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DOJ/DEA | RIN: 1117-AB40 | Publication ID: Fall 2022 |
Title: Special Registration to Engage in the Practice of Telemedicine | |
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. The DEA proposes to amend the registration requirements to permit such a special registration. |
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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:
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Timetable:
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Regulatory Flexibility Analysis Required: No | Government Levels Affected: None |
Federalism: No | |
Included in the Regulatory Plan: No | |
RIN Information URL: DRW@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 |