Florida Board will Revisit Franck's Lab and Anazao Health Corp cases at Dec. 11-12th meeting

Here is a summary:

A. Chair's Report - Cynthia Griffin, PharmD, Chair
1. Dr. Cynthia Griffin – Short Term Priority List
a. Emergency Rule
b. Re-visit Cases with Sterile Compounding Issues
i.
Franck’s Lab, Inc d/b/a Franck’s Compounding Pharmacy
ii.
Anazao Health Corp
c. Inspector Training
d. Non-Resident Pharmacies Compliance with Florida Law
e. Possible Requirement of FL Pharmacist in Non-Resident Pharmacy
f. USP Standards – Physician Exemptiong. Collaboration with other Professional Boards
h. Proposed Legislation
i. Disciplinary Guidelines
2. Dr. Michele Weizer
a. USP 797 Beyond Use Date (BUD)

To view complete agenda click here

No ruling coming in compounding dispute

No ruling coming in compounding dispute

11th Circuit Grants Joint Motion in Franck's; Oral Argument Removed from Calendar; Exhibits Filed Under Seal

 10/18/2012 ORDER: The parties joint motion to remove appeal from the oral argument calendar is GRANTED. [6692531-2]; Appellees' motion for leave to file certain exhibits under seal GRANTED. [6692505-2]; The parties joint motion to vacate and dismiss appeal as moot is GRANTED. [6692502-2] RB, AJ and JRH 10/18/2012 Notice of filing: Sealed Exhibits granted by Order of 10/18/12.

To view the order, click here

Vermont State Board of Pharmacy Tables Whether to Grant Wells Pharmacy Network (previously Francks Labs) a Non-Residence Pharmacy Licence

The Vermont State Board of Pharmacy August 22, 2012, board meeting minutes reflect the following:

The following applications were tabled until next month until we get more info. 

Wells Pharmacy Network, LLC – Ocala, FL.  It is unclear what the business actually is.  It appears the FDA shut down their compounding.  The Board would like more information about this.  DEA certificate was Francks Labs, not the applicant, Wells Pharmacy Network.   

The entire August 2012 board minutes can be found here.

Frank's Files Answer in Bienick Lawsuit

To view the answer click here.

Insurance Company Sues Franck's Over Death of Polo Horses

On July 19, 2012, the Cincinnati Insurance Company filed a complaint in federal district court in the Middle District of Florida seeking declaratory judgment against Franck's Pharmacy, Inc., Franck's Lab, Inc., Quorum Management Corporation, the management company for the horses, Diamond Insurance Company, and the individuals who owned the horses.  Cincinnati Insurance Company alleges that its policy excluded coverage because the damage causing the death of the horses occurred after the nutritional supplement was compounded and shipped.  The federal complaint can be viewed here.  The underlying basis for the federal cause of action is the state cause of action that Diamond filed against Franck's, Quorum, and the individuals who owned the horses.  The state complaint can be viewed here.

Franck's Pharmacy head opens new health care facility

By Carlos E. Medina
Correspondent

Published: Sunday, September 2, 2012 at 6:30 a.m.

Last Modified: Friday, August 31, 2012 at 5:42 p.m.

Say hello to the new boss of a new health care facility on Southeast 17th Street — and it's the same boss of the recently shuttered Franck's Pharmacy at the same location.

To read more, click here.

FDA Enforcement Report - Week of August 22, 2012

This report contains an overwhelming number of drug recalls from Franck's Pharmacy, which has closed its door (see previous post).    All recall drugs contain the following reason for the recall:

Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs distributed between 11/21/2011 and 05/21/2012 because FDA environmental sampling revealed the presence of microorganisms and fungal growth in the clean room where sterile products were prepared. 

 To view the report with the list of drugs, click here.

Franck's Answer to Complaint in Josephine Bienick Case

To view Franck's answer to Josephine Bienick complaint, click here.

Bienick v. Franck's Lab Inc.,: Discovery Deadlines Set

8/06/2012

13

TELEPHONIC RULE 16 PRELIMINARY PRETRIAL CONFERENCE held on 8/6/2012 before Magistrate Judge Roger B Cosbey. Pla appeared by atty David Farnbauch. Dft appeared by atty Stephen Peters. The 12 Report of the Parties Planning Meeting is approved in all respects (except dispositive motions deadline and establishment of a trial date) and is hereby made an ORDER of the Court. The Summary Judgment deadline in Fed.R.Civ.P. 56(b) SHALL NOT control. Any dispositive motion SHALL brief out in accordance with L.R. 56-1. DISCOVERY DEADLINE is 5/31/2013. Following the close of discovery, unless otherwise ordered by the Court, the assigned District Judge will establish all further deadlines and dates. John Whiteleather appointed as Mediator. Atty Farnbauch to notify Mediator by letter, copy to Atty Peters. Results of the Mediation shall be filed with the Court no later than 10 days before the Final Pretrial Conference. Magistrate Consent forms due by 8/27/2012. (FTR 1st floor.) (mr) (Entered: 08/06/2012)

Drug Manufacturing or Compounding?

