Florida Board orders survey on compounding practices

By Fred Hiers
Staff writer

Published: Tuesday, November 20, 2012 at 6:58 p.m.

Last Modified: Tuesday, November 20, 2012 at 6:58 p.m.

Florida pharmacy regulators issued an emergency order Tuesday requiring Florida's more than 7,700 pharmacies to complete a survey about their compounding practices.

To read this article click here

Florida State Department of Health's November 20th Meeting To Include Discussion About Compounding

Here is the outline on the agenda:


Tuesday, November 20, 2012 – 9:00 a.m. time p.m.
TAB 1 COMPOUNDING IN PHARMACIES LICENSED AND REGULATED BY
THE FLORIDA BOARD OF PHARMACY AND THE FLORIDA
DEPARTMENT OF HEALTH, (Cynthia Griffin, PharmD, Chair & Mark
Whitten, Executive Director)
 
1. Overview of Pharmacy Compounding
a. Chapter 465, Florida Statutes
b. Rule 64B16-27.700, Florida Administrative Code, Definition of
Compounding
2. Compounding of Sterile Preparations
a. United States Pharmacopeia (USP) 797
i. Understanding Revisions – USP 797
b. Rule 64B16-27.797, Florida Administrative Code, Standards of
Practice for Compounding Sterile Preparations
12
c. Rule 64B16-28.820, Florida Administrative Code, Sterile Products and
Special Parenteral/Enteral Compounding
3. Compounding of Non-sterile Preparations
a. United States Pharmacopeia (USP) 795
b. Rule 64B16-28.450, Florida Administrative Code, Centralized
Prescription Filling, Delivering and Returning
4. Non-resident Pharmacies – NO DOCUMENTS
TAB 2 PHARMACY COMPOUNDING SURVEYS, (David Flynn, Assistant
Attorney General)
1. Florida Pharmacy Compounding Survey, October 2012 Survey
2. Proposed Florida Mandatory Pharmacies Compounding Survey
 
TAB 3 DOH PHARMACY INSPECTION PROCESS, (Jeane Clyne, Chief of
Investigative Services Unit)
1. Inspection Forms
a. Current Inspection Form
b. Draft Inspection Form
2. Inspector Education and Training – NO DOCUMENTS
TAB 4 DEPARTMENT OF HEALTH’S PUBLIC PROTECTION CONCERNS,
(Cassandra Pasley, BSN, JD, Chief, Bureau of Health Care Practitioner
Regulation)
1. Representative from the Department of Health – NO DOCUMENTS
TAB 5 ADDITIONAL REFERENCE MATERIALS
1. Chapter 499, Florida Statutes
2. Federal Food, Drug, and Cosmetic Act
3. The Committee On Energy And Commerce – Briefing Document- Hearing on
“The Fungal Meningitis Outbreak: Could It Have Been Prevented?”
4. Massachusetts Compounding Survey
5. Correspondence, Florida Pharmacy Association

To review remaining agenda click here

Several Disciplinary Actions in October Relating to Compound Pharmacists or Pharmacies by Florida State Department of Health

To view the minutes from the October board meeting click here

Florida State suspends Boca Raton-based medical compounding pharmacy:Proposed State Legislative Fix for Compounding Pharmacies Regulations: More States Need to Be Pro-Active Like Florida If They Want to Retain Jurisdiction to Regulate Compound Pharmacies: Don't Forget to Make Transparency A Key Facotor

Florida Department of Health entered an emergency order shutting down or as the order states "suspensi[ing] [ ] Rejuvi's permit to operate as a community and sterile products and special — parenteral enteral compounding pharmacy in the State of Florida."  See order here.  This is a terrific pro-active approach that should have been done long ago by the states.  More states need to be taking this approach and shutting down dangerous, non-complaint compounding pharmacies.  This needs to be done not only for public health reasons but also,  if the states have any interest at all in retaining at least some of the authority to regulate compounding pharmacies.  While it is true that the United States Congress has plans to introduce legislation granting the FDA more authority to regulate these entities, that legislation has not been introduced, it is unclear at this point how broad the legislation will be, and there is always a question of which version, if any, of a draft piece of legislation will pass.  This leaves states a chance to take action as Florida has done.

States should be inspecting compounding pharmacies, noting  whether those compounding pharmacies have been previously written up for violations, and taking the strongest action allowed under the state law.  For example, if allowed under the state laws, state boards should issue orders shutting pharmacies down that are a public health risk; if closure is not allowed then state boards should impose the maximum fine allowed.  In any event state boards should require the pharmacies to become compliant within so many days before they can begin operating again.  Also state boards should make compounding pharmacies that have such violations recall all drugs linked to any possible contamination or public health risk.    

