⚖️Proposed Scheduling of 4-Fluoroamphetamine as a Schedule I Substance
The Drug Enforcement Administration proposes placing the substance 4-fluoroamphetamine (4-FA; 1-(4-fluorophenyl)propan-2-amine), including its salts, isomers, and salts of isomers, in schedule I of the Controlled Substances Act. This action is being taken, in part, to enable the United States to meet its obligations under the 1971 Convention on Psychotropic Substances. If finalized, this action would impose the regulatory controls and administrative, civil, and criminal sanctions applicable to schedule I controlled substances on persons who handle (manufacture, distribute, reverse distribute, import, export, engage in research, conduct instructional activities or chemical analysis with, or possess) or propose to handle 4-fluoroamphetamine.
Learn More⚖️Correction on 2-Methyl AP-237 Placement in Schedule I by DEA
On March 15, 2024, the Drug Enforcement Administration published a final order placing 1-(2-methyl-4-(3-phenylprop-2-en-1- yl)piperazin-1-yl)butan-1-one (commonly known as 2-methyl AP-237), including its optical and geometric isomers, esters, ethers, salts, and salts of isomers, esters, and ethers whenever the existence of such isomers, esters, ethers, and salts is possible within the specific chemical designation, in schedule I of the Controlled Substances Act. The effective date of that final order was 30 days after publication in the Federal Register. Before the effective date, DEA published another final order that made the instructions for 2-methyl AP-237 in the March 15 final order invalid. This document corrects that error, adding 2- methyl AP-237 and its drug code 9664 for regulatory purposes.
Learn More⚗️Proposed Regulation on Propionyl Chloride
The Drug Enforcement Administration is proposing the control of propionyl chloride as a list I chemical under the Controlled Substances Act (CSA). The Drug Enforcement Administration finds that propionyl chloride is used in the illicit manufacture of the controlled substances fentanyl, fentanyl analogues and fentanyl-related substances, and is important to the manufacture of these substances. In the respective synthetic pathways in which it is used to manufacture those substances, it is a replacement for propionic anhydride, which is currently a list I chemical. If finalized, the proposed rule would subject handlers of propionyl chloride to the chemical regulatory provisions of the CSA and its implementing regulations. This proposed rulemaking does not establish a threshold for domestic and international transactions of propionyl chloride. As such, all transactions of propionyl chloride, regardless of size, shall be regulated. In addition, chemical mixtures containing propionyl chloride are not exempt from regulatory requirements at any concentration. Therefore, all transactions of chemical mixtures containing any quantity of propionyl chloride shall be regulated pursuant to the CSA. Although no automatic exemption is available, manufacturers may submit an application for exemption.
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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