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 […]
Florida Pharmacy Owner Accused of Medicare Fraud
By 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 […]
Update: Fake DEA Agents Calling Citizens, Claiming to Have Arrest Warrant
By George F. Indest III, J.D., M.P.A., LL.M., Board Certified by The Florida Bar in Health Law Health care providers beware, there is a scam making its rounds in Central Florida. Con men are telephoning citizens, including physicians, and pretending to be Drug Enforcement Administration (DEA) agents in the hope of extorting money from them. […]
Osceola County Authorities Nab 29 People in Phony Prescription Ring
By George F. Indest III, J.D., M.P.A., LL.M., Board Certified by The Florida Bar in Health Law A sting on a prescription fraud ring netted 29 arrests in Osceola County, Florida. On December 13, 2012. Osceola County Investigative Bureau (OCIB) agents, along with the Osceola County Sheriff’s Office, Kissimmee Police Department and St. Cloud Police […]
Drug Enforcement Administration Releases Details of Investigation into Two CVS Stores in Sanford, Florida
By 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 […]
Nationwide Telephone Scam: Phony DEA Agents Extorting Money from Victims
By George F. Indest III, J.D., M.P.A., LL.M., Board Certified by The Florida Bar in Health Law The Drug Enforcement Administration (DEA) is warning the public to be aware of a prescription drug scam. This telephone scheme is extorting money from people all over the country. On November 28, 2012, the DEA released a press […]
Orlando Pharmacist Accused of Filling Phony Prescriptions for Painkillers
By 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 […]
Meningitis Cases in Florida Continue to Rise – Doctors Getting Sued
By 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 […]
University of Miami Employee Allegedly Caught Red Handed Stealing More Than $14 Million in Cancer Drugs
By Michael L. Smith, J.D., R.R.T., Board Certified by The Florida Bar in Health Law For three years, hundreds of life-saving cancer drugs disappeared from the shelves of the University of Miami’s (UM) Sylvester Comprehensive Cancer Center. A pharmacy technician at the center was arrested in connection to the thefts in May of 2011, and […]
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 […]
New Anti-Prescription Drug Abuse Campaign in Pinellas County
By George F. Indest III, J.D., M.P.A., LL.M., Board Certified by The Florida Bar in Health Law Pinellas County has started a new billboard campaign aimed at curbing prescription drug abuse. The billboard message reads, “We’re shutting down Pill Mills in Pinellas County.” The first two billboards were erected on April 1, 2012. Several smaller […]
Two More Compounding Pharmacies Recall Drugs

By 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 […]
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 […]
Walgreens Reaches Settlement in False Claims Act Case
By George F. Indest III, J.D., M.P.A., LL.M., Board Certified by The Florida Bar in Health Law Walgreens has reached a $7.9 million settlement with the United States and participating states that resolves allegations that Walgreens violated the False Claims Act. The DOJ announced the settlement on April 20, 2012. To view the DOJ’s press […]
Franck’s Pharmacy Closes; Compounding Lab is Now Wells Pharmacy Network
By George F. Indest III, J.D., M.P.A., LL.M., Board Certified by The Florida Bar in Health Law July 31, 2012, marked the end of an era for Franck’s Pharmacy in Ocala, Florida, as the retail location closed its doors for good. According to an Ocala Star-Banner article, in July 2012, Franck’s Compounding Lab, which was […]
More than 30 People Charged with Pharmaceutical Drug Trafficking in Central Florida
By Dr. Thu Pham, O.D., Law Clerk, The Health Law Firm Attorney General Pam Bondi along with special agent Mark R. Trouville of the Drug Enforcement Administration (DEA) and Longwood Police Chief Troy Hickson announced, on June 20, 2012, the execution of 37 arrest warrants stemming from state drug charges. The defendants all reside in […]
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, […]
