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News
Release
FOR IMMEDIATE RELEASE
September 28, 2005
Contact: DEA Public Affairs
Number: 303-705-7351
Record
7 Million Dollar Settlement
Kroger Corporation establishes corporate wide
compliance program
Denver, CO - Jeffrey
D. Sweetin, Special Agent in Charge (SAC) of the Drug Enforcement Administration
(DEA) Rocky Mountain
Division and Bill Leone, United States Attorney for the District
of Colorado, announced today that King Soopers, City Market, and
their parent company, Kroger, have agreed to pay a record $7 million
dollar settlement for systemic violations of the Controlled Substances
Act (CSA) by the company's pharmacies.
In addition to the penalty, the Kroger, Co., including King Soopers
and City Market, has agreed to implement a pharmacy compliance program
estimated to cost over $6 million dollars in all 1,900 of its pharmacies
nationwide, even though the DEA had no evidence of any CSA violations
outside of the King Soopers and City Market pharmacies.
According to SAC
Sweetin, “Americans
trust corporations like Kroger to supply them the medications they
need. They also trust them to ensure that controlled
substances aren't diverted to the illicit market. This record settlement is
a clear message that DEA will hold companies accountable for not safeguarding
these
potentially dangerous substances, as well as an acknowledgement by Kroger that
their internal monitoring systems need to be changed.”
“As a result of DEA's investigation, Kroger is initiating a corporate-wide
compliance program to improve their pharmaceutical controls. Seven million dollars
is a very large settlement. But, because diverted pharmaceuticals account for
a large percentage of the drugs illegally abused, the cost of not imposing such
settlements is much larger,” SAC Sweetin added. Responding to information concerning possible illegal diversions of
controlled substances, the DEA initiated an investigation, which included
audits of seven King Soopers pharmacies. The audits revealed multiple
discrepancies reflecting a pattern of non-compliance at King Soopers
pharmacies with the requirements of the CSA and Federal regulation. Record-keeping
and controlled substance security problems at King Soopers made it impossible
to determine how many drugs had been lost or diverted.
The record-keeping problem also complicated the determination of who
was responsible for potential diversions. King Soopers' inadequate accountability
and security
for controlled substances included from the time they were ordered to the time
they were dispensed. After the audits it became clear that many of the CSA
violations were the result of systemic weaknesses present in all King Soopers
and City Market
pharmacies.
As a result of the investigation, Kroger volunteered to implement a nationwide
training program of all pharmacy employees, as well as institute a Comprehensive
Regulatory Compliance Program. In addition to the $7 million dollar penalty,
both parties have agreed to an additional $3 million dollar penalty which
will be suspended as long as Kroger complies with their Comprehensive Regulatory
Plan. The DEA will work closely and cooperatively with Kroger to ensure the
plan is
implemented.
“Today’s historic settlement against one of our nation’s most
well-known pharmacy chains is a massive financial strike against those who fail
to fulfill their responsibility to prevent diversion of prescription drugs. DEA
will never tolerate irresponsible record-keeping and reckless practices that
often lead to dangerous prescription drug abuse,” concluded Joseph
T. Rannazzisi, Acting Deputy Assistant Administrator at DEA Headquarters.
For more information, please contact Special Agent Karen Flowers at 303-705-7351
or U.S. Attorney Public Affairs Officer Jeff Dorschner at (303) 454-0243.
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