Tag Archives: pharmacy investigation

Two More Compounding Pharmacies Recall Drugs

CCS Blog LabelBy Carole C. Schriefer, R.N., J.D., The Health Law Firm and George F. Indest III, J.D., M.P.A., LL.M., Board Certified by The Florida Bar in Health Law

Two different compounding pharmacies have recently recalled products due to concerns from the Food and Drug Administration (FDA). The New Jersey compounding pharmacy, Med Prep Consulting, and Clinical Specialties Compounding in Georgia, both recalled products between March 17, 2013 and March 20, 2013.

The recalls were issued as the FDA and state agencies step up regulation on compounding pharmacies across the country. These agencies are trying to prevent another widespread outbreak, like the fungal meningitis outbreak in the fall of 2012, which is responsible for 50 deaths.

Recall Upgraded in New Jersey.

Med Prep Consulting first issued a recall on March 17, 2013, for all lots of magnesium sulfate for injections after a hospital reported seeing visible particles in the containers. Three days later, the compounding pharmacy recalled all of its compounded products. Med Prep Consulting has halted production, processing and shipping. The FDA reported products distributed through March 15, 2013, in New Jersey, Pennsylvania, Delaware and Connecticut need to be returned to the company. Click here to see all the recalled products from Med Prep Consulting.

Eye Infections from Georgia Compounding Pharmacy Products.

According to Modern Healthcare, at least five people have acquired serious eye infections associated with the use of the cancer drug Avastin packaged in syringes from Clinical Specialties Compounding. At the company’s facility in Georgia the FDA raised concerns about the lack of sterility assurance. Products covered under the recall were distributed nationwide, between October 19, 2012 and March 19, 2013. Until further notice, healthcare providers are asked to stop using all of these sterile products and return them to the company. Click here to read the press release on the recall from the FDA.

Florida Compounding Pharmacy in Hot Water Due to Fungal Growth.
We have previously blogged about the problems encountered by Franck’s pharmacy in Ocala, Florida. It has been accused of distributing eye medications that contained a fungal infection. Click here for the first blog and here for the second blog on this.

Harsher Regulations on Compounding Pharmacies.

Since the widespread fungal meningitis outbreak, compounding pharmacies have fallen under heightened scrutiny. The FDA is beefing up their oversight of compounding, and, according to Modern Healthcare, the FDA and state Department of Health (DOH) agencies have been paying surprise visits to compounding pharmacies. Click here to read more from Modern Healthcare.

Common Deficiencies We See in Pharmacy Inspections.

Pharmacies and pharmacists are subject to many types of inspections. These inspections are necessary to determine whether the business and its employees are complying with state and federal laws and regulations. Administrative agencies, such as the Drug Enforcement Administration (DEA), FDA and DOH, have the authority to inspect pharmacies.

With our experience working with pharmacists and pharmacies we’ve seen a number of different inspection deficiencies. These errors may result in a complaint being filed and the beginning of the administrative law process regarding investigations and hearings.

Here are some common deficiencies often found during pharmacy inspections:

1. Pharmacy technicians not properly identified with name tags and identified as
pharmacy technicians (as opposed to pharmacists);

2. Pharmacy technicians not supervised by pharmacist;

3. Medication on shelves not properly labeled (including exact number of pills remaining in bottle);

4. Controlled substances not accurately recorded on appropriate forms; and

5. Not keeping schedule II inventory and dispensing records separate from schedule III-V records.

Click here to read a recently blog listing more deficiencies and your best defense to protect your pharmacy license and pharmacist license.

Contact Health Law Attorneys Experienced in Representing Pharmacies and Pharmacists.

The Health Law Firm represents pharmacists and pharmacies in investigations, regulatory matters, licensing issues, litigation, 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 www.TheHealthLawFirm.com.

Comments?

What do you think of the harsher regulations compound pharmacies are now facing? Please leave any thoughtful comments below.

