DENVER — John Walsh, U.S. Attorney for the District of Colorado, today announced that Palisade Pharmacy has entered into a civil settlement with the United States and have paid $60,000 in civil penalties to resolve allegations that it violated certain provisions of the Controlled Substances Act and the Combat Methamphetamine Epidemic Act of 2005 (CMEA).
The United States alleges that Palisade Pharmacy, a pharmacy located in Palisade, Colorado, committed over 480 violations of the Controlled Substances Act and the CMEA related to the distribution of controlled substances, including: shipping controlled substances to unregistered locations; failing to verify addresses on DEA order forms to the corresponding addresses registered with the DEA; filling prescriptions for controlled substances despite missing required information on the face of the prescription; failing to maintain, record, and retain complete and accurate records relating to distribution of controlled substances; and selling List I chemical products without a valid self-certification certificate.
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.
“Prescription drugs are controlled by federal law to protect the public; violations of the law by a pharmacy can put public health at risk,” said U.S. Attorney John Walsh. “Palisade Pharmacy’s agreement to pay a civil penalty not only addresses the issues in this case, but sends a message to all pharmacies to follow the rules to protect the public.”
“The diversion of pharmaceuticals and chemicals for illicit gain and profit is nothing more than drug trafficking,” stated Barbra Roach, Special Agent in Charge of the Drug Enforcement Administration’s Denver Field Division. “Those occupying positions of trust and responsibility, such as medical practitioners and pharmacists, have to be held accountable when they chose to operate illegally and threaten the safety of our communities.”
In addition to paying the civil penalty, Palisade Pharmacy has also signed an administrative settlement agreement. Under the terms of the administrative settlement agreement, Palisade Pharmacy has agreed to enhanced reporting and training requirements, as well as to a three-year surrender of its CMEA certification that allows it to sell List 1 chemicals.
In entering into a civil settlement, Palisade Pharmacy 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.