By George F. Indest III, J.D., M.P.A., LL.M., Board Certified by The Florida Bar in Health Law
Cardinal Health has reached a settlement with the Drug Enforcement Administration (DEA) that suspends its shipments of controlled substances from its Florida distribution facility for two years. Cardinal will now supply controlled substances from its distribution center in Jackson, Mississippi.
DEA can Still Purse Civil Penalties, Despite Settlement.
The settlement was announced on May 15, 2012. It includes an Administrative Memorandum of Agreement (MOA), the terms of which will apply to all of Cardinal Health’s registered distribution facilities. The MOA will not prevent Cardinal Health from possible civil penalties related to the DEA's case against the pharmaceutical distributor.
The obligations in the MOA will remain in effect for five years unless the DEA agrees to an earlier termination. Some of the terms require Cardinal Health to improve anti-diversion procedures and keep track of narcotics distributions.
Click here to view the Memorandum of Agreement between Cardinal Health and the DEA.
Cardinal Health's History with the DEA.
On February 3, 2012, Cardinal Health's Florida distribution center was served with an Immediate Suspension Order (ISO) from the DEA. The ISO alleged that the distribution center did not maintain effective safeguards against the diversion of controlled substance, including oxycodone.
According to the DEA, Cardinal Health’s Florida facility shipped a large quantity of oxycodone to four Florida pharmacies. The DEA alleged that Cardinal Health did not ensure that these drugs only went to legitimate patients.
The February 2012 ISO was not the DEA’s first action against Cardinal Health’s Florida distribution center. In 2007, the DEA issued an ISO at the facility because it allegedly distributed hydrocodone to illegitimate internet pharmacies. That action, and similar DEA actions at other Cardinal Health facilities across the United States, resulted in a $34 million fine.
Cardinal Health has been operating under an Administrative MOA with the DEA since October 2008. This MOA required Cardinal Health to maintain a compliance program designed to detect and prevent the diversion of controlled substances (as required under the Controlled Substances Act).
According to the DEA, Cardinal Health did not comply with the terms of the October 2008 MOA, which is partly why the agency issued the February 2012 ISO.
Cardinal Health Pursues Litigation Against DEA.
Cardinal Health had filed litigation to challenge the DEA's decision to impose the ISO, shortly after it happened. Click here for a copy of the Complaint filed in Federal Court in Washington, D.C. Ultimately the federal courts ruled against Cardinal Health on February 29, 2012. For a copy of the Court's decision against Cardinal click here.
Click here to view other blogs regarding the Cardinal Health case.
Contact Health Law Attorneys Experienced with DEA Cases.
The Health Law Firm represents pharmacists, pharmacies, physicians and other health provders in investigations, regulatory matters, licensing issues, litigation, inspections and audits involving the DEA, Department of Health (DOH) and other law enforcement agencies. Its attorneys include those who are board certified by The Florida Bar in Health Law as well as licensed health professionals who are also attorneys.
To contact The Health Law Firm, please call (407) 331-6620 or (850) 439-1001 and visit our website at http://www.thehealthlawfirm.com/.
Sources Include:
DEA Public Affairs. "DEA Suspends for Two Years Pharmaceutical Wholesale Distributor’s Ability to Sell Controlled Substances from Lakeland, Florida Facility." United States Drug Enforcement Administration. Press Release. (May 15, 2012). From
http://www.justice.gov/dea/pubs/pressrel/pr051512.html
Milford, Phil and Tom Schoenberg. "Cardinal DEA Settlement Calls for Two-Year Shipping Halt." Bloomberg. (May 15, 2012). From
http://www.bloomberg.com/news/2012-05-15/cardinal-dea-settlement-calls-for-two-year-shipping-halt.html
About the Author: George F. Indest III, J.D., M.P.A., LL.M., is Board Certified by The Florida Bar in Health Law. He is the President and Managing Partner of The Health Law Firm, which has a national practice. Its main office is in the Orlando, Florida, area. http://www.thehealthlawfirm.com/ The Health Law Firm, 1101 Douglas Ave., Altamonte Springs, FL 32714, Phone: (407) 331-6620.
