On January 20, 2023, the Drug Enforcement Administration (DEA’s) issued a Guidance Document reiterating DEA’s long-held position regarding the detection and reporting of suspicious orders. Specifically, DEA “clarified” that “neither the Controlled Substance Act (CSA) nor [DEA] regulations establish quantitative thresholds
Cote Law PLLC
Cote Law PLLC is a legal publisher specializing in issues related to Drug Enforcement Administration (DEA) litigation and compliance. The firm provides analysis and commentary on regulatory compliance, enforcement actions, controlled substance laws, and due diligence requirements under the Controlled Substances Act. Their publications often address challenges faced by distributors, pharmacies, and manufacturers in navigating DEA regulations, suspicious order monitoring, and state versus federal law conflicts. The content includes legislative updates, enforcement guidance, and practical compliance solutions, reflecting the firm's focus on controlled substance regulatory matters and risk management within the pharmaceutical supply chain.
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DEA Issues New/Old Guidance on Suspicious Order Monitoring
On January 20, 2023, the Drug Enforcement Administration (DEA’s) issued a Guidance Document reiterating DEA’s long-held position regarding the detection and reporting of suspicious orders. Specifically, DEA “clarified” that “neither the Controlled Substance Act (CSA) nor [DEA] regulations establish quantitative thresholds…
New Software Platform for Controlled Substance Compliance
Happy New Year everyone! I wanted to share with you some news about a project I have been working on that I believe can be a game-changer for your controlled substance compliance needs.
Whether you are a “Mom & Pop”…
New Software Platform for Controlled Substance Compliance
DEA to Remove Exemptions for All Butalbital Products
The Drug Enforcement Administration (DEA) issued a Notice of Proposed Rulemaking (NPRM) seeking to “revoke the exempted prescription product status for all butalbital products previously granted exemptions.”
If finalized as proposed, the significant impact of this change will be felt…
DEA to Remove Exemptions for All Butalbital Products
The Drug Enforcement Administration (DEA) issued a Notice of Proposed Rulemaking (NPRM) seeking to “revoke the exempted prescription product status for all butalbital products previously granted exemptions.”
If finalized as proposed, the significant impact of this change will be felt…
New DEA Regulation Addresses Transfers of Prescriptions
On November 19, 2021, the Drug Enforcement Administration (“DEA”) issued a Notice of Proposed Rulemaking (“NPRM”) “to allow the transfer of electronic prescriptions for schedule II-V controlled substances between registered retail pharmacies for initial filling on a one-time basis.”…
New DEA Regulation Addresses Transfers of Prescriptions
On November 19, 2021, the Drug Enforcement Administration (“DEA”) issued a Notice of Proposed Rulemaking (“NPRM”) “to allow the transfer of electronic prescriptions for schedule II-V controlled substances between registered retail pharmacies for initial filling on a one-time basis.”…
DEA Seeks Your Help with the Practice of Telepharmacy
On November 17, 2021, the Drug Enforcement Administration (DEA) issued an Advanced Notice of Proposed Rulemaking (the “Notice”) seeking the public’s help with understanding the “practice, industry, and state regulations of telepharmacy.”
As DEA acknowledges in the Notice, telepharmacy is…
DEA Seeks Your Help with the Practice of Telepharmacy
On November 17, 2021, the Drug Enforcement Administration (DEA) issued an Advanced Notice of Proposed Rulemaking (the “Notice”) seeking the public’s help with understanding the “practice, industry, and state regulations of telepharmacy.”
As DEA acknowledges in the Notice, telepharmacy is…
