|NEWARK – Acting Attorney General John J. Hoffman, the New Jersey Division of Consumer Affairs, and the State Board of Pharmacy today announced a settlement with CVS Pharmacy Inc. in which the company will pay more than $500,000 and will take steps to protect New Jersey consumers from purchasing medications, infant formula, or other items if they are exposed to elevated temperatures for prolonged periods of time.
The settlement follows two separate 2012 incidents in which CVS pharmacies in Scotch Plains and Clark experienced air conditioning outages for multiple days. The stores continued to operate after inside temperatures exceeded the maximum recommended for the storage of drugs and other items for extended periods of time.
Potentially affected items were sold between June 20, 2012 and July 27, 2012 at the CVS at 514 Park Avenue in Scotch Plains; and between July 10, 2012 and July 20, 2012 at the CVS at 60 Westfield Avenue in Clark.
Certain medications may lose effectiveness if exposed to elevated temperatures for prolonged periods of time. No injuries or illnesses resulting from the 2012 incidents have been reported.
“We have taken an incident in which the public was exposed to potential harm, and turned it into an opportunity to create model practices for pharmacies across New Jersey,” Acting Attorney General John J. Hoffman said. “Under this settlement, CVS will keep a close eye on the temperatures at its New Jersey pharmacies, and will act immediately to remove affected medications before they are sold to the public. Failure to do so will be punishable under New Jersey’s laws governing consumer fraud and pharmacy operations.”
Division of Consumer Affairs Acting Director Steve Lee said, “Consumers expect pharmacies to closely guard the integrity and quality of medications, infant formula, and other items that are essential to public health. Any deviation from this responsibility is unacceptable. This settlement is an important step for protecting the public.”
Acting Attorney General Hoffman noted that CVS in 2012 delayed in reporting, recognizing, and addressing the potential risks to the public that resulted from the incidents at the Scotch Plains and Clark pharmacies.
He acknowledged, however, that CVS has since worked with the Division of Consumer Affairs and Board of Pharmacy to investigate and address all issues arising from the incidents, and to improve CVS’s ability to respond to heating, ventilating, or air-conditioning failures and/or similar events in the future.
Among other things, CVS is converting its New Jersey stores to web-accessible or other systems to monitor and report on temperatures; establishing protocols and mechanisms to inspect merchandise and notify corporate headquarters about outages at New Jersey stores; changing its HVAC service provider in New Jersey; and assigning new field leadership to provide management and oversight of CVS pharmacies in New Jersey.
Under the settlement announced today:
- CVS will conduct continuous temperature monitoring in all of its New Jersey pharmacies and stores, maintain temperature information consistent with New Jersey’s record-keeping requirements for pharmacies, and provide these records for inspection and review by the Division or Board upon request.
- If the temperature in a CVS pharmacy in New Jersey deviates from acceptable guidelines for room temperature for more than 72 hours, CVS will quarantine all drugs and products whose manufacturers or packaging require or recommend storage within a particular temperature range. CVS also will quarantine any drugs or products that do not have such directions, but are visibly affected by the temperature deviation. CVS will cease and desist from the sale of those medications and products, including all prescription medication, as well as over-the-counter medication and products such as infant formula. Products may be sold if they require refrigeration and if refrigeration has been maintained without interruption. The quarantined medications will be disposed of in accordance with applicable law.
- If a temperature deviation exists for more than 72 hours and CVS fails to quarantine affected products, that failure shall be a violation of the settlement. In such an event, CVS will notify all patients who have purchased potentially affected medications. Those who purchased high- and moderate-priority medications, as defined in the Consent Order, will be notified by a telephone call from a pharmacist and by mail. Those who purchased lower-priority medications, as defined in the Consent Order, will be notified by mail and public notice. All such notifications must commence no later than 72 hours after the beginning of the temperature diversion, and must be completed within the following 72 hours.
- CVS will pay the State a total of $504,885.07, including $500,000 in civil penalties and the balance as reimbursement of the State’s investigative costs in this matter.
- Violations of the settlement will subject CVS and/or its registered pharmacies to discipline or civil penalties pursuant to the Pharmacy Practice Act and/or the Consumer Fraud Act.
The State Board of Pharmacy is in the process of promulgating regulations regarding temperature control and temperature monitoring for prescription drugs and chemicals. The terms of the settlement with CVS will remain in effect until either one year from its entry or upon the promulgation and adoption of regulations, whichever occurs first.
The Division of Consumer Affairs’ Enforcement Bureau investigated this matter.
Deputy Attorney General Jodi Krugman, within the Division of Law, represented the State in this matter.
Consumers who believe they have been cheated or scammed by a business, or suspect any other form of consumer abuse, can file a complaint with the State Division of Consumer Affairs by visiting its website or by calling 1-800-242-5846 (toll free within New Jersey) or 973-504-6200.