As you are likely aware, the Drug Enforcement Administration (DEA) has created a COVID-19 Information Page to “assure that there is an adequate supply of controlled substances” during the current public health emergency associated with the coronavirus. DEA previously published guidance regarding telemedicine and Medication Assisted Treatment, where the agency granted certain exceptions to regulatory

The Drug Enforcement Administration (DEA) issued a Notice of Proposed Rulemaking (NPRM) revising the registration requirements for mobile narcotic treatment programs (NTP).  DEA’s justification for the rule is to “make maintenance or detoxification treatments more widely available,” especially in rural and underserved communities.
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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.

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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:
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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.
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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.
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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.

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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.
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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.
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