Tag Archives: florida

22 New Synthetic Drugs Outlawed in Florida: Citizens Keep an Eye Out for Zombies

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

On December 11, 2012, Attorney General (AG) Pam Bondi filed an emergency rule outlawing 22 new synthetic drugs, commonly known as “bath salts,” “K2,” and “Spice.” This emergency rule modifies Section 893.03(1)(c), Florida Statutes, by expanding the list of synthetic drugs in Schedule I of controlled substances of the Florida Comprehensive Abuse Prevention and Control Act.

Click here to view a copy of the emergency rule.

I previously wrote a blog on House Bill 1175 in July 2012, which originally outlawed 90 forms of synthetic drugs. Click here to read that blog.

Authorities Having a Hard Time Staying on Top of These Drugs.

The new law puts restrictions on those who manufacture, sell or deliver synthetic substances including certain synthetic cannabinoids and synthetic stimulants. Many of the synthetic substances are also commonly known as synthetic marijuana, bath salts, K2, potpourri, and incense. According to an article in the Orlando Sentinel many of these drugs look like snacks for children. One of these drugs is even marketed as a “Scooby Snack,” another looks like cotton candy. To read the entire article from the Orlando Sentinel, click here.

Florida’s officials are continuously updating the list of outlawed synthetic substances because the chemical compounds in these substances are easy to change. The ease of converting these substances into illegal drugs helps drug makers, users and sellers avoid arrest and prosecution.

Click here to see the entire list of outlawed controlled substances.

Anyone with These Drugs Asked to Voluntarily Surrender Supply.

The emergency rule by the AG makes it a third-degree felony for an individual to sell, manufacture or deliver these synthetic drugs.

These drugs are widely available in smoke shops, truck stops, convenience stores and on the internet. In a press release the AG and local law enforcement reached out to people handling these drugs, asking them to voluntarily surrender the substances or face action from law enforcement.

To read the entire press release from the AG, click here.

AG Wants a Zombie-Free Holiday.

This emergency rule is evidence of Floridians’ fear of zombies and cannibal attacks allegedly linked to the misuse of the outlawed substances. Florida has been linked to both in the national news, thus scaring away many of our tourists who usually flood the state. For an update on the zombie apocalypse in Florida, click here. Of course, there are those detractor who contend that face-chewing and other alleged zombie behavior is just natural behavior for Floridians, regardless of the chemicals imbibed.

Since Florida seems to be the only state infected with these flesh-eaters, we are taking a poll. Should Florida be renamed “the Zombie State?” Let us hear from you.

Contact Experienced Health Law Attorneys.

The Health Law Firm routinely represents pharmacists, pharmacies, physicians, nurses and other health providers 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.

Comments?

What do you think of this new list of outlawed synthetic drugs? Do you think sellers will voluntarily surrender their products? Will this new list keep the zombies away? Tell us, do you think we should rename Florida the Zombie state? Click here to vote in a poll on our Facebook page.

Sources:

Meale, Jenn. “Attorney General Pam Bondi Outlaws Additional Synthetic Drugs.” Office of the Attorney General. (December 11, 2012). From: http://www.myfloridalegal.com/newsrel.nsf/newsreleases/C2FED4E8849E737685257AD1006EED54

Haughney, K. “Bondi Files Emergency Rule to Outlaw Additional Synthetic Drugs.” Orlando Sentinel. (December 11, 2012). From: http://blogs.orlandosentinel.com/news_politics/2012/12/bondi-files-emergency-rule-to-outlaw-additional-synthetic-drugs.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.
“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.

Central Florida Has Been Invaded By Zombies – No Twinkies Means No Food Source

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

You are already aware of Floridians’ fear of zombies, as shown by recent legislation against bath salts. Despite this, there continue to be reports of rampant zombie outbreaks across the Sunshine State. The zombie apocalypse has hit Central Florida, hard. As a citizen of Florida, you know you are not safe; not from zombies, not from British tourists, not from inability to count (notes in an election) and not from the state legislature. To make matters worse, Twinkies, the only food known to mankind that can survive a post-apocalyptic zombie outbreak (reference: Zombieland 2009) or a nuclear holocaust (reference: Family Guy, second season, third episode Dec. 26, 1999), may soon be out of production. Everyone knows Twinkies have a shelf life of 246 years.

