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Abstract:  Dispensing compounded sterile injectable drug preparations that contain particulates can have serious patient-safety implications. While there is a lack of controlled human studies to demonstrate the clinical concerns that particles can be carriers for microbiological contamination, they have been shown to potentially block blood vessels. Anecdotal studies found that foreign body emboli and granulomas are the most common result of particulate matter present in intravenous solutions. The compounding of absolutely particle-free injectable preparations is nearly impossible under real-life conditions. Hence, inspection of each filled and sealed compounded injectable drug before it is labeled and dispensed is mandatory. To avoid a noncompliance observation, this article aims to outline the regulatory expectations, visual inspector training and qualification program, and adequate visual-inspection procedures and equipment.

Related Keywords: Amy Summers, PharmD, BCSCP, compounded sterile preparations, sterile injectable drug preparations, particulates, contaminants, drug safety, microbiological contamination, foreign body emboli, granulomas, United States Pharmacopeia Chapter <790>, regulation, regulatory expectations, visual inspection test methods, manual visual inspection, automated visual inspection, visual inspectors, visual inspection training, inspection equipment

Related Categories: LEGAL, PARENTERALS, STERILE PREPARATIONS, QUALITY CONTROL, UNITED STATES PHARMACOPEIA CONVENTIONS, ADVERSE DRUG EVENTS

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