for a new registration category for emergency medical services agencies that handle controlled substances. It also established standards for registering emergency medical services agencies, and set forth new requirements for delivery, storage, and recordkeeping related to their handling of controlled substances. In addition, the Act allows emergency medical services professionals to administer controlled substances outside the physical presence of a medical director or authorizing medical professional pursuant to a valid standing or verbal order. The Drug Enforcement Administration is publishing this final rule to conform its regulations to the statutory amendments of the CSA and to otherwise implement its requirements. This final rule adopts, with minor modifications, the notice of proposed rulemaking published on October 5, 2020. </SUM> <EFFDATE> <HD SOURCE="HED">DATES:</HD> This rule is effective March 9, 2026. </EFFDATE> <FURINF> <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT:</HD> Heather E. Achbach, Regulatory Drafting and Policy Support Section (DPW), Diversion Control Division, Drug Enforcement Administration; Mailing Address: 8701 Morrissette Drive, Springfield, Virginia 22152; Telephone: (571) 776-3882. </FURINF> <SUPLINF> <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD> <HD SOURCE="HD1">Outline</HD> <EXTRACT> <FP SOURCE="FP-2">I. Background and Purpose</FP> <FP SOURCE="FP1-2">A. Legal Authority</FP> <FP SOURCE="FP1-2">B. Purpose</FP> <FP SOURCE="FP1-2">C. Background</FP> <FP SOURCE="FP1-2">D. Summary of the Act and Changes to the CSA</FP> <FP SOURCE="FP1-2">E. Summary of the Notice of Proposed Rulemaking</FP> <FP SOURCE="FP-2">II. Discussion of Public Comments</FP> <FP SOURCE="FP-2">III. Section-by-Section Summary of the Final Rule</FP> <FP SOURCE="FP-2">IV. Regulatory Analyses</FP> </EXTRACT> <HD SOURCE="HD1">I. Background and Purpose</HD> <HD SOURCE="HD2">A. Legal Authority</HD> On November 17, 2017, the “Protecting Patient Access to Emergency Medications Act of 2017,” Public Law 115-83 (131 Stat. 1267) (the Act), became law. The Act amended a section of the CSA, 21 U.S.C. 823, by adding a new subsection, 21 U.S.C. 823(k). This new subsection alters a number of CSA requirements “[f]or the purpose of enabling emergency medical services professionals to administer controlled substances in schedule II, III, IV, or V to ultimate users receiving emergency medical services.” 21 U.S.C. 823(k)(1). The Act also specifically authorizes the Attorney General (and thus the Administrator of the Drug Enforcement Administration (DEA) by delegation)  <SU>1</SU> <FTREF/> to issue certain regulations to implement the Act. <E T="03">Id.</E> 823(k)(11). <FTNT> <SU>1</SU>  21 U.S.C. 871(a); 28 CFR 0.100(b). </FTNT> <HD SOURCE="HD2">B. Purpose</HD> The purposes of this final rule are two-fold. First, this final rule codifies, in DEA regulations, the statutory amendments made by the Act, conforming DEA's implementing regulations to statutory amendments of the CSA that have already taken effect. Second, this final rule makes limited additional changes that are authorized by the CSA, as amended by the Act, and to further implement the Act and effectuate its purposes. <HD SOURCE="HD2">C. Background</HD> When an individual experiences a medical emergency, the entry into the healthcare system may not start with the care of a physician within a traditional clinical setting, but instead with the intervention of emergency medical services (EMS) personnel affiliated with a local EMS agency at the incident site. EMS personnel, who provide emergency medical services by ground, air, or otherwise, respond to 60 million calls in 2024. EMS involves the evaluation and management of patients with acute traumatic and medical conditions in a prehospital environment, <SU>2</SU> <FTREF/> and is an important component of medical care, as early medical intervention saves lives and often reduces the severity of injury. <SU>3</SU> <FTREF/> The nature of medical intervention at the incident site and during transport to the hospital can vary widely depending on the severity and type of injury or impairment, and may include the administering of controlled substances. <SU>4</SU> <FTREF/> <FTNT> <SU>2</SU>  Federal Interagency Committee on Emergency Medical Services (FICEMS) 2011 National EMS Assessment. </FTNT> <FTNT> <SU>3</SU>  Kuehl, Alexander. “25.” Prehospital Systems and Medical Oversight. Dubuque, IA: Kendall/Hunt Pub., 2002. (“For most prehospital medical conditions, patient outcome is assumed to be beneficially influenced by early medical intervention, and contemporary prehospital care systems are a well-defined