USP Regulatory Updates Delayed on Appeal

10/29/19
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. More

Understanding the Potential Impacts of USP <825> for Radiopharmaceutical Compounding

09/12/19
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... More

Maintaining the Integrity of High Consequence Spaces

08/19/19
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. More

Facing the Challenges of the Plasma Market

06/26/19
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.* More