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 […]
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 […]
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 […]
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 […]
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 […]
Selling Tobacco Can Get You Penalized By Insurance Panels
By Lance O. Leider, J.D., The Health Law Firm Beware: selling cigarettes could burn a hole in your pocket. The CVS Health Corporation (CVS), the nation’s second-largest drug store, is currently in the midst of launching a tobacco-free prescription-drug network. The company announced in October 2014, that it will begin offering a tobacco-free pharmacy plan […]
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 […]
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 […]
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 […]
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 […]
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 […]
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 […]
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 […]
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 […]
The 25 Biggest Mistakes Pharmacists Make After Being Notified of a Department of Health Complaint
By George F. Indest III, J.D., M.P.A., LL.M., Board Certified by The Florida Bar in Health Law The investigation of a complaint which could lead to the revocation of a pharmacist’s license to practice and the assessment of tens of thousands of dollars in fines, usually starts with a simple letter from the Department of […]
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 […]