Notice 22 Sep 2025 regulatory compliance, dea, business registration, healthcare, drug enforcement, controlled substances

🌿Groff Health Inc's Application to Manufacture Controlled Substances

Groff Health 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.

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Notice 19 Sep 2025 d-amphetamine, lisdexamfetamine, production quota, drug enforcement, dea, pharmaceuticals, manufacturing

💊DEA Adjusts Production Quota for Lisdexamfetamine and d-Amphetamine

The Drug Enforcement Administration (DEA) is adjusting the 2025 aggregate production quota for the schedule II controlled substances lisdexamfetamine and d-amphetamine (for conversion). In making this determination, DEA has considered the factors set forth in 21 CFR 1303.13(b) in accordance with 21 U.S.C. 826(a) and is expediting publication of this determination to comply with the timeframes specified in 21 U.S.C. 826(h)(1).

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Rule 18 Sep 2025 fentanyl, business compliance, drug traffic control, reporting and recordkeeping requirements, regulation, controlled substances, dea, administrative practice and procedure, drug enforcement

💼New Regulations on Fentanyl-Related Substances and Business Impact

The Drug Enforcement Administration places seven fentanyl- related substances, as identified in this final rule, including their isomers, esters, ethers, salts and salts of isomers, esters and ethers in schedule I of the Controlled Substances Act. The 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 seven specific controlled substances will continue to apply as a result of this action.

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Notice 12 Sep 2025 fda, compliance, pharmaceuticals, controlled substances, drug enforcement

💊Drug Enforcement Administration Notice on Fresenius Kabi Application

Fresenius Kabi USA, 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 12 Sep 2025 manufacturing, compliance, business regulation, drug enforcement, controlled substances

⚗️DEA Notice

Cambridge Isotope Laboratories, 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.

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Notice 12 Sep 2025 clinical trials, pharmaceutical industry, regulatory compliance, drug enforcement, controlled substances

💊Catalent Pharma Solutions Controlled Substances Import Application Notice

Catalent Pharma Solutions, 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 10 Sep 2025 dea, government regulation, drug enforcement, compliance, controlled substances, business registration

🏥DEA Registration Renewal Notice and Compliance 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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Notice 9 Sep 2025 regulation, justice department, drug enforcement, digital certificates, data collection, business compliance

📄DEA Information Collection Revision for Digital Certificates Explained

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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Notice 8 Sep 2025 research, pharmaceuticals, drug enforcement, controlled substances, regulatory compliance

💊VA Cooperative Studies Program Seeks Registration as Controlled Substance Importer

VA Cooperative Studies Program 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 5 Sep 2025 drug enforcement, business compliance, information collection, dea, doj, mail order transactions

📦DEA Proposed Information Collection for Mail Order Transactions

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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