Exploring Critical Business and Legal Issues across the Healthcare and Life Sciences Industries
Exploring Critical Business and Legal Issues across the Healthcare and Life Sciences Industries

DEA Proposes Regulations for Emergency Medical Services Agencies

By on October 8, 2020

On October 5, 2020, the US Drug Enforcement Administration (DEA) issued a notice of proposed rulemaking establishing a registration category for emergency medical services (EMS) agencies and more generally implementing the requirements of the Protecting Patient Access to Emergency Medications Act of 2017.
The majority of the proposed regulations closely track the Act. For example, the proposed rule would:

  • Add EMS agencies as a new category of DEA registrants
  • Allow an EMS agency to obtain one DEA registration for each state where the EMS agency operates (regardless of number of locations within a state)
  • Allow hospital-based EMS agencies to operate using the hospital’s DEA registration.

The DEA also exercised its authority to implement the purposes of the Act more broadly with additional proposed regulations, including:

  • Requirements around notice to the DEA prior to delivery of controlled substances to unregistered locations of the EMS agency
  • Requirements (and options) regarding storage of controlled substances
  • Requirements associated with documentation of individual EMS professionals’ authorization to dispense controlled substances
  • Recordkeeping requirements relating to deliveries of controlled substances among all locations of the EMS agency
  • Recordkeeping requirements associated with controlled substance acquisition, administration and disposal.

Comments on the notice of proposed rulemaking are due by December 4, 2020.

Karen Owen Gibbs
Karen Owen Gibbs joined McDermott in 2014 after serving as Vice President and Senior Counsel at CVS Health (formerly CVS Caremark), a Fortune 20 integrated pharmacy company. Karen advises a wide variety of health care companies, investors and lenders on operational, regulatory and enforcement issues related to all aspects of the pharmacy distribution chain. Her practice also covers synergistic areas such as substance abuse/behavioral health, physician and veterinarian office dispensing, evolving requirements related to opioid prescribing and dispensing, and a wide variety of prescription reimbursement issues. Read Karen Owen Gibbs' full profile.




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