Sources:

Meinhardt, Jane. “Compounding Pharmacies Set to Navigate Potential Regulations.” Tampa Bay Business Journal. (January 25, 2013). From: http://www.bizjournals.com/tampabay/print-edition/2013/01/25/compounding-pharmacies-set-to-navigate.html?s=print

Blesch, Gregg. “Georgia Compounding Pharmacy Widens Recall.” Modern Healthcare. (March 22, 2013). From: http://www.modernhealthcare.com/article/20130322/NEWS/303229959/#

Clinical Specialties. “Clinical Specialties Compounding Pharmacy Announces Voluntary Nationwide Recall of All lots of Sterile Products Repackaged and Distributed by Clinical Specialties Compounding Due to Lack of Sterility Assurance.” Food and Drug Administration. (March 20, 2013). From: http://www.fda.gov/Safety/Recalls/ucm344786.htm

About the Authors: Carole C. Schriefer is an attorney with 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 Avenue, Altamonte Springs, Florida 32714, Phone: (407) 331-6620.

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.

 

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.

Florida Pharmacy Owner Accused of Medicare Fraud

00011_RT8By George F. Indest III, J.D., M.P.A., LL.M., Board Certified by The Florida Bar in Health Law

A family that owns a number of South Florida pharmacies is allegedly under investigation for Medicare fraud, according to a number of sources. On January 17, 2013, federal authorities raided one pharmacy location in Naples, Florida. Drug Enforcement Administration (DEA) agents removed boxes of documents and computers from the pharmacy, according to Naples News. The pharmacy owner and his mother are allegedly being investigated by the U.S. Office of Inspector General (OIG) of the Department of Health and Human Services (HHS).

Click here to read the entire Naples News article.

Pharmacy Owner and Mother Allegedly Submitted False Claims to Medicare, Medicaid and Tricare.

According to NBC2, a South Florida television station, the pharmacy owner and his mother were both allegedly part of a scheme that defrauded Medicare. The family allegedly submitted claims to Medicare Part D after beneficiaries had died. This information came from a letter sent to Medicare Part D providers from the Centers for Medicare and Medicaid Services (CMS) on October 17, 2012. The letter was obtained by NBC2. The scheme allegedly also involved submitting false claims to Medicaid and Tricare.

Click here to watch the NBC2 news story.

Investigation is Ongoing.

The pharmacy that was raided is part of a chain of stores owned by the same family. So far, only the pharmacy located on Rattlesnake-Hammock Road in Naples is being investigated. That location is reportedly still closed, but the other pharmacy locations are open.

Neither the DEA nor the OIG of the HHS has released a press release on this investigation.

As in all media reports, please remember that all persons are presumed to be innocent until proven guilty in a court of law.

Pharmacies Are Being Raided and Shutdown  All Over the State.

If  you have watched the news at all lately or have been reading our blog, you can tell there have been an increased number of raids on pharmacies, arrests of pharmacists and emergency suspension orders issued from the Department of Health (DOH).

Recently, the DEA served a Walgreens distribution center in Florida with an immediate suspension order (click here to read more on this story), and pulled the controlled substance licenses from two Central Florida CVS Pharmacies (to learn more, click here).

In my personal opinion, the recent raids and investigations at pharmacies are especially hard on the independent operators. If the large retail giants can’t survive, the small independent pharmacies stand little chance.

Talk with an Experienced Health Law Attorney About Medicare, Medicaid and Tricare Issues Now.

The attorneys of The Health Law Firm represent healthcare providers in Medicare audits, ZPIC audits and RAC audits throughout Florida and across the U.S. They also represent physicians, medical groups, nursing homes, home health agencies, pharmacies, hospitals and other healthcare providers and institutions in Medicare and Medicaid investigations, audits, recovery actions and termination from the Medicare or Medicaid Program.

For more information please visit our website at www.TheHealthLawFirm.com or call (407) 331-6620 or (850) 439-1001.

What Do You Think?

As a pharmacy owner, pharmacy employee or health care facility owner, what do you think of the increased effort to find fraud? Do you think all facilities, not just pharmacies, are under the microscope? Please leave any thoughtful comments below.