If states do not already have strict compounding laws and regulations,  they should promptly adopted and enact the needed laws and regulation to deal with the problems.  The laws need to give the state boards (i.e., inspectors)  authority to immediately shut down compounding pharmacies that pose a public heath risk.  They also need to give the state boards authority to impose significant fines.  The fines need to be significant enough that the bad compounders would rather comply with the rules than pay the fines.  When the fine is a dollar amount that is merely a slap on the wrist and cheaper than actually complying  with most rules and regulations, then the bad pharmacies opt to pay the fine and continue to operate in an unsafe manner.  This also penalizes and is unfair to the good compounding pharmacies, and yes, there are some, who spend the money required to comply the rules and regulations.

One other key to fixing the compounding world that I have repeatedly stressed on this blog, is TRANSPARENCY.  The inspection reports, the orders and the fines need to be made readily available to the public.  While putting them on the Internet cost money--it is well worth the lives it could save.  Doctors, Veterinarians, Hospitals, Clinics, Consumers, . . .everyone can then look up the compounding pharmacy to see if their inspection report contained any violations, what corrections to the violations were made, etc.  For example, it was great that I could immediately go to the Florida Department of Health and download and read the emergency order as could any member of the public.  Reporters are reporting on it. Bloggers are blogging about it.  The public is becoming aware of it.   Florida has done a good job of making their disciplinary records for compound pharmacies transparent. Other states should follow Florida's lead. 

Emergency Order Entered by Florida State Department of Health Shutting Down Compounding Pharmacy: Rejuvi Pharmaceuticals

To the see the Emergency Ordered entered by the Florida State Department of Health click here

Flordia Board of Pharmacy's April 2012 Settlement With Paul Franck and Franck's Lab

The April 11, 2012 meeting of the Florida Department of Health Board of Pharmacy contains a discussion of the settlement agreement made with Paul Franck and Francks Lab.  It can be found here and states as follows:


Wednesday, April 11, 2012 – 8:00 a.m.
8:00 a.m. Call To Order by Cynthia Griffin, PharmD, Chair
The meeting was called to order by the Chair, Dr. Griffin. All Board members were present.
TAB 3 DISCIPLINARY CASES – John Truitt, Assistant General Counsel
A. SETTLEMENT AGREEMENT– APPEARANCE REQUIRED CASES
A-1  Paul Wayne Franck, PS 17342, Ocala, FL
  Case No. 2008-17152 – PCP Powers/Jones
Respondent violated:
Count One:  Section 465.016(1)(e), F.S., by violating Sections 499.01(1) and 499.005(22), F.S., by failing to obtain a prescription drug wholesaler’s permit or a retail pharmacy drug wholesaler’s permit prior to engaging in wholesale distribution of prescription drugs.
Count Two:  Section 465.016(1)(e), F.S., by violation of section 499.005(22)m by failing to obtain a permit prior to operation as a prescription drug repackager as required by section 499.01(1)(b).
Respondent shall be present. Respondent shall pay a fine in the amount of $2,000 and costs in the amount of $427.17. Respondent shall complete a 12 hour Laws and Rules CE course.
Respondent was present and sworn in by the court reporter. Respondent was represented by William Furlow.
Motion: by Weizer, seconded by Fallon, to accept the Settlement Agreement. Motion carried.
A-2  Francks Lab, Inc, PH 19761, Ocala, FL
Case No. 2008-16979, 2010-16555 – PCP Powers/Jones, Garcia/Weizer
(2008-16979) Respondent violated:
Count One:  Section 465.016(1)(e), F.S., by violating Sections 499.01(1) and 499.005(22), F.S., by failing to obtain a prescription drug wholesaler’s permit or a retail pharmacy drug wholesaler’s permit prior to engaging in wholesale distribution of prescription drugs.
Count Two:  Section 465.016(1)(e), F.S., by violation of section 499.005(22)m by failing to obtain a permit prior to operation as a prescription drug repackager as required by section 499.01(1)(b).
(2008-16979) Respondent shall be present. Respondent shall pay a fine in the amount of $2,000 and costs in the amount of $750.97.
 
Respondent was present and sworn in by the court reporter. Respondent was represented by William Furlow.
For the first Settlement Agreement:
Motion: by Ms. Mullins, seconded by Dr. Fallon, to dismiss the case. Motion carried with Dr. Griffin opposed.
(2010-16555) Respondent violated Section 456.072(1)(k), F.S., by failing to perform any statutory or legal
obligation placed upon a licensee. Page 8 of 19
(2010-16555) Respondent shall be present. Respondent shall pay a fine in the amount of $2,000 and costs in the
amount of $80.67.

