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    <RIN_INFO>
        <RIN>1117-AB40</RIN>
        <PUBLICATION>
            <PUBLICATION_ID>202504</PUBLICATION_ID>
            <PUBLICATION_TITLE>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>Special Registrations for Telemedicine and Limited State Telemedicine Registrations</RULE_TITLE>
        <ABSTRACT><![CDATA[<!DOCTYPE html>
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<p>The Ryan Haight Online Pharmacy Consumer Protection Act of 2008 (the Act) (Pub. L. 110-425) was enacted on October 15, 2008, and amended the Controlled Substances Act by adding various provisions to prevent the illegal distribution and dispensing of controlled substances by means of the Internet. Among other things, the Act required an in-person medical evaluation as a prerequisite to prescribing or otherwise dispensing controlled substances by means of the Internet, except in the case of practitioners engaged in the practice of telemedicine. The definition of the "practice of telemedicine" includes seven distinct categories that involve circumstances in which the prescribing practitioner might be unable to satisfy the Act&rsquo;s in-person medical evaluation requirement yet nonetheless has sufficient medical information to prescribe a controlled substance for a legitimate medical purpose in the usual course of professional practice. One specific category within the Act&rsquo;s definition of the "practice of telemedicine" includes "a practitioner who has obtained from the [DEA Administrator] a special registration under [21 U.S.C. 831(h)]." 21 U.S.C. 802(54)(E). The Act also specifies certain criteria that the DEA must consider when evaluating an application for such a registration. However, the Act contemplates that the DEA must issue regulations to effectuate this special registration provision.</p>
<p>After publishing an NPRM on March 1, 2023, and in response to the large volume of comments received, DEA has since published a Notice of Meeting to invite all interested persons, including medical practitioners, patients, pharmacy professionals, industry members, law enforcement, stakeholders, community leaders, and other third parties, to participate in listening sessions held on September 12 and 13, 2023.&nbsp;Approximately 50 people presented virtually and in person across two days of listening sessions.&nbsp; Additionally, several thousand watched the listening sessions.&nbsp; Feedback from these sessions has influenced changes in DEA&rsquo;s regulatory approach towards telemedicine and will continue to assist DEA in potential rulemaking.</p>
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        <PRIORITY_CATEGORY>Other Significant</PRIORITY_CATEGORY>
        <RIN_STATUS>Previously Published in The Unified Agenda</RIN_STATUS>
        <RULE_STAGE>Final Rule Stage</RULE_STAGE>
        <MAJOR>No</MAJOR>
        <UNFUNDED_MANDATE_LIST>
            <UNFUNDED_MANDATE>No</UNFUNDED_MANDATE>
        </UNFUNDED_MANDATE_LIST>
        <EO_13771_DESIGNATION>Deregulatory</EO_13771_DESIGNATION>
        <CFR_LIST>
            <CFR>21 CFR 1301</CFR>
        </CFR_LIST>
        <LEGAL_AUTHORITY_LIST>
            <LEGAL_AUTHORITY>21 U.S.C. 831(h)</LEGAL_AUTHORITY>
            <LEGAL_AUTHORITY>21 U.S.C. 802(54)</LEGAL_AUTHORITY>
            <LEGAL_AUTHORITY>Pub. L. 115-271, sec. 3232</LEGAL_AUTHORITY>
        </LEGAL_AUTHORITY_LIST>
        <LEGAL_DLINE_LIST>
            <LEGAL_DLINE_INFO>
                <DLINE_TYPE>Statutory</DLINE_TYPE>
                <DLINE_ACTION_STAGE>Final</DLINE_ACTION_STAGE>
                <DLINE_DATE>10/24/2019</DLINE_DATE>
                <DLINE_DESC></DLINE_DESC>
            </LEGAL_DLINE_INFO>
        </LEGAL_DLINE_LIST>
        <RPLAN_ENTRY>Yes</RPLAN_ENTRY>
        <TIMETABLE_LIST>
            <TIMETABLE>
                <TTBL_ACTION>NPRM</TTBL_ACTION>
                <TTBL_DATE>03/01/2023</TTBL_DATE>
                <FR_CITATION>88 FR 12875</FR_CITATION>
            </TIMETABLE>
            <TIMETABLE>
                <TTBL_ACTION>NPRM Comment Period End</TTBL_ACTION>
                <TTBL_DATE>03/31/2023</TTBL_DATE>
            </TIMETABLE>
            <TIMETABLE>
                <TTBL_ACTION>Temporary Rule</TTBL_ACTION>
                <TTBL_DATE>05/10/2023</TTBL_DATE>
                <FR_CITATION>88 FR 30037</FR_CITATION>
            </TIMETABLE>
            <TIMETABLE>
                <TTBL_ACTION>Temporary Rule Effective</TTBL_ACTION>
                <TTBL_DATE>05/11/2023</TTBL_DATE>
            </TIMETABLE>
            <TIMETABLE>
                <TTBL_ACTION>Second Temporary Rule</TTBL_ACTION>
                <TTBL_DATE>10/10/2023</TTBL_DATE>
                <FR_CITATION>88 FR 69879</FR_CITATION>
            </TIMETABLE>
            <TIMETABLE>
                <TTBL_ACTION>Second Temporary Rule Effective</TTBL_ACTION>
                <TTBL_DATE>11/11/2023</TTBL_DATE>
            </TIMETABLE>
            <TIMETABLE>
                <TTBL_ACTION>Third Temporary Rule</TTBL_ACTION>
                <TTBL_DATE>11/19/2024</TTBL_DATE>
                <FR_CITATION>89 FR 91253</FR_CITATION>
            </TIMETABLE>
            <TIMETABLE>
                <TTBL_ACTION>Third Temporary Rule Effective</TTBL_ACTION>
                <TTBL_DATE>01/01/2025</TTBL_DATE>
            </TIMETABLE>
            <TIMETABLE>
                <TTBL_ACTION>NPRM</TTBL_ACTION>
                <TTBL_DATE>01/17/2025</TTBL_DATE>
                <FR_CITATION>90 FR 6541</FR_CITATION>
            </TIMETABLE>
            <TIMETABLE>
                <TTBL_ACTION>Final Action</TTBL_ACTION>
                <TTBL_DATE>12/00/2025</TTBL_DATE>
            </TIMETABLE>
        </TIMETABLE_LIST>
        <ADDITIONAL_INFO>DEA Docket number 407 / Related rule 1117-AB88 DEA407VA</ADDITIONAL_INFO>
        <RFA_REQUIRED>No</RFA_REQUIRED>
        <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>www.regulations.gov</PUBLIC_COMMENT_URL>
        <PRINT_PAPER>No</PRINT_PAPER>
        <INTERNATIONAL_INTEREST>No</INTERNATIONAL_INTEREST>
        <RELATED_RIN_LIST>
            <RELATED_RIN>
                <RIN>1117-AB88</RIN>
                <RIN_RELATION>Related to</RIN_RELATION>
            </RELATED_RIN>
        </RELATED_RIN_LIST>
        <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>
