Prescriptions by e-mail

us-doj-guidance-DEA-DC-049Prescriptions by e-mailGuidance

Drug Enforcement Administration
Diversion Control Division
Diversion Website Q&A – Guidance Document
Title: Prescriptions by e-mail
Summary: This guidance document answers the question: “If electronic prescriptions for
controlled substances be sent by e-mail.”
Activity: Issuance of Electronic Controlled Substances Prescriptions
To Whom It Applies: DEA Registrants
Question: Can I send electronic controlled substance prescriptions to a pharmacy via e-mail?
Answer: No. “An electronic prescription”—that is, “a prescription that is generated on an
electronic application and transmitted as an electronic data file”—must “be created and signed
using an application that meets the requirements of part 1311 of this chapter.” 21 CFR 1300.03,
1306.05(e). 	These requirements include, among other things, an audit or certification to ensure
that the application “records, stores, and transmits” the necessary information “accurately and
consistently,” the capability to “[l]ink each registrant, by name to at least one DEA registration
number,” logical access controls “set by individual user name or role” that limit permissions for
“signing controlled substance prescriptions,” the ability to “accept two-factor authentication,”
and digital signature functionality that satisfies the relevant Federal Information Processing
Standards (FIPS) developed by the National Institute of Standards and Technology. 	21 CFR
1300.03, 1311.120(b). 	E-mail does not satisfy these requirements.
The contents of this document do not have the force and effect of law and are not meant to bind
the public in any way. This document is intended only to provide clarity to the public regarding
existing requirements under the law or Department policies.
EO-DEA094, DEA-DC-049, November 20, 2020
Complete printed PDF page 1

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