A Florida compounding pharmacy will recall its sterile drug products because the Food and Drug Administration (FDA) fears they may be contaminated.
The latest recall covers 91 batches of sterile product made at Balanced Solutions Compounding Pharmacy of Lake Mary, a division of Axium Healthcare Pharmacy Inc. According to a spokeswoman, the voluntary recall involves sterile non-expired drug products. There have been no reports of illness or injury.
The FDA is encouraging all health care facilities who have received injectable sterile products from the company to quarantine their supplies and follow the company’s recall instructions, reports the Associated Press.
The majority of the recall involved injectable drugs. An FDA inspection uncovered “poor practices and conditions” which may have allowed bacterial contamination. For example, a sample of chromium chloride injections uncovered gram-negative bacteria.
The FDA began inspecting state compounding facilities after a meningitis outbreak last year sickened over 720 and killed 53 people due to contaminated preparations. Those individuals had been injected with a steroid contaminated with fungal meningitis.
A recent FDA sweep of 31 compounding pharmacy facilities revealed problems at 30 pharmacies which received negative inspection reports.
As a result, the U.S. Senate has proposed that federal safety inspections and manufacturing standards be established. The draft bill would put large compounding pharmacies under direct FDA oversight and take them out of state jurisdiction.
The Senate bill is designed to clear up the uncertainty that exists between a patchwork of state regulations and federal law.
With about 7,700 pharmacies in Florida, the Florida Department of Health (DOH) recently issued a voluntary survey for pharmacists to complete. Ocala.com reports 90 percent of pharmacists ignored the request which is disturbing considering recent compounding failures in Florida:
- The Florida Department of Health had to suspend the license of Rejuvi Pharmaceuticals, a Boca Raton compounding pharmacy. The state said there was an immediate danger of contaminated products.
- Another compounding pharmacy in Ocala, Franck’s Pharmacy, announced last year it would stop producing sterile compounds after three cases of fungal eye infections were tracked to two ophthalmic products made by Franck’s Pharmacy.
Currently, a licensed pharmacist in Florida does not have to have any accreditation to compound medications.