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sterility issues 2 articles

FDA cracks down on compounding pharmacies, issuing warning letters for unsanitary practices

The Food and Drug Administration (FDA) is coming down hard on compounding pharmacies, issuing warning letters for unsanitary conditions and producing drugs without individual prescriptions. The action comes four months after congress passed the Drug Quality and Security Act, which puts compounding pharmacies that outsource their products under FDA oversight instead of being governed by state pharmacy boards like traditional pharmacies. Nora Apothecary and Alternative Therapies, Pallimed Solutions Inc., and Wedgwood Village Pharmacy received warning letters outlining sterility issues with facility procedures from visible sterile drug contaminants to inadequate clean rooms and monitoring programs. The FDA’s oversight into compounding pharmacies ... Read More

FDA inspection of laboratory uncovers microbial contamination, results in drug recalls

A recent Food and Drug Administration (FDA) inspection of Front Range Laboratories in Loveland, Colo., found microbial contamination in products intended to be sterile and has led to several recalls. If these tainted drug products are administered to patients, they could cause serious and potentially life-threatening infections. Front Range Laboratories has contracts with other drug companies, including JCB Laboratories and Wellness Pharmacy Inc. The following JCB Laboratories compounded products are subject to the recall: Sodium thiosulfate, 25% (250 mg/mL); Sodium citrate, 4% solution for injection; Sodium citrate, 4% with gentamicin 320 mcg/mL solution for injection; and Acetylcysteine, 20% solution for ... Read More