United States reaches settlement with pharmacy for violations of the Controlled Substance Act
DENVER — John Walsh, U.S. Attorney for the District of Colorado, today announced that Cornell Prescription Pharmacy has entered into a civil settlement with the United States and will pay $87,500 in civil penalties to resolve allegations that it violated certain provisions of the Controlled Substances Act.
The United States alleges that Cornell, a pharmacy located in Denver, committed over 200 violations of the Controlled Substance Act related to the distribution of controlled substances, including: failing to maintain, record, and retain complete and accurate records relating to distribution of controlled substances; failing to report suspicious orders of controlled substances to the DEA; and failing to ship controlled substances only to the purchaser and the location authorized by the DEA registration.
With the passage of the Controlled Substances Act, Congress took steps to attempt to create “a closed system” of distribution for controlled substances that is intended to regulate the movement of prescription medications from importation/manufacture through delivery to the ultimate user via the lawful dispensing, administering, or prescribing by a practitioner. A closed system of manufacture and distribution requires that each registrant maintain accounting and security systems so that no controlled substances are lost, stolen, or inappropriately dispensed to abusers or street dealers. This can only be accomplished through complete compliance with the Controlled Substance Act and its accompanying regulations, which are designed to require pharmacies to account for controlled substances.
“Pharmacists must comply with the Controlled Substances Act’s strict record-keeping requirements in order to ensure that addictive prescription drugs are not diverted for illegal purposes,” stated U.S. Attorney Walsh. “Pharmacists who fail to follow these rules must face the consequences and will be subject to vigorous enforcement of the civil penalty provisions of the Controlled Substances Act.”
“Prescription drug abuse is a serious threat to individuals, families, and communities in Colorado,” stated Barbra Roach, Special Agent in Charge for the Drug Enforcement Administration’s Denver Division. “DEA will continue to target and investigate businesses and individuals who violate federal law and regulations, thereby posing a danger to our state.”
In addition to paying the civil penalty, Cornell has also agreed to hire a compliance officer for three years and to comply with additional reporting requirements about its distribution of controlled substances.
In entering into a civil settlement, Cornell did not admit to liability, and the agreement indicates that the parties entered into the settlement to avoid the uncertainty and expense of further litigation.
The investigation was conducted by the Drug Enforcement Administration. The United States was represented in this matter by Assistant United States Attorney Amanda Rocque of the U.S. Attorney’s Office in Denver, Colorado.