What Happened
The Confederated Salish and Kootenai Tribes' Pharmacy in St. Ignatius, Montana, agreed to pay a $95,520 civil penalty after a DEA inspection triggered by roughly 2,500 missing oxycodone pills found the pharmacy had failed to properly track and report its controlled-substance inventory.
DEA has the responsibility to inspect pharmacies and medical providers that dispense controlled substances to ensure compliance with federal regulations designed to prevent theft or diversion. DEA inspected the Tribes' pharmacy on the Flathead Indian Reservation after learning that approximately 2,500 oxycodone pills had been stolen or were unaccounted for. The inspection, covering activity from March 2017 to March 2018, found significant regulatory violations, including a failure to adequately track records of the controlled substances in the pharmacy and a failure to report the missing oxycodone pills to DEA.
Under the settlement announced November 20, 2018, the pharmacy agreed to pay the $95,520 penalty and take additional compliance steps, including annual compliance evaluations for three years with certification to DEA. Any future violations would expose the pharmacy to the full potential penalty of $240,640 for the alleged violations.
What Went Wrong
About 2,500 oxycodone pills went missing before recordkeeping gaps were caught by a federal inspection rather than by the pharmacy's own controls. Key failures included:
- The pharmacy did not adequately track records of controlled substances, making it difficult to identify when and how the pills went missing.
- The missing oxycodone pills were not reported to DEA as required, delaying regulatory awareness of the loss.
- Internal reconciliation between what was ordered, dispensed, and on hand was not sufficient to catch a shortfall of this size before an external inspection surfaced it.
How It Could Have Been Prevented
- Maintain accurate, current records of controlled-substance receipts, dispensing, and on-hand counts, reconciled on a regular schedule rather than only at biennial inventory.
- Report any theft or significant loss of controlled substances to DEA immediately upon discovery, as required under federal law.
- Conduct periodic self-audits comparing DEA order forms and distributor records against actual dispensing logs to catch discrepancies before a federal inspection does.
- Complete the required annual compliance certifications and treat them as an ongoing operational discipline, not a one-time settlement condition.
Related Guidance
- Pharmacy Diversion Prevention Checklist — Pharmacy self-assessment covering inventory, recordkeeping, and DEA reporting controls.
- Controlled Substance Inventory Requirements — Biennial inventory requirements and recordkeeping practices that surface losses.
- 15 Red Flags of Drug Diversion — Behavioral and transactional indicators, including unexplained inventory shortfalls.