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Recent Updates

Telemedicine

The DEA's Expansion of Buprenorphine Treatment via Telemedicine Encounter was scheduled to be effective February 18, 2025 but has been delayed to December 31, 2025. Notably, this delayed final rule will require pharmacists filling buprenorphine telemedicine prescriptions to verify that the identity of the individual picking up the prescription matches the name of the patient or a member of the patient’s household. Until December 31, 2025, prescribers and pharmacists will continue prescribing and dispensing buprenorphine under the Third Temporary Extension of COVID-19 Telemedicine Flexibilities for Prescription of Controlled Medications  

A proposed rule, Special Registrations for Telemedicine and Limited State Telemedicine Registrations, which relates to telemedicine prescribing of all controlled substances is currently under review by the DEA. Until this proposed rule is finalized, the Third Temporary Extension of COVID-19 Telemedicine Flexibilities for Prescription of Controlled Medications is in effect until December 31, 2025.

See our Telemedicine page for more details.

Target Doses of Buprenorphine-Containing Transmucosal Products

On December 26, 2024, FDA issued a Federal Register notice to encourage changes to the labeling for buprenorphine-containing transmucosal products for the treatment of opioid use disorder and has issued a letter to health care professionals regarding the recommendations. The current buprenorphine label does not include a maximum daily dose. The suggested modifications include removing the term "target dose" and clarifying that doses higher than 24 mg per day may be appropriate for some patients.       

State Buprenorphine Prescribing Regulations

The Kentucky Board of Medical Licensure has proposed amendments to 201 KAR 9:270, which establishes professional standards for the prescribing of buprenorphine by physicians and PAs. KBML will hold a public hearing on March 26 and accept written comments through March 31. The current version of 201 KAR 9:270 remains in effect until the regulatory process is complete.