WASHINGTON Rite Aid has agreed to pay $5 million in civil penalties to settle allegations of violations of the Controlled Substances Act, the Department of Justice announced Monday.
According to information contained in the agreement, the Drug Enforcement Agency conducted an investigation of 53 separate Rite Aid locations starting in 2004. The DEA charged that Rite Aid violated the CSA, alleging the following:
• At pharmacies in Kentucky and New York, Rite Aid knowingly filled prescriptions for controlled substances that were not issued for a legitimate medical purpose pursuant to a valid physician-patient relationship;
• At five pharmacies in Maryland, four pharmacies in New York and 13 pharmacies in California, Rite Aid failed to notify the DEA in a timely manner of significant thefts and losses of controlled substances;
• At pharmacies in California, Pennsylvania and Maryland, Rite Aid either failed to maintain or failed to furnish to the DEA upon request records that are required to be kept under the CSA for a period of two years;
• At 53 pharmacies in eight states, Rite Aid failed to properly execute DEA forms used to ensure that the amount of Schedule II drugs ordered by Rite Aid were actually received.
In addition to the $5 million penalty, Rite Aid agreed to a compliance plan with the U.S. Drug Enforcement Administration to ensure compliance with all requirements of the CSA and applicable DEA regulations and to prevent diversion of controlled substances. The compliance plan also requires Rite Aid to implement a pseudoephedrine and ephedrine tracking system in each of its 4,915 stores that is designed to prevent the abuse of pseudoephedrine and ephedrine products.
“Congress regulates prescription medications because of their powerful and potentially harmful effects,” said Deputy Attorney General Mark Filip. “Today’s settlement will help to curb illegal access to these dangerous drugs that can often be abused.”
“This settlement demonstrates the important responsibilities all pharmacies have to prevent dangerous drugs from being diverted from their intended use,” commented DEA acting administrator Michele Leonhart.
The settlement agreement is neither an admission of liability by Rite Aid nor a concession by the United States that its claims are not well founded.