practice of medicine in the United States.”). </FTNT> <FTNT> <SU>4</SU>  A non-exhaustive list of common controlled substance pharmaceuticals utilized by EMS include the benzodiazepine class of drugs for seizures and sedation as well as morphine (schedule II), fentanyl (schedule II), and meperidine (schedule II) for pain management. </FTNT> The delivery of emergency medical care is primarily a local function; and, accordingly, a wide variety of organizational structures are utilized across the nation. EMS programs may be a part of the local municipal government, hospital, or independent government agency, or may be contracted by local government with a private entity. Each State has a State EMS licensing office that is responsible for the overall planning, coordination, and regulation of the State EMS system, as well as licensing or certifying EMS providers and ambulances. <SU>5</SU> <FTREF/> These agencies are often located within the State health department but may also be found as part of the public safety department or as independent agencies. <SU>6</SU> <FTREF/> <FTNT> <SU>5</SU>   <E T="03">http://www.ems.gov.</E> </FTNT> <FTNT> <SU>6</SU>   <E T="03">Id.</E> </FTNT> <HD SOURCE="HD2">D. Summary of the Act and Changes to the CSA</HD> The Act established uniform EMS agency requirements for the administration of controlled substances while ensuring adequate safeguards against theft and diversion. The Act added a new subsection to the CSA, 21 U.S.C. 823(k). The new 21 U.S.C. 823(k) makes several notable changes to the CSA. First, the Act creates a new registration category under the CSA for EMS agencies, directing the Attorney General (and thus the Administrator of DEA by delegation) to register such an agency under the CSA if the agency submits an application demonstrating that it is authorized to conduct emergency medical services under the laws of each State in which the agency practices. 21 U.S.C. 823(k)(1)(A). Pursuant to 21 U.S.C. 823(k)(1)(B), the Act authorizes the Attorney General to deny the application of an EMS agency if registering it is inconsistent with other requirements of 21 U.S.C. 823(k) or with the public interest based on the factors of 21 U.S.C. 823(g). Second, the Act directs the Attorney General (and thus the Administrator) to allow a registered EMS agency to obtain a single registration for each State in which the EMS agency administers controlled substances, rather than requiring the agency to obtain a separate registration for each location at which it operates within that State. 21 U.S.C. 823(k)(2). The Act also provides that a hospital-based emergency medical services agency registered under 21 U.S.C. 823(g) may use the registration of the hospital to administer controlled substances under 21 U.S.C. 823(k), without requiring the agency to acquire a separate registration. 21 U.S.C. 823(k)(3). Third, subject to certain restrictions, the Act authorizes EMS professionals of a registered EMS agency to administer controlled substances in schedule II, III, IV, or V outside the physical presence of a medical director or authorizing medical professional while providing emergency medical services. 21 U.S.C. 823(k)(4). EMS professionals are only allowed to make such administrations if authorized by State law and pursuant to standing or verbal orders that satisfy a number of statutory conditions. <E T="03">Id.</E> Fourth, the Act provides a variety of requirements for how registered EMS agencies must deliver controlled substances from registered to unregistered locations, store controlled substances, restock EMS vehicles at a hospital, maintain records, and otherwise conduct their operations. 21 U.S.C. 823(k)(5)-(10). Fifth, the Act specifically authorizes the Attorney General (and thus the Administrator) to issue regulations regarding the delivery and storage of controlled substances by EMS agencies. <E T="03">Id.</E> 823(k)(11). <HD SOURCE="HD2">E. Summary of the Notice of Proposed Rulemaking</HD> DEA published a notice of proposed rulemaking (NPRM) in the <E T="04">Federal Register</E> on October 5, 2020 to (1) codify in DEA regulations the statutory amendments of the CSA that have already taken effect; and (2) amend DEA regulations to implement the Act and effectuate its purposes, including by adding new regulations regarding the registration, security, recordkeeping, inventory, and administration requirements for EMS agencies. <SU>7</SU> <FTREF/> DEA invited c ━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━ Preview showing 10k of 198k characters. Full document text is stored and available for version comparison. ━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━