Tag Archives: Immediate Suspension Order

Drug Enforcement Agency (DEA) Blocks Shipping of Controlled Substances at Walgreens Distribution Center in Florida

By George F. Indest III, J.D., M.P.A., LL.M., Board Certified by The Florida Bar in Health Law 

On September 14, 2012, the Drug Enforcement Agency (DEA) blocked the Walgreens distribution center in Jupiter, Florida, from shipping oxycodone and other controlled drugs to its pharmacies in Florida and the East Coast with an immediate suspension order, according to the DEA. In the press release, the DEA called the Walgreens distribution facility an “imminent danger” to the public.

To see the entire press release from the DEA, click here.

Back in April 2012, the DEA served an administrative inspection warrant at the same facility, as well as its six top retail Walgreens pharmacies in Florida. To see my blog post on that story, click here.

DEA Suspension Order Only Stops the Distribution of Controlled Substances.

The DEA said the Jupiter distribution center has been “the single largest distributor of oxycodone products in Florida” since 2009. The DEA issued the suspension order because it believes Walgreens failed to maintain proper controls to ensure its retailers didn’t dispense drugs to addicts and drug dealers.

The order only applies to the Jupiter distribution center and only suspends the distribution of controlled substances.

Whether or not bath salts fall into this category is unclear. The Florida Legislature recently banned the sale of bath salts and 90 other substances to help stop the big face-eating zombie outbreak in Florida. See my blog on bath salts and the zombie outbreak in Florida.

Recently, the DEA revoked the controlled substance licenses from two CVS pharmacies in Sanford, Florida. The two stores are accused of dispensing an inappropriate number of prescriptions for oxycodone and had a suspicious number of sales of other controlled substances. There is a blog on this story on our website, click here to read it.

Millions of Oxycodone Pills Purchased by Walgreens Stores.

According to a USA Today article, six of Walgreens’ Florida pharmacies allegedly ordered more than a million oxycodone pills a year. One pharmacy in Oviedo, Florida, went from ordering more than 80,000 oxycodone pills in 2009, to nearly 1.7 million in 2011.

Click here to read the USA Today article
.

Continued War on Prescription Drug Abuse.

According to the DEA, this is an effort to curb Florida’s prescription drug epidemic. Special Agent Mark Trouville, with the DEA’s Miami Division, said all DEA licensees “have an obligation to ensure that medications are getting into the hands of legitimate patients. When they choose to look the other way, patients suffer and drug dealers prosper.”

Neither Agent Trouville nor the DEA was, apparently, requested to comment on the bath salts ban and its effect on the zombie outbreak, however.

Oxycodone Numbers Published for Shock Value.

I really do not see why the public or our elected representatives are shocked and awed by the meaningless numbers and statistics used in connection with these matters. The fact that Walgreens, the biggest pharmacy retailer in Florida, might distribute over a million oxycodone pills in a year, is a meaningless statistic by itself. If a doctor prescribes a pain management patient a prescription for three (3) pills a day, that is approximately 90 pills per month or 1,080 pills per year. If Walgreens has only 1,000 patients with such a prescription in a year throughout the entire state of Florida, that is in excess of one million (1,000,000) pills per year. I would venture to guess that many single Walgreens retail stores have more than 1,000 customers per day, much less all Walgreens stores throughout Florida.

My point is that any such statistics are meaningless out of context and are only meant to sound huge of one doesn’t stop and think about it.

Another concern is that many, if not the vast majority of the Walgreens customers who now will not be able to get their prescriptions filled, are legitimate pain management patients with legitimate prescriptions written by legitimate physicians.

Where Do Legitimate Chronic-Pain Patients Turn?

I am constantly being contacted by patients who are in dire straits, suffering because they cannot locate a pharmacy to fill their legitimate pain medicine prescriptions. These include injured military veterans, patients who are 100% disabled and on disability or social security, patients injured in automobile accidents and job-related accidents (whose medications are paid for by insurance, if they can find a pharmacy to fill it) and others with real chronic pain issues.

If the largest legitimate chains of pharmacies in the state and nation are not allowed to fill these prescriptions, where will these suffering patients turn? Are these actions driving our citizens into the hands of shady independent pharmacies that have fewer safeguards and less accountability? Are these actions driving our citizens to seek out illegal drug dealers and turn to illegal drugs to cope with their legitimate medical problems? I hope not.

Thank you. I will get off my soapbox now.

Contact Health Law Attorneys Experienced in Representing Pharmacies and Pharmacists.

The Health Law Firm represents pharmacists and pharmacies in DEA investigations, regulatory matters, licensing issues, litigation, administrative hearings, inspections and audits. The firm’s 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:

Leinwand, Donna. “DEA Inspects Walgreens for Oxycodone Probe.” USA Today. (September 15, 2012). From: http://www.usatoday.com/news/nation/story/2012/09/14/walgreens-and-oxycodone/57782912/1

Pavuk, Amy. “DEA Blocks Controlled-Substance Distribution at Florida Walgreens Facility.” Orlando Sentinel. (September 14, 2012). From: http://articles.orlandosentinel.com/2012-09-14/news/os-walgreens-dea-suspension-20120914_1_distribution-center-dea-miami-field-division

DEA. “DEA Serves a Suspension Order on Walgreens Distribution Center in Jupiter, Florida.” DEA.gov. (September 14, 2012). From: http://www.justice.gov/dea/divisions/mia/2012/mia091412.shtml

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. He does not own stock in Walgreens or any other pharmacy.

“The Health Law Firm” is a registered fictitious business name of George F. Indest III, P.A. – The Health Law Firm, a Florida professional service corporation, since 1999.

Copyright © 1996-2012 The Health Law Firm. All rights reserved.

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Cardinal Health’s Settlement With the DEA Results in Shipment Suspension

By George F. Indest III, J.D., M.P.A., LL.M., Board Certified by The Florida Bar in Health Law

Cardinal Health and the Drug Enforcement Administration (DEA) have reached a settlement which will suspend Cardinal Health’s ability to ship controlled substances from its Florida distribution facility for two years. The company will now supply controlled substances from its distribution center in Jackson, Mississippi.

Cardinal Health’s Settlement Does Not Prevent the DEA from Pursuing Civil Penalties.

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 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.  www.TheHealthLawFirm.com  The Health Law Firm, 1101 Douglas Ave., Altamonte Springs, FL 32714, Phone:  (407) 331-6620.