Food and Drug Administration (FDA) Recalls Sterile Drugs from Florida Compounding Pharmacy

Tuesday, May 14, 2013

By Lance O. Leider, J.D., The Health Law Firm

There’s been yet another recall from a compounding pharmacy. On May 8, 2013, the U.S. Food and Drug Administration (FDA) sent a warning to doctors and pharmacists to avoid drugs made by The Compounding Shop, based in St. Petersburg, Florida. The recall is due to potential safety concerns. Click here to read the press release from the FDA.

This recall is part of a nationwide crackdown by the FDA and state agencies on compounding pharmacies, setting off a number of recalls across the country. These agencies are trying to prevent another widespread outbreak, like the fungal meningitis outbreak in the fall of 2012. That outbreak was responsible for sickening more than 700 Americans and killing more than 50 others.


Products from The Compounding Shop Recalled Allegedly Due to Lack of Sterility Assurance.

According to the Tampa Bay Times, federal health inspectors allegedly found exposed rust and numerous splattered brownish stains on equipment used to prepare injectable drugs and eye medications. These findings raised concerns that the medications might be contaminated. The Compounding Shop is apparently in the process of notifying customers of the recall.

To read the entire article from the Tampa Bay Times, click here.


Franck’s Compounding Pharmacy in Florida Caused Fungal Growth.

We have previously blogged about the problems encountered by Franck’s pharmacy in Ocala, Florida. It has been accused of distributing eye medications that contained a fungal infection. Click here for the first blog and here for the second blog on this.


Nationwide Crackdown on Compounding Pharmacies.

Since the widespread fungal meningitis outbreak in 2012, compounding pharmacies have fallen under heightened scrutiny. The FDA is beefing up their oversight of compounding pharmacies, and the FDA and state Departments of Health (DOH) have been paying surprise visits to these pharmacies.

In March 2013, two different compounding pharmacies recalled products due to concerns from the FDA. The New Jersey compounding pharmacy, Med Prep Consulting, and Clinical Specialties Compounding in Georgia, both recalled products between March 17, 2013 and March 20, 2013. To read more on this recall, click here.

Common Deficiencies We See in Pharmacy Inspections.

Pharmacies and pharmacists are subject to many types of inspections. These inspections are necessary to determine whether the business and its employees are complying with state and federal laws and regulations. Administrative agencies, such as the Drug Enforcement Administration (DEA), FDA and DOH, have the authority to inspect pharmacies.

With our experience working with pharmacists and pharmacies we’ve seen a number of different inspection deficiencies. These errors may result in a complaint being filed and the beginning of the administrative law process regarding investigations and hearings.

Here are some common deficiencies often found during pharmacy inspections:

1.  Pharmacy technicians not properly identified with name tags and identified as
 pharmacy technicians (as opposed to pharmacists);

2.  Pharmacy technicians not supervised by a pharmacist;

3.  Medication on shelves not properly labeled (including exact number of pills remaining in bottle);

4.  Controlled substances not accurately recorded on appropriate forms; and

5.  Not keeping schedule II inventory and dispensing records separate from schedule III-V records.

Click here to read a blog listing more deficiencies, and your best defense to protect your pharmacy license and pharmacist license.


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 www.TheHealthLawFirm.com.


Comments?

What do you think of the harsher regulations compound pharmacies are now facing? Please leave any thoughtful comments below.


Sources:

Associated Press. “Florida Compounding Pharmacy Recalls Sterile Drugs Due to Contamination Concerns Raised by FDA.” Associated Press. (May 8, 2013). From: http://www.washingtonpost.com/politics/florida-compounding-pharmacy-recalls-sterile-drugs-due-to-contamination-concerns-raised-by-fda/2013/05/08/8da8532e-b810-11e2-b568-6917f6ac6d9d_story.html

Allen, Curtis. “FDA Alerts Health Care Providers of Lack of Sterility Assurance of Drug Products from The Compounding Shop.” U.S. Food and Drug Administration. (May 8, 2013) From: http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm351254.htm

Tillman, Jodie. “St. Petersburg Drug Compounder Recalls Medications.” Tampa Bay Times. (May 8, 2013). From: http://www.tampabay.com/news/health/st-petersburg-drug-compounder-recalls-medications/2119922


About the Author: Lance O. Leider is an attorney with 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 Avenue, Altamonte Springs, Florida 32714, Phone: (407) 331-6620.


Tag Words: administrative complaints, administrative law, attorney administrative law, Board of Pharmacy, Centers for Disease Control and Prevention (CDC), common deficiencies in pharmacy inspection, compounding pharmacy, defense attorney, defense lawyer, Department of Health (DOH), DOH hearing, DOH hearing attorney, drug recall, Florida compounding pharmacy, legal defense for administrative complaints, licensing issues, meningitis, meningitis outbreak, pharmacist, pharmacy, pharmacy attorney, pharmacy investigation, pharmacy lawyer, product recall, U.S. Food and Drug Administration (FDA), health care providers, hospital supply managers, The Compounding Shop, sterile drugs, medical supplies, The Health Law Firm




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5/14/2013

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