Sources:

Freeman, Liz. “Sunshine Pharmacy in East Naples Remains Close, Day After Federal Raid.” Naples News. (January 19, 2013). From: http://www.naplesnews.com/news/2013/jan/19/sunshine-pharmacy-east-remains-closed-raid-federal/

Ritter, Rick. “Naples Pharmacy Busted for Medicare Fraud.” NBC2. (January 20, 2013). From: http://www.nbc-2.com/story/20627104/detectives-investigating-medicare-fraud-at-naples-pharmacy

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.

“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.

Drug Enforcement Administration Releases Details of Investigation into Two CVS Stores in Sanford, Florida

10 Indest-2008-7By George F. Indest III, J.D., M.P.A., LL.M., Board Certified by The Florida Bar in Health Law

In September 2012, the Drug Enforcement Administration (DEA) revoked the controlled substance licenses from two CVS pharmacies in Sanford, Florida. Details into the investigation were made public on October 12, 2012, in a final order released by the DEA.

The order explains how the stores operated, whom they prescribed painkillers such as oxycodone to, and identified Central Florida’s top-prescribing doctors.

To read the final order from the DEA, click here.

I previously wrote about the two Sanford CVS stores losing their controlled substance licenses, click here to read that blog.

Testimonies from Employees Allegedly Explained Pharmacies’ Operating System.

The final order reveals testimonies from pharmacy personnel. In a press release from the DEA the pharmacist-in-charge at one of the Sanford stores told drug agents the stores would set a limit each morning on the number of oxycodone prescriptions they would fill based on the inventory. Once the limit was reached, the pharmacy would tell customers they were “out of stock,” even when they had inventory. The pharmacist told agents the reserved inventory was for their “real pain patients.”

Warning Signs.

Employees told drug agents that their customers would ask for oxycodone using street slang such as “the M’s” or “the blues.” Oxycodone was also allegedly dispensed frequently to customers who lived out of state, obtained prescriptions from South Florida doctors, and had the prescriptions filled in Seminole County.

Click here to read the press release from the DEA.

More Stings May Be Coming.

The Walgreens distribution center in Jupiter, Florida, is currently fighting its own war with the DEA. On October 17, 2012, the biggest pharmacy retailer in Florida filed a petition

asking a federal judge to lift an immediate suspension order (ISO) banning the center from shipping controlled substances to its stores in Florida and on the East Coast. To read more on that story, click here.

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 www.TheHealthLawFirm.com.

Comments?

What do you think of the DEA’s decision? As a pharmacist how to do you regulate prescriptions for painkillers? Please leave any thoughtful comments below.

Sources:

Pavuk, Amy. “Rx for Danger: DEA Blasts CVS for Ignoring ‘Red Flags’ at Sanford Stores.” Orlando Sentinel. (October 28, 2012). From: http://www.orlandosentinel.com/health/os-cvs-dea-oxycodone-ban-20121028,0,5395839.story

Drug Enforcement Administration. “Holiday CVS Final Order Reveals Gross Negligence By

Two CVS Pharmacies in Stanford, Florida.” DEA.gov. (October 15, 2012). Press Release From: http://www.justice.gov/dea/divisions/mia/2012/mia101512.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.  www.TheHealthLawFirm.com  The Health Law Firm, 1101 Douglas Ave., Altamonte Springs, FL 32714, Phone:  (407) 331-6620.

 

“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.

Orlando Pharmacist Accused of Filling Phony Prescriptions for Painkillers

6 Indest-2008-3By George F. Indest III, J.D., M.P.A., LL.M., Board Certified by The Florida Bar in Health Law

Sex, prescription drugs and money – sounds like the next big rock ‘n’ roll song, doesn’t it? According to a number of news sources, the owner of an Avalon Park-area pharmacist was allegedly knowingly filling phony prescriptions for painkillers. The pharmacist is also accused of exchanging sex for drugs with at least one woman, according to the Orlando Sentinel. This investigation was led by the Metropolitan Bureau of Investigation (MBI) and the Drug Enforcement Administration (DEA). Both agencies simultaneously raided the pharmacy on November 29, 2012.

