pharmacist lawyer | The Health Law Firm Blog

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 far, seven patients have allegedly suffered adverse reactions from the medications. The FDA says it is working with the Centers for Disease Control and Prevention (CDC) and the Tennessee Board of Pharmacy to investigate. The steroid injections were allegedly sent to 13 states, including Florida.

To read the press release from the FDA, click here.

Steroid […]

By The Health Law Firm|2024-03-14T10:01:13-04:00May 15, 2018|Compounding pharmacy, Department of Health, Legal Defense for Pharmacists, Pharmacist, Pharmacy, Pharmacy Law|

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 your pharmacist license or voluntarily relinquishing such a license? Then you must be aware of the following.

First, you should never voluntarily relinquish or resign your license after you know that an investigation has been opened or that disciplinary action has been taken against you. Such a resignation is considered to be a “disciplinary relinquishment” and is […]

By The Health Law Firm|2024-03-14T10:01:13-04:00May 15, 2018|Florida Board of Pharmacy, Pharmacist, Pharmacy, Pharmacy Law|

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 the manufacturer sold inferior drugs and made false statements to the U.S. Food and Drug Administration (FDA) about manufacturing practices at two factories in India. This announcement was made by the DOJ on May 13, 2013. This settlement is the largest drug settlement to date involving a generic drug manufacturer and drug safety.

To read […]

By The Health Law Firm|2024-03-14T10:01:14-04:00May 15, 2018|Pharmacy, Pharmacy Law|

“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 has been dubbed “Operation Main Pain” by the Sarasota County Sheriff’s Office.

Click here to view the press release from the Sarasota County Sheriff’s Office.

Investigation Unveiled Complex Fraudulent Drug Ring.

The investigation began in July 2011, when a fraudulent oxycodone prescription was noticed at a CVS pharmacy in Sarasota County. When more of the […]

By The Health Law Firm|2024-03-14T10:01:14-04:00May 15, 2018|Pain Management, Pharmacist, Pharmacy, Trafficking Prescription Painkillers|

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 most pharmacies that engage in the preparation of sterile compounded products in Florida to obtain a Special Sterile Compounding Permit. Pharmacies compounding sterile products under their current pharmacy permit may continue to do so, but must obtain the new Special Sterile Compounding Permit on or before March 21, 2014.

Click here […]

By The Health Law Firm|2024-03-14T10:01:15-04:00May 15, 2018|Compounding pharmacy, Florida Board of Pharmacy, Pharmacy, Pharmacy Law|

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 here to read a previous blog on the meningitis outbreak.

This bill does not give the U.S. Food and Drug Administration (FDA) absolute authority over compounders, but creates significant safeguards.

This particular piece of legislation passed the House of Representatives in September of 2013, passed in the Senate in November 2013, and President Obama […]

By The Health Law Firm|2024-03-14T10:01:15-04:00May 15, 2018|Compounding pharmacy, Florida Board of Pharmacy, Pharmacy Law|

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 thousands of letters to hospitals and other medical providers that may buy medicines from the compounding pharmacies. The letters urged providers to encourage compounding pharmacies to register as producers of sterile drugs in an effort to protect the public. The letters also mentioned last year’s meningitis outbreak stemming from unsanitary conditions at the New England […]

By The Health Law Firm|2024-03-14T10:01:15-04:00May 15, 2018|Compounding pharmacy, Florida Board of Pharmacy, Pharmacy|

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 consistent with respect to how long pharmacies were required to retain different types of records.

When approving new rules or changes to existing rules, administrative bodies are required to evaluate the regulatory costs of the changes. In examining these costs the Board found that any financial costs imposed upon small businesses would be balanced by the efficiencies […]

By The Health Law Firm|2024-03-14T10:01:16-04:00May 15, 2018|Florida Board of Pharmacy, Pharmacist, Pharmacy, Pharmacy Law|

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 medications into Florida. These increased regulations would apply to around 300 compounding pharmacies shipping medicine to Florida.

The bill was introduced to increase standards for compounding pharmacies that create medications that are tailored to the needs of individual patients. Currently the bill is out for reference review. Considering that this is a hot issue in Florida […]

By The Health Law Firm|2024-03-14T10:01:16-04:00May 15, 2018|Compounding pharmacy, Florida Board of Pharmacy, Pharmacy, Pharmacy Law|

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 that are routinely evaluated by Pharmacy Benefit Managers (PBMs). The purpose of these audits is to verify that certain claims are submitted and handled properly. If a PBM audit uncovers fraud or abuse, the pharmacy will be subject to penalties, including reimbursement of amounts paid. With the increase of rules regulating pharmacies, these audits have progressively […]

By The Health Law Firm|2024-03-14T10:01:17-04:00May 15, 2018|Florida Board of Pharmacy, Florida Legislature, Pharmacist, Pharmacy, Pharmacy Audit, Pharmacy Law|