By: Matt Fischer
The Drug Enforcement Administration (DEA) is responsible for monitoring the supply and distribution of all controlled substances. All medical providers, pharmacies, manufacturers of pharmaceuticals, and distributors of pharmaceuticals must be registered with the DEA. DEA registrants are governed by an ever-growing web of federal laws and regulations which if violated may result in revocation of registration, fines, and/or criminal prosecution. Therefore, it is important when starting a business or purchasing an existing business requiring DEA registration to be proactive and prepared for periodic administrative inspections or audits.
The Diversion Control Unit is tasked with monitoring compliance and empowered to conduct inspections by the Controlled Substances Act (CSA). Under the CSA, diversion investigators have the authority to (1) inspect, copy, and verify records required to be kept (e.g., prescription and inventory records); (2) inspect equipment; (3) make a physical inventory of controlled substances; (4) collect samples of controlled substances; and/or (5) inspect any other records appropriate for verification under the CSA. However, there are limits to what can be inspected (unless an owner or agent of the owner consents). Inspections do not extend to financial data, sales data (other than shipping data), or pricing data.read more