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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Quota Reductions

DEA is out with its proposed 2020 aggregate production quotas for Schedule I and II controlled substances, and they have been reduced dramatically from 2019’s numbers. From the press release:

DEA proposes to reduce the amount of fentanyl produced by 31 percent, hydrocodone by 19 percent, hydromorphone by 25 percent, oxycodone by nine percent and oxymorphone by 55 percent. Combined with morphine, the proposed quota would be a 53 percent decrease in the amount of allowable production of these opioids since 2016.”

How’d They Get There?

Why the size of the decrease? Aside from the obvious political pressures attendant to legitimate concern over the proliferation of the opioid crisis and, perhaps, some less-legitimate political posturing, the DEA cites the usual factors and a significant new one. As always, DEA consults “many sources, including estimates of the legitimate medical need from the Food and Drug Administration; estimates of retail consumption based on prescriptions dispensed; manufacturer’s disposition history and forecasts; data from DEA’s internal system for tracking controlled substance transactions; and past quota histories.”


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57339493On May 5, 2015, the United States Senate, Caucus on International Narcotics Control held a hearing exploring the findings and recommendations of a Government Accountability Office investigation into the Drug Enforcement Administration’s management of its quota process.  The hearing, called by Senators Grassley and Feinstein, sought to explore the connection between DEA’s quota process and