By George F. Indest III, J.D., M.P.A., LL.M., Board Certified by The Florida Bar in Health Law
A Lake Mary, Florida, compounding pharmacy recently recalled products due to concerns from the Food and Drug Administration (FDA). The Balanced Solutions Compounding Pharmacy, LLC (Balanced Solutions), a division of Axium Healthcare Pharmacy Inc., announced a voluntary recall of all lots of its sterile unexpired ophthalmic products on April 17, 2013.
Click here to read the press release from Balanced Solutions on the recall.
This recall was issued as the FDA and state agencies step up regulation on compounding pharmacies across the country. These agencies are trying to prevent another widespread outbreak, like the fungal meningitis outbreak in the fall of 2012, which is responsible for 50 deaths. Click here to read a blog on two other compounding pharmacies that issued product recalls in March 2013.
FDA Found “Poor Practices and Conditions” at Compounding Pharmacy.
According to a press release from the FDA, an inspection of Balanced Solutions found “poor practices and conditions” at the facility. This raised concerns about the sterility and possible microbial contamination of the solutions, injectables and ophthalmologic products. These recalled products were distributed nationwide. Balanced Solutions is working to notify customers of the recall. The FDA warns healthcare facilities and healthcare providers that have received sterile products from Balanced Solutions to immediately quarantine the products and send them back to the compounding pharmacy.
As of April 23, 2013, Balanced Solutions has not received any reports of injury or illness associated with the use of its products.
To read the press release from the FDA, 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.
Compounding Pharmacies Under Scrutiny.
Since the widespread fungal meningitis outbreak, compounding pharmacies have fallen under heightened scrutiny. The FDA is beefing up their oversight of compounding pharmacies, and, according to MedPage Today, the FDA and state Department of Health (DOH) agencies have been paying surprise visits to these facilities. The agency recently issued violation notices to 28 compounding pharmacies after inspections turned up mold in clean rooms and workers handling sterile products with their bare hands. Click here to read the MedPage Today article.
Common Deficiencies Found 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 pharmacist;
3. Medication on shelves not properly labeled (including exact number of pills remaining in the 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 recent 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.
What do you think of the harsh regulations compound pharmacies are now facing? Please leave any thoughtful comments below.
Petrochko, Cole. “Compounding Pharmacy Recalls Eye Products.” MedPage Today. (April 22, 2013). From: http://bit.ly/Y1tdwE
Allen, Curtis. “FDA Announces Voluntary Nationwide Recall by Balanced Solutions Compounding Pharmacy.” (April 21, 2013). From: http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm348787.htm
Mooney, Roxie. “Balanced Solutions Compounding Pharmacy, LLC Announces a Voluntary Recall of All Sterile Compounded Products Due to a Lack of Sterility Assurance.” Balanced Solutions Compounding Pharmacy. (April 17, 2013). From: http://www.axiumhealthcare.com/aboutUs/newsRoom/59.pdf
About the Author: George F. Indest III, J.D., M.P.A., LL.M., is Board Certified by The Florida Bar in Health Law. He is the President and Managing Partner of 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 Ave., Altamonte Springs, FL 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), FDA recall
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