Florida Administrative Code

Home/Tag: Florida Administrative Code

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

Attorney George IndestBy 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 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 gets legal representation on little or no advance notice or has to suffer the consequences of having no legal representation.

Administrative Proceedings Can be Complex.

In some cases, individuals may be fooled into believing that they can effectively represent themselves. They later find out that they have gotten in over their heads. Laypersons (meaning, in this case, nonlawyers) who are not aware of such complex matters as the Administrative Procedure Act, the Rules of Civil Procedure, the Rules of Evidence, the Florida Administrative Code (F.A.C.) Rules which the Board of Pharmacy and the Department of Health (DOH) have enacted, may quickly be confused.

The inexperienced individual, or even the inexperienced attorney, in these matters, can fall into a number of procedural traps that damage an effective defense. This can be advising the individual to talk to the DOH investigator, filing an unnecessary answer to an Administrative Complaint, forgetting or not knowing that the client’s right to be free of self-incrimination applies in this type of case and many, many others.

Procedural Mistakes Can Be Damaging To Your Legal Defense.

Often you will find that merely having an experienced attorney to represent you at a hearing or Board meeting will assist you in avoiding mistakes that damage your case and assist you in preserving your rights for an appeal. In other cases, it may even be possible to obtain a change in the forum to obtain a better result. For example, many laypersons do not know that if you elect an informal hearing before the Board of Pharmacy, you have waived your right to prove you are innocent by contesting the facts alleged against you.

What few know or think of in the heat of the moment is that you can ask at the informal hearing before the Board of Pharmacy to contest the facts, to prove you are not guilty of the charges, and to have the hearing converted to a formal hearing. A formal hearing will be in front of a neutral Administrative Law Judge (ALJ), and you have a great many more procedural rights than you have at an informal hearing. However, we still recommend that you have an experienced health lawyer represent you at a formal hearing.

Professional Liability Insurance May Pay Legal Fees for Deposition Coverage.

If you are a pharmacist or pharmacy that has professional liability insurance, these often provide legal coverage for depositions. This is primarily because the outcome of the deposition may include having you named as a defendant in a professional liability or negligence lawsuit or having disciplinary charges filed against you.

One of the first things you should do if you receive a subpoena or a notice of a deposition is to contact your professional liability insurance carrier and see if it will pay for an attorney to represent you. For example, Healthcare Providers Service Organization (HPSO), CPH & Associates, Nurses Service Organization (NSO), Dentists Advantage and many other malpractice insurance companies provide excellent deposition coverage.

The second thing you should do is to call an experienced attorney and schedule a consultation. Even if you cannot afford to retain the services of the attorney for the actual deposition, a consultation may assist you in properly preparing. Click here to read our blog on this matter and learn more.

Consult With A Health Law Attorney Experienced in the Representation of Pharmacists and Pharmacies.

We routinely provide deposition coverage to pharmacists, pharmacies and other health professionals being deposed in criminal cases, negligence cases, civil cases or disciplinary cases involving other health professionals.

The lawyers of The Health Law Firm are experienced in both formal and informal administrative hearings and in representing physicians, physician assistants and other health professionals in investigations and at Board of Pharmacy hearings. Call now or visit our website www.TheHealthLawFirm.com.

About the Author: George F. Indest III, J.D., M.P.A., LL.M., is Board Certified by The Florida Bar in Health Law. He is the President and Managing Partner of The Health Law Firm, which has a national practice. Its main office is in Orlando, Florida, area. www.TheHealthLawFirm.com The Health Law Firm, 1101 Douglas Ave., Altamonte Springs, FL 32714, Phone: (407) 331-6620.

KeyWords: Florida Board of Pharmacy, Legal Defense for Pharmacists, Pharmacist, Pharmacy and tagged Administrative Law Judge, administrative procedure act, administrative proceeding, ALJ, Board of Pharmacy, Board of Pharmacy hearing, defense attorney, defense lawyer, Department of Health, deposition coverage, disciplinary charges, disciplinary complaint, FAC, final hearing, Florida Administrative Code, formal hearing, health law firm, health professional, hearing representation, Informal hearing, last-minute deposition coverage, legal representation, legal representation for pharmacist, legal representation for pharmacy, local deposition coverage, negligence lawsuit, noticed of a deposition, pharmacist, pharmacy, professional liability insurance, rights for an appeal, Rules of Civil Procedure, Rules of Evidence, short notice of representation of pharmacy, short notice representation of pharmacist, subpoena, The Health Law Firm

“The Health Law Firm” is a registered fictitious business name of and a registered service mark of The Health Law Firm, P.A., a Florida professional service corporation, since 1999.
Copyright © 2019 The Health Law Firm. All rights reserved.

