Health Care Company and Cheshire Pharmacy Pay $500K to Resolve Controlled Substances Act Allegations
CHESHIRE, Conn. - Vanessa Roberts Avery, United States Attorney for the District of Connecticut, Brian D. Boyle, Special Agent in Charge of the Drug Enforcement Administration for New England, announced that Clarest, LLC, doing business as Clarest Health, ProCare LTC New England LTC, and ProCare LTC Pharmacy of Connecticut LLC (“ProCare”), have entered into a civil settlement agreement with the federal government and have paid $499,525 to resolve allegations that they violated the civil provisions of the Controlled Substances Act (“CSA”).
In passing the CSA, Congress took steps to create “a closed system” of distribution for controlled substances in which every facet of the handling of the substances – from their manufacture to their consumption by the ultimate user – was to be subject to intense governmental regulation. This mission was taken against the backdrop of trying to prevent the diversion and abuse of legitimate controlled substances, while still ensuring that an adequate supply of those substances meet the medical and scientific needs of the United States.
ProCare LTC Pharmacy of Connecticut, LLC, is a pharmacy located in Cheshire, Connecticut, and is owned by ProCare LTC New England, LTC, which is a wholly owned subsidiary of Clarest, LLC d/b/a Clarest Health. Clarest Health consists of eight pharmacy locations in the Northeast and Midwest regions of the U.S.
ProCare LTC Pharmacy of Connecticut services 65 long-term care (“LTC”) facilities, skilled nursing facilities, assisted living locations, and rehab and nursing practices in Connecticut and Rhode Island. In addition to filling prescriptions, it also fulfills orders for controlled substances for LTC facilities’ emergency stock needs. This emergency stock is commonly referred to as a facility’s “emergency box.”
The settlement resolves allegations that between September 2020 and September 2022, ProCare violated the CSA and its implementing regulations when supplying controlled substances for LTC facilities’ emergency box stock. The government contends that ProCare distributed controlled substances to practitioners that were not registered to dispense those controlled substances on 96 occasions. The government also alleges that ProCare failed to record certain required information on DEA Form 222s (order forms) on numerous occasions, such as dates, numbers of containers furnished, and DEA registration numbers, and that ProCare failed to reject order forms that were not properly prepared, were incomplete, or had been altered.
“Strict compliance with the recordkeeping requirements of the Controlled Substances Act is a key part of preventing diversion and ensuring the safety of our community,” said U.S. Attorney Avery. “Pharmacies play a vital role in ensuring controlled substances are properly handled, accounted for, and dispensed. This settlement demonstrates our office’s continued commitment to hold pharmacies accountable for their responsibilities under federal law.”
“The DEA is committed to ensuring that all registrants, including ProCare, are in compliance with the required regulations, which are enforceable through the Controlled Substances Act,” said DEA Special Agent in Charge Boyle. “Failure to do so increases the potential for diversion and jeopardizes public health and public safety. DEA pledges to work with our law enforcement and regulatory partners to ensure these rules and regulations are followed.”
As part of the settlement, ProCare has agreed to enter into a three-year Corrective Action Plan with the DEA that is designed to ensure future compliance with the requirements of the CSA and its implementing regulations.
This investigation was conducted by the Drug Enforcement Administration’s Office of Diversion Control, with the assistance of the Connecticut Department of Consumer Protection, Drug Control Division. This case was prosecuted by Assistant U.S. Attorney Sara Kaczmarek.