Since Florida seems to be the only state infected with this flesh-eating disease, we are taking a poll. Should we be renamed “the Zombie State?”

A Run With the Living Dead in Clermont.

For those of your reading this blog from another state, you’re in luck. There is actual video footage of how bad the zombie outbreak has gotten in Florida. In Clermont, thousands of cardio-enthusiasts showed up to run a 5K course filled with numerous obstacles that forced participants to crawl in the sticky mud to avoid being pricked by barbed wire above and walking along an unstable beam of wood. Unfortunately, the runners were bombarded along the way by the living dead looking for a quick bite to eat. The participants had to protect their brains while running for their lives. Only the fastest survived.

To see video of attack, click here.

Zombies Take Over the University of Central Florida (UCF).

If you are in Florida and were hoping to take shelter on the campus of the University of Central Florida (UCF), you’re too late. From now until December 2, 2012, the campus will be crawling with zombies who have taken to the stage in a production called “Zombie Town: A Documentary Play.”

We’ve heard it’s not bad. Click here to read a review of the performance.

No Twinkies = No Hope.

By now you’ve heard Hostess, the maker of Twinkies, may be on its way to a complete shutdown. As you know, these delicious treats are the only food that can survive a zombie outbreak. If Hostess closes its doors, we are doomed for sure. Thank goodness Hostess and its striking union members are renegotiating. If Hostess does shut down, it’s rumored a Boca Raton, Florida, company will purchase the brand. We can only hope.

To read the latest on the Hostess debacle, click here.

Given the increasing number of zombie attacks in Florida, the price of Twinkies could soar into the hundreds of dollars each in Florida. Doomsday enthusiasts and disenchanted stock market investors are allegedly pouring funds into warehouse loads of Twinkies.

Is the Ban on Synthetic Drugs in Florida Working?

If you remember, Florida Governor Rick Scott signed House Bill 1175 on March 23, 2012. This bill outlawed more than 90 new forms of synthetic drugs. It modified Section 893.03(1)(c), Florida Statutes, by expanding the list of banned hallucinogenic substances in Schedule I of the Florida Comprehensive Abuse Prevention and Control Act. To view Florida HB 1175, click here. To read more on the ban, click here.

HB 1175 was in response to the first known zombie attack in Miami. This cannibalistic attack was allegedly because the one man was high on bath salts. It was rumored that one prominent Florida lawmaker stated that banning bath salts, smiles and other synthetic drugs should help to reduce the reported acts of cannibalism and zombie-like behavior in Florida.

And he was wrong, the walking dead are alive, sort of, and well in Florida.

Contact Experienced Health Law Attorneys.

The Health Law Firm routinely represents pharmacists, pharmacies, physicians, nurses and other health providers 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.

Comments?

What do you think about all the zombies around town? What are you doing to survive? Are you stocking up on Twinkies now? Tell us, do you think we should rename Florida the Zombie state? Vote in a poll on our Facebook page.

Sources:

Armstrong, Cassie. “Zombies Invade Clermont in 5K Challenge.” Florida 360. (November 17, 2012). From: http://www.orlandosentinel.com/multimedia/os-fla360-zombies-invade-clermont-in-5k-challenge,0,110644.story

Palm, Matthew. “Theater review: ‘Zombie Town: A Documentary Play’ from Theatre UCF.” Orlando Sentinel. (November 18, 2012). From: http://www.orlandosentinel.com/community/ucf/os-zombie-town-review-ucf-20121116,0,4007008.story

Hsu, Tiffany. “Hostess, Union to Give Talks Another Chance.” Orlando Sentinel. (Novemeber 2012). From: http://www.orlandosentinel.com/la-fi-mo-twinkies-hostess-union-mediation-20121119,0,4220893.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.

New Popular Drug Called “Smiles” Outlawed in Florida – Zombie Attacks Still a Threat!