New Permit Law for Florida Pharmacies that Compound Sterile Products

LOL Blog Label 2Lance 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 to read the notice from the Florida Board of Pharmacy.

We believe the updated requirements are a result of the recent recalls of tainted compounded medications that have spread across the country and infected thousands of patients. These new standards will make it easier for authorities to quickly spot where tainted batches of medications were produced.

Special Sterile Compounding Permit Exceptions.

All permitees that are currently compounding sterile products are required to submit an application to obtain the Special Sterile Compounding Permit.

However, the exceptions are for stand-alone Special Parenteral/Enteral pharmacies, Special Parenteral/Enteral Extended Scope pharmacies, pharmacies that only perform non-sterile compounding, and non-resident pharmacies.

How to Apply for the Special Sterile Compounding Permit.

To obtain the new Special Sterile Compounding Permit, an applicant must already hold another pharmacy permit and must submit an application for the new permit. Those applying for this permit will be required to submit information from current policies and procedures which will be reviewed before an inspection is requested from the Florida Board of Pharmacy.

The application is available by clicking here.

Once approved, the Florida Board of Pharmacy will issue a new Special Sterile Compounding Permit. This means pharmacies that compound sterile products will have two pharmacy permits.

New Standards Most Likely Triggered by Tainted Compounded Medications.

These new standards are being implemented about a year after a nationwide outbreak of fungal meningitis linked to contaminated drugs made by a compounding pharmacy in Massachusetts. Click here to read our previous blog. Florida is no stranger to allegations of tainted compounded products. In May 2013, Franck’s pharmacy in Ocala, Florida, was accused of distributing eye medications that contained a fungal infection. Click here for the first blog and here for the second blog on this.

It’s likely this new permit is a direct result of the recent issues with compounded medications and compounding pharmacies. The aim of the permit is to help authorities, such as the Department of Health (DOH) and U.S. Food and Drug Administration (FDA), track Florida pharmacies compounding sterile products.

New Requirements Released for Physician Medical Records Related to Compounded Medications.

Similarly, on September 5, 2013, the Florida Board of Medicine and the Florida Board of Osteopathic Medicine published new requirements for medical record documentation related to compounded medications administered to patients in an office setting.  These standards became effective on September 9, 2013. The standards are contained in Florida Administrative Code Rules adopted by each board. Click here to read our previous blog on this.

Contact Health Law Attorneys Experienced in Representing Pharmacies and Pharmacists.

The Health Law Firm represents pharmacists and pharmacies in DEA, DOH and FDA investigations, regulatory matters, licensing issues, litigation, administrative hearings, inspections and audits. The firm’s attorneys include those who are board certified by The Florida Bar in Health Law as well as licensed health professionals who are also attorneys.

To contact The Health Law Firm please call (407) 331-6620 or (850) 439-1001 and visit our website at www.TheHealthLawFirm.com.

Comments?

Had you heard of this new permit? How will this affect pharmacies compounding sterile products? Please leave any thoughtful comments below.

About the Authors: Lance O. Leider is an attorney with The Health Law Firm, which has a national practice. Its main office is in the OrlandSeptember 18, 2013o, Florida, area. www.TheHealthLawFirm.com  The Health Law Firm, 1101 Douglas Avenue, Altamonte Springs, Florida 32714, Phone:  (407) 331-6620.

George F. Indest III, J.D., M.P.A., LL.M., is Board Certified by The Florida Bar in Health Law. He is the President and Managing Partner of The Health Law Firm, which has a national practice. Its main office is in the Orlando, Florida, area. www.TheHealthLawFirm.com The Health Law Firm, 1101 Douglas Ave., Altamonte Springs, FL 32714, Phone: (407) 331-6620.

“The Health Law Firm” is a registered fictitious business name of George F. Indest III, P.A. – The Health Law Firm, a Florida professional service corporation, since 1999.
Copyright © 1996-2012 The Health Law Firm. All rights reserved.