U.S. DEA Settles Civil Suit Against a Long-Term Care Pharmacy for Improper Dispensing of Controlled Substances and Flawed Recordkeeping
A long-term care pharmacy has agreed to pay $75,000 to settle a suit brought by the U.S. Drug Enforcement Administration (DEA) after an audit revealed discrepancies for six controlled substances including fentanyl. The audit also found that the pharmacy failed to disclose on its DEA registration renewal form that the pharmacy license and DEA registration of a part owner of the pharmacy had been previously revoked.
The government contends that the pharmacy also violated other recordkeeping requirements, i.e., failing to obtain a hard copy prescription after filling a phone order for controlled substances, filling prescriptions for controlled substances with an incorrect or inaccurate DEA registration number, and storing records “off-site” without the permission of the DEA.
A U.S. Attorney reiterated that the DEA strictly enforces regulatory requirements for storing and dispensing controlled substances because of the potential for abuse—stealing medication and diverting it for personal use or financial gain.
According to the DEA agent in charge of the investigation, “DEA registrants are responsible to handle controlled substances and ensure that complete and accurate records are being properly kept and accounted for in compliance with the Controlled Substance Act.”
The pharmacy cooperated with the DEA’s investigation and agreed to implement a corrective action plan to become compliant with the recordkeeping requirements of the Controlled Substance Act. They also agreed to permit the DEA to perform inspections of the pharmacy during the next three years without a warrant.
Compliance Perspective
Failure by a long-term care pharmacy to follow federal requirements for dispensing and recordkeeping of controlled substances and failure to disclose the revocation of a pharmacy license of a part owner of the company when renewing its DEA registration may be considered a violation of the U.S. Controlled Substance Act and result in fines and other sanctions.
Discussion Points:
- Review policies and procedures for ensuring that a pharmacy providing controlled substance medications to the facility is registered with the DEA and that its pharmacy license is valid.
- Train staff who negotiate contracts for pharmacy services about the policies and procedures for requiring a pharmacy that provides controlled substances to be registered with the DEA and have a valid pharmacy license.
- Periodically audit to determine if pharmacies providing medications, i.e., controlled substances, are registered with the DEA and have a valid pharmacy license. Periodically check all contracted companies/persons against the OIG list of debarred contractors and excluded individuals.