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

In previous blogs we’ve mentioned that Florida Governor Rick Scott signed House Bill 1175 on March 23, 2012. This bill outlawed more than 90 new forms of synthetic drugs and included bath salts, among others. It modifies Section 893.03(1)(c), Florida Statutes, by expanding the list of banned hallucinogenic substances in Schedule I of the Florida Comprehensive Abuse Prevention and Control Act. To see Florida HB 1175, click here. To see the entire list of banned substances, click here.

As you are no doubt aware, this was due, in part, to the recent outbreak of zombie attacks in the state of Florida. To see my prior blog on this, click here.

A new drug is popping up on the market with the name 2C-I or “smiles.” This drug is on the list of banned hallucinogenic substances, but has been linked to a number of deaths across the country.

Click here to learn more on the dangers of taking smiles.

Actor Thought to Have Taken Smiles Prior to Death.

According to CBS News, Johnny Lewis, an actor on the TV show “Sons of Anarchy,” is believed to have taken smiles before allegedly killing his landlady and falling to his death. Detectives believe the actor also had mental health issues.

To see the CBS News story, click here.

Florida’s Synthetic Drug Legislation Imposes Restrictions on Synthetic Substances.
The law that was passed in Florida put in place restrictions to prevent abuse of synthetic substances including certain synthetic cannabinoids and synthetic stimulants. Many of the synthetic substances are also commonly known as synthetic marijuana, smiles, bath salts, K2, potpourri, and incense.

The large quantities of synthetic substances are included in HB 1175 because the chemical compounds in these substances are easy to change. The ease of converting these substances into illegal drugs helps illegal drug makers, users and sellers to avoid arrest and prosecution. For example, one synthetic substance might be illegal under the Florida Comprehensive Abuse Prevention and Control Act, but a minor change in the molecular makeup might make the substance legal. Florida residents who desired to become zombies could just take one of these synthetic substances (don’t ask how). They no longer have to go to Haiti or watch “Weekend at Bernie’s” three times in a row.

Banning Synthetic Drugs Was An Attempt To Reduce Cannibalistic Attacks.

Who can forget the story of the Miami cannibal believed to have been on bath salts?

To refresh your memory, click here to see the story from CNN. Warning this does include actual video of the attack.

It was rumored that one prominent Florida lawmaker stated that banning bath salts, smiles and other synthetic drugs should help to reduce the reported acts of cannibalism and zombie-like behavior in Florida.

Manufacturers and Retailers, Watch Your Back.

The passing of HB 1175 could mean more issues for manufacturers and retailers of any products utilizing synthetic substances such as bath salts, herbal incense, or potpourri. If you manufacture or sell any product that is composed of synthetic substances you should regularly test your products to ensure that you are in full compliance with the new law.

On October 2, 2012, a Port Orange, Florida, store owner was charged with drug possession with intent to sell. Officials accused him of selling synthetic drugs, including marijuana and bath salts.

To see the Orlando Sentinel story on this arrest, click here.

Contact Experienced Health Law Attorneys.

The Health Law Firm routinely represents pharmacists, pharmacies, physicians, nurses and other health providers 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.

Comments?

What do you think about the ban on synthetic drugs? Do you think it is working or not working? Please submit any thoughtful comments below.

Sources:

Jaslow, Ryan. “‘Smiles’ Druge Implicated in Actor’s Death: What Are They?” CBS News. (September 28, 2012). From: http://www.cbsnews.com/8301-204_162-57522571/smiles-drug-implicated-in-actors-death-what-are-they/

Weiss, Piper. “2C-I or ‘Smiles’: The New Killer Drug Every Parent Should Know About.” Yahoo. (September 20, 2012). From: http://shine.yahoo.com/healthy-living/2c-smiles-killer-drug-every-parent-know-234200299.html

Hernandez, Arelis. “Store Owner Accused of Selling Synthetic Drugs, Bath Salts.” Orlando Sentinel. (October 2, 2012). From: http://www.orlandosentinel.com/news/local/breakingnews/os-bath-salts-arrest-20121002,0,7437907.story

CNN. “Security Video Shows Entire Miami ‘Zombie’ Attack.” CNN. (May 30, 2012). From: http://news.blogs.cnn.com/2012/05/30/security-video-shows-entire-miami-zombie-attack/

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.

