<?xml version="1.0" encoding="UTF-8" standalone="yes"?>
<REGINFO_RIN_DATA xmlns:xsi="http://www.w3.org/2001/XMLSchema-instance" RUN_DATE="2026-10-02-04:00" xsi:noNamespaceSchemaLocation="https://www.reginfo.gov/public/xml/REGINFO_XML_Ver10262011.xsd">
    <RIN_INFO>
        <RIN>1117-AA61</RIN>
        <PUBLICATION>
            <PUBLICATION_ID>202510</PUBLICATION_ID>
            <PUBLICATION_TITLE>The Regulatory Plan and the Unified Agenda of Federal Regulatory and Deregulatory Actions</PUBLICATION_TITLE>
        </PUBLICATION>
        <AGENCY>
            <CODE>1117</CODE>
            <NAME>Drug Enforcement Administration</NAME>
            <ACRONYM>DEA</ACRONYM>
        </AGENCY>
        <PARENT_AGENCY>
            <CODE>1100</CODE>
            <NAME>Department of Justice</NAME>
            <ACRONYM>DOJ</ACRONYM>
        </PARENT_AGENCY>
        <RULE_TITLE>Electronic Prescriptions for Controlled Substances</RULE_TITLE>
        <ABSTRACT><![CDATA[<!DOCTYPE html>
<html>
<head>
</head>
<body>
<p>The Drug Enforcement Administration (DEA) published an interim final rule (IFR) with request for comments in the Federal Register on March 31, 2010.&nbsp; The IFR established the requirements for creating, signing, transmitting, and processing prescriptions for controlled substances electronically and is codified in 21 CFR parts 1300, 1304, 1306, and 1311.&nbsp; DEA has recently identified an emerging trend of bad actors using electronic prescription applications to generate and fill fraudulent prescriptions for controlled substances.&nbsp; Because of this alarming trend, DEA has determined that additional safeguards are needed, and thus, the current regulations must be revised.&nbsp; To comply with the notice and comment requirements of the Administrative Procedure Act, DEA is issuing a notice of proposed rulemaking (NPRM), instead of finalizing the IFR.&nbsp; In this NPRM, DEA is proposing to require practitioners to undergo in-person identity proofing before being issued the two-factor authentication credentials required to prescribe controlled substances electronically.&nbsp; In addition, DEA is proposing to update the technical requirements for biometrics used as part of two-factor authentication for electronic prescribing of controlled substances.&nbsp; DEA is also proposing to revise certain technical requirements, which were based on the guidelines and standards that were incorporated by reference in the interim final rule and which are now superseded.&nbsp; Further, DEA is proposing to remove requirements that are now obsolete, unnecessary, or outmoded, as well as update the terminology used in the regulations.&nbsp; Finally, DEA is providing summaries of all the comments received in response to the IFR in 2010, and when the IFR comment period was reopened in 2020, and its responses to said comments.</p>
</body>
</html>]]></ABSTRACT>
        <PRIORITY_CATEGORY>Other Significant</PRIORITY_CATEGORY>
        <RIN_STATUS>Previously Published in The Unified Agenda</RIN_STATUS>
        <RULE_STAGE>Long-Term Actions</RULE_STAGE>
        <MAJOR>No</MAJOR>
        <UNFUNDED_MANDATE_LIST>
            <UNFUNDED_MANDATE>No</UNFUNDED_MANDATE>
        </UNFUNDED_MANDATE_LIST>
        <EO_13771_DESIGNATION>Other</EO_13771_DESIGNATION>
        <CFR_LIST>
            <CFR>21 CFR 1300</CFR>
            <CFR>21 CFR 1304</CFR>
            <CFR>21 CFR 1306</CFR>
            <CFR>21 CFR 1311</CFR>
        </CFR_LIST>
        <LEGAL_AUTHORITY_LIST>
            <LEGAL_AUTHORITY>21 U.S.C. 802</LEGAL_AUTHORITY>
            <LEGAL_AUTHORITY>21 U.S.C. 821</LEGAL_AUTHORITY>
