If passed, a Senate bill introduced Dec. 17, 2019, would modify the reporting requirements in the Controlled Substances Act and increase Drug Enforcement Administration (DEA) oversight of controlled substances at the pharmacy level. The Preventing Pill Mills Through Data Sharing Act was introduced by Sen. Dianne Feinstein (D-Calif.) and cosponsored by Sens. Chuck Grassley (R-Iowa), Shelley Moore Capito (R-W.Va.) and Dick Durbin (D-Ill.). This bill is part of a larger movement aimed at stemming the opioid epidemic. Sen. Grassley stated that “drug dealers wearing white coats” have contributed to the opioid epidemic and that this bill is intended to allow the DEA to identify and prevent suspicious drug orders.
In part, the bill aims to prevent pharmacies from ordering more drugs than can be responsibly or reasonably distributed. Sen. Feinstein noted one West Virginia town of 392 people that reportedly received nearly 9 million pills in a single year. The bill is intended to flag suspicious drug orders such as this to the DEA. The frequency of reporting would be increased for manufacturers and distributors and would be extended to pharmacies, as well.
If passed, the bill would:
- require drug manufacturers and distributors to report the sale, delivery or other disposal of all controlled substances on a monthly basis, rather than the quarterly basis current law requires;
- extend the penalties and reporting requirements that currently apply to drug manufacturers and distributors to pharmacies;
- require the DEA to provide quarterly reports to manufacturers, distributors and pharmacies in a format and manner that better facilitates the identification of suspicious orders; and
- require the DEA to provide Congress the same reports that it provides to states every six months, and expand the reporting requirements to include unusual volumes of controlled substances that are disposed of rather than sold, and unusual numbers of deleted transactions of high volumes of controlled substances.
Pharmacies, in particular, should note the proposed reporting requirements and familiarize themselves with the DEA’s Automated Reports and Consolidated Orders System (ARCOS). ARCOS is an automated drug reporting system that monitors the flow of DEA-controlled substances from their point of manufacture through commercial distribution channels to point of sale or distribution at the dispensing/retail level.
For questions related to current drug reporting requirements or the additional requirements proposed by this bill, please consult the author or another member of the McGuireWoods life sciences team.