Settlement Reached in GlaxoSmithKline Healthcare Fraud Case

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

GlaxoSmithKline (GSK), a prescription drug manufacturer, will pay $3 billion in fines to resolve allegations of healthcare fraud. The settlement was announced by federal prosecutors on July 1, 2012, and in a press release from the Florida Attorney General on July 2, 2012. This is the largest healthcare fraud settlement in U.S. history.

Settlement Resolves Allegations Against GSK Related to Healthcare Fraud.

The settlement resolves allegations that GSK:

  • Marketed the depression drug Paxil for off-label uses, such as use by children and adolescents; 
  • Marketed the depression drug Wellbutrin for off-label uses, such as for weight loss and treatment of sexual dysfunction, and at higher-than-approved dosages; 
  • Marketed the asthma drug Advair for off-label uses, including first-line use for asthma;
  • Marketed the seizure medication Lamictal for off-label uses, including bipolar depression, neuropathic pain, and various other psychiatric conditions; 
  • Marketed the nausea drug Zofran for off-label uses, including pregnancy-related nausea; 
  • Made false representations regarding the safety and efficacy of Paxil, Wellbutrin, Advair, Lamictal, Zofran, and the diabetes drug Avandia;
  • Offered kickbacks to healthcare professionals to induce them to promote and prescribe certain prescription drugs; and
  • Submitted incorrect pricing data for various prescription drugs, thereby underpaying rebates owed to Medicaid and other federal healthcare programs.

GSK Will Also Plead Guilty to Criminal Charges as Part of Settlement.

As part of the settlement, GSK has will plead guilty to criminal charges that it violated the federal Food, Drug, and Cosmetic Act (FDCA). Allegedly, GSK introduced Wellbutrin and Paxil into interstate commerce when the drugs contained labels that were not in accordance with their FDA approvals. Additionally, GSK allegedly failed to report certain clinical data regarding Avandia to the FDA.

Florida to Receive Over $56 Million In Settlement.

Florida will receive more than $56 million as part of the settlement with GSK. Florida Attorney General, Pam Bondi, announced the state’s participation in the settlement on July 2, 2012.

Settlement Stems From Whistleblower Actions.

The settlement is based on four qui tam, or whistleblower, actions brought by individuals pursuant to state and federal false claims. To view the federal False Claims Act, click here. A National Association of Medicaid Fraud Control Units team, along with several other federal agencies, investigated the matter and conducted settlement negotiations with the defendants. Florida’s civil investigation was handled by the Attorney General’s Complex Civil Enforcement Bureau, which is part of the Medicaid Fraud Control Unit.

Contact Health Law Attorneys Experienced in Healthcare Fraud Cases.

The Health Law Firm represents physicians, medical practices, pharmacists, pharmacies, and other health providers in healthcare fraud cases, including investigations, regulatory matters, litigation, and audits involving government health programs (Medicare, Medicaid, TRICARE).

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:

Meale, Jenn. “Attorney General Bondi’s Office Reaches Historic Healthcare Fraud Settlement.” Florida Office of the Attorney General. (July 2, 2012). Press Release. From: http://www.myfloridalegal.com/newsrel.nsf/newsreleases/E494FDADFF113AC885257A2F0068F790

Schmidt, Michael S. and Katie Thomas. “GlaxoSmithKline Agrees to Pay $3 Billion in Fraud Settlement.” New York Times. (July 2, 2012). From: http://www.nytimes.com/2012/07/03/business/glaxosmithkline-agrees-to-pay-3-billion-in-fraud-settlement.html?pagewanted=all

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.

411-PAIN Settles with Florida Attorney General

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

Florida Attorney General Pam Bondi announced that her office has reached a settlement with 411-PAIN. The settlement requires 411-PAIN to pay $550,000 and change its advertising practices for allegedly making misrepresentations to consumers. 411-PAIN is a Florida-based attorney and chiropractic referral service.

411-PAIN Allegedly Misrepresented Consumer Entitlements.

