đź’ŠNew 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⚖️High-Impact DEA Registration Revocation Notice for Medical Practitioners
The Department of Justice has ordered the revocation of Ron Dunchok, M.D.'s DEA registration due to legal noncompliance with state licensing requirements. This decision is significant for businesses in the pharmaceutical and healthcare sectors, emphasizing the need for adherence to state laws for the dispensing of controlled substances.
Learn Moređź’ŠANI Pharmaceuticals Inc. Application for Controlled Substances Registration
ANI Pharmaceuticals Inc. has applied to be registered as a bulk manufacturer of basic class(es) of controlled substance(s). Refer to SUPPLEMENTARY INFORMATION listed below for further drug information.
Learn Moređź’ŠDEA Suspends Registration of Dr. Lee Altman for Violations
The Drug Enforcement Administration issued an Order to Show Cause and Immediate Suspension of Registration to Dr. Lee S. Altman, alleging he poses an imminent danger due to material falsifications in his DEA application and issuing prescriptions without legitimate medical purpose. The document details his violations of the Controlled Substances Act and the subsequent proceedings leading to his registration's revocation.
Learn More⚗️DEA Updates Special Surveillance List for Controlled Substances
The Controlled Substances Act provides for civil penalties for the distribution of a laboratory supply to a person who uses, or attempts to use, that laboratory supply to manufacture a controlled substance or a listed chemical, if that distribution was made with reckless disregard for the illegal uses to which such laboratory supply will be put. The term laboratory supply is defined as a listed chemical or any chemical, substance, or item on a special surveillance list published by the Attorney General which contains chemicals, products, materials, or equipment used in the manufacture of controlled substances and listed chemicals. The Drug Enforcement Administration is hereby publishing a notice to update the Special Surveillance List.
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⚖️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 Moređź’ŠProposed DEA Registration Information Collection Overview
The Department of Justice (DOJ), Drug Enforcement Administration (DEA), will be submitting the following information collection request to the Office of Management and Budget (OMB) for review and approval in accordance with the Paperwork Reduction Act of 1995.
Learn Moređź’ŠNotice of Controlled Substances Registration for Veranova, L.P.
Veranova, L.P. has applied to be registered as a bulk manufacturer of basic class(es) of controlled substance(s). Refer to Supplementary Information listed below for further drug information.
Learn More