Avalon Park is a community it the greater Orlando area.

DEA Agents Raided Pharmacy and Pharmacist’s Home.

According to WFTV, the owner of the pharmacy and two employees sat handcuffed outside the pharmacy as federal drug agents reportedly removed boxes of evidence from the pharmacy during the raid. Agents then moved onto the pharmacist’s nearby home.

It’s believed another person was producing fake prescriptions and asking others to get them filled at the Avalon pharmacy and others around town. The people who fill the prescriptions are nicknamed “smurfs.” They are usually hired by a drug ring. They return the pills from the prescriptions they get filled, back to the ring. Click here to read what Papa Smurf has to say about his name being used in such a manner.

According to WFTV, 230 fraudulent prescriptions were produced and 33 were filled at the Avalon-area pharmacy.

Click here to watch WFTV’s report on this raid.

Smurf Allegedly Received Drugs for Sex.

A woman, who worked as a smurf, allegedly told federal agents she had sex with the pharmacist. Afterward, the pharmacist gave her cash and oxycodone, according to the Orlando Sentinel. However, we want to make it clear that those who break the law and get caught often point the finger at innocent people, trying to divert blame from themselves.

To read the article from the Orlando Sentinel, click here.

Charges Being Faced.

The pharmacist faces up to 32 counts of trafficking in controlled substance and one count of conspiracy to traffic. Federal agents believe the pharmacist is part of a larger drug ring.

On the Florida Department of Health (DOH) website his license is still listed as clear/active. To see his license status, click here.

Remember, all who are name or discussed in our blog are innocent until proven guilty in a court of law.

Contact Health Law Attorneys Experienced with Representing Pharmacists and Pharmacies.

The attorneys of The Health Law Firm provide legal representation to pharmacists and pharmacies in Department of Health (DOH) investigations, Drug Enforcement Administration (DEA) investigations, FBI investigations and other types of investigations of health professionals and providers.

To contact The Health Law Firm, please call (407) 331-6620 or (850) 439-1001 and visit our website at www.TheHealthLawFirm.com.

Comments?

Tell us your thoughts on this story. Are federal drug agents fighting a losing battle? Please leave any thoughtful comments below.

Sources:

Barrett, Steve. “Avalon Park Pharmacy Owner Accused of Filling Fake Oxycodone Prescriptions.” WFTV. (November 30, 2012). From: http://www.wftv.com/news/news/local/dea-agents-raid-avalon-park-pharmacy/nTJbw/

Pauk, Amy. “Pharmacist Accused of Over-Dispensing Painkillers, Exchanging Pills for Sex.” Orlando Sentinel. (November 29, 2012). From: http://www.orlandosentinel.com/news/local/breakingnews/os-avalon-park-pharmacy-20121129,0,6040870.story

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.

“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.

Meningitis Cases in Florida Continue to Rise – Doctors Getting Sued

10 Indest-2008-7By George F. Indest III, J.D., M.P.A., LL.M., Board Certified by The Florida Bar in Health Law

The Florida Department of Health (DOH) confirmed another case of fungal meningitis in Florida on November 19, 2012. A 56-year-old man allegedly received a contaminated steroid injection at Florida Pain Clinic in Marion County, Florida. This brings the state’s total number of fungal meningitis cases up to 24, including three deaths.

To read the entire press release from the Florida DOH, click here.

Meningitis Numbers Around the U.S. 

As of November 19, 2012, the Florida DOH reported the number of fungal meningitis cases nationwide is up to 480 with 33 deaths in 19 states.

The meningitis outbreak is reportedly linked to contaminated steroids made at the New England Compounding Center (NECC) in Framingham, Massachusetts, which is now closed. The compounding pharmacy was allegedly not following the requirements of its state license, according to the Massachusetts DOH. Under Massachusetts state law the NECC was only supposed to produce medications for patient-specific prescriptions, but it is believed the compounding pharmacy was preparing drugs in bulk. I previously wrote a blog on the reports related to the compounding pharmacy violating its license. Click here to read that blog.

