On January 20, 2023, the Drug Enforcement Administration (DEA’s) issued a Guidance Document reiterating DEA’s long-held position regarding the detection and reporting of suspicious orders. Specifically, DEA “clarified” that “neither the Controlled Substance Act (CSA) nor [DEA] regulations establish quantitative thresholds or place limits on the volume of controlled substances DEA registrants can order and dispense.”
Why the need for a clarification?
In my humble opinion and despite its title, this “guidance document” is not only directed at DEA-registered manufacturers and distributors. My educated guess is that the “other” intended audience for this document is Capitol Hill, the press, and angry patients (and parents of patients) who continue to have difficulty getting their prescriptions filled.
The current amphetamine shortage is a timely example. There is a lot of finger-pointing going on right now regarding the shortage of amphetamines and other ADHD medications. While some appear to “blame” manufacturers for failing to produce enough product or distributors for failing to supply pharmacies with the amount of product that the pharmacies need to meet patient demand, there are also a lot of fingers pointed at DEA.
To be clear, DEA’s Guidance Document is accurate. The agency does not place limits on the volume of controlled substances that pharmacies can dispense and order or limits on what distributors can distribute (note: DEA does set national manufacturing quotas for these products, but that is a topic for another day). That is NOT to say, however, that DEA does not have significant influence over how much a pharmacy will dispense or how much a distributor will distribute. DEA enforcement actions, the agency’s public statements regarding these drugs, and the establishment of an “amphetamines task force,” among other things, all impact the dispensing practices at pharmacies and the metrics used by distributors to detect and report suspicious orders. This applies to all controlled substances.
Why mention MOUD?
Obviously, the specific reference to Medication for Opioid Use Disorder (MOUD) is in response to the elimination of the DATA-Waiver Program in the Consolidated Appropriations Act of 2023. There is uncertainty on what impact, if any, the change in law will have on supply and demand for buprenorphine products. Is DEA worried about a huge spike in the prescribing and dispensing of these products? I don’t know for certain, but remember that these are opioids, so it would not surprise me if DEA is concerned about the impact of this sweeping change in the law. We also continue to see via enforcement actions that DEA and the Department of Justice remain concerned about the diversion of buprenorphine products, especially the single-entity products. So, one way you can interpret this Guidance Document is as a reminder/warning to DEA registrants that, regardless of the potential benefit of these drugs, MOUD are still controlled substances that are subject to the same requirements as all other controlled substances. Congress’ latest action does not change that.
I think that is a fair warning.
One more thing…
So, I always smile when I read the disclaimer DEA includes on its guidance documents.
The contents of this document do not have the force and effect of law and are not meant to bind the public in any way. This document is intended only to provide clarity to the public regarding existing requirements under the law or Department of Justice policies.
I understand why DEA does this. With this particular topic, however, the guidance document does not “provide clarity to the public regarding existing requirements.” It is, at best, a restatement of what DEA has been saying for nearly two decades.
While DEA may not “have a role in establishing or revising” customer thresholds, the agency does have an obligation to provide regulatory guidance that has “ the force and effect of law” with respect to the basic requirements for all suspicious order monitoring programs…even more so after Congress added the requirement to detect and report suspicious orders to the Controlled Substances Act via the SUPPORT Act. To that end, the issuance of a Final Rule on suspicious order monitoring would be a great step forward. As a reminder, the Notice of Proposed Rulemaking was published more than two years ago, on November 2, 2020.