Internal Mock DEA-Style and Mirror Inspections and Audits: Trust But Verify

Drug Enforcement Administration (“DEA”) diversion investigators conduct random, unannounced cyclic inspections of “non-practitioner” registrants (manufacturers, distributors, importers, exporters and narcotic treatment programs) about every three years.  Investigators also randomly inspect hospitals, pharmacies and practitioners.  With civil monetary penalties for violations of recordkeeping and reporting requirements adjusted for inflation up to $19,246 per violation, periodic mock DEA-style and mirror inspections and audits are more important for registrants than ever.

Mock Inspections/Audits

Periodic random internal mock DEA-style inspections are among the best tools that a registrant can undertake to prepare for actual DEA inspections.  After I left DEA I conducted mock inspections for a registered distributor every six months.  After about two years when DEA investigators conducted an actual inspection of the distributor, they found no deficiencies.  Their DEA group supervisor had never seen a perfect cyclic inspection before, and she sent the investigators back twice to find deficiencies.  The investigators still found nothing.

To ensure similar compliance while teaching employees how to manage DEA inspections, registrants are well-served by conducting periodic random DEA-style inspections comprised of controlled substance accountability audits, and record, report and security reviews.  Third-parties or knowledgeable employees without day-to-day controlled substance responsibilities for the registrant should conduct the mock inspections.  The periodic internal accountability audits of five to eight highly diverted controlled substances disclose potential losses, deter internal theft and identify potential underlying record issues.  Most important, mock inspections help ensure compliance.  They also instill familiarity and build employee confidence for actual DEA inspections.  Preparation for a mock inspection should begin with a review of prior DEA and internal inspection results to ensure that past deficiencies have been remedied, and that they are not continuing.

Mirror Inspections/Audits

When investigators conduct a controlled substance accountability audit during an inspection, registrants typically will not know the results for a number of months.  Registrants should keep in mind that investigators do make mistakes in their accountability audits and even with the records, reports and security that they review.  Registrants should rely on their own audits and reviews, not those of the investigators.  Registrants must ensure during a DEA inspection that investigators receive all required records and reports, and that they fully understand them and the security system.  During a DEA inspection, registrants should photocopy or set aside in a separate file every record and report that the investigators review or use during their inspection and accountability audit.  Concurrent with the DEA inspection, or very shortly afterwards, registrants should conduct an exact mirror of DEA’s inspection and audit.  For the accountability audit, registrants use the same beginning and ending inventories/physical counts that the investigators use, and the same receiving and disposition records for the same time period.  The mirror audit will disclose any controlled substance discrepancies.  Together the mirror inspection and audit will identify DEA’s potential findings to the registrant before the investigators may be prepared to share them.  Conducting a concurrent mirror inspection and audit will enable the registrant to respond to DEA’s findings without having to painstakingly reconstruct the inspection and audit when investigators finally share their results months later.  This is especially important if the investigators allege violations; it allows registrants to timely correct deficiencies.

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Registrants should conduct mock DEA-style inspections and mirror inspections/audits because not only will doing so help registrants prepare and respond confidently to actual DEA inspections and audits, more importantly they ensure compliance with their obligations under the Controlled Substances Act and regulations.