Victims Sue Physicians.

Victims of the meningitis outbreak are starting to file lawsuits against the physicians and clinics that administered the tainted steroids. In a Business Insurance article released on October 28, 2012, I was quoted as saying liability might be established to the extent that the physicians were aware that the steroids distributed by the NECC violated regulations on compounding prescription medications. To read the entire article from Business Insurance, click here.

Florida and Fungal Outbreaks.

 Florida has seen its share of fungal outbreaks. I previously blogged about the problems encountered by Franck’s pharmacy in Ocala, Florida. It was accused of distributing eye medications that contained a fungal infection. Click here for the first blog and here for the second blog.

Contact Health Law Attorneys Experienced in Representing Pharmacies and Pharmacists.

The Health Law Firm represents pharmacists and pharmacies in investigations, regulatory matters, licensing issues, litigation, 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 www.TheHealthLawFirm.com.Jameson. Marni. “Florida Health Officials Confirm State’s 24th Case of Fungal Meningitis.” Orlando Sentinel. (November 19, 2012). From: ttp://www.orlandosentinel.com/news/local/breakingnews/os-florida-fungal-meningitis-20121119,0,3451600.story

Comments?

What do you think of the lawsuits again the physicians and clinics that administered the tainted steroid shots? Please leave any thoughtful comments below.

Sources:

Hiers, Fred. “Man Who Received Injection Locally Confirmed to Have Fungal Meningitis.” Ocala Star Banner. (November 19, 2012). From: http://www.ocala.com/article/20121119/ARTICLES/121119679/1412?Title=Man-who-received-injection-locally-confirmed-to-have-fungal-meningitis

Greenwald, Judy. “Meningitis Lawsuits Target Physicians.” Business Insurance. (October 28, 2012), From: http://www.businessinsurance.com/article/20121028/NEWS07/310289984?tags=|75|303

Hammonds, Jessica. “Florida Department of Health Uncovers Case of Fungal Meningitis.” Florida Department of Healht. (November 19, 2012). From: ttp://newsroom.doh.state.fl.us/wp-content/uploads/newsroom/2012/11/111912MeningitisUpdateonecase.pdf

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.

“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.

Fake Pharmacist Sentenced to Prison for Working in Central Florida Pharmacies

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

On November 2, 2012, a former Altamonte Springs resident was sentenced to three and a half years in federal prison for fraudulently working as a Central Florida pharmacist from 2000 to 2009, according to the Department of Justice (DOJ).

Click here to read the press release from the DOJ.

I previously blogged about this story when the fake pharmacist pleaded guilty. Click here to read that blog.

Phony Pharmacist Worked at Central Florida Pharmacies Including CVS and Walgreens.

According to an article in the Orlando Sentinel, the man worked at pharmacies throughout Central Florida, including a CVS and a Walgreens. While working at one of the pharmacies, he allegedly gave a customer the incorrect medication, causing that person to suffer a stroke.

Man Will Spend Time in Prison and Must Change His Name.

Allegedly, the man fraudulently obtained a pharmacy license in September of 2000

from the Florida Department of Health (DOH) by using the name, date of birth, Social Security number and pharmacy education information of a licensed pharmacist in Arizona. In 2004 the man actually changed his legal name by fraud to the name of the licensed pharmacist.

Along with his prison sentence, the fake pharmacist was ordered to change his name back to his legal name.

Fun with Alliteration.

Pardon my alliteration, but I just love all of those “F” sounds like I used in the title for this blog. For comparison, see my blog on Franck’s Pharmacy fungus case.

Look for More Stories on Phony and Fraudulent Health Professionals to Come.

In the near future on this blog we will include additional articles on fake doctors and health professionals, some old, some new.

To see a recent blog on a fake dentist in Miami, click here. You can also read the story of a fake plastic surgeon in New York by clicking here.

