We’ve recently shared communications about updates to existing United States Pharmacopeia Convention (USP) Chapters surrounding pharmaceutical compounding regulations as well as a new regulation for handling hazardous drugs in health care facilities. The new and updated rules were scheduled to go into effect Dec. 1.
In recent years, there has been a significant amount of regulatory focus on compounding pharmacies. Specifically, regulatory agencies want to establish guidance for quality and sterility of products with the goal of providing the highest standard of finished product for patient administration. While new guidelines were created in various USP chapters, there has not been guidance for every aspect of compounding pharmacy practices. One notable exclusion was radiopharmaceutical compounding and...
There are areas in health care facilities that require specific environmental controls and operational procedures to ensure safety, such as patient isolation rooms, surgical suites and compounding areas. Environmental or procedural breaches in these “high consequence” spaces may lead to adverse events, causing harm, or even death, for pharmacists, caregivers and patients.
Plasma-derived therapeutics are part of a complex dynamic of global supply chain economics and clinical contributing factors, all of which can affect the ability to obtain the product needed for patient care. Immunoglobulin (Ig), the main driver in current plasma manufacturing, has experienced double-digit growth within North American markets, leading to an increased demand the manufacturing community has been challenged to meet.*
Please enjoy our Winter Reading List, a compilation of our most popular newsletter stories and blogs about clinical and care delivery, research and insights and supply chain issues from 2021. We hope it helps spark inspiration for the new year.
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