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DOJ/DEA RIN: 1117-AB40 Publication ID: Spring 2024 
Title: Special Registrations for Telemedicine and Limited State Telemedicine Registrations 
Abstract:

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’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’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.

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. The additional feedback received will assist DEA in potential rulemaking.

 
Agency: Department of Justice(DOJ)  Priority: Other Significant 
RIN Status: Previously published in the Unified Agenda Agenda Stage of Rulemaking: Proposed Rule Stage 
Major: No  Unfunded Mandates: No 
CFR Citation: 21 CFR 1301   
Legal Authority: 21 U.S.C. 831(h)    21 U.S.C. 802(54)    Pub. L. 115-271, sec. 3232   
Legal Deadline:
Action Source Description Date
Final  Statutory    10/24/2019 
Timetable:
Action Date FR Cite
NPRM  03/01/2023  88 FR 12875   
NPRM Comment Period End  03/31/2023 
Temporary Rule  05/10/2023  88 FR 30037   
Temporary Rule Effective  05/11/2023 
Second Temporary Rule  10/10/2023  88 FR 69879   
Second Temporary Rule Effective  11/11/2023 
Supplemental NPRM  09/00/2024 
Additional Information: DEA Docket number 407
Regulatory Flexibility Analysis Required: No  Government Levels Affected: None 
Federalism: No 
Included in the Regulatory Plan: Yes 
RIN Information URL: DPW@dea.gov   Public Comment URL: www.regulations.gov  
RIN Data Printed in the FR: No 
Agency Contact:
Scott A. Brinks
Section Chief, Regulatory Drafting and Support Section, Diversion Control Division
Department of Justice
Drug Enforcement Administration
8701 Morrissette Drive,
Springfield, VA 22152
Phone:571 362-8209
Email: scott.a.brinks@dea.gov