February 11, 2025
On Jan. 15, the Biden Administration issued new rules to establish a permanent framework for prescribing controlled substances via telemedicine. A final rule permits Drug Enforcement Agency (DEA)-registered practitioners to prescribe a six-month supply of buprenorphine for the treatment of opioid use disorder (OUD) via telemedicine, including audio-only encounters. The rule attempts to respond to the broad opposition from stakeholders to an initial proposal that would have limited prescriptions via telemedicine to a 30-day supply.
Additionally, the DEA issued a notice of proposed rulemaking to establish a Special Registration framework for prescribing controlled substances via an audio-video telemedicine encounter without first completing an in-person medical evaluation.
As proposed, the rule would establish three types of Special Registrations covering schedule II-V controlled substances, including registration types for individual practitioners and for telemedicine platforms. The rule would require registration with DEA in every state in which a patient is treated and impose new prescription and recordkeeping requirements. Both rules also establish standards for pharmacists filling prescriptions authorized under these rules.
Given the timing of the release, the final rule would require additional agency action – via the regulatory process – to delay the effective date, rescind the rule, or start a new rulemaking to amend an existing rule. The proposed rule is likely out of scope of the Regulatory Freeze Pending Review. Government Affairs will be working with our trade association partners to comment by the deadline for the proposed rule.
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