Orlando Pharmacist in Hot Water After Filling Fraudulent Prescriptions
By George F. Indest III, J.D., M.P.A., LL.M., Board Certified by The Florida Bar in Health Law Another pharmacist was led away in handcuffs during a September 25, 2012, raid on an Orlando-area pharmacy, according to a number of sources. The pharmacist is accused of filling prescriptions for oxycodone, even though he allegedly knew the […]
CVS Possibly Under Investigation for Medicare Fraud
By George F. Indest III, J.D., M.P.A., LL.M., Board Certified by The Florida Bar in Health Law The Office of Inspector General (OIG) for the U.S. Department of Health and Human Services (HHS) has reportedly launched an investigation into CVS’ practice for refilling prescriptions. According to an article in the Los Angeles Times, authorities are […]
Most Physicians Not Using the Prescription Drug Monitoring Program
By Danielle M. Murray, J.D. The Florida Prescription Drug Monitoring Program is apparently collecting dust as physicians are choosing not to use it. The Tampa Bay Times reported on October 5, 2012, that as few as one in twelve doctors have ever used the database. That is about eight percent (8%) of all physicians. Approximately […]
New England Compounding Pharmacy Linked to Meningitis Outbreak Suspected of Violated License
By George F. Indest III, J.D., M.P.A., LL.M., Board Certified by The Florida Bar in Health Law The compounding pharmacy behind the meningitis outbreak was allegedly not following the requirements of its state license, according to the Massachusetts Department of Health (DOH) in a released statement on October 10, 2012. To read the entire statement […]
Healthcare Providers Service Organization (HPSO) Attorneys, Lawyers and Defense Council in Florida
By George F. Indest III, J.D., M.P.A., LL.M., Board Certified by The Florida Bar in Health Law Often we learn after the fact that a health professional such as a mental health counselor, psychologist, or pharmacist has received Healthcare Providers Service Organization (HPSO) insurance, has had a legal problem, and has not been able to […]
Two Separate Lawsuits Against Novartis Pharmaceuticals Corporation Allege Illegal Kickbacks and False Claims
By George F. Indest III, J.D., M.P.A., LL.M., Board Certified by The Florida Bar in Health Law Novartis Pharmaceuticals Corporation (NPC) is currently fielding two different lawsuits, filed just days apart from each other, by the U.S. Department of Justice (DOJ). The first lawsuit was filed on April 23, 2013, alleging the company gave illegal […]
Supreme Court Rules that Government Regulators Can Sue Over Pay-for-Delay Agreements Between Brand and Generic Drug Manufacturers
By George F. Indest III, J.D., M.P.A., LL.M., Board Certified by The Florida Bar in Health Law The U.S. Supreme Court ruled on June 17, 2013, that pay-for-delay agreements between brand name and generic drug manufacturers are subject to anti-trust scrutiny. These pay-for-delay agreements, or reverse payments, are usually a form of settlement between the […]
Terrible Things That Can Happen after Discipline on Your Professional License or Resignation of a License after Notice of Investigation
By George F. Indest III, J.D., M.P.A., LL.M., Board Certified by The Florida Bar in Health Law Do you have a medical, pharmacy or nursing license in several different states? Do you have a license in more than one health profession? Have you been notified that an investigation has been opened against you? Are you […]
Orlando Health’s Restructuring Efforts Might Mean Pay Cuts and Layoffs for Employees
By George F. Indest III, J.D., M.P.A., LL.M., Board Certified by The Florida Bar in Health Law Many employees at Orlando Health might be getting hit hard in the wallet with pay cuts schedule for later this year. According to the Orlando Sentinel, the eight-hospital health system notified its night-shift workers that their differential pay […]
New Requirements Released for Physician Medical Records Related to Compounded Medications

By Michael L. Smith, R.R.T., J.D., Board Certified by The Florida Bar in Health Law and George F. Indest III, J.D., M.P.A., LL.M., Board Certified by The Florida Bar in Health Law On September 5, 2013, the Florida Board of Medicine and the Florida Board of Osteopathic Medicine published new requirements for medical record documentation […]
