The Rite Aid Corporation and nine subsidiaries in eight states have agreed to pay $5 million in civil penalties to settle allegations of violations of the federal Controlled Substances Act.
According to officials at the U.S. Department of Justice, Rite Aid, headquartered in Camp Hill, Pa., and all of its subsidiaries agreed to a plan with the U.S. Drug Enforcement Administration to ensure compliance with all requirements of the CSA and applicable DEA regulations and prevent diversion of controlled substances.
"This settlement demonstrates the important responsibilities all pharmacies have to prevent dangerous drugs from being diverted from their intended use," said DEA Acting Administrator Michele M. Leonhart. "The civil penalties paid today are just one example of DEA's determination to combat the troubling prescription drug abuse problem in this country by pursuing pharmacies that fail to comply with the law."
The compliance plan 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, which are used to make methamphetamine.
"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."
According to information contained in the agreement, the DEA conducted an investigation of 53 separate Rite Aid locations starting in 2004. The investigation revealed a pattern of violations of the CSA.
For instance, DEA officials revealed that, 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.
And at 53 pharmacies in all 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.
The DEA also conducted accountability audits of controlled substances at 25 of the 53 stores investigated to determine whether Rite Aid could properly account for Schedule II and III controlled substances purchased and dispensed. The results of the accountability audits revealed significant shortages or surpluses of the most highly abused drugs, including oxycodone and hydrocodone products.
As part of the compliance plan agreed to as part of the settlement, Rite Aid has agreed to audit each pharmacy to ensure that all of its controlled substances are maintained securely and that each pharmacy is compliant with the requirements of the CSA.
Rite Aid has also agreed to design and implement an electronic system to document and link all sales transactions involving non-prescription products containing pseudoephedrine and ephedrine at each of the 4,915 Rite Aid locations in the country. The new system will be designed to prevent individuals from obtaining illegal amounts of these products by visiting different pharmacy locations.