What Happened

Children's Hospital of the King's Daughters (CHKD) in Norfolk, Virginia, agreed to pay $68,400 to settle civil allegations that it violated Controlled Substances Act recordkeeping requirements after a fentanyl shipment could not be accounted for.

The government alleged that between March 29, 2021, and December 22, 2021, CHKD had packages of compounded prescription controlled-substance drugs delivered to its receiving warehouse — a location that was not registered with the DEA. Among these deliveries was a shipment of 200 one-milliliter fentanyl syringes (10 mcg/mL) that CHKD could not show had been delivered to its registered pharmacy location or otherwise account for.

CSA recordkeeping requirements exist to prevent diversion of highly addictive controlled substances into the illicit market while preserving legitimate patient access. As part of the resolution, CHKD entered a separate agreement with the DEA Diversion Group to take corrective measures to prevent the conduct from recurring. The civil claims settled were allegations only, with no determination of liability.

What Went Wrong

A hospital's controlled-substance recordkeeping gap meant an entire fentanyl shipment could not be traced from delivery to its registered pharmacy. Key failures included:

  • Compounded controlled-substance shipments were routed to a receiving warehouse that held no DEA registration for handling controlled substances.
  • No chain-of-custody record connected the warehouse delivery to the registered pharmacy, leaving a 200-syringe fentanyl shipment unaccounted for.
  • Recordkeeping practices did not flag the registration gap internally before a federal recordkeeping review caught it.

How It Could Have Been Prevented

  • Route all controlled-substance deliveries directly to a DEA-registered location, never to a general receiving warehouse without its own registration.
  • Maintain an unbroken chain-of-custody record from carrier delivery through receipt at the registered pharmacy for every controlled-substance shipment.
  • Reconcile incoming controlled-substance shipment quantities against pharmacy receiving records on a routine schedule, not only during an external audit.
  • Run periodic internal compliance reviews of registration status across every location that touches controlled substances, including logistics and receiving functions.

Related Guidance

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