MDHHS Tells Providers to Stay Tuned on Navigating Compliance with Michigan State Law
On Mar. 9, 2026, a U.S. Drug Enforcement Administration (DEA) Final Rule took effect, implementing the Protecting Patient Access to Emergency Medications Act of 2017 (PPAEM). The PPAEM added a new subsection to the federal Controlled Substances Act (CSA), 21 U.S.C. § 823(k). That provision, among other things:
- Created a new category of statewide DEA registrations for Emergency Medical Services (EMS) providers, subject to certain registration exceptions (e.g., allowing hospital-based EMS providers to use the hospital’s DEA registration to administer controlled substances without a separate registration);
- Set forth the conditions under which EMS professionals of a registered EMS agency can administer controlled substances outside the physical presence of a medical director or authorizing medical professional while providing EMS; and
- Provided a number of requirements for how registered EMS agencies must deliver controlled substances from registered to unregistered locations, store controlled substances, restock EMS vehicles, maintain records and otherwise conduct their operations.
The DEA’s Final Rule provides regulatory clarity concerning these changes. For example:
- Stationhouses (21 C.F.R. § 1301.20(b), 1302.12(b)(5). EMS registrants can deliver controlled substances from registered locations to unregistered “designated locations” that qualify as “stationhouses” — enclosed structures that are (1) in a state where the EMS agency is registered; (2) actively and primarily used by that EMS agency; and which (3) may (but need not) house EMS vehicles. See 21 C.F.R. § 1300.06(16).
- Jump Bags (21 C.F.R. § 1301.80). EMS personnel can carry “jump bags” with controlled substances while responding to an emergency. If EMS personnel are not actively working a call or engaging an emergency, the drugs must be stored in compliance with the CSA and its regulations.
- Standing and Verbal Orders (21 U.S.C. § 823(k)(4)). EMS professionals may administer Schedule II-IV controlled substances outside the presence of a medical director or authorized medical professional if (1) authorized by state law; and (2) done under a standing order (a written medical protocol in which a medical director prospectively defines clinical criteria for administration) or a verbal order (real-time directives from a medical director or other “authorizing medical professional” that can issue such controlled substance orders consistent with state law).
- Recordkeeping (21 C.F.R. §§ 1304.03, 1304.04, 1304.27). EMS agencies must keep documentation required by state law describing each EMS professional’s authority to administer or dispense controlled substances. They must also keep — at each registered and designated location — complete records of all controlled substances received, administered, transferred and destroyed.
Michigan providers should take note that on Mar. 5, 2026, MDHHS issued a memorandum regarding compliance with the DEA’s Final Rule. The MDHHS memorandum acknowledges apparent conflicts between the DEA’s Final Rule and Michigan state law, under which EMS agencies are ineligible for state controlled substances licenses and cannot purchase, own or store controlled substances. MDHHS advised that:
The State of Michigan will continue to coordinate with LARA and DEA as this situation takes shape. At this time, it is our understanding that, with respect to EMS agencies and controlled substances under the Final Rule and [PPAEM], Michigan operations should continue as usual. Accordingly, ALS agencies, medical control authorities and participating hospital pharmacies should maintain current practices regarding controlled substance procurement, storage, security, documentation and oversight under existing Michigan statutes, administrative rules and department approved protocols unless and until further guidance is issued.
MDHHS anticipates issuing additional formal guidance as information becomes available outlining the operational framework through which Michigan EMS agencies will be able to fully comply with the DEA’s Final Rule.
We will follow up with additional guidance as it becomes available. Please contact Adam Townshend, Madelaine Lane or your Warner attorney with any questions.
