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 […]

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 […]

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 […]

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 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 […]

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 […]

“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 […]