Florida Pharmacy Allegedly the Cause of Eye Infection Outbreak
The Centers for Disease Control (CDC) has allegedly traced a rare fungal infection to an Ocala pharmacy, according to media reports. As reported, Franck’s Compounding Lab is believed to be at least partially responsible for spreading a rare fungal eye infection to over 30 patients across the U.S. The CDC reports that eye drops and […]
Franck’s Pharmacy Recalls Compounding Prescriptions and Shuts Down Sterile Compounding Service
Franck’s Pharmacy, Inc. located in Ocala, Florida, has issued a recall for its compounded prescriptions. The prescriptions impacted by this recall include all sterile human and veterinary compounded prescriptions distributed by Franck’s Pharmacy from November 21, 2011 to May 21, 2012. Franck’s Pharmacy made the announcement on the company’s website on May 24, 2012. To […]
Franck’s Pharmacy Closes; Compounding Lab is Now Wells Pharmacy Network
By George F. Indest III, J.D., M.P.A., LL.M., Board Certified by The Florida Bar in Health Law July 31, 2012, marked the end of an era for Franck’s Pharmacy in Ocala, Florida, as the retail location closed its doors for good. According to an Ocala Star-Banner article, in July 2012, Franck’s Compounding Lab, which was […]
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 […]
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 […]
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 […]
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 […]
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 […]
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 […]
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 […]
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 […]
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 […]
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 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 […]
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 […]