Florida Nursing Home Owner Arrested for Alleged $395,000 Medicaid Fraud Scheme
By George F. Indest III, J.D., M.P.A., LL.M., Board Certified by The Florida Bar in Health Law A Miami-Dade nursing home owner was arrested for allegedly committing $395,000 worth of Medicaid fraud. The Florida Attorney General (AG) accused the nursing home owner of using the billing names of non-existent businesses to submit fraudulent invoices. The […]
Pharmacists: Talk to a Lawyer Before You Talk to an Investigator

By Christopher E. Brown, J.D. In Florida, You DO NOT Have to Speak to an Investigator! Despite mailing out hundreds of thousands of postcards and letters to pharmacists, throughout Florida, we continue to receive calls from new clients and from potential clients, after they have already spoken to and made critical harmful admissions against their […]
Nurses: Beware of Nationwide Telephone Prescription Drug Scam
By George F. Indest III, J.D., M.P.A., LL.M., Board Certified by The Florida Bar in Health Law The Drug Enforcement Administration (DEA) is warning nurses to be aware of a prescription drug scam. This telephone scheme is extorting money from people all over the country. On November 28, 2012, the DEA released a press release […]
Nurse: Please, Please, Please: Talk to an Attorney Before You Talk to an Investigator
By George F. Indest III, J.D., M.P.A., LL.M., Board Certified by The Florida Bar in Health Law In Florida, You DO NOT Have to Speak to an Investigator! Despite mailing out hundreds of thousands of postcards and letters to physicians, nurses, dentists, pharmacists, and psychologists throughout Florida, we continue to receive calls from new clients […]
Psychologists: Don’t Fall Victim to Scammers that Call and Claim to be DEA Agents
By George F. Indest III, J.D., M.P.A., LL.M., Board Certified by The Florida Bar in Health Law The Drug Enforcement Administration (DEA) is warning psychologists to be aware of a prescription drug scam. This telephone scheme is extorting money from people all over the country. On November 28, 2012, the DEA released a press release […]
Massage Therapists: Beware of Nationwide Telephone Prescription Drug Scheme
By George F. Indest III, J.D., M.P.A., LL.M., Board Certified by The Florida Bar in Health Law The Drug Enforcement Administration (DEA) is warning massage therapists to be aware of a prescription drug scam. This telephone scheme is extorting money from people all over the country. On November 28, 2012, the DEA released a press […]
Florida Board of Pharmacy Approves Change to Destruction of Controlled Substances Rule
By Lance O. Leider, J.D., The Health Law Firm At its meeting held in Orlando, Florida, on February 12, 2014, the Florida Board of Pharmacy approved final changes to Rule 64B16-28.303, Florida Administrative Code. This rule governs the destruction of controlled substances by Class II Institutional Pharmacies. The focus of the new rule changes is […]
Need Last Minute Deposition or Hearing Representation? Call The Health Law Firm
By George F. Indest III, J.D., M.P.A., LL.M., Board Certified by The Florida Bar in Health Law Our office often takes phone calls from pharmacies and pharmacists needing short-notice representation at a Board of Pharmacy hearing or at a deposition related to a health care matter. In our experience, many other law firms refuse to […]
CVS Blacklists Second Set of Doctors Accused of Overprescribing Painkillers
By George F. Indest III, J.D., M.P.A., LL.M., Board Certified by The Florida Bar in Health Law CVS is again stepping up its own internal efforts to combat the nation’s prescription drug abuse epidemic. According to Reuters, the second largest retail pharmacy chain announced it is cutting off access to the most powerful painkillers for […]
Negligence Will Determine the Success or Failure of the Meningitis Lawsuits Against Doctors and Clinics