Cardinal Health has reached a settlement with the Drug Enforcement Administration (DEA) that suspends its shipments of controlled substances from its Florida distribution facility for two years. Cardinal will now supply controlled substances from its distribution center in Jackson, Mississippi.
DEA can Still Purse Civil Penalties, Despite Settlement.
The settlement was announced on May 15, 2012. It includes an Administrative Memorandum of Agreement (MOA), the terms of which will apply to all of Cardinal Health’s registered distribution facilities. The MOA will not prevent Cardinal Health from possible civil penalties related to the DEA's case against the pharmaceutical distributor.
The obligations in the MOA will remain in effect for five years unless the DEA agrees to an earlier termination. Some of the terms require Cardinal Health to improve anti-diversion procedures and keep track of narcotics distributions.
Click here to view the Memorandum of Agreement between Cardinal Health and the DEA.
Cardinal Health's History with the DEA.
On February 3, 2012, Cardinal Health's Florida distribution center was served with an Immediate Suspension Order (ISO) from the DEA. The ISO alleged that the distribution center did not maintain effective safeguards against the diversion of controlled substance, including oxycodone.
According to the DEA, Cardinal Health’s Florida facility shipped a large quantity of oxycodone to four Florida pharmacies. The DEA alleged that Cardinal Health did not ensure that these drugs only went to legitimate patients.
The February 2012 ISO was not the DEA’s first action against Cardinal Health’s Florida distribution center. In 2007, the DEA issued an ISO at the facility because it allegedly distributed hydrocodone to illegitimate internet pharmacies. That action, and similar DEA actions at other Cardinal Health facilities across the United States, resulted in a $34 million fine.
Cardinal Health has been operating under an Administrative MOA with the DEA since October 2008. This MOA required Cardinal Health to maintain a compliance program designed to detect and prevent the diversion of controlled substances (as required under the Controlled Substances Act).
According to the DEA, Cardinal Health did not comply with the terms of the October 2008 MOA, which is partly why the agency issued the February 2012 ISO.
Cardinal Health Pursues Litigation Against DEA.
Cardinal Health had filed litigation to challenge the DEA's decision to impose the ISO, shortly after it happened. Click here for a copy of the Complaint filed in Federal Court in Washington, D.C. Ultimately the federal courts ruled against Cardinal Health on February 29, 2012. For a copy of the Court's decision against Cardinal click here.
Click here to view other blogs regarding the Cardinal Health case.
Contact Health Law Attorneys Experienced with DEA Cases.
The Health Law Firm represents pharmacists, pharmacies, physicians and other health provders in investigations, regulatory matters, licensing issues, litigation, inspections and audits involving the DEA, Department of Health (DOH) and other law enforcement agencies. Its attorneys include those who are board certified by The Florida Bar in Health Law as well as licensed health professionals who are also attorneys.
To contact The Health Law Firm, please call (407) 331-6620 or (850) 439-1001 and visit our website at http://www.thehealthlawfirm.com/.
Sources Include:
DEA Public Affairs. "DEA Suspends for Two Years Pharmaceutical Wholesale Distributor’s Ability to Sell Controlled Substances from Lakeland, Florida Facility." United States Drug Enforcement Administration. Press Release. (May 15, 2012). From
http://www.justice.gov/dea/pubs/pressrel/pr051512.html
Milford, Phil and Tom Schoenberg. "Cardinal DEA Settlement Calls for Two-Year Shipping Halt." Bloomberg. (May 15, 2012). From
http://www.bloomberg.com/news/2012-05-15/cardinal-dea-settlement-calls-for-two-year-shipping-halt.html
About the Author: George F. Indest III, J.D., M.P.A., LL.M., is Board Certified by The Florida Bar in Health Law. He is the President and Managing Partner of The Health Law Firm, which has a national practice. Its main office is in the Orlando, Florida, area. http://www.thehealthlawfirm.com/ The Health Law Firm, 1101 Douglas Ave., Altamonte Springs, FL 32714, Phone: (407) 331-6620.
