The DEA has recently audited several large pharmacies and drug wholesalers finding substantial non-compliance with the Controlled Substances Act (CSA). The non-compliance has resulted in large settlements, corrective action plans, and some business restructuring. The examples below concentrate on major pharmacy chains and large wholesalers, however, a number of smaller pharmacies and wholesalers have settled various allegations of the CSA violations.

Rite Aid:

In March 2017, it paid over $800,000 to settle allegations that some of its pharmacies had violated the CSA. During the investigation, the DEA had determined that pharmacies were using wrong DEA registration numbers as a result of a poorly maintained internal database. DEA also discovered illegal dispensing practices such as dispensing controlled substances based on prescriptions written by one practitioner whose DEA registration number had been revoked.


Paid $11.75 million to settle the case for similar allegations:

  • Filing prescriptions from practitioners who did not have a valid DEA number

  • Incorrectly recording the practitioner’s DEA number

  • Filing prescriptions outside the scope of a practitioner’s DEA registration

  • Filling prescriptions that did not contain all required information

  • Failing to maintain accurate dispensing records

  • Failing to maintain records for pharmacies’ central fill location


Paid over $150 million in civil penalties for its alleged violations of the statute: failure to identify and report suspicious orders of CS, such as orders of unusual size, unusual frequency, and those deviating from normal patterns. The settlement also requires McKesson to suspend sales of controlled substances from several of its distribution centers for multiple years.

Cardinal Health:

Agreed to pay $44 million for similar violations.

Lessons to be learned:

  • I might sound like a broken record but No. 1 prevention and remedy for many government investigations, penalties, and disciplinary action is proper record-keeping.

  • When dispensing controlled substances, strictly follow state and federal law on dispensing, record-keeping, and identifying red-flags (which must be documented).

  • Check prescribers’ DEA registration numbers (and re-check after sometime to make sure the DEA numbers are still valid).

  • Make sure a prescription complies with all state and federal laws.

  • Train your staff on the DEA  Pharmacist’s manual. Could be accessed here.

  • If you are a drug wholesaler, design and implement an effective system to detect and report suspicious orders distributed to its independent and small chain pharmacy customers.