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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.

Statement of Need:

In light of the information and feedback received in public comments to the NPRM published on March 1, 2023, DEA is considering a new NPRM on Telemedicine Prescribing of Controlled Substances when the Practitioner and the Patient Have Not Had a Prior In-Person Medical Evaluation in order to promulgate effective regulations responsive to the general public and industry concerns.

Summary of the Legal Basis:

DEA implements and enforces the CSA and the Controlled Substances Import and Export Act, (21 U.S.C. 801-971), as amended.  DEA publishes the implementing regulations for these statutes in 21 CFR parts 1300 to end.  These regulations are designed to ensure a sufficient supply of controlled substances for medical, scientific, and other legitimate purposes, and to deter the diversion of controlled substances for illicit purposes.

As mandated by the CSA, DEA establishes and maintains a closed system of control for manufacturing, distribution, and dispensing of controlled substances, and requires any person who manufactures, distributes, dispenses, imports, exports, or conducts research or chemical analysis with controlled substances to register with DEA, unless they meet an exemption, pursuant to 21 U.S.C. 822.  The CSA further authorizes the Administrator to promulgate regulations necessary and appropriate to execute the functions of subchapter I (Control and Enforcement) and subchapter II (Import and Export) of the CSA.  21 U.S.C. 871(b), 958(f).

Alternatives:

DEA is considering various alternatives, particularly the proposed requirements outlined in the March 1, 2023 NPRM.

Anticipated Costs and Benefits:

DEA anticipates this rule will not be economically significant (that is, that the rule will not have an annual effect on the economy of $200 million or more, or adversely affect in a material way the economy, a sector of the economy, productivity, competition, jobs, the environment, public health or safety, or State, local, territorial, or tribal governments or communities). DEA believes the rule will reduce the cost of providing and receiving medical care, increasing access, particularly for those patients where an in-person medical evaluation is difficult, such as patients in rural areas and with disabilities.

Risks:

Failing to issue a rule on telemedicine would interfere with DEA’s mission to prevent, detect, and investigate the diversion of controlled pharmaceuticals and listed chemicals from legitimate sources while ensuring an adequate and uninterrupted supply for legitimate medical, commercial, and scientific needs.