Written by Jamin Engel, Pharm.D, MBA, Lead Staff Pharmacist, Sterile Products Coordinator, Sentara RMH | April 15, 2014
The introduction of the United States Pharmacopeia Chapter <797> regulation in 2008 sent and continues to send shock waves through hospital pharmacy departments and other sterile drug preparation settings.
Compounding practices that had been ingrained in the pharmaceutical industry for decades were simply turned upside down, and many pharmacies today remain challenged in their pursuit to successfully comply.
The introduction of the United States Pharmacopeia Chapter <797> regulation in 2008 sent and continues to send shock waves through hospital pharmacy departments and other sterile drug preparation settings.
Compounding practices that had been ingrained in the pharmaceutical industry for decades were simply turned upside down, and many pharmacies today remain challenged in their pursuit to successfully comply.
A far-reaching regulation that impacts nearly every step of compounded sterile preparations, the 60-page document requires everything from documentation of compounding activities and staff competencies to compliance with specific architectural and environmental aspects of the clean room. Staff must undergo intensive and continuous education to accurately interpret the extensive protocols found in the all-encompassing regulation to ensure compliance.
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