United States Government Publishing Office publisher pbl distributor dst United States National Archives and Records Administration Office of the Federal Register author aut Government Organization text government publication eng FR Regulatory Information 2025_register executive 2025-01-21 article Part VI Rules and Regulations D09002ee1cf600f64 D09002ee1cf601115 United States Department of Justice originator org United States Government Agency or Subagency United States Drug Enforcement Administration originator org United States Government Agency or Subagency United States Department of Health and Human Services originator org United States Government Agency or Subagency The Drug Enforcement Administration and the Department of Health and Human Services are amending their regulations to expand the circumstances under which practitioners registered by the Drug Enforcement Administration are authorized to prescribe schedule III-V controlled substances approved by the Food and Drug Administration for the treatment of opioid use disorder via a telemedicine encounter, including an audio-only telemedicine encounter. Under these new regulations, after a practitioner reviews the patient's prescription drug monitoring program data for the state in which the patient is located during the telemedicine encounter, the practitioner may prescribe an initial six-month supply of such medications (split amongst several prescriptions totaling six calendar months) through audio-only means. Additional prescriptions can be issued under other forms of telemedicine as authorized under the Controlled Substances Act, or after an in-person medical evaluation is conducted. This regulation also requires the pharmacist to verify the identity of the patient prior to filling a prescription. The Ryan Haight Online Pharmacy Consumer Protection Act of 2008 generally requires an in- person medical evaluation prior to issuance of a controlled substance prescription. However, this regulation falls under one of the exceptions found within the Ryan Haight Act. Additionally, this regulation does not affect practitioner-patient relationships in cases where an in-person medical evaluation has previously occurred. The purpose of this regulation is to prevent lapses of care by continuing some of the telemedicine flexibilities that currently exist for those patients seeking treatment for opioid use disorder. 90 FR 6504 https://www.govinfo.gov/app/details/FR-2025-01-17/2025-01049 2025-01049 fr17ja25-47 RIN 1117-AB78 4410-09-P Docket No. DEA-948 https://www.govinfo.gov/app/details/FR-2025-01-17/2025-01049 https://www.govinfo.gov/content/pkg/FR-2025-01-17/html/2025-01049.htm https://www.govinfo.gov/content/pkg/FR-2025-01-17/pdf/2025-01049.pdf Administrative Practice and Procedure Drug Traffic Control Prescription Drugs Reporting and Recordkeeping Requirements 20 p. 6504 6523 90 FR 6504 Title 21 Part 1306 21 CFR Part 1306 Title 42 Part 12 42 CFR Part 12 RIN 1117-AB78 Expansion of Buprenorphine Treatment via Telemedicine Encounter; Federal Register Vol. 90, Issue RULE 2025-01049 VI DEPARTMENT OF JUSTICE Drug Enforcement Administration DEPARTMENT OF HEALTH AND HUMAN SERVICES 2025-02-18 Docket No. DEA-948 4410-09-P 2025-01049 Final rule.

The Drug Enforcement Administration and the Department of Health and Human Services are amending their regulations to expand the circumstances under which practitioners registered by the Drug Enforcement Administration are authorized to prescribe schedule III-V controlled substances approved by the Food and Drug Administration for the treatment of opioid use disorder via a telemedicine encounter, including an audio-only telemedicine encounter. Under these new regulations, after a practitioner reviews the patient's prescription drug monitoring program data for the state in which the patient is located during the telemedicine encounter, the practitioner may prescribe an initial six-month supply of such medications (split amongst several prescriptions totaling six calendar months) through audio-only means. Additional prescriptions can be issued under other forms of telemedicine as authorized under the Controlled Substances Act, or after an in-person medical evaluation is conducted. This regulation also requires the pharmacist to verify the identity of the patient prior to filling a prescription. The Ryan Haight Online Pharmacy Consumer Protection Act of 2008 generally requires an in- person medical evaluation prior to issuance of a controlled substance prescription. However, this regulation falls under one of the exceptions found within the Ryan Haight Act. Additionally, this regulation does not affect practitioner-patient relationships in cases where an in-person medical evaluation has previously occurred. The purpose of this regulation is to prevent lapses of care by continuing some of the telemedicine flexibilities that currently exist for those patients seeking treatment for opioid use disorder.

This rule is effective February 18, 2025. Heather E. Achbach, Regulatory Drafting and Policy Support Section, Diversion Control Division, Drug Enforcement Administration; Telephone: (571) 776-3882. Administrative Practice and Procedure Drug Traffic Control Prescription Drugs Reporting and Recordkeeping Requirements Expansion of Buprenorphine Treatment via Telemedicine Encounter, http://www.bls.gov/oes/current/oes291071.htm http://www.bls.gov/oes/current/oes291171.htm http://www.bls.gov/oes/current/oes291229.htm http://www.reginfo.gov/public/do/PRAMain https://aspr.hhs.gov/legal/PHE/Pages/2019-nCoV.aspx https://harmreductionjournal.biomedcentral.com/articles/10.1186/s12954-022-00651-3 https://nida.nih.gov/publications/research-reports/medications-to-treat-opioid-addiction/how-much-does-opioid-treatment-cost https://nida.nih.gov/publications/research-reports/medications-to-treat-opioid-addiction/overview https://washingtonstatestandard.com/2024/03/18/fourth-wave-of-opioid-epidemic-crashes-ashore-propelled-by-fentanyl-and-meth/ https://www.acpjournals.org/doi/10.7326/M17-3107 https://www.bls.gov/news.release/archives/ecec_03132024.pdf https://www.bls.gov/oes/current/oes291229.htm https://www.cdc.gov/nchs/nvss/vsrr/drug-overdose-data.htm https://www.deadiversion.usdoj.gov/GDP/ https://www.deadiversion.usdoj.gov/Telemedicine_listening_session.html https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10647122/#:∼:text=The%20primary%20reasons%20for%20selecting,better%20treatment%20of%20the%20disease https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9392838/ https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9734763/ https://www.publichealth.columbia.edu/public-health-now/news/only-one-four-people-needing-treatment-opioid-use-disorder-received-medication https://www.qualityforum.org/Publications/2022/09/2022_Opioid_and_Behavioral_Health_Final_Report.aspx https://www.samhsa.gov/medications-substance-use-disorders/medications-counseling-related-conditions/buprenorphine https://www.sba.gov/advocacy/firm-size-data https://www.sba.gov/sites/default/files/files/static_us_11.xls https://www.sciencedirect.com/science/article/pii/S1876034120305657?via%3Dihub SAMHSA.gov Vol. 90, no. 11 Office of the Federal Register, National Archives and Records Administration 2025-01-17 continuing daily deposited born digital 1312 p. Table of Contents: AE 2.7: GS 4.107: AE 2.106: KF70.A2 https://www.govinfo.gov/app/details/FR-2025-01-17 P0b002ee1cf5ff9c8 0097-6326 0042-1219 0364-1406 769-004-00000-9 000582072 f:fr17ja25 https://www.govinfo.gov/app/details/FR-2025-01-17 https://www.govinfo.gov/content/pkg/FR-2025-01-17/pdf/FR-2025-01-17.pdf https://www.govinfo.gov/content/pkg/FR-2025-01-17/xml/FR-2025-01-17.xml fdlp 5469 6776 DGPO 2025-01-21 2025-01-21 FR-2025-01-17 machine generated eng FR FR-2025-01-17 90 11