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“DEA Compliance Programs”

DEA Chronicles By Larry P. Cote and D. Linden Barber

Do you see what DEA sees? The Controlled Substances Act and the DEA’s regulations are unambiguous and DEA’s interactions with registrants are predictable, right? Well, not always. However, the maze of DEA compliance issues can be made a little less complex by understanding the Agency’s perspective on issues. In the DEA Chronicles you will find observations and commentary about DEA compliance and regulatory issues from two former DEA attorneys with a combined experience of nearly two decades working inside the Agency. We will discuss new regulations, interpretations of old regulations, enforcement actions, suspicious order monitoring, pharmacists’ corresponding responsibility, quota-related issues, and a host of other DEA compliance matters. While we don’t speak for the DEA, here we will share our perspectives that might help you see what DEA sees when they come looking at your DEA compliance program. Here’s an example. Should you rely on the plain language of 21 C.F.R. 1307.12 that allows a non-registrant to return controlled substances to the registrant from which the drugs were received? DEA’s website states that “Federal laws and regulations make no provisions for controlled substances that have already been dispensed to patients, regardless of the packaging method, to be returned to a pharmacy for further dispensing or disposal.” Hmmm. Did the website author miss 21 C.F.R. 1307.12? For insight into DEA’s attempt at articulating a rationale for its position (with which the court disagreed), check out the May 6, 2011 opinion in the Bates Pharmacy case in the U.S. District Court for the Eastern District of Washington. So what’s the lesson for DEA registrants? Although you might be complying with a regulation, you need to understand the risks of crossing DEA on its guidance found outside the regulations. DEA has created a blurry line for registrants. Maybe the DEA needs to change the prescription (pardon the pun) in its spectacles on the issue of drug returns.