Kyle Sampson, former DOJ lawyer, and Brian J.Wesoloski, of Hunton &Williams LLP have written a summary of the Franck's case that can be found here.   These attorneys represent former FDA officials who filed an amicus curiae brief in U.S. v. Franck's, which can be found here and at previous post.

Franck's Pharmacy closes its doors

By Carlos E. Medina
Correspondent

Published: Tuesday, July 31, 2012 at 11:05 a.m.

Last Modified: Tuesday, July 31, 2012 at 11:05 a.m.

The retail location of Franck's Pharmacy closed its doors Tuesday, bringing an end to Paul Franck's connection with his namesake operations.
To continue reading article click here.

Part of Franck's network sold

http://www.ocala.com/article/20120712/ARTICLES/120719895/1005/sports01?p=2&tc=pg

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.

What Happened to James Belden, DVM, in the Franck's case

Pursuant to the June 7, 2011, Florida Board of Veterinary Medicine the following occurred:

BOARD OF VETERINARY MEDICINE

General Business Meeting

June 7, 2011

Page 1

MINUTES

Board of Veterinary Medicine

General Business Meeting

Holiday Inn Resort – The Castle

8629 International Drive

Orlando, FL 32819

June 7, 2011

James Belden, DVM: Case number 2009-021573

Dr. Belden was present at the meeting and was represented by counsel, Daniel Bachi. Dr. Belden was sworn in by the court reporter.

Ms. Lewis was recused due to her participation on the probable cause panel.

Ms. Henderson presented the case as a settlement stipulation. Ms. Henderson advised the board the administrative complaint alleges the Respondent administered Stanzolol and Butorphanol without adhering to statutory record keeping requirements. Ms. Henderson advised the board the department recommended a fifteen hundred dollar ($1,500.00) fine, one thousand nine hundred and sixty two dollars and eighty five cents ($1,962.85) in costs and six (6) months probation.

After discussion by the board the following motion was made.

MOTION: Dr. Maxwell made a motion to accept the settlement stipulation as presented.

SECOND: Dr. Helm seconded the motion and the motion passed unanimously.

Another Article Suggest that the FDA May Start Inspecting More Compounding Pharmacies

Another article entitled Report: Compounding Regulatory Issues Come to Light After 'Urgent' Recall by Alexander Gaffney  suggest that the FDA may start inspecting more compounding pharmacies.  The article states:

Not all pharmacists have the same level of skills and equipment,” said Rear Admiral Steven Galson, deputy director of the Center for Drug Evaluation and Research at FDA and the US’s acting surgeon general. “In some cases, compounders may lack sufficient controls—equipment, training, testing, or facilities—to ensure product quality or to compound complex products such as sterile or modified release drugs.”

Because the majority compounds are made-to-order and exist in small quantities, many current good manufacturing practices such as lot and batch testing are impossible. “The quality of the drugs that these pharmacists compound is uncertain and these drugs pose potential risks to the patients who take them,” concluded Galson.

However, large-volume suppliers such as Franck’s are frequently making batches of products in amounts suitable for quality testing, creating tensions between FDA and the compounders, report The Star-Banner.

In response, FDA is starting to leverage its oversight authority towards companies “whose activities raise the kinds of concerns normally associated with a drug manufacturer and whose compounding practices result in significant violations of” The Federal Food, Drug and Cosmetic Act, said Galston in previous testimony before Congress.

To read the entitle article, click here.

Mistakes by Franck's Pharmacy put spotlight on FDA's limited oversight of compounding

Story appears at Ocala.com:

Mistakes by Franck's Pharmacy put spotlight on FDA's limited oversight of compounding

By Carlos E. Medina
Correspondent

Published: Saturday, June 2, 2012 at 7:16 p.m.

Last Modified: Saturday, June 2, 2012 at 7:16 p.m.

The recent recalls of sterile products made by Franck's Pharmacy in Ocala, as well as its position as a high-volume drug maker, are aspects of the compounding pharmacy business that has troubled federal regulators for years.

The Federal Drug Administration, which is tasked with ensuring the safety of drugs in the nation, has limited oversight over compounding pharmacies like Franck's because of a 74-year-old law that allows pharmacists to “compound,” or create unique variations of existing drugs for patients.

But that law, and the FDA's lack of authority over the practice of compounding, may draw new scrutiny in the wake of a well-publicized mistake at Franck's that killed two dozen prized polo ponies in 2009 and the production of contaminated solutions that reportedly damaged the vision of 33 eye surgery patients in recent months.

