Florida Board of Pharmacy | The Health Law Firm Blog

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|

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 medication.

The court defined the pharmacy’s duty to use due care in filling a prescription to mean more than what it called “robotic compliance” with the instructions of the prescribing physician.

From the court’s decision and some others from around the state it would seem that Florida pharmacists are now under an obligation to […]

By The Health Law Firm|2024-03-14T10:01:41-04:00May 15, 2018|Florida Board of Pharmacy, Florida Legislature, Legal Defense for Pharmacists, Pharmacist, Pharmacy, Pharmacy Law|

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 to ensure that either the prescription department manager (PDM) or the consultant pharmacist of record signs off on all destruction of controlled substances. Further, the rule requires that a copy of the destruction documents be mailed to the Drug Enforcement Administration (DEA) within one business day of destruction.

According to the Board’s statement, the purpose of the […]

By The Health Law Firm|2024-03-14T10:01:40-04:00May 15, 2018|Florida Board of Pharmacy, Pain Management, Pharmacy, Pharmacy Law|

Need Last Minute Deposition or Hearing Representation? Call The Health Law Firm

By George F. Indest III, J.D., M.P.A., LL.M., Board Certified by The Florida Bar in Health Law

Our office often takes phone calls from pharmacies and pharmacists needing short-notice representation at a Board of Pharmacy hearing or at a deposition related to a health care matter.

In our experience, many other law firms refuse to represent clients at a hearings unless the firm is given plenty of advance notice. We always prefer to have sufficient time to obtain documents, review files, interview witnesses, conduct research and prepare, in order to provide the best possible representation to our client. However, we realize that in certain cases, the alternative is that the client either […]

By The Health Law Firm|2024-03-14T10:01:40-04:00May 15, 2018|Florida Board of Pharmacy, Legal Defense for Pharmacists, Pharmacist, Pharmacy|

How to Prepare for an Informal Hearing Before the Florida Board of Pharmacy

By George F. Indest III, J.D., M.P.A., LL.M. Board Certified by The Florida Bar in Health Law

If you are scheduled to appear for an informal hearing before the Florida Board of Pharmacy, there are a number of facts that you will want to know in order to be properly prepared. This article will cover many of them.

Limited Circumstances for Informal Administrative Hearing.

First, you should understand that you will only be at an informal hearing in which you appear before the Board of Pharmacy itself for a very limited number of reasons. These will include the following:

1. If you completed […]

By The Health Law Firm|2024-03-14T10:01:38-04:00May 15, 2018|Florida Board of Pharmacy, Pharmacy Law|

Florida Compounding Pharmacy Pays $3.7 Million in Tricare False Claims Settlement

By George F. Indest III, J.D., M.P.A., LL.M., Board Certified by The Florida Bar in Health Law

In May of 2015, Tricare began screening all compound medication prescriptions to ensure approval of each ingredient with the Food and Drug Administration (FDA). This decision came after a finding of a significant increase in compound drug prescriptions reimbursed by Tricare over the last year.

In April 2015, just four months into the fiscal year, it was already determined that total costs for compound drug prescriptions filled for Tricare recipients were likely to come close to $1 billion. If the trend continues, the Defense Health Agency expects it may need to reallocate funds at the end […]

By The Health Law Firm|2024-03-14T10:01:19-04:00May 15, 2018|Florida Board of Pharmacy, Legal Defense for Pharmacists, Pharmacy Audit, Pharmacy Law|

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 to employers, unions, and insurance companies for which its Caremark arm manages prescription benefits. CVS is slapping patients with an extra co-payment “penalty” if they purchase their medications from pharmacies that sell tobacco products, regardless of whether the patient is a tobacco user.

According to US News, by adding a variable co-payment of […]

By The Health Law Firm|2024-03-14T10:01:18-04:00May 15, 2018|Florida Board of Pharmacy, Insurance, Insurance Network Plan, Pharmacist, Pharmacy, Pharmacy Benefit Manager, Prescription-Drug Network|

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 Board of Pharmacy and Florida Department of Health (DOH) more power to oversee and penalize these companies. Click here to read the new law.

The law was enacted to increase the standards for compounding pharmacies that create medications that are supposed to be tailored to the needs of individual patients. In an effort to prevent […]

By The Health Law Firm|2024-03-14T10:01:18-04:00May 15, 2018|Compounding pharmacy, Florida Board of Pharmacy, Florida Legislature|

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|

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 the pharmacy so “deplorable” that nothing short of immediately shutting down the pharmacy would suffice.

Click here to read the press release from the DOH.

State Inspector Finds Feces, Bugs and Much More in Compounding Pharmacy.

On October 12, 2012, a state inspector arrived at the Boca Raton compounding pharmacy for an […]

By The Health Law Firm|2024-03-14T10:01:07-04:00May 15, 2018|Compounding pharmacy, Department of Health, Florida Board of Pharmacy, Legal Defense for Pharmacists, Pharmacist, Pharmacy|