On January 13, 2026, the United States Department of Justice (DOJ) announced that Atlantic Biologicals Corporation, a Miami-based pharmaceutical distributor, paid a $450,000 criminal penalty and entered into a two-year deferred prosecution agreement. The settlement resolves the government’s allegations that from 2017 through May 2023, the company, through its business unit NAS, engaged in
“Breaking news: Controlled substance compliance failures rock major corporation.”
This is the kind of headline that doesn’t just attract attention. It plants doubt in your whole organization.
Imagine this:
A distributor notices unusual order growth for a controlled substance. It’s flagged, but no one follows up. Six months later, regulators investigate. The distributor is
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
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
(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
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
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 few things that can make managing a controlled substance compliance program more difficult. A state legislature that passes legislation imposing requirements that directly contradict and undermine the requirements and expectations of the Drug Enforcement Administration (DEA) is high on that list.
Which brings us to Arkansas.
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 bill is the “Block, Report, and Suspend Suspicious Shipments Act of 2022.” An identical bill, was passed in the House of Representative in the last Congress; however, it did not come up for a vote in the Senate.
What does it say?
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.”
Why the need for a clarification?
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 or data provided to you by a customer can lead to disastrous results for your business or company. It can also lead to dire consequences for patients and the public at large. I am a firm believer that all facets of the pharmaceutical supply chain have a legal and moral obligation to work together to detect and prevent diversion and to be “part of the solution.” An effective compliance program with the right tools is a great starting point.
But let’s be honest, there are currently very few software programs and analytical tools available that provide meaningful support to address your controlled substance compliance needs. There are even fewer that are created by experts in controlled substance compliance. Unfortunately, unless you have the internal resources and expertise to create data analytical tools, you are left with few options, if any.
That is no longer the case…