Recommendation: In order to strengthen DEA's communication with and guidance for registrants and associations representing registrants, as well as supporting the Office of Diversion Control's mission of preventing diversion while ensuring an adequate and uninterrupted supply of controlled substances for legitimate medical needs, the Deputy Assistant Administrator for the Office of Diversion Control should solicit input from distributors, or associations representing distributors, and develop additional guidance for distributors regarding their roles and responsibilities for suspicious orders monitoring and reporting.

Agency: Department of Justice: Drug Enforcement Administration: Operations Division: Office of Diversion Control: Deputy Assistant Administrator for the Office of Diversion Control
Status: Open
Priority recommendation

Comments: In September 2019, DEA told us that the agency had refocused its efforts on revising draft regulations in line with the SUPPORT for Patients and Communities Act, and that the revised draft was undergoing internal DEA and Department of Justice review. The agency noted that it expected the rule to codify existing legal obligations related to due diligence and suspicious order reporting and provide additional guidance regarding the nature and timing of the suspicious order reporting requirement, but also indicated that it was not possible to be certain of the precise nature of the draft rule. While DEA has reported taking some actions to address this recommendation, as noted above, until the regulations are finalized we cannot determine if these changes will fully address the recommendation. We will continue to monitor DEA's progress in addressing our recommendation.

Recommendation: In order to strengthen DEA's communication with and guidance for registrants and associations representing registrants, as well as supporting the Office of Diversion Control's mission of preventing diversion while ensuring an adequate and uninterrupted supply of controlled substances for legitimate medical needs, the Deputy Assistant Administrator for the Office of Diversion Control should solicit input from pharmacists, or associations representing pharmacies and pharmacists, about updates and additions needed to existing guidance for pharmacists, and revise or issue guidance accordingly.

Agency: Department of Justice: Drug Enforcement Administration: Operations Division: Office of Diversion Control: Deputy Assistant Administrator for the Office of Diversion Control
Status: Open

Comments: In April 2016, DEA reported that it had worked with the National Association of Boards of Pharmacy regarding issues raised during stakeholder discussions, which resulted in a March 2015 consensus document published by stakeholders entitled "Stakeholders' Challenges and Red Flag Warning Signs Related to Prescribing and Dispensing Controlled Substances." Additionally, in December 2016 DEA also described other ways in which the agency had been working with pharmacists or associations representing pharmacists to discuss their responsibilities, such as during regional one-day Pharmacy Diversion Awareness Conferences, and quarterly meetings with two pharmacy associations. In February 2018, DEA reported that following input from pharmacists, and representatives of pharmacies and pharmacists, it had revised its existing Pharmacist's Manual. DEA reported in September 2019 that the manual was currently in the final approval process for publication, and that when published, DEA would provide the manual to GAO. Until the updated Pharmacist's Manual is published and we have a chance to review the revisions, we cannot fully assess DEA's actions in this area. Therefore, the recommendation remains open.