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DOJ/DEA RIN: 1117-AA61 Publication ID: 2026 
Title: Electronic Prescriptions for Controlled Substances 
Abstract:

The Drug Enforcement Administration (DEA) published an interim final rule (IFR) with request for comments in the Federal Register on March 31, 2010.  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.  DEA has recently identified an emerging trend of bad actors using electronic prescription applications to generate and fill fraudulent prescriptions for controlled substances.  Because of this alarming trend, DEA has determined that additional safeguards are needed, and thus, the current regulations must be revised.  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.  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.  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.  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based on the guidelines and standards that were incorporated by reference in the interim final rule and which are now superseded.  Further, DEA is proposing to remove requirements that are now obsolete, unnecessary, or outmoded, as well as update the terminology used in the regulations.  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.

 
Agency: Department of Justice(DOJ)  Priority: Other Significant 
RIN Status: Previously published in the Unified Agenda Agenda Stage of Rulemaking: Long-Term Actions 
Major: No  Unfunded Mandates: No 
EO 14192 Designation: Other 
CFR Citation: 21 CFR 1300    21 CFR 1304    21 CFR 1306    21 CFR 1311   
Legal Authority: 21 U.S.C. 802    21 U.S.C. 821    21 U.S.C. 827    21 U.S.C. 829    21 U.S.C. 871(b)   
Legal Deadline:  None
Timetable:
Action Date FR Cite
ANPRM  03/05/2001  66 FR 13274   
NPRM  06/27/2008  73 FR 36722   
NPRM Comment Period End  09/25/2008    
Interim Final Rule  03/31/2010  75 FR 16236   
Interim Final Rule Comment Period End  06/01/2010    
Interim Final Rule Effective  06/01/2010    
Interim Final Rule Comment Period Reopened  04/21/2020  85 FR 22018   
Interim Final Rule Comment Period End  06/22/2020  85 FR 22018   
NPRM  To Be Determined 
Additional Information: DEA Docket number 218
Regulatory Flexibility Analysis Required: No  Government Levels Affected: None 
Small Entities Affected: Businesses  Federalism: No 
Included in the Regulatory Plan: No 
RIN Information URL: DPW@dea.gov   Public Comment URL: https://www.regulations.gov  
RIN Data Printed in the FR: No 
Agency Contact:
Heather E Achbach
Acting Section Chief, Regulatory Drafting and Support Section
Department of Justice
Drug Enforcement Administration
Diversion Control Division, 8701 Morrissette Drive,
Springfield, VA 22152
Phone:571 387-3185
Email: heather.e.achbach@dea.gov