The Drug Enforcement Administration (“DEA”), in response to the nationwide controlled pharmaceutical diversion and abuse crisis, now conducts more frequent regulatory inspections in greater depth to identify registrants who violate the Controlled Substances Act and implementing regulations. In addition to inspecting and auditing manufacturers, distributors, importers, exporters, and narcotic treatment programs, DEA diversion investigators now inspect pharmacies, hospitals and practitioners. These were registrants that historically had not been subject to scheduled inspections. Registrant noncompliance disclosed during a DEA inspection can lead to significant administrative, civil and even criminal consequences.
Hyman, Phelps & McNamara, P.C. attorney Larry K. Houck, a former DEA diversion investigator, authored an article that appears in the latest issue of the Food and Drug Law Institute’s “Update” magazine. The article, titled “DEA Preregistration and Cyclic Inspection: What Applicants and Registrants Must Know in the Prescription Opioid Epidemic Age,” explains what applicants and registrants must expect during DEA inspections in the current regulatory climate.