COVID-19 Off-Site OTP Delivery Method

U. S. Department of Justice
Drug Enforcement Administration
www.dea.gov
DEA-Registered Narcotic Treatment Program
Dear Registrant:
In light of the nationwide public health emergency declared by the Secretary of Health and
Human Services (HHS) on January 31, 2020, as a result of the Coronavirus Disease 2019 (COVID-
19), the Drug Enforcement Administration (DEA) is exercising its authorities to provide flexibility
in the delivery of controlled substances to ensure necessary patient therapies remain accessible. As
part of this effort, DEA has partnered with the Substance Abuse and Mental Health Services
Administration (SAMHSA) to develop temporary methods for Opioid Treatment Programs (OTPs)
to provide their patients with necessary take-home doses of medication assisted treatment (MAT)
during this emergency.1
Accordingly, DEA, following consultation with SAMHSA, is issuing this letter to provide OTPs
with greater flexibility in how they deliver take-home doses of methadone to their patients. DEA is
doing so by temporarily allowing OTPs to repeatedly use the same off-site location to deliver take-
home methadone doses to their patients without separately registering that location with DEA,
subject to certain conditions.
Patients that receive methadone through OTPs can be grouped into two categories: those who are
authorized to take home doses of methadone to use on their own,2 and those who are not so
authorized and who must instead have individual doses of methadone administered or dispensed
directly to them by the OTP each day. As discussed more fully below, the flexibility being
announced in this letter applies to the first category of patients—that is, patients who are authorized
to take home doses of methadone to use on their own.
As a result of the COVID-19 pandemic, some OTPs have had to close, placing increased
demand on those OTPs that are still operational. Other OTPs have had to reduce their services due
to staffing shortages. Because of this reduced staffing and other limitations imposed by COVID-19,
some OTPs have had difficulty delivering take-home doses of methadone to patients.
1 For additional information regarding DEA’s and SAMHSA’s responses to COVID-19, please see
https://www.deadiversion.usdoj.gov/coronavirus.html and https://www.samhsa.gov/coronavirus. The Controlled
Substances Act (CSA) and DEA regulations refer to OTPs as Narcotic Treatment Programs (NTPs).
2 For the purposes of this letter, the category of patients authorized to receive take-home methadone includes patients
temporarily authorized to take home doses of methadone pursuant to an exception granted during this public health
emergency. See https://www.samhsa.gov/sites/default/files/otp-guidance-20200316.pdf. The CSA and DEA regulations
refer to the dispensing of such take-home methadone as dispensing for “unsupervised use.” See 21 U.S.C. 823(g)(1)(C);
21 CFR 1301.74(k).
8701 Morrissette Drive
Springfield, Virginia 22152

DEA Narcotic Treatment Programs 	Page 2
In light of these challenges, some OTPs have inquired about setting up temporary off-site
locations in the state in which the OTP is registered with DEA where patients could pick up their
take-home doses of methadone from an OTP staff member. Doing so would potentially avoid
disruptions in the OTPs’ delivery of these take-home doses by allowing the OTPs to provide more
services with fewer staff.
Under normal circumstances, such off-site locations would have to be separately registered with
DEA if used regularly by the OTP to deliver take-home doses. This is because, under the Controlled
Substances Act, registrants, including OTPs, are generally required to separately register with DEA
“at each principal place of business or professional practice where the [registrant] . . . dispenses
controlled substances.” 21 U.S.C. 822(e)(1); see also 21 CFR 1301.12(a). Under this standard, a
registrant is generally required to separately register any location at which the registrant regularly
dispenses controlled substances, even if the registrant does not intend to use the location on a long-
term basis. This requirement normally would apply to off-site locations repeatedly used by OTPs to
deliver take-home doses of methadone to their patients.
In view of the extraordinary circumstances that have arisen during this public health emergency,
and in order to ensure adequate medical care for its duration, DEA will exercise its authorities to
permit OTPs to regularly use off-site locations located in the same state in which the OTP is
registered with DEA to deliver take-home doses of methadone to their patients without separately
registering those locations, subject to the following limitations:
• 	Before using the unregistered off-site location, the OTP must first contact its State
Opioid Treatment Authority (SOTA), and receive the SOTA’s approval to use the off-
site location.
• 	Before using the unregistered off-site location, the OTP must receive approval from the
local DEA field office. Once the SOTA approves the location, it should contact the local
DEA field office. If the SOTA does not contact the DEA field office, the OTP must
contact the field office itself.3 The DEA field office may have additional questions about
the off-site location and may need to inspect it to ensure that it does not present an
unacceptable risk of diversion.
• 	Each day, the OTP may only transport those take-home methadone doses to the
unregistered off-site location that the OTP reasonably anticipates will be delivered to
patients that day. That is, the OTP should never transport a reserve of methadone to the
off-site location.
• 	Any methadone not delivered to patients by the OTP at the off-site location must be
returned to the OTP’s DEA-registered location the same day. No methadone may be
stored at the off-site location when an OTP staff member is not present.
The allowance set forth in this letter is granted to DEA-registered OTPs meeting these
conditions from April 7, 2020, through the duration of this public health emergency as declared by
the Secretary of HHS (unless this allowance is first modified or withdrawn by DEA).
3 DEA’s COVID-19 information webpage contains a link to the contact information of DEA local field offices.

DEA Narcotic Treatment Programs 	Page 3
Please note, however, that this allowance does not extend to any off-site locations regularly used
by OTPs to provide daily doses of methadone directly to patients who are not authorized to receive
take-home doses. Providing daily doses presents a heightened risk of diversion. Thus, DEA has
concluded that such locations must continue to be separately registered with DEA to ensure that they
do not become sources of diversion.
We hope this information is helpful. For more information from SAMHSA please visit
www.samhsa.gov. For information regarding DEA’s Diversion Control Division please visit
www.DEAdiversion.usdoj.gov. Please contact the Diversion Control Division, Policy Section at
(571) 362-3260 if you seek additional assistance regarding this or any other matter.
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.
Sincerely,
Thomas W. Prevoznik
Deputy Assistant Administrator
Diversion Control Division
DEA078 – April 07, 2020