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Category: Pharmacy Law

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 […]

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 […]

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 Compounding Pharmacy Pays $3.7 Million in Tricare False Claims Settlement

By George F. Indest III, J.D., M.P.A., LL.M., Board Certified by The Florida Bar in Health Law In May of 2015, Tricare began screening all compound medication prescriptions to ensure approval of each ingredient with the Food and Drug Administration (FDA). This decision came after a finding of a significant increase in compound drug prescriptions […]

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 […]

South Florida Man Pleads Guilty to Fraudulently Working as a Pharmacist

By George F. Indest III, J.D., M.P.A., LL.M., Board Certified by The Florida Bar in Health Law On July 24, 2012, a 49-year-old man from Ruskin in South Fla., pleaded guilty in federal court to fraudulently working as a Central Florida pharmacist from 2000 to 2009, according to the Department of Justice (DOJ) in a press […]

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 […]

Florida’s Medicaid Program Receives Settlement Payment from Pharmaceutical Company

By George F. Indest III, J.D., M.P.A., LL.M., Board Certified by The Florida Bar in Health Law The Florida Attorney General’s (AG) Medicaid Fraud Control Unit (MFCU), 46 other states and the federal government reached a $48 million agreement with pharmaceutical company Healthpoint Ltd., on February 25, 2013. According to the Florida AG, the settlement […]

United Parcel Service (UPS) Agrees to Pay Settlement for Online Pharmacy Shipping

By George F. Indest III, J.D., M.P.A., LL.M., Board Certified by The Florida Bar in Health Law United Parcel Service, Inc. (UPS) will pay $40 million to the Department of Justice (DOJ) to settle a probe related to its shipments on behalf of illicit online pharmacies. This announcement came on March 29, 2013. Click here […]

The Fight for Medical Marijuana Lights Up in Florida and Across the U.S.

By George F. Indest III, J.D., M.P.A., LL.M., Board Certified by The Florida Bar in Health Law The fight to legalize medical marijuana seems to be spreading across the country. In Florida, a medical marijuana group said it cleared the first major hurdle to get a proposed constitutional amendment for medical marijuana on the 2014 […]

Generic Drug Labeling Change Proposed by FDA is Significant and Will Likely Negate Preemption of State Failure-to-Warn Claims in Generic Drug Cases

Guest Post: Alina Denis Jarjour, Esquire, Jarjour | Legal Under current law, an individual can bring a product liability action for failure to warn against a brand name drug company, i.e., the NDA (New Drug Application) holder, but generally not against a generic manufacturer, the holder of an ANDA (Abbreviated New Drug Application). Federal preemption […]

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 […]

DEA Offers New Prescription Drug Return Policy

By George F. Indest III, J.D., M.P.A., LL.M., Board Certified by The Florida Bar in Health Law Looking to improve the prescription drug abuse epidemic in the United States, the Drug Enforcement Administration (DEA) announced September 8, 2014, that it would permit patients to return their unused prescription medications to pharmacies. This new rule, covering […]

Pharmacies May be Liable for Filling Valid Prescriptions

By Lance O. Leider, J.D. Florida pharmacies have had their potential liability significantly expanded by the Fifth District Court of Appeal. In its recent decision, Oleckna v. Daytona Discount Pharmacy, the appellate court held that a pharmacy owes a duty to its patients that go beyond following the prescribing physician’s directions and properly dispensing 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 […]

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 […]

Key West Pharmacy Blows Whistle on Medicaid Fraud and Comes Out on Top

By Danielle M. Murray, J.D. On September 27, 2012, Public Citizen, a watchdog group, reported whistleblowers have initiated $6.6 billion in penalties against drug manufacturers in 2012. Most of these penalties are for fraudulently overcharging government programs. The report names a small Key West, Florida, pharmacy as one of the top whistleblowers in the country. […]

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, […]

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 […]

Phony Pharmacist Gets Prison Time for Working at Pharmacies in Central Florida

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 […]

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 […]

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 […]

Specialty Pharmacy Settles Lawsuit Over Illegal Kickbacks

By Lance O. Leider, J.D., and George F. Indest III, J.D., M.P.A., LL.M., Board Certified by The Florida Bar in Health Law The Department of Justice (DOJ) announced on December 27, 2012, that a specialty pharmacy, based in San Diego, California, has agreed to pay a $11.4 million settlement. That payment is to resolve allegations […]

California, Pennsylvania and Kentucky Move to Tighten Laws Related to Controlled Substance

By Lance O. Leider, J.D., The Health Law Firm In reports from both coasts, three states have recently made moves to tighten monitoring and prescribing of controlled substances. Legislators in California, Pennsylvania and Kentucky are contemplating new actions. Health professionals should take note, these prescription drug monitoring programs can, and will be, used as a […]

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 […]

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