Judge Accepts Gary Osborn and Apothecure Pleas of Gulity

The judge in the Northern District of Oklahoma has accepted Gary Osborn and Apothecure plea of guilty.  The orders accepting the plea can be viewed here and here.

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.

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.

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