Florida Pharmacist Gets More Than Six Years in Prison For Role in Compounding Fraud Scheme
By George F. Indest III, J.D., M.P.A., LL.M., Board Certified by The Florida Bar in Health Law On November 29, 2018, a Florida pharmacist was sentenced to six and a half years in prison and ordered to pay $3.4 million, for her role in a scheme to defraud the government. Marjorie Robinson pled guilty one […]
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 […]
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 […]
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 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 […]
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 […]
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 […]
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 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 […]
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 […]
“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 […]
Generic Drug Maker Ranbaxy Pleaded Guilty to Claims of Adulterated Drugs-Must Pay $500 Million Fine
By George F. Indest III, J.D., M.P.A., LL.M., Board Certified by The Florida Bar in Health Law Generic drug maker Ranbaxy USA Inc., pleaded guilty to drug safety violations and will be responsible for paying $500 million in criminal and civil fines, according to the Department of Justice (DOJ). The fines will resolve claims that […]
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 […]
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 […]
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 […]