Franck's Pharmacy Announces Sterile Compounding Service Shutdown; Recalls Compunding Prescriptions

Franck's Pharmacy, Inc. located in Ocala, Florida, recently issued a recall for its compounded prescriptions. The prescriptions impacted by this recall include all sterile human and veterinary compounded prescriptions distributed by Franck’s Pharmacy from November 21, 2011 to May 21, 2012. Franck's Pharmacy made the announcement on the company's website on May 24, 2012. To see the recall click here.
Recall Based on FDA Findings of Fungal Growth in Pharmacy's Clean Room.
The recall was allegedly prompted by action by the U.S. Food and Drug Administration (FDA). The FDA notified Franck's Pharmacy that environmental sampling of the pharmacy's clean room revealed the presence of microorganisms and fungal growth. Because of the FDA's findings, Franck's Pharmacy decided to recall its sterile compounds to prevent any possible risk of infection to patients.
Franck's Pharmacy Urges Physicians to Assist in Recall Efforts.
Franck's Pharmacy is seeking the assistance of physicians in alerting patients who may be impacted by the recall. Franck's Pharmacy is also advising physicians to review and evaluate patient records to determine if any adverse events may have resulted from use of the recalled products. Any adverse events should be reported to Franck’s Pharmacy and the FDA’s MedWatch program.
Franck's Pharmacy Ceases Production of Sterile Compounds.
Franck's Pharmacy also announced that it will stop producing sterile compounds at its Ocala lab facility for the present. Franck's Pharmacy made the announcement via e-mail on May 23, 2012. The e-mail also confirmed that several employees had been laid off. Allegedly, these employees were terminated due to the sterile compounding shutdown. Franck's Pharmacy will continue to compound non-sterile human and veterinary medicine.
Franck's Pharmacy Recently Linked to Eye Infection Outbreak.
Franck's Pharmacy decided to cease sterile compounding after the Centers for Disease Control and Prevention (CDC) issued a warning urging physicians not to use sterile products made by Franck's Pharmacy. The warning was issued after the CDC traced a rare fungal eye infection back to the pharmacy. The infection impacted at least 30 patients who allegedly had undergone some type of eye procedure in which Franck's Pharmacy products were used. For additional information on this, click here.
Prior Deaths of 30 Polo Ponies.
In an earlier unfortunate incident in 2009, Franck's Pharmacy's compounding of veterinarian prescriptions allegedly led to the deaths of approximately 30 expensive polo ponies here in Florida. Click here for details. In the aftermath of that case, the FDA attempted to prevent Franck's Pharmacy from any further compounding of pharmaceuticals for veterinary purposes. The FDA eventually lost the case heard by the U.S. District Court, Middle District of Florida, which ruled in favor of Franck's Pharmacy. The decision can be seen here.
Contact Health Law Attorneys Experienced in Representing Pharmacies and Pharmacists.
The Health Law Firm represents pharmacists and pharmacies in investigations, regulatory matters, licensing issues, litigation, 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 http://www.thehealthlawfirm.com/.
Sources Include:
Franck, Paul. "Urgent: Compounding Prescriptions Recall." Franck's Pharmacy. Press Release. (May 23, 2012). From
http://www.francks.com/
Medina, Carlos E. "Franck's Ceases Sterile Compounding Service." Ocala.com. (May 23, 2012) From
http://www.ocala.com/article/20120523/ARTICLES/120529872/-1/entertainment02?template/

Florida Pain Clinics Continue to be a Target for Law Enforcement

Florida pain clinics began to really feel the impact of becoming law enforcement's newest target about a year ago. This was based in part on televison "magazine" shows and investigative reporters' shows and articles publicizing many abuses by patients who were "doctor shopping" and physicians who were allegedly "over-prescribing."
Regulations increased, and lawmakers enacted severe penalties for doctors accused of over-prescribing, including prison sentences. Most physicians were banned from dispensing drugs in their offices, and the governor created a Florida drug "strike team" whose mission was to eliminate any pain clinics that were found to be suspicious. The Florida Surgeon General and the Board of Medicine made announcements about the "crackdown" on "over-prescribing."
According to the Orlando Sentinel, since the implementation of the new pain management and prescribing laws, the Florida strike force has made thousands of arrests and seized millions of pills in an effort to curb alleged over-prescribing and prescription drug abuse.
Now, after a year of strict regulations and punishments for Florida's pain management physicians, pain clinics, pharmacists and pharmacies, the state is continuing to attack the pain management profession. While the planned measures aren't as harsh as those that began a year ago, such as installing prescription drop boxes at police stations, they continue to place a stigma on the practice of pain management - a medical subspecialty with the purpose of alleviating the pain of suffering patients.
In addition, patients with true medical need for prescription pain medications are finding it increasingly difficult to even locate a physician to treat them, given the stigma and the possibility of arrest and prosecution. Medical ethicists have commented on this problem, an issue that will become increasingly problematic for the foreseeable future.
If you work in the pain management industry (physician, pharmacist, pain clinic, pharmacy, etc.) and feel that your medical license, pharmacy license, or business is at risk or is under investigation by the Drug Enforcement Administration (DEA) or Florida Department of Health (DOH), please visit our website at http://www.thehealthlawfirm.com/ for more information about this.

Florida Pain Clinics Continue to be Targeted by Law Enforcement

Pain clinics in Florida began to feel the pressure of becoming law enforcement's newest target about one year ago. This was based in part on televison "magazine" shows and investigative reporters' shows and articles publicizing many abuses by patients who were "doctor shopping" and physicians who were allegedly "over-prescribing."

More regulations were enacted. Lawmakers began to approve severe penalties for doctors accused of over-prescribing, including prison sentences. Most physicians were banned from dispensing drugs in their offices. A Florida drug "strike team" was created whose mission was to eliminate any pain clinics that were found to be suspicious. The Florida Surgeon General and the Board of Medicine made announcements about the "crackdown" on "over-prescribing."

Since the implementation of the new pain management and prescribing laws, the Florida strike force has made thousands of arrests and seized millions of pills in an effort to curb alleged over-prescribing and prescription drug abuse, according to the Orlando Sentinel.

After a year of strict regulations and punishments for Florida's pain management physicians, pain clinics, pharmacists and pharmacies, the state is continuing to attack the pain management profession. While the planned measures aren't as harsh as those that began a year ago, such as installing prescription drop boxes at police stations, they continue to place a stigma on the practice of pain management - a medical subspecialty with the purpose of alleviating the pain of suffering patients.

In addition, patients with true medical need for prescription pain medications are finding it increasingly difficult to even locate a physician to treat them, given the stigma and the possibility of arrest and prosecution. Medical ethicists have commented on this problem, an issue that will become increasingly problematic for the foreseeable future.

If you work in the pain management industry (physician, pharmacist, pain clinic, pharmacy, etc.) and feel that your medical license, pharmacy license, or business is at risk or is under investigation by the Drug Enforcement Administration (DEA) or Florida Department of Health (DOH), please visit our website at www.TheHealthLawFirm.com for more information about this.