It appears that the Drug Enforcement Administration (DEA) is on the cusp of publishing a new regulation in the next few weeks, with two more to follow in the coming months. This is based on notifications received by the Office
DEA Chronicles
Drug Enforcement Administration Compliance & Litigation Issues
Latest from DEA Chronicles - Page 4
2019 National Drug Threat Assessment: Key Takeaways
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…
DEA Signals that Substantive SOM Guidance is Not Likely Forthcoming
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…
What to Expect from DEA in 2020 – One Guy’s Opinion
Note: The following is my best guess for what to expect in the coming year regarding controlled substance compliance obligations. I have relied on publicly available information, my experience and expertise with all things involving pharmaceutical controlled substance, and a…
The Curious Case of Colorado: DEA Sues the BOP
DEA is investigating two pharmacies in Colorado. It doesn’t want those pharmacies to know it is investigating them. But it needs information relating to these pharmacies and the prescriptions they are dispensing to assist with its investigation. So DEA is…
Judge Dissolves ISO Against West Virginia Pharmacy: Suspicion Of Diversion Not Enough to Support Suspension
In a decision issued on October 30, Judge Joseph Goodwin of the Southern District of West Virginia dissolved an Order of Immediate Suspension of Registration (“ISO”) issued by DEA against Oak Hill Hometown Pharmacy, a West Virginia pharmacy. Without getting…
DEA Announces its New Suspicious Orders Report System Online: the devil is in the details we don’t yet have
On October 23, 2019, the Drug Enforcement Administration (DEA) announced the launch of its Suspicious Orders Report System (SORS) Online, a portal allowing for the centralized reporting of suspicious orders, as required by the SUPPORT ACT.
According to DEA’s…
What’s new in pharmacy law? Join me at the 2019 ASPL Fall Meeting and find out!
If you are looking to stay informed on legal issues as they pertain to pharmacy, pharmaceuticals and related products and services, there’s still time to register for the American Society for Pharmacy Law Fall Meeting. You’ll learn from industry experts…
Problems Identified, Solutions Proposed: the OIG Review of DEA
Is “Suspicious Order” about to be defined?
The recently-released DOJ OIG Review of the Drug Enforcement Administration’s Regulatory and Enforcement Efforts to Control the Diversion of Opioids has met with extensive media coverage focused on the sexier aspects of the…
FDA Approves New Packaging for “Poor Man’s Methadone”
While acknowledging the safety of the approved daily doses of OTC loperamide for adults (8mg per day) and prescription loperamide (16mg per day), the FDA recently approved new package-size and package-type limits for the brand-name OTC tablet and capsule forms…