There is legislation making the rounds on Capitol Hill that seeks to provide clarity regarding the process for reviewing orders for controlled substances to determine if an order is a “suspicious order” that should be reported to the Drug Enforcement Administration (DEA) and withheld from shipment. Sponsored by Rep. Harshbarger (R-Tenn.), the title of the bill is the “Block, Report, and Suspend Suspicious Shipments Act of 2022.” An identical bill, was passed in the House of Representative in the last Congress; however, it did not come up for a vote in the Senate.
What does it say?
The relatively succinct bill seeks to amend the Controlled Substances Act (CSA) to add requirements that upon discovering a potentially suspicious order, the registrant must “exercise due diligence as appropriate,” keep a record of the due diligence performed by the registrant, decline to fill the order (or series of orders) if the due diligence fails to dispel all “indicators that give rise to the suspicion that if the order is filled, the drugs that are subject to the order, are likely to be diverted,” and report such orders to DEA.
The bill also requires DEA to promulgate regulations within one year of enactment. Specifically, Congress directs DEA to “[specify] the indicators that give rise to a suspicion that filling an order or series of order would cause a violation of the [CSA] by a registrant or a prospective purchaser.”
Lastly, the bill states that the new provisions will become effective one year after date of enactment. I assume that the delayed enactment is to give DEA time to issue a final regulation.
On its face, the bill could provide much needed clarity to registrants who are required to detect and report suspicious orders. Providing specific criteria for what makes an order suspicious and providing an understanding of not only what due diligence is required, but what information must be documented when reviewing potentially suspicious orders is something that DEA has been unwilling to provide registrants. While many were hopeful that such clarity would come from the suspicious order regulation DEA proposed in November 2020, that regulation has yet to be finalized.
Unfortunately, even assuming this bill is enacted, there is no guarantee that the outcome will meet the sponsor’s intent.
The bill leaves significant discretion to DEA. While DEA is directed to define what makes an order suspicious, the agency has refused to do so for nearly the past two decades. Will this bill force their hand? My expectation is that DEA will revert to size, pattern, and frequency as the non-exhaustive “indicators” of what makes an order suspicious. DEA would also not likely be inclined to define what would be considered “appropriate” due diligence or define the requirements of the records documenting the diligence (beyond maybe the retention period). I hope I am wrong.
While the bill requires DEA “to promulgate a final regulation” within one year of enactment, that deadline is not realistic, and Congress historically has not held DEA accountable for failing to follow such directives (note: The Ryan Haight Act of 2008 and the requirement for DEA to promulgate regulations establishing a telemedicine registration).
Perhaps as the bill makes its way through Capitol Hill it will be amended to provide greater specificity on the criteria or indicators that should be considered when determining whether an order is suspicious. I would also like to see stronger language holding DEA accountable for timely promulgating a regulation and maybe even a requirement for the establishment of a task force of interested parties to create a list of indicators. Such task force could be modeled after the Suspicious Orders Task Force that was established by DEA at the direction of Congress in the Comprehensive Methamphetamine Control Act of 1996.
This bill is on the agenda to be discussed in an upcoming hearing in the Subcommittee on Health, House Energy and Commerce Committee. I am sure this will also be on the list of topics that John Gilbert and I discuss at the 2023 Distribution Management Conference and Expo in March.
Hope to see you there.