What Happened
Northern Maine Medical Center (NMMC), a hospital in Fort Kent, Maine, agreed to pay $125,000 to settle allegations that it violated the Controlled Substances Act at its long-term care and rehabilitation location.
NMMC operates as a DEA-registered hospital/clinic, and also offers long-term care and skilled rehabilitation at a separate location known as Forest Hill, which did not carry its own DEA registration. The government alleged that NMMC negligently failed to maintain records documenting the amount, date, and manner of destruction of Schedule II through V controlled substances at Forest Hill and at its on-site pharmacy — in some cases, the only record of destruction was a notation that the drug had simply been "wasted," with no manner of disposal recorded.
The government further alleged that NMMC unlawfully distributed controlled substances at Forest Hill because it lacked a registration permitting it to distribute and dispense controlled substances there. NMMC admitted no wrongdoing and maintained that its practices complied with the CSA, but cooperated fully with the DEA's Office of Diversion Control investigation. The civil settlement was announced August 29, 2016.
What Went Wrong
A satellite long-term care location operated for years without its own controlled-substances registration or adequate destruction recordkeeping. Key failures included:
- Forest Hill dispensed and distributed controlled substances without a separate DEA registration covering that location, as required when a facility operates at a distinct address from its parent registration.
- Destruction records for Schedule II-V drugs did not document the required amount, date, and manner of destruction — some entries recorded only that a drug was "wasted."
- Pharmacy records omitted the manner of disposal for destroyed controlled substances, leaving no audit trail to confirm proper destruction occurred.
- No internal compliance review caught the registration gap or recordkeeping shortfalls before a federal investigation did.
How It Could Have Been Prevented
- Confirm and maintain a separate DEA registration for every physical location that dispenses or distributes controlled substances, including satellite long-term care units.
- Document the specific amount, date, and manner of destruction for every controlled-substance waste or disposal event — never rely on a generic "wasted" notation.
- Conduct periodic internal compliance audits of destruction and disposal records against DEA recordkeeping requirements, independent of any external inspection.
- Centralize registration and recordkeeping oversight across all locations under a single hospital system to avoid satellite facilities operating with less rigor than the main campus.
Related Guidance
- Hospital Diversion Prevention Checklist — Hospital self-assessment, 8 sections 63 items, including inventory, recordkeeping, and DEA reporting controls.
- Waste Documentation Policies — Requirements for documenting the destruction and disposal of controlled substances.
- DEA Form 41 Destruction Guide — Proper documentation of controlled-substance destruction and disposal.
- Regulatory Guide — DEA registration requirements across multiple practice locations.