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 […]
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 […]
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 […]
“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 […]
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 […]
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 […]
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 […]
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 […]