COVID-19 QAAdministering CS in vehicle during COVID-19

Drug Enforcement Administration
Diversion Control Division
Guidance Document
Public Health Emergency – COVID-19
Title: Administering Certain CS in the parking lot of a healthcare provider’s DEA-registered
location during the COVID-19 public health emergency
Question: The Food and Drug Administration (FDA) made an allowance for certain Risk
Evaluation and Mitigation Strategies (REMS)-certified healthcare providers (HCPs) to provide
medically supervised treatment in the patient’s home during the Coronavirus Disease 2019
(COVID-19) Public Health Emergency. As an alternative to this, would DEA allow HCPs to
administer REMS-designated controlled substances to patients in the parking lot at the HCPs’
DEA-registered locations?
Answer: The Controlled Substances Act (CSA) and its implementing regulations require a
separate registration for each principal place of business or professional practice where
controlled substances are manufactured, distributed, or dispensed, as set forth in 21 U.S.C.
822(e) and 21 C.F.R. 1301.12(a). The term “dispense,” as defined in 21 U.S.C. 802(10), means
to “deliver a controlled substance to an ultimate user or research subject by, or pursuant to the
lawful order of, a practitioner, including the prescribing and administering of a controlled
substance….” Neither the CSA nor DEA regulations specifically address whether healthcare
providers may dispense controlled substances to patients in the parking lots of their DEA-
registered locations. Nevertheless, in consideration of safety concerns for the aforementioned
healthcare providers and their patients, DEA is exercising its authorities to provide flexibilities in
the dispensing of controlled substances so as to permit the dispensing of controlled substances in
provider parking lots under certain conditions. For the duration of the nationwide public health
emergency declared by the Secretary of Health and Human Services on January 31, 2020, as a
result of COVID-19 (unless this allowance is first modified or withdrawn by DEA), DEA will
consider it permissible under the CSA for healthcare providers to provide medically supervised
treatment using controlled substances, including REMS-designated controlled substances, in the
parking lots of their DEA-registered healthcare facilities, so long as a provider’s parking lot is
located immediately adjacent to the provider’s DEA-registered facility. This activity, however,
must be carried out in compliance with all other applicable federal, state, and tribal laws and
regulations.
Guidance documents, like this document, are not binding and lack the force and effect of
law, unless expressly authorized by statute or expressly incorporated into a contract, grant, or
cooperative agreement. Consistent with Executive Order 13891 and the Office of Management
and Budget implementing memoranda, the Department will not cite, use, or rely on any guidance
document that is not accessible through the Department’s guidance portal, or similar guidance
portals for other Executive Branch departments and agencies, except to establish historical
facts. To the extent any guidance document sets out voluntary standards (e.g., recommended
practices), compliance with those standards is voluntary, and noncompliance will not result in

enforcement action. Guidance documents may be rescinded or modified in the Department’s
complete discretion, consistent with applicable laws.
EO-DEA213, DEA-DC-043, July 28, 2020