U. S. Department of Justice

Drug Enforcement Administration
8701 Morrissette Drive
Springfield, Virginia 22152

www.dea.gov
DEA Qualifying Practitioners
DEA Qualifying Other Practitioners
Dear Registrant:
In light of the nationwide public health emergency declared by the Secretary of Health andHuman Services (HHS) on January 31, 2020, as a result of the Coronavirus Disease 2019 (COVID19), the Drug Enforcement Administration (DEA) is exercising its authorities to provide flexibility
in the prescribing and dispensing 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 ensure authorized practitioners may admit and treat
new patients with opioid use disorder (OUD) during the public health emergency. DEA has alreadyannounced that practitioners may prescribe controlled substances to patients using telemedicine
without first conducting an in-person evaluation during this public health emergency under 21
U.S.C. 802(54)(D). 1 Today, DEA notes that practitioners have further flexibility during thenationwide public health emergency to prescribe buprenorphine to new and existing patients withOUD via telephone by otherwise authorized practitioners without requiring such practitioners to first
conduct an examination of the patient in person or via telemedicine. 2 This additional flexibility
under which authorized practitioners may prescribe buprenorphine to new patients on the basis of atelephone evaluation is in effect from March 31, 2020, until the public health emergency declared by
the Secretary ends, unless DEA specifies an earlier date.
The Controlled Substances Act (CSA) allows practitioners to dispense narcotic drugs, including
buprenorphine, to individuals with OUD for maintenance or detoxification treatment if thepractitioners separately register with DEA as an opioid treatment program (OTP). See 21 U.S.C.
823(g)(1). The CSA also permits practitioners to dispense narcotic drugs for OUD by providing fora waiver of this separate registration requirement for practitioners dispensing schedule III, IV, or V
narcotic controlled substances approved by the Food and Drug Administration specifically for theuse in maintenance or detoxification treatment. Id. at 21 U.S.C. 823(g)(2); 21 CFR 1301.28.
Currently, the only controlled substance meeting these criteria is buprenorphine. To qualify for thewaiver to dispense buprenorphine for maintenance or detoxification treatment, the practitioner mustmeet the qualifications set by SAMHSA. Practitioners who have met these SAMHSA qualifications
and obtained authorization from DEA to dispense buprenorphine for maintenance or detoxification
treatment are often referred to as “DATA-waived practitioners” (in reference to the Drug Addiction
Treatment Act of 2000, which added 21 U.S.C. 823(g)(2) to the CSA).

See https://www.deadiversion.usdoj.gov/coronavirus.html.
This letter only addresses the topic of prescribing buprenorphine for maintenance and detoxification treatment. The
dispensing of methadone for maintenance and detoxification treatment is addressed in a separate letter.

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Under the CSA, all prescriptions for controlled substances, including those issued formaintenance or detoxification treatment, must be issued for a legitimate medical purpose by apractitioner acting in the usual course of his/her professional practice. See 21 CFR 1306.04(a). As
noted above, despite the CSA’s limitations on issuing prescriptions for controlled substances bymeans of the Internet, for the duration of the public health emergency, a practitioner may prescribe acontrolled substance to a new patient via telemedicine—using a real-time, two-way, interactive
audio-visual communication—without first conducting an in-person examination. 3 See 21 U.S.C.
802(54)(D).
Independently, SAMHSA’s regulations also require that an OTP conduct an in-person medicalevaluation of a patient before prescribing or directly dispensing controlled substances, including
buprenorphine, for maintenance treatment or detoxification. See 42 CFR 8.12(f)(2). On March 19,
2020, however, SAMHSA exempted OTPs from the requirement that they perform such an inperson physical evaluation for any patient who will be treated by the OTP with buprenorphine if a
program physician, primary care physician, or an authorized healthcare professional under thesupervision of a program physician, determines that an adequate evaluation of the patient can beaccomplished via the use of a telephone. SAMHSA also announced that it was allowing DATAwaived practitioners to prescribe buprenorphine for maintenance or detoxification treatment to do so
via telephone, “while complying with all applicable standards of care.” 4Under normal circumstances, DEA would not consider the initiation of treatment with acontrolled substance based on a mere phone call to be consistent with the framework of the CSA
given that doing so creates a high risk of diversion. However, in light of the extraordinary
circumstances presented by the COVID-19 public health emergency, and being mindful of theexemption issued by SAMHSA, DEA likewise advises that, only for the duration of the publichealth emergency (unless DEA specifies an earlier date), OTPs should feel free to dispense, andDATA-waived practitioners should feel free to prescribe, buprenorphine to new patients with OUD
for maintenance treatment or detoxification treatment following an evaluation via telephone voice
calls, without first performing an in-person or telemedicine evaluation. This may only be done,
however, if the evaluating practitioner determines that an adequate evaluation of the patient can beaccomplished via the use of a telephone. The prescription also must otherwise be consistent withthe practitioner’s aforementioned obligation under the CSA and DEA regulations to only prescribe
controlled substances for a legitimate medical purpose while acting in the usual course ofprofessional practice.

Where a prescription for a controlled substance is issued by means of the Internet, the CSA (as amended by the Ryan
Haight Act) requires that such prescription involve at least one in-person medical evaluation, with limited exceptions.
After conducting one in-person medical evaluation, a practitioner may thereafter prescribe controlled substances bymeans of the Internet or via telephone. Except where an exception applies, however, a new patient must ordinarily beexamined in-person prior to a practitioner prescribing or dispensing a controlled substance to the patient. One suchexception is an examination via telemedicine conducted pursuant to 21 U.S.C. 802(54)(D).
4https://www.samhsa.gov/sites/default/files/faqs-for-oud-prescribing-and-dispensing.pdf.
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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 on the public and lack the force andeffect 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,
Digitally signed by
THOMAS
THOMAS PREVOZNIK
2020.03.31
PREVOZNIK Date:
12:33:17 -04'00'

Thomas W. Prevoznik
Deputy Assistant Administrator
Diversion Control Division

DEA068 – March 31, 2020