By George F. Indest III, J.D., M.P.A., LL.M., Board Certified by The Florida Bar in Health Law The victims and survivors of the meningitis outbreak are now filing lawsuits against the physicians and clinics that administered the tainted steroids. According to an article in The Tennessean, on January 29, 2013, a husband who lost his […]
Finding a Healthcare Providers Service Organization (HPSO) Insurance Defense Lawyer
By George F. Indest III, J.D., M.P.A., LL.M., Board Certified by The Florida Bar in Health Law We are sometimes told by the health professionals we represent especially pharmacists, licensed mental health counselors (LMHCs), advanced registered nurse practitioners (ARNPs), massage therapists and physical therapists that after they received a complaint regarding their license from the […]
Pharmacists: Beware of Scammers that Call and Claim to be DEA Agents
By George F. Indest III, J.D., M.P.A., LL.M., Board Certified by The Florida Bar in Health Law The Drug Enforcement Administration (DEA) is warning pharmacists to be aware of a prescription drug scam. This telephone scheme is extorting money from people all over the country. On November 28, 2012, the DEA released a press release […]
Drug Enforcement Agency (DEA) Serves Up Immediate Suspension Order for Walgreens Distribution Center
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, […]
How to Prepare for an Informal Hearing Before the Florida Board of Pharmacy
By George F. Indest III, J.D., M.P.A., LL.M. Board Certified by The Florida Bar in Health Law If you are scheduled to appear for an informal hearing before the Florida Board of Pharmacy, there are a number of facts that you will want to know in order to be properly prepared. This article will cover […]
Supreme Court to Determine if Pay-for-Delay Agreements Between Brand and Generic Drug Manufacturers are Legal
By George F. Indest III, J.D., M.P.A., LL.M., Board Certified by The Florida Bar in Health Law The Supreme Court is currently looking into whether brand name drug manufacturers may pay generic drug manufacturers to keep the generic drugs off the market. These payments, often called pay-for-delay, are usually a form of settlement between the […]
37 Central Floridians Charged with Illicit Pharmaceutical Drug Trafficking
By Dr. Thu Pham, O.D., Law Clerk, The Health Law Firm Attorney General Pam Bondi along with special agent Mark R. Trouville of the Drug Enforcement Administration (DEA) and Longwood Police Chief Troy Hickson announced, on June 20, 2012, the execution of 37 arrest warrants stemming from state drug charges. The defendants all reside in […]
Two Central Florida CVS Pharmacies Get Controlled Substance Licenses Pulled by Drug Enforcement Administration (DEA)
By George F. Indest III, J.D., M.P.A., LL.M., Board Certified by The Florida Bar in Health Law The U.S. Drug Enforcement Administration (DEA) revoked the registrations (controlled substance licenses) from two CVS pharmacies in Sanford, Florida, on September 12, 2012, according to a number of sources. The two pharmacies will no longer be able to […]
Filling Phony Prescriptions for Pain Killers Lands Orlando Pharmacist Behind Bars
By George F. Indest III, J.D., M.P.A., LL.M., Board Certified by The Florida Bar in Health Law Another pharmacist was led away in handcuffs during a September 25, 2012, raid on an Orlando-area pharmacy, according to a number of sources. The pharmacist is accused of filling prescriptions for oxycodone, even though he allegedly knew the […]
Dentists: Beware of Nationwide Telephone Prescription Drug Scam – Callers Claim to be DEA Agents
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CVS Has Allegedly Been Refilling Prescriptions and Submitting Insurance Claims Without Patients’ Permission
By George F. Indest III, J.D., M.P.A., LL.M., Board Certified by The Florida Bar in Health Law The Office of Inspector General (OIG) for the U.S. Department of Health and Human Services (HHS) has reportedly launched an investigation into CVS’ practice for refilling prescriptions. According to an article in the Los Angeles Times, authorities are […]
Walgreens Files a Petition to Lift the Immediate Suspension Order
