In its ongoing efforts to ensure an adequate supply of controlled substances for the legitimate medical needs of the United States, DEA is granting a temporary exception to 21 C.F.R. 1307.11 – what industry commonly refers to as the 5% Rule.

The 5% Rule allows practitioners to distribute controlled substances without being registered as a distributor, if they fulfill certain requirements.  In addition to the security and recordkeeping obligations, practitioners wishing to use the authority granted by the 5% Rule must ensure that the “total number of dosage units of all controlled substances distributed by the practitioner pursuant to this section … during each calendar year in which the practitioner is registered to dispense does not exceed 5 percent of the total number of dosage units of all controlled substances distributed and dispensed by the practitioner during the same calendar year.” Continue Reading DEA Announces Exception to 5% Rule

UPDATE: The Healthcare Distribution Alliance has retooled its annual conference and expo and is now offering the programs via webinar at no cost.

If you are involved in pharmaceutical distribution, I highly recommend you check out this year’s lineup. Whether virtual or in person, this annual event remains on my list of “must-attend” conferences on healthcare supply chain management.

HDA Distribution Management Webinar Series
April 14-16, 2020

On Thursday, April 16, 2020, I will again be serving on a virtual panel at a session on controlled substances where my colleagues and I will share our perspective on suspicious order monitoring and reporting along with other legal and regulatory issues affecting the pharmaceutical supply chain.

Regardless of your company’s role in the supply chain, this webinar series will provide you with a range of sessions geared toward improving the efficiency, effectiveness and safety of the healthcare supply chain.

I hope you can join us!

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 requirements.

In the past few days, DEA issued additional guidance regarding other areas of concern brought to the agency’s attention by the regulated industry.  Below is a quick summary of that guidance:

Continue Reading DEA Issues Additional Guidance in Response to COVID-19 Pandemic

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. Continue Reading DEA Publishes New Rule Expanding Access to Maintenance and Detoxification Treatment

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