⚖️DEA Temporarily Schedules New Synthetic Opioids - Compliance Needed
The Drug Enforcement Administration issues this temporary order to schedule two benzimidazole-opioids in schedule I of the Controlled Substances Act. DEA bases this action on a finding that placing these substances in schedule I is necessary to avoid imminent hazard to public safety. This order imposes 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, or possess) or propose to handle these substances.
Learn More⚖️Business Implications of Dipentylone as a Controlled Substance
The Drug Enforcement Administration (DEA) is establishing a specific listing and DEA Controlled Substances Code Number (drug code) for 1-(1,3-benzodioxol-5-yl)-2-(dimethylamino)pentan-1-one (dipentylone; N,N-dimethylpentylone) in schedule I of the Controlled Substances Act (CSA). Although dipentylone is not specifically listed in schedule I of the CSA with its own unique drug code, it is a schedule I controlled substances in the United States because it is a positional isomer of N-ethylpenthylone (controlled August 31, 2018), which is a schedule I hallucinogen. Therefore, DEA is simply amending the schedule I hallucinogenic substances list in its regulations to separately include dipentylone.
Learn More⚖️Proposed Rule for Scheduling Designer Benzodiazepines as Controlled Substances
The Drug Enforcement Administration proposes placing clonazolam, diclazepam, etizolam, flualprazolam, and flubromazolam and their salts, isomers, and salts of isomers, whenever the existence of such salts, isomers, and salts of isomers is possible within the specific chemical designation, as identified in this proposed rule, in schedule I of the Controlled Substances Act. These five substances were temporarily scheduled in an order dated July 26, 2023, and subsequently extended until July 26, 2026, pursuant to an extension published elsewhere in this issue of the Federal Register. This action will also enable the United States to meet its obligations under the 1971 Convention on Psychotropic Substances. If finalized, this action would make permanent the existing regulatory controls and administrative, civil, and criminal sanctions applicable to schedule I controlled substances on persons who handle (manufacture, distribute, import, export, engage in research, conduct instructional activities or chemical analysis, or possess), or propose to handle these five specific controlled substances.
Learn More⚖️Temporary Scheduling of Benzimidazole-Opioids for Public Safety
The Acting Administrator of the Drug Enforcement Administration is issuing this notice of intent to publish a temporary order to schedule seven benzimidazole-opioid substances in schedule I of the Controlled Substances Act. When it is finalized, the temporary scheduling order will 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, or possess) or propose to handle these seven specified substances.
Learn More💊New Regulations for Fentanyl-Related Substances Impacting Businesses
The Drug Enforcement Administration proposes placing three fentanyl-related substances, as identified in this proposed rule, in schedule I of the Controlled Substances Act. These three substances fall within the definition of fentanyl-related substances set forth in the February 6, 2018 temporary scheduling order. Through the Temporary Reauthorization and Study of Emergency Scheduling of Fentanyl Analogues Act, which became law on February 6, 2020, Congress extended the temporary control of fentanyl-related substances until May 6, 2021. This temporary order was subsequently extended multiple times, most recently on March 15, 2025, which extended the order until September 30, 2025. If finalized, this action would make permanent the existing regulatory controls and administrative, civil, and criminal sanctions applicable to schedule I controlled substances on persons who handle (manufacture, distribute, import, export, engage in research, conduct instructional activities or chemical analysis, or possess), or propose to handle these three specific controlled substances.
Learn More⚖️Proposed Schedule I Classification for 3-Methoxyphencyclidine
The Drug Enforcement Administration proposes placing 3- methoxyphencyclidine, including its salts, isomers, and salts of isomers, an arylcyclohexylamine hallucinogen, in schedule I of the Controlled Substances Act. This action is proposed 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 3-methoxyphencyclidine.
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 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⚗️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.
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