Automated compounding enhances safety and regulatory compliance

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By Niels Erik Hansen, Ph.D. In January, the Department of Health and Human Services’ Office of the Inspector General (OIG) issued a report about hospitals’ use of standalone compounding pharmacies to produce compounded sterile preparations (CSPs). The study was spurred by concerns about the quality of CSPs following the 2012 meningitis outbreak caused by contaminated... Read more

Categories: Automation | Blog | Regulatory | Safety
Tags: Drug Quality and Security Act | Manual Compounding | RIVA | Safety | Sterile Compounding

Recent Regulatory Actions: Focus on Quality in Compounding

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by Craig A. Boyce , RPh Over the past month, a number of regulatory changes have occurred surrounding aseptic and sterile compounding.  Some of the significant regulatory actions include:  FDA release of the cGMP Interim Guidance for Human Drug Compounding Outsourcing Facilities Under Section 503B of the FD&C Act (7-1-2014)  Massachusetts passage and signing of... Read more

Categories: Blog | Regulatory | Safety
Tags: Drug Quality and Security Act | Manual Compounding | RIVA | Safety | Sterile CompoundingAseptic | cGMP | FDA | IV compounding | Manual Compounding | QbD | Quality by Design | Sterile Compounding | USP 795 | USP 797
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