Compounding pharmacies make medications and other medical preparations from scratch. They cannot make straight copies of commercially available medications and can only make medications when they are ordered by a doctor.

These pharmacies fine tune drugs to a patient's need, whether that means creating a specific dosage not offered by a manufacturer or a liquid form of a drug only available in pill form.

Historically, compounding was the way most people got their prescription medicines. As recently as the 1960s pharmacists routinely ground and mixed compounds in their stores to make the medicines prescribed by local doctors.

The age of mass-produced drugs is a phenomenon of the last fifty years. The availability of those mass-produced drugs eventually led most pharmacies only to dispense ready-made medicines.

To read the rest of the story, click here.

Urgent: Franck's Compounded Prescription Recall

Urgent: Compounded Prescription Recall

Contact
Consumer:
352-690-6773

Media:
352-622-2913

FOR IMMEDIATE RELEASE - May 25, 2012 - This is to inform you of a product recall involving:

All Sterile Human and Veterinary Prescriptions Distributed by Franck’s Pharmacy From November 21, 2011 to May 21, 2012.

This recall is being initiated after the U.S. Food and Drug Administration ("FDA") notified us that environmental sampling of our clean room revealed the presence of microorganisms and fungal growth. In light of the FDA’s findings and the resulting possible risk of infection, we have decided that it is imperative that we recall all human and veterinary sterile preparations that have left our control. Accordingly, we are extending the recall to all sterile preparations we have provided to you since November 21, 2011.
If any of these sterile preparations remains under your control, it is essential that you do not use them and that employing appropriate practices, you destroy all such sterile preparations and all remaining portions of such sterile preparations.
This recall should be carried out to the User/Physician level. Your assistance is appreciated and necessary to prevent patient illness. Physicians should be advised to review and evaluate their patient records to determine if any adverse events may have resulted from use of the recalled products. Please report any adverse events to Franck’s Compounding Pharmacy and FDA’s MedWatch program.
FDA will expect us to be able to account for all of the sterile preparations subject to this recall. As a result, it is critically important that you read, complete, and return the enclosed response form as soon as possible.
We will update you with any relevant details as they become available to us. If you have any questions please call us at 352-690-6773, Monday through Friday from 9AM to 5 PM, EST.
This recall is being made with the knowledge of the Food and Drug Administration.

Breaking News: Franck's Ceases Sterile Compounding Service

Franck's ceases sterile compounding service

The following appears at Ocala.com:

By Carlos E. Medina
Correspondent

Published: Wednesday, May 23, 2012 at 6:01 p.m.

Last Modified: Wednesday, May 23, 2012 at 6:01 p.m.

Franck's Pharmacy announced Wednesday it will stop producing sterile compounds at its Ocala lab and also confirmed the layoffs of several employees.

The decisions come after the Centers for Disease Control and Prevention warned doctors to avoid sterile products made by the pharmacy. The warning, issued on May 3, came after two ophthalmic products made by Franck's were suspected in causing at least 33 cases of fungal eye infections.

The cases were spread over California, Colorado, Illinois, Indiana, Louisiana, Nevada and New York, and in many cases the patients suffered partial to severe vision loss and required additional eye surgery, according to the CDC report.

The products involved are injected directly into the eye.

Tests on sealed bottles and syringes of the preparations conducted by the CDC confirmed the presence of several bacterial and fungal contaminants.

Initially, Franck's said it would continue to compound sterile products after identifying and fixing the cause of the contamination. The cause was not disclosed.

On Wednesday, Franck's business manager, Stephen Floyd, announced the change in direction via email.

"Franck's has made the difficult but necessary decision to cease production of sterile compound products and is turning our focus to the non-sterile side of the business. This change necessitated a reduction in force," the email stated.

The company did not say how many people were laid off or how many people it employs. In 2007 the company said it had more than 75 employees. It was not clear what portion of Franck's business came from sterile compounding."We greatly value and appreciate our employees and are providing support to them to help bridge the gap during their transition," according to the email.

Specifics of the support were not disclosed.

Franck's will continue to compound non-sterile human and veterinary medicine. The retail pharmacy, home infusion pharmacy and wellness store will continue normal operation.

It is the second time the company has faced claims of improper compounding. In 2009, Franck's veterinary division improperly mixed a nutritional supplement for 21 polo horses that contained far more selenium than required. The horses all died.

That incident prompted the Food and Drug Administration to try to stop Franck's from compounding veterinary medicine and supplements. Franck's eventually prevailed in U.S. District Court.

The FDA as well as the Florida Department of Health are investigating the latest case.

Compound pharmacies make medications and other medical preparations from scratch. They cannot make commercially available medications and can only make medications when they are ordered by a doctor.

These pharmacies fine tune drugs to a patient's need, whether it be for a specific dosage not offered by a manufacturer or a liquid form of a drug only available in pill form.

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.