I know it can be said about many areas of the law; however, the statue, regulations, and administrative caselaw governing controlled substances is truly a different animal. I frequently get calls from attorneys seeking advice on matters involving Drug Enforcement Administration investigations. Many have little to no experience with such matters. My first (and perhaps
Latest from DEA Chronicles
Introducing ARCOS IQ
I am extremely excited to announce the latest addition to the Controlled Substance Solutions (CSS) software suite – ARCOS IQ.
So, what is ARCOS IQ? I am glad you asked. ARCOS IQ is a user-friendly, one-stop shop, for your ARCOS data analysis needs.
TLI? (Hoping that TLI is the opposite of TMI, but not confident
I Always Feel Like Somebody’s Watching Me
(If this song is stuck in your head all day long, you are welcome.)
As my loyal readers are aware (too Bridgerton?), customer due diligence obligations, especially for distributors and manufacturers, have significantly evolved over the past several years. When I joined the Drug Enforcement Administration (DEA) nearly two decades ago (back when registrants
Ignore Red Flags at Your Own Peril
Today, the Drug Enforcement Administration announced the revocation of Coconut Grove Pharmacy’s DEA registration.
DEA issued an Order to Show Cause and Immediate Suspension of Registration back in September 2022, premised on Coconut Grove’s alleged failure to identify, resolve, and document the resolution of potential red flags associated with prescriptions for controlled substances. If
A Distributor’s Conundrum: When DEA and state law collide
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 companies and may adversely impact the public’s access to medication for legitimate medical purposes. There are
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 Administration (DEA) and withheld from shipment. Sponsored by Rep. Harshbarger (R-Tenn.), the title of the
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 or place limits on the volume of controlled substances DEA registrants can order and dispense.”
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” pharmacy or a Fortune 500 company, you know that failure to sufficiently analyze your data
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 throughout the pharmaceutical supply chain.
The Controlled Substances Act and DEA’s regulations provide the agency
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.”
This proposed rule aligns with the regulatory guidance provided by DEA in October 2017, that