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
DEA Chronicles
Controlled Substance Litigation & Compliance Issues
DEA Chronicles, published by Cote Law PLLC, focuses on legal and regulatory issues related to the Controlled Substances Act and Drug Enforcement Administration (DEA) compliance. The blog covers topics such as controlled substance litigation, DEA enforcement actions, suspicious order monitoring, due diligence obligations, drug policy, legislation affecting controlled substances, and state law interactions. It also addresses challenges faced by distributors, pharmacies, and manufacturers in maintaining compliance, including the impact of new regulations and enforcement trends. The blog provides updates on DEA guidance, compliance software solutions, and legislative developments relevant to controlled substance regulation and enforcement.
Latest from DEA Chronicles - Page 2
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
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”…
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…