Franck's and Florida Department of Health Settlement Agreement and Final Order Re: Vitreo Retinal Consultants

A copy of the final order approving the settlement agreement between Franck's and the Florida Department of Health, along with a copy of the settlement agreement dated May 1, 2012, can be viewed here.   This settlement relates to an Medicaid audit on or about July 15, 2008, where a representative of the Florida Department of Health visited Vitreo Retinal Consultants.  During the Medicaid audit inspection, the DOH representative discovered that the Pharmacy was selling and shipping quantities of a non-patient specific prescription drug (Bevacizumab) to Vitreo Retinal Consultants.

Franck's Mentioned in Florida Department of Health Document Showing Verbal Agreement

On the Florida Department of Health, A Best Practice Submission, shows the following with regard to Franck's Pharmacy:

An anonymous donor contacted Dr. Mike Jordan, Executive Director of the Marion County Children’s Alliance, in the summer of 2007 and volunteered to establish a fund of
$4000.00 to assist medically and financially needy children in Marion County. The Marion
County Children’s Alliance is a community organization working toward providing a safe,
healthy and nurturing environment for all children. Dr. Mike Jordan, Marion County
Children’s Alliance Executive Director, contacted Barbara Timmington, RN, Marion County
Health Department School Health Supervisor, to request the assistance of School Nurses
as the referral source for financially and medically needy students. A Marion County
Health Department Standard Operating Procedure was created to determine the method
of implementation of this funding source. No money was transferred or utilized by the
Marion County Health Department staff. A referral request form was created to verify
financial need. The form indicates the medical need and justification of financial need (free
and reduced lunch). The School Nurses complete the form and fax it to the School Health
Supervisor. The School Health Supervisor conducts an investigation into cost, availability
and possible delivery to the student. A verbal agreement with a local pharmacy (Franck’s 
Pharmacy), established a cost effective supply source for medications and durable 
medical supplies with free delivery if needed. The School Health Supervisor obtains the 
lowest quoted price for the requested supply and then contacts the Pharmacy partner to 
advise quote.  The referral form with a prescription copy is faxed to the Pharmacy partner.

Click here to read entire document.

Settlement Agreement Between Franck's and Florida State Department of Health

A draft of the Florida State Department of Health board meeting minutes for April shows more trouble for Paul Franck and Franck Pharmacy.  To read the entire draft of the minutes, click here.  Here are the disciplinary actions against Franck.

TAB 3 DISCIPLINARY CASES – John Truitt, Assistant General Counsel
A. SETTLEMENT AGREEMENT– APPEARANCE REQUIRED CASES
A-1  Paul Wayne Franck, PS 17342, Ocala, FL
  Case No. 2008-17152 – PCP Powers/Jones
Respondent violated:
Count One:  Section 465.016(1)(e), F.S., by violating Sections 499.01(1) and 499.005(22), F.S., by failing to obtain a prescription drug wholesaler’s permit or a retail pharmacy drug wholesaler’s permit prior to engaging in wholesale distribution of prescription drugs.
Count Two:  Section 465.016(1)(e), F.S., by violation of section 499.005(22)m by failing to obtain a permit prior to operation as a prescription drug repackager as required by section 499.01(1)(b).
Respondent shall be present. Respondent shall pay a fine in the amount of $2,000 and costs in the amount of $427.17. Respondent shall complete a 12 hour Laws and Rules CE course.
Respondent was present and sworn in by the court reporter. Respondent was represented by William Furlow.
Motion: by Weizer, seconded by Fallon, to accept the Settlement Agreement. Motion carried.
A-2  Francks Lab, Inc, PH 19761, Ocala, FL
Case No. 2008-16979, 2010-16555 – PCP Powers/Jones, Garcia/Weizer
(2008-16979) Respondent violated:
Count One:  Section 465.016(1)(e), F.S., by violating Sections 499.01(1) and 499.005(22), F.S., by failing to obtain a prescription drug wholesaler’s permit or a retail pharmacy drug wholesaler’s permit prior to engaging in wholesale distribution of prescription drugs.
Count Two:  Section 465.016(1)(e), F.S., by violation of section 499.005(22)m by failing to obtain a permit prior to operation as a prescription drug repackager as required by section 499.01(1)(b).
(2008-16979) Respondent shall be present. Respondent shall pay a fine in the amount of $2,000 and costs in the amount of $750.97.

Respondent was present and sworn in by the court reporter. Respondent was represented by William Furlow.
For the first Settlement Agreement:
Motion: by Ms. Mullins, seconded by Dr. Fallon, to dismiss the case. Motion carried with Dr. Griffin opposed.
(2010-16555) Respondent violated Section 456.072(1)(k), F.S., by failing to perform any statutory or legal obligation placed upon a licensee.
(2010-16555) Respondent shall be present. Respondent shall pay a fine in the amount of $2,000 and costs in the amount of $80.67.
For the second Settlement Agreement:
Motion: by Dr. Fallon, seconded by Ms. Glass, to accept the Settlement Agreement. Motion carried.