            <LEGAL_AUTHORITY>21 U.S.C. 827</LEGAL_AUTHORITY>
            <LEGAL_AUTHORITY>21 U.S.C. 829</LEGAL_AUTHORITY>
            <LEGAL_AUTHORITY>21 U.S.C. 871(b)</LEGAL_AUTHORITY>
        </LEGAL_AUTHORITY_LIST>
        <LEGAL_DLINE_LIST/>
        <RPLAN_ENTRY>No</RPLAN_ENTRY>
        <TIMETABLE_LIST>
            <TIMETABLE>
                <TTBL_ACTION>ANPRM</TTBL_ACTION>
                <TTBL_DATE>03/05/2001</TTBL_DATE>
                <FR_CITATION>66 FR 13274</FR_CITATION>
            </TIMETABLE>
            <TIMETABLE>
                <TTBL_ACTION>NPRM</TTBL_ACTION>
                <TTBL_DATE>06/27/2008</TTBL_DATE>
                <FR_CITATION>73 FR 36722</FR_CITATION>
            </TIMETABLE>
            <TIMETABLE>
                <TTBL_ACTION>NPRM Comment Period End</TTBL_ACTION>
                <TTBL_DATE>09/25/2008</TTBL_DATE>
            </TIMETABLE>
            <TIMETABLE>
                <TTBL_ACTION>Interim Final Rule</TTBL_ACTION>
                <TTBL_DATE>03/31/2010</TTBL_DATE>
                <FR_CITATION>75 FR 16236</FR_CITATION>
            </TIMETABLE>
            <TIMETABLE>
                <TTBL_ACTION>Interim Final Rule Comment Period End</TTBL_ACTION>
                <TTBL_DATE>06/01/2010</TTBL_DATE>
            </TIMETABLE>
            <TIMETABLE>
                <TTBL_ACTION>Interim Final Rule Effective</TTBL_ACTION>
                <TTBL_DATE>06/01/2010</TTBL_DATE>
            </TIMETABLE>
            <TIMETABLE>
                <TTBL_ACTION>Interim Final Rule Comment Period Reopened</TTBL_ACTION>
                <TTBL_DATE>04/21/2020</TTBL_DATE>
                <FR_CITATION>85 FR 22018</FR_CITATION>
            </TIMETABLE>
            <TIMETABLE>
                <TTBL_ACTION>Interim Final Rule Comment Period End</TTBL_ACTION>
                <TTBL_DATE>06/22/2020</TTBL_DATE>
                <FR_CITATION>85 FR 22018</FR_CITATION>
            </TIMETABLE>
            <TIMETABLE>
                <TTBL_ACTION>NPRM</TTBL_ACTION>
                <TTBL_DATE>To Be Determined</TTBL_DATE>
            </TIMETABLE>
        </TIMETABLE_LIST>
        <ADDITIONAL_INFO>DEA Docket number 218</ADDITIONAL_INFO>
        <RFA_REQUIRED>No</RFA_REQUIRED>
        <SMALL_ENTITY_LIST>
            <SMALL_ENTITY>Businesses</SMALL_ENTITY>
        </SMALL_ENTITY_LIST>
        <GOVT_LEVEL_LIST>
            <GOVT_LEVEL>None</GOVT_LEVEL>
        </GOVT_LEVEL_LIST>
        <FEDERALISM>No</FEDERALISM>
        <FURTHER_INFO_URL>DPW@dea.gov</FURTHER_INFO_URL>
        <PUBLIC_COMMENT_URL>https://www.regulations.gov</PUBLIC_COMMENT_URL>
        <PRINT_PAPER>No</PRINT_PAPER>
        <INTERNATIONAL_INTEREST>No</INTERNATIONAL_INTEREST>
        <AGENCY_CONTACT_LIST>
            <CONTACT>
                <FIRST_NAME>Heather</FIRST_NAME>
                <LAST_NAME>Achbach</LAST_NAME>
                <MIDDLE_NAME>E</MIDDLE_NAME>
                <TITLE>Acting Section Chief, Regulatory Drafting and Support Section</TITLE>
                <AGENCY>
                    <CODE>1117</CODE>
                    <NAME>Drug Enforcement Administration</NAME>
                    <ACRONYM>DEA</ACRONYM>
                </AGENCY>
                <PHONE>571 387-3185</PHONE>
                <EMAIL>heather.e.achbach@dea.gov</EMAIL>
                <MAILING_ADDRESS>
                    <STREET_ADDRESS>Diversion Control Division, 8701 Morrissette Drive,</STREET_ADDRESS>
                    <CITY>Springfield</CITY>
                    <STATE>VA</STATE>
                    <ZIP>22152</ZIP>
                </MAILING_ADDRESS>
            </CONTACT>
        </AGENCY_CONTACT_LIST>
    </RIN_INFO>
</REGINFO_RIN_DATA>
