Shell Point community pays $250,000 to settle probe of drug violations at pharmacy
Shell Point Retirement Community’s foundation has agreed to pay $250,000 to settle allegations of failing to maintain records and inventory of controlled substances at its pharmacy, according to the U.S. Department of Justice.
The agreement made by the nonprofit Christian & Missionary Alliance Foundation stems from an inspection by the Drug Enforcement Agency on July 14, 2021 where numerous violations were found, according to a news release from the U.S. Attorney’s Office for the Middle District of Florida.
The nonprofit ministry founded Shell Point, a continuing care retirement community off Summerlin Road, in 1968. Today it has 2,500 residents and 1,200 employees.
The DEA inspection determined Shell Point’s pharmacy at 15051 Shell Point Blvd. committed 176 violations of the Controlled Substances Act, which included failure to take new inventory of all controlled substances on hand at least once every two years.
In addition, the pharmacy failed to maintain records of the number of units acquired from other persons and failed to notify the DEA of a theft or loss within one business day, according to the release.
The federal government did not disclose which controlled substances were involved, for how long the pharmacy was not maintaining adequate records or any details of a theft or loss of controlled drugs.
“Scrupulous recordkeeping is essential to maintaining the CSA’s closed system of distribution and preventing dangerous drugs from falling into the wrong hands,” said U.S. Attorney Roger Handberg. “We expect all DEA registrants, no matter their size, to be especially meticulous in their recordkeeping because the CSA and the welfare of the public demand it.”
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Officials at The Christian & Missionary Alliance Foundation said in a statement that it learned in December 2021 through what it calls "internal processes" of pharmacy record-keeping deficiencies.
"Upon self-reporting to the Drug Enforcement Administration, an investigation occurred and fines were assessed as is normal course," the statement said. "Due to the complexity of regulatory compliance, the Foundation chose to outsource pharmacy services and subsequently returned its DEA registration. The organization cooperated fully, and the matter was resolved without any determination of liability. The foundation remains committed to maintaining the highest standards of compliance and integrity in all operations.”
Federal officials said the Christian & Missionary Foundation relinquished its DEA registration for controlled substances on Feb. 4, 2022.
Medical providers that have DEA registration licenses for controlled substances are obligated to comply with regulations of the Controlled Substances Abuse Act for accurate inventory, tracking of drugs and record keeping, according to the federal government.
Failure to do so jeopardizes the safety and health of communities, DEA Miami Field Division Special Agent Deanne Reuter said.
“DEA remains committed to working with our law enforcement and regulatory partners to hold registrants accountable and ensure these regulations are followed,” Reuter said in a news release.
The claims resolved by the settlement are allegations and there has been no determination of liability.
The settlement resulted from a coordinated investigation by the Middle District Court in Fort Myers and the DEA in Miami.
This article originally appeared on Naples Daily News: Shell Point pharmacy gives up DEA registration after drug probe
