Laminated Particleboard not a Great Idea for Sterile Compounding, FDA says in Warning Letter to a Texas Based Compounding Pharmacy!!

Posted 22 July 2014 By Alexander Gaffney, RAC Pharmaceutical compounders, take note: The US Food and Drug Administration (FDA) wants you to stop using laminated particleboard in your aseptic processing areas.That nugget of wisdom comes by way of a January 2014 Warning Letter to a Texas-based pharmaceutical compounding pharmacy, Home Intensive Care Pharmacy, released to the public on 22 July 2014.In its letter, FDA alleges that the company violated numerous federal regulations, including that it failed to receive "valid prescriptions for individually-identified patients" prior to compounding the drugs. FDA has cracked down on that practice in recent months, issuing 13 Warning Letters citing the deficiency since March 2013. In contrast, FDA issued just two letters citing the issue in the five years preceding that letter.But more concerning to FDA, it said, was the unsanitary conditions under which the drugs were allegedly compounded. "[Y]our sterile drug products are prepared, packed, or held under insanitary conditions whereby they may have been contaminated with filth, or whereby they may have been rendered injurious to health," the agency wrote in its letter. - See more at: http://www.raps.org/regulatory-focus/news/2014/07/19801/FDA-Warning-for-Particleboard-Workbenches/#sthash.dV3wErRf.dpuf