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
(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
DEA rolled out its proposed aggregate production quotas for 2021 earlier this week, the same day, in fact, that it proposed adjustments to its 2020 quotas. Let’s start off by looking at the Big Five, at least as far as the SUPPORT Act is concerned: fentanyl, oxycodone, hydrocodone, oxymorphone, and hydromorphone.
On July 29, 2020, the Drug Enforcement Administration (DEA) issued a Notice of Proposed Rulemaking (NPRM) related to the reporting of thefts or significant losses of controlled substances. Specifically, DEA proposes two changes to the reporting process:
On March 13, 2020, the Drug Enforcement Administration (DEA) issued a Notice of Proposed Rulemaking (NPRM) seeking to raise registration fees on all DEA registrants. The proposed fees represent a 21% increase over current fees for all registrant categories. DEA indicates that the increase will provide an additional $318 million for the Diversion Fee Account over the next three fiscal years.
As discussed here, the Controlled Substances Act requires that registration fees “shall be set at a level that ensures the recovery of the full costs of operating the various aspects of [the diversion control program].” 21 USC 886a(1)(C). DEA alleges in the NPRM that “[w]ithout an increase in registration fees, DEA will be unable to continue current operations” and will be unable to comply with the statutory mandate to recover all costs associated with managing the Diversion Control Program (DCP).
To support this doom and gloom prediction, DEA points to several reasons to justify the fee increase. They include, but are not limited to, the ongoing opioid crisis, the growing number of DEA registrants, a need for additional personnel at Headquarters and in Field Division Offices throughout the country, and additional requirements imposed by Congress in recent legislation.
On January 30, 2020, the Drug Enforcement Administration (DEA) released the 2019 National Drug Threat Assessment (NDTA). The 152-page publication “outlines the threats posed to the United States by domestic and international drug trafficking and the abuse of illicit drugs.” Of specific relevance to readers of DEA Chronicles, the report also discusses the abuse and misuse of controlled prescription drugs (CPDs). While I encourage you to read the entire report, here are a few key takeaways regarding CPDs:
On January 20, 2020, the Government Accountability Office (GAO) released its report Drug Control: Actions Needed to Ensure Usefulness of Data on Suspicious Opioid Orders. The report, mandated by Congress in the SUPPORT Act, focuses almost exclusively on the need for the Drug Enforcement Administration (DEA) to beef up its capabilities for analyzing the vast amount of data provided to DEA by registrants. GAO’s investigation revealed, among other things, that DEA conducted “limited proactive and robust analysis of industry reported data” and that DEA did not have the appropriate data governance structure in place to manage drug transaction data.