Contact Health Law Attorneys Experienced with Representing Pharmacists and Pharmacies.

The attorneys of The Health Law Firm provide legal representation to pharmacists and pharmacies in Department of Health (DOH) investigations, Drug Enforcement Administration (DEA) investigations, FBI investigations and other types of investigations of health professionals and providers.

To contact The Health Law Firm, please call (407) 331-6620 or (850) 439-1001 and visit our website at www.TheHealthLawFirm.com.

Comments?

What do you think of all the fake health provider stories? Please leave any thoughtful comments below.

Sources:

FBI.gov. “Pharmacist Impersonator Sentenced to Prison and Ordered to Change His Name.” FBI, Tampa Division. (November 1, 2012). From Press Release: http://www.fbi.gov/tampa/press-releases/2012/pharmacist-impersonator-sentenced-to-prison-and-ordered-to-change-his-name

Pavuk, Amy. “Fake Pharmacist Sentenced to Federal Prison.” Orlando Sentinel. (November 1, 2012). From: http://www.orlandosentinel.com/news/local/breakingnews/os-fake-pharmacist-prison-20121101,0,4565731.story
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.

“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.

Boca Raton Compounding Pharmacy Shuts Its Doors After Receiving an Emergency Suspension Order

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

On October 26, 2012, the Florida Department of Health (DOH) issued an emergency suspension order (ESO) against a Boca Raton compounding pharmacy, according to a number of sources. The DOH in a press release called the conditions in the pharmacy so “deplorable” that nothing short of immediately shutting down the pharmacy would suffice.

Click here to read the press release from the DOH.

Rodent Feces, Dead Bugs and a Sink Full of Dirty Water all Found at Compounding Pharmacy.

On October 12, 2012, a state inspector arrived at the Boca Raton compounding pharmacy for an inspection. According to an article on Health News Florida, rodent feces, dead bugs and a sink full of dirty water were discovered. A film of powder covered surfaces in the drug-compounding area, where containers of drugs were open. Information on patients and prescriptions was missing, and drug labels were missing important information on the dose, lot number and prescribing physician.

Apparently the compounding pharmacy had been cited in past inspections for similar issues.

To read the Health News Florida article, click here.

All Compounding Pharmacies Are Now Under Pressure.

The compounding pharmacy can have a DOH hearing before final action is taken. The suspension is in effect until final disciplinary action, until the suspension is lifted or the case is appealed.

This inspection and ESO occurred in the wake of a nationwide outbreak of fungal meningitis linked to contaminated drugs made by a compounding pharmacy in Massachusetts. I previously wrote a blog on the Massachusetts compounding pharmacy shutting down. To read more click here.

It’s believed because of the meningitis outbreak, all compounding pharmacies are under the microscope.

Another Florida Compounding Pharmacy in Trouble Due to Fungal Growth.

I previously blogged about the problems encountered by Franck’s pharmacy in Ocala, Florida. It has been accused of distributing eye medications that contained a fungal infection. Click here for the first blog and here for the second blog I wrote on this.

Contact Health Law Attorneys Experienced in Representing Pharmacies and Pharmacists.

The Health Law Firm represents pharmacists and pharmacies in investigations, regulatory matters, licensing issues, litigation, 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 www.TheHealthLawFirm.com.

Comments?

Do you think the Boca Raton compounding pharmacy was unfairly served with an ESO due to the meningitis outbreak? Or do you think it is better for the Florida DOH to be safe rather than sorry? Please leave any thoughtful comments below.

Sources:

Gentry, Carol. “State Finds Pharmacy Conditions ‘Deplorable,’ Suspends License.” Health News Florida. (October 26, 2012). From: http://wusfnews.wusf.usf.edu/post/state-finds-pharmacy-conditions-deplorable-suspends-license

Florida Department of Health. “Department of Health Takes Action Against Florida Pharmacy.” DOH. (October 26, 2012). Press Release From: http://newsroom.doh.state.fl.us/wp-content/uploads/newsroom/2011/08/102612RejuviESO.pdf

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.

“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.