Rule 3 Jun 2025 regulatory compliance, administrative practice and procedure, reporting and recordkeeping requirements, pharmaceuticals, dea, controlled substances, drug traffic control, drug enforcement

⚖️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.

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Notice 3 Jun 2025 business compliance, registration, dea, controlled substances, drug enforcement

💊Proposed 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.

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Proposed Rule 3 Jun 2025 regulatory compliance, administrative practice and procedure, reporting and recordkeeping requirements, business operations, pharmaceuticals, controlled substances, legal obligations, drug traffic control, drug enforcement

⚖️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.

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Notice 2 Jun 2025 compliance, pharmaceuticals, business regulations, usa, dea, controlled substances

💊Notice on ANI Pharmaceuticals’ Controlled Substances Import Application

ANI Pharmaceuticals Inc has applied to be registered as an importer of basic class(es) of controlled substance(s). Refer to Supplementary Information listed below for further drug information.

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Notice 2 Jun 2025 regulatory compliance, manufacturing, controlled substances, drug enforcement, veranova

💊Notice 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.

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Notice 20 May 2025 compliance, healthcare, import regulations, research, controlled substances, drug enforcement

⚗️Usona Institute Seeks Registration to Import Controlled Substances

Usona Institute. has applied to be registered as an importer of basic class(es) of controlled substance(s). Refer to Supplementary Information listed below for further drug information.

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Notice 20 May 2025 regulatory compliance, controlled substances, drug enforcement administration, business applications, patheon api inc

📦Patheon API Inc. Applies for Controlled Substances Import Registration

Patheon API Inc. has applied to be registered as an importer of basic class(es) of controlled substance(s). Refer to Supplementary Information listed below for further drug information.

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Notice 20 May 2025 compliance, regulation, business operations, pharmaceuticals, dea, controlled substances, quagen pharmaceuticals

💊Quagen Pharmaceuticals LLC's Application for Controlled Substance Import

Quagen Pharmaceuticals LLC has applied to be registered as an importer of basic class(es) of controlled substance(s). Refer to SUPPLEMENTARY INFORMATION listed below for further drug information.

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Notice 14 May 2025 regulatory compliance, business operations, pharmaceutical industry, controlled substances, drug enforcement

📦DEA Notice

Research Triangle Institute has applied to be registered as an importer of basic class(es) of controlled substance(s). Refer to SUPPLEMENTARY INFORMATION listed below for further drug information.

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Notice 14 May 2025 regulatory compliance, business operations, pharmaceuticals, dea, controlled substances

💊Wedgewood Pharmacy Seeks Import Registration for Controlled Substances

Wedgewood Pharmacy LLC has applied to be registered as an importer of basic class(es) of controlled substance(s). Refer to Supplementary Information listed below for further drug information.

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