💊FDA Proposes New Labeling Requirements for Prescription Drugs
The Food and Drug Administration (FDA or we) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995.
Learn More💊New Telemedicine Rules for Buprenorphine Prescribing
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.
Learn More🩺New VA Regulations on Telemedicine Prescriptions for Controlled Substances
This final rule authorizes Department of Veterans Affairs (VA) practitioners acting within the scope of their VA employment to prescribe controlled substances via telemedicine to a VA patient with whom they have not conducted an in-person medical evaluation. VA practitioners are permitted to prescribe controlled substances to VA patients if another VA practitioner has, at any time, previously conducted an in-person medical evaluation of the VA patient, subject to certain conditions.
Learn More💊New DEA Regulations on Telemedicine and Special Registration
The Ryan Haight Online Pharmacy Consumer Protection Act of 2008 (the "Ryan Haight Act") generally requires an in-person medical evaluation prior to the issuance of a prescription of controlled substances but provides an exception to this in-person medical evaluation requirement where the practitioner is engaged in the "practice of telemedicine" within the meaning of the Ryan Haight Act. These proposed regulatory changes would establish a Special Registration framework and authorize three types of Special Registration. This proposed rulemaking also provides for heightened prescription, recordkeeping, and reporting requirements. DEA believes such changes are necessary to effectively expand patient access to controlled substance medications via telemedicine while mitigating the risks of diversion associated with such expansion. A summary of this rule may be found at https://www.regulations.gov/docket/DEA-2023-0029.
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