By George F. Indest III, J.D., M.P.A., LL.M., Board Certified by The Florida Bar in Health Law There’s a firefight brewing between Walgreens and the Drug Enforcement Administration (DEA). On October 10, 2012, Walgreens filed a petition asking a federal judge to lift the Immediate Suspension Order (ISO) that bans its distribution center in Jupiter, […]
Florida Department of Health (DOH) Shuts Down Boca Raton Compounding Pharmacy
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 […]
Sanford CVS Pharmacies in Hot Water for Ignoring Red Flags
By 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 […]
Employee Steals More Than $14 Million in Cancer Drugs from University of Miami Pharmacy

By Michael L. Smith, J.D., R.R.T., Board Certified by The Florida Bar in Health Law For three years, hundreds of life-saving cancer drugs disappeared from the shelves of the University of Miami’s (UM) Sylvester Comprehensive Cancer Center. A pharmacy technician at the center was arrested in connection to the thefts in May of 2011, and […]
Sex, Drugs and Money Lands Avalon Park Pharmacist in Handcuffs
By 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 […]
Drug Enforcement Administration (DEA) Investigates Six Walgreens Pharmacies in Florida
By George F. Indest III, J.D., M.P.A., LL.M., Board Certified by The Florida Bar in Health Law The Drug Enforcement Administration (DEA) served an Order to Show Cause (OSC) on a Fort Myers Walgreens pharmacy on February 21, 2013. According to the DEA, the OSC was served as a notice to provide Walgreens with an […]
Food and Drug Administration (FDA) Recalls Products from Two Different Compounding Pharmacies
By 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 […]
Healthcare Providers Service Organization (HPSO) Attorneys, Lawyers and Defense Council for Pharmacists
By George F. Indest III, J.D., M.P.A., LL.M., Board Certified by The Florida Bar in Health Law Often we learn after the fact that a health professional such as a mental health counselor, psychologist, or pharmacist has received Healthcare Providers Service Organization (HPSO) insurance, has had a legal problem, and has not been able to […]
Feds File Two Lawsuits Against Novartis for Allegedly Giving Kickback to Pharmacists and Physicians
By George F. Indest III, J.D., M.P.A., LL.M., Board Certified by The Florida Bar in Health Law Novartis Pharmaceuticals Corporation (NPC) is currently fielding two different lawsuits, filed just days apart from each other, by the U.S. Department of Justice (DOJ). The first lawsuit was filed on April 23, 2013, alleging the company gave illegal […]
Purpose of Florida E-FORCSE Prescription Database Not for Disciplinary or Criminal Prosecution Purposes Against Physicians, Pharmacists or Other Health Professionals
By George F. Indest III, J.D., M.P.A., LL.M., Board Certified by The Florida Bar in Health Law As you are no doubt aware now, Florida has an active prescription drug monitoring program (PDMP). It is called the “Electronic-Florida Online Reporting of Controlled Substances Evaluation” or “E-FORCSE.” More often it is referred to simply as the […]
Recall Alert: FDA Warns Steroid Injections Compounded by Tennessee Pharmacy May Be Contaminated
By George F. Indest III, J.D., M.P.A., LL.M., Board Certified by The Florida Bar in Health Law The U.S. Food and Drug Administration (FDA) sent out a warning to health care professionals that steroid injections compounded by Main Street Family Pharmacy, LLC, in Tennessee, may be contaminated. The announcement came on May 24, 2013. So […]
Two Orlando-Area Pharmacists Arrested on Charges of Allegedly Trafficking Drugs
By George F. Indest III, J.D., M.P.A., LL.M., Board Certified by The Florida Bar in Health Law Two Orlando-area pharmacists were arrested on June 4, 2013, allegedly in connection to trafficking oxycodone, according to a number of local media sources. An Orlando Sentinel article states that the pharmacists are also co-owners of an Orlando pharmacy […]
Terrible Things That Can Happen after Discipline on Your Pharmacist License or Resignation of a Pharmacist License after Notice of Investigation

By George F. Indest III, J.D., M.P.A., LL.M., Board Certified by The Florida Bar in Health Law Do you have a pharmacist license in several different states? Do you have a license in more than one health profession? Have you been notified that an investigation has been opened against you? Are you thinking about resigning […]
