If you are involved in pharmaceutical distribution, I highly recommend you check out this year’s Healthcare Distribution Alliance (HDA) Distribution Management Conference and Expo, an annual event on my list of “must-attend” conferences on healthcare supply chain management.

On Tuesday, March 10, 2020, I will again be serving on a panel at a session on controlled substances where my colleagues and I will share our perspective on suspicious orders monitoring and reporting along with other legal and regulatory issues affecting the pharmaceutical supply chain.

HDA Distribution Management Conference and Expo
March 8 – 11, 2020
San Diego, California

Regardless of your company’s role in the supply chain, this conference will provide you with a range of sessions geared toward improving the efficiency, effectiveness and safety of the healthcare supply chain. Read more at hda.org.

I hope to see you there!

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 of Management and Budget (OMB), the government’s final review authority for Executive Branch regulations.

Continue Reading DEA Poised to Roll Out Three Regulations in the Coming Months

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: Continue Reading 2019 National Drug Threat Assessment: Key Takeaways

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. Continue Reading DEA Signals that Substantive SOM Guidance is Not Likely Forthcoming

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 Magic 8 Ball in creating the list below.

Suspicious Orders

This is the year (I think) that DEA will publish a Notice of Proposed Rule Making (NPRM) updating 1301.74(b).  While industry is anxiously awaiting the new regulations, I fear that many will be disappointed.  My best guess is that the new regulations will be more about changing the process for reporting suspicious orders and less about guidance for industry on the metrics to use for detecting suspicious orders.  This is in part because Congress recently codified the existing definition of suspicious orders that has been in DEA’s regulations for decades, which takes away a great deal of DEA’s interpretative authority and discretion.  There is also an argument to be made that DEA would prefer suspicious order guidance and definitions to be vague, providing the agency significant enforcement discretion. Continue Reading What to Expect from DEA in 2020 – One Guy’s Opinion

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 doing what it does on a regular basis in many states. It is issuing subpoenas for the Colorado Prescription Drug Monitoring Program (“PDMP”) data relevant to these registrants. And Colorado is objecting.

Continue Reading The Curious Case of Colorado: DEA Sues the BOP

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 too far into the factual weeds of this case, I do think there are two or three critical takeaways related to both the adjudication of this matter and to DEA’s view of Subutex vs. Suboxone. Continue Reading Judge Dissolves ISO Against West Virginia Pharmacy: Suspicion Of Diversion Not Enough to Support Suspension

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 announcement, 12 registrant business activity classes will utilize this reporting system:

  • Distributors
  • Manufacturers
  • Importers
  • Pharmacies
  • Hospitals/Clinics
  • Teaching Institutions
  • Practitioners
  • Mid-Level Practitioners
  • Mid-Level Practitioners – Ambulance Services
  • Researchers
  • Analytical Labs
  • Narcotic Treatment Programs (NTPs)

Reverse distributors and exporters are excluded from the requirement. Continue Reading DEA Announces its New Suspicious Orders Report System Online: the devil is in the details we don’t yet have

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 on topics critical to managing the legal risk and compliance inherent in pharmacy operations while earning up to 15 hours of continuing legal and pharmacy education credits.

Having attended and presented multiple times and now as a sponsor, I can tell you that this is the must-attend industry conference for pharmacy law.

2019 ASPL Fall Meeting
Developments in Pharmacy Law Seminar XXX
November 7-10, 2019
Westin San Diego Gaslamp Quarter San Diego, California

I will be co-presenting with Kimberly Frazier from Walmart, covering the topic of “Dispensing Controlled Substances: Navigating a Minefield of Contradictions.” We will be providing an overview of the current enforcement and litigation landscape and will address the various minefields that pharmacists must traverse when dispensing controlled substances. Keynote speaker Carmen Catizone, Executive Director National Association of Boards of Pharmacy, will share his thoughts on the future of pharmacy regulation. Other conference topics include ethics, telepharmacy, online pharmacies, CPB and cannabis, employment law, patient safety, drug pricing reform, privacy, litigation enforcement, attorney-client privilege and more.

For more information and registration, visit www.aspl.org.

Hope to see you there!

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 story. What did DEA do or not do to stem the opioids crisis? What internal battles may have led DEA to drop the ball in some aspects of the response? These are important questions, but they have been well-covered.

Instead, we are going to focus on a handful of the nine recommendations (listed below) made by the IG and DEA’s and ODAG’s responses. Continue Reading Problems Identified, Solutions Proposed: the OIG Review of DEA