A new Drug Enforcement Administration (DEA) final rule took effect March 9 codifying regulations enacted in 2017 within the Controlled Substances Act (CSA) related to the handling of controlled substances by Emergency Medical Services (EMS) agencies.
While many provisions reiterate existing statutory requirements, the rule creates a process allowing EMS agencies to register with the DEA. It remains unclear whether EMS agencies must register with the DEA or if the rule creates an alternative to operating under a hospital’s existing DEA registration; the current process in Michigan.
If the rule requires EMS agencies to register with the DEA, it would conflict with the state’s current statutory framework, which does not allow EMS agencies to obtain their own controlled substance licenses.
Michigan’s Current Framework
Three key aspects of Michigan law include:
- Hospital pharmacies own and maintain inventory of all EMS medications; EMS agencies serve only as custodians.
- EMS agencies are ineligible for a state-controlled substance license under the current statute.
- Existing MDHHS licensure and MCA protocols authorize EMS agencies to administer controlled substances but not to purchase, own or independently store them.
MHA Actions
The MHA has engaged key stakeholders, including Michigan Department of Health and Human Services (MDHHS), the Michigan Department of Licensing and Regulatory Affairs, the Michigan Pharmacists Association, the Michigan Board of Pharmacy and the Michigan Association of Ambulance Services — as well as the Michigan DEA Field Office to provide guidance. DEA staff have informally recommended a “business as usual” approach and the MHA is working to obtain a more formal written statement.
MDHHS Bureau of Emergency Preparedness, EMS and Systems of Care released a memo March 6 outlining that Michigan’s existing custodial framework and EMS licensure protocols remain sufficient to comply with the new rule and reaffirm the DEA position of “business as usual.”
The MHA believes this clarification will allow Michigan hospitals and EMS agencies to continue operating under current processes without disruption and will share further direction from the DEA when available.
Members with questions should contact Kelsey Ostergren at the MHA.