The Attorney General pursued action against 411-PAIN for the company’s alleged violation of Florida’s Deceptive and Unfair Trade Practices Act, Chapter 501, Part II, Florida Statutes. To view Florida’s Deceptive and Unfair Trade Practices Act, click here.

Allegedly, the company misrepresented that consumers could be entitled to $100,000 or more for injuries and lost wages as a result of accidents. The company also allegedly misrepresented that consumers could be entitled to more than $10,000 in personal injury protection compensation or benefits for injuries and lost wages. The alleged misrepresentations were made through the company’s advertising.

Additionally, 411-PAIN was accused of falsely stating that police officers require consumers to call 411-PAIN after calling emergency services following an auto accident. This was allegedly conveyed through the company’s advertisements which used actors dressed as police officers. The advertisements allegedly did not feature a disclosure that the individuals in the commercials were actors and not actual law enforcement officers.

Attorney Services Allegedly Misrepresented by 411-PAIN.

411-Pain also allegedly misrepresented attorney services to consumers. The company is accused of stating that consumers would be referred to a “qualified” attorney or “specialized” attorney who specializes in the type of injury or accident they sustained, when no such attorney specialization exists in Florida.

Settlement Restricts the Company’s Advertising.

The settlement reached by the state in Broward Circuit Court prohibits 411-PAIN from
 • Promising any monetary compensation in its ads; 
 • Saying it’s referring victims to a “specialized attorney;” 
 • Using images of law enforcement officers to suggest that officials are directing consumers to use 411-Pain after calling 911, unless the officer is labeled as a “paid actor.”

To view the full settlement, click here.

Sources:

Cohen, Bryan. “Florida AG Settles with 411-PAIN.” Legal Newsline. (June 5, 2012). From:
http://www.legalnewsline.com/news/contentview.asp?c=236354

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.

Franck’s Pharmacy Recalls Compounding Prescriptions and Shuts Down Sterile Compounding Service

Franck’s Pharmacy, Inc. located in Ocala, Florida, has issued a recall for its compounded prescriptions. The prescriptions impacted by this recall include all sterile human and veterinary compounded prescriptions distributed by Franck’s Pharmacy from November 21, 2011 to May 21, 2012. Franck’s Pharmacy made the announcement on the company’s website on May 24, 2012. To see the recall click here.

Recall Based on FDA Findings of Fungal Growth in Pharmacy’s Clean Room.

The recall was apparently prompted by action by the U.S. Food and Drug Administration (FDA). The FDA notified Franck’s Pharmacy that environmental sampling of the pharmacy’s clean room revealed the presence of microorganisms and fungal growth. Because of the FDA’s findings, Franck’s Pharmacy decided to recall its sterile compounds to prevent any possible risk of infection to patients.

Franck’s Pharmacy Urges Physicians to Assist in Recall Efforts.

Franck’s Pharmacy is seeking the assistance of physicians in alerting patients who may be impacted by the recall. Franck’s Pharmacy is also advising physicians to review and evaluate patient records to determine if any adverse events may have resulted from use of the recalled products. Any adverse events should be reported to Franck’s Pharmacy and the FDA’s MedWatch program.

Franck’s Pharmacy Ceases Production of Sterile Compounds.

Franck’s Pharmacy also announced that it will stop producing sterile compounds at its Ocala lab facility for the present. Franck’s Pharmacy made the announcement via e-mail on May 23, 2012. The e-mail also confirmed that several employees had been laid off. Allegedly, these employees were terminated due to the sterile compounding shutdown. Franck’s Pharmacy will continue to compound non-sterile human and veterinary medicine.

Franck’s Pharmacy Recently Linked to Eye Infection Outbreak.

Franck’s Pharmacy decided to cease sterile compounding after the Centers for Disease Control and Prevention (CDC) issued a warning urging physicians not to use sterile products made by Franck’s Pharmacy. The warning was issued after the CDC traced a rare fungal eye infection back to the pharmacy. The infection impacted at least 30 patients who allegedly had undergone some type of eye procedure in which Franck’s Pharmacy products were used. For additional information on this, click here.

Prior Deaths of 30 Polo Ponies.