Jury Awards Walgreens Customer $1.44 Million Over HIPAA Violation

By Lance O. Leider, 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 An Indiana jury awarded a Walgreens customer $1.44 million on July 26, 2013, over a Health Insurance Portability and Accountability Act (HIPAA) violation, according to the Indianapolis Star. The […]
“Operation Main Pain” Targets More Than 60 in Fraudulent Prescription Drug Ring
By George F. Indest III, J.D., M.P.A., LL.M., Board Certified by The Florida Bar in Health Law The Sarasota County Sheriff’s Office announced a fraudulent prescription drug ring bust that spanned throughout Sarasota and Manatee counties in Florida, on September 19, 2013. So far, 61 people, including the alleged ringleader have been arrested. The operation […]
New Permit Law for Florida Pharmacies that Compound Sterile Products
Lance O. Leider, 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 The Florida Board of Pharmacy announced a new law which will be required for pharmacies that compound sterile products. Effective September 23, 2013, Rule 64B16-28.100(8), Florida Administrative Code (F.A.C.), requires […]
Drug Quality and Security Act Boosts FDA Regulations Over Compounding Pharmacies
By Lance O. Leider, J.D., The Health Law Firm On November 18, 2013, the United States Senate voted to increase federal oversight of compounding pharmacies that produce large volumes of mixed drugs. This bill comes in the wake of last year’s meningitis outbreak stemming from unsanitary conditions at the New England Compounding Center (NECC). Click […]
Compounding Pharmacies Urged to Sign Up for U.S. Food and Drug Administration Oversight
By Lance O. Leider, J.D., The Health Law Firm It is estimated there are 3,000 compounding pharmacies in the United States, 14 of which have signed up to be regulated by the U.S. Food and Drug Administration (FDA) under the Drug Quality and Security Act. On January 8, 2014, the commissioner of the FDA sent […]
Florida Board of Pharmacy Updates Record Retention Rules for Pharmacies
By Lance O. Leider, J.D., The Health Law Firm At its meeting held on February 12, 2014, the Florida Board of Pharmacy voted to approve language changes to a number of rules. Specifically, those changes were put into effect to establish a uniform four-year retention policy for pharmacy records. Previously the Board’s rules were not […]
Out-of-State Compounding Pharmacies May Need a Permit To Do Business in Florida
By Lance O. Leider, J.D., The Health Law Firm Beginning on October 1, 2014, out-of-state compounding pharmacies may be required to hold a compounded sterile product permit. That’s because the Regulated Industries Committee of the Florida Senate voted on March 13, 2014, to approve a bill increasing the restrictions on out-of-state compounding pharmacies that ship […]
Florida Legislature Reforms Pharmacy Benefit Manager Audit Practices
According to the Florida Legislature, it’s time for pharmacists to focus on their patients instead of paperwork. On June 13, 2014, Florida Governor Rick Scott signed Florida Senate Bill 702 into law. This law introduces clear guidelines of acceptable audit practices of pharmacies in the Sunshine State. There are more than 2,700 pharmacies across Florida […]
OIG Issues Advisory Opinion to Specialty Pharmacy for Support Service Payments

By Lenis L. Archer, J.D., M.P.H., The Health Law Firm There is an inherent risk in entering into financial arrangements where payments to a service provider are only made when a referral is generated. On August 15, 2014, the Office of Inspector General (OIG) made this perfectly clear in an unfavorable advisory opinion issued to […]
Florida Toughens Up Drug Compounding Law for Out-of-State Pharmacies
By George F. Indest III, J.D., M.P.A., LL.M., Board Certified by The Florida Bar in Health Law A new, stricter law on Florida’s compounding pharmacy industry took effect October 1, 2014. The new law increases the restrictions for out-of-state compounding pharmacies and outsourcing facilities that ship medications into Florida. The law also gives the Florida […]