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| DOJ/DEA | RIN: 1117-AA61 | Publication ID: 2026 |
| Title: Electronic Prescriptions for Controlled Substances | |
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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based on the guidelines and standards that were incorporated by reference in the interim final rule and which are now superseded.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. |
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| 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) | |
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Legal Deadline:
None |
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Timetable:
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| 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 | |
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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 |
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