In a highly regulated industry, such as controlled substance distribution, having clarity of regulatory requirements facilitates implementation and execution of an effective compliance program. Uncertainty on expectations from regulators and/or significant “grey area” in compliance requirements present additional risk for
DEA Chronicles
Drug Enforcement Administration Compliance & Litigation Issues
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Congress Seeks to Provide Clarity on Suspicious Order Monitoring
There is legislation making the rounds on Capitol Hill that seeks to provide clarity regarding the process for reviewing orders for controlled substances to determine if an order is a “suspicious order” that should be reported to the Drug Enforcement…
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”…
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.”…
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…
Annual ASPL Pharmacy Law Seminar is Back and In Person
When was the last time you went to an in-person conference? Well, it’s time. The American Society of Pharmacy Law is meeting in person (and virtually) this year in Summerlin, Nevada for its 32nd Annual Pharmacy Law Seminar. The team…
In Pharmaceutical Distribution? Join Me Virtually at the Distribution Management Conference
The 2021 Healthcare Distribution Alliance Distribution Management Conference and Expo is still on! Yes, it’s virtual, and if you are involved in pharmaceutical distribution, you will want to register for one of the industry’s “must-attend” healthcare supply chain management events.…
Active Prosecution Continues for Controlled Substance Violations
The COVID pandemic notwithstanding, the Drug Enforcement Administration (DEA), Department of Justice and other federal and state agencies continue to actively pursue and prosecute pharmacies, pharmacists, doctors and others in the industry for violations of the Controlled Substance Act, False…