In an earlier unfortunate incident in 2009, Franck’s Pharmacy’s compounding of veterinarian prescriptions allegedly led to the deaths of approximately 30 expensive polo ponies here in Florida. Click here for details. In the aftermath of that case, the FDA attempted to prevent Franck’s Pharmacy from any further compounding of pharmaceuticals for veterinary purposes. The FDA eventually lost the case heard by the U.S. District Court, Middle District of Florida, which ruled in favor of Franck’s Pharmacy. The decision can be seen here.

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.

Sources Include:

Franck, Paul. “Urgent: Compounding Prescriptions Recall.” Franck’s Pharmacy. Press Release. (May 23, 2012). From
http://www.francks.com/

Medina, Carlos E. “Franck’s Ceases Sterile Compounding Service.” Ocala.com. (May 23, 2012) From
http://www.ocala.com/article/20120523/ARTICLES/120529872/-1/entertainment02?template/

Florida Pharmacy Allegedly the Cause of Eye Infection Outbreak

The Centers for Disease Control (CDC) has allegedly traced a rare fungal infection to an Ocala pharmacy, according to media reports. As reported, Franck’s Compounding Lab is believed to be at least partially responsible for spreading a rare fungal eye infection to over 30 patients across the U.S.

The CDC reports that eye drops and injections traced back to the lab caused the infections. These ophthalmic products contained multiple fungal and bacterial species, according to the CDC. The products have now been recalled, but were in use for over a year before the recall. The CDC has also issued a warning to avoid any product labeled sterile from Franck’s.

The patients impacted by the contaminated products had all undergone some type of eye procedure in which the Franck’s products were used. 23 patients have allegedly suffered some vision loss as a result of the infection.

The Florida Department of Health (DOH) has stated that it cannot divulge if Franck’s or any other pharmacy is being investigated at this time. If the pharmacy is believed to pose an immediate threat to patient safety, the DOH could issue an emergency suspension order (ESO) to immediately suspend the pharmacy’s license.

Franck’s has released a statement saying that the pharmacy is fully cooperating with the DOH and FDA. Franck’s says it is currently cooperating to conduct product recalls and will assist in post-recall inspections to prevent future occurrences.

This is not the first time that this Central Florida pharmacy has made headlines. In 2009, the pharmacy was blamed for the deaths of over twenty polo horses in south Florida. This was also allegedly caused by a contaminated compound. Because of this case, the FDA tried to stop Franck’s from compounding veterinary products.

However, Franck’s won in U.S. District Court when United States v. Franck’s Lab, Inc. was decided in December 2011. In this case, the federal court ruled that the FDA does not have the authority to regulate the practice of pharmacists compounding veterinary prescriptions from bulk substances. The decision in favor of the pharmacy can be found here.

The Health Law Firm represents pharmacists and pharmacies in investigations, regulatory matters, licensing issues, litigation, inspections and audits. It’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.

Sources Include:

Associated Press. “CDC Links Eye Infections to Troubled Florida Pharmacy.” Fox News.com. (May 04, 2012). From
http://www.foxnews.com/health/2012/05/04/cdc-links-eye-infections-to-troubled-florida-pharmacy/#ixzz1tvHCA4yg

CBS News Staff. “Rare Fungal Eye Infections Tied to Fla. Pharmacy, CDC Warns.” CBS News. (May 04, 2012). From:
http://www.cbsnews.com/8301-504763_162-57427915-10391704/rare-fungal-eye-infections-tied-to-fla-pharmacy-cdc-warns/

Medina, Carlos E. “Eye Infections Linked to Ocala’s Franck’s Compounding Lab.” The Gainesville Sun. (May 03, 2012) From
http://www.gainesville.com/article/20120503/ARTICLES/120509811?tc=ar

United States v. Franck’s Lab, Inc., No. 5:10-cv-147-Oc-32TBS (M.D. Fla., Sept. 12, 2011).

WFTV. “Ocala Pharmacy Blamed for Dozens of People Suffering Vision Loss.” WFTV.com. (May 04, 2012). From
http://www.wftv.com/news/news/local/ocala-pharmacy-blamed-dozens-people-suffering-visi/nNWCR/