DEA Considering Rulemaking on Suspicious Order ReportingOctober 23, 2015
By Larry K. Houck –
Ruth Carter, Chief of the Drug Enforcement Administration’s (“DEA”) Office of Liaison and Policy Section, was among the presenters who addressed the 31st Annual Conference of the National Association of State Controlled Substance Authorities (“NASCSA”) this week in Scottsdale, Arizona. Ms. Carter provided an update on DEA activities and initiatives following the recent leadership changes at the agency and the Office of Diversion Control. Ms. Carter stated that the agency is considering issuing further clarification of suspicious order requirements, possibly a regulation specifying the format for suspicious order reporting and how registrants must maintain those reports with other required controlled substance records.
In the wake of almost ten years of significant DEA civil and administrative enforcement action related to suspicious orders, it remains to be seen the extent to which such rulemaking will clarify the standard for such reporting or only focus on a reporting format. Issuance of additional clarification of what DEA requires and expects for suspicious order reporting is overdue and would be most welcome by registrants.
In addition, Ms. Carter stated that DEA may issue a final rule on electronic prescriptions (the agency issued an interim final rule on March 31, 2010) and a proposed rule on transporting controlled substances by ambulance, vessels and ships and athletic team physicians. Ms. Carter did not provide a timeframe for these actions. Ms. Carter also noted that DEA will hold two Drug Take-Back events in 2016: one in April and the second in October. Ms. Carter observed that DEA has established goals to conduct cyclic inspections of nonpractitioners every three to five years. She also stated that the agency has begun conducting scheduled inspections of retail and hospital pharmacies. Previously, DEA’s inspections of practitioners (doctors, pharmacies, etc.) was primarily limited to investigations into alleged violations.